Monday,

January 14, 2002

Part II

Environmental

Protection Agency

40 CFR Parts 9, 141, and 142

National Primary Drinking Water

Regulations: Long Term 1 Enhanced

Surface Water Treatment Rule; Final Rule

1812 Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 9, 141, and 142

[WH–FRL–7124–2]

RIN 2040–AD18

National Primary Drinking Water

Regulations: Long Term 1 Enhanced

Surface Water Treatment Rule

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: In this document, EPA is

finalizing the Long Term 1 Enhanced

Surface Water Treatment Rule

(LT1ESWTR). The purposes of the

LT1ESWTR are to improve control of

microbial pathogens, specifically the

protozoan Cryptosporidium, in drinking

water and address risk trade-offs with

disinfection byproducts. The rule will

require systems to meet strengthened

filtration requirements as well as to

calculate levels of microbial inactivation

to ensure that microbial protection is

not jeopardized if systems make changes

to comply with disinfection

requirements of the Stage 1 Disinfection

and Disinfection Byproducts Rule

(DBPR). The LT1ESWTR applies to

public water systems that use surface

water or ground water under the direct

influence of surface water and serve

fewer than 10,000 persons. The

LT1ESWTR builds upon the framework

established for systems serving a

population of 10,000 or more in the

Interim Enhanced Surface Water

Treatment Rule (IESWTR). This rule

was proposed in combination with the

Filter Backwash Recycling Rule (FBRR)

in April 2000.

DATES: This regulation is effective

February 13, 2002. As discussed in the

supplementary information section and

consistent with sections 1412(b)(10) and

1445 of SDWA, regulated entities must

comply with this rule starting March 15,

2002. For judicial review purposes, this

final rule is promulgated as of 1 p.m.

eastern time on January 14, 2002.

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 (W–99–10, Final

Long Term 1 Enhanced Surface Water

Treatment Rule) 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., Eastern

Time, Monday through Friday,

excluding legal holidays. For access to

docket materials or to schedule an

appointment please call (202) 260–3027.

FOR FURTHER INFORMATION CONTACT: For

technical inquiries contact Tom Grubbs

at 1200 Pennsylvania Avenue, NW.,

MC4607, Washington, DC 20460, (202)

564–5262. 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.

SUPPLEMENTARY INFORMATION:

Regulated Entities

Entities potentially regulated by the

LT1ESWTR are public water systems

(PWSs) that use surface water or ground

water under the direct influence of

surface water (GWUDI) and serve fewer

than 10,000 persons. Regulated

categories and entities include:

Category Examples of regulated entities

Industry ..................... PWSs that use surface water or

GWUDI.

State, Local, Tribal or

Federal Governments.

PWSs that use surface water or

GWUDI.

This table is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

regulated by the LT1ESWTR. This table

lists the types of entities that EPA is

now aware could potentially be

regulated by this 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

definition of PWS in § 141.2 of title 40

of the Code of Federal Regulations and

applicability criteria in § 141.501 of

today’s final rule. If you have questions

regarding the applicability of the

LT1ESWTR to a particular entity,

consult the person listed in the

preceding FOR FURTHER INFORMATION

CONTACT section.

List of Abbreviations Used in This

Document:

AWWA American Water Works

Association

AWWSCo American Water Works

Service Company

°C Degrees Celsius

CCP Composite Correction Program

CCR Consumer Confidence Report

CDC Centers for Disease Control

CFR Code of Federal Regulations

CFSII Continuing Survey of Food

Intakes by Individuals

COI Cost of Illness

CPE Comprehensive Performance

Evaluation

CTA Comprehensive Technical

Assistance

DAF Dissolved Air Flotation

DBP Disinfection Byproducts

DBPR Disinfectants and Disinfection

Byproduct Rule

EPA Environmental Protection Agency

ESWTR Enhanced Surface Water

Treatment Rule

FACA Federal Advisory Committee

Act

FBRR Filter Backwash Recycle Rule

FR Federal Register

gpm Gallons per Minute

GWUDI Ground Water Under Direct

Influence of Surface Water

HAA5 Haloacetic Acids

(Monochloroacetic, Dichloroacetic,

Trichloroacetic, Monobromoacetic

and Dibromoacetic Acids)

HRRCA Health Risk Reduction and

Cost Analysis

ICR Information Collection Request

IESWTR Interim Enhanced Surface

Water Treatment Rule

LT1ESWTR Long Term 1 Enhanced

Surface Water Treatment Rule

MCLG Maximum Contaminant Level

Goal

M-DBP Microbial and Disinfectants/

Disinfection Byproducts

NDWAC National Drinking Water

Advisory Council

NPDWR National Primary Drinking

Water Regulation

NODA Notice of Data Availability

NTTAA National Technology Transfer

and Advancement Act

NTU Nephelometric Turbidity Units

O&M Operation and Maintenance

OMB Office of Management and

Budget

PBMS Performance-based

Measurement System

PRA Paperwork Reduction Act

PWS Public Water System

PWSS Public Water Supply

Supervision

RFA Regulatory Flexibility Act

RIA Regulatory Impact Analysis

SAB Science Advisory Board

SBA Small Business Administration

SBAR Small Business Advocacy

Review

SBREFA Small Business Regulatory

Enforcement Fairness Act of 1996

SDWA Safe Drinking Water Act

SDWIS Safe Drinking Water

Information System

SWTR Surface Water Treatment Rule

TTHM Total Trihalomethanes

UMRA Unfunded Mandates Reform

Act

WTP Willingness to Pay

Table of Contents

I. Summary

Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations 1813

A. Why is EPA Promulgating the

LT1ESWTR?

B. What is Cryptosporidium?

C. What are the Health Concerns

Associated with Cryptosporidium?

D. Does this Regulation Apply to My Water

System?

E. How is the EPA Regulating

Cryptosporidium in the LT1ESWTR?

F. What Other Requirements are Included

in this Rule?

G. How Will this Regulation Protect Public

Health?

II. Background

A. What is the Statutory Authority for the

LT1ESWTR?

B. What is the Regulatory History for the

LT1ESWTR?

C. How were Stakeholders Involved in

Developing the LT1ESWTR?

D. What did the April 10, 2000 Proposal

Contain?

III. Discussion of the Final Rule

A. What Level of Cryptosporidium

Removal does the LT1ESWTR Require?

B. What Combined Filter Effluent

Requirements does the LT1ESWTR

Contain?

C. What Individual Filter Monitoring

Requirements does the LT1ESWTR

Contain?

D. What Disinfection Profiling and

Benchmarking Requirements does the

LT1ESWTR Contain?

E. How does the Definition of Ground

Water Under the Direct Influence of

Surface Water Change?

F. What Additional Requirements does the

LT1ESWTR Contain for Unfiltered

Systems?

G. What does the LT1ESWTR Require for

Finished Water Reservoirs?

H. What is the Compliance Schedule for

the LT1ESWTR?

I. What Public Notification and Consumer

Confidence Report Requirements are

Contained in the LT1ESWTR?

IV. State Implementation

A. What Special State Primacy

Requirements does the LT1ESWTR

Contain?

B. What State Recordkeeping Requirements

does the LT1ESWTR Contain?

C. What State Reporting Requirements does

the LT1ESWTR Contain?

D. How Must a State Obtain Interim

Primacy for the LT1ESWTR?

V. Economic Analysis (Health Risk

Reduction and Cost Analysis)

A. What are the Costs of the LT1ESWTR?

B. What are the Household Costs of the

LT1ESWTR?

C. What are the Benefits of the

LT1ESWTR?

D. What are the Incremental Costs and

Benefits?

E. Are there Benefits From the Reduction

of Co-Occurring Contaminants?

F. Is there Increased Risk From Other

Contaminants?

G. What are the Uncertainties in the Risk,

Benefit, and Cost Estimates for the

LT1ESWTR?

H. What is the Benefit/Cost Determination

for the LT1ESWTR?

VI. Other Requirements

A. Regulatory Flexibility Act (RFA), as

amended by the Small Business

Regulatory Enforcement Fairness Act of

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

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. Consultations with the Science

Advisory Board, National Drinking

Water Advisory Council, and the

Secretary of Health and Human Services

I. Executive Order 13132: Executive Orders

on Federalism

J. Executive Order 13175: Consultation and

Coordination With Indian Tribal

Governments

K. Likely Effect of Compliance with the

LT1ESWTR on the Technical, Financial,

and Managerial Capacity of Public Water

Systems

L. Plain Language

M. Congressional Review Act

N. Executive Order 13211: Actions

Concerning Regulations That

Significantly Affect Energy Supply,

Distribution, or Use

VII. References

I. Summary

A. Why Is EPA Promulgating the

LT1ESWTR?

The Safe Drinking Water Act (SDWA)

requires EPA to set enforceable

standards to protect public health from

contaminants that may occur in

drinking water. As explained in more

detail in the April 10, 2000 proposal for

today’s rule (65 FR 19046), EPA has

determined that the presence of

microbiological contaminants is a

substantial health concern. If finished

water supplies contain microbiological

contaminants, disease outbreaks may

result. Disease symptoms may include

diarrhea, cramps, nausea, jaundice,

headaches, and fatigue. EPA has set

enforceable drinking water treatment

techniques to reduce the risk of

waterborne disease outbreaks.

Treatment technologies such as

filtration and disinfection can remove or

inactivate microbiological

contaminants.

Physical removal is critical to the

control of Cryptosporidium because it is

highly resistant to standard disinfection

practices. Cryptosporidiosis, the

infection caused by Cryptosporidium,

may manifest itself as a severe infection

that can last several weeks and may

cause the death of individuals with

compromised immune systems. In 1993,

Cryptosporidium caused over 400,000

people in Milwaukee, WI to experience

intestinal illness. More than 4,000 were

hospitalized and at least 50 deaths were

attributed to the cryptosporidiosis

outbreak. There have also been

cryptosporidiosis outbreaks in Nevada,

Oregon, and Georgia over the past

several years.

In 1990, the EPA Science Advisory

Board (SAB) 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

(USEPA/SAB, 1990). The LT1ESWTR

addresses this challenge by improving

the control of a wide range of microbial

pathogens in public drinking water

systems and, specifically addressing

Cryptosporidium for the first time in

systems serving fewer than 10,000

people.

B. What Is Cryptosporidium?

Cryptosporidium is a protozoan

parasite found in humans, other

mammals, birds, fish, and reptiles. It is

common in the environment and widely

found in surface water supplies (Rose,

1998; LeChevallier and Norton, 1995;

Atherholt et al., 1998; EPA, 2000a). In

the infected animal, the parasite

multiplies in the gastrointestinal tract.

The animal then excretes oocysts of the

parasite in its feces. These oocysts are

tiny spore-like organisms 4 to 6 microns

in diameter (too small to be seen

without a microscope), which carry

within them the infective sporozoites.

The oocysts of Cryptosporidium are very

resistant to adverse factors in the

environment and can survive dormant

for months in cool, dark conditions such

as moist soil, or for up to a year in clean

water. When ingested by another animal

they can transmit the cryptosporidiosis

disease and start a new cycle of

infection. Cryptosporidiosis is primarily

a waterborne disease, but has also been

transmitted by consumption of

contaminated food, unhygienic diaper

changing practices (and other person-toperson contact), and contact with young

farm animals.

Cryptosporidium oocysts are not

easily killed by commonly-used

disinfectants. They are relatively

unaffected by chlorine and chloramines

in the concentrations that are used for

drinking water treatment. Oocyst

infectivity appears to persist under

normal temperatures, although oocysts

may lose infectivity if sufficiently

cooled or heated (USEPA, 2000a).

Research indicates that oocysts may

remain viable even after freezing (Fayer

and Nerad, 1996).

1814 Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations

C. What Are the Health Concerns

Associated With Cryptosporidium?

When someone is infected with

Cryptosporidium, they may contract

cryptosporidiosis, a disease which can

cause diarrhea, stomach cramps, nausea,

loss of appetite, and a mild fever.

Cryptosporidium has become

recognized as one of the most common

causes of waterborne disease (drinking

and recreational) in humans in the

United States. The parasite is found in

every region of the United States and

throughout the world (www.cdc.gov/

ncidod/dpd/parasites/cryptosporidiosis/

factsht_cryptosporidiosis.htm). The

symptoms of cryptosporidiosis begin an

average of seven days after infection.

Persons with a normal, healthy immune

system can expect their illness to last for

two weeks or less, with constant or

intermittent diarrhea. However, even

after symptoms cease, an individual can

still pass Cryptosporidium in the stool

for up to two months, and may be a

source of infection for others.

Cryptosporidiosis is not treatable with

antibiotics, so prevention of infection is

critical. People with weakened immune

systems (those with HIV/AIDS, on

cancer chemotherapy, or who have

received organ transplants) will have

cryptosporidiosis for a longer period of

time, and it could become lifethreatening. Young children, pregnant

women, or the elderly infected with

cryptosporidiosis can quickly become

severely dehydrated.

Twelve waterborne cryptosporidiosis

outbreaks have occurred at drinking

water systems since 1984 (Craun, 1998;

USEPA, 2000a). The largest of the

known outbreaks occurred in

Milwaukee and was responsible for over

400,000 illnesses and at least 50 deaths

(Hoxie, et al., 1997; MacKenzie et al.,

1994); other known outbreaks have

occurred in smaller communities and

have involved many fewer people. An

incident such as a rainstorm that flushes

many oocysts into the source water or

causes a sanitary sewer overflow

combined with a water treatment plant

upset could allow a large pulse of

oocysts to move past the multiple

barriers of a water treatment plant.

D. Does This Regulation Apply to My

Water System?

Today’s final regulation applies to all

small (serving less than 10,000 people)

public water systems (PWSs) that use

surface water or ground water under the

direct influence of surface water

(GWUDI).

E. How Is the EPA Regulating

Cryptosporidium in the LT1ESWTR?

In the IESWTR (63 FR 69478), EPA

established a maximum contaminant

level goal (MCLG) of zero for

Cryptosporidium. When establishing an

MCLG, EPA must also establish either a

corresponding Maximum Contaminant

Level (MCL) or a treatment technique. In

the IESWTR and in today’s LT1ESWTR,

the Agency chose to establish a

treatment technique that relies on

strengthening water treatment processes

already in place. For filtered systems

this means achieving at least 2-log (99

percent) removal of Cryptosporidium by

meeting strengthened combined filter

effluent turbidity limits as established

by today’s rule. For unfiltered systems

it means maintaining and improving

Cryptosporidium control under existing

watershed control plans.

F. What Other Requirements Are

Included in This Rule?

Today’s final regulation includes

several requirements.

—All surface water and GWUDI systems

serving fewer than 10,000 people

must meet the requirements for

achieving a 2-log removal or control

of Cryptosporidium;

—Conventional and direct filtration

systems must comply with specific

combined filter effluent turbidity

requirements while alternative

filtration systems (systems using

filtration other than conventional

filtration, direct filtration, slow sand

filtration, or diatomaceous earth

filtration), must demonstrate the

ability to achieve 2-log removal of

Cryptosporidium and comply with

specific State-established combined

filter effluent turbidity requirements;

—Conventional and direct filtration

systems must continuously monitor

the turbidity of individual filters and

perform follow-up activities if this

monitoring indicates a potential

problem;

—Systems must develop a disinfection

profile unless they can demonstrate

that their TTHM and HAA5

disinfection byproduct (DBP) levels

are less than 0.064 mg/L and 0.048

mg/L respectively;

—Systems considering a significant

change to their disinfection practice

must develop a disinfection

inactivation benchmark of their

existing level of microbial protection

and consult with the State for

approval prior to implementing the

disinfection change;

—Finished water reservoirs for which

construction begins after the effective

date of today’s rule must be covered;

and

—Unfiltered systems must comply with

updated watershed control

requirements that add

Cryptosporidium as a pathogen of

concern.

G. How Will This Regulation Protect

Public Health?

Today’s rule for the first time

establishes Cryptosporidium control

requirements for small systems by

requiring a minimum 2-log removal for

Cryptosporidium. The rule also

strengthens filter performance

requirements to ensure 2-log

Cryptosporidium removal, establishes

individual filter monitoring to minimize

contaminant pass-through and support

improved performance, includes

Cryptosporidium in the definition of

GWUDI, and explicitly considers

unfiltered system watershed control

provisions. Today’s rule also reflects a

commitment to the importance of

maintaining existing levels of microbial

protection in public water systems as

plants take steps to comply with newly

applicable DBP standards. Systems

considering significant changes to their

disinfection practices must first evaluate

current levels of Giardia inactivation

(and virus inactivation if applicable)

and consult with their State Primacy

Agency for approval before

implementing those changes to assure

that current microbial protection is not

significantly reduced. Thus, compliance

with the provisions of today’s rule will

improve public health protection by

reducing the risk of exposure to

Cryptosporidium in small systems

serving fewer than 10,000 people even

as those systems begin to take steps to

comply with related DBP standards.

II. Background

A. What Is the Statutory Authority for

the LT1ESWTR?

The Safe Drinking Water Act (SDWA

or the Act), as amended in 1986,

requires EPA to publish a maximum

contaminant level goal (MCLG) for each

contaminant which in the judgement of

the EPA Administrator, may have an

adverse effect on the health of persons,

occurs in public water systems with a

frequency and at a level of public health

concern, and whose regulation would

represent a meaningful public health

risk reduction (Section 1412(b)(1)(A)).

MCLGs are non-enforceable health goals

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 again

Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations 1815

amended in August 1996 (Public Law

104–83), resulting in the renumbering

and augmentation of certain sections

with additional statutory language. New

sections were added establishing new

drinking water requirements.

The 1986 Amendments to SDWA

requires EPA to publish an enforceable

National Primary Drinking Water

Regulation (NPDWR) that specifies

either a maximum contaminant level

(MCL) or treatment technique (Sections

1401(1) and 1412(7)(a)) at the same time

it publishes an MCLG. EPA is

authorized to promulgate a NPDWR that

requires the use of a treatment

technique in lieu of establishing an

MCL, if the Agency finds that it is not

economically or technologically feasible

to ascertain the level of the

contaminant. Today’s rule relies upon

the treatment technique of improved

filter performance based on

strengthened turbidity limits to control

for Cryptosporidium because an

analytical method suitable for finished

water compliance purposes is currently

not economically or technologically

feasible. In accordance with a schedule

established by Section 1412(b)(2)(C) of

SDWA as added by the 1996

Amendments to SDWA, EPA is required

to promulgate today’s rule by November

2000.

B. What Is the Regulatory History for the

LT1ESWTR?

In 1989, EPA promulgated the Surface

Water Treatment Rule (SWTR) (54 FR

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

that set MCLGs of zero for Giardia

lamblia, viruses, and Legionella and

promulgated regulatory requirements for

all PWSs using surface water or GWUDI.

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 percent) for Giardia and 4-log

(99.99 percent) for viruses; (3) combined

filter effluent turbidity performance

standard of 5 nephelometric turbidity

units (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.

Systems seeking to avoid filtration were

required to meet avoidance criteria and

obtain avoidance determinations from

States by December 30, 1991, otherwise

filtration must have been provided by

June 29,1993. For systems properly

avoiding filtration, later failures to meet

avoidance criteria triggered a

requirement that filtration be provided

within 18 months.

The intention of the SWTR was to

provide appropriate multiple barriers of

treatment to control pathogen

occurrence in finished drinking water.

Cryptosporidium, however, was not

addressed under the SWTR, because

EPA lacked sufficient health,

occurrence, and water treatment control

data regarding this organism at the time

of the rule’s development. The IESWTR

and today’s final rule address these gaps

in microbial protection.

In 1992, EPA initiated a negotiated

rulemaking (Reg-Neg) to develop a

disinfectants and disinfection

byproducts rule. The Reg-Neg

Committee consisting of a variety of

stakeholder groups met from November

1992 through June 1993. As part of this

effort, the Committee concluded that the

SWTR needed to be revised to address

the health risk of high densities of

pathogens in poorer quality source

waters than the SWTR addressed as well

as the health risks of Cryptosporidium.

The Committee recommended the

development of three sets of rules: a

two-staged Disinfectants/Disinfection

Byproducts Rule (DBPR), an ‘‘interim’’

Enhanced Surface Water Treatment Rule

(IESWTR), a ‘‘long term’’ Enhanced

Surface Water Treatment Rule

(LT1ESWTR), and an Information

Collection Rule. The IESWTR was only

to apply to those systems serving 10,000

or more persons. The Committee agreed

that the ‘‘long term’’ Enhanced Surface

Water Treatment Rule would be needed

for systems serving fewer than 10,000

persons.

Congress legislatively affirmed this

Microbial/Disinfection Byproduct (MDBP) strategy as part of the 1996 SDWA

Amendments. As part of those new

Amendments, Congress also established

a new schedule for EPA promulgation of

these rules (which is the basis for the

November 2000 schedule for today’s

rule). EPA established the M-DBP

Advisory Committee under the Federal

Advisory Committee Act (FACA) in

1997 to seek advice on how to proceed

towards these deadlines in light of new

information available since the 1993

negotiated rulemaking discussions. The

Committee met five times in March

through July 1997 to discuss issues

related to the IESWTR and the Stage 1

DBPR. The Committee reached

agreement in July of 1997 and its

recommendations are embodied in an

Agreement in Principle document dated

July 15, 1997, which is also found in

two Notices of Data Availability (NODA)

(USEPA1997a,b). The major issues

addressed in the Agreement in Principle

were discussed in the NODA for the

IESWTR (62 FR 59486, November 3,

1997) and Stage 1 DBPR (62 FR 59388,

November 3, 1997).

On December 16, 1998, EPA

promulgated the IESWTR (63 FR 69478),

which applies to surface water and

GWUDI systems serving 10,000 or more

persons. The purposes of the IESWTR

are to improve control of microbial

pathogens (specifically

Cryptosporidium) and to address risk

trade-offs with DBPs. Key provisions

established in the IESWTR include: (1)

An MCLG of zero for Cryptosporidium;

(2) a 2-log Cryptosporidium removal

requirements for systems that filter; (3)

strengthened combined filter effluent

turbidity performance standards and

individual filter turbidity provisions; (4)

disinfection benchmarking provisions to

assure continued levels of microbial

protection while facilities take the

necessary steps to comply with new

DBP standards; (5) inclusion of

Cryptosporidium in the definition of

GWUDI, as another pathogen that would

indicate the presence of GWUDI, and in

the watershed control requirements for

unfiltered public water systems; (6)

requirements for covers on new finished

water reservoirs; and (7) sanitary

surveys for all surface water and

GWUDI systems regardless of size.

Today’s rule is based in large part

upon the data, research, and technical

analysis that supported the major

components included in the 1998

IESWTR. To that degree, it reflects the

national interim microbial protection

control strategy ratified by a wide range

of experts and stakeholders as part of

the 1997 M/DBP Agreement in

Principle. However, as was discussed in

the April 10, 2000 proposal, today’s rule

also is based on new small system

information that became available since

1998 and, equally important, it also

reflects a major commitment to

significantly reduce small system

compliance burdens wherever possible,

while maintaining public health

protection.

C. How Were Stakeholders Involved in

the Development of the LT1ESWTR?

EPA began outreach efforts to develop

the LT1ESWTR in the summer of 1998

with two public meetings: one in

Denver, Colorado and the other in

Dallas, Texas (USEPA, 1999a,b).

Building on these two public meetings,

EPA has also held a number of

additional meetings with stakeholders,

1816 Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations

trade associations, environmental

groups, and representatives of State and

local elected officials. Of particular

importance for this rule, given its focus

on small systems, EPA received

valuable input from small entity

representatives as part of the Small

Business Regulatory Enforcement

Fairness Act (SBREFA) panel. The panel

was initiated in April of 1998 and

officially convened in August of 1998.

Many of the panel’s recommendations

are reflected in today’s rule.

EPA provided numerous

opportunities for stakeholder and public

involvement. In early June 1999, EPA

mailed an informal draft of the

LT1ESWTR preamble to the

approximately 100 stakeholders who

attended either of the public stakeholder

meetings. Members of trade associations

and the SBREFA panel also received the

draft preamble. EPA received valuable

suggestions and stakeholder input from

15 State representatives, trade

associations, environmental interest

groups, and individual stakeholders.

EPA proposed the LT1ESWTR on April

10, 2000. During the comment period,

the Agency held a public meeting in

Washington D.C. on April 14, 2000.

Additionally, the proposed rule was

presented to industry, State

representatives, and the public in nearly

50 meetings across the US, including a

May 30, 2000 meeting in Washington,

D.C. with ten representatives of elected

State and local officials (USEPA

2000g,h). Finally, EPA mailed

approximately 200 copies of the

proposed rule to stakeholders.

D. What Did the April 10, 2000 Proposal

Contain?

The proposed rulemaking package,

which is the basis for today’s final rule,

was entitled The Long Term 1 Enhanced

Surface Water Treatment and Filter

Backwash Proposed Rule (USEPA,

2000b).

The proposed rule included two

distinct sets of provisions: LT1ESWTR

provisions and Filter Backwash

Recycling Rule (FBRR) provisions. The

Agency promulgated the final FBRR in

a Federal Register announcement on

June 8, 2001 (66 FR 31086), separate

from today’s final rule. The LT1ESWTR

proposed rule provisions applied to

surface and GWUDI systems serving

fewer than 10,000 persons and included

the following provisions:

—2-log removal of Cryptosporidium;

—Compliance with specific combined

filter effluent turbidity requirements;

—Continuous turbidity monitoring for

individual filters with follow-up

activities if monitoring results

indicated a potential problem;

—Development of a disinfection profile

unless optional monitoring at a

particular plant demonstrated TTHM

and HAA5 levels less than 0.064 mg/

L and 0.048 mg/L respectively;

—Development of a Giardia inactivation

disinfection benchmark and

consultation with the State for

approval before making a significant

change in disinfection practices;

—Mandatory covers for all newly

constructed finished water reservoirs;

and

—Unfiltered system compliance with

updated watershed control

requirements that add

Cryptosporidium as a pathogen of

concern.

III. Discussion of the Final Rule

A. What Level of Cryptosporidium

Removal Does the LT1ESWTR Require?

1. What Does Today’s Rule Require?

Today’s final rule establishes a

treatment technique requirement for 2-

log removal of Cryptosporidium for

surface water and GWUDI systems

serving fewer than 10,000 persons. This

requirement applies between a point

where the raw water is not subject to

contamination by surface water runoff

and a point downstream before or at the

first customer.

2. How Was This Requirement

Developed?

As discussed previously in today’s

rule, Cryptosporidium is a

microbiological contaminant that has

caused several outbreaks of

cryptosporidiosis and poses serious

health risks. For these reasons, the

Agency set forth to develop

requirements to minimize risks

associated with Cryptosporidium in

drinking water. In the IESWTR, EPA

established a MCLG of zero for

Cryptosporidium. EPA decided to

establish 2-log removal of

Cryptosporidium as the accompanying

treatment technique for this MCLG. This

requirement is based on a number of

treatment effectiveness studies that

demonstrate the ability of well-operated

conventional and direct filtration plants

to achieve at least a 2-log removal of

Cryptosporidium (Patania et al., 1995;

Nieminski and Ongerth, 1995; Ongerth

and Pecoraro, 1995; LeChevallier and

Norton, 1992; LeChevallier et al., 1991;

Foundation for Water Research, 1994;

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

The information and data in these eight

studies provide convincing evidence

that conventional and direct filtration

plants that employ coagulation,

flocculation, sedimentation (in

conventional filtration only), and

filtration steps, have the ability to

achieve a minimum of 2-log removal of

Cryptosporidium when meeting specific

turbidity limits. EPA has also provided

data in the proposal for today’s final

rule that indicate the ability of slow

sand filtration, diatomaceous earth

filtration, and alternative filtration

(membrane filtration, cartridge

filtration, etc.) to achieve at least 2-log

removal of Cryptosporidium (Jacangelo

et al., 1995; Drozd & Schartzbrod, 1997;

Hirata & Hashimoto, 1998; Goodrich et

al., 1995; Collins et al., 1996; Lykins et

al., 1994; Adham et al., 1998; Shuler &

Ghosh, 1991; Timms et al., 1995; Shuler

et al., 1990; and Ongerth & Hutton,

1997). The Agency believes that the

technological feasibility for 2-log

removal is demonstrated for both large

and small systems and therefore today’s

rule extends the 2-log Cryptosporidium

removal requirement established for

large and medium systems in the 1998

IESTWR to small systems serving fewer

than 10,000 persons.

3. What Major Comments Were

Received?

The majority of the commenters on

the proposed rule agreed with the

appropriateness of establishing a 2-log

removal requirement for

Cryptosporidium. A few commenters

noted that small systems should not be

required to meet the same

Cryptosporidium log removal

requirements as large systems. EPA

disagrees. The technological feasibility

of 2-log removal is well demonstrated

(as shown in the studies discussed in

the proposal for today’s final rule) and

the Agency believes that persons served

by all sized systems should be afforded

comparable levels of public health

protection (i.e., the small systems

subject to the LT1ESWTR should have

the same MCLG, and the 2-log

Cryptosporidium removal treatment

technique as large systems subject to the

IESWTR).

B. What Combined Filter Effluent

Requirements Does the LT1ESWTR

Contain?

1. What Does Today’s Rule Require?

Today’s final rule requires

strengthened combined filter effluent

performance for conventional filtration,

direct filtration, and alternative

filtration systems (systems using

filtration technologies other than

conventional filtration, direct filtration,

diatomaceous earth filtration, or slow

sand filtration) as the treatment

technique for achieving a 2-log removal

of Cryptosporidium. For conventional

and direct filtration systems, the

Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations 1817

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. Under today’s rule,

conventional and direct filtration plants

meeting these filter performance

requirements are presumed to achieve at

least a 2-log removal of

Cryptosporidium. Slow sand and

diatomaceous earth filtration plants are

presumed to achieve at least 2-log

removal of Cryptosporidium if they

continue to meet the existing filter

performance requirements established

in the SWTR. Systems using alternative

filtration (i.e., membrane filtration,

cartridge filtration, etc.) must

demonstrate to the State that their

system achieves 2-log removal of

Cryptosporidium. The State will then

establish appropriate turbidity limits to

reflect this performance. At the end of

each month, systems must report the

total number of combined filter effluent

turbidity measurements taken each

month, as well as the number and

percentage of turbidity measurements

that exceeded their 95th percentile

turbidity limit and the number of

measurements that exceeded their

maximum turbidity limit. Combined

filter effluent turbidity measurements

must be kept for at least three years.

2. How Was This Requirement

Developed?

In establishing the 2-log removal as a

treatment technique for

Cryptosporidium, the Agency relied on

the aforementioned studies to

demonstrate the technological feasibility

of establishing the 2-log removal. These

studies demonstrated that specific

treatment would achieve 2-log removal

of Cryptosporidium when operated to

achieve specific turbidity performance

limits. For conventional and direct

filtration systems, studies demonstrated

that achieving a turbidity of 0.3 NTU 95

percent of the time and never exceeding

1 NTU would ensure at least 2-log

removal of Cryptosporidium. For slow

sand and diatomaceous earth filtration

systems, the studies demonstrated that

meeting existing SWTR turbidity limits

would ensure at least 2-log removal of

Cryptosporidium. Alternative filtration

systems were shown to achieve at least

2-log removal of Cryptosporidium at a

variety of turbidities based on the type

of filtration and other site-specific

characteristics. The requirements of

today’s final rule reflect the

recommendations of the 1997 M-DBP

Committee.

As part of the LT1ESWTR

development process, EPA analyzed

performance data from 211 small

systems in 15 different States. That data

indicated that a substantial number of

small systems are presently meeting the

tighter performance standards of today’s

rule. For example, 50 percent of the 211

systems are currently meeting 0.3 NTU

12 months out of the year. In addition,

93 percent of the 211 systems never

exceeded the 1 NTU maximum 12

months out of the year. Therefore, EPA

believes that the strengthened filter

performance standards established for

small systems in today’s final rule are

feasible and achievable.

3. What Major Comments Were

Received?

The majority of the commenters on

the proposal agreed with the

appropriateness of the combined filter

effluent requirements. Many

commenters raised concerns with the

proposal’s reliance on turbidity as an

indicator for demonstrating that

membrane filtration meets the same

Cryptosporidium removal requirements

as conventional and direct filtration

systems. Commenters indicated that

although turbidity is the most prevalent

form of water quality monitoring,

establishing a 0.3 NTU 95th percentile

limit and 1 NTU maximum limit would

not be as appropriate an indicator of the

performance of membranes than other

parameters such as flux or membrane

integrity. They noted that using

turbidity was appropriate if site specific

turbidity limits were utilized. At most

facilities these limits would typically be

much lower than 0.3 NTU.

Additionally, commenters asserted that

since the typical operational turbidities

of membranes (< 0.05 NTU) were so

much lower than those of conventional

filtration, it would be inappropriate to

require membranes to meet turbidity

limits that were significantly higher

than standard operating practices. In

response, EPA notes that in the

proposed rule, EPA allowed membrane

systems to meet either conventional

filtration or alternative filtration

combined filter effluent requirements.

After further evaluating existing studies

and information provided by

commenters, EPA agrees that other

appropriate indicators may be used to

determine the treatment efficiency of

membrane filtration, and that given the

different operational turbidities of

conventional filtration and membrane

filtration, different turbidity limits are

appropriate. Therefore, today’s final rule

treats membrane filtration as an

available alternative filtration

technology, instead of requiring

membranes to meet the same turbidity

limits as conventional and direct

filtration.

C. What Individual Filter Monitoring

Requirements Does the LT1ESWTR

Contain?

1. What Does Today’s Rule Require?

Today’s final rule establishes a

requirement that all systems using

surface water or GWUDI, serving fewer

than 10,000 persons, and utilizing

conventional or direct filtration must

continuously monitor the individual

filter turbidity for each filter used at the

system. For purposes of this rule,

continuous monitoring means at least

every 15 minutes. Systems must keep

the results of this monitoring for at least

three years. Each month systems must

report to the State that they have

conducted individual filter turbidity

monitoring, and are required to indicate

the dates, filter number, and turbidities

of any measurements that exceeded 1.0

NTU. Today’s rule provides that

systems with two or fewer filters may

monitor combined filter effluent

turbidity continuously, in lieu of

individual filter turbidity monitoring.

Based on this monitoring, if a system

exceeds 1.0 NTU in two consecutive

measurements the system must include

the filter number, date, time and reason

for the exceedance at the end of the

month in its monthly filter performance

report to the State. If this occurs three

months in a row for the same filter, a

system is required to conduct a selfassessment of the filter. If a selfassessment is required, it must take

place within 14 days of the day the filter

exceeded 1.0 NTU in two consecutive

measurements for the third straight

month. The system must report to the

State that the self-assessment was

completed. A self-assessment must

include 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 self-assessment

report.

If a system exceeds 2.0 NTU (in two

consecutive measurements 15 minutes

apart) for two months in a row, the

system must contact the State to arrange

for the State or an approved third party

to conduct a Comprehensive

Performance Evaluation (CPE) not later

than 60 days following the day the filter

exceeded 2.0 NTU in two consecutive

measurements for the second straight

month. The CPE must be completed and

1818 Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations

submitted to the State no later than 120

days following the day the filter

exceeded 2.0 NTU in two consecutive

measurements for the second straight

month.

2. How Was This Requirement

Developed?

Performance of individual filters

within a plant is of paramount

importance in preventing pathogen

breakthrough. Two important concepts

regarding individual filters underlie

today’s individual filter monitoring

requirement. First, as discussed in more

detail in the April 10, 2000 proposal,

poor performance (and potential

pathogen breakthrough) of one filter can

be masked by optimal performance of

the remaining filters, without exceeding

combined filter effluent turbidity

performance standards. Second, recent

filter performance research

demonstrates that individual filters are

susceptible to turbidity spikes of short

duration that may not be captured by

four-hour combined filter effluent

measurements. Several studies

(Amirthatajah, 1988; Bucklin et al.,

1988; Cleasby 1990; Hall and Croll 1996;

and McTigue et al., 1998) have

confirmed the frequency and magnitude

of individual filter turbidity spikes. To

address these spikes and the potential

for masking, and provide system

operators with information and

advanced warning with regards to

individual filter performance problems

before they lead to treatment technique

violations, the Agency proposed

individual filter turbidity monitoring.

EPA proposed one option and requested

comment on two alternative approaches.

The alternatives consisted of an

approach identical to the IESWTR that

entailed significantly more burden, and

an approach that included 95th

percentile and maximum triggers

instead of a trigger based on two

consecutive measurements. The

proposed option has been revised in

three minor ways. In today’s rule:

—Systems with two or fewer filters may

monitor combined filter effluent

turbidity continuously, in lieu of

individual filter turbidity (the

proposal required all filters be

monitored);

—Systems must schedule CPEs within

60 days and complete them within

120 days (the proposal required 30

and 90 days);

—A system has 14 days following a

turbidimeter malfunction to resume

continuous individual filter

monitoring before a violation occurs

(the proposal required 5 days).

3. What Major Comments Were

Received?

The majority of the commenters on

the proposal agreed with the

appropriateness of the individual filter

monitoring requirements. The Agency

requested comment on a variety of

issues to which commenters responded.

Most commenters supported the

modification that States be provided the

opportunity to allow systems with two

or fewer filters to monitor combined

filter effluent turbidity continuously, in

lieu of individual filter turbidity

indicating that poor performance of one

filter could not simply be masked by

optimal performance of an additional

filter. The Agency has included this

modification in today’s final rule

because it reduces the burden on small

systems while still providing

continuous monitoring that can be used

to indicate whether filters are

performing poorly.

Several commenters supported a

modification to lengthen CPE schedules

by 30 days. The Agency has included

this modification in today’s final rule in

order to provide States added flexibility

in performing these activities. The extra

30 days will provide States the

opportunity to marshal unique

resources (specifically, employees

trained in conducting CPEs) and

prioritize the conduct of CPEs, when

several systems trigger them during the

same time period.

Several commenters indicated that

allowing only five working days for an

on-line turbidimeter to be off-line before

a violation resulted would be

inappropriate for small systems.

Commenters indicated that smaller

systems often do not have back-up units

onsite and would be required to contact

manufacturers and await shipping and

installation which could easily exceed

the five days. EPA agrees and has

modified the requirement to allow

systems serving fewer than 10,000

persons, 14 days to resume online

monitoring prior to incurring a

violation.

Several commenters noted that

systems serving fewer than 10,000

persons should be subject to less

frequent monitoring of individual filter

effluent. EPA believes that continuous

individual filter monitoring is feasible

and assures improved performance of

filtration systems. As explained in the

proposal, continuous filter monitoring is

necessary to identify short duration

turbidity spikes which are likely to be

missed with less frequent monitoring.

This is true for systems of all sizes. Less

frequent monitoring would not identify

many turbidity spikes and accordingly

would not provide a comparable level of

public health protection as that of

continuous monitoring required for

large systems under the IESWTR. In

fact, the actual frequency of individual

filter monitoring has little effect on

burden as much of the costs associated

with monitoring are derived from the

purchase of the necessary equipment

and would be incurred regardless of the

frequency. Reduced monitoring would

represent reduced public health

protection and the Agency firmly

believes that the consumers of these

small systems should be afforded a

comparable level of public health

protection as larger systems.

D. What Disinfection Profiling and

Benchmarking Requirements Does the

LT1ESWTR Contain?

1. What Does Today’s Rule Require?

Today’s final rule requires community

and non-transient non-community

systems that use surface water or

GWUDI and serve fewer than 10,000

persons to develop a disinfection profile

based on a 52 week period. Systems

serving between 500 and 9,999 must

begin profiling and notify the State to

this effect by July 1, 2003. Systems

serving fewer than 500 must begin

profiling and notify the State to this

effect by January 1, 2004. To conduct

the profile, systems must:

—Monitor disinfectant residual

concentration, water temperature in

degrees Celsius, pH, and contact time

during peak hourly flow once a week

(on the same calendar day) during all

months that the system is operational;

—Calculate Giardia lamblia inactivation

for each of the 52 weeks; and

—Plot graphically, the 52 weekly

inactivations.

Results of the profile must be kept

indefinitely. EPA is developing

guidance materials that provide detailed

information on this procedure. A State

may determine that a system’s profile is

unnecessary where a system submits

TTHM and HAA5 data that:

—Is taken during the month of warmest

water temperature (beginning no

earlier than 1998);

—Is taken at the point of maximum

residence time; and

—Reports levels of TTHM and HAA5 of

less than 0.064 mg/L and 0.048 mg/L

respectively.

Today’s final rule also requires any

system which developed a profile and

which decides to make a significant

change to their disinfection practice to

determine their disinfection benchmark

(the average microbial inactivation

during the month with the lowest

Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations 1819

inactivation), consult with the State for

approval, and provide the following

information during consultation:

—Description of the proposed change;

—Disinfection profile (and data used to

develop profile); and

—Analysis of how the proposed change

will affect the current levels of

disinfection.

Results of the disinfection benchmark

(including the raw data and analysis)

must be kept indefinitely.

2. How Was This Requirement

Developed?

The disinfection benchmarking

requirements provide the necessary link

between simultaneous compliance with

microbial protection requirements of the

IESWTR and LT1ESWTR and

disinfection byproduct requirements of

the DBPR. The requirements were

established pursuant to the authority of

Section 1445 of SDWA to ensure that

systems would not jeopardize microbial

protection when making changes in

disinfection practices to comply with

the DBPR.

During the 1997 M/DBP FACA

deliberations, all participants agreed to

the fundamental premise that new

standards for control of DBPs must not

lead to significant reductions in existing

levels of microbial protection. This

premise is reflected in the 1997 M–DBP

Advisory Committee Agreement in

Principle document. The Advisory

Committee reached agreement on the

use of a microbial profiling and

benchmarking process, whereby a

system and State, working together,

could assure that there would not be a

significant increase in microbial risk as

a result of modifying disinfection

practices to meet MCLs for TTHM and

HAA5. The final IESWTR established

the disinfection benchmark procedure

to require large systems (serving 10,000

or more persons) that might be

considering a significant change to their

disinfection practice (defined as systems

with TTHM or HAA5 concentrations at

or above 80 percent of the respective

MCLs (e.g., 0.064 mg/L TTHM or 0.048

mg/L HAA5)) to evaluate the impact on

microbial risk. Under the IESWTR, large

systems whose TTHM and/or HAA5

average levels exceeded the

aforementioned values were required to

develop a disinfection profile of

microbial inactivation over the course of

a year by calculating the daily level of

Giardia inactivation. Those large

systems required to develop a

disinfection profile that also plan to

make a significant change to

disinfection practices were required to

develop a ‘‘benchmark’’ of existing

levels of Giardia microbial protection

and to consult with the State prior to

implementing the change.

In developing the disinfection

benchmarking requirements of the

LT1ESWTR, EPA used the IESWTR

requirements as a starting point and,

using significant input from

stakeholders, modified the requirements

to significantly reduce burden yet

maintain a comparable level of public

health protection. The April 10, 2000

proposal included several alternatives

for establishing the microbial profiling

and benchmarking process.

Of the four TTHM and HAA5

monitoring alternatives, the first was

identical to the IESWTR, and included

four quarters of monitoring at four

points in the distribution system. The

second alternative matched DBP

compliance monitoring, requiring

systems serving fewer than 500 to

monitor once per year, and systems

serving 500 or greater to monitor

quarterly. A third alternative required

only one sample taken at the point of

maximum residence time for all

systems. The fourth alternative (which

was proposed) made TTHM and HAA5

monitoring optional. This alternative

was chosen over the others, because it

significantly reduces burden and the

concern about ‘‘early implementation,’’

that is, the need for systems to comply

with requirements of a rule before

primacy states have adopted new

conforming regulations, while still

retaining the ability for systems and

States to utilize monitoring data to

demonstrate low TTHM and HAA5

levels, and therefore avoid profiling.

Since this monitoring is no longer

required to determine the applicability

of systems to conduct profiles, the final

LT1ESWTR refers to this monitoring as

‘‘optional monitoring.’’ The associated

TTHM and HAA5 samples that must be

conducted under this optional

monitoring, are described in section

141.531. Of the four profiling

alternatives, the first was identical to

the IESWTR, requiring daily profiling

for a year. The second alternative did

not require profiling. The third

alternative, which was proposed,

required weekly profiling for a year. The

fourth alternative required daily

profiling during a single month. The

Agency proposed weekly profiling over

the course of a full year because it

significantly reduces burden associated

with conducting profiling (as compared

to the first alternative), but still provides

information on the seasonal variation

associated with microbial inactivation,

and develops an accurate microbial

benchmark as systems moved to comply

with the Stage 1 DBPR. The second and

fourth profiling alternatives would not

provide such information. The Agency

has revised the proposed option in one

minor way. In today’s rule:

—Systems serving between 500 and

9,999 persons must begin weekly

profiling no later than July 1, 2003,

and systems serving fewer than 500

persons must begin weekly profiling

no later than January 1, 2004 (the

proposal required all systems to begin

profiling no later than January 7,

2003).

3. What Major Comments Were

Received?

The Agency received significant

comment on the disinfection

benchmarking provisions of the

proposed rule. Commenters both

supported and opposed the proposed

‘‘optional’’ TTHM and HAA5

monitoring. Several commenters argued

that EPA should not require systems or

states to undertake activities, even

optional monitoring, before three years

from the date a rule is promulgated

because it would result in early

implementation of the rule. While the

Agency agrees that to the extent

possible, implementation should be

minimized in the first three years after

the promulgation of a national primary

drinking water regulation, as required

by Section 1412(b)(10) of SDWA, the

Agency continues to believe that

allowing systems to conduct optional

monitoring prior to three years after

promulgation is appropriate and

authorized under section 1445 of

SDWA.

Several commenters raised ‘‘early

implementation’’ concerns with

profiling as well, and suggested

profiling should take place only after

using the first round of DBP monitoring

in 2004 as optional monitoring for

profiling activities. The Agency does

agree, that to the extent possible, early

implementation should be minimized in

the first two years after the

promulgation of the rule. However, the

Agency believes that developing a

microbial profile and benchmark prior

to compliance monitoring under the

Stage 1 DBPR is key to ensuring that

systems do not jeopardize existing

microbial protection when making

changes to their disinfection practices to

comply with the Stage 1 DBPR.

Consequently, today’s final rule requires

systems serving fewer than 500 persons

to begin profiling in January 2004, while

systems serving greater than 500 to

9,999 persons are required to begin

profiling in July 2003.

Other commenters believed that the

proposed requirement represented

burden reduction for small systems and

1820 Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations

States while still achieving the goals of

optional monitoring and profiling as

developed by the 1997 FACA and EPA.

Additionally, commenters noted that

EPA should provide States and systems

the ability to use more representative

data if available (i.e., allowing systems

to average over several quarters of data

similar to the IESWTR requirements).

EPA agrees that systems and States

should be allowed the opportunity to

use more representative samples, and

today’s final rule affords States the

opportunity to allow more

representative data for optional

monitoring and profiling.

E. How Does the Definition of Ground

Water Under the Direct Influence of

Surface Water Change?

1. What Does Today’s Rule Require?

Today’s final rule modifies the

definition of ground water under the

direct influence of surface water

(GWUDI) to include Cryptosporidium,

as another pathogen that would indicate

the presence of GWUDI, for all PWSs.

2. How Was This Requirement

Developed?

Although ground water is typically

protected from microbial contaminants

that are characteristic of surface water

supplies, some ground water systems

are susceptible to microbial

contamination from surface water.

Ground water that exhibits physical

water quality indicators that closely

correlate with nearby surface water and

which contain surface water indicator

organisms is ‘‘under the influence,’’ of

that surface water. In order to protect

customers of such systems from

illnesses resulting from exposure to

Giardia and other microbial pathogens,

the Agency addressed this issue during

development of the 1989 SWTR. The

final SWTR requires that systems with

source water found to be GWUDI are

subject to the filtration and disinfection

requirements of Section 141 subpart H.

During development of today’s final

rule, the Agency proposed to modify the

definition of GWUDI to include

Cryptosporidium, as another pathogen

that would indicate the presence of

GWUDI. This is consistent with the

approach taken by the Agency in the

IESWTR and is further supported by

recently available data indicating

Cryptosporidium occurrence in 21

public water system wells (Hancock et

al., 1998). As a result, EPA believes it

appropriate and necessary to include

Cryptosporidium in the definition of

GWUDI for systems serving fewer than

10,000 persons in today’s rule.

3. What Major Comments Were

Received?

Commenters agreed with the

appropriateness of modifying the

definition of GWUDI to include

Cryptosporidium for all PWSs. Today’s

final rule reflects the GWUDI definition

as proposed.

F. What Additional Requirements Does

the LT1ESWTR Contain for Unfiltered

Systems?

1. What Does Today’s Rule Require?

Today’s rule modifies the

requirements for surface water or

GWUDI systems serving fewer than

10,000 persons that do not provide

filtration by including Cryptosporidium

in the watershed control provisions

everywhere Giardia lamblia is

mentioned.

2. How Was This Requirement

Developed?

Watershed control requirements were

initially established in 1989 as part of

the SWTR. The SWTR contains specific

conditions that a system must meet in

order to avoid filtration. These

conditions include good source water

quality disinfection requirements,

periodic on-site inspections, the absence

of waterborne disease outbreaks,

compliance with the Total Coliform

Rule, and a watershed control program.

The SWTR requires that the watershed

control program must be maintained

specifically to minimize the potential

for contamination by Giardia lamblia

cysts and viruses in the source water.

During development of today’s rule,

the Agency proposed that

Cryptosporidium should also be

included as a focus in watershed

program for unfiltered systems. For the

same public health reasons explained in

detail as part of the April 10, 2000

proposal and outlined earlier regarding

the risks associated with exposure to

Cryptosporidium, the Agency believes it

is important that watershed control

requirements for unfiltered systems be

revised to include Cryptosporidium.

This is particularly important since

such systems do not have the additional

treatment barrier provided by filtration

to protect against possible pass-through

of Cryptosporidium into the distribution

system.

3. What Major Comments Were

Received?

Commenters agreed with the

appropriateness of including

Cryptosporidium in the watershed

control program requirements for

unfiltered systems. No substantive

changes were made to this provision

between proposal and today’s final rule.

G. What Does the LT1ESWTR Require

for Finished Water Reservoirs

1. What Does Today’s Rule Require?

Today’s final rule requires that all

finished water reservoirs, holding tanks,

or storage water facilities for finished

water at systems serving fewer than

10,000 persons, for which construction

begins after March 15, 2002 must be

covered.

2. How Was This Requirement

Developed?

Open finished water reservoirs,

holding tanks, and storage tanks are

utilized by PWSs throughout the

country. Because these reservoirs are

open to the environment and outside

influences, they can be subject to the

reintroduction of contaminants that the

treatment plant was designed to remove.

Existing EPA guidelines recommend

that all finished water reservoirs and

storage tanks be covered (USEPA, 1991).

Additionally, many States currently

require that finished water storage be

covered, and the American Water Works

Association (AWWA) has issued a

policy statement strongly supporting the

covering of reservoirs that store potable

water (AWWA, 1983). In the July 29,

1994 IESWTR proposal (59 FR 38832),

the Agency requested comment on

whether to issue regulations requiring

systems to cover finished water storage.

Most commenters supported either

Federal or State requirements, with

some suggesting requirements should

only apply to newly constructed

reservoirs. In the final IESWTR, the

Agency required systems using surface

water and GWUDI and serving 10,000

persons or more to cover any newly

constructed finished water reservoirs,

holding tanks, or storage tanks. Through

discussions with stakeholders and

evaluations of available information, the

Agency is unaware of any newly

constructed uncovered finished water

reservoirs at small systems since

discussions with stakeholders regarding

the LT1ESWTR began in 1998. The

Agency is furthermore unaware of any

future plans of small systems to

construct uncovered finished water

reservoirs. In fact the drinking water

industry (regulators, consultants, and

industry groups) have discouraged the

construction of new uncovered

reservoirs for many years. Furthermore,

creating a prohibition on newly

constructed uncovered finished water

reservoirs would not affect current

unfinished water reservoirs or even any

system, which, despite the industry

Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations 1821

standard of constructing only covered

finished water reservoirs, may have

already commenced construction on an

uncovered finished water reservoir

unbeknownst to the Agency or

stakeholders which provided input on

the rule. Therefore, in accordance with

Section 1412(b)(10) of SDWA, the

Agency has determined it is practicable

to require as part of today’s rule that

systems serving fewer than 10,000

people provide covers for all finished

water reservoirs, holding tanks, or

storage reservoirs constructed after

March 15, 2002.

3. What Major Comments Were

Received?

Commenters agreed with the

appropriateness of requiring that newly

constructed finished water storage be

covered. Several States noted that they

currently require that all finished water

reservoirs be covered. No substantive

changes were made to this provision

between proposal and today’s final rule.

H. What Is the Compliance Schedule for

the LT1ESWTR?

1. When Must My System Comply With

Each of the Requirements of the Rule?

Each of the components of the final

LT1ESWTR has a specific compliance

date. The following table lists each

requirement, along with the appropriate

Federal Register citation and the

compliance date:

Rule requirements FR citation Compliance date

Cover new finished water reservoirs ...... § 141.511 ............................................... March 15, 2002.

Comply with updated watershed control

requirements (unfiltered PWSs).

§§ 141.520, 141.521 & 141.522 ............ January 14, 2005.

Begin Developing Disinfection Profile ..... §§ 141.530–141.536 .............................. July 1, 2003 for systems serving between 500 and 9,999

persons and January 1, 2004 for systems serving fewer

than 500 persons.

Complete the Disinfection Profile ........... §§ 141.530–141.536 .............................. July 1, 2004 for systems serving between 500 and 9,999

persons and January 1, 2005 for systems serving fewer

than 500 persons.

Combined Filter Effluent Turbidity Limits §§ 141.550, 141.551, 141.552, &

141.553.

January 11, 2005.

Individual Filter Turbidity Monitoring ....... §§ 141.560, 141.561, 141.562, 141.563,

141.564.

January 11, 2005.

2. What Major Comments Were

Received?

Many commenters noted that they

would not support requirements that

would take place prior to two years after

the promulgation of today’s final rule.

Several others recommended requiring

that no portions of the rule should take

effect until three years after the date of

promulgation. The Agency does agree

that to the extent possible,

implementation should be minimized in

the first two years after the

promulgation of the rule. However,

today’s final rule requires systems

serving fewer than 500 persons to begin

profiling in January 2004, while systems

serving greater than 500 to 9,999

persons are required to begin profiling

in July 2003. This would allow time for

States to work with systems, yet still

provide profiling data prior to

compliance sampling under the Stage 1

DBPR.

I. What Public Notification and

Consumer Confidence Report

Requirements Are Contained in the

LT1ESWTR?

Today’s final rule modifies the Public

Notification (PN) requirements found in

Appendix A and B of subpart Q of Part

141 to include public notification

requirements for systems subject to the

LT1ESWTR that are consistent with

those for systems subject to the

IESWTR.

Today’s rule does not specifically

modify the Consumer Confidence

Report (CCR) Requirements found in

subpart O of Part 141. However,

consumer confidence reports must

contain any violations of treatment

techniques or requirements of NPDWRs

as specified in § 141.153(d)(6) and

§ 141.153(f). This includes any such

violations of the LT1ESWTR.

Updated CCR and PN appendices can

be found on the Agency’s Web site at

http://www/epa.gov/safewater/

tables.html.

IV. State Implementation

A. What Special State Primacy

Requirements does the LT1ESWTR

Contain?

In addition to adopting drinking water

regulations at least as stringent as the

Federal regulations of the LT1ESWTR,

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

assists EPA in its oversight of State

programs.

Under the final LT1ESWTR, there are

several special primacy requirements

that a State’s application must include:

—Description of how the State will

consult with the system and approve

modifications to disinfection

practices;

—Description of how the State will

approve a more representative data set

for optional monitoring and profiling

under §§ 141.530–141.536.

—Description of how existing rules,

adoption of appropriate rules or other

authority under § 142.16(i)(1) require

systems to participate in a

Comprehensive Technical Assistance

(CTA) activity, and the performance

improvement phase of the Composite

Correction Program (CCP);

—Description of how the State will

approve a method to calculate the logs

of inactivation for viruses for a system

that uses either chloramines, chlorine

dioxide, or ozone for primary

disinfection; and

—For alternative filtration technologies

(filtration other than conventional

filtration treatment, direct filtration,

slow sand filtration or diatomaceous

earth filtration), a description of how

the State will determine under

§ 142.16(i)(2)(iv), that a PWS 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 subpart T of this title, consistently

achieves 3-log (99.9 percent) removal

and/or inactivation of Giardia lamblia

cysts and 4-log (99.99 percent)

removal and/or inactivation of

viruses, and 2-log (99 percent)

removal of Cryptosporidium oocysts;

and a description of how, for the

1822 Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations

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.

B. What State Recordkeeping

Requirements Does the LT1ESWTR

Contain?

Today’s rule includes changes to the

existing recordkeeping provisions to

implement the requirements in today’s

final rule. States must maintain records

of the following:

(1) Records of turbidity

measurements;

(2) Records of disinfectant residual

measurements and other parameters

necessary to document disinfection

effectiveness;

(3) Decisions made on a system-bysystem basis and case-by-case basis

under provisions of section 141, subpart

H or subpart P or subpart T;

(4) Records of systems consulting

with the State concerning a significant

modification to their disinfection

practice (including the status of the

consultation);

(5) Records of decisions that a system

using alternative filtration technologies

can consistently achieve a 2-log (99

percent) removal of Cryptosporidium

oocysts, as well as the required levels of

removal and/or inactivation of Giardia

and viruses for systems using alternative

filtration technologies, including Stateset 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, and;

(6) Records of those systems required

to perform filter self-assessments, CPE

or CCP.

C. What State Reporting Requirements

Does the LT1ESWTR Contain?

Currently States must report

information to EPA under section

142.15 regarding violations, variances

and exemptions, enforcement actions

and general operations of State public

water supply programs. There are no

additional requirements under this rule,

but States are required to report

violations, variances and exemptions,

and enforcement actions related to this

rule.

D. How Must a State Obtain Interim

Primacy for the LT1ESWTR?

To maintain primacy for the Public

Water Supply Supervision (PWSS)

program and to be eligible for interim

primacy enforcement authority for

future regulations, States must adopt

today’s final rule. A State must submit

a request for approval of program

revisions that adopt the revised MCL or

treatment technique and implement

regulations within two years of

promulgation, unless EPA approves an

extension per § 142.12(b). Interim

primacy enforcement authority allows

States to implement and enforce

drinking water regulations once State

regulations are effective and the State

has submitted a complete and final

primacy revision application. To obtain

interim primacy, a State must have

primacy with respect to each existing

NPDWR. Under interim primacy

enforcement authority, States are

effectively considered to have primacy

during the period that EPA is reviewing

their primacy revision application.

V. Economic Analysis (Health Risk

Reduction and Cost Analysis)

This section summarizes the Health

Risk Reduction and Cost Analysis

(HRRCA) in support of the LT1ESWTR

as required by section1412(b)(3)(C) of

the 1996 SDWA. In addition, under

Executive Order 12866, Regulatory

Planning and Review, EPA must

estimate the costs and benefits of the

LT1ESWTR. EPA has prepared an

economic analysis to comply with the

requirements of this order and the

SDWA Health Risk Reduction and Cost

Analysis (USEPA, 2001a). The final

economic analysis has been published

on the Agency’s Web site, and can be

found at http://www.epa.gov/safewater/

lt1eswtr. The analysis can also be found

in the docket for this rulemaking.

EPA has estimated the total

annualized cost for implementing the

LT1ESWTR and analyzed the total

benefits that result from the rule. Total

annual costs for the rule are $39.5

million, in 1999 dollars, using three

percent discount rate [$44.8 million

using a seven percent discount rate].

The cost estimate includes capital costs

for treatment changes and start-up and

annual labor costs for monitoring and

reporting activities. More detailed

information, including the basis for

these estimates and alternate cost

estimates using different cost of capital

assumptions are described in the

LT1ESWTR economic analysis (USEPA,

2001a). Combining the value of illness

and mortalities avoided, the estimate of

the total quantified annual benefits of

the LT1ESWTR range from $18.9

million to $90.9 million. However, this

range does not incorporate many of the

sources of uncertainty related to

quantifying benefits, including many

benefits the Agency was unable to

evaluate. Accordingly, incorporating

additional uncertainties would

necessarily increase the size of the

range. For example, the number of

avoided cases of cryptosporidiosis

might be higher or lower than the

number reflected in this range. More

detailed information, including the

basis for these estimates, are described

in the LT1ESWTR economic analysis

(USEPA, 2001a).

A. What Are the Costs of the

LT1ESWTR?

In estimating the costs of today’s final

rule, the Agency considered impacts on

PWSs and on States (including

territories and EPA implementation in

non-primacy States). The LT1ESWTR

will result in increased costs to public

water systems for implementing the

components of today’s final rule. States

will also incur implementation costs.

EPA estimates that the annualized cost

of today’s final rule will be $39.5

million using a three percent discount

rate ($44.8 million using a seven percent

discount rate).

Approximately 84 percent ($33.1

million using a 3 percent discount rate

and $38.2 million using a 7 percent

discount rate) of the rule’s total annual

costs are imposed on drinking water

utilities. States incur the remaining 16

percent ($6.4 million using 3 percent

and $6.6 million using 7 percent) of the

LT1ESWTR’s total annual cost. The

turbidity provisions, which include

treatment changes, monitoring, and

reporting, account for the largest portion

of the total rule costs ($37.7 million

using 3 percent and $42.7 million using

7 percent). Systems will incur most of

the turbidity provision costs and this is

discussed in more detail in the next

section. The national estimate of annual

system costs is based on estimates of

system-level costs for the rule and

estimates of the number of systems

expected to incur each type of cost.

Total capital costs for the LT1ESWTR

(non-annualized) is $173.6 million.

Turbidity Provision Costs—The

turbidity provisions are estimated to

cost both public drinking water systems

and States approximately $37.7 million

annually using a three percent discount

rate ($42.7 million using 7 percent).

However, the majority of these costs

will be borne by the systems and are the

result of treatment changes to meet the

0.3 NTU turbidity standard as well as

the cost for some systems to purchase

turbidimeters in order to meet the

monitoring requirements of this rule.

The Agency estimates that 2,207

systems will modify their water

treatment in response to this rule

provision while 2,327 conventional and

direct filtration systems will need to

install turbidimeters. In addition to the

capital costs associated with this rule

Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations 1823

provision there will also be increases in

operation and maintenance (O&M)

costs. These combined capital and O&M

costs have an estimated cost to systems

of $27.1 million annually using a 3

percent discount rate ($31.8 million

using a 7 percent discount rate). The

O&M expenditures account for 59

percent of the $27.1 million using a 3

percent discount rate ($31.8 million

using a 7 percent discount rate) while

the remaining 41 percent represents

annualized capital costs. In addition to

the turbidity treatment costs, turbidity

monitoring costs apply to all small

surface water or GWUDI systems using

conventional or direct filtration

methods. There are an estimated 5,817

systems that fall under this criterion.

The annualized individual filter

turbidity monitoring cost to PWSs is

approximately $4.5 million using a 3

percent discount rate ($4.7 million

using 7 percent). In addition to the

turbidity treatment and monitoring

costs, individual filter turbidity

exceedance reporting is estimated to

cost systems $0.6 million annually

(using either a 3 percent or 7 percent

discount rate).

The Agency estimated that the total

State cost for the turbidity provision

(monitoring and exceptions) is $6.1

million annually (using either a 3

percent or 7 percent discount rate), with

start-up and monitoring comprising of

81 percent of these annual costs ($4.9

million annually using either a 3

percent or 7 percent discount rate). The

remaining $1.2 million (using either a 3

percent or 7 percent discount rate) in

annual costs includes the costs for

States to review the individual filter

turbidity exceedance reports and

individual filter self-assessment costs.

Disinfection Benchmarking Costs—

The disinfection benchmarking

provision involves three components:

benchmarking, profiling, and optional

monitoring. The start-up costs for this

provision are estimated to cost systems

$2.9 million ($0.2 million annualized

using a three percent discount rate and

$0.3 million using a seven percent

discount rate). Disinfection

benchmarking and profiling are

estimated to cost systems approximately

$0.4 million annually using a 3 percent

discount rate ($0.5 million using 7

percent). TTHM and HAA5 monitoring

is optional and estimated to cost $0.3

million annually using a 3 percent

discount rate ($0.4 million using a 7

percent discount rate). State disinfection

benchmarking annualized costs are

estimated to be $0.4 million using a 3

percent discount rate ($0.5 million

using a 7 percent discount rate). This

estimate includes start-up, compliance

tracking/recordkeeping, and

consultation costs.

Covered Finished Water Reservoir

Provision Costs—The LT1ESWTR

requires that small systems cover all

newly constructed finished water

reservoirs, holding tanks, or other

storage facilities for finished water.

Total annual costs, including

annualized capital costs and one year of

O&M costs are expected to be $0.8

million (using either a 3 percent or 7

percent discount rate) for this provision.

This estimate is calculated from a

projected construction rate of new

reservoirs and unit cost assumptions for

covering new finished water reservoirs.

Also, the Agency believes that this is an

overestimate since there may be

additional States that currently require

finished water requirement.

Although EPA has estimated the cost

of all the rule’s components on drinking

water systems and States, there are some

costs that the Agency did not quantify.

These non-quantifiable costs result from

uncertainties surrounding rule

assumptions and from modeling

assumptions. For example, EPA did not

estimate a cost for systems to acquire

land if they needed to build a treatment

facility or significantly expand their

current facility because the need for and

cost of land is highly system specific.

Additionally, if the cost for land was

prohibitive, an alternative compliance

option may be available (such as

connecting to another source). Once

again, the Agency has not quantified

costs for this scenario due to the high

degree of site specificity. However,

based on evaluations of Comprehensive

Performance Evaluations (CPEs), EPA

believes that most systems possess more

than adequate property to construct new

facilities.

In addition, other LT1ESWTR

provisions may affect some systems but

the Agency was not able to quantify

these costs. These non-quantified costs

include those for systems that incur

incremental costs increases as a result of

including Cryptosporidium in the

definition of GWUDI and also by

including Cryptosporidium in the

watershed control requirements for

unfiltered systems. The Agency lacked

data on the number of systems

potentially affected by these two

provisions and was therefore, unable to

estimate their costs. By including

Cryptosporidium in the definition, more

ground water systems may be

determined to be under the direct

influence of surface water resulting in

additional cost because these systems

must comply with the 1989 Surface

Water Treatment Rule and today’s rule.

EPA also did not estimate the costs for

unfiltered systems to control

Cryptosporidium in their watersheds.

These systems already control for other

pathogens from similar sources as

Cryptosporidium so it is likely that this

provision will have a relatively minor

impact.

B. What Are the Household Costs of the

LT1ESWTR?

The mean annual cost per household

is $6.24 and the cost per household is

less than $15 for 90 percent of 6.3

million households potentially affected

by today’s final rule. Of the remaining

households, nine percent will

experience a range of annual costs from

$15 to $120 ($10/month), while only

one percent of households are estimated

to experience annual costs exceeding

$120.

As indicated in the economic analysis

supporting today’s final rule, perhousehold costs exceed $240/year for

approximately 5,600 households out of

the 6.3 million households potentially

impacted by the LT1ESWTR. However,

this analysis likely overestimates costs

for most of these households, allowing

that systems might choose to incur costs

with up to 28 separate treatment

changes when in fact it is likely to be

more cost-effective to install a new

treatment system. (This can be thought

of as building an automobile piece by

piece from an auto parts store compared

to buying one at a dealership.) The

aforementioned 5,600 households are

associated with the end of the cost

distribution where systems undertake

an unrealistically large number of

treatment changes.

C. What Are the Benefits of the

LT1ESWTR?

The primary benefits of today’s final

rule come from reductions in the risks

of microbial illness from drinking water.

In particular, LT1ESWTR focuses on

reducing the risk associated with

disinfection resistant pathogens, such as

Cryptosporidium. Exposure to other

pathogenic protozoa, such as Giardia, or

other waterborne bacteria, viral

pathogens, and other emerging

pathogens are likely to be reduced by

the provisions of this rule as well, but

are not quantified. In addition,

LT1ESWTR produces non-quantifiable

benefits associated with the risk

reductions that result from the

uncovered reservoir provision,

including Cryptosporidium in GWUDI

definition, and including

Cryptosporidium in watershed

requirements for unfiltered systems.

Non-quantifiable benefits also include

reducing the risks to sensitive

subpopulations and the likelihood of

1824 Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations

incurring costs associated with

outbreaks.

1. Quantifiable Health Benefits

The quantified benefits from this rule

are based solely on the reductions in the

risk of cryptosporidiosis that result from

the turbidity provision. As a result of

data limitation, this analysis only

addresses endemic illness and not

illness that results from epidemic

disease outbreaks. Cryptosporidiosis is

an infection caused by Cryptosporidium

which is an acute, self-limiting illness

lasting 7 to 14 days, with symptoms that

include diarrhea, abdominal cramping,

nausea, vomiting and fever (Juranek,

1995). The monetized value of an

avoided case of cryptosporidiosis is

estimated to range from $796 to $1,411

per case based on a cost-of-illness

methodology (Harrington et al., 1985;

USEPA 2001a). The high end of the

range includes losses for medical costs,

work time, productivity, and leisure

time. However, the low end of the range

only values medical costs and work

time. The medical costs may be

overestimated as they are assumed to be

the same as medical costs for a case of

Giardiasis which has a significantly

longer duration. However, the Agency

believes it is appropriate not to prorate

medical costs for the shorter duration of

Cryptosporidiosis because (1) available

data suggests that the median length of

hospital stays is essentially the same for

Cryptosporidiosis compared to

Giardiasis; (2) the Harrington et al.

study was conducted in the mid-1980’s,

and consequently, the higher direct

medical costs associated with treating

individuals with HIV/AIDS, who are

more severely impacted by

Cryptosporidiosis, was not included;

and (3) Cryptosporidiosis has no known

medical treatment and available data

indicates that the range of the length of

hospital stays for immunocompromised

individuals is larger for cases of

Cryptosporidiosis compared to

Giardiasis. The Agency also recognizes

however, that many individuals with

Cryptosporidiosis do not seek medical

treatment and thus have little or no

associated medical cost, and that the

percentage of such cases may be higher

for Cryptosporidiosis than Giardiasis

given its shorter duration.

The benefits of the turbidity

provisions of LT1ESWTR come from

improvements in filtration performance

at water systems. The benefits analysis

accounts for some of the variability and

uncertainty in the analysis by estimating

benefits under two different current

treatment and three improved removal

assumptions. In addition, EPA used

Monte Carlo simulations to derive a

distribution of estimates to address

uncertainty.

In order to quantify the benefits of

this rule, the Agency estimated changes

in the incidence of cryptosporidiosis

that would result from the rule. The

analysis included estimating the

baseline (pre-LT1ESWTR) level of

exposure and risk from

Cryptosporidium in drinking water and

the reductions in such exposure and

risk resulting from the turbidity

provisions of the LT1ESWTR. 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 LT1ESWTR economic analysis,

the following two assumptions were

made regarding the current

Cryptosporidium oocyst removal

performance to estimate finished water

Cryptosporidium concentrations. First,

based on treatment removal efficiency

data presented in the proposal, EPA

assumed a national distribution of

physical removal efficiencies with a

mean of 2.0 logs and a standard

deviation of 0.63 logs. Because the

finished water concentrations of oocysts

represent the baseline against which

improved removal from the LT1ESWTR

is compared, variations in the log

removal assumption could have

considerable impact on the risk

assessment. Second, to evaluate the

impact of the removal assumptions on

the baseline and resulting

improvements, an alternative mean log

removal/inactivation assumption of 2.5

logs and a standard deviation of 0.63

logs were also used to calculate finished

water concentrations of

Cryptosporidium.

For each of the two baseline

assumptions, EPA assumed that a

certain number of plants would show

low, mid, or high improved removal as

a result of the turbidity provisions. The

amount of improved removal depends

upon factors such as water matrix

conditions, filtered water turbidity

effluent levels, and coagulant treatment

conditions. The low, mid, and high

improved removals were derived from

Patania et al., (1995). This study

demonstrated that an incremental

decrease in turbidity from 0.3 NTU to

0.1 NTU (or a 0.2 NTU reduction

overall) resulted in increased oocyst

removals of up to one-log. The Agency

used this data to construct low, mid,

and high removal assumptions that

would capture uncertainty associated

with improved removal. The Agency

also utilized different low, mid, and

high removal assumptions for distinct

categories of current turbidity

performance (<.2NTU, 0.2–0.3 NTU,

0.3–0.4 NTU, and > 0.4 NTU). For

instance, systems currently operating at

greater than 0.4 NTU would need to

target 0.2 NTU to ensure compliance

with the 0.3 NTU limit and EPA

accordingly assumed a low improved

removal of 0.5-log, a mid improved

removal of 0.75-log and a high improved

removal of 0.9-log. However, systems

currently operating between 0.2 NTU

and 0.3 NTU were only expected to

minimally improve turbidity

performance and would therefore only

expect improved log removals of 0.15,

0.25, and 0.3 (low, mid, and high). As

a result, the economic analysis

considers various baseline and with-rule

scenarios to develop a range of endemic

health damages avoided. Additional

information is found in the Benefits

chapter of the Economic Analysis

supporting today’s final 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 systems currently operating at the

highest filtered water turbidity levels

would show the largest improvements

or high improved removal assumption.

For example, plants now failing to meet

a 0.4 NTU limit would show greater

removal improvements than plants now

meeting a 0.3 NTU limit.

In addition to assuming the more

conservative baseline and removal

assumptions, the lower-end of the

LT1ESWTR’s benefit estimate does not

include valuations for leisure time,

productivity losses (returning to work

but still experiencing symptoms), and

other loss categories that the authors

discuss but do not quantify (e.g., ‘‘high

valued’’ leisure). The authors

(Harrington et al.) were highly confident

in the estimates for direct medical

expenditures and work losses which

comprise the lower benefit estimate; and

less confident in the values for leisure

time losses and productivity losses

which are included in the upper benefit

estimate only. The decreased level of

confidence was based on the data and

methods used to estimate only these

losses. The authors also conclude that:

‘‘* * * nonetheless, the loss categories

in this group–[productivity, leisure

time, etc.] are unquestionably present

and therefore, raise losses above those

reported in [the lower-end benefit

estimate]’’. The Agency believes that

these categories have positive value as

stated in Harrington et al. consequently

the lower-end estimate for the

Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations 1825

LT1ESWTR understates the true value

of these loss categories.

The Agency further notes that the

medical expense component of the

valuation may be overstated because it

is not prorated for the shorter duration

of Cryptosporidiosis relative to

Giardiasis (mean duration of 11.5 v. 41.6

days). The Agency believes this is

appropriate however, because (1)

available data suggests that the median

length of hospital stays is essentially the

same for Cryptosporidiosis compared to

Giardiasis; (2) the Harrington et al.

study was conducted in the mid-1980’s,

and consequently, the higher direct

medical costs associated with treating

individuals with HIV/AIDS, who are

more severely impacted by

Cryptosporidiosis, was not included;

and (3) Cryptosporidiosis has no known

medical treatment and available data

indicates that the range of the length of

hospital stays for immunocompromised

individuals is larger for cases of

Cryptosporidiosis compared to

Giardiasis. The Agency also recognizes

however, that many individuals with

Cryptosporidiosis do not seek medical

treatment and thus have little or no

associated medical cost, and that the

percentage of such cases may be higher

for Cryptosporidiosis than Giardiasis

given its shorter duration.

Table V.1 indicates estimated annual

quantified benefits associated with

implementing the LT1ESWTR. The

benefits analysis examines only the

endemic health damages avoided based

on the LT1ESWTR for each of the

turbidity provision scenarios discussed

previously. For each of these scenarios,

EPA calculated the mean of the

distribution of the number of illnesses

avoided. The 10th and 90th percentiles

imply that there is a 10 percent chance

that the estimated value could be lower

than the 10th percentile and there is a

10 percent chance that the estimated

value could be higher than the 90th

percentile. The modeling assumptions

used to obtain the distribution of illness

and mortality avoided for each baseline

and the removal scenarios considers

both variability and uncertainty.

Specifically, the Agency used a 2-

dimensional Monte Carlo simulation to

include both uncertainty and variability

inputs. The components that EPA

considered uncertain include the

probability of illness given an infection,

the variability of Cryptosporidium to

cause either an infection or illness, and

the infectivity dose-response factor. The

variability components include:

Cryptosporidium occurrence in the

finished water, individual daily

drinking water consumption, and the

number of days per year of exposure. In the 2-dimensional simulation

structure, a set of values for the

uncertainty parameters is chosen from

their respective distributions. This set of

values is then ‘‘frozen’’ and a specified

number of iterations are run where

different values are chosen for the

variability factors. This process is

repeated for some specified number of

sets of uncertainty parameters. For this

analysis, 250 sets of uncertainty

parameters were used, with 1,000

variability iterations performed on each

of the 250 uncertainty sets. This modeling exercise provides the

Agency with 250 sets of statistics for

individual annual risk of illness (e.g.,

mean, standard deviation) that each

reflect different possible combinations

of uncertainty factors. The 250 estimates

for each set of statistics (i.e., mean,

confidence intervals) were then used to

compute an overall population average

annual risk of illness.

Next, the Agency estimates cases of

illness and mortality from the average

annual risk of illness estimates. In order

to do this, the average annual

probability of illness is multiplied by

the number of exposed individuals. In a

separate Monte Carlo simulation for this

calculation, the average annual

probability of illness is treated as an

uncertainty variable. As a result, the

Agency has mean estimates with

confidence intervals for various baseline

and post LT1ESWTR assumptions

regarding Cryptosporidium removal

from source water. The 90th percentile

confidence bounds on the expected

values largely reflect the following

uncertainty variables: the probability of

illness given infection, the variability of

Cryptosporidium to cause either an

infection or illness, and the infectivity

dose-response factor.

The Agency has done its best to

represent a reasonable range of

quantifiable uncertainty using standard

modeling techniques. However, the

Agency recognizes that additional

sources of uncertainty exist which could

not be quantified. To the extent that

these are significant, the true range of

uncertainty may be greater than that

reflected in the quantified analysis.

EPA has evaluated drinking water

consumption data from USDA’s 1994–

1996 Continuing Survey of Food Intakes

by Individuals (CSFII) Study. EPA’s

analysis of the CSFII Study using the

‘‘all sources, consumer only’’

information resulted in a daily water

ingestion lognormally distributed with a

mean of 1.2 liters per person per day

(USEPA, 2000j). Results of alternative

model calculations based on USDA

consumption data for ‘‘community

water supplies, all respondents’’ (mean

of 0.93 liters per person per day) are

presented in the appendix to the

economic analysis as a lower bound

estimate.

TABLE V.1.—QUANTIFIED BENEFITS FROM ILLNESSES AND MORTALITIES AVOIDED ANNUALLY FROM TURBIDITY

PROVISIONS

[$Millions]*

Quantified benefits

Daily drinking water ingestion and baseline Cryptosporidium log-removal assumptions, $Millions, 1999

2.0 log 2.5 log

Low Mild High Low Mid High

Mean Benefit from Avoided Illnesses ...................................... $23.9–$42.4 $31.6–$56.0 $32.9–$58.3 $9.5–$16.8 $11.2–$19.8 $12.7–$22.6

10th Percentile ...................... 11.4–20.3 15.2–27.0 14.1–24.9 2.2–3.9 2.8–5.0 4.2–7.5

90th Percentile ...................... 50.1–88.8 58.8–104.2 56.5–100.2 26.6–47.2 27.6–48.9 33.6–59.5

Mean Benefits from Avoided Mortalities ....................................... 23.7 31.3 32.5 9.4 11.1 12.6

10th Percentile ...................... 11.3 15.0 13.9 2.2 2.8 4.2

90th Percentile ...................... 49.6 58.2 55.9 26.3 27.3 33.2

Total Mean Quantified Benefits ...................................... 47.6–66.1 62.9–87.3 65.4–90.9 18.9–26.2 22.2–30.9 25.4–35.2

* Totals may not equal due to rounding.

1826 Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations

According to the economic analysis

performed for the LT1ESWTR published

today, the rule is estimated to reduce

the mean annual number of illnesses

caused by Cryptosporidium in water

systems with improved filtration

performance by 12,000 to 41,000 cases

per year depending upon which of the

six baseline and improved

Cryptosporidium removal assumptions

was used, and assuming the 1.2 liter

drinking water consumption

distribution. Based on these values, the

mean estimated annual benefits of

reducing the illnesses ranges from $9.5

million to $58.3 million per year. The

economic analysis also indicated that

the rule could result in a mean

reduction of 1 to 5 fatalities each year,

depending upon the varied baseline and

improved removal assumptions. Using a

mean value of $6.3 million per

statistical life saved, reducing these

fatalities could produce benefits in the

range of $9.4 million to $32.5 million.

Combining the value of illness and

mortalities avoided, the estimate of the

total quantified annual benefits of the

LT1ESWTR range from $18.9 million to

$90.9 million. However, this range does

not incorporate many of the sources of

uncertainty related to quantifying

benefits, including many benefits the

Agency was unable to evaluate.

Accordingly, incorporating additional

uncertainties would necessarily increase

the size of the range.

New occurrence data and infectivity

data is currently being evaluated by the

Agency in the context of the Long Term

2 Enhanced Surface Water Treatment

Rule (LT2ESWTR). The analysis is

currently ongoing and peer review has

not been completed. EPA conducted a

sensitivity analysis in the economic

analysis supporting today’s final rule to

predict the effect that new data may

have on the benefits presented earlier.

Table V.2 provides a summary of this

sensitivity analysis and depicts the

cumulative change to the benefits range

that each of the four new changes (new

occurrence data, new infectivity data,

new morbidity data, and new viability

data) could have on benefits. The

economic analysis includes a more

detailed analysis using this data.

TABLE V.2.—SUMMARY OF RESULTS OF SENSITIVITY ANALYSIS TO PREDICT EFFECTS OF NEW DATA AND INFORMATION

ON RANGE OF BENEFITS

Current EA New occurence data New infectivity data New morbidity data New viability data

Change ....................... No Changes .............. Occurrence changes

from 4.7 oocyst/L

to 1.06 oocyst/L.

Rate of infection from

.00424 to .02317.

Morbidity changes

from 0.39 to 0.5.

Viability changes from

16.4 percent to

55.2 percent.

Benefits Range ........... $18.9–$90.9 .............. $5.4–$25.2 ................ $17.3–$74.4 .............. $22.5–$88.0 .............. $51.2–$195.8

2. Non-Quantified Health and NonHealth Related Benefits

The quantified benefits from filter

performance improvements do not fully

capture all the benefits of the turbidity

provision. Even the upper bound

estimates, which are based on a cost-ofillness (COI) methodology (expanded to

incorporate lost leisure time and lost

productivity while working), may not

fully capture the willingness-to-pay to

avoid a case of Cryptosporidiosis. In

addition, the Harrington, et al. study

was conducted in the mid-1980’s in a

rural community and may not be fully

representative of the current national

population including individuals with

HIV/AIDS and chemotherapy patients

that are more severely impacted by

Cryptosporidiosis. If this population

was more accurately represented, it may

be that the average per-case valuation

would be higher than the range

presented in this analysis. Further, the

turbidity provisions are also expected to

decrease the risk of waterborne disease

outbreaks. However, the quantified

benefits reflect only the reduction in

endemic Cryptosporidiosis and not any

outbreak-related illness or mortalities.

Other disinfection resistant pathogens

may also be removed more efficiently

due to implementation of the

LT1ESWTR. Exposure to other

pathogenic protozoa, such as Giardia, or

other waterborne bacterial or viral

pathogens are likely to be reduced by

the provisions of this rule as well.

In addition to preventing illnesses,

this rule is expected to have other nonhealth related benefits. During an

outbreak, local governments and water

systems must issue warnings and alerts

and may need to provide an alternative

source of water. Systems also face

negative publicity and possibly legal

costs. Businesses have to supply their

customers and employees with

alternative sources of water and some,

especially restaurants, may even have to

temporarily close. Households also have

to boil their water, purchase water, or

obtain water from another source. A

study of a Giardia outbreak in Luzerne

County, Pennsylvania showed that these

non-health related outbreak costs can be

quite significant (Harrington et al.,

1985). This outbreak resulted in an

estimated loss to individuals of $31

million to $92 million. Additional

losses were also calculated for

restaurants and bars ($2 million to $7

million), government agencies ($0.4

million) and the water supply utility ($3

million).

The remaining rule provisions

(disinfection benchmarking, covered

finished water reservoirs, inclusion of

Cryptosporidium in the GWUDI

definition, and inclusion of

Cryptosporidium in watershed control

requirements for unfiltered systems)

provide additional benefits. However,

EPA is only able to discuss the benefits

of these rule provisions qualitatively

because of data limitations. The

disinfection benchmark provision will

ensure that adequate microbial

protection is in place if a system must

make changes to its disinfection

practices as a result of the Stage 1 DBP

rule. Covering finished water reservoirs

will protect the finished water from

becoming re-contaminated from such

things as animal or bird droppings,

surface water runoff, and algae. If

Cryptosporidium is found in ground

water supplies, they will be required to

change treatment practice to prevent

illness. Finally, by requiring

Cryptosporidium control in watersheds

of unfiltered systems, this will minimize

the potential for illness and may also

lower the overall costs of drinking water

treatment.

D. What Are the Incremental Costs and

Benefits?

EPA evaluated the incremental or

marginal costs of today’s final rule

turbidity provision by analyzing various

turbidity limits, 0.3 NTU, 0.2 NTU, and

0.1 NTU. For each turbidity limit, EPA

developed assumptions about which

process changes systems might

implement to meet the turbidity level

and how many systems would adopt

each change. The comparison of total

compliance cost estimates shows that

costs are expected to increase

Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations 1827

significantly across other turbidity

limits considered by the Agency. The

total cost of a 0.2 NTU limit is 346

percent higher than the final rule limit

of 0.3 NTU, and a 0.1 NTU limit would

be 1,192 percent higher.

E. Are There Benefits From the

Reduction of Co-Occurring

Contaminants?

If a system chooses to install

treatment, it may choose a technology

that would also address other drinking

water contaminants. For example, some

membrane technologies installed to

remove bacteria or viruses can reduce or

eliminate many other drinking water

contaminants including arsenic.

The technologies used to reduce

individual filter turbidities have the

potential to reduce concentrations of

other pollutants as well. Reductions in

turbidity that result from today’s

proposed rule are aimed at reducing

Cryptosporidium by physical removal.

However, health risks from Giardia

lamblia and emerging disinfection

resistant pathogens, such as

microsporidia, Toxoplasma, and

Cyclospora, are also likely to be reduced

as a result of improvements in turbidity

removal. The frequency and extent that

LT1ESWTR would reduce risk from

other contaminants has not been

quantitatively evaluated because of the

Agency’s lack of data on the removal

efficiencies of various technologies for

emerging pathogens and the lack of cooccurrence data for microbial pathogens

and other contaminants from drinking

water systems.

F. Is There Increased Risk From Other

Contaminants?

It is unlikely that LT1ESWTR will

result in any increased risk from other

contaminants. Improvements in plant

turbidity performance will not result in

any increases in risk. In fact the

disinfection benchmarking component

of today’s final LT1ESWTR will provide

information to systems so they can

minimize the increased risk from

microbial contaminants as they take

steps to address risks associated with

DBPs under the Stage 1 DBPR.

G. What Are the Uncertainties in the

Risk, Benefit and Cost Estimates for the

LT1ESWTR?

EPA has included in the economic

analysis, a detailed discussion of the

possible sources of uncertainty in risk,

benefit and cost estimates. Some sources

of possible uncertainty associated with

calculation of risk and benefits include

occurrence of Cryptosporidium oocysts

in source waters and finished waters,

reduction of Cryptosporidium oocysts

due to improved treatment, viability and

infectivity of Cryptosporidium oocysts,

characterization of risk, and willingness

to reduce risk and avoid costs.

Uncertainty associated with costs

includes assumptions with respect to

treatment a system might choose to

employ to comply with the rule,

assumptions about costs of labor,

maintenance, and capital, and the

number of systems expected to

undertake certain activities. The Agency

believes that the risks, benefits, and

costs have been accurately portrayed.

Discussions and analyses of risks,

benefits, and costs in the economic

analysis indicate where uncertainty may

be introduced and to the extent

possible, the effect uncertainty may

have on analysis (USEPA, 2001a).

H. What Is the Benefit/Cost

Determination for the LT1ESWTR?

The Agency has determined that the

benefits of the LT1ESWTR justify the

costs. As shown in Table V.3, the

quantified net benefits of this rule based

on the Agency’s estimate range from

$20.6 million to $51.4 million using the

3 percent discount rate ($25.9 million to

$46.1 million at the 7 percent discount

rate). Additionally, EPA believes that

quantified net benefits would be larger

if both unquantified benefits and costs

were able to be monetized.

TABLE V.3.—ANNUALIZED NET BENEFITS OF THE LT1ESWTR, MILLIONS, 1999 DOLLARS

Benefit range

Costs using a 3

percent discount rate

Costs using a 7

percent discount rate

Net benefits (3

percent)

Net benefits (7

percent)

Estimate of Benefits ................................................... $18.9–$90.9 $39.5 $44.8 $¥20.6–$51.4 $¥25.9–$46.1

VI. Other Requirements

A. Regulatory Flexibility Act (RFA), as

Amended by the Small Business

Regulatory Enforcement Fairness Act of

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

The RFA generally requires an agency

to prepare a regulatory flexibility

analysis of any rule subject to notice

and comment rulemaking requirements

under the Administrative Procedure Act

or any other statute unless the agency

certifies that the rule will not have a

significant economic impact on a

substantial number of small entities.

Small entities include small businesses,

small organizations, and small

governmental jurisdictions.

The RFA provides default definitions

for each type of small entity. It also

authorizes an agency to use alternative

definitions for each category of small

entity, ‘‘which are appropriate to the

activities of the agency’’ after proposing

the alternative definition(s) in the

Federal Register and taking comment. 5

U.S.C. 601(3)–(5). In addition to the

above, to establish an alternative small

business definition, agencies must

consult with SBA’s Chief Counsel for

Advocacy.

For purposes of assessing the impacts

of today’s rule on small entities, EPA

considered small entities to be PWSs

serving fewer than 10,000 persons. This

is the cut-off level specified by Congress

in the 1996 Amendments to the SDWA

for small system flexibility provisions.

In accordance with the RFA

requirements, EPA proposed using this

alternative definition in the Federal

Register (63 FR 7620, February 13,

1998), requested comment, consulted

with the Small Business Administration

(SBA), and expressed its intention to

use the alternative definition for all

future drinking water regulations in the

Consumer Confidence Reports

regulation (63 FR 44511, August 19,

1998). As stated in that final rule, the

alternative definition would be applied

to this regulation as well.

After considering the economic

impacts of today’s final rule on small

entities, I certify that this action will not

have a significant economic impact on

a substantial number of small entities.

In accordance with section 603 of the

RFA, EPA convened a Small Business

Advocacy Review (SBAR) Panel to

obtain advice and recommendations

from representatives of small entities

that would potentially be regulated by

the rule in accordance with section

609(b) of the RFA. A detailed discussion

of the Panel’s advice and

recommendations is found in the Panel

Report found in the docket for today’s

final rule (USEPA, 1998k). The Panel

recommendations emphasized the need

to provide small systems flexibility. The

Agency has structured today’s final

1828 Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations

LT1ESWTR with an emphasis on

providing flexibility and reducing

burden for small systems. For example,

the Agency originally contemplated

requiring four quarters of TTHM and

HAA5 monitoring and disinfection

profiling based on daily measurements.

Today’s final rule requires profiling

based on weekly measurements and

allows systems the option of using one

quarter of TTHM and HAA5 monitoring

to opt-out of profiling. Today’s rule also

provides systems with two or fewer

filters the flexibility to monitor

combined filter effluent in lieu of

individual filter turbidity monitoring,

effectively allowing these systems to

reduce their recordkeeping burden. A

complete summary of the Panel’s

recommendations is presented in the

proposal (65 FR 19046, 19127–19130).

While EPA could have certified the

proposed rule based on the proposed

rule requirements, the Agency originally

developed an IRFA (see 65 FR 19046,

19126–19127) and convened an SBAR

Panel because several of the additional

alternatives EPA was requesting

comment on would have resulted in

substantial costs for small systems

thereby preventing the Agency from

certifying. While EPA included these

additional alternatives in the proposal

and estimated costs in the economic

analysis for the proposal, the Agency reevaluated the economic effects on small

entities after publication of the April 10,

2000 LT1ESWTR proposal using the

rule requirements of today’s final rule

and was able to certify that today’s final

rule will not have a significant

economic impact on a substantial

number of small entities.

EPA’s analysis showed that of the

approximately 11,000 small entities

potentially affected by the LT1ESWTR,

over 5,000 are expected to incur average

annualized costs of less than $70 dollars

(0.003 percent of average annual

revenue) while slightly more than 3,000

are expected to incur average

annualized costs of less than $850

dollars (0.03 percent of average annual

revenue). Of the remaining systems,

approximately 500 systems are expected

to incur average annualized costs of

approximately $2,500 dollars (0.1

percent of average annual revenue),

approximately 2,000 systems are

expected to incur average annualized

costs of approximately $13,000 dollars

(0.6 percent of average annual revenue).

Less than 100 systems are expected to

incur average annualized costs of

approximately $15,700 dollars (0.7

percent of average annual revenue). The

Agency has included a detailed

description of this analysis in the

Regulatory Flexibility Screening

Analysis prepared for the rule (USEPA,

2000e).

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 2040–0229. The

information collected as a result of this

rule will allow the States and EPA to

determine appropriate requirements for

specific systems, in some cases, and to

evaluate compliance with the rule. For

the first three years after February 13,

2002, the major information

requirements are related to disinfection

profiling activities. The information

collection requirements in §§ 141.530–

141.536, 141.540–141.544, 141.550–

141.553, 141.560–141.564, and 141.570–

141.571, for systems, and §§ 142.14 and

142.16, for States, are mandatory. The

information collected is not

confidential. The final estimate of

aggregate annual average burden hours

for LT1ESWTR is 330,329. Annual

average aggregate cost estimate is

$1,583,538 for capital (expenditures for

monitoring equipment), and $1,919,563

for operation and maintenance

including lab costs (which is a purchase

of service). The burden hours per

response is 21.8. The frequency of

response (average responses per

respondent) is 2.8 annually. The

estimated number of likely respondents

is 5,404 (the product of burden hours

per response, frequency, and

respondents does not total the annual

average burden hours due to rounding).

Burden means the total time, effort, or

financial resources expended by persons

to generate, maintain, retain, or disclose

or provide information to or for a

Federal agency. This includes the time

needed to review instructions; develop,

acquire, install, and utilize technology

and systems for the purposes of

collecting, validating, and verifying

information; processing and

maintaining information, and disclosing

and providing information; adjust the

existing ways to comply with any

previously applicable instructions and

requirements; train personnel to be able

to respond to a collection of

information; search data sources;

complete and review the collection of

information; and transmit or otherwise

disclose the information.

An Agency may not conduct or

sponsor, and a person is not required to

respond to a collection of information

unless it displays a currently valid OMB

control number. The OMB control

numbers for EPA’s regulations are listed

in 40 CFR part 9 and 48 CFR Chapter

15. 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.

C. Unfunded Mandates Reform Act

1. Summary of UMRA Requirements

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA), Public

Law 104–4, establishes requirements for

Federal agencies to assess the effects of

their regulatory actions on State, local,

and Tribal governments and the private

sector. Under UMRA section 202, EPA

generally must prepare a written

statement, including a cost-benefit

analysis, for proposed and final rules

with ‘‘Federal mandates’’ that may

result in expenditures by State, local,

and Tribal governments, in the

aggregate, or by the private sector, of

$100 million or more in any one year.

Before promulgating an EPA rule for

which a written statement is needed,

section 205 of the UMRA generally

requires EPA to identify and consider a

reasonable number of regulatory

alternatives and adopt the least costly,

most cost-effective or least burdensome

alternative that achieves the objectives

of the rule. The provisions of section

205 do not apply when they are

inconsistent with applicable law.

Moreover, section 205 allows EPA to

adopt an alternative other than the least

costly, most cost effective or least

burdensome alternative if the

Administrator publishes with the final

rule an explanation why that alternative

was not adopted.

Before EPA establishes any regulatory

requirements that may significantly or

uniquely affect small governments,

including Tribal governments, it must

have developed, under section 203 of

the UMRA, a small government agency

plan. The plan must provide for

notifying potentially affected small

governments, enabling officials of

affected small governments to have

meaningful and timely input in the

development of EPA regulatory

proposals with significant Federal

intergovernmental mandates and

informing, educating, and advising

small governments on compliance with

the regulatory requirements.

EPA has determined that this rule

does not contain a Federal mandate that

may result in expenditures of $100

million or more for State, local and

Tribal governments, in the aggregate, or

the private sector in any one year. The

estimated annual cost of this rule is

$39.5 million. Thus today’s rule is not

Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations 1829

subject to the requirements of sections

202 and 205 of the UMRA.

EPA has determined that this rule

contains no regulatory requirements that

might significantly or uniquely affect

small governments. Of the

approximately 6,500 small government

entities potentially affected by the

LT1ESWTR, approximately 3,000 are

expected to incur average annualized

costs of less than $70 dollars (0.003

percent of average annual revenue)

while approximately 2,000 are expected

to incur average annualized costs of less

than $850 dollars (0.03 percent of

average annual revenue). Of the

remaining systems, less than 300 are

expected to incur average annualized

costs of approximately $2,500 dollars

(0.1 percent of average annual revenue),

approximately 1,200 systems are

expected to incur average annualized

costs of approximately $13,000 dollars

(0.6 percent of average annual revenue).

Less than 100 systems are expected to

incur average annualized costs of

approximately $15,700 dollars (0.7

percent of average annual revenue).

While today’s final rule only applies to

systems serving fewer than 10,000, it is

not unique as it provides a comparable

level of health protection to individuals

served by small systems as the IESWTR

provided to individuals served by large

systems. While there are small

differences between the LT1ESWTR and

IESWTR, these differences reflect an

effort to reduce burden for small

systems while still maintaining a

comparable level of health protection.

Thus, today’s rule is not subject to the

requirements of section 203 of UMRA.

Nevertheless, EPA has tried to ensure

that State, local, and Tribal governments

had opportunities to provide comment.

EPA consulted with small governments

to address impacts of regulatory

requirements in the rule that might

significantly or uniquely affect small

governments. As discussed next, a

variety of stakeholders, including small

governments, were provided the

opportunity for timely and meaningful

participation in the regulatory

development process. EPA used these

opportunities to notify potentially

affected small governments of regulatory

requirements being considered.

EPA began outreach efforts to develop

the LT1ESWTR in the summer of 1998.

Two public stakeholder meetings,

which were announced in the Federal

Register, were held on July 22–23, 1998,

in Lakewood, Colorado, and on March

3–4, 1999, in Dallas, Texas.

Stakeholders include representatives of

State, local and Tribal governments,

environmental groups and publicly

owned and privately owned public

water systems. In addition to these

meetings, EPA has held several formal

and informal meetings with

stakeholders including the Association

of State Drinking Water Administrators

and representatives of State and local

elected officials. A summary of each

meeting and attendees is available in the

public docket for this rule. EPA also

convened a Small Business Advocacy

Review (SBAR) Panel in accordance

with the RFA, as amended by the Small

Business Regulatory Enforcement

Fairness Act (SBREFA) to address small

entity concerns including those of small

local governments. The SBAR Panel

allows small regulated entities to

provide input to EPA early in the

regulatory development process. In

early June 1999, EPA mailed an

informal draft of the LT1ESWTR

preamble to the approximately 100

stakeholders who attended one of the

public stakeholder meetings. Members

of trade associations and the SBREFA

Panel also received the draft preamble.

EPA received valuable suggestions and

stakeholder input from 15 State

representatives, trade associations,

environmental interest groups, and

individual stakeholders. The majority of

concerns dealt with reducing burden on

small systems and maintaining

flexibility.

To inform and involve Tribal

governments in the rulemaking process,

EPA presented the LT1ESWTR at three

venues: the 16th Annual Consumer

Conference of the National Indian

Health Board, the annual conference of

the National Tribal Environmental

Council, and the EPA/Inter Tribal

Council of Arizona, Inc. Tribal

consultation meeting. Over 900

attendees representing Tribes from

across the country attended the National

Indian Health Board’s Consumer

Conference and over 100 Tribes were

represented at the annual conference of

the National Tribal Environmental

Council. At the first two conferences, an

EPA representative conducted two

workshops on EPA’s drinking water

program and upcoming regulations,

including the LT1ESWTR.

At the EPA/Inter Tribal Council of

Arizona meeting, representatives from

15 Tribes participated. The presentation

materials and meeting summary were

sent to over 500 Tribes and Tribal

organizations. Additionally, EPA

contacted each of the 12 Native

American Drinking Water State

Revolving Fund Advisors to invite

them, and representatives of their

organizations to the stakeholder

meetings described previously.

During the comment period for

today’s final rule, the Agency held a

public meeting in Washington D.C. on

April 14, 2000. Additionally, the

proposed rule was either presented or

discussed in nearly 50 meetings across

the U.S. Finally, EPA mailed

approximately 200 copies of the

proposed rule to stakeholders requesting

comment. EPA received 67 comments

from a variety of stakeholders including

24 States, 21 municipalities, one Tribe,

one elected official, two consultants,

eight trade groups, and four private

industries.

In addition, EPA will educate, inform,

and advise small systems, including

those run by small governments, about

the LT1ESWTR requirements. The

Agency is developing plain-English

guidance that will explain what actions

a small entity must take to comply with

the rule. Also, the Agency has

developed a fact sheet that concisely

describes various aspects and

requirements of the LT1ESWTR. This

fact sheet is available by calling the Safe

Drinking Water Hotline at 800–426–

4791.

D. National Technology Transfer and

Advancement Act

As noted in the proposed rule, section

12(d) of the National Technology

Transfer and Advancement Act of 1995

(NTTAA), Public Law No. 104–113,

section 12(d) (15 U.S.C. 272 note),

directs EPA to use voluntary consensus

standards in its regulatory activities

unless to do so would be inconsistent

with applicable law or otherwise

impractical. Voluntary consensus

standards are technical standards (e.g.,

materials specifications, test methods,

sampling procedures, and business

practices) that are developed or adopted

by voluntary consensus standards

bodies. The NTTAA directs EPA to

provide Congress, through the Office of

Management and Budget, explanations

when the Agency decides not to use

available and applicable voluntary

consensus standards.

Today’s rule does not establish any

technical standards, thus, NTTAA does

not apply to this rule. It should be

noted, however, that systems complying

with this rule need to use one of three

previously approved technical

standards already included in § 141.74

(a). Method 2130B (APHA, 1995), is

published in Standard Methods for the

Examination of Water and Wastewater

(19th ed.) and is a voluntary consensus

standard. The Great Lakes Instrument

Method 2, has been approved by USEPA

as an alternate test procedure (Great

Lakes Instruments, 1992). EPA Method

180.1 for turbidity measurement was

published in August 1993 in Methods

for the Determination of Inorganic

1830 Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations

Substances in Environmental Samples

(EPA–600/R–93–100) (USEPA, 1993).

Today’s final rule also requires

calibration of the individual

turbidimeter to be conducted using

procedures specified by the

manufacturer. EPA encouraged

comments on this aspect of the

rulemaking and specifically invited the

public to identify potentially applicable

voluntary consensus standards and to

explain why such standards should be

used in this regulation. EPA received no

comments on this issue.

E. Executive Order 12866: Regulatory

Planning and Review

Under Executive Order 12866 (58 FR

51735, 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, 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 the Executive

Order 12866, it has been determined

that this rule is a ‘‘significant regulatory

action.’’ As such, this action was

submitted to OMB for review. Changes

made in response to OMB suggestions or

recommendations are documented in

the public record.

F. Executive Order 12898:

Environmental Justice

Executive Order 12898 establishes a

Federal policy for incorporating

environmental justice into Federal

agency missions by directing agencies to

identify and address disproportionately

high and adverse human health or

environmental effects of its programs,

policies, and activities on minority and

low-income populations. The Agency

has considered environmental justice

related issues concerning the potential

impacts of this action and consulted

with minority and low-income

stakeholders.

This preamble has discussed how the

IESWTR served as a template for the

development of the LT1ESWTR. As

such, the Agency also built on the

efforts conducted during the IESWTRs

development to comply with Executive

Order 12898. On March 12, 1998, the

Agency held a stakeholder meeting 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 11 cities. This

meeting was a continuation of

stakeholder meetings that started in

1995 to obtain input on the Agency’s

Drinking Water Programs. The major

objectives for the March 12, 1998

meeting were to:

—Solicit ideas from stakeholders on

known issues concerning current

drinking water regulatory efforts;

—Identify key issues of concern to

stakeholders, and;

—Receive suggestions from stakeholders

concerning ways to increase

representation of communities in

EPA’s Office of Water drinking water

regulatory efforts.

In addition, EPA developed a plainEnglish guide specifically for this

meeting to assist stakeholders in

understanding the multiple and

sometimes complex issues surrounding

drinking water regulation.

The LT1ESWTR applies to

community water systems, nontransient non-community water

systems, and transient non-community

water systems that use surface water or

GWUDI as their source water for PWSs

serving less than 10,000 people. These

requirements will also be consistent

with the protection already afforded to

people being served by systems serving

10,000 or more persons.

G. Executive Order 13045: Protection of

Children From Environmental Health

Risks and Safety Risks

Executive Order 13045: ‘‘Protection of

Children from Environmental Health

Risks and Safety Risks’’ (62 FR 19885,

April 23, 1997) applies to any rule that:

(1) Is determined to be economically

significant as defined under Executive

Order 12866, and; (2) concerns an

environmental health or safety risk that

EPA has reason to believe may have a

disproportionate effect on children. If

the regulatory action meets both criteria,

the Agency must evaluate the

environmental health or safety effects of

the planned rule on children and

explain why the planned regulation is

preferable to other potentially effective

and reasonably feasible alternatives

considered by the Agency.

While this final rule is not subject to

the Executive Order because it is not

economically significant as defined in

Executive Order 12866, we nonetheless

have reason to believe that the

environmental health or safety risk

addressed by this action may have a

disproportionate effect on children. As

a matter of EPA policy, we therefore

have assessed the environmental health

effects of Cryptosporidium on children.

The results of this assessment are

contained in the LT1ESWTR economic

analysis (USEPA, 2001a). A copy of the

analysis and supporting documents are

found in the public docket for today’s

final rule (W–99–10, Final Long Term 1

Enhanced Surface Water Treatment

Rule. The docket is available for public

review at EPA’s Drinking Water Docket:

401 M Street, SW., Rm. EB57,

Washington, DC 20460.

The risk of illness and death due to

cryptosporidiosis depends on several

factors, including age, nutrition,

exposure, genetic variability, disease

and immune status of the individual.

Mortality resulting from diarrhea shows

the greatest risk of mortality occurring

among the very young and elderly

(Gerba et al., 1996). For

Cryptosporidium, young children are a

vulnerable population subject to

infectious diarrhea (CDC 1994).

Cryptosporidiosis is prevalent

worldwide, and its occurrence is higher

in children than in adults (Fayer and

Ungar, 1986).

Cryptosporidiosis appears to be more

prevalent in populations, such as

infants, that may not have established

immunity against the disease and may

be in greater contact with

environmentally contaminated surfaces

(DuPont, et al., 1995). An infected child

may spread the disease to other children

or family members. Evidence of such

secondary transmission of

cryptosporidiosis from children to

household and other close contacts has

been found in a number of outbreak

investigations (Casemore, 1990; Cordell

et al., 1997; Frost et al., 1997). Chapelle

et al., (1999) found that prior exposure

to Cryptosporidium through the

ingestion of a low oocyst dose provides

protection from infection and illness.

However, it is not known whether this

immunity is life-long or temporary. Data

Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations 1831

also indicate that either mothers confer

short term immunity to their children or

that babies have reduced exposure to

Cryptosporidium, resulting in a

decreased incidence of infection during

the first year of life. For example, in a

survey of over 30,000 stool sample

analyses from different patients in the

United Kingdom, the one to five year

age group suffered a much higher

infection rate than individuals less than

one year of age. For children under one

year of age, those older than six months

of age showed a higher rate of infection

than individuals aged fewer than six

months (Casemore, 1990).

EPA has not been able to quantify the

health effects for children as a result of

Cryptosporidium-contaminated

drinking water. However, the result of

the LT1ESWTR will be a reduction in

the risk of illness for the entire

population, including children. Because

available evidence indicates that

children may be more vulnerable to

Cryptosporidiosis than the rest of the

population, the LT1ESWTR would,

therefore, result in greater risk reduction

for children than for the general

population.

H. Consultations With the Science

Advisory Board, National Drinking

Water Advisory Council, and the

Secretary of Health and Human Services

In accordance with section 1412 (d)

and (e) of the SDWA, the Agency

consulted with the National Drinking

Water Advisory Council (NDWAC), the

Secretary of Health and Human

Services, and the EPA Science Advisory

Board (SAB) on the proposed

LT1ESWTR. None of the three

consultations resulted in substantive

comments on the LT1ESWTR.

On March 13 and 14, 2000 in

Washington, DC, the Agency met with

SAB during meetings open to the public

where several of the Agency’s drinking

water rules were discussed. A copy of

the SAB’s comments are found in the

docket (USEPA, 2000l). Comments on

the LT1ESWTR were generally

supportive.

On May 10, 2000 in San Francisco,

California, the Agency met with

NDWAC. A copy of the materials

presented to the NDWAC, as well as the

charge presented to the council are

found in the docket (USEPA, 2000f,

NDWAC, 2000).

EPA invited the Secretary of Health

and Human Services to the April 14th,

2000 informational meeting regarding

the proposed Long Term 1 Enhanced

Surface Water Treatment Rule and

consulted with the Centers for Disease

Control (CDC) during a June 20, 2000

conference call with the Centers’

Working Group on Waterborne

Cryptosporidiosis. The meeting notes

for that call are found in the docket

(CDC, 2000). CDC’s role as an Agency of

the Department of Health and Human

Services is to provide a system of health

surveillance to monitor and prevent the

outbreak of diseases. With the assistance

of States and other partners, CDC guards

against international disease

transmission, maintains national health

statistics, and provides for

immunization services and supports

research into disease and injury

prevention.

I. Executive Order 13132: Executive

Orders on Federalism

Executive Order 13132, entitled

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

1999), requires EPA to develop an

accountable process to ensure

‘‘meaningful and timely input by State

and local officials in the development of

regulatory policies that have federalism

implications.’’ ‘‘Policies that have

federalism implications’’ is defined in

the Executive Order to include

regulations that have ‘‘substantial direct

effects on the States, on the relationship

between the national government and

the States, or on the distribution of

power and responsibilities among the

various levels of government.’’

This final rule does not have

federalism implications. It will not have

substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132. Today’s final

rule does not have a substantial direct

effect on local and State governments

because it is not expected to impose

substantial direct compliance costs. The

rule imposes annualized compliance

costs on State and local governments of

approximately $30.6 million. $6.4

million of these costs are attributable to

States, while $24.2 million is

attributable to local governments

serving fewer than 10,000 persons. As

described in Section V1.A of the

preamble for today’s final rule, this rule

will not have a significant economic

impact on a substantial number of small

entities, including small governments.

Furthermore, the rule does not have a

substantial direct effect on the

relationship between the national

government and the States, or the

distribution of power and

responsibilities among the various

levels of government as specified in

Executive Order 13132 because the rule

does not change the current roles and

relationships of the Federal government,

State governments and local

governments in implementing drinking

water programs. Thus Executive Order

13132 does not apply to this rule.

Although the Executive Order does not

apply to this rule, EPA did consult with

State and local officials in developing

this rule. In addition to our outreach

efforts described earlier, on May 30,

2000, the Agency held a meeting in

Washington, DC with ten

representatives of elected State and

local officials to discuss how new

Federal drinking water regulations

(LT1ESWTR, FBRR, Ground Water Rule,

Radon Rule, Radionuclides Rule, and

Arsenic Rule) may affect State, county,

and local governments. Throughout the

consultation, stakeholders asked EPA

for clarification of basic concepts and

rule elements. EPA addressed these

issues throughout the consultation and

provided background and clarification

to promote better understanding of the

issues. For example, stakeholders asked

EPA to describe what Cryptosporidium

is and how individuals are diagnosed

with cryptosporidiosis. A detailed

summary of this consultation meeting

and the concerns raised is found in the

docket (USEPA, 2000g). No significant

concerns were raised regarding the

LT1ESWTR.

J. Executive Order 13175: Consultation

and Coordination With Indian Tribal

Governments

On November 6, 2000, the President

issued Executive Order 13175 (65 FR

67249) entitled, ‘‘Consultation and

Coordination with Indian Tribal

Governments.’’ Executive Order 13175

took effect on January 6, 2001, and

revoked Executive Order 13084 (also

entitled Consultation and Coordination

with Indian Tribal Governments.’’) as of

that date. However, EPA developed and

proposed this final rule when Executive

Order 13084 was in effect, and before

the effective date of the consultation

requirements of Executive Order 13175.

Therefore, the consultation

requirements of Executive Order 13084

apply to this rule.

Under Executive Order 13084, EPA

could not issue a regulation that was not

required by statute, that significantly or

uniquely affected the communities of

Indian Tribal governments, and that

imposed substantial direct compliance

costs on those communities, unless the

Federal government provided the funds

necessary to pay the direct compliance

costs incurred by the Tribal

governments, or EPA consulted with

those governments.

Executive Order 13084 required EPA

to provide to the Office of Management

and Budget, in a separately identified

1832 Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations

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 required EPA to develop an

effective process permitting elected

officials and other representatives of

Indian Tribal governments ‘‘to provide

meaningful and timely input in the

development of regulatory policies on

matters that significantly or uniquely

affect their communities.’’

EPA has concluded that this rule will

not significantly or uniquely affect

communities of Indian Tribal

governments, and will not impose

substantial direct compliance costs on

such communities. This rule will affect

approximately 70 of the 700 total Tribal

drinking water systems. Of these 70

systems, half are estimated to incur

annualized compliance costs of less

than $70 per year (0.003 percent of

average annual revenue) and

approximately 20 systems are estimated

to incur annualized compliance costs of

less than $850 per year (0.03 percent of

average annual revenue). The remaining

systems would incur an estimated

annualized compliance costs of less

than $13,000, or 0.6 percent of average

annual revenue.

Nonetheless, EPA provided

representatives of Tribal governments

with several opportunities to become

knowledgeable of the proposed rule and

to provide meaningful and timely input

in its development. EPA began outreach

efforts to develop the LT1ESWTR in the

summer of 1998 as discussed in detail

above in the UMRA and Federalism

sections. To inform and involve the

representatives of Tribal governments

specifically, EPA presented the

LT1ESWTR at three venues: The 16th

Annual Consumer Conference of the

National Indian Health Board, the

annual conference of the National Tribal

Environmental Council, and the EPA/

Inter Tribal Council of Arizona, Inc.

Tribal consultation meeting. Summaries

of the meetings have been included in

the public docket for this rulemaking.

EPA’s consultation, the nature of the

Tribal concerns, and the position

supporting the need for this rule are

discussed in Section VI.C., which

addresses compliance with UMRA.

Over 900 Tribal representatives from

across the country attended the National

Indian Health Board’s Consumer

Conference and over 100 Tribes were

represented at the annual conference of

the National Tribal Environmental

Council. At the first two conferences, an

EPA representative conducted two

workshops on EPA’s drinking water

program and upcoming regulations,

including the LT1ESWTR. At the EPA/

Inter Tribal Council of Arizona meeting,

representatives from 15 Tribes

participated. The presentation materials

and meeting summary were sent to over

500 Tribes and Tribal organizations.

Additionally, EPA contacted and

invited each of the 12 Native American

Drinking Water State Revolving Fund

Advisors to attend the meetings

described above.

During the comment period for

today’s final rule, the Agency held a

public meeting in Washington, DC on

April 14, 2000 which was announced in

the Federal Register. Additionally, the

proposed rule was either presented or

discussed in nearly 50 meetings across

the country. Finally, EPA mailed

approximately 200 copies of the

proposed rule to stakeholders, including

Tribal representatives, requesting

comment. EPA received 67 comments,

one of which was from a Tribe. The

Tribe indicated that they operated one

surface water treatment plant and asked

several clarifying questions with respect

to optional monitoring and turbidity

monitoring.

K. Likely Effect of Compliance With the

LT1ESWTR 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

include an analysis of the likely effect

of compliance with the regulation on

the technical, financial, and managerial

capacity of public water systems. This

analysis can be found in the LT1ESWTR

economic analysis (USEPA, 2001a).

Overall water system capacity is defined

in EPA guidance (USEPA, 1998j) 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. Managerial capacity is the

ability of a water system to conduct its

affairs to achieve and maintain

compliance with SDWA requirements.

Managerial capacity refers to the

system’s institutional and

administrative capabilities. 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. Technical, managerial,

and financial capacity can be assessed

through key issues and questions,

including:

Technical Capacity

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

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?

Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations 1833

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

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?

Systems not making significant

modifications to the treatment process

to meet LT1ESWTR requirements are

not expected to require significantly

increased technical, financial, or

managerial capacity. As noted

previously, less than 1 percent of

affected systems are expected to incur

annual costs exceeding 1 percent of

their annual revenue as described in

Section VI.A. Accordingly, most

systems are not expected to require

significantly increased technical,

financial, or managerial capacity. EPA

does recognize that a very small number

of facilities may realize some technical,

managerial, or financial capacity

concerns as a result of the rule. EPA

works closely with organizations such

as the National Rural Water Association

and the American Water Works

Association to develop technical and

managerial tools, materials, and

assistance to aid small systems.

Additionally, the Safe Drinking Water

Act, as amended in 1996, established

the Drinking Water State Revolving

Fund (DWSRF) to make funds available

to drinking water systems to finance

infrastructure improvements. The

program emphasizes providing funds to

small and disadvantaged communities

and to programs that encourage

pollution prevention as a tool for

ensuring safe drinking water.

L. Plain Language

Executive Order 12866 requires each

agency to write its rules in plain

language. Readable regulations help the

public find requirements quickly and

understand them easily. They increase

compliance, strengthen enforcement,

and decrease mistakes, frustration,

phone calls, appeals, and distrust of

government. Of the several techniques

typically utilized for writing readably,

using a question and answer format, and

using the word ’you’ for whoever must

comply, do the most to improve the look

and sound of a regulation. Today’s

preamble and final rule use both of

these principles and was developed

using a plain language format, except in

the case of modifications or additions to

existing subparts of parts 141 and 142,

where such a format would not fit into

existing rule language. The Agency

requested comment on this approach

and several commenter’s indicated that

the proposal was clear and easy to

understand.

M. Congressional Review Act

The Congressional Review Act, 5

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

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of the rule in

the Federal Register. A major rule

cannot take effect until 60 days after it

is published in the Federal Register.

This action is not a ‘‘major rule’’ as

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

will be effective February 13, 2002.

N. Executive Order 13211: Actions

Concerning Regulations That

Significantly Affect Energy Supply,

Distribution, or Use

This rule is not a ‘‘significant energy

action’’ as defined in Executive Order

13211, Actions Concerning Regulations

That Significantly Affect Energy Supply,

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

22, 2001), because it is not likely to have

a significant adverse effect on the

supply, distribution, or use of energy.

The requirements in this rule would

have a negligible impact upon the

energy demands of some public water

supply systems. Therefore, there is not

a significant adverse effect on energy

supply, distribution, or use.

VII. References

Adham, S., Gagliado, P., Smith, D., Ross, D.,

Gramith, K., and Trussell, R. 1998.

Monitoring of Reverse Osmosis for Virus

Rejection, Proceedings Water Quality

and Technology Conference. 9pp.

American Water Works Association

Committee Report. 1983. Deterioration of

water quality in large distribution

reservoirs (open reservoirs). AWWA

Committee on Control of Water Quality

in Transmission and Distribution

Systems. J. AWWA. June 1983, 313–318.

Amirtharajah, A. 1988. Some theoretical and

conceptual views of filtration. J. AWWA.

(80:12: 36–46).

APHA. 1995. 19th Edition of Standard

Methods for the Examination of Water

and Wastewater, 1995. American Public

Health Association. 1015 15th Street

NW, Washington D.C. 20005. (Includes

method 2130A, B).

Atherholt, T., LeChevallier, M., Norton, W.,

and Rosen, J. 1998. Effect of rainfall on

Giardia and crypto. J.AWWA (90:9:66–

80).

Bucklin, K., Amirtharajah, A., and Cranston,

K. 1988. The characteristics of initial

effluent quality and its implications for

the filter-to-waste procedure. AWWARF.

Denver, 158pp.

Casemore, D. 1990. Epidemiological aspects

of human cryptosporidiosis. Epidemiol.

Infect. (104:1–28).

CDC 1994. Addressing Emerging Infectious

Disease Threats: A Prevention Strategy

for the United States. Executive

Summary. P. 1–3.

CDC 2000. Notes from June 20, and October

10, 2000, CDC Working Group on

Waterborne Cryptosporidiosis

Teleconference. October 10, 2000.

Chappell, C., Okhuysen, P., Sterling, C.,

Wang, C., Jakubowski, W., and Dupont,

H. 1999. Infectivity of Cryptosporidium

Parvum in Healthy Adults with Preexisting Anti-C. Parvum Serum

Immunoglobulin G. Am. J. Trop. Med.

Hyg. (60:1:157–164).

Cleasby, J. 1990. Filtration, Chapter 8, IN: (F.

Pontius, ed) Water Quality and

Treatment. AWWA, Denver, 57pp.

Collins, M., Dwyer, P., Margolin, A., and

Hogan, S. 1996. Assessment of MS2

Bacteriphage Virus Giardia Cyst and

Cryptosporidium Oocyst Removal by

Hollow Fiber Ultrafiltration

(Polysulfone) Membranes. Proceedings

AWWA Membrane Conference, Reno,

NV 1996.

Cordell, R., Thor, P., Addiss, D., Theurer, J.,

Lichterman, R., Ziliak, S., Juranek, D.,

and Davis, J. 1997. Impact of a massive

waterborne cryptosporidiosis outbreak

on child care facilities in metropolitan

Milwaukee, Wisconsin. Pediatr Infect Dis

J. (16:639–44).

Craun, Gunther. 1998. Memorandum from G.

Craun to U. S. Environmental Protection

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

Waterborne outbreak data 1971–1996,

community and noncommunity water

systems.

Drozd, C., and Schartzbrod, J. 1997.

‘‘Removal of Cryptosporidium from River

Water by Crossflow Microfiltration: A

Pilot Scale Study,’’ Water Science and

Technology. (35:11–12:391–395).

1834 Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations

Dupont, H., Chappell, C., Sterling, C.,

Okhuysen, P., Rose, J., and Jakubowski,

W. 1995. The Infectivity of

Cryptosporidium parvum in Healthy

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859).

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cryptosporidiosis. Microbial Review.

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Fayer, R., and T. Nerad. 1996. Effects of low

temperatures on viability of

Cryptosporidium parvum oocysts. Appl.

Environ. Microbiol. 62:1431–1433.

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water treatment processes. Foundation

for Water Research, Britain. April.

Frost, F., Craun, G., Calderon, R., and Hubbs,

S. 1997. So many oocysts, so few

outbreaks. J. AWWA (89:12:8–10).

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

Sensitive populations: who is at the

greatest risk? International Journal of

Food Microbiology: 30(1–2), 10pp.

Goodrich, J., Sylvana, Y., and Lykins, B.

1995. Cost and Performance Evaluations

of Alternative Filtration Technologies for

Small Communities. Proceedings

AWWA Annual Conference.

Great Lakes Instruments. 1992. Analytical

Method for Turbidity Measurement: GLI

Method 2. GLI, Milwaukee, WI. 8 pp.

Hall, T., and Croll, B. 1996. The UK

Approach to Cryptosporidium Control in

Water Treatment. Proceedings AWWA

Water Quality and Technology

Conference, 14pp.

Hancock, C., Rose, J., and Callahan, M. 1998.

Crypto and Giardia in U.S. groundwater.

J. AWWA (90:3:58–61).

Harrington W., Krupnick, A.J., and W.O.

Spofford. 1985. ‘‘The Benefits of

Preventing an Outbreak of Giardiasis Due

to Drinking Water Contamination.’’ EPA/

Resources for the Future Report.

Hirata, T., and Hashimoto, A. 1998.

‘‘Experimental Assessment of the

Efficacy of Microfiltration and

Ultrafiltration for Cryptosporidium

Removal,’’ Water Science and

Technology. (38:12:103–107).

Hoxie, N., Davis, J., Vergeront, J., Nashold, R.,

and Blair, K. 1997. Cryptosporidiosisassociated mortality following a massive

waterborne outbreak in Milwaukee,

Wisconsin. Amer. J. Publ. Health

(87:12:2032–2035).

Jacangelo, J., Adham, S., and Laine, J. 1995.

Mechanism of Cryptosporidium, Giardia,

and MS2 virus removal by MF and UF.

J. AWWA (87:9:107–121).

Juranek, D. 1995. Cryptosporidiosis: Sources

of Infection and Guidelines for

Prevention. Clinical Infectious Diseases:

21 (1). See also www.cdc.gov/ncidod/

dpd/sources.html

Kelley, M., Warrier, P., Brokaw, J., Barrett, K.

and Komisar, S. 1995. A Study of Two

U.S. Army Installation Drinking Water

Sources and Treatment Systems for the

Removal of Giardia and

Cryptosporidium. Proceedings AWWA

Annual Conference.

LeChevallier, M., Norton, W., and Lee, R.

1991. Giardia and Cryptosporidium spp.

in filtered drinking water supplies. Appl.

Environ. Microbial. (57:9:2617–2621).

LeChevallier, M., and Norton, W. 1992.

Examining relationships between

particle counts and Giardia,

Cryptosporidium and turbidity. J.

AWWA (84:120:54–60).

LeChevallier, M., and Norton, W. 1995.

Giardia and Cryptosporidium in raw and

finished water. J. AWWA (87:9:54–68).

Lykins, B., Adams, J., Goodrich, J., and Clark,

R., Meeting Federal Regulations with

MF/UF—EPA Ongoing Projects.

Microfiltration II Conference, November

12–13, 1994, San Diego, CA.

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

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

J.J. Kazmierczak, D.G. Addiss, K.R. Fox,

J.B. Rose, and J.P. Davis. 1994. A massive

outbreak in Milwaukee of

Cryptosporidium infection transmitted

through the public water supply. New

England Jour. Med. 331(3):161–167.

McTigue, N., LeChevallier, M., Arora, H., and

Clancy, J. 1998. National Assessment of

Particle Removal by Filtration.

AWWARF. Denver, 256pp.

NDWAC, 2000. National Drinking Water

Advisory Council Meeting Minutes and

Recommendations, June 14, 2000.

Nieminski, E., and Ongerth, J. 1995.

Removing Giardia and Cryptosporidium

by Conventional Treatment and Direct

Filtration. J. AWWA (87:9:96–106).

Ongerth, J., and Pecoraro, J. 1995. Removing

Cryptosporidium Using Multimedia

Filters. J. AWWA. (87:12:83–89).

Ongerth, J., and Hutton, P. 1997. DE

Filtration to Remove Cryptosporidium.

JAWWA. December. pp. 39–46.

Patania, N., Jacangelo, J., Cummings, L.,

Wilczak, A., Riley, K., and Oppenheimer,

J. 1995. Optimization of Filtration for

Cyst Removal. AWWARF. Denver,

178pp.

Rose, J.B., 1988, ‘‘Occurrence and

Significance of Cryptosporidium in

water, J. AWWA 80(2):53–58.

Schuler, P., and Gosh, M. 1990.

Diatomaceous Earth Filtration of Cysts

and Other Particulates Using Chemical

Additives. Journal AWWA (Dec 1990).

82(12):67–75.

Schuler, P., and Gosh, M. 1991. Slow Sand

Filtration of Cysts and Other

Particulates. AWWA Annual Conference

Proceedings. June. Pp 235–252.

Timms, S., Slade, J. and Fricker, C. 1995.

Removal of Cryptosporidium by Slow

Sand Filtration. Wat. Sci. Tech. Vol. 31.

No. 5–6, pp. 81–84.

USEPA.1989. National Primary Drinking

Water Regulations: Filtration,

Disinfection; Turbidity, Giardia lamblia,

Viruses, Legionella, and Heterotrophic

Bacteria; Final Rule (SWTR). 54 FR

27486, June 29, 1989.

USEPA.1991. Guidance Manual for

compliance with the filtration and

disinfection requirements for public

water systems using surface water

sources. Washington, D.C., 574pp. [Also

published by AWWA].

USEPA.1993. Methods for the Determination

of Inorganic Substances in

Environmental Samples. Environmental

Monitoring Systems Laboratory.

Cincinnati, OH 45268. August. 169pp.

600/R–93–100.

USEPA.1997a. National Primary Drinking

Water Regulations: Interim Enhanced

Surface Water Treatment Notice of Data

Availability. 62 FR 59486. EPA–815–Z–

97–001.

USEPA.1997b. National Primary Drinking

Water Regulations: Disinfectants and

Disinfection Byproducts; Notice of Data

Availability. 62 FR 59388. EPA–815–Z–

97–002/USEPA.1998a. National Primary

Drinking Water Regulations: Interim

Enhanced Surface Water Treatment;

Final Rule. 63 FR 69477, December 16,

1998. EPA 815–Z–98–009.

USEPA.1998b. Cryptosporidium and Giardia

Occurrence Assessment for the Interim

Enhanced Surface Water Treatment Rule.

Prepared for the Office of Ground Water

and Drinking Water, Washington, DC by

Science Applications International

Corporation, McLean, VA, 185pp.

USEPA.1998c. National Primary Drinking

Water Regulations: Disinfectants and

Disinfection Byproducts; Final Rule. 63

FR 69389, December 16, 1998.

USEPA.1998d. Addendum to the Drinking

Water Criteria Document for Giardia.

Prepared for Office of Water, Office of

Science and Technology, U.S. EPA,

Washington, D.C., by ARCTECH, Inc.,

1999. Gunther F. Craun & Associates.

271pp.

USEPA 1998e. Demographic Distribution of

Sensitive Population Groups. Final

Report. Prepared by SRA Technologies,

Inc., Falls Church, VA. Work Assignment

No. B–11/22 (SRA 557–05/14: February

24).

USEPA 1998f. National Primary Drinking

Water Regulation: Consumer Confidence

Reports; Final Rule. 63 FR 44511, August

19, 1998.

USEPA 1998g. Revision of Existing Variance

and Exemption Regulations To Comply

With Requirements of the Safe Drinking

Water Act. 63 FR 43833, August 14,

1998.

USEPA 1998h. Announcement of the

Drinking Water Contaminant Candidate

List; Notice. 63 FR 10273, March 2, 1998.

USEPA.1998i. Revisions to State Primacy

Requirements to Implement Safe

Drinking Water Act Amendments; Final

Rule. 63 FR 23362.

USEPA.1998j. Guidance on Implementing the

Capacity Development Provisions of the

Safe Drinking Water Act Amendments of

1996. EPA Document Number: 816–R–

98–006.

USEPA.1998k. Final Report of the SBREFA

Small Business Advocacy Review Panel

on EPA’s Planned Proposed Rule: Long

Term 1 Enhanced Surface Water

Treatment Rule, 76pp.

USEPA.1998l. Response to Comment

Document for the Interim Enhanced

Surface Water Treatment Rule.

USEPA.1999a. Meeting Summary: Long Term

1 Enhanced Surface Water Treatment

Rule (LT1ESWTR) and Filter Backwash

Recycle Rule (FBR). Dallas, TX. March.

11pp.

USEPA.1999b. Stakeholder Meeting

Summary: Long Term 1 Enhanced

Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations 1835

Surface Water Treatment Rule and Filter

Backwash Recycle Rule. Denver, CO.

July. 67pp.

USEPA.2000a. Occurrence Assessment for

the Long Term 1 Enhanced Surface

Water Treatment and Filter Backwash

Recycle Rule, (EPA/815/R/00/019).

USEPA.2000b. National Primary Drinking

Water Regulations: Long Term 1

Enhanced Surface Water Treatment and

Filter Backwash Rule; Proposed Rule. 65

FR 19046. April 10, 2000. (EPA/815/Z/

00/01).

USEPA.2000c. Summary of the Proposed

Long Term 1 Enhanced Surface Water

Treatment and Filter Backwash Rule.

April, 14, 2000.

USEPA.2000d. Application of the Microbial

Framework to LT2ESWTR FACA

Options, M/DBP FACA Meeting, June 1,

2000.

USEPA.2000e. Regulatory Flexibility

Screening Analysis for the Long Term 1

Enhanced Surface Water Treatment Rule,

September 26, 2000.

USEPA.2000f. Proposed Long Term 1

Enhanced Surface Water Treatment and

Filter Backwash Rule (LT1FBR) Issues

for the National Drinking Water

Advisory Council. April 20, 2000.

USEPA.2000g. Meeting Summary,

Government Dialogue on EPA’s

Upcoming Drinking Water Regulations,

May 30, 2000.

USEPA.2000h. Representative List of

Meetings Attended where Presentations

were Made or where Materials were

Handed out (LT1ESWTR and FBRR).

USEPA.2000i. Response to Comment

Document for the Filter Backwash

Recycle Rule.

USEPA.2000j. Estimated Per Capita Water

Ingestion in the United States. Office of

Science and Technology. February, 2000.

USEPA.2000k. M/DBP FACA Meeting

Materials. June 1–2, 2000.

USEPA.2000l. SAB Commentary on EPA’s

Draft Proposal for LT1ESWTR and FBRR.

EPA–SAB–DWC–COM–00–004. May 23,

2000.

USEPA.2001a. Economic Analysis for the

Long Term 1 Enhanced Surface Water

Treatment Rule. EPA Document Number

815–R–00–021. October 12, 2001.

USEPA.2001b. Response to Comment

Document for the Long Term 1 Enhanced

Surface Water Treatment Rule. EPA

Document Number EPA 815–R–01–026.

USEPA/SAB 1990. Reducing Risk: Setting

Priorities and Strategies for

Environmental Protection. U.S.

Environmental Protection Agency

Science Advisory Board (A–101),

Washington, D.C. Report No. SAB–EC–

90–021 (September).

West, T., Danile, P., Meyerhofer, P., DeGraca,

A., Leonard, S., and Gerba, C. 1994.

Evaluation of Cryptosporidium Removal

through High-rate Filtration. Proceedings

AWWA Annual Conference, June. Pp

493–504.

List of Subjects

40 CFR Parts 9

Reporting and recordkeeping

requirements.

40 CFR Part 141

Environmental protection, Chemicals,

Indians-lands, Intergovernmental

relations, Radiation protection,

Reporting and recordkeeping

requirements, Water supply.

40 CFR Part 142

Environmental protection,

Administrative practice and procedure,

Chemicals, Indians-lands, Radiation

protection, Reporting and recordkeeping

requirements, Water supply.

Dated: December 20, 2001.

Christine Todd Whitman,

Administrator.

For the reasons set forth 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; Executive Order 11735, 38 FR

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

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

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

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

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

9601–9657, 11023, 11048.

2. In § 9.1 the table is amended by

adding under the indicated heading: a. By adding entries 141.530–141.536,

141.540–141.544, 141.550–141.553,

141.560–141.564 and 141.570–141.571

in numerical order.

b. By removing the entry 142.14(a)–

(d)(7) and adding in its place a new

entry § 142.14(b)–(d)(7).

c. By adding a new entry for 142.14(a)

in numerical order.

d. By adding new entries for 142.16(g)

and 142.16(j) in numerical order. The additions read as follows:

§ 9.1 OMB approvals under the Paperwork

Reduction Act.

* * * * *

40 CFR citation OMB control

No.

*****

National Primary Drinking Water

Regulations

*****

141.530–141.536 .................. 2040–0229

141.540–141.544 .................. 2040–0229

141.550–141.553 .................. 2040–0229

141.560–141.564 .................. 2040–0229

141.570–141.571 .................. 2040–0229

40 CFR citation OMB control

No.

National Primary Drinking Water

Regulations Implementation

*****

142.14(a) .............................. 2040–0229

2040–0090

142.14(b)–(d)(7) .................... 2040–0090

*****

142.16(g) .............................. 2040–0229

142.16(j) ................................ 2040–0229

* * * * *

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 definitions of

‘‘Comprehensive performance

evaluation’’ (CPE), ‘‘Ground water under

the direct influence of surface water’’

and ‘‘Disinfection profile’’ 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

purpose of compliance with subparts P

and T 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

Giardia lamblia inactivation through the

treatment plant. The procedure for

developing a disinfection profile is

contained in § 141.172 (Disinfection

profiling and benchmarking) in subpart

P and §§ 141.530–141.536 (Disinfection

profile) in subpart T of this part.

* * * * *

1836 Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations

Ground water under the direct

influence of surface water (GWUDI)

means any water beneath the surface of

the ground with significant occurrence

of insects or other macroorganisms,

algae, or large-diameter pathogens such

as Giardia lamblia or 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 sitespecific measurements of water quality

and/or documentation of well

construction characteristics and geology

with field evaluation.

* * * * *

5. Section 141.70 is amended by

adding paragraph (e) to read as follows:

§ 141.70 General requirements.

* * * * *

(e) Additional requirements for

systems serving fewer than 10,000

people. In addition to complying with

requirements in this subpart, systems

serving fewer than 10,000 people must

also comply with the requirements in

subpart T of this part.

6. Section 141.73 is amended by

adding paragraph (a)(4) and revising

paragraph (d) to read as follows:

§ 141.73 Filtration.

* * * * *

(a) * * *

(4) Beginning January 14, 2005,

systems serving fewer than 10,000

people must meet the turbidity

requirements in §§ 141.550 through

141.553.

* * * * *

(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 January 1, 2002, systems

serving at least 10,000 people must meet

the requirements for other filtration

technologies in § 141.173(b). Beginning

January 14, 2005, systems serving fewer

than 10,000 people must meet the

requirements for other filtration

technologies in § 141.550 through

141.553.

7. 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 or § 141.551: the

highest single measurement and the

lowest monthly percentage of samples

meeting the turbidity limits specified in

§ 141.73 or § 141.173, or § 141.551 for

the filtration technology being used.

***

* * * * *

8. The heading to Subpart P is revised

to read as follows:

Subpart P—Enhanced Filtration and

Disinfection—Systems Serving 10,000

or More People

* * * * *

9. Section 141.170 is amended by

adding paragraph (d) to read as follows:

§ 141.170 General requirements.

* * * * *

(d) Subpart H systems that did not

conduct optional monitoring under

§ 141.172 because they served fewer

than 10,000 persons when such

monitoring was required, but serve more

than 10,000 persons prior to January 14,

2005 must comply with §§ 141.170,

141.171, 141.173, 141.174, and 141.175.

These systems must also consult with

the State to establish a disinfection

benchmark. A system that decides to

make a significant change to its

disinfection practice, as described in

§ 141.172(c)(1)(i) through (iv) must

consult with the State prior to making

such change.

10. Section 141.202 is amended in

Table 1 by revising entry 6 to read as

follows:

§ 141.202 Tier 1 Public Notice—Form,

manner, and frequency of notice.

* * * * *

(a) * * *

TABLE 1 TO SEC. 141.202.—VIOLATION CATEGORIES AND OTHER SITUATIONS REQUIRING A TIER 1 PUBLIC NOTICE

*******

(6) Violation of the Surface Water Treatment Rule (SWTR), Interim Enhanced Surface Water Treatment Rule (IESWTR) or Long Term 1 Enhanced Surface Water Treatment Rule (LT1ESWTR) treatment technique requirement resulting from a single exceedance of the maximum allowable turbidity limit (as identified in Appendix A), where the primacy agency determines after consultation that a Tier 1 notice is required or

where consultation does not take place within 24 hours after the system learns of the violation;

*******

* * * * *

11. Section 141.203 is amended by

revising paragraph (b)(3)(ii) to read as

follows:

§ 141.203 Tier 2 Public Notice—Form,

manner, and frequency of notice.

* * * * *

(b) * * *

(3) * * *

(ii) Violation of the SWTR, IESWTR or

LT1ESWTR treatment technique

requirement resulting from a single

exceedance of the maximum allowable

turbidity limit.

* * * * *

12. Appendix A to subpart Q is

amended:

a. Under I.A. by revising entry 5.

b. Under I.A. by revising entry 7.

c. Adding a new entry 9.

d. Under I.G. by revising entry 10.

e. Revising endnote 6.

The additions and revisions read as

follows:

Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations 1837

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

Contaminant

MCL/MRDL/TT violations 2 Monitoring & testing procedure violations

Tier of public notice required

Citation

Tier of public notice required

Citation

I. Violations of National Primary Drinking

Water Regulations (NPDWR): 3

*******

A. Microbiological Contaminants

*******

5. Turbidity (for TT violations resulting

from a single exceedance of maximum allowable turbidity level).

6 2,1 141.71(a)(2),141.71(c)(2)(i),

141.73(a)(2), 141.73 (b)(2),

141.73 (c)(2), 141.73(d),

141.173(a)(2), 141.173(b),

141.551(b).

3 141.74(a)(1), 141.74(b)(2),

141.74(c)(1), 141.174,

141.560(a)–(c), 141.561.

*******

7. Interim Enhanced Surface Water

Treatment Rule violations, other than

violations resulting from single exceedance of max. turbidity level (TT).

7 2 141.170–141.173, 141.500–

141.553.

3 141.172, 141.174, 141.530–

141.544, 141.560–141.564.

*******

9. Long Term 1 Enhanced Surface

Water Treatment Rule violations.

2 141.500–141.553 ........................ 3 141.530–141.544, 141.560–

141.564.

*******

G. Disinfection Byproducts (DBPs), Byproduct Precursors, Disinfectant Residuals.

Where disinfection is used in the treatment

of drinking water, disinfectants combine

with organic and inorganic matter present

in water to form chemicals called disinfection byproducts (DBPs). EPA sets standards for controlling the levels of disinfectants and DBPs in drinking water, including

trihalomethanes (THMs) and haloacetic

acids (HAAs).9

*******

10. Bench marking and disinfection

profiling.

N/A N/A .............................................. 3 141.172 141.530–141.544.

*******

Appendix A–Endnotes: 1Violations and other situations not listed in this table (e.g., reporting violations and failure to prepare Consumer Confidence Reports), do not

require notice, unless otherwise determined by the primacy agency. Primacy agencies may, at their option, also require a more stringent public

notice tier (e.g., Tier 1 instead of Tier 2 or Tier 2 instead of Tier 3) for specific violations and situations listed in this Appendix, as authorized

under § 141.202(a) and § 141.203(a). 2 MCL—Maximum contaminant level, MRDL—Maximum residual disinfectant level, TT—Treatment technique 3The term Violations of National Primary Drinking Water Regulations (NPDWR) is used here to include violations of MCL, MRDL, treatment

technique, monitoring, and testing procedure requirements.

*******

6Systems with treatment technique violations involving a single exceedance of a maximum turbidity limit under the Surface Water Treatment

Rule (SWTR), the Interim Enhanced Surface Water Treatment Rule (IESWTR), or the Long Term 1 Enhanced Surface Water Treatment Rule

(LT1ESWTR) are required to consult with the primacy agency within 24 hours after learning of the violation. Based on this consultation, the primacy agency may subsequently decide to elevate the violation to Tier 1. If a system is unable to make contact with the primacy agency in the

24-hour period, the violation is automatically elevated to Tier 1. 7 Most of the requirements of the Interim Enhanced Surface Water Treatment Rule (63 FR 69477) (§§ 141.170—141.171, 141.173—141.174)

become effective January 1, 2002 for the Subpart H systems (surface water systems and ground water systems under the direct influence of surface water) serving at least 10,000 persons. However, § 141.172 has some requirements that become effective as early as April 16, 1999. The

Surface Water Treatment Rule remains in effect for systems serving at least 10,000 persons even after 2002; the Interim Enhanced Surface

Water Treatment Rule adds additional requirements and does not in many cases supercede the SWTR.

* * * * * **

9Subpart H community and non-transient non-community systems serving ≥10,000 must comply with new DBP MCLs, disinfectant MRDLs,

and related monitoring requirements beginning January 1, 2002. All other community and non-transient non-community systems must meet the

MCLs and MRDLs beginning January 1, 2004. Subpart H transient non-community systems serving 10,000 or more persons and using chlorine

dioxide as a disinfectant or oxidant must comply with the chlorine dioxide MRDL begining January 1, 2002. Subpart H transient non-community

systems serving fewer than 10,000 persons and using only ground water not under the direct influence of surface water and using chlorine dioxide as a disinfectant or oxidant must comply with the chlorine dioxide MRDL beginning January 1, 2004.

1838 Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations

Appendix B—[Amended]

13. Appendix B to subpart Q is

amended by:

a. Revising entry A.2c.

b. Revising heading B.

c. Revising entries B.3., B.4, B.5, B.6.,

and B.7.

d. Revising endnotes 4, 6 and 10.

e. Revising endnote 8.

The revisions read as follows:

APPENDIX B TO SUBPART Q OF PART 141.—STANDARD HEALTH EFFECTS LANGUAGE FOR PUBLIC NOTIFICATION

Contaminant MCLG 1, mg/L MCL 2 mg/L Standard health effects language for public notification

National Primary Drinking Water Regulations

(NPDWR):

A. Microbiological Contaminants

*******

2c. Turbidity (IESWTR TT and LT1ESWTR

TT) 8.

None .............................. TT Turbidity has no health effects. However, turbidity

can interfere with disinfection and provide a

medium for microbial growth. Turbidity may indicate the presence of disease-causing organisms. These organisms include bacteria, viruses, and parasites that can cause symptoms

such as nausea, cramps, diarrhea and associated headaches.

*******

B. Surface Water Treatment Rule (SWTR), Interim

Enhanced Surface Water Treatment Rule

(IESWTR), Long Term 1 Enhanced Surface

Water Treatment Rule (LT1ESWTR) and the

Filter Backwash Recycling Rule (FBRR) violations:

*******

3. Giardia lamblia ............................................

(SWTR/IESWTR/LT1ESWTR)

Zero ............................... TT 10 Inadequately treated water may contain diseasecausing organisms. These organisms include

bacteria, viruses, and parasites which can

cause symptoms such as nausea, cramps, diarrhea, and associated headaches.

4. Viruses

(SWTR/IESWTR/LT1ESWTR)

5. Heterotrophic plate count (HPC) bacteria 9

(SWTR/IESWTR/LT1ESWTR)

6. Legionella

(SWTR/IESWTR/LT1ESWTR)

7. Cryptosporidium

(IESWTR/FBRR/LT1ESWTR)

*******

1 MCLG—Maximum contaminant level goal. 2 MCL—Maximum contaminant level. 4There are various regulations that set turbidity standards for different types of systems, including 40 CFR 141.13, and the 1989 Surface

Water Treatment Rule, the 1998 Interim Enhanced Surface Water Treatment Rule and the 2001 Long Term 1 Enhanced Surface Water Treatment Rule. The MCL for the montly turbidity average is 1 NTU; the MCL for the 2-day average is 5 NTU for systems that are required to filter but

have not yet installed filtration (40 CFR 141.13). 6There are various regulations that set turbidity standards for different types of systems, including 40 CFR 141.13, and the 1989 Surface

Water Treatment Rule, the 1998 Interim Enhanced Surface Water Treatment Rule and the 2001 Long Term 1 Enhanced Surface Water Treatment Rule. Systems subject to the Surface Water Treatment Rule (both filtered and unfiltered) may not exceed 5 NTU. In addition, in filtered systems, 95 percent of samples each month must not exceed 0.5 NTU in systems using conventional or direct filtration and must not exceed 1 NTU

in systems using slow sand or diatomaceous earth filtration or other filtration technologies approved by the primacy agency. 8There are various regulations that set turbidity standards for different types of systems, including 40 CFR 141.13, the 1989 Surface Water

Treatment Rule (SWTR), the 1998 Interim Enhanced Surface Water Treatment Rule (IESWTR) and the 2001 Long Term 1 Enhanced Surface

Water Treatment Rule (LT1ESWTR). For systems subject to the IESWTR (systems serving at least 10,000 people, using surface water or

ground water under the direct influence of surface water), that use conventional filtration or direct filtration, after January 1, 2002, the turbidity

level of a system’s combined filter effluent may not exceed 0.3 NTU in at least 95 percent of monthly measurements, and the turbidity level of a

system’s combined filter effluent must not exceed 1 NTU at any time. Systems subject to the IESWTR using technologies other than conventional, direct, slow sand, or diatomaceous earth filtration must meet turbidity limits set by the primacy agency. For systems subject to the

LT1ESWTR (systems serving fewer than 10,000 people, using surface water or ground water under the direct influence of surface water) that

use conventional filtration or direct filtration, after January 14, 2005 the turbidity level of a system’s combined filter effluent may not exceed 0.3

NTU in at least 95 percent of monthly measurements, and the turbidity level of a system’s combined filter effluent must not exceed 1 NTU at any

time. Systems subject to the LT1ESWTR using technologies other than conventional, direct, slow sand, or diatomaceous earth filtration must

meet turbidity limits set by the primacy agency. 9The bacteria detected by heterotrophic plate count (HPC) are not necessarily harmful. HPC is simply an alternative method of determining

disinfectant residual levels. The number of such bacteria is an indicator of whether there is enough disinfectant in the distribution system. 10SWTR, IESWTR, and LT1ESWTR treatment technique violations that involve turbidity exceedances may use the health effects language for

turbidity instead.

Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations 1839

14. Part 141 is amended by adding a

new subpart T to read as follows:

Subpart T—Enhanced Filtration and

Disinfection—Systems Serving Fewer Than

10,000 People

General Requirements

141.500 General requirements

141.501 Who is subject to the requirements

of subpart T?

141.502 When must my system comply

with these requirements?

141.503 What does subpart T require?

Finished Water Reservoirs

141.510 Is my system subject to the new

finished water reservoir requirements?

141.511 What is required of new finished

water reservoirs?

Additional Watershed Control Requirements

for Unfiltered Systems

141.520 Is my system subject to the updated

watershed control requirements?

141.521 What updated watershed control

requirements must my unfiltered system

implement to continue to avoid

filtration?

141.522 How does the State determine

whether my system’s watershed control

requirements are adequate?

Disinfection Profile

141.530 What is a Disinfection Profile and

who must develop one?

141.531 What criteria must a State use to

determine that a profile is unnecessary?

141.532 How does my system develop a

Disinfection Profile and when must it

begin?

141.533 What data must my system collect

to calculate a Disinfection Profile?

141.534 How does my system use this data

to calculate an inactivation ratio?

141.535 What if my system uses

chloramines, ozone, or chlorine dioxide

for primary disinfection?

141.536 My system has developed an

inactivation ratio; what must we do

now?

Disinfection Benchmark

141.540 Who has to develop a Disinfection

Benchmark?

141.541 What are significant changes to

disinfection practice?

141.542 What must my system do if we are

considering a significant change to

disinfection practices?

141.543 How is the Disinfection Benchmark

calculated?

141.544 What if my system uses

chloramines, ozone, or chlorine dioxide

for primary disinfection?

Combined Filter Effluent Requirements

141.550 Is my system required to meet

subpart T combined filter effluent

turbidity limits?

141.551 What strengthened combined filter

effluent turbidity limits must my system

meet?

141.552 My system consists of ‘‘alternative

filtration’’ and is required to conduct a

demonstration. What is required of my

system and how does the State establish

my turbidity limits?

141.553 My system practices lime

softening—is there any special provision

regarding my combined filter effluent?

Individual Filter Turbidity Requirements

141.560 Is my system subject to individual

filter turbidity requirements?

141.561 What happens if my system’s

turbidity monitoring equipment fails?

141.562 My system only has two or fewer

filters—is there any special provision

regarding individual filter turbidity

monitoring?

141.563 What follow-up action is my

system required to take based on

continuous turbidity monitoring?

141.564 My system practices lime

softening—is there any special provision

regarding my individual filter turbidity

monitoring?

Reporting and Recordkeeping Requirements

141.570 What does subpart T require that

my system report to the State?

141.571 What records does subpart T

require my system to keep?

Subpart T—Enhanced Filtration and

Disinfection—Systems Serving Fewer

Than 10,000 People

General Requirements

§ 141.500 General requirements.

The requirements of this subpart

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 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. The

treatment technique requirements

consist of installing and properly

operating water treatment processes

which reliably achieve:

(a) 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; and

(b) Compliance with the profiling and

benchmark requirements in §§ 141.530

through 141.544.

§ 141.501 Who is subject to the

requirements of subpart T?

You are subject to these requirements

if your system:

(a) Is a public water system;

(b) Uses surface water or GWUDI as a

source; and

(c) Serves fewer than 10,000 persons.

§ 141.502 When must my system comply

with these requirements?

You must comply with these

requirements in this subpart beginning

January 14, 2005 except where

otherwise noted.

§ 141.503 What does subpart T require?

There are seven requirements of this

subpart, and you must comply with all

requirements that are applicable to your

system. These requirements are:

(a) You must cover any finished water

reservoir that you began to construct on

or after March 15, 2002 as described in

§§ 141.510 and 141.511;

(b) If your system is an unfiltered

system, you must comply with the

updated watershed control requirements

described in §§ 141.520–141.522;

(c) If your system is a community or

non-transient non-community water

systems you must develop a disinfection

profile as described in §§ 141.530–

141.536;

(d) If your system is considering

making a significant change to its

disinfection practices, you must develop

a disinfection benchmark and consult

with the State for approval of the change

as described in §§ 141.540–141.544;

(e) If your system is a filtered system,

you must comply with the combined

filter effluent requirements as described

in §§ 141.550–141.553;

(f) If your system is a filtered system

that uses conventional or direct

filtration, you must comply with the

individual filter turbidity requirements

as described in §§ 141.560–141.564; and

(g) You must comply with the

applicable reporting and recordkeeping

requirements as described in §§ 141.570

and 141.571.

Finished Water Reservoirs

§ 141.510 Is my system subject to the new

finished water reservoir requirements?

All subpart H systems which serve

fewer than 10,000 are subject to this

requirement.

§ 141.511 What is required of new finished

water reservoirs?

If your system begins construction of

a finished water reservoir on or after

March 15, 2002 the reservoir must be

covered. Finished water reservoirs for

which your system began construction

prior to March 15, 2002 are not subject

to this requirement.

Additional Watershed Control

Requirements for Unfiltered Systems

§ 141.520 Is my system subject to the

updated watershed control requirements?

If you are a subpart H system serving

fewer than 10,000 persons which does

1840 Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations

not provide filtration, you must

continue to comply with all of the

filtration avoidance criteria in § 141.71,

as well as the additional watershed

control requirements in § 141.521.

§ 141.521 What updated watershed control

requirements must my unfiltered system

implement to continue to avoid filtration?

Your system must take any additional

steps necessary to minimize the

potential for contamination by

Cryptosporidium oocysts in the source

water. Your system’s watershed control

program must, for Cryptosporidium:

(a) Identify watershed characteristics

and activities which may have an

adverse effect on source water quality;

and

(b) Monitor the occurrence of

activities which may have an adverse

effect on source water quality.

§ 141.522 How does the State determine

whether my system’s watershed control

requirements are adequate?

During an onsite inspection

conducted under the provisions of

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

whether your watershed control

program 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 your

program to monitor and control

detrimental activities occurring in the

watershed; and the extent to which your

system has maximized land ownership

and/or controlled land use within the

watershed.

Disinfection Profile

§ 141.530 What is a Disinfection Profile

and who must develop one?

A disinfection profile is a graphical

representation of your system’s level of

Giardia lamblia or virus inactivation

measured during the course of a year. If

you are a subpart H community or nontransient non-community water systems

which serves fewer than 10,000 persons,

your system must develop a disinfection

profile unless your State determines that

your system’s profile is unnecessary.

Your State may approve the use of a

more representative data set for

disinfection profiling than the data set

required under §§ 141.532–141.536.

§ 141.531 What criteria must a State use to

determine that a profile is unnecessary?

States may only determine that a

system’s profile is unnecessary if a

system’s TTHM and HAA5 levels are

below 0.064 mg/L and 0.048 mg/L,

respectively. To determine these levels,

TTHM and HAA5 samples must be

collected after January 1, 1998, during

the month with the warmest water

temperature, and at the point of

maximum residence time in your

distribution system.

§ 141.532 How does my system develop a

Disinfection Profile and when must it

begin?

A disinfection profile consists of three

steps: (a) First, your system must collect

data for several parameters from the

plant as discussed in § 141.533 over the

course of 12 months. If your system

serves between 500 and 9,999 persons

you must begin to collect data no later

than July 1, 2003. If your system serves

fewer than 500 persons you must begin

to collect data no later than January 1,

2004.

(b) Second, your system must use this

data to calculate weekly log inactivation

as discussed in §§ 141.534 and 141.535;

and

(c) Third, your system must use these

weekly log inactivations to develop a

disinfection profile as specified in

§ 141.536.

§ 141.533 What data must my system

collect to calculate a Disinfection Profile?

Your system must monitor the

following parameters to determine the

total log inactivation using the

analytical methods in § 141.74 (a), once

per week on the same calendar day, over

12 consecutive months:

(a) The temperature of the disinfected

water at each residual disinfectant

concentration sampling point during

peak hourly flow;

(b) If your system uses chlorine, the

pH of the disinfected water at each

residual disinfectant concentration

sampling point during peak hourly flow;

(c) The disinfectant contact time(s)

(‘‘T’’) during peak hourly flow; and

(d) The residual disinfectant

concentration(s) (‘‘C’’) of the water

before or at the first customer and prior

to each additional point of disinfection

during peak hourly flow.

§ 141.534 How does my system use this

data to calculate an inactivation ratio?

Calculate the total inactivation ratio

as follows, and multiply the value by

3.0 to determine log inactivation of

Giardia lamblia:

If your system * * * Your system must determine * * *

(a) Uses only one point of disinfectant application.(1) One inactivation ratio (CTcalc/CT99.9) before or at the first customer during peak hourly flow

or

(2) 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, your 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 (3CTcalc/CT99.9).

(b) Uses more than one point of

disinfectant application before the

first customer.

The (CTcalc/CT99.9) 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 using the

procedure specified in paragraph (a)(2) of this section.

§ 141.535 What if my system uses

chloramines, ozone, or chlorine dioxide for

primary disinfection?

If your system uses chloramines,

ozone, or chlorine dioxide for primary

disinfection, you must also calculate the

logs of inactivation for viruses and

develop an additional disinfection

profile for viruses using methods

approved by the State.

§ 141.536 My system has developed an

inactivation ratio; what must we do now?

Each log inactivation serves as a data

point in your disinfection profile. Your

system will have obtained 52

measurements (one for every week of

the year). This will allow your system

and the State the opportunity to

evaluate how microbial inactivation

varied over the course of the year by

looking at all 52 measurements (your

Disinfection Profile). Your system must

retain the Disinfection Profile data in

graphic form, such as a spreadsheet,

which must be available for review by

the State as part of a sanitary survey.

Your system must use this data to

calculate a benchmark if you are

considering changes to disinfection

practices.

Disinfection Benchmark

§ 141.540 Who has to develop a

Disinfection Benchmark?

If you are a subpart H system required

to develop a disinfection profile under

Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations 1841

§§ 141.530 through 141.536, your

system must develop a Disinfection

Benchmark if you decide to make a

significant change to your disinfection

practice. Your system must consult with

the State for approval before you can

implement a significant disinfection

practice change.

§ 141.541 What are significant changes to

disinfection practice?

Significant changes to disinfection

practice include:

(a) Changes to the point of

disinfection;

(b) Changes to the disinfectant(s) used

in the treatment plant;

(c) Changes to the disinfection

process; or

(d) Any other modification identified

by the State.

§ 141.542 What must my system do if we

are considering a significant change to

disinfection practices?

If your system is considering a

significant change to its disinfection

practice, your system must calculate a

disinfection benchmark(s) as described

in §§ 141.543 and 141.544 and provide

the benchmark(s) to your State. Your

system may only make a significant

disinfection practice change after

consulting with the State for approval.

Your system must submit the following

information to the State as part of the

consultation and approval process:

(a) A description of the proposed

change;

(b) The disinfection profile for Giardia

lamblia (and, if necessary, viruses) and

disinfection benchmark;

(c) An analysis of how the proposed

change will affect the current levels of

disinfection; and

(d) Any additional information

requested by the State.

§ 141.543 How is the Disinfection

Benchmark calculated?

If your system is making a significant

change to its disinfection practice, it

must calculate a disinfection benchmark

using the procedure specified in the

following table.

To calculate a disinfection benchmark your system must perform the following steps

Step 1: Using the data your system collected to develop the Disinfection Profile, determine the average Giardia lamblia inactivation for each calendar month by dividing the sum of all Giardia lamblia inactivations for that month by the number of values calculated for that month.

Step 2: Determine the lowest monthly average value out of the twelve values. This value becomes the disinfection benchmark.

§ 141.544 What if my system uses

chloramines, ozone, or chlorine dioxide for

primary disinfection?

If your system uses chloramines,

ozone or chlorine dioxide for primary

disinfection your system must calculate

the disinfection benchmark from the

data your system collected for viruses to

develop the disinfection profile in

addition to the Giardia lamblia

disinfection benchmark calculated

under § 141.543. This viral benchmark

must be calculated in the same manner

used to calculate the Giardia lamblia

disinfection benchmark in § 141.543.

Combined Filter Effluent Requirements

§ 141.550 Is my system required to meet

subpart T combined filter effluent turbidity

limits?

All subpart H systems which serve

populations fewer than 10,000, are

required to filter, and utilize filtration

other than slow sand filtration or

diatomaceous earth filtration must meet

the combined filter effluent turbidity

requirements of §§ 141.551–141.553 . If

your system uses slow sand or

diatomaceous earth filtration you are

not required to meet the combined filter

effluent turbidity limits of subpart T,

but you must continue to meet the

combined filter effluent turbidity limits

in § 141.73.

§ 141.551 What strengthened combined

filter effluent turbidity limits must my

system meet?

Your system must meet two

strengthened combined filter effluent

turbidity limits.

(a) The first combined filter effluent

turbidity limit is a ‘‘95th percentile’’

turbidity limit that your system must

meet in at least 95 percent of the

turbidity measurements taken each

month. Measurements must continue to

be taken as described in § 141.74(a) and

(c). Monthly reporting must be

completed according to § 141.570. The

following table describes the required

limits for specific filtration

technologies.

If your system consists of * * * Your 95th percentile turbidity value is * * *

(1) Conventional Filtration or Direct Filtration ................................................................................. 0.3 NTU.

(2) All other ‘‘Alternative’’ Filtration ................................................................................................. A value determined by the State (no to exceed

1 NTU) based on the demonstration described in § 141.552.

(b) The second combined filter

effluent turbidity limit is a ‘‘maximum’’

turbidity limit which your system may

at no time exceed during the month.

Measurements must continue to be

taken as described in § 141.74(a) and (c).

Monthly reporting must be completed

according to § 141.570. The following

table describes the required limits for

specific filtration technologies.

If your system consists of * * * Your maximum turbidity value is * * *

(1) Conventional Filtration or Direct Filtration ................................................................................. 1 NTU.

(2) All other ‘‘Alternative’’ ................................................................................................................ A value determined by the State (not to exceed 5 NTU) based on the demonstration as

described in § 141.552.

1842 Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations

§ 141.552 My system consists of

‘‘alternative filtration’’ and is required to

conduct a demonstration—what is required

of my system and how does the State

establish my turbidity limits?

(a) If your system consists of

alternative filtration(filtration other than

slow sand filtration, diatomaceous earth

filtration, conventional filtration, or

direct filtration) you are required to

conduct a demonstration (see tables in

§ 141.551). Your system must

demonstrate to the State, using pilot

plant studies or other means, that your

system’s filtration, in combination with

disinfection treatment, consistently

achieves:

(1) 99 percent removal of

Cryptosporidium oocysts;

(2) 99.9 percent removal and/or

inactivation of Giardia lamblia cysts;

and

(3) 99.99 percent removal and/or

inactivation of viruses.

(b) [Reserved]

§ 141.553 My system practices lime

softening—is there any special provision

regarding my combined filter effluent?

If your system practices lime

softening, you may acidify

representative combined filter effluent

turbidity samples prior to analysis using

a protocol approved by the State.

Individual Filter Turbidity

Requirements

§ 141.560 Is my system subject to

individual filter turbidity requirements?

If your system is a subpart H system

serving fewer than 10,000 people and

utilizing conventional filtration or direct

filtration, you must conduct continuous

monitoring of turbidity for each

individual filter at your system. The

following requirements apply to

continuous turbidity monitoring:

(a) Monitoring must be conducted

using an approved method in

§ 141.74(a);

(b) Calibration of turbidimeters must

be conducted using procedures

specified by the manufacturer;

(c) Results of turbidity monitoring

must be recorded at least every 15

minutes;

(d) Monthly reporting must be

completed according to § 141.570; and

(e) Records must be maintained

according to § 141.571.

§ 141.561 What happens if my system’s

turbidity monitoring equipment fails?

If there is a failure in the continuous

turbidity monitoring equipment, your

system must conduct grab sampling

every four hours in lieu of continuous

monitoring until the turbidimeter is

back on-line. Your system has 14 days

to resume continuous monitoring before

a violation is incurred.

§ 141.562 My system only has two or fewer

filters—is there any special provision

regarding individual filter turbidity

monitoring?

Yes, if your system only consists of

two or fewer filters, you may conduct

continuous monitoring of combined

filter effluent turbidity in lieu of

individual filter effluent turbidity

monitoring. Continuous monitoring

must meet the same requirements set

forth in § 141.560(a) through (d) and

§ 141.561.

§ 141.563 What follow-up action is my

system required to take based on

continuous turbidity monitoring?

Follow-up action is required

according to the following tables:

If * * * Your system must * * *

(a) The turbidity of an individual filter (or the turbidity of combined filter effluent (CFE) for systems with 2 filters that monitor CFE in lieu of

individual filters) exceeds 1.0 NTU in two consecutive recordings 15 minutes apart.

Report to the State by the 10th of the following month and include the filter number(s), corresponding date(s), turbidity value(s) which exceeded 1.0 NTU, and the cause (if known) for

the exceedance(s).

If a system was required to report to the State

*** Your system must * * *

(b) For three months in a row and turbidity exceeded 1.0 NTU in two consecutive recordings 15 minutes apart at the same filter (or

CFE for systems with 2 filters that monitor

CFE in lieu of individual filters).

Conduct a self-assessment of the filter(s) within 14 days of the day the filter exceeded 1.0

NTU in two consecutive measurements for the third straight month unless a CPE as specified in paragraph (c) of this section was required. Systems with 2 filters that monitor CFE in

lieu of individual filters must conduct a self assessment on both filters. 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. If a self-assessment is required, the date that it was triggered and the date that it was

completed.

(c) For two months in a row and turbidity exceeded 2.0 BTU in 2 consecutive recordings

15 minutes apart at the same filter (or CFE

for systems with 2 filters that monitor CFE in

lieu of individual filters).

Arrange to have a comprehensive performance evaluation (CPE) conducted by the State or a

third party approved by the State not later than 60 days following the day the filter exceeded

2.0 NTU in two consecutive measurements for the second straight month. If a CPE has

been completed by the State or a third party approved by the State within the 12 prior

months or the system and State are jointly participating in an ongoing Comprehensive Technical Assistance (CTA) project at the system, a new CPE is not required. If conducted, a

CPE must be completed and submitted to the State no later than 120 days following the

day the filter exceeded 2.0 NTU in two consecutive measurements for the second straight

month.

§ 141.564 My system practices lime

softening—is there any special provision

regarding my individual filter turbidity

monitoring?

If your system utilizes lime softening,

you may apply to the State for

alternative turbidity exceedance levels

for the levels specified in the table in

§ 141.563. You must be able to

demonstrate to the State that higher

turbidity levels are due to lime

carryover only, and not due to degraded

filter performance.

Reporting and Recordkeeping

Requirements

§ 141.570 What does subpart T require that

my system report to the State?

This subpart T requires your system

to report several items to the State. The

following table describes the items

which must be reported and the

Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations 1843

frequency of reporting. Your system is

required to report the information

described in the following table, if it is

subject to the specific requirement

shown in the first column.

Corresponding

requirement Description of information to report Frequency

(a) Combined Filter Effluent Requirements.

(§§ 141.550–141.553)

(1) The total number of filtered water turbidity measurements

taken during the month.

By the 10th of the following month.

(2) The number and percentage of filtered water turbidity

measurements taken during the month which are less than

or equal to your system’s required 95th percentile limit.

By the 10th of the following month.

(3) The date and value of any turbidity measurements taken

during the month which exceed the maximum turbidity

value for your filtration system.

By the 10th of the following month.

(b) Individual Turbidity Requirements.

(§§ 141.560–141.564)

(1) That your system conducted individual filter turbidity monitoring during the month.By the 10th of the following month.

(2) The filter number(s), corresponding date(s), and the turbidity value(s) which exceeded 1.0 NTU during the month,

but only if 2 consecutive measurements exceeded 1.0 NTU.

By the 10th of the following month.

(3) If a self-assessment is required, the date that it was triggered and the date that it was completed.By the 10th of the following month (or 14 days

after the self-assessment was triggered only

if the self-assessment was triggered during

the last four days of the month)

(4) If a CPE is required, that the CPE is required and the

date that it was triggered.

By the 10th of the following month.

(5) Copy of completed CPE report ........................................... Within 120 days after the CPE was triggered.

(c) Disinfection Profiling ............

(§§ 141.530–141.536)

(1) Results of optional monitoring which show TTHM levels

<0.064 mg/l and HAA5 levels <0.048 mg/l (Only if your system wishes to forgo profiling) or that your system has

begun disinfection profiling.

(i) For systems serving 500–9,999 by July 1,

2003;

(ii) For systems serving fewer than 500 by

January 1, 2004.

(d) Disinfection Benchmarking ..

(§§ 141.540–141.544)

(1) A description of the proposed change in disinfection, your

system’s disinfection profile for Giardia lamblia (and, if necessary, viruses) and disinfection benchmark, and an analysis of how the proposed change will affect the current levels of disinfection.

Anytime your system is considering a significant change to its disinfection practice.

§ 141.571 What records does subpart T

require my system to keep?

Your system must keep several types

of records based on the requirements of

subpart T, in addition to recordkeeping

requirements under § 141.75. The

following table describes the necessary

records, the length of time these records

must be kept, and for which

requirement the records pertain. Your

system is required to maintain records

described in this table, if it is subject to

the specific requirement shown in the

first column.

Corresponding requirement Description of necessary records Duration of time

records must be kept

(a) Individual Filter Turbidity Requirements .........................

(§§ 141.560–141.564)

Results of individual filter monitoring ................................... At least 3 years.

(b) Disinfection Profiling .......................................................

(§§ 141.530–141.536)

Results of Profile (including raw data and analysis) ........... Indefinitely.

(c) Disinfection Benchmarking .............................................

(§§ 141.540–141.544)

Benchmark (including raw data and analysis) .................... Indefinitely.

PART 142—NATIONAL PRIMARY

DRINKING WATER REGULATIONS

IMPLEMENTATION

15. 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.

16. Section 142.14 is amended by

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

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

141.550–141.553 and 141.560–141.564

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

the reporting requirements of §§ 141.75,

141.175, and 141.570, 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

1844 Federal Register / Vol. 67, No. 9 / Monday, January 14, 2002 / Rules and Regulations

under provisions of part 141, subpart H,

subpart P, or subpart T of this chapter,

must be made in writing and kept by the

State.

* * * * *

(7) Any decisions made pursuant to

the provisions of part 141, subpart P or

subpart T of this chapter.

(i) Records of systems consulting with

the State concerning a modification to

disinfection practice under

§§ 141.170(d), 141.172(c), and 141.542

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) and

§ 141.552 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

and 141.563 of this chapter.

* * * * *

17. Section 142.16 is amended by

revising paragraph (g) introductory text

and adding paragraph (j) to read as

follows:

§ 142.16 Special primacy requirements.

* * * * *

(g) Requirements for States to adopt

40 CFR part 141, Subpart P Enhanced

Filtration and Disinfection—Systems

Serving 10,000 or More People. 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—Systems Serving

10,000 or More People, must contain the

information specified in this paragraph:

* * * * *

(j) Requirements for States to adopt 40

CFR part 141, Subpart T Enhanced

Filtration and Disinfection—Systems

Serving Fewer than 10,000 People. 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 T Enhanced Filtration

and Disinfection—Systems Serving

Fewer than 10,000 People, must contain

the information specified in this

paragraph:

(1) Enforceable requirements. States

must have rules or other authority to

require systems to participate in a

Comprehensive Technical Assistance

(CTA) activity, the performance

improvement phase of the Composite

Correction Program (CCP). The State

must determine whether a CTA must be

conducted based on results of a CPE

which indicate the potential for

improved performance, and a finding by

the State that the system is able to

receive and implement technical

assistance provided through the CTA. A

CPE is a thorough review and analysis

of a system’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. During the CTA phase, the

system must identify and systematically

address factors limiting performance.

The CTA is a combination of utilizing

CPE results as a basis for follow-up,

implementing process control prioritysetting techniques and maintaining

long-term involvement to systematically

train staff and administrators.

(2) State practices or procedures.

(i) Section 141.530–141.536—How the

State will approve a more representative

data set for optional TTHM and HAA5

monitoring and profiling.

(ii) Section 141.536 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, ozone, or chlorine dioxide

for primary disinfection.

(iii) Section 141.542 of this chapter—

How the State will consult with the

system and approve significant changes

to disinfection practices.

(iv) Section 141.552 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

§ 141.72(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. 02–409 Filed 1–11–02; 8:45 am]

BILLING CODE 6560–50–P