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Water: Microbial & Disinfection Byproducts Rules

National Primary Drinking Water Regulations: Interim Enhanced Surface Water Treatment

Federal Register Document

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[Federal Register: December 16, 1998 (Volume 63, Number 241)]

[Rules and Regulations]

[Page 69477-69521]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr16de98-18]





[[Page 69477]]



_______________________________________________________________________



Part V











Environmental Protection Agency











_______________________________________________________________________







40 CFR Parts 9, 141, and 142







National Primary Drinking Water Regulations: Interim Enhanced Surface

Water Treatment; Final Rule





[[Page 69478]]







ENVIRONMENTAL PROTECTION AGENCY



40 CFR Parts 9, 141, and 142



[WH-FRL-6199-9]

RIN 2040-AC91





National Primary Drinking Water Regulations: Interim Enhanced

Surface Water Treatment



AGENCY: Environmental Protection Agency (EPA).



ACTION: Final rule.



-----------------------------------------------------------------------



SUMMARY: In this document, EPA is finalizing the Interim Enhanced

Surface Water Treatment Rule (IESWTR). The purposes of the IESWTR are

to: Improve control of microbial pathogens, including specifically the

protozoan Cryptosporidium, in drinking water; and address risk trade-

offs with disinfection byproducts. Key provisions established in

today's final IESWTR include: A Maximum Contaminant Level Goal (MCLG)

of zero for Cryptosporidium; 2-log Cryptosporidium removal requirements

for systems that filter; strengthened combined filter effluent

turbidity performance standards and individual filter turbidity

provisions; disinfection benchmark provisions to assure continued

levels of microbial protection while facilities take the necessary

steps to comply with new disinfection byproduct standards; inclusion of

Cryptosporidium in the definition of ground water under the direct

influence of surface water (GWUDI) and in the watershed control

requirements for unfiltered public water systems; requirements for

covers on new finished water reservoirs; and sanitary surveys for all

surface water systems regardless of size. The IESWTR builds upon the

treatment technique requirements of the Surface Water Treatment Rule.

    EPA believes that implementation of the IESWTR will significantly

reduce the level of Cryptosporidium in finished drinking water supplies

through improvements in filtration. The Agency estimates that the

likelihood of endemic illness from Cryptosporidium will decrease by

110,000 to 463,000 cases annually. The Agency believes that the rule

will also reduce the likelihood of the occurrence of outbreaks of

cryptosporidiosis by providing a larger margin of safety against such

outbreaks for some systems. In addition, the filtration provisions of

the rule are expected to increase the level of protection from exposure

to other pathogens (i.e., Giardia or other waterborne bacterial or

viral pathogens).

    The IESWTR applies to public water systems that use surface water

or GWUDI and serve 10,000 or more people. The rule also requires

primacy States to conduct sanitary surveys for all surface water and

GWUDI systems regardless of size.



EFFECTIVE DATE: This regulation is effective February 16, 1999.

Compliance dates for specific components of the rule are discussed in

the Supplementary Information section.



ADDRESSES: Public comments, the comment/response document, applicable

Federal Register notices, other major supporting documents, and a copy

of the index to the public docket for this rulemaking are available for

review at EPA's Drinking Water Docket: 401 M Street, SW., Rm. EB57,

Washington, DC 20460 from 9 a.m. to 4 p.m., Monday through Friday,

excluding legal holidays. For access to docket materials, please call

(202) 260-3027 to schedule an appointment.



FOR FURTHER INFORMATION, CONTACT: For general information contact the

Safe Drinking Water Hotline, Telephone (800) 426-4791. The Safe

Drinking Water Hotline is open Monday through Friday, excluding Federal

holidays, from 9 a.m. to 5:30 p.m. Eastern Time. For technical

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

(Microbiology), Office of Ground Water and Drinking Water (MC 4607),

U.S. Environmental Protection Agency, 401 M Street SW, Washington DC

20460; telephone (202) 260-8907 (Corr) or (202) 260-3039 (Berger). For

Regional contacts see Supplementary Information.



SUPPLEMENTARY INFORMATION: This regulation is effective 60 days after

publication of FR document for purposes of the Administrative

Procedures Act and the Congressional Review Act. Compliance dates for

specific components of the rule are discussed below. Solely for

judicial review purposes, this final rule is promulgated as of 1 p.m.

Eastern Time December 30, 1998 as provided in 40 CFR 23.7.

    Regulated entities. Entities potentially regulated by the IESWTR

are public water systems that use surface water or ground water under

the direct influence of surface water and serve at least 10,000 people.

(States are required to carry out sanitary surveys for all surface

water and GWUDI systems including those that serve less than 10,000

people.) Regulated categories and entities include:



------------------------------------------------------------------------

           Category                  Examples of regulated entities

------------------------------------------------------------------------

Industry.....................  Public Water Systems (PWSs) that use

                                surface water or ground water under the

                                direct influence of surface water and

                                serve at least 10,000 people

State, Local, Tribal or        PWSs that use surface water or ground

Federal Governments.           water under the direct influence of

                                surface water and serve at least 10,000

                                people.

------------------------------------------------------------------------



    This table is not intended to be exhaustive, but rather provides a

guide for readers regarding entities likely to be regulated by the

IESWTR. This table lists the types of entities that EPA is now aware

could potentially be regulated by the rule. Other types of entities not

listed in this table could also be regulated. To determine whether your

facility is regulated by this action, you should carefully examine the

applicability criteria in subpart H (Sec. 141.70(a)--systems subject to

the Surface Water Treatment Rule) and subpart P (Sec. 141.170(a)--

subpart H systems that serve 10,000 or more people) of the final rule.

If you have questions regarding the applicability of the IESWTR to a

particular entity, consult one of the persons listed in the preceding

FOR FURTHER INFORMATION CONTACT section.



Regional Contacts



I. Kevin Reilly, Water Supply Section, JFK Federal Bldg., Room 203,

Boston, MA 02203, (617) 565-3616

II. Michael Lowy, Water Supply Section, 290 Broadway, 24th Floor, New

York, NY 10007-1866, (212) 637-3830

III. Jason Gambatese, Drinking Water Section (3WM41), 1650 Arch Street,

Philadelphia, PA 19103-2029, (215) 814-5759

IV. David Parker, Water Supply Section, 345 Courtland Street, Atlanta,

GA 30365, (404) 562-9460

V. Kimberly Harris, Water Supply Section, 77 W. Jackson Blvd., Chicago,

IL 60604, (312) 886-4239



[[Page 69479]]



VI. Blake L. Atkins, Drinking Water Section, 1445 Ross Avenue, Dallas,

TX 75202, (214) 665-2297

VII. Ralph Flournoy, Drinking Water/Ground Water Management Branch, 726

Minnesota Ave., Kansas City, KS 66101, (913) 551-7374

VIII. Bob Clement, Public Water Supply Section (8P2-W-MS), 999 18th

Street, Suite 500, Denver, CO 80202-2466, (303) 312-6653

IX. Bruce Macler, Water Supply Section, 75 Hawthorne Street, San

Francisco, CA 94105, (415) 744-1884

X. Wendy Marshall, Drinking Water Unit, 1200 Sixth Avenue (OW-136),

Seattle, WA 98101, (206) 553-1890



List of Abbreviations Used in This Document



ASCE: American Society of Civil Engineers

ASDWA: Association of State Drinking Water Administrators

ASTM: American Society for Testing and Materials

AWWA: American Water Works Association

AWWARF: American Water Works Association Research Foundation

deg.C: Degrees Centigrade

CCP: Composite Correction Program

CDC: Centers for Disease Control

CFE: Combined Filter Effluent

CFR: Code of Federal Regulations

CPE: Comprehensive Performance Evaluation

CT: The Residual Concentration of Disinfectant (mg/L) Multiplied by the

Contact Time (in minutes)

CTA: Comprehensive Technical Assistance

DBPs: Disinfection Byproducts

DBPR: Disinfectants/Disinfection Byproducts Rule

ESWTR: Enhanced Surface Water Treatment Rule

FACA: Federal Advisory Committee Act

GAC: Granular Activated Carbon

GAO: Government Accounting Office

GWUDI: Ground Water Under the Direct Influence of Surface Water

HAA5: Haloacetic acids (Monochloroacetic, Dichloroacetic,

Trichloroacetic, Monobromoacetic and Dibromoacetic Acids)

HPC: Heterotropic Plate Count

hrs: Hours

ICR: Information Collection Rule

IESWTR: Interim Enhanced Surface Water Treatment Rule

IFA: Individual Filter Assessment

Log Inactivation: Logarithm of (N<INF>0</INF>/N<INF>T</INF>)

Log: Logarithm (common, base 10)

LTESWTR: Long Term Enhanced Surface Water Treatment Rule

LT1: Long Term 1 Enhanced Surface Water Treatment Rule

MCL: Maximum Contaminant Level

MCLG: Maximum Contaminant Level Goal

M-DBP: Microbial and Disinfectants/Disinfection Byproducts

MPA: Microscopic Particulate Analysis

NODA: Notice of Data Availability

NPDWR: National Primary Drinking Water Regulation

N<INF>T</INF>: The Concentration of Surviving Microorganisms at Time T

NTTAA: National Technology Transfer and Advancement Act

NTU: Nephelometric Turbidity Unit

PE: Performance Evaluation

PWS: Public Water System

Reg. Neg.: Regulatory Negotiation

RIA: Regulatory Impact Analysis

RFA: Regulatory Flexibility Act

RSD: Relative Standard Deviation

SAB: Science Advisory Board

SDWA: Safe Drinking Water Act

SWTR: Surface Water Treatment Rule

TC: Total Coliforms

TCR: Total Coliform Rule

TTHM: Total Trihalomethanes

TWG: Technical Work Group

UMRA: Unfunded Mandates Reform Act

x log removal: Reduction to \1/10\<SUP>x </SUP>of original

concentration

 

Table of Contents



I. Background



A. Statutory Requirements and Legal Authority

B. Regulatory History

    1. Existing Regulations

    --Surface Water Treatment Rule (SWTR)

    --Total Coliform Rule (TCR)

    --Total Trihalomethane (TTHM) Rule

    --Information Collection Rule (ICR)

    2. Public Health Concerns to be Addressed

    3. Regulatory Negotiation Process

    4. Federal Advisory Committee Process

    5. Overview of 1994 Proposal and 1997 Notice of Data

Availability



II. Summary of the Final Rule



III. Explanation of Today's Action



A. MCLG for Cryptosporidium

    1. Today's Rule

    2. Background and Analysis

    3. Summary of Major Comments

B. Removal of Cryptosporidium by Filtration

    1. Today's Rule

    2. Background and Analysis

    3. Summary of Major Comments

C. Turbidity Control

    1. Today's Rule

    2. Background and Analysis

    3. Summary of Major Comments

D. Disinfection Benchmark for Stage 1 DBPR MCLs

    1. Today's Rule

    2. Background and Analysis

    3. Summary of Major Comments

E. Definition of Ground Water Under the Direct Influence of Surface

Water

    1. Today's Rule

    2. Background and Analysis

    3. Summary of Major Comments

F. Inclusion of Cryptosporidium in Watershed Control Requirements

    1. Today's Rule

    2. Background and Analysis

    3. Summary of Major Comments

G. Covered Finished Water Reservoirs

    1. Today's Rule

    2. Background and Analysis

    3. Summary of Major Comments

H. Sanitary Survey Requirements

    1. Today's Rule

    2. Background and Analysis

    3. Summary of Major Comments

I. Compliance Schedules

    1. Today's Rule

    2. Background and Analysis

    3. Summary of Major Comments



IV. State Implementation



A. Special State Primacy Requirements

B. State Recordkeeping Requirements

C. State Reporting Requirements

D. Interim Primacy



V. Economic Analysis



A. Today's Rule

B. Overview of RIA for Proposed Rule

C. What's Changed Since the Proposed Rule

D. Summary of Cost Analysis

E. Household Costs

F. Summary of Benefits Analysis

G. Comparison of Costs and Benefits



VI. Additional Issues Discussed in 1994 Proposal and 1997 NODA



A. Inactivation of Cryptosporidium

B. Giardia Inactivation CT values for Profiling/Benchmarking

C. Cross Connection Control

D. Filter Backwash Recycling

E. Certification Criteria for Water Plant Operators



VII. Other Requirements



A. Regulatory Flexibility Act

B. Paperwork Reduction Act

C. Unfunded Mandates Reform Act

D. National Technology Transfer and Advancement Act

E. Executive Order 12866, Regulatory Planning and Review

F. Executive Order 12898: Environmental Justice

G. Executive Order 13045: Protection of Children from Environmental

Health Risks and Safety Risks

H. Executive Order 12875: Enhancing the Intergovernmental

Partnership

I. Executive Order 13084: Consultation and Coordination With Indian

Tribal Governments

J. Consultation with the Science Advisory Board, National Drinking

Water Council, and Secretary of Health and Human Services

K. Likely Effect of Compliance with the IESWTR on the Technical,

Financial, and Managerial Capacity of Public Water Systems

L. Submission to Congress and the General Accounting Office



VIII. References



I. Background



A. Statutory Requirements and Legal Authority



    The Safe Drinking Water Act (SDWA or the Act), as amended in 1986,



[[Page 69480]]



requires USEPA to publish a ``maximum contaminant level goal'' (MCLG)

for each contaminant which, in the judgement of the USEPA

Administrator, ``may have any adverse effect on the health of persons

and which is known or anticipated to occur in public water systems''

(Section 1412(b)(3)(A)). MCLGs are to be set at a level at which ``no

known or anticipated adverse effect on the health of persons occur and

which allows an adequate margin of safety'' (Section 1412(b)(4)).

    The Act was amended in August 1996. As a result of these

Amendments, several of these provisions were renumbered and augmented

with additional language. Other sections were added establishing new

drinking water requirements. These modifications are outlined below.

    The Act also requires that at the same time USEPA publishes an

MCLG, which is a non-enforceable health goal, it also must publish a

National Primary Drinking Water Regulation (NPDWR) that specifies

either a maximum contaminant level (MCL) or treatment technique

(Sections 1401(l) and 1412(a)(3)). USEPA is authorized to promulgate a

NPDWR ``that requires the use of a treatment technique in lieu of

establishing a MCL,'' if the Agency finds that ``it is not economically

or technologically feasible to ascertain the level of the contaminant''

EPA's general authority to set a maximum contaminant level goal (MCLG)

and National Primary Drinking Water Regulation (NPDWR) applies to

contaminants that may ``have an adverse effect on the health of

persons,'' that are ``known to occur or there is a substantial

likelihood that the contaminant will occur in public water systems with

a frequency and at levels of public health concern,'' and for which

``in the sole judgement of the Administrator, regulation of such

contaminant presents a meaningful opportunity for health risk reduction

for persons served by public water systems'' (SDWA Section

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

    The amendments, also require EPA, when proposing a NPDWR that

includes an MCL or treatment technique, to publish and seek public

comment on an analysis of health risk reduction and cost impacts. In

addition, EPA is required to take into consideration the effects of

contaminants upon sensitive subpopulations (i.e. infants, children,

pregnant women, the elderly, and individuals with a history of serious

illness), and other relevant factors. (Section 1412 (b)(3)(C)).

    The amendments established a number of regulatory deadlines,

including schedules for a Stage 1 Disinfection Byproduct Rule (DBPR),

an Interim Enhanced Surface Water Treatment Rule (IESWTR), a Long Term

Final Enhanced Surface Water Treatment Rule (LTESWTR) affecting Public

Water Systems (PWSs) that serve under 10,000 people, and a Stage 2 DBPR

(Section 1412(b)(2)(C)). The Act as amended also requires EPA to

promulgate regulations to address filter backwash (Section 1412(b)(14))

and to promulgate regulations specifying criteria for requiring

disinfection ``as necessary'' for ground water systems.

    Finally, as part of the 1996 SDWA Amendments, recordkeeping

requirements were modified to apply to every person who is subject to a

requirement of this title or who is a grantee (Section 1445(a)(1)(A)).

Such persons are required to establish and maintain such records, make

such reports, conduct such monitoring, and provide such information as

the Administrator may reasonably require by regulation.



B. Regulatory History



1. Existing Regulations



Surface Water Treatment Rule (SWTR)

    Under the Surface Water Treatment Rule (SWTR) (54 FR 27486, June

29, 1989) (EPA, 1989b), EPA set maximum contaminant level goals of zero

for Giardia lamblia, viruses, and Legionella; and promulgated National

Primary Drinking Water Regulations for all PWSs using surface water

sources or ground water sources under the direct influence of surface

water. The SWTR includes treatment technique requirements for filtered

and unfiltered systems that are intended to protect against the adverse

health effects of exposure to Giardia lamblia, viruses, and Legionella,

as well as many other pathogenic organisms. Briefly, those requirements

include (1) requirements for maintenance of a disinfectant residual in

the distribution system; (2) removal and/or inactivation of 3 log

(99.9%) for Giardia and 4 log (99.99%) for viruses; (3) combined filter

effluent turbidity performance standard of 5 NTU as a maximum and 0.5

NTU at the 95th percentile monthly, based on 4-hour monitoring for

treatment plants using conventional treatment or direct filtration

(with separate standards for other filtration technologies); and (4)

watershed protection and other requirements for unfiltered systems.

Total Coliform Rule (TCR)

    The Total Coliform Rule (TCR) (54 FR 27544, June 29, 1989) applies

to all public water systems (EPA, 1989c). This regulation sets

compliance with the Maximum Contaminant Level (MCL) for total coliforms

(TC) as follows. For systems that collect 40 or more samples per month,

no more than 5.0% of the samples may be TC-positive; for those that

collect fewer than 40 samples, no more than one sample may be TC-

positive. In addition, if two consecutive samples in the system are TC-

positive, and one is also fecal coliform or E. coli-positive, then this

is defined as an acute violation of the MCL. If a system exceeds the

MCL, it must notify the public using mandatory language developed by

the EPA. The required monitoring frequency for a system depends on the

number of people served and ranges from 480 samples per month for the

largest systems to once annually for certain of the smallest systems.

All systems must have a written plan identifying where samples are to

be collected.

    If a system has a TC-positive sample, it must test that sample for

the presence of fecal coliforms or E. coli. The system must also

collect a set of repeat samples, and analyze for TC (and fecal coliform

or E. coli if necessary) within 24 hours of being notified of a TC-

positive sample.

    The TCR also requires an on-site inspection (referred to as a

sanitary survey) every 5 years for each system that collects fewer than

five samples per month. (This requirement is extended to every10 years

for non-community systems using only protected and disinfected ground

water.)

Total Trihalomethane (TTHM) Rule

    In November 1979 (44 FR 68624) (EPA, 1979) EPA set an interim MCL

for total trihalomethanes (TTHM) of 0.10 mg/L as an annual average.

Compliance is defined on the basis of a running annual average of

quarterly averages of all samples. The value for each sample is the sum

of the measured concentrations of chloroform, bromodichloromethane,

dibromochloromethane and bromoform.

    The interim TTHM standard only applies to community water systems

using surface water and/or ground water serving at least 10,000 people

that add a disinfectant to the drinking water during any part of the

treatment process. At their discretion, States may extend coverage to

smaller PWSs; however, most States have not exercised this option.

Information Collection Rule (ICR)

    The Information Collection Rule (ICR) is a monitoring and data

reporting rule that was promulgated on May 14, 1996 (61 FR 24354) (EPA,

1996b). The purpose of the ICR is to collect occurrence and treatment

information to



[[Page 69481]]



help evaluate the need for possible changes to the current SWTR and

existing microbial treatment practices, and to help evaluate the need

for future regulation for disinfectants and disinfection byproducts

(DBPs). The ICR will provide EPA with additional information on the

national occurrence in drinking water of (1) chemical byproducts that

form when disinfectants used for microbial control react with naturally

occurring compounds already present in source water and (2) disease-

causing microorganisms, including Cryptosporidium, Giardia, and

viruses. The ICR will also provide engineering data on how PWSs

currently control for such contaminants. This information is being

collected because the 1992 Regulatory Negotiating (Reg. Neg.) Committee

on microbial pathogens and disinfectants and DBPs concluded that

additional information was needed to assess the potential health

problem created by the presence of DBPs and pathogens in drinking water

and to assess the extent and severity of risk in order to make sound

regulatory and public health decisions. The ICR will also provide

information to support regulatory impact analyses for various

regulatory options, and to help develop monitoring strategies for cost-

effectively implementing regulations.

    The ICR pertains to large public water systems serving populations

of at least 100,000; a more limited set of ICR requirements pertain to

ground water systems serving between 50,000 and 100,000 people. About

300 PWSs operating 500 treatment plants are involved with the extensive

ICR data collection. Under the ICR, these PWSs monitor for water

quality factors affecting DBP formation and DBPs within the treatment

plant and in the distribution system monthly for 18 months. In

addition, PWSs must provide operating data and a description of their

treatment plant design and surface water systems must monitor for

bacteria, viruses, and protozoa. Finally, a subset of PWSs must perform

treatment studies, using either granular activated carbon (GAC) or

membrane processes, to evaluate DBP precursor removal and control of

DBPs. Monitoring for treatment study applicability began in September

1996. The remaining occurrence monitoring began in July 1997.

    One initial intent of the ICR was to collect pathogen occurrence

data and other information for use in developing the Interim Enhanced

Surface Water Treatment Rule (IESWTR) and to estimate national costs

for various treatment options. However, because of delays in

promulgating the ICR and technical difficulties associated with

laboratory approval and review of facility sampling plans, ICR

monitoring did not begin until July 1, 1997, which was later than

originally anticipated. As a result of this delay and the new statutory

deadlines for promulgating the Stage 1 DBPR and IESWTR in November of

1998 (resulting from the 1996 SDWA amendments), ICR data were not

available in time to support these rules. In place of the ICR data, the

Agency worked with stakeholders to identify other sources of data

developed since 1994 that could be used to support the development of

the Stage 1 DBPR and IESWTR. EPA will continue to work with

stakeholders in analyzing and using the comprehensive ICR data and

research for developing future Enhanced Surface Water Treatment

requirements and the Stage 2 DBPR.



2. Public Health Concerns To Be Addressed



    In 1990, EPA's Science Advisory Board (SAB), an independent panel

of experts established by Congress, cited drinking water contamination

as one of the most important environmental risks and indicated that

disease-causing microbial contaminants (i.e., bacteria, protozoa and

viruses) are probably the greatest remaining health risk management

challenge for drinking water suppliers (EPA/SAB, 1990). Information on

the number of waterborne disease outbreaks from the U.S. Centers for

Disease Control and Prevention (CDC) underscores this concern. CDC

indicates that, between 1980 and 1996, 401 waterborne disease outbreaks

were reported, with over 750,000 associated cases of disease (Craun

1998, 1997a; Kramer et al 1996). During this period, a number of agents

were implicated as the cause, including protozoa, viruses and bacteria,

as well as several chemicals. Most of the cases (but not outbreaks)

were associated with surface water, and specifically with a single

outbreak of cryptosporidiosis in Milwaukee (over 400,000 cases)

(MacKenzie et al, 1994).

    It is important to note that for a number of reasons, the CDC

reports may substantially understate the actual number of waterborne

disease outbreaks and cases in the U.S. First, few States have an

active outbreak surveillance program. Second, disease outbreaks are

often not recognized in a community or, if recognized, are not traced

to the drinking water source. Third, a large number of people

experiencing gastrointestinal illness (predominantly diarrhea) do not

seek medical attention. Fourth, physicians may often not have a broad

enough community-wide basis of information to attribute

gastrointestinal illness to any specific origin such as a drinking

water source. Finally, an unknown but probably significant portion of

waterborne disease is endemic (i.e., not associated with an outbreak),

and thus is even more difficult to recognize.

    Waterborne disease is usually acute (i.e., sudden onset and

typically lasting a short time in healthy people). Some pathogens

(e.g., Giardia, Cryptosporidium) may cause extended illness, sometimes

lasting months or longer, in otherwise healthy individuals. Most

waterborne pathogens cause gastrointestinal illness, with diarrhea,

abdominal discomfort, nausea, vomiting, and/or other symptoms. Other

waterborne pathogens cause, or at least are associated with, more

serious disorders such as hepatitis, gastric cancer, peptic ulcers,

myocarditis, swollen lymph glands, meningitis, encephalitis, and a

myriad of other diseases.

    Gastrointestinal illness may be chronic in vulnerable populations

(e.g., immunocompromised individuals). The severity and duration of

illness is often greater in immunocompromised persons than in healthy

individuals and may be fatal among this population. For instance, a

follow-up study of the 1993 Milwaukee waterborne disease outbreak

reported that at least 50 Cryptosporidium-associated deaths occurred

among the severely immunocompromised (Hoxie et al., 1997).

Immunocompromised persons include infants, pregnant women, the elderly,

and especially those with severely weakened immune systems (e.g., AIDS

patients, those receiving treatment for certain types of cancer, organ-

transplant recipients and people on immunosuppressant drugs) (Gerba et

al., 1996).

    With specific reference to cryptosporidiosis, the disease is caused

by ingestion of environmentally-resistant Cryptosporidium oocysts,

which are readily carried by the waterborne route. Humans and other

animals may excrete these oocysts. Transmission of this disease often

occurs through ingestion of the infective oocysts from contaminated

water or food, but may also result from direct or indirect contact with

infected persons or animals (Casemore, 1990; Cordell and Addiss, 1994).

Symptoms of cryptosporidiosis include typical gastrointestinal symptoms

(Current et al., 1983). As noted above, these may persist for several

days to several months.

    While cryptosporidiosis is generally a self-limiting disease with a

complete



[[Page 69482]]

 

recovery in otherwise healthy persons, it can be very serious in

immunosuppressed persons. EPA has a particular concern regarding

drinking water exposure to Cryptosporidium, especially in severely

immunocompromised persons, because there is no effective therapeutic

drug to cure the disease. There have been a number of waterborne

disease outbreaks caused by Cryptosporidium in the United States,

United Kingdom and many other countries (Rose, 1997). There appears to

be an immune response to Cryptosporidium, but it is not known if this

results in protection (Fayer and Ungar, 1986).

    One of the key regulations EPA has developed and implemented to

counter pathogens in drinking water is the SWTR. Among its provisions,

the rule requires that a surface water system have sufficient treatment

to reduce the source water concentration of Giardia and viruses by at

least 99.9% (3 log) and 99.99% (4 log), respectively. A shortcoming of

the SWTR is that the rule does not specifically control for the

protozoan Cryptosporidium. The first report of a recognized outbreak

caused by Cryptosporidium was published during the development of the

SWTR (D'Antonio et al., 1985).

    In terms of occurrence, Cryptosporidium is common in the

environment. Runoff from unprotected watersheds allows transport of

these microorganisms to water bodies used as intake sites for drinking

water treatment plants. A particular public health challenge is that

simply increasing existing disinfection levels above those most

commonly practiced in the United States today does not appear to be an

effective strategy for controlling Cryptosporidium, because the

Cryptosporidium oocyst is especially resistant to disinfection

practices commonly used at water treatment plants. Today's rule

addresses the concern of passage of Cryptosporidium through physical

removal processes during water treatment. It also strengthens the

effectiveness and reliability of physical removal for particulate

matter and microorganisms in general, thereby reducing the likelihood

of the disinfection barrier being over challenged. Waterborne disease

outbreaks have been associated with a high level of particles passing

through a water treatment plant (Fox and Lytle, 1996). This presents a

significant public health concern. Hence, there is a need to optimize

treatment reliability and to enhance physical removal efficiencies to

minimize the Cryptosporidium levels in finished water. This rule, with

tightened turbidity performance criteria and required individual filter

monitoring, is formulated to address these public health concerns.



3. Regulatory Negotiation Process



    In 1992 EPA initiated a negotiated rulemaking to address public

health concerns associated with disinfectants, DBPs and microbial

pathogens. The negotiators included representatives of State and local

health and regulatory agencies, public water systems, elected

officials, consumer groups and environmental groups. The Reg. Neg.

Committee met from November 1992 through June 1993.

    Early in the process, the negotiators agreed that large amounts of

information necessary to understand how to optimize the use of

disinfectants to concurrently minimize microbial and DBP risk on a

plant-specific basis were unavailable. Nevertheless, the Reg. Neg.

Committee agreed that EPA propose a Stage 1 DBPR to extend coverage to

all community and nontransient noncommunity water systems that use

disinfectants, reduce the current TTHM MCL, regulate additional DBPs,

set limits for the use of disinfectants, and reduce the level of

organic precursor compounds in the source water that may react with

disinfectants to form DBPs.

    EPA's most significant concern in developing regulations for

disinfectants and DBPs was the need to ensure that adequate treatment

be maintained for controlling risks from microbial pathogens. One of

the major goals addressed by the Reg. Neg. Committee was to develop an

approach that would reduce the level of exposure from disinfectants and

DBPs without undermining the control of microbial pathogens. The

intention was to ensure that drinking water is microbiologically safe

at the limits set for disinfectants and DBPs and that these chemicals

do not pose an unacceptable health risk at these limits. Thus, the Reg.

Neg. Committee also considered a range of microbial issues and agreed

that EPA should also propose a companion microbial rule (IESWTR).

    Following months of intensive discussions and technical analysis,

the Reg. Neg. Committee recommended the development of three sets of

rules: a two-staged approach for the DBPs (proposal: 59 FR 38668, July

29, 1994) (EPA, 1994a), an ``interim'' ESWTR (proposal: 59 FR 38832,

July 29, 1994) (EPA, 1994b) and ``long-term'' ESWTR, and an Information

Collection Rule (proposal: 59 FR 6332, February 10, 1994) (EPA, 1994c)

(promulgation: 61FR24354, May 14, 1996) (EPA, 1996b). The approach used

in developing these proposals considered the constraints of

simultaneously treating water to control for both microbial

contaminants and disinfectants/DBPs.

    The Reg. Neg. Committee agreed that the schedules for IESWTR and

LTESWTR should be ``linked'' to the schedule for the Stage 1 DBPR to

assure simultaneous compliance and a balanced risk-risk based

implementation. The Reg. Neg. Committee agreed that additional

information on health risk, occurrence, treatment technologies, and

analytical methods needed to be developed in order to better understand

the risk-risk tradeoff, and how to accomplish an overall reduction in

health risks from both pathogens and disinfectants/DBPs.

    Finally, the Reg. Neg. Committee agreed that to develop a

reasonable set of rules and to understand more fully the limitations of

the current SWTR additional field data were critical. Thus, a key

component of the regulation negotiation agreement was the promulgation

of the ICR previously described.



4. Federal Advisory Committee Process



    In May 1996, the Agency initiated a series of public informational

meetings to provide an update on the status of the 1994 proposal and to

review new data related to microbial and DBP regulations that had been

developed since July 1994. In August 1996, Congress enacted the 1996

SDWA Amendments which contained a number of new requirements, as

discussed above, as well as specifying deadlines for final promulgation

of the IESWTR and Stage 1 DBPR. To meet these deadlines and to maximize

stakeholder participation, the Agency established the Microbial-

Disinfectants/Disinfection Byproducts (M-DBP) Advisory Committee under

the Federal Advisory Committee Act (FACA) in March 1997, to collect,

share, and analyze new information and data, as well as to build

consensus on the regulatory implications of this new information. The

Committee consisted of 17 members representing EPA, State and local

public health and regulatory agencies, local elected officials,

drinking water suppliers, chemical and equipment manufacturers, and

public interest groups.

    The M-DBP Advisory Committee met five times in March through July

1997 to discuss issues related to the IESWTR and Stage 1 DBPR.

Technical support for these discussions was provided by a Technical

Work Group (TWG) established by the Committee at its first meeting in

March 1997. The



[[Page 69483]]



Committee's activities resulted in the collection, development,

evaluation, and presentation of substantial new data and information

related to key elements of both proposed rules. The Committee reached

agreement on a number of major issues that were discussed in Notices of

Data Availability (NODA) for the IESWTR (62 FR 59486, November 3, 1997)

(EPA, 1997a) and the Stage 1 DBPR (62 FR 59388, November 3, 1997) (EPA,

1997b). The major issues addressed by the Committee and in the NODAs

include: (1) Maintain the proposed MCLs for TTHMs, HAA5 and bromate;

(2) modify the enhanced coagulation requirements as part of DBP

control; (3) include a microbial benchmarking/profiling to provide a

methodology and process by which a PWS and the State, working together,

assure that there will be no significant reduction in microbial

protection as the result of modifying disinfection practices in order

to meet MCLs for TTHM and HAA5; (4) continue credit for compliance with

applicable disinfection requirements for disinfection applied at any

point prior to the first customer, consistent with the existing SWTR;

(5) modify the turbidity performance requirements and add requirements

for individual filters; (6) establish an MCLG for Cryptosporidium; (7)

add requirements for removal of Cryptosporidium; (8) provide for

mandatory sanitary surveys; and (9) a commitment to additional analysis

of the role of Cryptosporidium inactivation as part of a multiple

barrier concept in the context of a subsequent Federal Register

microbial proposal. The new data and analysis supporting the technical

areas of agreement were summarized and explained at length in EPA's

1997 NODAs. The Committee's recommendations are embodied in an

Agreement In Principle document dated July 15, 1997.



5. Overview of 1994 Proposal and 1997 Notice of Data Availability



    EPA proposed to amend the Surface Water Treatment Rule in 1994 to

provide additional protection against disease-causing organisms

(pathogens) in drinking water (59 FR 38832: July 29, 1994). In November

1997 EPA published a Notice of Data Availability (62 FR 59486) (EPA,

1997a, b) that summarized the 1994 proposal; described new data and

information that the Agency had obtained and analyses that had been

developed since the proposal; provided information concerning the July

1997 recommendations of the M-DBP Advisory Committee described above on

key issues related to the proposal; and requested comment on these

recommendations as well as on other regulatory implications that flowed

from the new data and information. The Agency also solicited additional

data and information that were relevant to the issues discussed in the

Notice. In addition, EPA provided notice that the Agency was re-opening

the comment period for the 1994 proposal for 90 days. EPA also

requested that any information that members of the public would like

the Agency to consider as part of the final rule development process

regarding data or views submitted to the Agency since the close of the

comment period on the 1994 proposal be formally resubmitted during the

reopened 90-day comment period unless already in the underlying record

in the Docket for the Notice of Data Availability.



II. Summary of the Final Rule



    The primary purposes of the IESWTR are (1) to improve control of

microbial pathogens in drinking water, particularly for the protozoan

Cryptosporidium, and (2) to guard against significant increases in

microbial risk that might otherwise occur when systems implement the

Stage 1 Disinfectants/Disinfection Byproducts Rule. Major components of

the IESWTR include the following provisions:

    (a) A Maximum Contaminant Level Goal (MCLG) of zero is established

for the protozoan genus Cryptosporidium.

    (b) Surface water systems serving 10,000 or more people, that are

required to filter under the SWTR, must achieve at least 2 log removal

of Cryptosporidium. Systems that use conventional or direct filtration

meet this requirement if they comply with strengthened turbidity

performance standards for combined filter effluent (described below)

and the current requirements under the SWTR (e.g., meet design and

operating conditions as specified by the State). Systems that use slow

sand filtration or diatomaceous earth meet the 2 log removal

requirement if they are in compliance with existing turbidity

performance standards under the SWTR (less than or equal to 1 NTU in at

least 95% of measurements taken each month or, for slow sand,

alternative criteria as approved by the State; and a maximum of 5 NTU).

    (c) The rule includes a series of requirements related to

turbidity. These address the following:

    Strengthened turbidity performance requirements for the combined

filter effluent. For all surface water or GWUDI systems that use

conventional treatment or direct filtration, serve 10,000 or more

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

system's combined filtered water at each plant must be less than or

equal to 0.3 NTU in at least 95 percent of the measurements taken each

month, and (b) the turbidity level of a system's combined filtered

water at each plant must at no time exceed 1 NTU. For both the maximum

and the 95th percentile requirements, compliance is determined based on

measurements of the combined filter effluent at four-hour intervals.

    Individual Filter Requirements. All surface water or GWUDI systems

that use conventional or direct filtration, serve 10,000 or more

people, and are required to filter must conduct continuous monitoring

of turbidity for each individual filter and must provide an exceptions

report to the State on a monthly basis. Exceptions reporting must

include the following: (1) Any individual filter with a turbidity level

greater than 1.0 NTU based on two consecutive measurements fifteen

minutes apart; and (2) any individual filter with a turbidity level

greater than 0.5 NTU at the end of the first 4 hours of filter

operation based on two consecutive measurements fifteen minutes apart.

A filter profile (which is a graphical representation of an individual

filter performance) must be produced within seven days of the

exceedance if no obvious reason for the abnormal filter performance can

be identified.

    If an individual filter has turbidity levels greater than 1.0 NTU

based on two consecutive measurements fifteen minutes apart at any time

in each of three consecutive months, the system must make an exceptions

report and conduct a self-assessment of the filter. If an individual

filter has turbidity levels greater than 2.0 NTU based on two

consecutive measurements fifteen minutes apart at any time in each of

two consecutive months, the system must make an exception report and

arrange for the conduct of a Comprehensive Performance Evaluation (CPE)

by the State or a third party approved by the State.

    State Authority. States must have rules or other authority to

require systems to conduct a Composite Correction Program (CCP) and to

assure that systems implement any follow-up recommendations that result

as part of the CCP. The CCP consists of two elements--a CPE and

Comprehensive Technical Assistance (CTA). The CPE is a thorough review

and analysis of a plant's performance-based capabilities and associated

administrative, operation and maintenance practices. It is conducted to

identify factors that may



[[Page 69484]]



be adversely impacting a plant's capability to achieve compliance and

emphasizes approaches that can be implemented without significant

capital improvements. The CPE must include the following components:

(1) Assessment of plant performance; (2) evaluation of major unit

processes; (3) identification and prioritization of performance

limiting factors; (4) assessment of the applicability of comprehensive

technical assistance; and (5) preparation of a CPE report. A CTA is the

performance improvement phase that is implemented if the CPE results

indicate improved performance potential. During the CTA phase, the

system must identify and systematically address plant-specific factors.

The CTA is a combination of utilizing CPE results as a basis for follow

up, implementing process control priority-setting techniques, and

maintaining long-term involvement to systematically train staff and

administrators.

    (d) Microbial benchmarking/profiling requirements are included to

provide a methodology and process by which a public water system and

the State, working together, assure that there will be no significant

reduction in microbial protection as the result of significant

disinfection practice modifications in order to meet MCLs for TTHM and

HAA5. The disinfection profiling requirement included in today's rule

applies to surface water systems serving 10,000 or more people and

which have, based on a one year running annual average of

representative samples taken in the distribution system, (1) measured

TTHM levels of at least 80% of the MCL (0.064 mg/L) or (2) measured

HAA5 levels of at least 80% of the MCL (0.048 mg/L). Those PWSs

required to develop a disinfection profile that subsequently decide to

make a significant change in disinfection practice must consult with

the State prior to implementing such a change.

    (e) States are required to conduct sanitary surveys for all public

water systems using surface water or ground water under the direct

influence of surface water, regardless of system size. Sanitary surveys

are required no less frequently than every three years for community

systems and no less frequently than every five years for noncommunity

systems. For community systems determined by the State to have

outstanding performance based on prior sanitary surveys, subsequent

sanitary surveys may be conducted no less frequently than every five

years. States must have the appropriate rules or other authority to

require systems to respond in writing to significant deficiencies

outlined in a sanitary survey report within at least 45 days,

indicating how and on what schedule the system will address significant

deficiencies noted in the survey. States must also have the appropriate

rules or other authority to assure that facilities take the steps

necessary to address significant deficiencies identified in the survey

report that are within the control of the PWS and its governing body.

    (f) Cryptosporidium is added to the definition of ground water

under the direct influence of surface water (for systems serving 10,000

or more people).

    (g) Cryptosporidium is added to the watershed protection

requirements for systems that are avoiding filtration (for systems

serving 10,000 or more people).

    (h) Surface Water and GWUDI systems serving 10,000 or more people

are required to cover all new treated water reservoirs, holding tanks

or other storage facilities for which construction begins after the

effective date of the rule.

    The Surface Water Treatment Rule remains the base rule regulating

public water systems that use surface water and ground water under the

influence of surface water. All systems, filtered and unfiltered, must

continue to comply with all the requirements of the SWTR and, where

applicable, meet the new requirements of the IESWTR. The IESWTR's

requirements for filtered systems are intended to ensure that where a

filtration plant is required to protect public health, as specified in

the SWTR, that plant will be operating well for the removal of

Cryptosporidium and other microorganisms. EPA wishes to emphasize that

compliance with today's requirements in no way relieves a public water

system of its obligation to comply fully with pre-existing SWTR

requirements. With regard to unfiltered systems in particular,

development of today's rule was based on the assumption of full

compliance with all filtration avoidance criteria in the SWTR.

    Finally, EPA notes that today's Federal Register also contains the

final Stage 1 Disinfectants/Disinfection Byproducts Rule (DBPR). EPA

proposed this rule at the same time as the IESWTR and has finalized it

along with the IESWTR.



III. Explanation of Today's Action



A. MCLG for Cryptosporidium



1. Today's Rule



    The Agency is establishing an MCLG of zero for Cryptosporidium, as

proposed. During the 1997 M-DBP Advisory Committee discussions, the

Committee supported the proposed establishment of an MCLG of zero for

Cryptosporidium. A key issue identified by the Advisory Committee and

public commenters was whether the MCLG should be set at the genus level

(i.e., Cryptosporidium) or at the more specific species level (i.e., C.

parvum). Because of the uncertainties regarding taxonomy, cross

reactions and cross transmission among mammals, EPA believes it is

premature to establish the Cryptosporidium MCLG at the species level.

In addition, the Agency believes that establishing an MCLG for

Cryptosporidium at the genus level is consistent with the Safe Drinking

Water Act, which requires EPA to set the MCLG with an adequate margin

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



2. Background and Analysis



    In the 1994 proposal of the IESWTR (59 FR 145, p. 38855; July 29,

1994), EPA proposed to establish an MCLG of zero for Cryptosporidium.

The Agency based its proposal upon concerns about significant health

effects on persons consuming inadequately treated surface waters and

ground water under the influence of surface waters. Technical

justifications for the proposed MCLG relied upon animal studies and

human epidemiology studies of waterborne outbreaks of

cryptosporidiosis.

    Since the proposed rule, results of a human feeding study have

become available which further warrant the establishment of an MCLG of

zero (1997 NODA 59492). DuPont et al. (1995) fed 29 healthy volunteers

single doses ranging from 30 to 1 million C. parvum oocysts obtained

from a calf. Of the 16 volunteers who received 300 or more oocysts, 88%

became infected. Of the five volunteers who received the lowest dose

(30 oocysts), one became infected. According to a mathematical model

based upon the DuPont et al. data, if an individual ingests a single

viable oocyst there is about a 0.5% chance of infection (Haas et al.,

1996). The probability of infection from C. parvum may be different for

different strains.

    In the process of further reviewing new information since 1994, EPA

has re-examined the issues related to setting an MCLG at the genus

level versus the species level. This issue was discussed in some detail

during the M-DBP Advisory Committee meetings. Currently, the

classification of a number of Cryptosporidium species is based, in

part, on the animal host from which they were isolated. The Agency is

aware that investigators have not found a Cryptosporidium species other

than C. parvum that infects humans (with one highly questionable

exception). To the Agency's knowledge, however, no human infectivity

studies have been conducted to date with any species



[[Page 69485]]



other than C. parvum. Moreover, the taxonomy of the genus

Cryptosporidium is uncertain and changing (Tzipori and Griffiths, 1998;

Fayer et al., 1997). As a result, EPA cannot preclude the possibility

that a new classification of the species comprising the genus

Cryptosporidium may include more than one species capable of infecting

humans. Recently, for example, Peng et al. (1997) analyzed 39 isolates

of C. parvum from humans and cattle and found they could be separated

into either of two genotypes, one of which could infect humans but not

cattle or mice. In the future, these two genotypes may be separated

into two different species.

    In addition to the taxonomic issue, the current tests for C. parvum

in stool specimens and water, which involve the microscopic examination

of a stained specimen, may give positive results for Cryptosporidium

species other than C. parvum. Often this results because other

Cryptosporidium species (as well as other microorganisms) may react

with the stains used to detect C. parvum. This is especially true for

the commonly used acid-fast stain. In addition, C. parvum oocysts do

not differ in size and shape from those of C. baileyi and C.

meleagridis (Arrowood, 1997). As a result, it is not necessarily

certain that oocysts in a human fecal specimen identified by a clinical

laboratory as C. parvum are always C. parvum. (In general, clinical

labs do not use a stain or other procedure that can distinguish between

C. parvum and other Cryptosporidium species).

    The Agency is aware that a few attempts have been made to infect

one type of animal (e.g., mammals) with Cryptosporidium species

isolated from other types of animals (e.g., birds), generally without

success (Fayer, 1997). In addition, Graczyk et al. (1996b) found that

C. parvum was not transmissible to fish, amphibia, or reptiles.

Nevertheless, until more cross-species transmission data are available,

the Agency cannot foreclose on the possibility that species other than

C. parvum may be infective to humans. In their review of the

literature, Fayer et al. (1990) concluded that the success of

transmission studies is contingent upon not only species specificity,

but also the condition and age of the oocysts, the route of inoculation

of oocysts, and the age and immune status of the recipient. Therefore,

negative results to date on transmission are not necessarily conclusive

regarding host specificity.

    EPA believes that it is prudent to set an MCLG at zero not only for

taxonomic reasons but also because of concern that certain populations

are at greater risk of waterborne cryptosporidiosis than others. This

concern is heightened by the fact that currently there is no cure for

cryptosporidiosis (for healthy individuals the disease tends to be self

limiting). Thus, the importance of prevention and avoidance of

infection becomes even more central to EPA's consideration of this

issue. Until the taxonomy of Cryptosporidium has been clarified, EPA

believes that an MCLG of zero for Cryptosporidium at the genus level is

appropriate especially in light of the statutory requirement to

establish MCLGs with ``an adequate margin of safety''.



3. Summary of Major Comments



    Regarding the value of the MCLG most commenters supported the

establishment of a MCLG of zero for Cryptosporidium. Reasons that were

given for their support included: (1) Uncertainty exists in the

infective dose for both healthy and vulnerable (immunocompromised)

individuals; (2) an MCLG of zero is consistent with the regulatory

approach for pathogens under the existing Surface Water Treatment Rule

(SWTR); (3) one viable oocyst can cause an infection at least in some

people; and (4) Cryptosporidium has particularly adverse effects on

persons with immune disorders. No commenter proposed an MCLG value

other than zero. Some commenters opposed any MCLG for Cryptosporidium,

arguing that: (1) Current levels of treatment have some level of

effectiveness against Cryptosporidium transmission to drinking water;

(2) uncertainty exists associated with the analytical procedures used

to detect Cryptosporidium; (3) current technology limits the ability to

determine viability, infectivity, and species; and (4) the infectivity

threshold has not been determined.

    EPA agrees with the commenters who supported an MCLG of zero for

Cryptosporidium for reasons stated in the previous section. EPA does

not agree with comments opposing any MCLG for Cryptosporidium. While it

is true that current levels of treatment control Cryptosporidium to

some extent, studies have found Cryptosporidium oocysts in filtered

water supplies of some treatment plants (LeChevallier, 1991b;

LeChevallier, 1995). Therefore, the Agency believes that regulation of

Cryptosporidium and enhanced treatment practices are warranted.

Furthermore, the effectiveness of treatment is irrelevant to the

question of setting an MCLG, which asks what is the level of

(uncontrolled) Cryptosporidium in drinking water that will pose no risk

to the health of persons. For the reasons discussed, that level is at

zero. The availability of effective treatment merely ensures that EPA

can regulate to control the health risk from Cryptosporidium reflected

by the MCLG.

    Comments which address the uncertainty related to the analytical

method for Cryptosporidium and the fact that current technology does

not allow viability, infectivity, and species to be determined may

relate to the issue of whether EPA establishes an MCL versus treatment

technique requirements for Cryptosporidium. However, they are not

compelling with regard to the public health goal that should be set for

this contaminant.

    With regard to the infectivity threshold for Cryptosporidium,

according to a mathematical model based upon the DuPont et al., 1995

data, if an individual ingests a single viable oocyst there is a 0.5%

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

Cryptosporidium oocysts are capable of causing an infection in both

healthy and seriously ill individuals. Death has been associated with

some cryptosporidiosis cases, particularly among sensitive

subpopulations (i.e., immunocompromised individuals) (Hoxie et al.,

1997). For such reasons, EPA considers an MCLG of zero for

Cryptosporidium to be appropriate.

    EPA also received comments on whether the MCLG for Cryptosporidium

should be set at the genus or the species level. Commenters offered

several reasons for supporting an MCLG for C. parvum, as opposed to

Cryptosporidium. Several professed that only C. parvum could infect

humans, and therefore EPA should establish an MCLG based on that

particular species. Commenters also contended that if, in future

regulations, EPA were to establish a treatment technique requirement

based on the Cryptosporidium density in the source water, publishing an

MCLG for Cryptosporidium at the genus level might require systems to

provide an additional level of treatment for Cryptosporidium species

that are not known to be infectious to humans. In contrast, other

commenters who supported the establishment of an MCLG for

Cryptosporidium at the genus level stated that, unless further research

justifies an MCLG at the species level, the MCLG should be set at the

genus level. They reasoned that Cryptosporidium method limitations

argued for setting the MCLG at the genus level.

    In response to comments that did not support establishing an MCLG

of zero for Cryptosporidium at the genus level,



[[Page 69486]]



EPA has carefully considered the issue of genus versus species level

for Cryptosporidium. As mentioned earlier, EPA concludes that there

exists much uncertainty regarding Cryptosporidium taxonomy, cross

reactions and cross transmissions. Thus, EPA cannot conclude that these

other species pose no health risk. For reasons mentioned above, the

Agency believes that it is more appropriate to establish an MCLG for

Cryptosporidium at the genus level at this time. This decision does not

affect the level of treatment required under the IESWTR. EPA will

revisit the impact of the MCLG in the context of future rules that

include consideration of risk-based options.



B. Removal of Cryptosporidium by Filtration



1. Today's Rule



    Today's final rule establishes a requirement for 2-log removal of

Cryptosporidium for surface water and GWUDI systems serving 10,000 or

more people that must filter under the SWTR. The requirement for at

least 99 percent (2-log) removal of Cryptosporidium applies between a

point where the raw water is not subject to recontamination by surface

water runoff and a point downstream before or at the first customer. As

discussed below, the data available to EPA indicate that rapid granular

filtration systems (i.e., systems using conventional or direct

filtration) when operated under appropriate coagulation conditions and

optimized to meet the turbidity performance standards of the IESWTR

(less than or equal to 0.3 NTU in 95% of the measurements each month

and a maximum of 1 NTU) are achieving at least 2-log removal.



2. Background and Analysis



    The 1994 proposal to amend the Surface Water Treatment Rule

included several proposed treatment alternatives. Two of these

alternatives--Alternatives B and C--specifically addressed

Cryptosporidium. Alternative B envisioned treatment options for

Cryptosporidium based on levels of source water occurrence. Alternative

C called for 99% (2-log) removal of Cryptosporidium. EPA was unable to

consider Alternative B for the IESWTR because occurrence data and

related analysis from the ICR sampling and analysis survey discussed

above were not available in time to meet the statutory promulgation

deadline of November 1998. For the reasons outlined below and as

recommended by the M-DBP Advisory Committee, EPA is proceeding with a

2-log removal requirement for Cryptosporidium for surface water and

GWUDI systems serving 10,000 or more people that are required to filter

under the SWTR.

    As part of the 1997 M-DBP Advisory Committee process, substantial

new data and information related to removal of Cryptosporidium by

filtration were collected, evaluated and analyzed. The Committee

recommended adoption of a 2-log Cryptosporidium removal requirement for

all surface water systems that serve more than 10,000 people and are

required to filter. The Committee also recommended that systems which

use rapid granular filtration (direct filtration or conventional

filtration treatment) and meet today's strengthened combined filter

effluent turbidity requirements would be in compliance with the

requirement for at least a 2-log removal of Cryptosporidium. Systems

which use slow sand filtration and diatomaceous earth filtration and

meet existing SWTR turbidity performance requirements (less than or

equal to 1 NTU for the 95th percentile or alternative criteria as

approved by the State) also would be in compliance with the requirement

for at least a 2-log removal of Cryptosporidium.

    In November of 1997, EPA issued a Notice of Data Availability

(NODA) which discussed new data and information that the Agency had

obtained and analyses that had been developed since the 1994 proposal.

It also summarized recommendations of the M-DBP Advisory Committee on

Cryptosporidium removal. The 1997 NODA requested comment on the new

information, the Advisory Committee's recommendations, and on other

regulatory implications and impacts.

    The November 3, 1997 NODA provided new information regarding eight

studies (Patania et al., 1995; Nieminski and Ongerth, 1995; Ongerth and

Pecoraro, 1995; LeChevallier and Norton, 1992; LeChevallier et al.,

1991b; Foundation for Water Research, 1994; Kelley et al., 1995; and

West et al., 1994) that indicated that rapid granular filtration when

operated under appropriate coagulation conditions and optimized to

achieve a filtered water turbidity of less than 0.3 NTU should achieve

at least 2-log of Cryptosporidium removal. These studies were analyzed

as part of the 1997 IESWTR NODA.

 

3. Summary of Major Comments



    In response to the 1994 Proposal, most commenters addressing the

issue of treatment alternatives supported Alternative C which would

require 2-log physical removal of Cryptosporidium. Some opposed any

treatment requirement greater than a 2-log removal due to a lack of

better understanding of dose-response, effectiveness of treatment and

analyses to justify the higher treatment costs involved. Today's rule

requires at least 2-log removal for Cryptosporidium. EPA will revisit

issues related to further control of Cryptosporidium in future

rulemakings.

    The majority of commenters to the November 1997 NODA agreed with

the appropriateness of establishing a 2-log removal requirement for

Cryptosporidium in the IESWTR, although some commenters had additional

concerns. One major concern was that a quantitative relationship

between removal of Cryptosporidium and lowered turbidity was premature

and had not been established. EPA believes that the studies identified

in the NODA illustrate the removal efficiencies for Cryptosporidium by

several filtration technologies. While these studies demonstrated a

range of Cryptosporidium log-removals, it is important to realize that

2-log removal was consistently obtainable at turbidity levels of less

than 0.3 NTU when systems were operated under appropriate coagulation

conditions and optimized to achieve a filtered water turbidity level of

less than 0.3 NTU. EPA will continue to assess data for control of

Cryptosporidium by physical removal and disinfection as it becomes

available, and will consider such data in subsequent regulations.

    Another significant issue noted by several commenters was that

systems should be provided the opportunity to demonstrate greater log

removal of Cryptosporidium. Consistent with a key point made during M-

DBP Advisory Committee discussions on this issue, EPA takes this

opportunity to note the Agency's position that the requirement for at

least 2-log removal is not intended to prevent a facility from

demonstrating that it can achieve higher than 2-log removal of

Cryptosporidium on a site-specific basis or States from demonstrating

based on site-specific information that a specific facility may

actually be achieving less than 2-log removal of Cryptosporidium even

though it is meeting strengthened turbidity standards of 0.3 NTU for

the 95th percentile and a maximum of 1 NTU.



C. Turbidity Control



1. Today's Rule



    Today's rule establishes a number of requirements for filtration

performance and filter monitoring and reporting, outlined below, which

apply to surface



[[Page 69487]]



water systems or ground water under the direct influence of surface

water (GWUDI) that serve 10,000 or more people and are required to

filter under the SWTR. The basis for these provisions is explained at

greater length in background sections of the 1997 IESWTR NODA.

Combined Filter Effluent Requirements

    For conventional and direct filtration systems, the turbidity level

of representative samples of a system's combined filter effluent water

must be less than or equal to 0.3 NTU in at least 95 percent of the

measurements taken each month. The turbidity level of representative

samples of a system's filtered water must at no time exceed 1 NTU. For

slow sand and diatomaceous earth filtration, the turbidity level of

representative samples of a system's filtered water must be less than

or equal to 1 NTU in at least 95 percent of the measurements taken each

month and the turbidity level of representative samples of a system's

filtered water must at no time exceed 5 NTU (no change from the

combined filter effluent turbidity requirements in the 1989 SWTR). For

both the maximum and 95th percentile requirements, compliance is

determined based on measurements of the combined filter effluent at

four-hour intervals.

    In carrying out these combined effluent requirements, and the

individual filter requirements described below, systems must use

methods for turbidity measurement previously approved by EPA. These are

Method 2130B, published in Standard Methods for the Examination of

Water and Wastewater (19th ed.); Great Lakes Instrument Method 2; and

the revised EPA Method 180.1, approved in August 1993 in Methods for

the Determination of Inorganic Substances in Environmental Samples

(EPA-600/R-93-100). EPA notes that today's rule requires the

measurement of turbidity. Turbidity is a method-defined parameter.

Turbidity therefore is not a candidate for, and will not be subject to,

the performance-based measurements system.

Individual Filter Requirements

    Conventional and direct filtration systems must conduct continuous

monitoring of turbidity for each individual filter and must provide an

exceptions report to the State on a monthly basis as part of the

existing combined filter effluent reporting process. Exceptions

reporting must include the following: (1) Any individual filter with a

turbidity level greater than l.0 NTU based on two consecutive

measurements fifteen minutes apart; and (2) any individual filter with

a turbidity level greater than 0.5 NTU at the end of the first 4 hours

of filter operation based on two consecutive measurements fifteen

minutes apart. The system must produce a filter profile for either

situation if no obvious reason for the abnormal filter performance can

be identified. EPA is including a discussion on filter profiles in its

guidance document on turbidity which is currently being developed with

input from stakeholders.



Individual Filter Follow-Up Activities



    If an individual filter has turbidity levels greater than l.0 NTU

based on two consecutive measurements fifteen minutes apart at any time

in each of three consecutive months, the system must, in addition to

filing an exceptions report, conduct a self-assessment of the filter.

The self-assessment must consist of at least the following components:

(1) Assessment of filter performance; (2) development of a filter

profile; (3) identification and prioritization of factors limiting

filter performance; (4) assessment of the applicability of corrections;

and (5) preparation of a filter self-assessment report. The system must

conduct the self-assessment within 14 days of the exceedance and report

to the State that the self-assessment was conducted. If an individual

filter has turbidity levels greater than 2.0 NTU based on two

consecutive measurements fifteen minutes apart at any time in each of

two consecutive months, the system must file an exceptions report and

must no later than 30 days following the exceedance arrange for the

conduct of a CPE by the State or a third party approved by the State.

The CPE must be completed and submitted to the State no later than 90

days following the exceedance.



2. Background and Analysis



    A primary focus of the 1994 proposal was the establishment of

treatment requirements that would address public health risks from high

densities of pathogens in poor quality source waters and from the

waterborne pathogen Cryptosporidium. Approaches outlined in the 1994

proposal included treatment requirements based on site-specific

concentrations of pathogens in source water and a proposed 2-log

removal requirement for Cryptosporidium by filtration.

    EPA specifically requested comment on what criteria, if any, should

be included to ensure that systems optimize treatment plant performance

and on whether any of the existing turbidity performance criteria

should be modified (e.g., should systems be required to base compliance

with the turbidity standards on individual filter effluent monitoring

in lieu of or in addition to monitoring the confluence of all filters;

and should any performance standard value be changed). In addition, the

Agency also requested comment in the 1994 proposal on possible

supplemental requirements for State notification of persistent high

turbidity levels (e.g., broadening the requirements for State

notification of turbidity exceedances).

    The 1997 M-DBP Advisory Committee meetings resulted in the

collection, development, evaluation, and presentation of substantial

data and information related to turbidity control. The Committee's

recommendations are reflected in today's rule.

    The November 3, 1997 IESWTR NODA discussed new data and information

regarding turbidity control with respect to three areas: (1) Current

turbidity levels at systems throughout the country; (2) individual

filter performance; and (3) turbidity measurement.

Current Turbidity Levels

    The November 3, 1997 NODA discussed three data sets that summarized

the historical turbidity performance of various filtration plants

(AWWSC, 1997; Bissonette, 1997; SAIC, 1997b). These were evaluated to

assess the national impact of modifying existing turbidity

requirements. Each of the data sets was analyzed to assess the current

performance of plants with respect to the number of months in which

selected 95th percentile and maximum turbidity levels were exceeded.

The data show that upwards of 90% of the systems are currently meeting

the new requirements of a maximum turbidity limit of 1 NTU. With

respect to the 95th percentile turbidity limit, roughly 78% of the

systems are currently meeting the new requirement of 0.3 NTU. Estimates

for systems needing to make changes to meet a turbidity performance

limit of 0.3 NTU were based on the ability of systems currently to meet

a 0.2 NTU. This assumption was intended to take into account a

utility's concern with possible turbidity measurement error and to

reflect the expectation that a number of utilities will ``aim'' lower

than the regulatory performance level to assure compliance. The

percentage of systems estimated to modify treatment practices to meet

the revised turbidity requirements (i.e., 0.3 NTU 95th percentile and 1

NTU maximum combined filter effluent levels) is



[[Page 69488]]



approximately 50%. Based on the turbidity performance data, EPA assumed

that for systems serving less than 100,000 people, 51.2 percent of the

systems can be expected to make treatment changes to consistently

comply with a monthly 95th percentile limit of 0.3 NTU. Similarly, for

systems serving over 500,000 people, EPA assumed that 41.7 percent can

be expected to make treatment changes to comply with a 0.3 NTU

regulatory limit. For systems serving 100,000 to 500,000 people, EPA

assumed that 46.5 percent of systems can be expected to make changes.

As discussed in greater detail in the November 3, 1997 NODA, the

tighter turbidity performance criteria for combined filter effluent in

today's rule reflect actual current performance for a substantial

percentage of systems nationally. Revising the turbidity criteria

effectively ensures that these systems continue to perform at these

levels (in addition to improving performance of systems that currently

meet existing SWTR criteria but operate at turbidity levels higher than

those in today's final rule).

Individual Filter Performance

    Several of the studies published since 1994, considered by both EPA

and the M-DBP Advisory Committee and outlined in the 1997 NODA, note

that the greatest potential for a peak in turbidity (and thus, pathogen

break-through) is near the beginning of the filter run after filter

backwash or start up of operation (Amirtharajah 1988; Bucklin et al.

1988; Cleasby 1990; and Hall and Croll 1996). During a turbidity spike,

significant amounts of particulate matter (including oocysts, if

present) may pass through the filter. Various factors affect the

duration and amplitude of filter spikes, including sudden changes to

the flow rate through the filter, treatment of the filter backwash

water, filter-to-waste capability, and site-specific water quality

conditions. As discussed in the 1997 IESWTR NODA, these issues

highlighted the need to ensure that systems have a greater

understanding of individual filter performance and thus for

establishment of individual filter monitoring and reporting

requirements.

Turbidity Measurement

    The November 3, 1997 NODA discussed several issues relating to

measurement of turbidity. It was noted that issues exist concerning the

accuracy and precision of turbidity measurement due to design criteria,

calibration methods, calibration standards, and sampling technique.

Performance evaluation (PE) studies conducted by EPA provide an

indication of the current level of accuracy and precision for turbidity

measurements among different laboratories for a common synthetically

prepared water. In PE studies, PE samples with known turbidity levels

are sent to participating laboratories (which are not informed of the

turbidity level). Laboratories participating in these studies used

turbidimeters from various manufacturers and conducted their analysis

in accordance with calibration and analytical procedures they are

familiar with. Thus, the variability of the results reflects

differences resulting from using different turbidimeter models and

methods and the effects of different laboratory procedures. Four PE

studies were discussed in the NODA with turbidities in the range of

0.35 to 0.72 NTU. The Relative Standard Deviations (RSD) at turbidity

levels considered in these PE studies are slightly below 20%.



3. Summary of Major Comments



    In response to the 1994 proposal, EPA received a range of comments

both in support of and in opposition to optimizing existing water

treatment processes to address Cryptosporidium removal. Several

commenters supported tighter turbidity standards as well as monitoring

of individual filters. Other commenters suggested no modifications be

made to turbidity standards until further implementation of the SWTR

and/or further supporting data was gathered.

    Commenters on the 1997 NODA provided additional views on the

general subject of filtration performance and turbidity. Commenters

generally supported tightening combined filter effluent performance

standards as well as the establishment of individual filter monitoring

requirements. EPA agrees with these comments, as reflected in today's

rule. EPA also notes that turbidity performance data that reflects

implementation of the SWTR was analyzed as part of the M-DBP Advisory

Committee discussions and was considered by the Committee in developing

the recommendations for turbidity which are reflected in today's rule.

    Several commenters discussed the ability of systems to measure

turbidity at low levels (<0.3 NTU) with accuracy and consistency. EPA

believes that the performance evaluation (PE) studies cited in the NODA

provide an indication of the precision and accuracy of turbidity

measurements at low levels. While turbidities in these studies only

ranged from 0.35 to 0.72 NTU, they provided an understanding of the

ability to measure at such levels. EPA recognizes that accurate and

consistent measurements are not only a function of available technology

but also a function of a range of operator/technician factors including

calibration, maintenance, training, and adherence to manufacturer

instructions. In conjunction with the IESWTR, EPA is currently

developing guidance, with stakeholder input, targeted at assisting

owners/operators with understanding turbidity as well as focusing on

the importance of accuracy and consistency in turbidity measurement,

including the low level measurement concerns noted by the commenters.

    Many commenters discussed the issue of lime-softening plants and

how the new requirements would affect such plants which, because of the

softening processes, have artificially elevated levels of turbidity.

The IESWTR allows acidification of samples for the combined filter

effluent at lime softening plants. In addition, EPA is allowing systems

that use lime softening to apply to States for alternative exceedance

reporting levels for individual filters if they can demonstrate that

higher turbidity levels in individual filters are due to lime carryover

and not due to degraded filter performance.

    Several commenters noted that special filters would present

difficulties in complying with the individual filter monitoring

requirements. While EPA realizes that variations exist in filter

configurations and filters in use at systems throughout the country,

the IESWTR will not seek to address the specific requirements of each

and every one. EPA intends to provide States the flexibility and the

tools necessary to effectively deal with special filters discussed by

the commenters on a more appropriate case-by-case basis.

    Another issue raised in public comments was the need to clarify how

public notice requirements in the IESWTR would be integrated with

future public notice requirements under the SDWA. EPA notes that

today's action addresses public notification by using the existing

public notification language for microbiological contaminants in 40 CFR

141.32 (e)(10) for violations of treatment technique requirements under

the IESWTR. EPA takes this opportunity to note that the 1996 amendments

to the SDWA require the Agency to make certain technical changes to the

public notice regulations. EPA intends to propose changes to the public

notice requirements in the Federal Register shortly after promulgation

of the IESWTR. Applicable changes in the public notice



[[Page 69489]]



requirements, when they become effective, will supersede today's

provisions. EPA also takes this opportunity to note that today's rule

amends the Consumer Confidence Report Regulation (CCR) to extend the

CCR requirements to apply to Subpart P violations.

    Several respondents indicated that it would be necessary to provide

guidance materials to systems to aid in compliance with these rules.

EPA is currently developing a number of guidance manuals, with

stakeholder input, to aid systems in understanding and complying with

requirements. One such manual will address issues of turbidity control

and filter performance.



D. Disinfection Benchmark for Stage 1 DBPR MCLs



1. Today's Rule



    Today's rule establishes the disinfection benchmark as a procedure

requiring certain PWSs to evaluate the impact on microbial risk of

proposed changes in disinfection practice. It reflects the

recommendation of the M-DBP Advisory Committee to develop a mechanism

that allows utilities and States working together to assure that

pathogen control is maintained while the Stage 1 DBPR provisions are

implemented. In essence, this procedure involves a PWS charting daily

levels of Giardia lamblia inactivation for a period of at least one

year to create a profile of inactivation performance. The PWS must then

use this profile to determine a baseline or benchmark of inactivation

against which proposed changes in disinfection practices can be

measured. However, only certain systems are required to develop a

profile and keep it on file for State review during sanitary surveys.

When those systems required to develop a profile plan a significant

change in disinfection practice, they must submit the profile, along

with an analysis of how the proposed change will affect the current

disinfection benchmark, to the State for review. The disinfection

benchmark provisions, then, contain three major components:

applicability requirements, characterization of disinfection practice,

and State review of proposed changes in disinfection practice. Each of

these components is discussed in turn below.

Applicability

    Systems are required to prepare a disinfection profile if at least

one of the following criteria is met:

    (1) TTHM levels are at least 80% of the MCL (0.064 mg/L) as an

annual average

    (2) Haloacetic acid (HAA5) levels are at least 80% of the MCL

(0.048 mg/L) as an annual average

    In connection with TTHM and HAA5 monitoring to create a

disinfection profile, the following provisions apply:

    First, the TTHM annual average must be the annual average during

the same period as is used for the HAA5 annual average. Second, systems

that have collected TTHM and HAA5 data under the ICR must use the

results of samples collected during the last 12 months of monitoring

unless the State determines that there is a more representative annual

data set. Third, systems not required to collect data under the ICR but

which have collected four consecutive quarters of TTHM and HAA5 data

that substantially meet the sample location, handling, and analytical

methods requirements of the ICR may use those data if approved by the

State. (Systems must coordinate with the State to confirm acceptability

of the existing data). Fourth, if the system does not have four

quarters of acceptable HAA5 and TTHM data by the end of 90 days

following the IESWTR promulgation date, the PWS must conduct HAA5 and

TTHM monitoring to determine an annual average. Alternatively, the

system may elect to conduct profiling, as described below, and forego

TTHM/HAA5 monitoring to determine applicability. This monitoring must

be completed no later than 15 months after promulgation of this rule

and conform to the monitoring location requirements of the 1979 TTHM

Rule and the analytical methods in the May 1996 Information Collection

Rule.

    Today's rule applies profiling requirements to systems with TTHM or

HAA5 concentrations of at least 80% of the MCL, based upon the M-DBP

Advisory Committee technical recommendation that this level will cover

most systems that might be expected to modify their disinfection

practices to comply with the Stage 1 DBPR. Also, EPA previously

considered this 80% target level at the recommendation of the 1992 Reg

Neg Committee to evaluate Stage 1 DBPR compliance forecasts and costs,

based upon the judgment that most facilities will take additional steps

to ensure continuing MCL compliance if they are at or above this level.

Developing the Profile and Benchmark

    Profiling is the characterization of a system's disinfection

practice over a one year period. The system can create the profile by

conducting new daily monitoring and also by using ``grandfathered''

data (as explained below). A disinfection profile consists of a

compilation of daily Giardia lamblia log inactivations (plus virus

inactivations for systems using either chloramines or ozone for primary

disinfection), computed over the period of a year, based on daily

measurements of operational data (disinfectant residual

concentration(s), contact time(s), temperature(s), and, where

necessary, pH).

    Grandfathered data are those operational data that a system has

previously collected at a treatment plant during the course of normal

operation. These data may or may not have been used previously for

compliance determinations with the SWTR. Those systems that have all

necessary data to determine profiles using existing operational data

collected prior to promulgation of the IESWTR may use these data in

developing profiles. However, grandfathered data must be substantially

equivalent to operational data that would be collected under this rule.

These data must be representative of inactivation through the entire

treatment plant and not just of certain treatment segments. The State

determines whether grandfathered data are acceptable. (EPA believes

that grandfathered data used in constructing profiles should be the

most recent data available, unless the State determines that there is a

more representative data.)

    Systems required to develop disinfection profiles under this rule

must exercise one of the following three options:

    Option 1--Systems must conduct daily monitoring as described below.

This monitoring must begin no later than 15 months after IESWTR

promulgation and must continue for a period of one year. The data

collected from this monitoring must be used to develop a one year

disinfection profile;

    Option 2--Systems that conduct monitoring under this rule, as

described under Option 1, may also use one or two years of acceptable

grandfathered data, in addition to the one year of new operational

data, in developing the disinfection profile;

    Option 3--Systems that have three years of acceptable existing

operational data are not required to conduct monitoring to develop the

disinfection profile under this rule. Instead, they may use

grandfathered data to develop a three year disinfection profile.

Systems must coordinate with the State to confirm acceptability of

grandfathered data no later than 15 months after promulgation of this

rule, but must conduct the required monitoring until the State approves

the system's request to use grandfathered



[[Page 69490]]



data. In order to develop the profile, a system must:



--Measure disinfectant residual concentration (C, in mg/L) before or at

the first customer and just prior to each additional point of

disinfectant addition, whether with the same or a different

disinfectant.

--Determine contact time (T, in minutes) for each residual disinfectant

monitoring point during peak flow conditions. T can be based on either

a tracer study or assumptions based on contactor basin geometry and

baffling. However, systems must use the same method for both

grandfathered data and new data.

--Measure water temperature ( deg.C).

--Measure pH (for chlorine only).



The system must then convert daily operational data to daily log

inactivation values for Giardia (and viruses when chloramines or ozone

is used for primary disinfection) as follows:



--Determine CTcalc for each disinfection segment.

--Determine CT<INF>99.9</INF> (i.e., 3-log inactivation) from tables in

the SWTR using temperature (and pH for chlorine) for each disinfection

segment. Alternatively, States may allow an alternate calculation

procedure (e.g. use of spreadsheet).

--For each segment, log inactivation = (CTcalc/

CT<INF>99.9</INF>) x 3.0.

--Sum the log inactivations for each segment to get the daily log

inactivation.



    A log inactivation benchmark is then calculated as follows:



    1. Calculate the average log inactivation of all the days for each

calendar month.

    2. Determine the calendar month with the lowest average log

inactivation.

    3. The lowest average month becomes the critical period for that

year.

    4. If acceptable data from multiple years are available, the

average of critical periods for each year becomes the benchmark.

    5. If only one year of data is available, the critical period

(lowest monthly average inactivation level) for that year is the

benchmark.

State Review

    If a system that is required to produce a disinfection profile

decides to make a significant change in disinfection practice after the

profile is developed, it must consult with the State before

implementing such a change. Significant changes in disinfection

practice are defined as: (1) Moving the point of disinfection (this is

not intended to) include routine seasonal changes already approved by

the State), (2) changing the type of disinfectant or (3) changing the

disinfection process, (4) making other modifications designated as

significant by the State. Supporting materials for such consultation

with the State must include a description of the proposed change, the

disinfection profile developed under this rule for Giardia lamblia

(and, if necessary, viruses), and an analysis of how the proposed

change will affect the current disinfection benchmark. In addition, the

State is required to review disinfection profiles as part of its

periodic sanitary survey.

    EPA is currently developing, with stakeholder input, the

Disinfection Benchmarking Guidance Manual for States and systems. This

manual will provide instruction on the development of disinfection

profiles, identification and evaluation of significant changes in

disinfection practices, and considerations for setting an alternative

benchmark. This manual will also provide guidance for systems that are

required to develop a profile based on virus inactivation instead of

Giardia lamblia inactivation.

 

2. Background and Analysis



    A fundamental principle of the 1992-93 regulatory negotiation

reflected in the 1994 proposal for the IESWTR was that new standards

for control of disinfection byproducts must not result in significant

increases in microbial risk. This principle was also one of the

underlying premises of the 1997 M-DBP Advisory Committee's

deliberations, i.e., that existing microbial protection must not be

significantly reduced or undercut as a result of systems taking the

necessary steps to comply with the Stage 1 DBPR. The Advisory Committee

reached agreement on the use of microbial profiling and benchmarking as

a process by which a PWS and the State, working together, assure that

there will be no significant reduction in microbial protection as the

result of modifying disinfection practices in order to meet MCLs for

TTHM and HAA5.

    The strategy of disinfection profiling and benchmarking stemmed

from data provided to the EPA and M-DBP Advisory Committee by PWSs and

reviewed by stakeholders, in which the baseline of microbial

inactivation (expressed as logs of Giardia lamblia inactivation)

demonstrated high variability. Inactivation varied by several log on a

day-to-day basis at any particular treatment plant and by as much as

tens of logs over a year due to changes in water temperature, flow rate

(and, consequently, contact time), seasonal changes in residual

disinfectant, pH, and disinfectant demand (and, consequently,

disinfectant residual). There were also differences between years at

individual plants. To address these variations, M-DBP stakeholders

developed the procedure of profiling a plant's inactivation levels over

a period of at least one year, and then establishing a benchmark of

minimum inactivation as a way to characterize disinfection practice.

This approach makes it possible for a plant that may need to change its

disinfection practice in order to meet DBP MCLs to determine the impact

the change would have on its current level of disinfection and,

thereby, to assure that there is no significant increase in microbial

risk.



3. Summary of Major Comments



    In the 1997 IESWTR NODA, EPA requested public comment on all

aspects of the benchmarking procedure, along with any alternative

suggestions, from stakeholders and other interested parties. EPA

specifically requested comment on the following issues: Applicability

requirements; characterization of disinfection practices and

components; use of TTHM and HAA5 data from the same time period instead

of TTHM data from one year and HAA5 data from another; definition of

significant changes to disinfection practice; different approaches to

evaluating possible changes in disinfection practice against a

disinfection profile; and whether the use of grandfathered data, if

available, should be mandatory for profiling and benchmarking.

    The majority of comments on the overall benchmarking procedure

outlined in the 1997 IESWTR NODA were positive. Commenters acknowledged

the procedure as a way to maintain microbial control in systems

changing their disinfection practices to comply with DBP MCLs. However,

a significant area of concern expressed in comments was that if PWSs

believe they will be held to a relatively higher regulatory standard as

a result of maintaining a greater level of disinfection than is

currently required, then some PWSs may reduce log inactivation during

profiling in order to lower their benchmarks. EPA emphasizes that

benchmarking is not intended to function as a regulatory standard.

Rather, the objective of the disinfection benchmark is to facilitate

interactions between the States and PWSs for the purpose of assessing

the impact on microbial risk of proposed significant changes to

existing disinfection practices. Final decisions regarding levels of

disinfection beyond



[[Page 69491]]



those required by the SWTR that are necessary to protect public health

will continue to be left to the States. For this reason EPA has not

mandated specific evaluation protocols or decision matrices for

analyzing changes in disinfection practice. EPA is, however, providing

support to the States in making these analyses through the issuance of

guidance. This approach is consistent with a majority of comments on

this issue which requested that EPA not require specific procedures for

the setting of alternative benchmarks but, rather, provide guidance to

States.

    Several commenters suggested that instead of requiring profiling

and benchmarking in regulations, EPA should place these procedures in

guidance and allow the States to implement them at their discretion.

EPA considers benchmarking to be an important measure in preventing

significant increases in microbial risk during implementation of the M-

DBP rule cluster. Moreover, States have different statutory authorities

governing what they can mandate and some State agencies are prohibited

by State law from adopting procedures not required by federal

regulations. Consequently, EPA believes the inclusion of benchmarking

as a regulation is warranted.

    Commenters were concerned that the benchmarking procedure would not

take into account source water characteristics and that benchmarking

would not be accurate for systems switching from one disinfectant to

another (e.g. chlorine to ozone). EPA will cover both of these topics

in the Disinfection Benchmarking Guidance Manual in sections that

address setting an alternative benchmark. Commenters also asked EPA to

provide instruction on awarding disinfection credits taking into

account possible synergistic effects for different sequential

disinfectants. However, as discussed in other parts of this preamble,

research in this area is not adequate for a disinfection credit scheme

to be developed based on synergistic inactivation.

    Most comments submitted to EPA on the issue of applicability

favored using 80% of the MCLs for TTHM and HAA5 as threshold levels for

profiling. Commenters agreed with the EPA and M-DBP Advisory Committee

that these values would capture most of the PWSs likely to change their

disinfection processes to meet DBP MCLs. One commenter proposed that

using TTHM and HAA5 data from two different years would not present a

problem because either one of these parameters can trigger the

profiling requirement. However, the majority of comments on this

subject supported requiring TTHM and HAA5 data to be collected during

the same period since changes in water quality and treatment conditions

influence not only the total quantity of DBPs but also the relative

formation of different DBP species. In today's rule EPA requires that

TTHM and HAA5 data used in determining applicability be collected

during the same period. A few commenters recommended that the

applicability requirements for profiling should also include ozonation

systems with bromate concentrations at least 80% of the MCL (i.e.

8<greek-m>g/L). EPA has elected not to include bromate levels in the

profiling requirements because operational changes, such as dropping

the pH during ozonation, can decrease bromate formation without

reducing disinfection efficacy.

    Certain commenters felt that disinfection profiling should only be

required in the event that a system planned to change disinfection

practice and that requiring plants which meet water quality standards

to perform additional studies is unwarranted. EPA believes, however,

that a profile should span all seasons of at least one year to show how

seasonal variations impact the log inactivation provided. Consequently,

waiting to profile until a disinfection change is needed is not

practical because at least one year of monitoring is required and this

could significantly delay the desired modifications. Accordingly, EPA

maintains that profiling in advance of a decision to change

disinfection practices will allow systems to comply with TTHM and HAA5

MCLs in a timely manner without increasing microbial risk. For this

reason, EPA requires profiling of those PWSs most like to modify their

disinfection procedures (i.e. those with TTHM and HAA5 concentrations

at or above 80% of the MCLs).

    Many comments advocated allowing the use of grandfathered data in

developing disinfection profiles. However, commenters were

predominantly against making the use of existing operational data

mandatory. They expressed concern that such a requirement would be

inherently inequitable, could entail significant retrieval costs, and

that the data might not be representative of a system's current

operations. EPA believes that grandfathered data will often provide the

most accurate picture of historic levels of microbial disinfection and

encourages its use in constructing the disinfection profile. However,

EPA recognizes that certain problems, such as those identified by

commenters, may justify the exclusion of grandfathered data and,

therefore, has made the use of such data optional. EPA notes that

States may consider issues related to profiling data when determining

whether a proposed change in disinfection practice is acceptable.

    The benchmarking procedure in today's rule, therefore, reflects the

concerns of commenters in many respects. On issues such as the use of

grandfathered data, applicability requirements, and evaluating proposed

changes in disinfection practice, the disinfection benchmark

requirements conform to the majority view of comments. In cases where

the rule is at variance with certain commenters' suggestions, such as

making the disinfection benchmarking procedure discretionary and

requiring profiling only in advance of a proposed change in

disinfection practice, EPA has acted in accordance with the need to

achieve risk-risk balancing, which is a central objective of the M-DBP

rule cluster.



E. Definition of Ground Water Under the Direct Influence of Surface

Water



1. Today's Rule



    In today's rule, EPA includes Cryptosporidium in the definition of

ground water under the direct influence of surface water (GWUDI). This

change in definition applies only to public water systems that serve

10,000 or more people.



2. Background and Analysis



    EPA issued guidance in October 1992 as the Consensus Method for

Determining Groundwater Under the Direct Influence of Surface Water

Using Microscopic Particulate Analysis (MPA). As part of this method, a

microscopic examination is made of the ground water to determine

whether insect parts, plant debris, rotifers, nematodes, protozoa, and

other material associated with the surface or near surface environment

are present. Additional guidance for making GWUDI determinations is

also available (EPA, 1994d, e). Since 1990, States have acquired

substantial experience in making GWUDI determinations and have

documented their approaches (Massachusetts Department of Environmental

Protection, 1993; Maryland, 1993; Sonoma County Water Agency, 1991).

Guidance on existing practices undertaken by States in response to the

SWTR may also be found in the State Sanitary Survey Resource Directory,

jointly published in December 1995 by EPA and the Association of State

Drinking Water Administrators. AWWARF has also



[[Page 69492]]



published guidance (Wilson et al., 1996).

    In the existing MPA guidance (EPA, 1992), Cryptosporidia oocysts

are included under the general category of coccidian protozoans, a more

encompassing grouping, some of which are pathogenic to humans. The

score assigned to an occurrence of a coccidian is equivalent to the

score assigned to an occurrence of a Giardia cyst. Thus, it not

anticipated that any change is needed in the MPA scoring methodology to

accommodate the regulation of Cryptosporidium by this rule.

    The 1997 NODA summarized the available guidance and additional

information provided by the States and regulated community. Most

recently, Hancock et al. (1998) summarized some of the available data

on parasitic protozoan occurrence in ground water and EPA compiled

additional data on such occurrence in wells (SAIC, 1997a).



3. Summary of Major Comments



    The July 29, 1994, Federal Register notice proposed to amend the

SWTR by including Cryptosporidium in the definition of a GWUDI system.

Under the 1994 IESWTR proposal, a system using ground water considered

vulnerable to Cryptosporidium contamination would be subject to the

provisions of the SWTR. EPA proposed that this determination be made by

the State for individual sources using State-established criteria. The

1994 proposed IESWTR also requested comment on revisions to EPA's

guidance on this issue.

    Commenters generally agreed that Cryptosporidium should be added to

the definition.



F. Inclusion of Cryptosporidium in Watershed Control Requirements



1. Today's Rule



    In today's final rule, EPA is extending the existing watershed

control regulatory requirements for unfiltered systems serving 10,000

or more people to include the control of Cryptosporidium.

Cryptosporidium will be included in the watershed control provisions

for these systems wherever Giardia lamblia is mentioned.



2. Background and Analysis



    Watershed control requirements were initially established in 1989

(EPA, 1989b, 54 FR 27496, June 29, 1989) as one of a number of

preconditions that a public water system using surface water must meet

to avoid filtration. As part of its 1994 IESWTR proposal (EPA, 1994b,

59 FR 38839, July 29, 1994), EPA requested comment on extending these

existing watershed control requirements for unfiltered systems at 40

CFR 141.71(b)(2) to include the control of Cryptosporidium. This was

intended to be analogous to and build upon the existing requirements

for Giardia lamblia and viruses; Cryptosporidium would be included in

the watershed control provisions wherever Giardia lamblia is mentioned.

In the November 3, 1997 NODA (EPA, 1997a, 62 FR 59506), the Agency also

requested comment on issues pertaining to monitoring for Giardia and

Cryptosporidium for unfiltered systems serving 10,000 or more people.

    As noted above, the SWTR specifies the conditions under which a

system can avoid filtration (40 CFR 141.71). These conditions include

good source water quality, as measured by concentrations of coliforms

and turbidity; disinfection requirements; watershed control; periodic

on-site inspections; the absence of waterborne disease outbreaks; and

compliance with the Total Coliform Rule and the MCL for TTHMs. This

watershed control program under the SWTR must include a

characterization of the watershed hydrology characteristics, land

ownership, and activities which may have an adverse effect on source

water quality, and must minimize the potential for source water

contamination by Giardia lamblia and viruses. The SWTR Guidance Manual

(EPA, 1991a) identifies both natural and human-caused sources of

contamination to be controlled. These sources include wild animal

populations, wastewater treatment plants, grazing animals, feedlots,

and recreational activities. The Guidance Manual recommends that

grazing and sewage discharges not be permitted within the watershed of

unfiltered systems, but indicates that these activities may be

permissible on a case-by-case basis where there is a long detention

time and a high degree of dilution between the point of activity and

the water intake. Although there are no specific monitoring

requirements in the watershed protection program, the non-filtering

utility is required to develop State-approved techniques to eliminate

or minimize the impact of identified point and non-point sources of

pathogenic contamination. The guidance already suggests identifying

sources of microbial contamination, other than Giardia, transmitted by

animals, and points out specifically that Cryptosporidium may be

present if there is grazing in the watershed.

    As discussed in the 1997 IESWTR NODA, the Seattle Water Department

summarized the Giardia and Cryptosporidium monitoring results from

several unfiltered water systems (Montgomery Watson, 1995). The central

tendency of this data is approximately 1 oocyst/100L. In light of data

previously discussed that indicates that at least 2-log removal of

Cryptosporidium is achievable with filtration, and considering the

Seattle data analysis, it appears that unfiltered water systems that

comply with the source water requirements of the SWTR have a risk of

cryptosporidiosis equivalent to that of a water system with a well-

operated filter plant using a water source of average quality. EPA

plans to continue to evaluate this issue when additional data becomes

available.



3. Summary of Major Comments



    Commenters generally supported specific inclusion of

Cryptosporidium in the watershed control requirements for unfiltered

systems. Some commenters supported watershed control programs in

general without specifically offering an opinion on Cryptosporidium. A

few commenters specifically opposed the inclusion of Cryptosporidium in

the watershed control program, maintaining that other avenues of

watershed control could be promoted without including this organism in

the control plan and that environmental sources of Giardia and

Cryptosporidium were not sufficiently understood.

    In response, EPA believes that the environmental sources of

Cryptosporidium are sufficiently understood, as described above, to

support rule requirements. Cryptosporidium cannot be easily controlled

with conventional disinfection practices, and therefore its presence in

source water serving unfiltered surface water systems must be

addressed. EPA also believes that Cryptosporidium poses a potential

hazard to public health and, as noted above, is establishing in today's

rule an MCLG of zero for this pathogenic protozoan. EPA is therefore

amending the existing watershed control requirements for unfiltered

systems to include Cryptosporidium in order to protect public health.

EPA believes that an effective watershed protection program will help

to improve source water quality. Existing guidance already references

the need to guard against pathogenic protozoa including specifically

Cryptosporidium. EPA is proceeding on the presumption that existing

watershed programs already consider and State reviews have evaluated

the adequacy of watershed provisions to assure that raw drinking water

supplies are adequately protected against Cryptosporidium

contamination.



[[Page 69493]]



To the extent this is not the case, however, EPA expects that

unfiltered systems, and States in their annual review, will reassess

their program with regard to this concern and take whatever steps are

necessary to ensure that potential vulnerability to Cryptosporidium

contamination is considered and adequately addressed.

    With regard to monitoring, many NODA commenters supported some form

of routine monitoring for Giardia and Cryptosporidium in unfiltered

watershed systems serving 10,000 or more people. A few NODA commenters

supported event monitoring (i.e., an occasion where the raw water

turbidity and/or fecal/total coliform concentration exceeds a specific

value or possibly a site-specific 90th percentile value) for large

unfiltered systems while others were silent on the issue or against

event monitoring. In response, today's final rule does not include

monitoring requirements for unfiltered systems for several reasons. The

IFA method is the only method currently and widely available to

evaluate the presence or absence of Cryptosporidium in a water supply.

However, EPA does not believe this method is appropriate for regulatory

compliance purposes because of its low recovery and variability. EPA

therefore believes that monitoring is most appropriately handled

through guidance at this time. EPA is working with stakeholders to

develop a guidance document for unfiltered systems which will describe

possible monitoring programs. Moreover, the Agency is supporting and

participating in the development of improved Cryptosporidium analytical

methods, including a draft interim method 1622. At the moment, it is

unclear when prototype Cryptosporidium methods (both method 1622, as

well as methods under development to determine viability and

infectivity) will be adequate for regulatory use and compliance

determinations at low concentration levels, but ongoing research

appears promising in this area. As a result, establishment of

Cryptosporidium monitoring requirements for unfiltered systems will be

considered during the development of future microbial rules when EPA

has more information on which to base a regulation (e.g. availability

of better methods, ICR monitoring data, and research characterizing the

relationship between watershed control and pathogen occurrence).



G. Covered Finished Water Reservoirs



1. Today's Rule



    In today's final rule EPA is requiring surface water and GWUDI

systems that serve 10,000 or more people to cover all new reservoirs,

holding tanks or other storage facilities for finished water for which

construction begins after the effective date of this rule, February 16,

1999. Today's final rule does not apply these requirements to existing

uncovered finished water reservoirs.



2. Background and Analysis



    The proposed IESWTR (EPA, 1994b, 59 FR 38841) indicated that EPA

was considering whether to issue regulations requiring systems to cover

finished water reservoirs and storage tanks, and requested public

comment. The IESWTR Notice of Data Availability (EPA, 1997a, 62 FR

59509) indicated that EPA was considering a requirement that systems

cover all new reservoirs, holding tanks or other storage facilities for

finished water for which construction begins after the effective date

of the rule and invited comment on this issue. The IESWTR NODA also

invited further comment on whether there should be a requirement that

all finished water reservoirs, holding tanks and other storage

facilities be covered as part of the development of future regulations.

    As discussed in the 1997 IESWTR Notice of Data Availability, when a

finished water reservoir is open to the atmosphere it may be subject to

some of the environmental factors that surface water is subject to,

depending upon site-specific characteristics and the extent of

protection provided. Potential sources of contamination to uncovered

reservoirs and tanks include airborne chemicals, surface water runoff,

animal carcasses, animal or bird droppings and growth of algae and

other aquatic organisms due to sunlight that results in biomass (Bailey

and Lippy, 1978). In addition, uncovered reservoirs may be subject to

contamination by persons tossing items into the reservoir or illegal

swimming (Pluntze 1974; Erb, 1989). Increases in algal cells,

heterotrophic plate count (HPC) bacteria, turbidity, color, particle

counts, biomass and decreases in chlorine residuals have been reported

(Pluntze, 1974, AWWA Committee Report, 1983, Silverman et al., 1983,

LeChevallier et al. 1997a).

    Small mammals, birds, fish, and the growth of algae may contribute

to the microbial degradation of an open finished water reservoir

(Graczyk et al., 1996a; Geldreich, 1990; Fayer and Ungar, 1986;

Current, 1986). In one study, sea gulls contaminated a 10 million

gallon reservoir and increased bacteriological growth, and in another

study waterfowl were found to elevate coliform levels in small

recreational lakes by twenty times their normal levels (Morra, 1979).

Algal growth increases the biomass in the reservoir, which reduces

dissolved oxygen and thereby increases the release of iron, manganese,

and nutrients from the sediments. This, in turn, supports more growth

(Cooke and Carlson, 1989). In addition, algae can cause drinking water

taste and odor problems as well as impact water treatment processes.

    EPA suggested in the proposal that covering reservoirs and storage

tanks would reduce the potential for contamination of the finished

water by pathogens and hazardous chemicals, as well as limit the

potential for taste and odor problems and increased operation and

maintenance costs resulting from algal blooms associated with

environmental factors such as sunlight. Because of these concerns, EPA

guidelines recommend that all finished water reservoirs and storage

tanks be covered (EPA, 1991a,b). The American Water Works Association

(AWWA) also has issued a policy statement strongly supporting the

covering of reservoirs that store potable water (AWWA, 1993). In

addition, a survey of nine States was conducted in the summer of 1996

(Montgomery Watson, 1996). The States which were surveyed included

several in the West (Oregon, Washington, California, Idaho, Arizona,

and Utah), two States in the East known to have water systems with open

reservoirs (New York and New Jersey), and one midwestern State

(Wisconsin). Seven of the nine States which were surveyed require by

direct rule that all new finished water reservoirs and tanks be

covered.

    EPA is currently developing, with stakeholder input, an Uncovered

Finished Water Reservoir Guidance Document. The manual will discuss

methods to maintain water quality, control aquatic and microbial

growths, describe methods to cover and line reservoirs, and discuss the

use of sampling and sampling points to monitor reservoir water quality.

 

3. Summary of Major Comments



    Most commenters on the proposed rule supported either federal or

State requirements for covered finished water reservoirs. Some

commenters on the proposed rule suggested that regulations apply only

to new reservoirs while other commenters opposed any requirement,

citing high cost, the notion that ``one size does not fit all,'' and

aesthetic benefits of an open reservoir. Nearly all



[[Page 69494]]



the commenters on the NODA supported regulatory requirements for

covered finished water reservoirs in order to protect human health.

Many commenters on the NODA supported requirements for covered finished

water reservoirs for both new and existing reservoirs. Some commenters

on the NODA supported requirements for new reservoirs only to be

covered and believed that requirements for existing uncovered

reservoirs should be included in a future regulation rather than in

today's rule. Several commenters on the NODA were against a federal

requirement for covered finished reservoirs. One commenter thought that

EPA should provide States with sufficient flexibility to make the final

decision on this issue while another commenter suggested that any

future regulatory action for existing reservoirs should take the form

of guidance to States. One commenter believes that EPA does not have

enough information to require covered finished reservoirs.

    In response, EPA believes, in light of the substantial information

summarized above, that microbial contamination risks are posed by

uncovered finished water reservoirs and therefore is requiring that all

new reservoirs be covered. The final rule requires that finished water

reservoirs for which construction begins after the effective date of

today's rule be built with covers. With respect to existing reservoirs,

EPA needs more time to collect and analyze additional information to

evaluate regulatory impacts on systems with existing uncovered

reservoirs on a national basis. EPA needs this information in order to

carry out the cost benefit analysis for a requirement that existing

reservoirs be covered. The IESWTR therefore does not require that

existing reservoirs have covers installed. EPA will further consider

whether to require the covering of existing reservoirs during the

development of subsequent microbial regulations when additional data

and analysis to develop the national costs of coverage are available.



H. Sanitary Survey Requirements



1. Today's Rule



    The State must complete sanitary surveys for all surface water and

GWUDI systems no less frequently than every three years for community

systems and no less frequently than every five years for noncommunity

systems. The State may ``grandfather'' sanitary surveys conducted after

December 1995 for the first set of required sanitary surveys if the

surveys address the eight survey components of the 1995 EPA/State

guidance. The rule also provides that for community systems determined

by the State to have outstanding performance based on prior sanitary

surveys, successive sanitary surveys may be conducted no less

frequently than every five years. In its primacy application, the State

must include: (1) How it will decide whether a system has outstanding

performance and is thus eligible for sanitary surveys at a reduced

frequency, and (2) how it will decide whether a deficiency identified

during a survey is significant.

    In the IESWTR, a sanitary survey is defined as an onsite review of

the water source (identifying sources of contamination using results of

source water assessments where available), facilities, equipment,

operation, maintenance, and monitoring compliance of a public water

system to evaluate the adequacy of the system, its sources and

operations and the distribution of safe drinking water.

    Components of a sanitary survey may be completed as part of a

staged or phased State review process within the established frequency

interval set forth below. A sanitary survey must address each of the

following eight elements: Source; treatment; distribution system;

finished water storage; pumps, pump facilities, and controls;

monitoring and reporting and data verification; system management and

operation; and operator compliance with State requirements. In

addition, sanitary surveys include review of disinfection profiles for

systems required to comply with the disinfection benchmarking

requirements discussed elsewhere in today's notice.

    States must have the appropriate rules or other authority to assure

that facilities take the steps necessary to address any significant

deficiencies identified in the survey report that are within the

control of the public water system and its governing body. As noted

above, a State must also, as part of its primary application, include

how it will decide; (1) Whether a system has outstanding performance

and is thus eligible for sanitary surveys at a reduced frequency, and

(2) whether a deficiency identified during a survey is significant for

the purposes of this rule. In addition, a State must have appropriate

rules or other authority to ensure that a public water system responds

to significant deficiencies outlined in a sanitary survey report within

45 days of receipt of the report, indicating how and on what schedule

the system will address significant deficiencies noted in the survey.

    EPA notes that it will consider sanitary surveys that meet IESWTR

requirements to also meet the requirements for sanitary surveys under

the Total Coliform Rule (TCR), since the definition of a sanitary

survey under the IESWTR is broader than that for the TCR (i.e., a

survey as defined under the IESWTR includes all the elements, and more,

of a sanitary survey as required under the TCR). Moreover, with regard

to TCR sanitary survey frequency, the IESWTR requires that surveys be

conducted at least as frequently, or, in some cases, possibly more

often than required under the TCR.



2. Background and Analysis



    The July 29, 1994, Federal Register proposed to amend the SWTR to

require periodic sanitary surveys for all public water systems that use

surface water, or ground water under the direct influence of surface

water, regardless of whether they filter or not. States would be

required to review the results of each sanitary survey to determine

whether the existing monitoring and treatment practices for that system

are adequate, and if not, what corrective measures are needed to

provide adequate drinking water quality.

    The July 1994 notice proposed that only the State or an agent

approved by the State would be able to conduct the required sanitary

survey, except in the unusual case where a State has not yet

implemented this requirement, i.e., the State had neither performed the

required sanitary survey nor generated a list of approved agents. The

proposal suggested that under exceptional circumstances the sanitary

survey could be conducted by the public water system with a report

submitted to the State within 90 days. EPA also requested comment on

whether sanitary surveys should be required every three or every five

years.

    In 1993, the Government Accounting Office (GAO) issued a report

summarizing the findings of a survey conducted to examine sanitary

survey programs as well as GAO's key observations (GAO, 1993). ``On the

basis of a nationwide questionnaire and a review of 200 sanitary

surveys conducted in four States (Illinois, Montana, New Hampshire and

Tennessee), GAO found that sanitary surveys are often deficient in how

they are conducted, documented and/or interpreted.''

    The GAO survey found that 45 States omit one or more of the key

elements of surveys that EPA recommends be evaluated. The report also

indicated that, ``regardless of a system's size,



[[Page 69495]]



deficiencies previously disclosed frequently went uncorrected.''

    In summary, GAO observed that problems with sanitary survey

programs are compounded by the lack of any minimum requirements on how

surveys are to be conducted and documented. The GAO report notes that

the result ``has been that a key benefit of surveys-- identifying and

correcting problems before they become larger problems affecting water

quality-- has often not been realized.''

    Sanitary surveys have historically been conducted by State drinking

water programs as a preventive tool to identify water system

deficiencies that could pose a threat to public health. The general

requirements for State primacy in Sec. 142.10(b)(2) of subpart B

include a provision that the State have a systematic program for

conducting sanitary surveys for public water systems, with priority

given to those systems not in compliance with the State's primary

drinking water regulations. In addition, the TCR includes regulatory

requirements for systems to have a periodic on-site sanitary survey (54

FR 27544-27568, 29 June 1989). This rule requires all systems that

collect fewer than 5 total coliform samples each month to undergo such

surveys. These sanitary surveys must be conducted by the State or an

agent approved by the State. Community water systems were to have had

the first sanitary survey conducted by June 29, 1994, and every five

years thereafter while non-community water systems are to have the

first sanitary survey conducted by June 29, 1999, and every five years

thereafter unless the system is served by a protected and disinfected

ground water supply, in which case, a survey must be conducted every 10

years. The TCR does not specify in detail what must be addressed in a

sanitary survey or how such a survey should be conducted.

    The SWTR does not specifically require water systems to undergo a

sanitary survey. Instead, it requires that unfiltered water systems, as

one criterion to remain unfiltered, have an annual on-site inspection

to assess the system's watershed control program and disinfection

treatment process. The on-site survey must be conducted by the State or

a party approved by the State. This on-site survey is not a substitute

for a more comprehensive sanitary survey, but the information can be

used to supplement a full sanitary survey.

    EPA's SWTR Guidance Manual (EPA, 1991a), Appendix K, suggests that,

in addition to the annual on-site inspection, a sanitary survey be

conducted every three to five years by both filtered and unfiltered

systems. This time period is suggested ``since the time and effort

needed to conduct the comprehensive survey makes it impractical for it

to be conducted annually.''

    Since the publication of the proposed ESWTR and GAO report, EPA and

the States (through the Association of State Drinking Water

Authorities) have issued a joint guidance on sanitary surveys entitled

EPA/State Joint Guidance on Sanitary Surveys (1995). The Guidance

outlines the following elements as integral components of a

comprehensive sanitary survey:

    <bullet> Source

    --Protection

    --Physical Components and Condition

    <bullet> Treatment

    <bullet> Distribution System

    <bullet> Finished Water Storage

    <bullet> Pumps/Pump Facilities and Controls

    <bullet> Monitoring/Reporting/Data Verification

    <bullet> Water System Management/Operations

    <bullet> Operator Compliance with State Requirements

    The guidance also addresses the qualifications for sanitary survey

inspectors, the development of assessment criteria, documentation,

follow-up after the survey, tracking and enforcement.

    As discussed earlier, EPA published a NODA (62 FR 59485) in

November 1997 discussing new information the Agency has received since

the 1994 IESWTR proposal as well as recommendations of the M-DBP

Advisory Committee. The Advisory Committee made recommendations on the

definition and frequency of surveys, as well as on survey components

based on the 1995 EPA/State Guidance, and follow-up activities. In the

1997 Notice, EPA requested comment on the Advisory Committee

recommendations. In addition, the Agency requested comment on whether

systems should be required to respond in writing to a State's sanitary

survey report. EPA also requested comment on (1) what would constitute

``outstanding performance'' for purposes of allowing sanitary surveys

for a community water system to be conducted every five years and (2)

how to define ``significant deficiencies.''



3. Summary of Major Comments



    Commenters on the 1994 proposal generally voiced support for

requiring a periodic sanitary survey for all systems. One commenter

suggested that EPA develop sanitary survey guidance for administration

by the States, while another commenter suggested that sanitary surveys

by the private sector be certified by States or national associations

using EPA-defined criteria. Commenters recommended that surveys be

conducted either by the State or a private independent party/

contractor. One respondent contended that sanitary surveys, as

presently conducted, were insufficient to assess operational

effectiveness in surface water systems.

    With regard to sanitary survey frequency, commenters on the 1994

proposal were nearly evenly divided between every three years and every

five years. Some commenters argued that the frequency should depend on:

(1) Whether a system's control is effective or marginal, (2) system

size (less frequent for small systems), (3) source water quality, (4)

whether the State believes a system's water quality is likely to change

over time, (5) results of the previous survey, and (6) population

density on the watershed. One commenter suggested an annual sanitary

survey.

    In terms of the frequency of conducting a sanitary survey,

commenters on the 1997 notice generally voiced support for the

frequencies recommended by the M-DBP Advisory Committee. One commenter

suggested that all public water systems should have a sanitary survey

no less often than once every three years and that systems with

unsatisfactory or provisional ratings should be surveyed annually or

more often. Another commenter suggested that even outstanding systems

should be surveyed on a three year cycle because personnel or

management changes can impact plant performance. One respondent

recommended that sanitary surveys be required at a maximum frequency of

every five years for all public water systems using surface water or

ground water under the direct influence of surface water as a source.

One commenter suggested that three and five year schedules be given as

targets rather than requirements to allow States flexibility in

deploying resources.

    EPA believes that the frequencies in today's rule allow States the

flexibility to prioritize and carry out the sanitary survey process,

while also ensuring that these surveys will be conducted as an

effective preventive tool to identify and correct water system

deficiencies that could pose a threat to public health. Given these

considerations and recognizing that there are many more non-community

than community water systems, EPA believes that the required

frequencies for sanitary surveys are reasonable.



[[Page 69496]]



    With respect to the definition of outstanding performance, most

commenters on the 1997 notice suggested some combination of both a

history of no rule or public health violations and past surveys without

significant deficiencies. One commenter suggested that a system with no

rule violations in a year meeting 0.1 NTU ninety-five percent of the

time and practicing filter to waste should get some type of formal

recognition from EPA and be considered to have outstanding performance.

Another respondent pointed out that in addition to performance, other

factors such as management, emergency preparedness and backup

structures are critical to maintain outstanding performance.

    EPA believes that today's rule provides State flexibility to work

within their existing programs in addressing how to define outstanding

performance and significant deficiencies as part of their primacy

application. The Agency will discuss these issues in further detail in

Sanitary Survey Guidance which is currently under development with

stakeholder input.



I. Compliance Schedules



1. Today's rule



    Today's action establishes revised compliance deadlines for States

to adopt and for public water systems to implement the requirements in

this rulemaking. Central to the determination of these deadlines are

the principles of simultaneous compliance between the Stage 1 DBPR and

the corresponding rules (Interim Enhanced Surface Water Treatment Rule,

Long Term Enhanced Surface Water Treatment Rule, and Ground Water Rule)

to ensure continued microbial protection, and minimization of risk-risk

tradeoffs. These deadlines also reflect new legislative provisions

enacted as part of 1996 SDWA amendments. Section 1412 (b)(10) of the

SDWA as amended provides PWSs must comply with new regulatory

requirements 36 months after promulgation (unless EPA or a State

determines that an earlier time is practicable or that additional time

up to two years is necessary for capital improvements). In addition,

section 1413(a)(1) provides that States have 24 instead of the previous

18 months from promulgation to adopt new drinking water standards.

    Applying the 1996 SDWA Amendments to today's action, this

rulemaking provides that States have two years from promulgation to

adopt and implement the requirements of this regulation. Simultaneous

compliance will be achieved as follows.

    Subpart H water systems that serve a population of 10,000 or more

generally have three years from promulgation to comply with all

requirements of this rule, except for profiling and benchmarking, which

require systems to begin sampling after three months. In cases where

capital improvements are needed to comply with the rule, States may

grant such systems up to an additional two years to comply. These

deadlines were consistent with those for the Stage 1 DBPR.

    While only subpart H systems serving at least 10,000 people are

affected by today's rule, EPA has included information on the

compliance requirements for other system categories for the reader.

Subpart H systems that serve a population of less than 10,000 and all

ground water systems will be required to comply with applicable Stage 1

DBPR requirements within five years from promulgation. Since the Long

Term 1 Enhanced Surface Water Treatment Rule (LT1) requirements that

apply to systems under 10,000 and the Ground Water Rule (GWR) are

scheduled to be promulgated two years after today's rule or in November

2000, the net result of this staggered deadline is that these systems

will be required to comply with both Stage 1 DBPR and LT1/GWR

requirements three years after promulgation of LT1/GWR at the same end

date of November 2003. For reasons discussed in more detail below, EPA

believes this is both consistent with the requirements of section

1412(b)(10) as well as with legislative history affirming the Reg. Neg.

objectives of simultaneous compliance and minimization of risk-risk

tradeoff.



2. Background and Analysis



    The background, factors, and competing concerns that EPA considered

in developing the compliance deadlines in today's rule are explained in

detail in both the Agency's IESWTR and Stage 1 DBPR November 1997

NODAs. As explained in those NODAs, EPA identified four options to

implement the requirements of the 1996 SDWA Amendments. The

requirements outlined above reflect the fourth option that EPA

requested comment upon in November 1997.

    By way of background, the SDWA 1996 Amendments affirmed several key

principles underlying the M-DBP compliance strategy developed by EPA

and stakeholders as part of the 1992 regulatory negotiation process.

First, under section 1412(b)(5)(A), Congress recognized the critical

importance of addressing risk/risk tradeoffs in establishing drinking

water standards and gave EPA the authority to take such risks into

consideration in setting MCL or treatment technique requirements. The

technical concerns and policy objectives underlying M-DBP risk-risk

tradeoffs are referred to in the initial sections of today's rule and

have remained a key consideration in EPA's development of appropriate

compliance requirements. Second, Congress explicitly adopted the phased

M-DBP regulatory development schedule developed by the Negotiating

Committee. Section 1412(b)(2)(C) requires that the M-DBP standard

setting intervals laid out in EPA's proposed ICR rule be maintained

even if promulgation of one of the M-DBP rules is delayed. As explained

in the 1997 NODA, this phased or staggered regulatory schedule was

specifically designed as a tool to minimize risk/risk tradeoff. A

central component of this approach was the concept of ``simultaneous

compliance'', which provides that a PWS must comply with new microbial

and DBP requirements at the same time to assure that in meeting a set

of new requirements in one area, a facility does not inadvertently

increase the risk (i.e., the risk ``tradeoff'') in the other area.

    A complicating factor that EPA took into account in developing

today's deadlines is that the SDWA 1996 Amendments changed two

statutory provisions that elements of the 1992 Negotiated Rulemaking

Agreement were based upon. The 1994 Stage 1 DBPR and ICR proposals

provided that 18 months after promulgation large PWS would comply with

the rules and States would adopt and implement the new requirements. As

noted above, Section 1412(b)(10) of the SDWA as amended now provides

that drinking water rules shall become effective 36 months after

promulgation (unless the Administrator determines that an earlier time

is practicable or that additional time for capital improvements is

necessary--up to two years). In addition, section 1413(a)(1) now

provides that States have 24 instead of the previous 18 months to adopt

new drinking water standards that have been promulgated by EPA.

    Today's compliance deadline requirements reflect the principle of

simultaneous compliance and the concern with risk-risk tradeoffs.

Subpart H systems serving a population of at least 10,000 will be

required to comply with the key provisions of this rule on the same

schedule as they will be required to comply with the parallel

requirements of the accompanying Stage 1 DBPR that is also included in

today's Federal Register.



[[Page 69497]]



    With regard to subpart H systems serving fewer than 10,000, EPA

believes that providing a five year compliance period under Stage 1

DBPR is appropriate and warranted under section 1412(b)(10), which

expressly allows five years where necessary for capital improvements.

As discussed in more detail in the 1997 IESWTR NODA, capital

improvements require, of necessity, preliminary planning and

evaluation. An essential prerequisite of such planning is a clear

understanding of final compliance requirements that must be met. In the

case of the staggered M-DBP regulatory schedule established as part of

the 1996 SDWA Amendments, LT1 microbial requirements for systems under

10,000 are required to be promulgated two years after the final Stage 1

DBPR. As a result, small systems will not even know what their final

combined compliance obligations are until promulgation of the LT 1

rule. Thus, an additional two year period reflecting the two year Stage

1 DBPR/LT 1 regulatory development interval established by Congress is

required to allow for the preliminary planning and design steps which

are inherent in any capital improvement process.

    In the case of ground water systems, the statutory deadline for

promulgation of the GWR is May 2002. However, EPA intends to promulgate

this rule by November 2000, in order to allow three years for

compliance and still ensure simultaneous compliance by ground water

systems with the Stage 1 DBPR and the GWR. As in the case of subpart H

systems serving fewer than 10,000, system operators will not know until

November 2000 what the final compliance requirements for both rules

are. EPA thus believes it appropriate to grant the additional two years

for compliance with the Stage 1 DBPR allowed by the statute.

    EPA has been very successful in meeting all of the new statutory

deadlines and is on track for the LT1 Rule and GWR. While EPA fully

intends to meet the schedule discussed earlier, if those rules are

delayed the Agency will evaluate all available options to protect

against unacceptable risk-risk trade-offs. Part of this effort is the

extensive outreach to systems already underway to fully inform water

supplies of the likely elements in the upcoming rules. In addition, EPA

would consider including provisions for streamlined variance and/or

exemption processing in these rules if they were delayed, in order to

enhance State flexibility in ensuring that compliance with the Stage 1

DBPR is not required before the corresponding microbial protection

rule.

    Under today's Stage 1 DBPR, EPA has already provided small subpart

H systems and ground water systems the two-year extension for capital

improvements since these systems will not know with certainty until

November 2000 if capital improvements will be needed for simultaneous

compliance with the Stage 1 DBPR and LT1/GWR. States considering

whether to grant a two-year capital improvement extension for

compliance with the GWR or LT1 will also need to consider the impact of

such extensions on compliance with today's rule, since the two-year

extension for the Stage 1 DBPR has already been used. EPA believes,

however, that these systems will generally not require extensive

capital improvements that take longer than three years to install to

meet Stage 1 DBPR, GWR, and LT1 requirements, or will require no

capital improvements at all. However if needed, EPA will work with

States and utilities to address systems that require time beyond

November 2003 to comply. This strategy may include exemptions. In

addition, EPA will provide guidance and technical assistance to States

and systems to facilitate timely compliance with both DBP and microbial

requirements. EPA will request comment on how best to do this when the

Agency proposes the LTESWTR and GWR.



3. Summary of Major Comments



    Commenters were in general agreement that the compliance deadline

strategy contained in the fourth option of the 1997 NODA did the best

job of complying with the requirements to 1996 SDWA Amendments and

meeting the objectives of the 1993 Reg. Neg. Agreement that Congress

affirmed as part of the 1996 Amendments. Nonetheless, a number of

commenters expressed concern about the ability of large surface water

systems that had to make capital improvements to comply with all

requirements of the Stage 1 DBPR and IESWTR. They pointed out that

capital improvements include more than just the construction, but also

financing, design, and approval.

    EPA believes that the provisions of section 1412(b)(10) of the SDWA

as amended allow systems the flexibility needed to comply. As noted

earlier in this section, States may grant up to an additional two years

compliance time for an individual system if capital improvements are

necessary. Moreover, as both of these rules have been under negotiation

since 1992, proposed in 1994 and further clarified in 1997, EPA

believes that most systems have had substantial time to consider how to

proceed with implementation and to initiate preliminary planning.

Several commenters also supported delaying the promulgation of the

Stage 1 DBPR for ground water systems until the GWR is promulgated, in

order to ensure simultaneous compliance with both rules. EPA believes

that this option would not be consistent with the reg-neg agreement, as

endorsed by Congress, because the agreement specifies that the Stage 1

DBPR will apply to all community and nontransient noncommunity water

systems. Moreover, EPA has committed to the LT1 and GWR promulgation

schedule outlined above precisely to address this issue.

    In conclusion EPA believes that the compliance deadlines outlined

above for systems covered by this rule are appropriate and consistent

with the requirements of the 1996 SDWA amendments. The Agency notes,

however, that some elements of Option 4 outlined in the 1997 NODA apply

to systems that may be covered by future Long Term Enhanced and Ground

Water rules. EPA intends to follow the deadline strategy outlined in

Option 4 for these future rules. However, as today's action only

relates to the IESWTR, the Agency will defer final action on deadlines

associated with future rules until those rules, themselves, are

finalized.

 

IV. State Implementation



    This section describes the regulations and other procedures and

policies States have to adopt, or have in place, to implement today's

final rule. States must continue to meet all other conditions of

primacy in section 142.

    Section 1413 of the SDWA establishes requirements that a State or

eligible Indian tribe must meet to maintain primary enforcement

responsibility (primacy) for its public water systems. These include

(1) adopting drinking water regulations that are no less stringent than

Federal NPDWRs in effect under sections 1412(a) and 1412(b) of the Act,

(2) adopting and implementing adequate procedures for enforcement, (3)

keeping records and making reports available on activities that EPA

requires by regulation, (4) issuing variances and exemptions (if

allowed by the State) under conditions no less stringent than allowed

by sections 1415 and 1416, and (5) adopting and being capable of

implementing an adequate plan for the provision of safe drinking water

under emergency situations.

    40 CFR part 142 sets out the specific program implementation

requirements for States to obtain primacy for the public water supply

supervision



[[Page 69498]]



program, as authorized under section 1413 of the Act. In addition to

adopting the basic primacy requirements, States may be required to

adopt special primacy provisions pertaining to a specific regulation.

These regulation-specific provisions may be necessary where

implementation of the NPDWR involves activities beyond those in the

generic rule. States are required by 40 CFR 142.12 to include these

regulation-specific provisions in an application for approval of their

program revisions. These State primacy requirements apply to today's

final rule, along with the special primacy requirements discussed

below.

    To implement today's final rule, States are required to adopt

revisions to Sec. 141.2--definitions; Sec. 141.32--public notification;

Sec. 142.14--records kept by States; Sec. 142.15--reports by States;

Sec. 142.16--special primacy requirements; Sec. 141.52--maximum

contaminant level goals for microbiological contaminants; Sec. 141.70--

general requirements; Sec. 141.71--criteria for avoiding filtration;

Sec. 141.73--filtration; Sec. 141.153--content of the reports; and a

new subpart P, consisting of Sec. 141.170 to Sec. 141.175.



A. Special State Primacy Requirements



    In addition to adopting drinking water regulations at least as

stringent as the Federal regulations listed above, EPA requires that

States adopt certain additional provisions related to this regulation

to have their program revision application approved by EPA. This

information advises the regulated community of State requirements and

helps EPA in its oversight of State programs. States which require

without exception all public water systems using a surface water source

or a ground water source under the direct influence of surface water to

provide filtration need not demonstrate that the State program has

provisions that apply to systems which do not provide filtration

treatment. However, such States must provide the text of the State

statutes or regulations which specifies that public water systems using

a source water must provide filtration.

    EPA is currently developing, with stakeholder input, several

guidance documents to aid the States and water systems in implementing

today's final rule. This includes guidance for the following topics:

Enhanced coagulation, disinfection benchmark and profiling, turbidity,

alternative disinfectants, M-DBP simultaneous compliance, sanitary

survey, unfiltered systems and uncovered finished water reservoirs. In

addition, upon promulgation of the IESWTR, EPA will work with States to

develop a State implementation guidance manual.

    To ensure that the State program includes all the elements

necessary for a complete enforcement program, the State's application

must include the following in order to obtain EPA's approval for

implementing this rule:

    (1) Adoption of the promulgated IESWTR.

    (2) Description of how the State will implement its sanitary survey

program and how the State will assure that a system responds in writing

to a sanitary survey report within 45 days indicating how and on what

schedule the system will address significant deficiencies noted in the

survey. The description must also identify the appropriate rules or

other authority of the State to assure that PWSs respond to significant

deficiencies. The State must conduct sanitary surveys that include

eight specified components (described below) for all surface water and

GWUDI systems no less frequently than every 3 years for community

systems and no less frequently than every five years for noncommunity

systems. The State may ``grandfather'' sanitary surveys conducted after

December 1995 for the first set of required sanitary surveys if the

surveys address the eight sanitary survey components (source;

treatment; distribution system; finished water storage; pumps, pump

facilities and controls; monitoring and reporting and data

verification; system management and operation; and operator compliance

with State requirements). For community systems determined by the State

to have outstanding performance based on prior sanitary surveys,

subsequent sanitary surveys may be conducted no less than every five

years. The State must include how it will decide whether a system has

outstanding performance in its primacy application. Components of a

sanitary survey may be completed as part of a staged or phased State

review process within the established frequency. The State must also

describe how it will decide whether a deficiency identified during a

sanitary survey is significant.

    (3) Description of the procedures the State will use to determine

the adequacy of changes in disinfection process by systems required to

profile and benchmark under Sec. 141.172 and how the State will consult

with PWSs to evaluate modifications to disinfection practice.

    (4) Description of existing or adoption of appropriate rules or

other authority to assure PWSs to conduct a Composite Correction

Program (CCP) and to require that PWSs implement any follow up

recommendations that results as part of the CCP.

    (5) Description of how the State will approve a more representative

annual data set than the data set determined under Sec. 141.172(a)(1)

or (2) for the purpose of determining applicability of the requirements

of Sec. 141.172 (disinfection benchmarking/profiling).

    (6) Description of how the State will approve a method to calculate

the logs of inactivation for viruses for a system that uses either

chloramines or ozone for primary disinfection.

    (7) For filtration technologies other than conventional filtration

treatment, direct filtration, slow sand filtration or diatomaceous

earth filtration, a description of how the State will determine that a

public water system may use a filtration technology if the PWS

demonstrates to the State, using pilot plant studies or other means,

that the alternative filtration technology, in combination with the

disinfection treatment that meets the requirements of Sec. 141.172(b)

of this title, consistently achieves 99.9 percent removal and/or

inactivation of Giardia lamblia cysts and 99.99 percent removal and/or

inactivation of viruses, and 99 percent removal of Cryptosporidium

oocysts; and a description of how, for the system that makes this

demonstration, the State will set turbidity performance requirements

that the system must meet 95 percent of the time and that the system

may not exceed at any time at a level that consistently achieves 99.9

percent removal and/or inactivation of Giardia lamblia cysts, 99.99

percent removal and/or inactivation of viruses, and 99 percent removal

of Cryptosporidium oocysts.



B. State Recordkeeping Requirements



    Today's rule includes changes to the existing record-keeping

provisions to implement the requirements in today's final rule. States

must maintain records of the following: (1) Turbidity measurements must

be kept for not less than one year, (2) disinfectant residual

measurements and other parameters necessary to document disinfection

effectiveness must be kept for not less than one year, (3) decisions

made on a system-by-system basis and case-by-case basis under

provisions of part 141, subpart H or subpart P, (4) a list of systems

consulting with the State concerning a modification of disinfection

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

decisions that a system using alternative filtration technologies can

consistently achieve a 99 percent removal of Cryptosporidium oocysts as

well as the required levels of removal and/or



[[Page 69499]]



inactivation of Giardia and viruses for systems using alternative

filtration technologies, including State-set enforceable turbidity

limits for each system. A copy of the decision must be kept until the

decision is reversed or revised and the State must provide a copy of

the decision to the system, (6) a list of systems required to do filter

self-assessments, CPE or CCP. These decision records must be kept for

40 years (as currently required by Sec. 142.14 for other State decision

records) or until a subsequent determination is made, whichever is

shorter.



C. State Reporting Requirements



    Currently States must report to EPA information under 40 CFR 142.15

regarding violations, variances and exemptions, enforcement actions and

general operations of State public water supply programs. Today's rule

requires States to provide additional information to EPA within the

context of the existing special report requirements for the SWTR

(Sec. 142.15(c)(1)). States must report a list of Subpart H systems

that have had a sanitary survey completed during the previous year and

an evaluation of the State's program for conducting sanitary surveys.



D. Interim Primacy



    On April 28, 1998, EPA amended its State primacy regulations at 40

CFR 142.12 (EPA 1998d, 63 FR 23362) to incorporate the new process

identified in the 1996 SDWA amendments for granting primary enforcement

authority to States while their applications to modify their primacy

programs are under review. The new process grants interim primary

enforcement authority for a new or revised regulation during the period

in which EPA is making a determination with regard to primacy for that

new or revised regulation. This interim enforcement authority begins on

the date of the primacy application submission or the effective date of

the new or revised State regulation, whichever is later, and ends when

EPA makes a final determination. However, this interim primacy

authority is only available to a State that has primacy for every

existing national primary drinking water regulation in effect when the

new regulation is promulgated.

    As a result, States that have primacy for every existing NPDWR

already in effect may obtain interim primacy for this rule, beginning

on the date that the State submits its complete and final application

for primacy for this rule to EPA, or the effective date of its revised

regulations, whichever is later. In addition, a State which wishes to

obtain interim primacy for future NPDWRs must obtain primacy for this

rule. After the effective date of today's rule, any State that does not

have primacy for this rule cannot obtain interim primacy for future

rules.



V. Economic Analysis



A. Today's Rule



    EPA has estimated that the total annualized cost for implementing

the IESWTR is $307 million, in 1998 dollars, at 7 percent rate cost of

capital. This estimate includes annualized treatment costs to utilities

($192 million), start-up and annualized monitoring costs to utilities

($99 million), and start-up and annualized monitoring costs to States

($16 million). Annualized treatment costs to utilities includes annual

operation and maintenance costs ($106 million) and annualized capital

costs assuming 7 percent cost of capital ($86 million). The two cost

elements which have the greatest impact on total annualized costs are

treatment ($192 million), which for the most part reflects turbidity

treatment costs, and turbidity monitoring ($96 million). More detail

including the basis for these estimates and alternate cost estimates

using different cost of capital assumptions are described later in this

section. The benefits resulting from this rule range from $0.263

billion to $1.240 billion per year using a valuation of $2,000 in

health damages avoided per cryptosporidiosis illness prevented (based

on the mean of a distribution of values ascribed to health damages

avoided, as discussed below). Based on this analysis, EPA has

determined that the benefits of today's rule justify the costs.



B. Overview of RIA for Proposed Rule



    The Regulatory Impact Analysis (RIA) (EPA, 1994f) for the proposed

IESWTR (59 FR 38832, July 29, 1994) only considered one of the rule

options that were proposed: that which would require systems to provide

enough treatment to achieve less than a 10<SUP>-4</SUP> risk level from

giardiasis while meeting the Stage 1 DBPR. Other rule options were not

considered for the RIA because of insufficient data at the time of

proposal. The RIA for the proposed 1994 IESWTR estimated national

capital and annualized costs (amortized capital and annual operating

costs) for surface water systems serving at least 10,000 people at $4.4

billion and $468 million (in 1998 dollars at a 10% cost of capital)

respectively. In estimating these costs, it was assumed that additional

Giardia reduction beyond the requirements of the SWTR to achieve the

10<SUP>-4</SUP> risk level would be achieved solely by using chlorine

as the disinfectant and providing additional contact time by increasing

the disinfectant contact basin size. Under the 1994 RIA, EPA also

estimated that 400,000 to 500,000 Giardia infections per year that

could be avoided would have an economic value of $1.4 to $1.7 billion

per year (in 1998 dollars at a 10% cost of capital), suggesting under

this rule option, the benefit nationwide of avoiding Giardia infections

would be as much as three or four times greater than the estimated $468

million national annual cost of providing additional contact time.

Development of the proposed rule option was based on the availability

of an analytical method to quantify Giardia source water concentrations

and prescribe appropriate levels of treatment to achieve the

10<SUP>-4</SUP> risk level. This rule option was dropped from

consideration of a final IESWTR since adequate methods for measuring

Giardia were not available during the final development phase of this

rule. Also, ICR data was not available to evaluate the validity of

assumed national Giardia source water concentration levels under the

RIA for the proposed rule.



C. What's Changed Since the Proposed Rule



    National source water occurrence data for Giardia and

Cryptosporidium are being collected as part of the ICR but this data

will not become available until after promulgation of the IESWTR. Since

February 1997, the Agency worked with stakeholders to identify

additional data available since 1994 to support the RIA for the IESWTR

published today. USEPA established the Microbial and Disinfectants/

Disinfection Byproducts Advisory Committee to collect, share and

analyze new information and data, as well as to build consensus on the

regulatory implications of this new information.



D. Summary of Cost Analysis



    The IESWTR will result in increased costs to public water systems

for improved turbidity treatment, monitoring, disinfection benchmarking

and covering new finished water reservoirs, as well as State

implementation costs. As discussed earlier in this Notice, the rule

will only apply to systems using surface water or ground water under

the direct influence of surface water that serve 10,000 or more

persons. (EPA notes that the rule does include provisions for primacy

States to conduct sanitary surveys for all surface water and GWUDI

systems regardless of size.) EPA intends to address systems serving

less than 10,000 people, under the Long Term 1



[[Page 69500]]



Enhanced Surface Water Treatment Rule.

    Table V.1 indicates estimated annual costs associated with

implementing the IESWTR in 1998 dollars for different cost of capital

assumptions. A cost of capital rate of 7 percent was used to calculate

the unit costs for the national compliance cost model. This rate

represents the standard discount rate preferred by the Office of

Management and Budget (OMB) for benefit-cost analyses of government

programs and regulations. The 3 percent rate and 10 percent rate are

provided as a sensitivity analysis. The 10 percent rate also provides a

link to the 1994 Stage 1 DBPR cost analysis which was based on a 10

percent rate.

    Estimated costs are presented as either public water system

(utility) or State costs. Utility costs include all costs associated

with improved turbidity treatment, start-up and annual costs for

turbidity monitoring, the one-time cost of performing disinfection

benchmarking, and costs for covering new finished water reservoirs.

State costs include program start-up and ongoing implementation costs,

including sanitary surveys.

    The 1994 proposal, in 1998 dollars, is equivalent to $4.370 billion

for total capital costs, a difference of $3.611 billion (in 1998

dollars) from the capital costs estimated for today's final rule. The

difference is accounted for primarily by rule criteria evaluated in the

benefit-cost analysis, i.e., changes in the level of disinfection

required. Under the final IESWTR virtually no systems would need to

install additional disinfection contact basins. Also, the capital costs

associated with physical removal under the final IESWTR are

substantially lower than those estimated in the 1994 RIA.

    To comply with the IESWTR, systems would be expected to employ

treatment enhancement and/or modifications. These activities were

grouped into 10 decision tree categories based on general process

descriptions as follows: chemical addition, coagulant improvements,

rapid mixing, flocculation improvements, settling improvements,

filtration improvements, hydraulic improvements, administration culture

improvements, laboratory modifications and process control testing

modifications. Descriptions of how systems were expected to evaluate

these activities are included in the document Technologies and Costs

for the Interim Enhanced Surface Water Treatment Rule (USEPA, 1998b).

    The decision tree stratifies public water systems into groups or

categories based on the number of people served and the range of

treatment choices available to them to achieve compliance. The decision

tree incorporates estimates of the percent of public water systems in

each category selecting a particular approach to achieve compliance.

These percentages were factors in the national cost model and represent

the percentage of systems needing to modify treatment to meet the

limits. Further description of the compliance decision tree and

methodology are included in the Regulatory Impact Analysis for the

Interim Enhanced Surface Water Treatment Rule (USEPA, 1998a). Based on

this decision tree analysis and the total costs indicated in Table V.1,

the two cost elements which have the greatest impact on national costs

are Total Treatment, which for the most part reflects turbidity

treatment costs, and Turbidity Monitoring. The percent of systems

estimated to modify treatment practices to meet the revised turbidity

requirements (i.e., 0.3 NTU 95 percentile and 1 NTU maximum combined

filter effluent levels) is 50 percent (or 691 out of a possible 1,381

systems), as shown in Table V.2. Turbidity monitoring is required of

all systems covered by the rule and using rapid granular filtration

(i.e., conventional or direct filtration). As shown in table V.3, total

annual cost to utilities for turbidity monitoring are $96 million.



E. Household Costs



    Household costs are a way to represent water system treatment costs

as costs to the system customer. Under the IESWTR, households will face

the increases in annual costs displayed in Figure V.1. All households

served by large surface water systems will incur additional costs under

the IESWTR since all systems are required to perform turbidity

monitoring activities. However, as shown in the cumulative distribution

of households affected by the rule, 92 percent of households (60

million) will incur less than a cost of $1 per month. 7 percent of

households (5 million) will face an increase in cost of between $1 and

$5 per month. The highest cost faced by 23,000 households is

approximately $100 per year ($8 per month).

    The assumptions and structure of this analysis, in describing the

curve, tend to overestimate the highest costs. To be on the upper bound

of the curve, a system would have to implement all, or almost all, of

the treatment activities. These systems, however, might seek less

costly alternatives, such as connecting into a larger regional water

system.



F. Summary of Benefits Analysis



    The economic benefits of the IESWTR derive from the increased level

of protection to public health. The primary goal of these provisions is

to improve public health by increasing the level of protection from

exposure to Cryptosporidium and other pathogens (i.e., Giardia, or

other waterborne bacterial or viral pathogens) in drinking water

supplies through improvements in filtration at water systems. The

IESWTR is expected to reduce the level of Cryptosporidium and other

pathogen contamination in finished drinking water supplies through

improvements in filtration at water systems (i.e., revised turbidity

requirements). In this case, benefits will accrue due to the decreased

likelihood of endemic incidences of cryptosporidiosis, giardiasis and

other waterborne disease, and the avoidance of resulting health costs.

In addition to reducing the endemic disease, the provisions are

expected to reduce the likelihood of the occurrence of Cryptosporidium

outbreaks and their associated economic costs, by providing a larger

margin of safety against such outbreaks for some systems.

    The benefit analysis attempts to take into account some of the

uncertainties in the analysis by estimating benefits under two

different current treatment assumptions and three improved removal

assumptions. The benefit analysis also used Monte Carlo simulations to

derive a distribution of estimates, rather than a single point

estimate.

    The benefits analysis focused on estimating changes in incidence of

cryptosporidiosis that would result from the rule. The analysis

included estimating the baseline (pre-IESWTR) levels of exposure from

Cryptosporidium in drinking water, reductions in such exposure

resulting from treatment changes to comply with the IESWTR, and

resultant reductions of risk.

    Baseline levels of Cryptosporidium in finished water were estimated

by assuming national source water occurrence distribution (based on

data by LeChevallier and Norton 1995) and a national distribution of

Cryptosporidium removal by treatment.

    In the IESWTR RIA, the following two assumptions were made about

the performance of current treatment in removing oocysts to estimate

finished water Cryptosporidium concentrations. Based on treatment

removal efficiency data presented in the 1997 IESWTR NODA, EPA assumed

a national distribution of physical removal



[[Page 69501]]



efficiencies with a mean of 2.5 logs and a standard deviation of

<plus-minus>0.63 logs. Under this assumption, average log removal for

different plants would generally range from 1.25 logs to 3.75 logs.

Because the finished water concentrations of oocysts represent the

baseline against which improved removal from the IESWTR is compared,

variations in the log removal assumption could have considerable impact

on the risk assessment. To evaluate the impact of the removal

assumptions on the baseline and resulting improvements, an alternative

mean log removal/inactivation assumption of 3.0 logs and a standard

deviation of <plus-minus>0.63 logs was also used to calculate finished

water concentrations of Cryptosporidium. Under this assumption average

log removal for different plants would generally range from 1.75 to

4.25 logs.

    For each of the two baseline assumptions, USEPA assumed that a

certain number of plants would show low, mid or high improved removal,

depending upon factors such as water matrix conditions, filtered water

turbidity effluent levels, and coagulant treatment conditions. As a

result, the RIA considers six scenarios that encompass the range of

endemic health damages avoided based on the rule.

    The finished water Cryptosporidium distributions that would result

from additional log removal with the turbidity provisions were derived

assuming that additional log removal was dependent on current removal,

i.e., that sites currently operating at the highest filtered water

turbidity levels would show the largest improvements or high improved

removal assumption (e.g., plants now failing to meet a 0.4 NTU limit

would show greater removal improvements than plants now meeting a 0.3

NTU limit).

    Table V.4 indicates estimated annual benefits associated with

implementing the IESWTR. The benefits analysis quantitatively examines

endemic health damages avoided based on the IESWTR for each of the six

scenarios mentioned above. For each of these scenarios, EPA calculated

the mean of the distribution of the number of illnesses avoided. The

assessment also discusses, but does not quantify, other economic

benefits that may result from the provisions, including the avoided

health damage costs associated with reduced risk of outbreaks and

avoided costs of averting behavior such as boiling water or use of an

alternative water source during outbreaks or periods of high turbidity.

    According to the RIA performed for the IESWTR published today, the

rule is estimated to reduce the mean annual number of illnesses caused

by Cryptosporidium in water systems improving filtration by 110,000 to

463,000 cases depending upon which of the six baseline and improved

Cryptosporidium removal assumptions was used. Based on these values,

the mean estimated annual benefits of reducing the illnesses ranges

from $0.263 billion to $1.240 billion per year. This calculation is

based on a valuation of $2,000 per incidence of cryptosporidiosis

prevented which is the mean of a distribution of values ascribed to

health damages avoided. The RIA also indicated that the rule could

result in a mean reduction of 14 to 64 fatalities each year, depending

upon the varied baseline and improved removal assumptions. Using a mean

value of $5.6 million per statistical life saved, reducing these

fatalities could produce benefits in the range of $0.085 billion to

$0.363 billion.



G. Comparison of Costs and Benefits



    Given the costs summarized in Table V.1 and the benefits summarized

in Table V.4, the IESWTR results in positive net benefits under all

three improved removal scenarios (low, mid, and high) assuming that

current treatment as a national average achieves 2.5 log of

Cryptosporidium removal, taking into account only the value of cost of

illness avoided. Using a current national average treatment removal

assumption of 3.0 logs, net benefits are positive under the high and

mid improved removal scenarios. Net benefits using the 3.0 log current

removal assumption are negative under the low improved removal scenario

using only the value of cost of illness avoided, however, when the

value of mortalities prevented is added into the benefits, all

scenarios have positive net benefits at the mean.

    Thus, the monetized net benefits are positive across most of the

range of current treatment assumptions, improved log removal scenarios,

and discount rates. The benefits due to the illnesses avoided may be

slightly overstated when aggregated with benefits due to mortalities

avoided, because the mortalities were not netted out of the number of

illnesses. This value is minimal and would not be captured at the level

of significance of the analysis. Several categories of benefits,

including reducing the risk of outbreaks, reducing exposure to other

pathogens such as Giardia, and avoiding the cost of averting behavior

have not been quantified for this analysis, but could represent

substantial additional economic value. In addition, the estimates for

avoided costs of illness do not include the value for pain and

suffering or the risk premium.



              Table V.1.--Annual Costs of the Interim Enhanced Surface Water Treatment Rule ($000s)

----------------------------------------------------------------------------------------------------------------

                                                       Final Rule (1998 dollars)              1994 Proposal

                                                ----------------------------------------------------------------

                                                                                        10% Cost of  10% Cost of

                                                  3% Cost of   7% Cost of  10% Cost of    Capital      Capital

                                                   Capital      Capital      Capital        1992         1998

                                                                                          dollars      dollars

----------------------------------------------------------------------------------------------------------------

                 Utility Costs



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



                  Annual Costs



    Annualized Capital <dagger>................       65,999       85,611      103,437

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

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

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

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

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

                                                ----------------------------------------------------------------

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

          Annualized One-Time Costs**



    Turbidity Monitoring Start-Up..............          289          405          504  ...........  ...........



[[Page 69502]]





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

                                                ----------------------------------------------------------------

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

                                                ----------------------------------------------------------------

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



                  State Costs



                  Annual Costs



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

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

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

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

                                                ----------------------------------------------------------------

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



          Annualized One-Time Costs**



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

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

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

                                                ----------------------------------------------------------------

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

                                                ----------------------------------------------------------------

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

                                                ----------------------------------------------------------------

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

----------------------------------------------------------------------------------------------------------------

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

  Filter Assessments.

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

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

<dagger> Most costs are annualized over 20 years. Some costs, including turbidimeters and process control

  monitoring, are annualized over 7 years.





                  Table V.2.--Final Annual Cost Estimates for Turbidity Treatment Requirements

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

----------------------------------------------------------------------------------------------------------------

                                                                Systems     3 Percent    7 Percent    10 Percent

        System Size (population served)           Number of    Modifying     Cost of      Cost of      Cost of

                                                   Systems     Treatment     Capital      Capital      Capital

----------------------------------------------------------------------------------------------------------------

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

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

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

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

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

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

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

                                                ----------------------------------------------------------------

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

----------------------------------------------------------------------------------------------------------------





                       Table V.3.--Utility Turbidity Start-Up and Monitoring Annual Costs

----------------------------------------------------------------------------------------------------------------

         Compliance Activities            Respondents Affected      Unit Costs         CF *        Annual Costs

----------------------------------------------------------------------------------------------------------------

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

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

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

                                       -------------------------------------------------------------------------

    Total Annual Utility Costs for        ......................                                      96,328,996

     Turbidity Monitoring and Start-Up.

----------------------------------------------------------------------------------------------------------------

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

  capitalization (20 years), and the current value of money ($1).

** Start-up costs are annualized over 20 years with a CF of 0.09439.





[[Page 69503]]





                                Table V.4.--Summary of Potential Annual Benefits

----------------------------------------------------------------------------------------------------------------

                                                                 Baseline Assumes

----------------------------------------------------------------------------------------------------------------

                                      2.5 Log Cryptosporidium Removal         3.0 Log Cryptosporidium Removal

----------------------------------------------------------------------------------------------------------------

                                         Mean                Range               Mean                Range

----------------------------------------------------------------------------------------------------------------

    Cryptosporidiosis Illness

        Avoided Annually



    Low Estimate of Number of     338,000...........  0-1,029,000.......  110,000...........  0-322,500

     Illnesses Avoided.

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

    Mid Number of Illnesses       432,000...........  0-1,074,000.......  141,000...........  0-333,000

     Avoided.

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

    High Number of Illnesses      463,000...........  0-1,080,000.......  152,000...........  0-338,000

     Avoided.

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



   Value of Cryptosporidiosis

  Mortalities Avoided Annually



    Low Number of Mortalities     48................  0-129.............  14................  0-40

     Avoided.

        Value of Mortalities      0.272 billion.....  0-0.674 billion...  0.085 billion.....  0-0.209 billion

         Avoided.

    Mid Number of Mortalities     60................  0-135.............  18................  0-42

     Avoided.

        Value of Mortalities      0.341 billion.....  0-0.706 billion...  0.107 billion.....  0-0.219 billion

         Avoided.

    High Number of Mortalities    64................  0-136.............  20................  0-42

     Avoided.

        Value of Mortalities      0.363 billion.....  0-0.708 billion...  0.115 billion.....  0-0.221 billion

         Avoided.



         Reduced Risk of

   Cryptosporidiosis Outbreaks



    Cost of Illness Avoided

    Emergency Expenditures

    Liability Costs                 Benefits not quantified, but could be substantial for large outbreak ($0.800

                                          billion cost of illness avoided for a Milwaukee-level outbreak).

Reduced Risk from Other                                      Benefits not quantified.

Pathogens.

Enhanced Aesthetic Water Quality                   Difference may not be noticeable to consumer.

Averting Behavior...............    Benefits not quantified, but could be substantial for large outbreak ($0.020

                                             billion to $0.062 billion for a Milwaukee-level outbreak).

----------------------------------------------------------------------------------------------------------------





BILLING CODE 6560-50-P





[[Page 69504]]



[GRAPHIC] [TIFF OMITTED] TR16DE98.009









BILLING CODE 6560-50-C



VI. Additional Issues Discussed in 1994 Proposal and 1997 NODA



A. Inactivation of Cryptosporidium



    When the IESWTR was proposed in 1994, EPA recognized that chlorine

disinfectants were relatively ineffective in inactivating

Cryptosporidium, but was not certain if alternative disinfectants might

be more effective than chlorine. In the NODA for the IESWTR, EPA

discussed the present data on Cryptosporidium disinfection for a

variety of disinfectants. Many commenters thought that sufficient data

was not available to develop guidelines for estimating inactivation of

Cryptosporidium in water. Several commenters pointed out the

inconsistency of inactivation data from different studies. Some

commenters also supported the use of Giardia as the target organism for

defining the disinfection benchmark required by today's rule. EPA

believes that variability in inactivation results is not surprising,

given the absence of standard testing protocol and methodology, and

agrees that the existing data is not sufficient to enable the

development of guidelines for estimating inactivation efficiencies for

Cryptosporidium in water. The Agency also notes that research is

underway to better clarify inactivation efficiencies for

Cryptosporidium and anticipates that new research results will be

available for consideration during the development of the Long Term 2

Enhanced Surface Water Treatment Rule which EPA plans to promulgate

simultaneously with the Stage 2 DBPR.



B. Giardia Inactivation CT Values for Profiling/Benchmarking



    In the 1997 NODA for the IESWTR, EPA requested comment on

developing CT tables for free chlorine at pH levels above 9, which are

not currently available in EPA's guidance to the SWTR. This effort was

intended to support implementation of the microbial profiling/

benchmarking required in the today's rule. Under the profiling/

benchmarking requirement, certain utilities must determine CT values

and compute daily average log inactivation of Giardia.

    While some commenters supported the CT tables for high pHs

presented in the NODA, other commenters opposed them because they

thought that the literature data were not sufficient for development of

these CT tables. Commenters also noted that for the systems with pH

levels higher than 9, States currently provide guidelines by which

utilities can estimate inactivation levels for the purpose of

compliance with the SWTR. State guidelines are to use inactivation

levels at pH 9 for above pH 9 conditions. EPA believes these

guidelines, along with existing CT tables, are sufficient for

implementing the benchmark/profiling requirements and therefore no

additional CT tables have been developed at this time.

    As explained previously, in conjunction with today's rule, EPA is

also concurrently promulgating the Stage 1 DBPR under which the maximum

disinfectant residual level for free chlorine is 4 mg/L. However, the

CT tables for free chlorine that appear in the SWTR Guidance Manual

only cover the chlorine residual up to 3 mg/L. Some commenters

expressed a need for CT values for higher chlorine residuals. Since it

has been observed that the free chlorine residual concentration (C) is

not as significant as the contact time (T) in terms of inactivation

kinetics for Giardia cysts and no data are currently available to

support the development of additional CT tables for the range of

chlorine residuals between 3 and 4 mg/L, EPA recommends that for the

purpose of microbial profiling/benchmarking the value of 3 mg/L as

Cl<INF>2</INF> be used for estimating log inactivation when the

chlorine residual level is higher than 3 mg/L.



C. Cross Connection Control



Today's Rule



    EPA is not establishing requirements for cross connection control

in today's final rule. The Agency does plan to consider cross

connection control issues during the development of subsequent

microbial regulations, in the context of a broad range of issues

related to distribution systems. At that time the results of research

currently in progress should be available to the Agency and enable EPA

to make regulatory decisions.



Background and Analysis



    The proposed IESWTR (EPA, 1994b, 59 FR 38841, July 29, 1994)

requested



[[Page 69505]]



public comment on whether the Agency should require States and/or

systems to have a cross-connection control program. In addition, the

Agency solicited comment on a number of associated issues, including

(1) what specific criteria, if any, should be included in such a

requirement, (2) how often such a program should be evaluated, (3)

whether EPA should limit any requirement to only those connections

identified as a cross connection by the public water system or the

State, and (4) conditions under which a waiver from this requirement

would be appropriate. The Agency also requested commenters to identify

other regulatory measures EPA should consider to prevent contamination

of drinking water in the distribution system (e.g., minimum pressure

requirements in the distribution system).

    Historically, a significant portion of waterborne disease outbreaks

reported by CDC are caused by distribution system deficiencies.

Distribution system deficiencies are defined in CDC's publication

Morbidity and Mortality Weekly Report as cross connections,

contamination of water mains during construction or repair, and

contamination of a storage facility. Between 1971-1994, approximately

53 waterborne disease outbreaks reported were associated with cross

connections or backsiphonage. Fifty-six outbreaks were associated with

other distribution system deficiencies (Craun, Pers. Comm. 1997b). Some

outbreaks have resulted from water main breaks or repairs.

    There is no centralized repository where backflow incidents are

reported or recorded. The vast majority of backflow incidents are

probably not reported. Examples of specific backflow incidents are

described in detail in EPA's Cross-Connection Control Manual (EPA,

1989a).

    Where cross connections exist, some protection is still afforded to

the distribution system by the maintenance of a positive water pressure

in the system. Adequate maintenance of pressure provides a net movement

of water out through breaks in the distribution pipes and prevents

contaminated water outside of the pipes from entering the drinking

water supply. The loss of pressure in the distribution system, less

than 20 psi, can cause a net movement of water from outside the pipe to

the inside, possibly allowing the introduction of fecal contamination

into the system. This problem is of special concern where wastewater

piping is laid in the same street as the water pipes, creating a

potential threat to public health whenever there is low or no pressure.

    A number of States have cross connection control programs, although

the extent to which they vary is unclear. A Florida Department of

Environmental Protection survey evaluated cross-connection control

regulations in the 50 States (Florida DEP 1996). The survey results

showed that 29 of the 40 States that responded to the survey request

have programs. The rigor of the programs and the extent to which they

are enforced was not addressed by the survey. An EPA report suggests

that the responsibility for administration and enforcement of the State

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

 

Summary of Major Comments



    Most commenters supported either a federal or State cross

connection control program in order to prevent disease outbreaks and

injury to the public. Some commenters suggested EPA update its guidance

document on cross connection control. Commenters opposed to a cross

connection control program indicated that (1) a federally-mandated

program would be impractical, burdensome, and would fail, (2) a State

or local program would be more appropriate than an EPA-mandated

program, (3) most States already have a comprehensive program, thus

negating need for federal regulations, (4) EPA should publish general

guidelines only, and (5) there should be a separate regulation because

a cross connection control program would affect both surface water and

ground water.

    As noted above, EPA plans to consider cross connection control in

the context of future microbial rules rather than in the IESWTR. The

Agency will consider cross connection control issues in connection with

a broad range of issues related to distribution systems as it develops

these microbial rules. Issues to be considered include biofilm growth

and the potential for biofilm associated with pathogens, water

treatment and distribution system operations to minimize microbial

growth, and causes of pathogen intrusion into the distribution system.

These are all areas that are the focus of a significant research

effort, most of which is still in progress. The American Water Works

Association Research Foundation (AWWARF) presently has 17 projects

pertaining to maintenance of water quality in the distribution system

that are not yet complete. EPA's laboratories are also working on

important research questions in these areas. EPA intends to evaluate

this large body of distribution system research as well as data on

State and local government requirements and their impact in order to

develop comprehensive regulations and guidance on distribution system

maintenance and operations, including the prevention of cross-

connections.

    EPA has previously published guidance on cross connection control

entitled the Cross Connection Control Manual (EPA, 1989a, EPA 570/9-89-

007, June 1989). This guidance describes methods, devices, etc. for

prevention of backflow and back-siphonage, testing procedures for

backflow preventers, administration of cross-connection programs and

cross-connection control ordinance provisions. The Agency plans to

update this Cross Connection Control Manual during the development of

future microbial rules that address cross connection. The Agency will

request public comment on issues related to cross connection control at

that time. EPA would also like to point out that a number of States and

local governments have existing cross connection control programs and

strongly encourages States and local governments to implement effective

cross connection control programs.



D. Filter Backwash Recycling



    The SDWA Amendments of 1996 require that the EPA promulgate a

regulation governing the recycle of filter backwash water within the

treatment process by August 2000. The Agency is currently developing

data and collecting information to consider these issues in a separate

rule rather than in the IESWTR. The Agency held a public meeting in

Denver, Colorado, in July 1998 and plans to hold another meeting in

early 1999 to discuss available data and possible regulatory options,

and intends to propose a rule in August of 1999.



E. Certification Criteria for Water Plant Operators



    The July 29, 1994 notice requested comment on whether the ESWTR

should define minimum certification criteria for surface water

treatment plant operators. Currently, the SWTR (141.70) requires such

systems to be operated by ``qualified personnel who meet the

requirements specified by the State''. EPA is not further defining

``qualified'' in the IESWTR as the operator certification requirements

discussed below will address this issue. The 1996 Amendments to the

SDWA direct the Administrator, EPA, in cooperation with the States, to

publish guidelines in the Federal Register specifying minimum standards

for certification and recertification of operators of



[[Page 69506]]



community and nontransient noncommunity public water systems. Draft

guidelines were published in the Federal Register Friday, March 27,

1998 (EPA 1998f) with a 90-day public comment period. Final guidelines

are required to be published by February 1999. States then have two

years to adopt and implement an operator certification program that

meets these guidelines. After that date, if a State has not adopted and

implemented an approved program, the Administrator must withhold 20

percent of the funds a State is otherwise entitled to receive in its

Drinking Water State Revolving Fund (DWSRF) capitalization grants under

section 1452 of SDWA. Questions regarding the draft guidelines may be

directed to Jenny Jacobs (202-260-2939) or Richard Naylor (202-260-

5135) of EPA's Office of Ground Water and Drinking Water. Their e-mail

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

naylor.richard@epamail.epa.gov. In light of the 1996 Amendments and the

draft guidelines, certification criteria need not be included in

today's rule.



VII. Other Requirements



A. Regulatory Flexibility Act



    Under the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq.,

as amended by the Small Business Regulatory Enforcement Fairness Act of

1996, EPA is generally required to prepare a regulatory flexibility

analysis describing the impact of the regulatory action on small

entities as part of the rulemaking. However, under section 605(b) of

the RFA, if EPA certifies that the rule will not have a significant

economic impact on a substantial number of small entities, EPA is not

required to prepare a regulatory flexibility analysis. Pursuant to

section 605(b) of the RFA, the Administrator certifies that this rule

will not have a significant economic impact on a substantial number of

small entities.

    The RFA authorizes use of an alternative definition to that of the

Small Business Administration for a small water utility. Throughout the

1992-93 negotiated rulemaking process for the Stage 1 DBPR and IESWTR

and in the July 1994 proposals for these rules, a small public water

system (PWS) was defined as a system serving fewer than 10,000 persons.

This definition reflects the fact that the original 1979 standard for

total trihalomethanes applied only to systems serving at least 10,000

people. The definition thus recognizes that baseline conditions from

which systems serving fewer than 10,000 people will approach

disinfection byproduct control and simultaneous control of microbial

pathogens is different than that for systems serving 10,000 or more

persons. EPA again discussed this approach to the definition of a small

system for these rules in the March 1998 Disinfectants/Disinfection

Byproducts Notice of Data Availability (63 FR 15676, March 31, 1998).

EPA is continuing to define ``small system'' for purposes of this rule

and the Stage 1 DBPR as a system which serves fewer than 10,000 people.

The IESWTR applies only to systems serving at least 10,000 people and

accordingly does not have a significant economic impact on a

substantial number of small entities. Accordingly EPA has not completed

a regulatory flexibility analysis for the IESWTR or a small entity

compliance guide.

    The Agency has since proposed and taken comment on its intent to

define ``small entity'' as a public water system that serves 10,000 or

fewer persons for purposes of its regulatory flexibility assessments

under the RFA for all future drinking water regulations. (See Consumer

Confidence Reports Rule, 63 FR 7620, Feb. 13, 1998.) In that proposal,

the Agency discussed the basis for its decision to use this definition

and to use a single definition of small public water system whether the

system was a ``small business'', ``small nonprofit organization'', or

``small governmental jurisdiction.'' EPA also consulted with the Small

Business Administration on the use of this definition as it relates to

small businesses. Subsequently, the Agency has used this definition in

developing its regulations under the Safe Drinking Water Act. This

approach is virtually identical to the approach used in the IESWTR and

Stage 1 DBPR.



B. Paperwork Reduction Act



    The Office of Management and Budget (OMB) has approved the

information collection requirements contained in this rule under the

provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and

has assigned OMB control number 2040-0205.

    The information collected as a result of this rule will allow the

States and EPA to evaluate PWS compliance with the rule. For the first

three years after promulgation of this rule, the major information

requirements pertain to monitoring, compliance reporting and sanitary

surveys. Responses to the request for information are mandatory (Part

141). The information collected is not confidential.

    EPA is required to estimate the burden on PWS for complying with

the final rule. Burden means the total time, effort, or financial

resources expended by persons to generate, maintain, retain, or

disclose or provide information to or for a Federal agency. This

includes the time needed to review instructions; develop, acquire,

install, and utilize technology and systems for the purposes of

collecting, validating, and verifying information, processing and

maintaining information, and disclosing and providing information;

adjust the existing ways to comply with any previously applicable

instructions and requirements; train personnel to be able to respond to

a collection of information; search data sources; complete and review

the collection of information; and transmit or otherwise disclose the

information.

    EPA estimates that the annual burden on PWS and States for

reporting and recordkeeping will be 150,557 hours. This is based on an

estimate that there will be 998 respondents per year who will each, on

average, need to provide 3,803 responses and that the average response

will take 40 hours. The total annual cost burden is $27,448,013. This

includes total annual labor costs of $4,615,791 for the following

activities: reading and understanding the rule, planning, training,

data collection, data review, data reporting, recordkeeping, compliance

tracking and making determinations. The cost burden also includes

capital costs of $17,137,222 for turbidimeter installation by PWS, and

an operations and maintenance cost of $5,695,000 for turbidimeters.

    An Agency may not conduct or sponsor, and a person is not required

to respond to a collection of information unless it displays a

currently valid OMB control number. The OMB control numbers for EPA's

regulations are listed in 40 CFR part 9 and 48 CFR chapter 15. EPA is

amending the table in 40 CFR part 9 of currently approved ICR control

numbers issued by OMB for various regulations to list the information

requirements contained in this final rule. This ICR was previously

subject to public notice and comment prior to OMB approval. As a

result, EPA finds that there is ``good cause'' under section 553 (b)

(B) of the Administrative Procedures Act (5 U.S.C. 553 (b) (B) to amend

this table without prior notice and comment. Due to the technical

nature of the table, further notice and comment would be unnecessary.



C. Unfunded Mandates Reform Act



1. Summary of UMRA requirements



    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub.

L. 104-4, establishes requirements for Federal agencies to assess the

effects of their regulatory actions on State, local,



[[Page 69507]]



and tribal governments and the private sector. Under UMRA section 202,

EPA generally must prepare a written statement, including a cost-

benefit analysis, for proposed and final rules with ``Federal

mandates'' that may result in expenditures to State, local, and tribal

governments, in the aggregate, or to the private sector, of $100

million or more in any one year. Before promulgating an EPA rule for

which a written statement is needed, section 205 of the UMRA generally

requires EPA to identify and consider a reasonable number of regulatory

alternatives and adopt the least costly, most 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 an explanation

why that alternative was not adopted with the final rule.

    Before EPA establishes any regulatory requirements that may

significantly or uniquely affect small governments, including tribal

governments, it must have developed under section 203 of the UMRA a

small government agency plan. The plan must provide for notifying

potentially affected small governments, enabling officials of affected

small governments to have meaningful and timely input in the

development of EPA regulatory proposals with significant Federal

intergovernmental mandates, and informing, educating and advising small

governments on compliance with the regulatory requirements.



2. Written Statement for Rules With Federal Mandates of $100 Million or

More



    EPA has determined that this rule contains a Federal mandate that

may result in expenditures of $100 million or more for State, local,

and tribal governments, in the aggregate and the private sector in any

one year. Accordingly, EPA has prepared under section 202 of the UMRA a

written statement which is summarized below. The written statement

addresses the following areas: (a) Authorizing legislation; (b) cost-

benefit analysis including an analysis of the extent to which the costs

of State, local and Tribal governments will be paid for by the Federal

government; (c) estimates of future compliance costs and

disproportionate budgetary effects; (d) macro-economic effects; and (e)

a summary of EPA's consultation with State, local, and Tribal

governments and their concerns, including a summary of the Agency's

evaluation of those comments and concerns; (f) identification and

consideration of regulatory alternatives; and (g) selection of the

least costly, most cost-effective or least burdensome alternative that

achieves the objectives of the rule. The major points of this written

statement are summarized below. A more detailed description of this

analysis is presented in EPA's Unfunded Mandates Reform Act Analysis

for the IESWTR (EPA,1998c) which is included in the docket for this

rule.

a. Authorizing Legislation

    Today's rule is promulgated pursuant to (section 1412(b)(2)(C)) of

the 1996 amendments to the SDWA; paragraph C of this section

establishes a statutory deadline of November 1998 to promulgate this

rule. In addition, the Interim Enhanced Surface Water Treatment Rule

(IESWTR) is closely integrated with the Stage 1 DBPR, which also has a

statutory deadline of November 1998.

b. Cost Benefit Analysis

    Section V of this preamble discusses in detail the cost and

benefits associated with the IESWTR. Also, the EPA's Regulatory Impact

Analysis of the Interim Enhanced Surface Water Treatment Rule (EPA,

1998a) contains a detailed cost benefit analysis. The analysis includes

both qualitative and monetized benefits for improvements to health and

safety. Because of scientific uncertainty regarding the exposure

assessment and the risk assessment for Cryptosporidium, the Agency

calculated partial monetary benefit estimates for three different

scenarios (low, medium, high) of improved removal of Cryptosporidium

concentrations assuming two different levels of current inactivation

(2.5 log baseline or 3.0 log baseline). Potential monetized annual

benefits for illness avoided associated with Cryptosporidium ranged

from a mean of $0.263 billion (3.0 log) to a mean of $1.24 billion (2.5

log) for this rule depending upon varied baseline and improved

Cryptosporidium removal assumptions. The benefits from reduction in

exposure to Cryptosporidium have been compared with the aggregate

annualized costs to State, local, and tribal governments and the

private sector that totaled approximately $307 million (annualized at

7%).

    Using a current national average treatment removal assumption of

3.0 logs, net benefits are positive under the high and mid improved

removal scenarios. Net benefits using the 3.0 log current removal

assumption are negative near and below the mean associated with the low

improved removal assumption using only the value of cost of illness

avoided; however, when the value of mortalities prevented is added with

the benefits, all scenarios have positive net benefits at the mean.

    Thus, the monetized net benefits are positive across most of the

range of current treatment assumptions, improved log removal scenarios,

and discount rates. The benefits due to the illnesses avoided may be

slightly overstated because mortalities were not netted out of the

number of illnesses avoided. This value is minimal and would not be

captured at the level of significance of the analysis. Other possible

benefits considered in the analysis but not monetized are reducing the

risk of outbreaks, reducing the exposure to other pathogens, enhancing

aesthetic water quality, avoiding the cost of averting behavior, and

reducing the cost of pain and suffering. These benefits could add

substantial economic value to this rule.

    Various Federal programs exist to provide financial assistance to

State, local, and Tribal governments in complying with this rule. The

Federal government provides funding to States that have primacy

enforcement responsibility for their drinking water programs through

the Public Water Systems Supervision Grants program. Additional funding

is available from other programs administered either by EPA or other

Federal agencies. These include the Drinking Water State Revolving Fund

(DWSRF) and Housing and Urban Development's Community Development Block

Grant Program.

    For example, SDWA authorizes the Administrator of the EPA to award

capitalization grants to States, which in turn can provide low cost

loans and other types of assistance to eligible public water systems.

The DWSRF assists public water systems with financing the costs of

infrastructure needed to achieve or maintain compliance with SDWA

requirements. Each State will have considerable flexibility to

determine the design of its program and to direct funding toward its

most pressing compliance and public health protection needs. States may

also, on a matching basis, use up to ten percent of their DWSRF

allotments for each fiscal year to assist in running the State drinking

water program.

c. Estimates of Future Compliance Costs and Disproportionate Budgetary

Effects

    EPA believes that the cost estimates indicated above in Section V

to be a fairly accurate assessment of future



[[Page 69508]]



compliance costs and generally does not anticipate any disproportionate

budgetary effects. In general, the costs that a public water system,

whether publicly or privately owned, will incur to comply with this

rule will depend on many factors that are not generally based on

location. However, the data needed to confirm this assessment and to

analyze other impacts of this problem are not available; therefore, EPA

looked at three other factors: The impacts of the regulation on small

versus large systems, the costs to public versus private water systems,

and the costs to households. First, EPA notes that the IESWTR does not

have a significant impact on a substantial number of small entities, as

discussed previously in Section VII.A. These small systems are the

subject of a subsequent rulemaking planned for 2000.

    Second, the review of costs to public versus private systems is

based on estimates of the allocation of the systems across size

categories and can only be viewed as an indication of possible impacts.

More important, implementation of the rule affects both public and

private water systems equally, with the variance in total cost by

system size merely a function of the number of affected systems. This

analysis is presented in further detail in the IESWTR UMRA Analysis

Document (EPA, 1998c).

    Finally, the highest estimated household costs would be for those

households served by systems that would have to implement all proposed

combined filter effluent alternative treatment activities to meet the

0.3 NTU requirement for 95 percent of samples in a given month and a

maximum of 1 NTU. However, this analysis may overstate costs because

these systems may choose a less costly alternative such as point-of-use

devices, selecting alternative water sources, or connecting to a larger

regional water system.

d. Macro-economic Effects

    As required under UMRA Section 202, EPA is required to estimate the

potential macro-economic effects of the regulation. Macro-economic

effects tend to be measurable in nationwide econometric models only if

the economic impact of the regulation reaches 0.25 percent to 0.5

percent of Gross Domestic Product (GDP). In 1997, real GDP was $7,188

billion so a rule would have to cost at least $18 billion to have a

measurable effect. A regulation with a smaller aggregate effect is

unlikely to have any measurable impact unless it is highly focused on a

particular geographic region or economic sector. The macro-economic

effects on the national economy from the IESWTR should be negligible

based on the fact that the total annual costs are about $307 million

per year (at a 7 percent cost of capital) and the costs are not

expected to be highly focused on a particular geographic region or

sector.

e. Summary of EPA's Consultation With State, Local, and Tribal

Government and Their Concerns

    Under UMRA section 202, EPA is to provide a summary of its

consultation with elected representatives (or their designated

authorized employees) of affected State, local and Tribal governments

in this rulemaking. Although this rule was proposed before UMRA became

a statutory requirement, EPA initiated consultations with governmental

entities and the private sector affected by this rule through various

means. This included participation on a Regulatory Negotiation

Committee, chartered under the Federal Advisory Committee Act (FACA),

in 1992-93 that included stakeholders representing State and local

governments, public health organizations, public water systems, elected

officials, consumer groups, and environmental groups.

    After the amendments to SDWA in 1996, the Agency initiated a second

FACA process, similarly involving a broad range of stakeholders, and

held meetings during 1997 to address the expedited deadline for

promulgation of the IESWTR in November 1998. EPA established the M-DBP

Advisory Committee to collect, share, and analyze new data reviewed

since the earlier Reg. Neg. process and also to build a consensus on

the regulatory implications of this new information. The M-DBP Advisory

Committee established a technical working group to assist them with the

many scientific issues surrounding this rule. The Committee included

representatives from organizations such as the National League of

Cities, the National Association of City and County Health Officials,

the Association of Metropolitan Water Agencies, the Association of

State Drinking Water Administrators, and the National Association of

Water Companies. In addition, the Agency invited the Native American

Water Association to participate in the FACA process to develop this

rule. Although they eventually decided not to take part, the

Association continued to be informed of meetings and developments

through a stakeholders mailing list. Stakeholders who participated in

the FACA processes, as well as all other interested members of the

public, were invited to comment on the proposed rule and NODA. Also, as

part of the Agency's Communication Strategy, EPA sent copies of the

proposed rule and NODA to many stakeholders, including six tribal

associations.

    In addition, the Agency notified governmental entities and the

private sector of opportunities to provide input on this rule in the

Federal Register on July 29, 1994 (59 FR 38832) and on November 3, 1997

(62 FR 59485). EPA received written comments from approximately 37

commenters on the July 29, 1994 notice and from approximately 157

commenters on the November 3, 1997 notice. Of the 37 commenters on the

1994 proposed rule, approximately 22% were States and 35% were local

governments. Of the 157 commenters on the 1997 Notice of Data

Availability, approximately 8% were States and 27% were local

governments.

    The public docket for this rulemaking contains all comments

received by the Agency and provides details about the nature of State

and local governments' concerns. Issues addressed by State and local

government commenters included concerns about the cost and feasibility

of proposed regulatory alternatives to require treatment levels based

on Giardia and/or Cryptosporidium occurrence in a public water system's

source water; preferences for requiring 2 log removal of

Cryptosporidium for filtered systems; and concerns about the

feasibility of requiring source water monitoring for unfiltered

systems. A number of commenters on the issue of sanitary survey

frequencies supported the three and five years frequencies for

community and non-community water systems, respectively, as recommended

by the M-DBP Advisory Committee. Some State commenters, however,

expressed concern about resources for carrying out the surveys on such

a schedule. On the issue of flexibility in implementing the Stage 1

DBPR and IESWTR to ensure that the rules are implemented

simultaneously, most commenters preferred option four (discussed in the

November 1997 IESWTR NODA) that calls for simultaneous implementation

of both the IESWTR and the Stage 1 DBPR.

    EPA understands the State and local government concerns noted

above. EPA agrees that of the regulatory alternatives proposed, the

appropriate alternative is the 2 log removal requirement for

Cryptosporidium included in the final rule; the rule does not include

treatment requirements based on microbial occurrence in source water.

Nor does it require source water monitoring for unfiltered systems,

based in part on concerns about current availability of



[[Page 69509]]



analytical methods. With respect to sanitary survey frequencies, the

final IESWTR reflects the M-DBP Advisory Committee's recommendations,

including provisions that allow States to (1) grandfather surveys done

after December 1995 if they address eight elements that are currently

part of existing State/EPA guidance; (2) do sanitary surveys on a five-

year instead of a three-year schedule for community water systems that

the State determines to be outstanding performers; and (3) carry out

survey components in a staged or phased manner within the established

frequency. EPA believes that these frequencies and associated

provisions in the final rule allow States the flexibility to prioritize

and carry out the sanitary survey process as an effective tool to

identify and correct water system deficiencies that could pose a threat

to public health. EPA agrees that concurrent implementation of the

Stage 1 DBPR and IESWTR, as described in option 4 and reflected in the

final Stage 1 DBPR compliance schedules, is the most effective means of

implementing both rules. Finally, the Agency believes that the final

IESWTR will provide public health benefits that justify the costs of

the rule by reducing the public's exposure to microbial pathogens,

including Cryptosporidium. EPA notes that, as discussed in Section V.

above, over 90% of affected households will incur costs of less than $1

per month.

f. Regulatory Alternatives Considered

    As required under section 205 of the UMRA, EPA considered several

regulatory alternatives that developed from the Regulatory Negotiation

process, M-DBP Advisory Committee, and stakeholder comments. These

approaches sought to improve microbial protection and balance the risk/

risk tradeoff of controlling microbial pathogens while simultaneously

limiting the formation of disinfection byproducts. EPA proposed core

requirements related to ground water under the direct influence of

surface water, watershed control for unfiltered systems and sanitary

surveys for all surface water systems, as well as five treatment

alternatives for controlling pathogens, including a number of sub-

options. In addition, the Agency requested comment on possible

supplemental treatment requirements for requiring covers on finished

water reservoirs, cross connection control programs and State

notification of high turbidity levels and other issues related to

turbidity control. Among these various approaches, the Agency was

unable to pursue certain ones in the final IESWTR because additional

data was needed.

    Additional analysis of the regulatory alternatives was provided by

the M-DBP Advisory Committee. The M-DBP Advisory Committee assessed

tightening turbidity performance criteria and monitoring individual

filtration performance. The Committee discussed at least one

alternative that would have required the use of membrane technology to

improve turbidity performance but concluded that utilities could more

affordably achieve sufficient performance levels through changes in

operation and administrative practices. The Committee considered three

different turbidity standards as well as some existing State

requirements for individual filter monitoring. A more detailed

description of these alternatives is discussed in Chapter V of the

IESWTR Regulatory Impact Analysis (EPA, 1998a).

g. Selection of the Least Costly, Most Cost-Effective or Least

Burdensome Alternative That Achieves the Objectives of the Rule

    As discussed above, EPA considered various regulatory options that

would reduce exposures to pathogens and disinfectant byproducts that

are the objectives of the SDWA. For instance, the M-DBP Committee

analyzed the cost for three different levels of turbidity performance

for the combined filter effluent turbidity requirements (measured in

NTUs). The three NTU limits considered at the 95th percentile were 0.1,

0.2, and 0.3 and their cost estimates show a clear distinction among

the three different levels. At the 0.1 NTU, the total annual costs of

treatment were estimated to be $3,213 million. At 0.2 NTU and 0.3 NTU,

the total annual costs of treatment were estimated to be $317 million

and $174 million, respectively. The costs of the 0.1 NTU requirement

were roughly 20 times the 0.3 NTU scenario and 10 times the 0.2 NTU

scenario.

    The large increase in costs for the 1.0 NTU scenario occurs because

it was assumed that 95 percent of systems would need to install costly

membrane technology to comply with this level. Most of the difference

between the 0.2 and 0.3 levels is attributable to twice as many systems

having to install coagulant aid polymer feed and filter aid polymer

feed capabilities in complying with the 0.2 NTU limit as compared with

the 0.3 NTU limit. The Committee recommended the 0.3 option because

they felt that this level would provide adequate health protection at

the least cost. The 0.3 NTU limit was the option that was eventually

adopted as part of this rule and is the least costly option that

accomplishes the objectives of the IESWTR.



3. Impacts on Small Governments



    EPA has determined that this rule contains no regulatory

requirements that might significantly or uniquely effect small

governments. Thus this rule is not subject to the requirements of

section 203 of UMRA. For purposes of the IESWTR, EPA has defined small

public water systems as those that serve a population of fewer than

10,000, as discussed above in Section VIIA. Consequently, section 203

of UMRA does not apply because, as discussed above, the IESWTR applies

to systems serving 10,000 or more people. As noted above, EPA plans to

address surface water systems serving fewer than 10,000 people in the

Long Term 1 Enhanced Surface Water Treatment Rule.

    Even though section 203 does not apply, the FACA processes gave a

variety of stakeholders, including small governments, the opportunity

for timely and meaningful participation in the regulatory development

process. Groups such as the National Association of City and County

Health Officials and the National League of Cities participated in the

rule making process. Through such participation and exchange, EPA

notified small governments of requirements under consideration and

provided officials of these small governments with an opportunity to

have meaningful and timely input into the development of regulatory

proposals.



D. National Technology Transfer and Advancement Act



    Under section 12(d) of the National Technology Transfer and

Advancement Act (``ANTTAA''), the Agency is required to use voluntary

consensus standards in its regulatory activities unless to do so would

be inconsistent with applicable law or otherwise impractical. Voluntary

consensus standards are technical standards (e.g., materials

specifications, test methods, sampling procedures, business practices,

etc.) that are developed or adopted by voluntary consensus standards

bodies. Where available and potentially applicable voluntary consensus

standards are not used by EPA, the Act requires the Agency to provide

Congress, through the Office of Management and Budget, an explanation

of the reasons for not using such standards.

    Today's rule requires the use of previously approved technical

standards for the measurement of turbidity. In previous rulemakings,

EPA



[[Page 69510]]



approved three methods for measuring turbidity in drinking water.

Turbidity is a method-defined parameter and therefore modifications to

any of the three approved methods requires prior EPA approval. One of

the approved methods was published by the Standard Methods Committee of

American Public Health Association, the American Water Works

Association, and the Water Environment Federation, a voluntary

consensus standard body. That method, Method 2130B is published in

Standard Methods for the Examination of Water and Wastewater (19th

ed.). Standard Methods is a widely used reference which has been peer-

reviewed throughout the scientific community. In addition to this

voluntary consensus standard, EPA approved Great Lakes Instrument

Method 2 as an alternate test procedure for the measurement of

turbidity. Finally, the Agency approved a revised EPA Method 180.1 for

turbidity measurement in August 1993 in Methods for the Determination

of Inorganic Substances in Environmental Samples (EPA-600/R-93-100).

    In 1994, EPA reviewed and rejected an additional technical standard

for the measurement of turbidity, the ISO 7027 standard, which measures

turbidity at a higher wavelength than the approved test measurement

standards. The ISO 7027 is an analytical method for the measurement of

turbidity. ISO 7027 measures turbidity using either 90 deg. scattered

or transmitted light depending on the turbidity concentration

evaluated. Although instruments conforming to ISO 7027 specifications

are similar to the GLI instrument, only the GLI instrument uses pulsed,

multiple detectors to simultaneously read both 90 deg. scattered and

transmitted light. EPA has no data upon which to evaluate whether the

separate 90 deg. scattered or transmitted light measurement evaluations

according to the ISO 7027 method would produce results that are

equivalent to results produced using GLI Method 2, Standard Method

2130B, or EPA Method 180.1.

    Today's final rule also requires continuous individual filter

monitoring for turbidity and requires PWSs to calibrate the individual

turbidimeter according to the turbidimeter manufacturer's instructions.

These calibration instructions may constitute technical standards as

that term is defined in the NTTAA. EPA has looked for voluntary

consensus standards with regard to calibration of turbidimeter. The

American Society for Testing and Materials (ASTM) is developing such

voluntary consensus standards; however, there do not appear to be any

voluntary consensus standards available at this time.



E. Executive Order 12866, Regulatory Planning and Review



    Under Executive Order 12866, (58 FR 51,735 (October 4, 1993)) the

Agency must determine whether the regulatory action is ``significant''

and therefore subject to OMB review and the requirements of the

Executive Order. The Order defines ``significant regulatory action'' as

one that is likely to result in a rule that may:

    (1) Have an annual effect on the economy of $100 million or more or

adversely affect in a material way the economy, a sector of the

economy, productivity, competition, jobs, the environment, public

health or safety, or State, local, or tribal governments or

communities;

    (2) Create a serious inconsistency or otherwise interfere with an

action taken or planned by another agency;

    (3) Materially alter the budgetary impact of entitlements, grants,

user fees, or loan programs or the rights and obligations of recipients

thereof; or

    (4) Raise novel legal or policy issues arising out of legal

mandates, the President's priorities, or the principles set forth in

the Executive Order.

    Pursuant to the terms of Executive Order 12866, it has been

determined that this rule is a ``significant regulatory action''

because it will have an annual effect on the economy of $100 million or

more. As such, this action was submitted to OMB for review. Changes

made in response to OMB suggestions or recommendations are documented

in the public record.



F. Executive Order 12898: Environmental Justice



    Executive Order 12898 (59 FR 7629) establishes a Federal policy for

incorporating environmental justice into Federal agency missions by

directing agencies to identify and address disproportionately high and

adverse human health or environmental effects of its programs,

policies, and activities on minority and low-income populations. The

Agency has considered environmental justice related issues concerning

the potential impacts of this action and has consulted with minority

and low-income stakeholders.

    Three aspects of today's rule comply with the Environmental Justice

Executive Order and they can be classified as follows: (1) The overall

nature of the rule; (2) the inclusion of sensitive sub-populations in

the regulatory development process; and (3) the convening of a

stakeholder meeting specifically to address environmental justice

issues. The IESWTR applies uniformly to all surface water and GWUDI

systems that serve a population of at least 10,000 and consequently,

the health protection benefits this rule provides are equal across all

income and minority groups within these communities. A complementary

regulation is under development that will address similar issues for

systems serving fewer than 10,000 people.

    In addition, concerns of the sensitive sub-populations were

included in the IESWTR through the Reg. Neg. and M-DBP Advisory

Committee process undertaken to craft the regulation. Both Committees

were chartered under the FACA authorization, and included a broad

cross-section of regulators, regulated communities, industry, public

interest groups, and State and local public health officials.

Representatives of sensitive sub-populations, in particular people with

AIDS, participated in the regulatory development process. Extensive

discussion on setting treatment requirements that provide the maximum

feasible protection took place, and the final consensus that resulted

in the rule considered issues of affordability, equity, and safety.

    Finally, as part of EPA's responsibilities to comply with E.O.

12898, the Agency held a stakeholder meeting on March 12, 1998 (EPA

1998e) to address various components of pending drinking water

regulations; and how they may impact sensitive sub-populations,

minority populations, and low-income populations. Topics discussed

included treatment techniques, costs and benefits, data quality, health

effects, and the regulatory process. Participants included national,

State, tribal, municipal, and individual stakeholders. EPA conducted

the meetings by video conference call between eleven cities. This

meeting was a continuation of stakeholder meetings that started in 1995

to obtain input on the Agency's Drinking Water Programs. The major

objectives for the March 12, 1998 (EPA 1998e) meeting were:

    <bullet> Solicit ideas from Environmental Justice (EJ) stakeholders

on known issues concerning current drinking water regulatory efforts;

    <bullet> Identify key issues of concern to EJ stakeholders; and

    <bullet> Receive suggestions from EJ stakeholders concerning ways

to increase representation of EJ communities in OGWDW regulatory

efforts.

In addition, EPA developed a plain-English guide specifically for this

 

[[Page 69511]]



meeting to assist stakeholders in understanding the multiple and

sometimes complex issues surrounding drinking water regulation.

    Overall, EPA believes this rule will equally protect the health of

all minority and low income populations within communities served by

public water systems regulated under this rule.



G. Executive Order 13045: Protection of Children From Environmental

Health Risks and Safety Risks



    Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any

rule initiated after April 21, 1997, or proposed after April 21, 1998,

that (1) is determined to be ``economically significant'' as defined

under E.O. 12866 and (2) concerns an environmental health or safety

risk that EPA has reason to believe may have a disproportionate effect

on children. If the regulatory action meets both criteria, the Agency

must evaluate the environmental health or safety effects of the planned

rule on children, and explain why the planned regulation is preferable

to other potentially effective and reasonably feasible alternatives

considered by the Agency.

    The final rule is not subject to the Executive Order because EPA

published a notice of proposed rulemaking before April 21, 1998.

However, EPA's policy since November 1, 1995, is to consistently and

explicitly consider risks to infants and children in all risk

assessments generated during its decision making process including the

setting of standards to protect public health and the environment.

    In promulgating the IESWTR the Agency recognizes that the health

risks associated with exposure to the protozoan Cryptosporidium are of

particular concern for certain sensitive subpopulations, including

children and immunocompromised individuals. These concerns were

considered as part of the regulatory development process, particularly

in the establishment of the MCLG for Cryptosporidium in drinking water,

and are reflected in the final rule. The IESWTR establishes a Maximum

Contaminant Level Goal (MCLG) of zero for Cryptosporidium at the genus

level, taking into account the need to protect sensitive populations

(e.g., children) and providing for an adequate margin of safety. For

public water systems that use surface water, filter and serve at least

10,000 people, the Agency is establishing physical removal treatment

requirements for Cryptosporidium. For systems that use conventional or

direct filtration, the Agency is strengthening the existing turbidity

standards for finished water and is also requiring individual filter

monitoring to assist in controlling pathogen breakthrough during the

treatment process.



H. Executive Order 12875: Enhancing the Intergovernmental

Partnership



    Under Executive Order 12875, EPA may not issue a regulation that is

not required by statute and that creates a mandate upon a State, local

or tribal government, unless the Federal government provides the funds

necessary to pay the direct compliance costs incurred by those

governments, or EPA consults with those governments. If EPA complies by

consulting, Executive Order 12875 requires EPA to provide to the Office

of Management and Budget a description of the extent of EPA's prior

consultation with representatives of affected State, local and tribal

governments, the nature of their concerns, copies of any written

communications from the governments, and a statement supporting the

need to issue the regulation. In addition, Executive Order 12875

requires EPA to develop an effective process permitting elected

officials and other representatives of State, local and tribal

governments ``to provide meaningful and timely input in the development

of regulatory proposals containing significant unfunded mandates.''

    EPA has concluded that this rule will create a mandate on State,

local, and tribal governments and that the Federal government will not

provide all of the funds necessary to pay the direct costs incurred by

the State, local, and tribal governments in complying with the mandate.

In developing this rule, EPA consulted with State and local governments

to enable them to provide meaningful and timely input in the

development of this rule. EPA also invited the Native American Water

Association to participate in the FACA process to develop this rule.

Although they decided not to take part in the deliberations, the

Association continued to be informed of meetings and developments

through a stakeholders mailing list.

    As described above in Section VII. C.2(e), EPA held extensive

meetings with a variety of State and local representatives who provided

meaningful and timely input in the development of the proposed rule.

State and local representatives were part of the FACA committees

involved in the development of this rule. Summaries of the meetings

have been included in the public docket for this rulemaking. See

section VII.C.2(e) for summaries of the extent of EPA's consultation

with State, local, and tribal governments; the nature of the government

concerns; and EPA's position supporting the need to issue the rule.



I. Executive Order 13084: Consultation and Coordination With Indian

Tribal Governments



    Under Executive Order 13084, EPA may not issue a regulation that is

not required by statute, that significantly or uniquely affects the

communities of Indian tribal governments, and that imposes substantial

direct compliance costs on those communities, unless the Federal

government provides the funds necessary to pay the direct compliance

costs incurred by the tribal governments, or EPA consults with those

governments. If EPA complies by consulting, Executive Order 13084

requires EPA to provide to the Office of Management and Budget, in a

separately identified section of the preamble to the rule, a

description of the extent of EPA's prior consultation with

representatives of affected tribal governments, a summary of the nature

of their concerns, and a statement supporting the need to issue the

regulation. In addition, Executive Order 13084 requires EPA to develop

an effective process permitting elected officials and other

representatives of Indian tribal governments ``to provide meaningful

and timely input in the development of regulatory policies on matters

that significantly or uniquely affect their communities.''

    Today's rule does not significantly or uniquely affect the

communities of Indian tribal governments. There are very few Tribal

surface water systems that serve 10,000 or more people. Moreover, the

rule does not impose requirements on the Tribal systems that differ

from those required for other water systems covered under the rule.

Accordingly, the requirements of section 3(b) of Executive Order 13084

do not apply to this rule.



J. Consultation With the Science Advisory Board, National Drinking

Water Council, and Secretary of Health and Human Services



    In accordance with section 1412(d) and (e) of SDWA, EPA consulted

with the Science Advisory Board, National Drinking Water Council, and

Secretary of Health and Human Services, and requested and considered

their comments in developing this rule.



K. Likely Effect of Compliance With the IESWTR on the Technical,

Financial, and Managerial Capacity of Public Water Systems



    Section 1420(d)(3) of the SDWA as amended requires that, in

promulgating a NPDWR, the Administrator shall



[[Page 69512]]



include an analysis of the likely effect of compliance with the

regulation on the technical, financial, and managerial capacity of

public water systems. The following analysis has been performed to

fulfill this statutory obligation.

    Overall water system capacity is defined in EPA guidance (EPA 816-

R-98-006) (EPA 1998g) as the ability to plan for, achieve, and maintain

compliance with applicable drinking water standards. Capacity has three

components: technical, managerial, and financial.

    Technical capacity is the physical and operational ability of a

water system to meet SDWA requirements. Technical capacity refers to

the physical infrastructure of the water system, including the adequacy

of source water and the adequacy of treatment, storage, and

distribution infrastructure. It also refers to the ability of system

personnel to adequately operate and maintain the system and to

otherwise implement requisite technical knowledge. A water system's

technical capacity can be determined by examining key issues and

questions, including:

    <bullet> Source water adequacy. Does the system have a reliable

source of drinking water? Is the source of generally good quality and

adequately protected?

    <bullet> 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?

    <bullet> Technical knowledge and implementation. Is the system's

operator certified? Does the operator have sufficient technical

knowledge of applicable standards? Can the operator effectively

implement this technical knowledge? Does the operator understand the

system's technical and operational characteristics? Does the system

have an effective operation and maintenance program?

    Managerial capacity is the ability of a water system to conduct its

affairs in a manner enabling the system to achieve and maintain

compliance with SDWA requirements. Managerial capacity refers to the

system's institutional and administrative capabilities.

    Managerial capacity can be assessed through key issues and

questions, including:

    <bullet> Ownership accountability. Are the system owner(s) clearly

identified? Can they be held accountable for the system?

    <bullet> 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?

    <bullet> Effective external linkages. Does the system interact well

with customers, regulators, and other entities? Is the system aware of

available external resources, such as technical and financial

assistance?

    Financial capacity is a water system's ability to acquire and

manage sufficient financial resources to allow the system to achieve

and maintain compliance with SDWA requirements.

    Financial capacity can be assessed through key issues and

questions, including:

    <bullet> Revenue sufficiency. Do revenues cover costs? Are water

rates and charges adequate to cover the cost of water?

    <bullet> Credit worthiness. Is the system financially healthy? Does

it have access to capital through public or private sources?

    <bullet> Fiscal management and controls. Are adequate books and

records maintained? Are appropriate budgeting, accounting, and

financial planning methods used? Does the system manage its revenues

effectively?

    1,381 systems are affected by the IESWTR. Of these, 691 may need to

modify their treatment process and undertake turbidity monitoring, and

will need to meet the disinfection benchmarking and turbidity

exceptions reporting requirements. The other 690 systems will need to

do turbidity monitoring and will need to meet the disinfection

benchmarking and turbidity exceptions reporting requirements as

applicable, but will not need to modify their treatment process.

    Systems not modifying treatment will need to do turbidity

monitoring, disinfection benchmarking, and turbidity exceptions

reporting, These systems are not generally expected to require

significantly increased technical, financial, or managerial capacity to

comply with these new requirements. Some individual facilities may have

weaknesses in one or more of these areas, but overall surface water

systems should have or be able to easily obtain the capacity needed for

these activities.

    Systems needing to modify treatment will employ one or more of a

variety of steps. The steps expected to be employed by 25% or more of

systems in virtually all size categories covered by the rule are:

install backwash water polymer feed capability; install individual

filter turbidimeters; account for recycle flow in process control

decisions; implement a policy and commitment to lower water quality

goals; utilize alternative process control testing equipment; modify/

implement process control monitoring and control; and designate a

process control strategy facilitator.

    Furthermore, there are a number of actions that are expected to be

taken disproportionately by the smaller sized systems covered under the

IESWTR (that is to say, a greater percentage of smaller sized systems

will undertake these activities than will larger sized systems). These

steps include: Structural and mechanical rapid mix improvements; filter

underdrain retrofits and gravel media; filter rate-of-flow controller

replacement; hydraulic improvements in flow distribution/control/

measurement; increase plant staffing; replace obsolete bench top

turbidimeters; purchase jar test apparatus; and train staff to

understand process control strategy.

    For many systems serving between 10,000 and 100,000 persons which

need to make treatment modifications an enhancement of technical,

financial, and managerial capacity may likely be needed. As the

preceding paragraph makes clear, these systems will be making

structural improvements and enhancing laboratory and staff capacity.

Larger sized systems have typically already made these improvements as

part of normal operations. Meeting the requirements of the IESWTR will

require operating at a higher level of sophistication and in a better

state of repair than some plants in the 10,000-100,000 person size

category have considered acceptable in the past.

    Certainly there will be exceptions both between 10,000 and 100,000

persons and above. Some larger plants are expected to find that their

technical, managerial, and financial capacity needs to be upgraded to

support the system in meeting the new requirements. Likewise, some

plants serving 10,000-100,000 persons will already have more than

adequate technical, financial, and managerial capacity to meet these

requirements. However, in general, the systems serving 10,000-100,000

persons needing to make treatment modifications will be the ones most

needing to enhance their capacity.



L. Submission to Congress and the General Accounting Office



    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the

Small Business Regulatory Enforcement



[[Page 69513]]



Fairness Act of 1996, generally provides that before a rule may take

effect, the agency promulgating the rule must submit a rule report,

which includes a copy of the rule, to each House of the Congress and to

the Comptroller General of the United States. EPA will submit a report

containing this rule and other required information to the U.S. Senate,

the U.S. House of Representatives, and the Comptroller General of the

United States prior to publication of the rule in the Federal Register.

A major rule cannot take effect until 60 days after it is published in

the Federal Register. This rule is a ``major rule'' as defined by 5

U.S.C. 804(2). This rule will be effective February 16, 1999.



VIII. References



    Amirtharajah A (1988). Some theoretical and conceptual views of

filtration. Journal AWWA (Dec 1988), pgs 36-46.

    Arrowood, M J (1997). Diagnosis. pp. 43-64, In: R. Fayer (ed.),

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    AWWA Water Industry Data Base (WIDB) (1996) AWWA, Denver, CO.

    AWWA (1993). American Water Works Association. Officers and

Committee Directory. AWWA Denver, CO.

    AWWA Committee Report (1983). Deterioration of water quality in

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Journal AWWA (June 1983), pgs 313-318.

    AWWSC (1997). Treatment Plant Turbidity Data. Provided to the

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    Bailey S W and E C Lippy (1978). Should all finished water

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    Bissonette E (1997). Summary of the Partnership for Safe Water

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    Bucklin K, A Amirtharajah, and KO Cranston (1988). The

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    Casemore D P (1990). Epidemiological aspects of human

cryptosporidiosis. Epidemiol. Infect. 104:1-28.

    Cleasby J L (1990). Filtration, Chapter 8, IN: (F Pontius, ed)

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    Cooke G D and R E Carlson (1989). Manual: Reservoir management

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    Cordell, R L, and D G Addiss (1994). Cryptosporidiosis in child

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    Craun G F (1998). Waterborne outbreaks 1995-1996. Memorandum to

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    Craun G F (Pers. Comm. 1997a). Note to the IESWTR NODA Docket,

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    Craun G F (Pers. Comm 1997b). Note to the IESWTR NODA Docket,

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    Current W L (1986). Cryptosporidium: its biology and potential

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    Current W L, Reese N C, Ernst J V, Bailey W S, Heyman M B and W

M Weistein (1983).

    Human Cryptosporidiosis in Immunocompetent and Immunodeficient

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    EPA (1998a). Environmental Protection Agency. Regulatory Impact

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815-B-98-003. September 1998.

    EPA (1998b). Environmental Protection Agency. Technologies and

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815-R-98-015. July 1998.

    EPA (1998c). Unfunded Mandates Reform Act Analysis for the

Interim Enhanced Surface Water Treatment Rule. September 1998.

    EPA (1998d). Revisions to State Primacy Requirements to

Implement Safe Drinking Water Act Amendments; Final Rule. 63 FR

23362.

    EPA (1998e). Environmental Justice Stakeholder Meeting

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    EPA (1998f). Public Review Draft Guidelines for the

Certification and Recertification of the Operators of Community and

Nontransient Noncommunity Public Water Systems, Notice. 63 FR 15064.

    EPA (1998g). Guidance on Implementing the Capacity Development

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816-R-98-006, July 1998.

    EPA (1997a) National Primary Drinking Water Regulations: Interim

Enhanced Surface Water Treatment Rule Notice of Data Availability;

62 FR59486.

    EPA (1997b) National Primary Drinking Water Regulations:

Disinfectants and Disinfection Byproducts Notice of Data

Availability; 62 FR 59388.

    EPA (1996a). ``An Evaluation of the Statistical Performance of a

Method f or Monitoring Protozoan Cysts in US Source Waters,'' (June

26, 1996), 58 pages. Appendix to the report, about 50 pages.

    EPA (1996b). National Primary Drinking Water Regulations:

Monitoring Requirements for Public Drinking Water Supplies; Final

Rule. May 14, 1996. 61 FR 24354.

    EPA (1995a). Survey Report on the Cross-Connections Control

Program. E1HWG4-01-0091-5400070.

    EPA (1995b). Research Plan for Microbial Pathogens and

Disinfection Byproduct in Drinking Water. SAB Review Draft (Oct

1995). Office of Research and Development & Office of Water, EPA.

    EPA, American Water Works Association (AWWA), AWWA Research

Foundation (AWWARF), Association of Metropolitan Water Agencies

(AMWA), Association of States Drinking Water Administrators (ASDWA),

and National Association of Water Companies (NAWC) (1995).

Partnership for Safe Water Voluntary Water Treatment Plant

Performance Improvement Program Self-Assessment Procedures. October,

1995.

    EPA/ASDWA State Joint Guidance on Sanitary Surveys. December

1995.

    EPA (1994a). National Primary Drinking Water Regulations;

Disinfectants and Disinfection Byproducts; Proposed Rule. 59 FR

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

    EPA (1994b). National Primary Drinking Water Regulations:

Enhanced Surface Water Treatment Requirements; Proposed Rule. 59 FR

38832: July 29, 1994.

    EPA (1994c). Monitoring Requirements for Public Drinking Water

Supplies; Proposed Rule. 59 FR 6332, February 10, 1994.

    EPA (1994d). Training on GWUDI Determinations Workshop Manual.

Office of Groundwater and Drinking Water, EPA. Washington DC (April

1994).

    EPA (1994e). January 10, 1994 letter from Jim Elder, Director,

Office of Ground Water and Drinking Water to John H. Sullivan,

Deputy Executive Director, AWWA.

    EPA (1994f) The Regulatory Impact Analysis for the Interim

Enhanced Surface Water Treatment Rule. Office of Ground Water and

Drinking Water, May 1994.

    EPA (1993). Nephelometric Method 180.1. 600/R-93-100.

    EPA (1992). Consensus Method for Determining Groundwater Under

the Direct Influence of Surface Water Using Microscopic Particulate

Analysis (MPA). EPA 910/9-92-029.

    EPA (1991a). Guidance manual for compliance with the filtration

and disinfection requirements for public water systems using surface

water sources. Environmental Protection Agency, Washington, DC.

(Also Published by AWWA in 1991)

    EPA (1991b). Optimizing Water Treatment Plant Performance Using

the Composite Correction Program. EPA/625/6-91/027.

    EPA/SAB (1990). Reducing Risk: Setting Priorities and Strategies

for Environmental Protection (September 1990).

    EPA (1989a). Cross-Connection Control Manual. EPA 570/9-89-007.

Environmental Protection Agency. Washington, DC.

    EPA (1989b). Drinking Water; National Primary Drinking Water

Regulations: Disinfection; Turbidity, Giardia lamblia, Viruses,

Legionella, and Heterotrophic Bacteria; Final Rule. 54 FR 27486,

June 29, 1989.

    EPA (1989c). Drinking Water; National Primary Drinking Water

Regulations; Total Coliforms (including Fecal Coliforms and E.

Coli); Final Rule. 54 FR 27544, June 29, 1989.

    EPA (1979). National Interim Primary Drinking Water Regulations;

Control of



[[Page 69514]]



Trihalomethanes in Drinking Water. 44 FR 68624, November 29, 1979.

    Erb T M (1989). Implementation of Environmental Regulations for

Improvements to Distribution Reservoirs in Los Angeles. Proc. AWWA

Annual Conference. p.197-205.

    Fayer R, C A Speer, J P Dubey. (1997). General Biology of

Cryptosporidium. In: Cryptosporidium and Cryptosporidiosis. R Fayer,

ed. Boca Raton, FL: CRC Press, Inc. pp.2-5.

    Fayer R, C A Speer, J P Dubey. (1990). General Biology of

Cryptosporidium. In: Cryptosporidium and Cryptosporidiosis. R Fayer,

C A Speer, and J B Dubey eds. Boca Raton, FL: CRC Press, Inc. pp.2-

29.

    Fayer R and B L P Ungar (1986). Cryptosporidium spp. and

cryptosporidiosis. Microbiol. Rev. 50(4):458-483.

    Florida DEP (1996). The State of Florida's Evaluation of Cross-

Connection Control Rules/Regulations in the 50 States. Florida

Department of Environmental Protection. Aug. 1996 (Rev.).

    Foundation for Water Research [Hall, Pressdee, and Carrington]

(1994). Removal of Cryptosporidium oocysts by water treatment

processes. (April 1994) Foundation for Water Research, Britain.

    Fox K R and Lytle D A (1996) Milwaukee's Cryptosporidium

Outbreak: Investigation and Recommendations. JAWWA 88(9): 87-94.

    GAO (1993). Report to the Chairman, Subcommittee on Health and

the Environment, Committee on Energy and Commerce, House of

Representatives: Drinking Water: Key Quality Assurance Program is

Flawed and Underfunded. GAO/RCED-93-97. April 1993.

    Geldreich E E (1990). Microbiological Quality Control in

Distribution Systems. IN: (FW Pontius, ed) Water Quality and

Treatment 4th Ed. McGraw-Hill, Inc.

    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 (1996): 113-123.

    Gertig K R, G L Williamson-Jones, F E Jones, and B D Alexander

(1988). Filtration of Giardia Cysts and Other Particles Under

Treatment Conditions: Vol. 3: Rapid Rate Filtration Using 1' x 1'

Pilot Filters on the Cache La Poudre River. American Water Works

Association, Denver, Colorado, February 1988.

    Graczyk T K, M R Cranfield, R Fayer, and M S Anderson (1996a).

Viability and Infectivity of Cryptosporidium parvum Oocysts are

Retained upon Intestinal Passage through a Refractory Avian Host.

Applied and Environmental Microbiology 62(9): 3234-3237.

    Graczyk T K, R Fayer and M R Cranfield (1996b). Cryptosporidium

parvum is not transmissable to fish, amphibians or reptiles. J.

Parasitol. 82(5): 748-751.

    Great Lakes Instruments (1992). Analytical Method for Turbidity

Measurement: GLI Method 2. GLI, Milwaukee, WI.

    Grubbs W D, B Macler, and S Regli (1992). Modeling Giardia

occurrence and risk. EPA-811-B-92-005. Office of Water Resource

Center. Washington, DC.

    Haas C N, C S Crockett, J B Rose, C P Gerba, and A M Fazil

(1996). Assessing the Risk Posed By Oocysts in Drinking Water.

Journal AWWA (Sept 1996), 88(9): 131-136.

    Haas C N and J B Rose (1995). Developing an action level for

Cryptosporidium. Journal AWWA (Sept 1995), 87(9): 81-84.

    Hall T and B Croll (1996). The UK Approach to Cryptosporidium

Control in Water Treatment. AWWA Water Quality Technology Conference

Proceedings. Oct. 1996.

    Hancock C M, J B Rose, M Callahan (1998). Cryptosporidium and

Giardia in US Groundwater. Journal AWWA (March 1998), 90(3): 58-61.

    Hoxie N J, J P Davis, J M Vergeront, R D Nashold and K A Blair.

(1997). Cryptosporidiosis--associated mortality following a massive

waterborne outbreak in Milwaukee, WI. Amer. J. Publ. Health 87 (12)

2032-2035.

    Kelley M B, P K Warrier, J K Brokaw, K L Barrett, and S Komisar

(1995). A study of two US Army installations drinking water sources

and treatment systems for the removal of Giardia and

Cryptosporidium. Proceedings of AWWA Water Quality Technology

Conference, New Orleans, LA, pp. 2197-2230.

    Kramer M H, B L Herwaldt, G F Craun, R L Calderon and D D

Juranek. 1996. Waterborne Disease: 1993 and 1994 (Fig 4). J. AWWA

88(3): 66-80.

    LeChevallier M W, W D Norton, and T B Atherholt (1997a).

Protozoa in open reservoirs. Journal AWWA (Sept 1997), 89(9): 84-96.

    LeChevallier M W and W D Norton (1995). Giardia and

Cryptosporidium in Raw and Finished Water, Journal AWWA 87: 54-68.

    LeChevallier M W and W D Norton (1992). Examining relationships

between particle counts and Giardia, Cryptosporidium and turbidity.

Journal AWWA (Dec 1992), pgs 52-60.

    LeChevallier M W, D N Norton, and R G Lee (1991a). Occurrence of

Giardia and Cryptosporidium spp in surface water supplies. Appl

Environ Microbiol 57: 2610-2616.

    LeChevallier M W, D N Norton, and R G Lee (1991b). Giardia and

Cryptosporidium spp. in filtered drinking water supplies. Appl

Environ Microbiol 57(9): 2617-2621.

    Logsdon G S, M M Frey, TC Stefanich, S L Johnson, D E Feely, J B

Rose, M Sobsey (1994). The removal and disinfection efficiency of

lime softening process for Giardia and Viruses. AWWARF, Denver, CO.

    Maryland Compliance Monitoring Division, Chesapeake Bay and

Watershed Management. Water Quality Monitoring Program (Steinfort,

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Water Influence on Warrenfelts and Keedysville Springs, Addressing

Bacteriological Monitoring, Streamflow Discharges and Various

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    Massachusetts Department of Environmental Protection. (Rapacz MV

and HC Stephens) (1993). Groundwater: To Filter or Not to Filter.

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1996.

    Montgomery Watson (1995). Enhanced Monitoring Program; Giardia

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    Nieminski EC (1995). Effectiveness of Direct Filtration and

Conventional Treatment in Removal of Cryptosporidium and Giardia.

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    Nieminski EC and J E Ongerth (1995). Removing Giardia and

Cryptosporidium by Conventional Treatment and Direct Filtration.

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    Ongerth J E and J P Pecoraro (1995). Removing Cryptosporidium

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    Patania N L, J G Jacangelo, L Cummings, A Wilczak, K Riley, and

J Oppenheimer (1995). Optimization of Filtration for Cyst Removal.

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Public Health Implications. Annual Rev. Public Health 18: 135-61.

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[[Page 69515]]



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Gerba (1994). Evaluation of Cryptosporidium Removal through High-

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Determining Groundwater Under the Direct Influence of Surface Water.

AWWA Research Foundation, Denver CO.



List of Subjects



40 CFR Parts 9



    Reporting and recordkeeping requirements.



40 CFR Parts 141 and 142



    Drinking water, Environmental protection, Public utilities,

Reporting and recordkeeping requirements, Reservoirs, Utilities, Water

supply, Watersheds.



    Dated: November 30, 1998.

Carol M. Browner,

Administrator.

    For the reasons set out in the preamble, title 40 chapter I of the

Code of Federal Regulations is amended as follows:



PART 9--[AMENDED]



    1. The authority citation for part 9 continues to read as follows:



    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,

2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33

U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,

1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,

1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,

300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,

300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,

9601-9657, 11023, 11048.



    2. In Sec. 9.1 the table is amended by adding under the indicated

heading the new entries in numerical order to read as follows:





Sec. 9.1  OMB approvals under the Paperwork Reduction Act.



* * * * *

 

------------------------------------------------------------------------

                                                            OMB control

                     40 CFR citation                            no.

------------------------------------------------------------------------



                  *        *        *        *        *

------------------------------------------------------------------------

               National Primary Drinking Water Regulations

------------------------------------------------------------------------



                  *        *        *        *        *

141.170.................................................       2040-0205

141.172.................................................       2040-0205

141.174-141.175.........................................       2040-0205



                  *        *        *        *        *

------------------------------------------------------------------------



PART 141--National Primary Drinking Water Regulations



    3. The authority citation for part 141 continues to read as

follows:



    Authority: 42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-

5, 300g-6, 300j-4, 300j-9, and 300j-11.



    4. Section 141.2 is amended by revising the definition of ``ground

water under the direct influence of surface water'' and adding the

following definitions in alphabetical order to read as follows:





Sec. 141.2  Definitions.



* * * * *

    Comprehensive performance evaluation (CPE) is a thorough review and

analysis of a treatment plant's performance-based capabilities and

associated administrative, operation and maintenance practices. It is

conducted to identify factors that may be adversely impacting a plant's

capability to achieve compliance and emphasizes approaches that can be

implemented without significant capital improvements. For purposes of

compliance with subpart P of this part, the comprehensive performance

evaluation must consist of at least the following components:

Assessment of plant performance; evaluation of major unit processes;

identification and prioritization of performance limiting factors;

assessment of the applicability of comprehensive technical assistance;

and preparation of a CPE report.

* * * * *

    Disinfection profile is a summary of daily Giardia lamblia

inactivation through the treatment plant. The procedure for developing

a disinfection profile is contained in Sec. 141.172.

* * * * *

    Filter profile is a graphical representation of individual filter

performance, based on continuous turbidity measurements or total

particle counts versus time for an entire filter run, from startup to

backwash inclusively, that includes an assessment of filter performance

while another filter is being backwashed.

* * * * *

    Ground water under the direct influence of surface water means any

water beneath the surface of the ground with significant occurrence of

insects or other macroorganisms, algae, or large-diameter pathogens

such as Giardia lamblia or (for subpart H systems serving at least

10,000 people only) Cryptosporidium, or significant and relatively

rapid shifts in water characteristics such as turbidity, temperature,

conductivity, or pH which closely correlate to climatological or

surface water conditions. Direct influence must be determined for

individual sources in accordance with criteria established by the

State. The State determination of direct influence may be based on

site-specific measurements of water quality and/or documentation of

well construction characteristics and geology with field evaluation.

* * * * *

    Uncovered finished water storage facility is a tank, reservoir, or

other facility used to store water that will undergo no further

treatment except residual disinfection and is open to the atmosphere.

* * * * *

    5. Section 141.32 is amended by revising paragraph (e)(10) to read

as follows:





Sec. 141.32  Public notification.



* * * * *

    (e) * * *

    (10) Microbiological contaminants (for use when there is a

violation of the treatment technique requirements for filtration and

disinfection in subpart H or subpart P of this part). The United States

Environmental Protection Agency (EPA) sets drinking water standards and

has determined that the presence of microbiological contaminants are a

health concern at certain levels of exposure. If water is inadequately

treated, microbiological contaminants in that water may cause disease.

Disease symptoms may include diarrhea, cramps, nausea, and possibly

jaundice, and any associated headaches and fatigue. These symptoms,

however, are not just associated with disease-causing organisms in

drinking water, but also may be caused by a number of factors other

than your drinking water. EPA has set enforceable requirements for

treating drinking water to reduce the risk of these adverse health

effects. Treatment such as filtering and disinfecting the water removes

or destroys microbiological contaminants. Drinking water which is

treated to meet EPA requirements is associated with little to none of

this risk and should be considered safe.

* * * * *

    6. In Sec. 141.52, the table is amended by adding a new entry, in

numerical order, to read as follows:





Sec. 141.52  Maximum contaminant level goals for microbiological

contaminants.



* * * * *



[[Page 69516]]







------------------------------------------------------------------------

                 Contaminant                             MCLG

------------------------------------------------------------------------



                  *        *        *        *        *

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

------------------------------------------------------------------------



    7. Section 141.70 is amended by adding paragraph (d) to read as

follows:





Sec. 141.70  General requirements.



* * * * *

    (d) Additional requirements for systems serving at least 10,000

people. In addition to complying with requirements in this subpart,

systems serving at least 10,000 people must also comply with the

requirements in subpart P of this part.

    8. Section 141.71 is amended by revising paragraph (b)(6) to read

as follows:





Sec. 141.71  Criteria for avoiding filtration.



* * * * *

    (b) * * *

    (6) The public water system must comply with the requirements for

trihalomethanes in Secs. 141.12 and 141.30 until December 17, 2001.

After December 17, 2001, the system must comply with the requirements

for total trihalomethanes, haloacetic acids (five), bromate, chlorite,

chlorine, chloramines, and chlorine dioxide in subpart L of this part.

* * * * *

    9. Section 141.73 is amended by adding paragraph (a)(3) and

revising paragraph (d) to read as follows:





Sec. 141.73  Filtration.



* * * * *

    (a) * * *

    (3) Beginning December 17, 2001, systems serving at least 10,000

people must meet the turbidity requirements in Sec. 141.173(a).

* * * * *

    (d) Other filtration technologies. A public water system may use a

filtration technology not listed in paragraphs (a) through (c) of this

section if it demonstrates to the State, using pilot plant studies or

other means, that the alternative filtration technology, in combination

with disinfection treatment that meets the requirements of

Sec. 141.72(b), consistently achieves 99.9 percent removal and/or

inactivation of Giardia lamblia cysts and 99.99 percent removal and/or

inactivation of viruses. For a system that makes this demonstration,

the requirements of paragraph (b) of this section apply. Beginning

December 17, 2001, systems serving at least 10,000 people must meet the

requirements for other filtration technologies in Sec. 141.173(b).

    10. Section 141.153 is amended by revising the first sentence of

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





Sec. 141.153  Content of the reports.



* * * * *

    (d) * * *

    (4) * * *

    (v) * * *

    (C) When it is reported pursuant to Secs. 141.73 or 141.173: The

highest single measurement and the lowest monthly percentage of samples

meeting the turbidity limits specified in Secs. 141.73 or 141.173 for

the filtration technology being used. * * *

* * * * *

    11. Part 141 is amended by adding a new subpart P to read as

follows:



Subpart P--Enhanced Filtration and Disinfection



Sec.

141.170  General requirements.

141.171  Criteria for avoiding filtration.

141.172  Disinfection profiling and benchmarking.

141.173  Filtration.

141.174  Filtration sampling requirements.

141.175  Reporting and recordkeeping requirements.





Sec. 141.170  General requirements.



    (a) The requirements of this subpart P constitute national primary

drinking water regulations. These regulations establish requirements

for filtration and disinfection that are in addition to criteria under

which filtration and disinfection are required under subpart H of this

part. The requirements of this subpart are applicable to subpart H

systems serving at least 10,000 people, beginning December 17, 2001

unless otherwise specified in this subpart. The regulations in this

subpart establish or extend treatment technique requirements in lieu of

maximum contaminant levels for the following contaminants: Giardia

lamblia, viruses, heterotrophic plate count bacteria, Legionella,

Cryptosporidium, and turbidity. Each subpart H system serving at least

10,000 people must provide treatment of its source water that complies

with these treatment technique requirements and are in addition to

those identified in Sec. 141.70. The treatment technique requirements

consist of installing and properly operating water treatment processes

which reliably achieve:

    (1) At least 99 percent (2-log) removal of Cryptosporidium between

a point where the raw water is not subject to recontamination by

surface water runoff and a point downstream before or at the first

customer for filtered systems, or Cryptosporidium control under the

watershed control plan for unfiltered systems.

    (2) Compliance with the profiling and benchmark requirements under

the provisions of Sec. 141.172.

    (b) A public water system subject to the requirements of this

subpart is considered to be in compliance with the requirements of

paragraph (a) of this section if:

    (1) It meets the requirements for avoiding filtration in

Secs. 141.71 and 141.171 and the disinfection requirements in

Secs. 141.72 and 141.172; or

    (2) It meets the applicable filtration requirements in either

Sec. 141.73 or Sec. 141.173 and the disinfection requirements in

Secs. 141.72 and 141.172.

    (c) Systems are not permitted to begin construction of uncovered

finished water storage facilities beginning February 16, 1999.





Sec. 141.171  Criteria for avoiding filtration.



    In addition to the requirements of Sec. 141.71, a public water

system subject to the requirements of this subpart that does not

provide filtration must meet all of the conditions of paragraphs (a)

and (b) of this section.

    (a) Site-specific conditions. In addition to site-specific

conditions in Sec. 141.71(b), systems must maintain the watershed

control program under Sec. 141.71(b)(2) to minimize the potential for

contamination by Cryptosporidium oocysts in the source water. The

watershed control program must, for Cryptosporidium:

    (1) Identify watershed characteristics and activities which may

have an adverse effect on source water quality; and

    (2) Monitor the occurrence of activities which may have an adverse

effect on source water quality.

    (b) During the onsite inspection conducted under the provisions of

Sec. 141.71(b)(3), the State must determine whether the watershed

control program established under Sec. 141.71(b)(2) is adequate to

limit potential contamination by Cryptosporidium oocysts. The adequacy

of the program must be based on the comprehensiveness of the watershed

review; the effectiveness of the system's program to monitor and

control detrimental activities occurring in the watershed; and the

extent to which the water system has maximized land ownership and/or

controlled land use within the watershed.





Sec. 141.172  Disinfection profiling and benchmarking.



    (a) Determination of systems required to profile. A public water

system subject to the requirements of this subpart must determine its

TTHM annual average using the procedure in paragraph (a)(1) of this

section and its HAA5 annual average using the procedure in



[[Page 69517]]



paragraph (a)(2) of this section. The annual average is the arithmetic

average of the quarterly averages of four consecutive quarters of

monitoring.

    (1) The TTHM annual average must be the annual average during the

same period as is used for the HAA5 annual average.

    (i) Those systems that collected data under the provisions of

subpart M (Information Collection Rule) must use the results of the

samples collected during the last four quarters of required monitoring

under Sec. 141.142.

    (ii) Those systems that use ``grandfathered'' HAA5 occurrence data

that meet the provisions of paragraph (a)(2)(ii) of this section must

use TTHM data collected at the same time under the provisions of

Secs. 141.12 and 141.30.

    (iii) Those systems that use HAA5 occurrence data that meet the

provisions of paragraph (a)(2)(iii)(A) of this section must use TTHM

data collected at the same time under the provisions of Secs. 141.12

and 141.30.

    (2) The HAA5 annual average must be the annual average during the

same period as is used for the TTHM annual average.

    (i) Those systems that collected data under the provisions of

subpart M (Information Collection Rule) must use the results of the

samples collected during the last four quarters of required monitoring

under Sec. 141.142.

    (ii) Those systems that have collected four quarters of HAA5

occurrence data that meets the routine monitoring sample number and

location requirements for TTHM in Secs. 141.12 and 141.30 and handling

and analytical method requirements of Sec. 141.142(b)(1) may use those

data to determine whether the requirements of this section apply.

    (iii) Those systems that have not collected four quarters of HAA5

occurrence data that meets the provisions of either paragraph (a)(2)(i)

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

    (A) Conduct monitoring for HAA5 that meets the routine monitoring

sample number and location requirements for TTHM in Secs. 141.12 and

141.30 and handling and analytical method requirements of

Sec. 141.142(b)(1) to determine the HAA5 annual average and whether the

requirements of paragraph (b) of this section apply. This monitoring

must be completed so that the applicability determination can be made

no later than March 16, 2000, or

    (B) Comply with all other provisions of this section as if the HAA5

monitoring had been conducted and the results required compliance with

paragraph (b) of this section.

    (3) The system may request that the State approve a more

representative annual data set than the data set determined under

paragraph (a)(1) or (2) of this section for the purpose of determining

applicability of the requirements of this section.

    (4) The State may require that a system use a more representative

annual data set than the data set determined under paragraph (a)(1) or

(2) of this section for the purpose of determining applicability of the

requirements of this section.

    (5) The system must submit data to the State on the schedule in

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

    (i) Those systems that collected TTHM and HAA5 data under the

provisions of subpart M (Information Collection Rule), as required by

paragraphs (a)(1)(i) and (a)(2)(i) of this section, must submit the

results of the samples collected during the last 12 months of required

monitoring under Sec. 141.142 not later than December 16, 1999.

    (ii) Those systems that have collected four consecutive quarters of

HAA5 occurrence data that meets the routine monitoring sample number

and location for TTHM in Secs. 141.12 and 141.30 and handling and

analytical method requirements of Sec. 141.142(b)(1), as allowed by

paragraphs (a)(1)(ii) and (a)(2)(ii) of this section, must submit those

data to the State not later than April 16, 1999. Until the State has

approved the data, the system must conduct monitoring for HAA5 using

the monitoring requirements specified under paragraph (a)(2)(iii) of

this section.

    (iii) Those systems that conduct monitoring for HAA5 using the

monitoring requirements specified by paragraphs (a)(1)(iii) and

(a)(2)(iii)(A) of this section, must submit TTHM and HAA5 data not

later than March 16, 2000.

    (iv) Those systems that elect to comply with all other provisions

of this section as if the HAA5 monitoring had been conducted and the

results required compliance with this section, as allowed under

paragraphs (a)(2)(iii)(B) of this section, must notify the State in

writing of their election not later than December 16, 1999.

    (v) If the system elects to request that the State approve a more

representative annual data set than the data set determined under

paragraph (a)(2)(i) of this section, the system must submit this

request in writing not later than December 16, 1999.

    (6) Any system having either a TTHM annual average <gr-thn-eq>0.064

mg/L or an HAA5 annual average <gr-thn-eq>0.048 mg/L during the period

identified in paragraphs (a)(1) and (2) of this section must comply

with paragraph (b) of this section.

    (b) Disinfection profiling. (1) Any system that meets the criteria

in paragraph (a)(6) of this section must develop a disinfection profile

of its disinfection practice for a period of up to three years.

    (2) The system must monitor daily for a period of 12 consecutive

calendar months to determine the total logs of inactivation for each

day of operation, based on the CT99.9 values in Tables 1.1-1.6, 2.1,

and 3.1 of Sec. 141.74(b), as appropriate, through the entire treatment

plant. This system must begin this monitoring not later than March 16,

2000. As a minimum, the system with a single point of disinfectant

application prior to entrance to the distribution system must conduct

the monitoring in paragraphs (b)(2)(i) through (iv) of this section. A

system with more than one point of disinfectant application must

conduct the monitoring in paragraphs (b)(2)(i) through (iv) of this

section for each disinfection segment. The system must monitor the

parameters necessary to determine the total inactivation ratio, using

analytical methods in Sec. 141.74(a), as follows:

    (i) The temperature of the disinfected water must be measured once

per day at each residual disinfectant concentration sampling point

during peak hourly flow.

    (ii) If the system uses chlorine, the pH of the disinfected water

must be measured once per day at each chlorine residual disinfectant

concentration sampling point during peak hourly flow.

    (iii) The disinfectant contact time(s) (``T'') must be determined

for each day during peak hourly flow.

    (iv) The residual disinfectant concentration(s) (``C'') of the

water before or at the first customer and prior to each additional

point of disinfection must be measured each day during peak hourly

flow.

    (3) In lieu of the monitoring conducted under the provisions of

paragraph (b)(2) of this section to develop the disinfection profile,

the system may elect to meet the requirements of paragraph (b)(3)(i) of

this section. In addition to the monitoring conducted under the

provisions of paragraph (b)(2) of this section to develop the

disinfection profile, the system may elect to meet the requirements of

paragraph (b)(3)(ii) of this section.

    (i) A PWS that has three years of existing operational data may

submit those data, a profile generated using those data, and a request

that the State approve use of those data in lieu of monitoring under

the provisions of



[[Page 69518]]



paragraph (b)(2) of this section not later than March 16, 2000. The

State must determine whether these operational data are substantially

equivalent to data collected under the provisions of paragraph (b)(2)

of this section. These data must also be representative of Giardia

lamblia inactivation through the entire treatment plant and not just of

certain treatment segments. Until the State approves this request, the

system is required to conduct monitoring under the provisions of

paragraph (b)(2) of this section.

    (ii) In addition to the disinfection profile generated under

paragraph (b)(2) of this section, a PWS that has existing operational

data may use those data to develop a disinfection profile for

additional years. Such systems may use these additional yearly

disinfection profiles to develop a benchmark under the provisions of

paragraph (c) of this section. The State must determine whether these

operational data are substantially equivalent to data collected under

the provisions of paragraph (b)(2) of this section. These data must

also be representative of inactivation through the entire treatment

plant and not just of certain treatment segments.

    (4) The system must calculate the total inactivation ratio as

follows:

    (i) If the system uses only one point of disinfectant application,

the system may determine the total inactivation ratio for the

disinfection segment based on either of the methods in paragraph

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

    (A) Determine one inactivation ratio (CTcalc/CT<INF>99.9</INF>)

before or at the first customer during peak hourly flow.

    (B) Determine successive CTcalc/CT<INF>99.9</INF> values,

representing sequential inactivation ratios, between the point of

disinfectant application and a point before or at the first customer

during peak hourly flow. Under this alternative, the system must

calculate the total inactivation ratio by determining (CTcalc/

CT<INF>99.9</INF>) for each sequence and then adding the (CTcalc/

CT<INF>99.9</INF>) values together to determine (<greek-S> (CTcalc/

CT<INF>99.9</INF>)).

    (ii) If the system uses more than one point of disinfectant

application before the first customer, the system must determine the CT

value of each disinfection segment immediately prior to the next point

of disinfectant application, or for the final segment, before or at the

first customer, during peak hourly flow. The (CTcalc/CT<INF>99.9</INF>)

value of each segment and ((CTcalc/CT<INF>99.9</INF>)) must be

calculated using the method in paragraph (b)(4)(i) of this section.

    (iii) The system must determine the total logs of inactivation by

multiplying the value calculated in paragraph (b)(4)(i) or (ii) of this

section by 3.0.

    (5) A system that uses either chloramines or ozone for primary

disinfection must also calculate the logs of inactivation for viruses

using a method approved by the State.

    (6) The system must retain disinfection profile data in graphic

form, as a spreadsheet, or in some other format acceptable to the State

for review as part of sanitary surveys conducted by the State.

    (c) Disinfection benchmarking. (1) Any system required to develop a

disinfection profile under the provisions of paragraphs (a) and (b) of

this section and that decides to make a significant change to its

disinfection practice must consult with the State prior to making such

change. Significant changes to disinfection practice are:

    (i) Changes to the point of disinfection;

    (ii) Changes to the disinfectant(s) used in the treatment plant;

    (iii) Changes to the disinfection process; and

    (iv) Any other modification identified by the State.

    (2) Any system that is modifying its disinfection practice must

calculate its disinfection benchmark using the procedure specified in

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

    (i) For each year of profiling data collected and calculated under

paragraph (b) of this section, the system must determine the lowest

average monthly Giardia lamblia inactivation in each year of profiling

data. The system must determine the average Giardia lamblia

inactivation for each calendar month for each year of profiling data by

dividing the sum of daily Giardia lamblia of inactivation by the number

of values calculated for that month.

    (ii) The disinfection benchmark is the lowest monthly average value

(for systems with one year of profiling data) or average of lowest

monthly average values (for systems with more than one year of

profiling data) of the monthly logs of Giardia lamblia inactivation in

each year of profiling data.

    (3) A system that uses either chloramines or ozone for primary

disinfection must also calculate the disinfection benchmark for viruses

using a method approved by the State.

    (4) The system must submit information in paragraphs (c)(4)(i)

through (iii) of this section to the State as part of its consultation

process.

    (i) A description of the proposed change;

    (ii) The disinfection profile for Giardia lamblia (and, if

necessary, viruses) under paragraph (b) of this section and benchmark

as required by paragraph (c)(2) of this section; and

    (iii) An analysis of how the proposed change will affect the

current levels of disinfection.





Sec. 141.173  Filtration.



    A public water system subject to the requirements of this subpart

that does not meet all of the criteria in this subpart and subpart H of

this part for avoiding filtration must provide treatment consisting of

both disinfection, as specified in Sec. 141.72(b), and filtration

treatment which complies with the requirements of paragraph (a) or (b)

of this section or Sec. 141.73 (b) or (c) by December 17, 2001.

    (a) Conventional filtration treatment or direct filtration. (1) For

systems using conventional filtration or direct filtration, the

turbidity level of representative samples of a system's filtered water

must be less than or equal to 0.3 NTU in at least 95 percent of the

measurements taken each month, measured as specified in Sec. 141.74(a)

and (c).

    (2) The turbidity level of representative samples of a system's

filtered water must at no time exceed 1 NTU, measured as specified in

Sec. 141.74(a) and (c).

    (3) A system that uses lime softening may acidify representative

samples prior to analysis using a protocol approved by the State.

    (b) Filtration technologies other than conventional filtration

treatment, direct filtration, slow sand filtration, or diatomaceous

earth filtration. A public water system may use a filtration technology

not listed in paragraph (a) of this section or in Sec. 141.73(b) or (c)

if it demonstrates to the State, using pilot plant studies or other

means, that the alternative filtration technology, in combination with

disinfection treatment that meets the requirements of Sec. 141.72(b),

consistently achieves 99.9 percent removal and/or inactivation of

Giardia lamblia cysts and 99.99 percent removal and/or inactivation of

viruses, and 99 percent removal of Cryptosporidium oocysts, and the

State approves the use of the filtration technology. For each approval,

the State will set turbidity performance requirements that the system

must meet at least 95 percent of the time and that the system may not

exceed at any time at a level that consistently achieves 99.9 percent

removal and/or inactivation of Giardia lamblia cysts, 99.99 percent

removal and/or inactivation of viruses,



[[Page 69519]]



and 99 percent removal of Cryptosporidium oocysts.





Sec. 141.174  Filtration sampling requirements.



    (a) Monitoring requirements for systems using filtration treatment.

In addition to monitoring required by Sec. 141.74, a public water

system subject to the requirements of this subpart that provides

conventional filtration treatment or direct filtration must conduct

continuous monitoring of turbidity for each individual filter using an

approved method in Sec. 141.74(a) and must calibrate turbidimeters

using the procedure specified by the manufacturer. Systems must record

the results of individual filter monitoring every 15 minutes.

    (b) If there is a failure in the continuous turbidity monitoring

equipment, the system must conduct grab sampling every four hours in

lieu of continuous monitoring, but for no more than five working days

following the failure of the equipment.





Sec. 141.175  Reporting and recordkeeping requirements.



    In addition to the reporting and recordkeeping requirements in

Sec. 141.75, a public water system subject to the requirements of this

subpart that provides conventional filtration treatment or direct

filtration must report monthly to the State the information specified

in paragraphs (a) and (b) of this section beginning December 17, 2001.

In addition to the reporting and recordkeeping requirements in

Sec. 141.75, a public water system subject to the requirements of this

subpart that provides filtration approved under Sec. 141.173(b) must

report monthly to the State the information specified in paragraph (a)

of this section beginning December 17, 2001. The reporting in paragraph

(a) of this section is in lieu of the reporting specified in

Sec. 141.75(b)(1).

    (a) Turbidity measurements as required by Sec. 141.173 must be

reported within 10 days after the end of each month the system serves

water to the public. Information that must be reported includes:

    (1) The total number of filtered water turbidity measurements taken

during the month.

    (2) The number and percentage of filtered water turbidity

measurements taken during the month which are less than or equal to the

turbidity limits specified in Sec. 141.173(a) or (b).

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

the month which exceed 1 NTU for systems using conventional filtration

treatment or direct filtration, or which exceed the maximum level set

by the State under Sec. 141.173(b).

    (b) Systems must maintain the results of individual filter

monitoring taken under Sec. 141.174 for at least three years. Systems

must report that they have conducted individual filter turbidity

monitoring under Sec. 141.174 within 10 days after the end of each

month the system serves water to the public. Systems must report

individual filter turbidity measurement results taken under

Sec. 141.174 within 10 days after the end of each month the system

serves water to the public only if measurements demonstrate one or more

of the conditions in paragraphs (b)(1) through (4) of this section.

Systems that use lime softening may apply to the State for alternative

exceedance levels for the levels specified in paragraphs (b)(1) through

(4) of this section if they can demonstrate that higher turbidity

levels in individual filters are due to lime carryover only and not due

to degraded filter performance.

    (1) For any individual filter that has a measured turbidity level

of greater than 1.0 NTU in two consecutive measurements taken 15

minutes apart, the system must report the filter number, the turbidity

measurement, and the date(s) on which the exceedance occurred. In

addition, the system must either produce a filter profile for the

filter within 7 days of the exceedance (if the system is not able to

identify an obvious reason for the abnormal filter performance) and

report that the profile has been produced or report the obvious reason

for the exceedance.

    (2) For any individual filter that has a measured turbidity level

of greater than 0.5 NTU in two consecutive measurements taken 15

minutes apart at the end of the first four hours of continuous filter

operation after the filter has been backwashed or otherwise taken

offline, the system must report the filter number, the turbidity, and

the date(s) on which the exceedance occurred. In addition, the system

must either produce a filter profile for the filter within 7 days of

the exceedance (if the system is not able to identify an obvious reason

for the abnormal filter performance) and report that the profile has

been produced or report the obvious reason for the exceedance.

    (3) For any individual filter that has a measured turbidity level

of greater than 1.0 NTU in two consecutive measurements taken 15

minutes apart at any time in each of three consecutive months, the

system must report the filter number, the turbidity measurement, and

the date(s) on which the exceedance occurred. In addition, the system

must conduct a self-assessment of the filter within 14 days of the

exceedance and report that the self-assessment was conducted. The self

assessment must consist of at least the following components:

assessment of filter performance; development of a filter profile;

identification and prioritization of factors limiting filter

performance; assessment of the applicability of corrections; and

preparation of a filter self-assessment report.

    (4) For any individual filter that has a measured turbidity level

of greater than 2.0 NTU in two consecutive measurements taken 15

minutes apart at any time in each of two consecutive months, the system

must report the filter number, the turbidity measurement, and the

date(s) on which the exceedance occurred. In addition, the system must

arrange for the conduct of a comprehensive performance evaluation by

the State or a third party approved by the State no later than 30 days

following the exceedance and have the evaluation completed and

submitted to the State no later than 90 days following the exceedance.



PART 142--NATIONAL PRIMARY DRINKING WATER REGULATIONS

IMPLEMENTATION



    12. The authority citation for Part 142 continues to read as

follows:



    Authority: 42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-

5, 300g-6, 300j-4, 300j-9, and 300j-11.



    13. Section 142.14 is amended by revising paragraphs (a)(3),

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

(a)(7) to read as follows:





Sec. 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

Secs. 141.71, 141.73, 141.173 and 141.175 of this chapter. Until June

29, 1993, for any public water system which is providing filtration

treatment and until December 30, 1991, for any public water system not

providing filtration treatment and not required by the State to provide

filtration treatment, records kept must be set forth in a form which

makes possible comparison with the limits contained in Sec. 141.13 of

this chapter.

* * * * *

    (4)(i) Records of disinfectant residual measurements and other

parameters necessary to document disinfection effectiveness in

accordance with Secs. 141.72 and 141.74 of this chapter and



[[Page 69520]]



the reporting requirements of Secs. 141.75 and 141.175 of this chapter

must be kept for not less than one year.

    (ii) Records of decisions made on a system-by-system and case-by-

case basis under provisions of part 141, subpart H or subpart P of this

chapter, must be made in writing and kept at the State.

* * * * *

    (7) Any decisions made pursuant to the provisions of part 141,

subpart P of this chapter.

    (i) Records of systems consulting with the State concerning a

modification to disinfection practice under Sec. 141.172(c) of this

chapter, including the status of the consultation.

    (ii) Records of decisions that a system using alternative

filtration technologies, as allowed under Sec. 141.173(b) of this

chapter, can consistently achieve a 99.9 percent removal and/or

inactivation of Giardia lamblia cysts, 99.99 percent removal and/or

inactivation of viruses, and 99 percent removal of Cryptosporidium

oocysts. The decisions must include State-set enforceable turbidity

limits for each system. A copy of the decision must be kept until the

decision is reversed or revised. The State must provide a copy of the

decision to the system.

    (iii) Records of systems required to do filter self-assessment,

CPE, or CCP under the requirements of Sec. 141.175 of this chapter.

* * * * *

    14. Section 142.15 is amended by adding paragraph (c)(5) to read as

follows:





Sec. 142.15  Reports by States.



* * * * *

    (c) * * *

    (5) Sanitary surveys. A list of subpart H systems that have had a

sanitary survey completed during the previous year and an annual

evaluation of the State's program for conducting sanitary surveys under

Sec. 141.16(b)(3) of this chapter.

* * * * *

    15. Section 142.16 is amended by redesignating paragraph (b)(1) as

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

follows:





Sec. 142.16  Special primacy requirements.



* * * * *

    (b) * * *

    (1) Enforceable requirements. (i) * * *

    (ii) States must have the appropriate rules or other authority to

assure that PWSs respond in writing to significant deficiencies

outlined in sanitary survey reports required under paragraph (b)(3) of

this section no later than 45 days after receipt of the report,

indicating how and on what schedule the system will address significant

deficiencies noted in the survey.

    (iii) States must have the appropriate rules or other authority to

assure that PWSs take necessary steps to address significant

deficiencies identified in sanitary survey reports required under

paragraph (b)(3) of this section, if such deficiencies are within the

control of the PWS and its governing body.

* * * * *

    (3) Sanitary survey. In addition to the general requirements for

sanitary surveys contained in Sec. 142.10(b)(2), an application must

describe how the State will implement a sanitary survey program that

meets the requirements in paragraphs (b)(3)(i) through (v) of this

section. For the purposes of this paragraph, ``sanitary survey'' means

an onsite review of the water source (identifying sources of

contamination using results of source water assessments where

available), facilities, equipment, operation, maintenance, and

monitoring compliance of a public water system to evaluate the adequacy

of the system, its sources and operations and the distribution of safe

drinking water.

    (i) The State must conduct sanitary surveys for all surface water

systems (including groundwater under the influence) that address the

eight sanitary survey components listed in paragraphs (b)(3)(i)(A)

through (H) of this section no less frequently than every three years

for community systems and no less frequently than every five years for

noncommunity systems. The State may allow sanitary surveys conducted

after December 1995 to serve as the first set of required sanitary

surveys if the surveys address the eight sanitary survey components

listed in paragraphs (b)(3)(i)(A) through (H) of this section.

    (A) Source.

    (B) Treatment.

    (C) Distribution system.

    (D) Finished water storage.

    (E) Pumps, pump facilities, and controls.

    (F) Monitoring and reporting and data verification.

    (G) System management and operation.

    (H) Operator compliance with State requirements.

    (ii) For community systems determined by the State to have

outstanding performance based on prior sanitary surveys, subsequent

sanitary surveys may be conducted no less than every five years. In its

primacy application, the State must describe how it will decide whether

a system has outstanding performance and is thus eligible for sanitary

surveys at a reduced frequency.

    (iii) Components of a sanitary survey may be completed as part of a

staged or phased state review process within the established frequency.

    (iv) When conducting sanitary surveys for systems required to

comply with the disinfection profiling requirements in Sec. 141.172 of

this chapter, the State must also review the disinfection profile as

part of the sanitary survey.

    (v) In its primacy application, the State must describe how it will

decide whether a deficiency identified during a sanitary survey is

significant for the purposes of paragraph (b)(1)(ii) of this section.

* * * * *

    (g) Requirements for States to adopt 40 CFR part 141, subpart P

Enhanced Filtration and Disinfection. In addition to the general

primacy requirements enumerated elsewhere in this part, including the

requirement that State provisions are no less stringent than the

federal requirements, an application for approval of a State program

revision that adopts 40 CFR part 141, subpart P Enhanced Filtration and

Disinfection, must contain the information specified in this paragraph:

    (1) Enforceable requirements. States must have the appropriate

rules or other authority to require PWSs to conduct a Composite

Correction Program (CCP) and to assure that PWSs implement any followup

recommendations that result as part of the CCP. The CCP consists of two

elements--a Comprehensive Performance Evaluation (CPE) and

Comprehensive Technical Assistance (CTA). A CPE is a thorough review

and analysis of a plant's performance-based capabilities and associated

administrative, operation and maintenance practices. It is conducted to

identify factors that may be adversely impacting a plant's capability

to achieve compliance and emphasizes approaches that can be implemented

without significant capital improvements. A CTA is the performance

improvement phase that is implemented if the CPE results indicate

improved performance potential. During the CTA phase, the system must

identify and systematically address plant-specific factors. The CTA is

a combination of utilizing CPE results as a basis for followup,

implementing process control priority-setting techniques and

maintaining long-term involvement to systematically train staff and

administrators.



[[Page 69521]]



    (2) State practices or procedures. (i) Section 141.172(a)(3) of

this chapter--How the State will approve a more representative annual

data set than the data set determined under Sec. 141.172 (a)(1) or (2)

of this chapter for the purpose of determining applicability of the

requirements of Sec. 141.172 of this chapter.

    (ii) Section 141.172(b)(5) of this chapter--How the State will

approve a method to calculate the logs of inactivation for viruses for

a system that uses either chloramines or ozone for primary

disinfection.

    (iii) Section 141.172(c) of this chapter--How the State will

consult with PWSs to evaluate modifications to disinfection practice.

    (iv) Section 141.173(b) of this chapter--For filtration

technologies other than conventional filtration treatment, direct

filtration, slow sand filtration, or diatomaceous earth filtration, how

the State will determine that a public water system may use a

filtration technology if the PWS demonstrates to the State, using pilot

plant studies or other means, that the alternative filtration

technology, in combination with disinfection treatment that meets the

requirements of Sec. 141.172(b) of this chapter, consistently achieves

99.9 percent removal and/or inactivation of Giardia lamblia cysts and

99.99 percent removal and/or inactivation of viruses, and 99 percent

removal of Cryptosporidium oocysts. For a system that makes this

demonstration, how the State will set turbidity performance

requirements that the system must meet 95 percent of the time and that

the system may not exceed at any time at a level that consistently

achieves 99.9 percent removal and/or inactivation of Giardia lamblia

cysts, 99.99 percent removal and/or inactivation of viruses, and 99

percent removal of Cryptosporidium oocysts.



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

BILLING CODE 6560-50-P

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