federal register

Friday

September 17, 1999

Part II

Environmental

Protection Agency

40 CFR Parts 9, 141 and 142

Revisions to the Unregulated

Contaminant Monitoring Regulation for

Public Water Systems; Final Rule
50556 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 9, 141 and 142

[FRL–6433–1]

RIN 2040–AD15

Revisions to the Unregulated

Contaminant Monitoring Regulation for

Public Water Systems

AGENCY: Environmental Protection

Agency.

ACTION: Final rule.

SUMMARY: The Safe Drinking Water Act

(SDWA), as amended in 1996, requires

the U.S. Environmental Protection

Agency (EPA) to establish criteria for a

program to monitor unregulated

contaminants and, by August 6, 1999, to

publish a list of contaminants to be

monitored. To conform to the

Amendments, today EPA is

promulgating the Unregulated

Contaminant Monitoring Regulation

(UCMR) for Public Water Systems

(PWSs), which revises substantially the

existing regulations for unregulated

contaminant monitoring.

This final rule includes a list of

contaminants to be monitored,

procedures for selecting a representative

nationwide sample of small PWSs that

will be required to monitor, the

frequency and schedule for monitoring,

the sampling points, the approved

analytical methods to be used, and

procedures for entering the monitoring

data in the National Drinking Water

Contaminant Occurrence Database

(NCOD), as required under section 1445

of SDWA, as amended. The data in the

database will be used to identify

contaminants on the Drinking Water

Contaminant Candidate List (CCL), to

support the Administrator’s

determination of whether or not to

develop drinking water standards for a

particular contaminant, and to develop

standards for the contaminants that the

Administrator selects.

DATES: Effective Date: The final rule is

effective January 1, 2001.

For purposes of judicial review, this

final rule is promulgated as on 1 p.m.

Eastern time on October 1, 1999 as

provided in 40 CFR 23.7.

The incorporation by reference of the

publications listed in today’s rule is

approved by the Director of the Federal

Register as of January 1, 2001.

ADDRESSES: Documents relevant to this

action are available for inspection from

9 a.m. to 4 p.m. Monday through Friday,

excluding legal holidays, at the Water

Docket, East Tower Basement, U.S. EPA,

401 M Street, SW, Washington DC. For

access to docket (Docket No. W–98–02)

materials, please call (202) 260–3027

between 9 a.m. and 3:30 p.m, Eastern

Time, Monday through Friday, to

schedule an appointment. A reasonable

fee may be charged for copying.

FOR FURTHER INFORMATION CONTACT:

Charles Job, Standards and Risk

Management Division, Office of Ground

Water and Drinking Water (MC–4607),

U.S. Environmental Protection Agency,

401 M Street, SW, Washington, D.C.

20460, (202) 260–7084. General

information may also be obtained from

the EPA Safe Drinking Water Hotline.

Callers within the United States may

reach the Hotline at (800) 426–4791.

The Hotline is open Monday through

Friday, excluding federal holidays, from

9:00 a.m. to 5:30 p.m. Eastern Time.

SUPPLEMENTARY INFORMATION:

Regional Contacts

I. Jane Downing, JFK Federal Bldg., Room

2203, Boston, MA 02203. Phone: 617–

918–1571.

II. Bruce Kiselica, 290 Broadway, Room 2432,

New York, NY 10007–1866. Phone: 212–

637–3879.

III. Michelle Hoover, 1650 Arch Street,

Philadelphia, PA 19103–2029. Phone:

215–814–5258.

IV. Janine Morris, 345 Courtland Street, NE,

Atlanta, GA 30365. Phone: 404–562–

9480.

V. Thomas Poleck, 77 West Jackson Blvd.,

Chicago, IL 60604–3507. Phone: 312–

886–2407.

VI. Larry Wright, 1445 Ross Avenue, Dallas,

TX 75202. Phone: 214–665–7150.

VII. Stan Calow, 726 Minnesota Ave., Kansas

City, KS 66101. Phone: 913–551–7410.

VIII. Rod Glebe, One Denver Place, 999 18th

Street, Suite 500, Denver, CO 80202.

Phone: 303–312–6627.

IX. Bruce Macler, 75 Hawthorne Street, San

Francisco, CA 94105. Phone: 415–744–

1884.

X. Gene Taylor, 1200 Sixth Avenue, Seattle,

WA 98101. Phone: 206–553–1389.

Abbreviations and Acronyms Used in

the Preamble and Final Rule

2,4-DNT—2,4-dinitrotoluene

2,6-DNT—2,6-dinitrotoluene

4,4′-DDE—4,4′-dichloro dichlorophenyl

ethylene, a degradation product of DDT

Alachlor ESA—alachlor ethanesulfonic acid,

a degradation product of alachlor

AOAC—Association of Official Analytical

Chemists

APHA—American Public Health Association

ASDWA—Association of State Drinking

Water Administrators

ASTM—American Society for Testing and

Materials

BGM—Buffalo Green Monkey cells, a specific

cell line used to grow viruses

CAS—Chemical Abstract Service

CASRN—Chemical Abstract Service Registry

Number

CCL—Contaminant Candidate List

CCR—Consumer Confidence Reports

CERCLA—Comprehensive Environmental

Response, Compensation & Liability Act

CFR—Code of Federal Regulations

CFU—colony forming unit

CFU/mL—colony forming units per milliliter

CWS—community water system

DCPA—dimethyl tetrachloroterephthalate,

chemical name of the herbicide dacthal

DCPA mono- and di-acid degradates—

degradation products of DCPA

DDE—dichloro dichlorophenyl ethylene, a

degradation product of DDT

DDT—dichloro diphenyl trichloroethane, a

general insecticide

DNA—deoxyribonucleic acid

EDL—estimated detection limit

EPA—Environmental Protection Agency

EPTC—s-ethyl-dipropylthiocarbamate, an

herbicide

EPTDS—Entry Point to the Distribution

System

ESA—ethanesulfonic acid, a degradation

product of alachlor

FACA—Federal Advisory Committee Act

FTE—full-time equivalent

GC—gas chromatography, a laboratory

method

GLI method—Great Lakes Instruments

method

GW—ground water

GWUDI—ground water under the direct

influence (of surface water)

HPLC—high performance liquid

chromatography, a laboratory method

ICR—Information Collection Request/Rule

IRFA—initial regulatory flexibility analysis

IMS—immunomagnetic separation

IRIS—Integrated Risk Information System

IS—internal standard

LLE—liquid/liquid extraction, a laboratory

method

MAC—Mycobacterium avium complex

MOA—Memorandum of Agreement

MCL—maximum contaminant level

MDL—method detection limit

MRL—minimum reporting level

MS—mass spectrometry, a laboratory method

MSD—sample matrix spike duplicate

MTBE—methyl-tertiary-butyl-ether, a

gasoline additive

NAWQA—National Water Quality

Assessment Program

NCOD—National Drinking Water

Contaminant Occurrence Database

NDWAC—National Drinking Water Advisory

Council

NERL—National Environmental Research

Laboratory

NPS—National Pesticide Survey

NTIS—National Technical Information

Service

NTNCWS—non-transient non-community

water system

NTTAA—National Technology Transfer and

Advancement Act

OGWDW—Office of Ground Water and

Drinking Water

OMB—Office of Management and Budget

PAH—Poly-aromatic hydrocarbon

PB—particle beam

PBMS—Performance-Based Measurement

System

pCi/L—picocuries per liter

PCR—polymerase chain reaction
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50557

210Pb—Lead-210 (also Pb-210), a lead isotope

and radionuclide; part of the uranium

decay series 210Po—Polonium-210 (also Po-210), a

polonium isotope and radionuclide; part

of the uranium decay series

PWS—Public Water System

PWSF—Public Water System Facility

QA—quality assurance

QC—quality control

RDX—royal demolition explosive,

hexahydro-1,3,5-trinitro-1,3,5-triazine

RFA—Regulatory Flexibility Act

RPD—relative percent difference

RSD—relative standard deviation

SBREFA—Small Business Regulatory

Enforcement Fairness Act

SD—standard deviation

SDWA—Safe Drinking Water Act

SDWIS—Safe Drinking Water Information

System

SDWIS FED—the Federal Safe Drinking

Water Information System

SM—Standard Methods

SMF—Standard Compliance Monitoring

Framework

SMS—sample matrix spike

SOC—synthetic organic compound

SPE—solid phase extraction, a laboratory

method

SRF—State Revolving Fund

STORET—Storage and Retrieval System

SW—surface water

TBD—to be determined

TNCWS—transient non-community water

system

UCMR—Unregulated Contaminant

Monitoring Regulation/Rule

UCM—Unregulated Contaminant Monitoring

UMRA—Unfunded Mandates Reform Act of

1995

USEPA—United States Environmental

Protection Agency

UV—ultraviolet

VOC—volatile organic compound

μg/L—micrograms per liter

Preamble Outline

I. Statutory Authority

II. Major Program Revisions

III. Regulatory Background

IV. Process of Preparing the Final Rule

V. Concise Description of Today’s Action

A. Which Systems Must Monitor

B. System Monitoring Requirements

C. System Reporting Requirements

D. State and Tribal Participation

VI. Final Changes in the Unregulated

Contaminant Monitoring Program

A. Revised List of Unregulated

Contaminants to be Monitored

1. Criteria for Selecting Contaminants for

the UCMR

(a) Revising the UCMR (1999) List

(b) Regulatory Approach for the UCMR

(1999) List

(c) Analytical Methods Applicable to the

UCMR (1999) List

(i) Chemical Analytical Methods

(ii) Microbiological Analytical Methods

2. List of Contaminants To Be Monitored

(a) Final UCMR (1999) List

(b) Number of Contaminants on the UCMR

(1999) List

B. Public Water Systems Subject to the

UCMR

C. Type of Monitoring Required of Public

Water Systems Based on Listing Group

1. Assessment Monitoring

2. Screening Survey

3. Pre-Screen Testing

D. Monitoring Requirements Under the

Final UCMR

1. Monitoring Frequency

(a) Systems Serving More Than 10,000

Persons

(i) Chemical Contaminants.

(ii) Microbiological Contaminants.

(b) Systems Serving 10,000 or Fewer

Persons

2. Monitoring Time for Vulnerable Period

3. Monitoring Location

(a) Chemical Contaminants

(b) Microbiological Contaminants

4. Quality Control Procedures for Sampling

and Testing

5. Monitoring of Routinely Tested Water

Quality Parameters

6. Relation to Compliance Monitoring

Requirements

7. Previous Monitoring of the

Contaminants on the Final UCMR (1999)

List

E. Waivers

1. Waivers for Systems Serving More than

10,000 Persons

2. Waivers for Small Systems in State Plans

F. Representative Sample of Systems

Serving 10,000 or Fewer Persons

1. System Size

2. System Type

(a) Public Water System Monitoring

(b) Nontransient Non-Community Water

Systems

(c) Transient Non-Community Systems

3. Geographic Location

4. Likelihood of Finding Contaminants

5. State Plans for the Representative

Sample

(a) Representative State Plans

(b) Systems Selected for Pre-Screen Testing

(c) Tribal Water Systems

(d) ‘‘Index’’ Systems

(e) Other State Data

G. Reporting of Monitoring Results

1. Reporting Requirements (Data Elements)

2. Reporting to the Primacy Agency

3. Timing of Reporting

4. Method of Reporting

5. Public Notification of Availability of

Results

VII. Section-by-Section Analysis of Public

Comment and EPA Response

A. Section 141.35—Reporting of

Unregulated Contaminant Monitoring

Results

1. Does this reporting apply to me?

2. To whom must I report?

3. When do I report monitoring results?

4. What information must I report?

5. How must I report this information?

6. Can the laboratory to which I send

samples report the results for me?

7. Can I report previously collected data to

meet the testing and reporting

requirements for the contaminants in

§ 141.40(a)(3)?

B. § 141.40—Monitoring Requirements for

Unregulated Contaminants

1. Requirements for Owners and Operators

of Public Water Systems

(a) Do I have to monitor for unregulated

contaminants?

(b) How would I be selected for the

monitoring under the State Monitoring

Plan, the screening survey, or the prescreen testing?

(c) For which contaminants must I

monitor?

(d) What general monitoring requirements

must I follow for List 1 monitoring?

(e) What specific sampling and quality

control requirements must I follow for

monitoring of List 1 contaminants?

(i) All systems

(ii) Large systems

(A) Timeframe

(B) Frequency

(C) Location

(D) Sampling instructions

(E) Testing and analytical methods

(F) Sampling deviations

(G) Testing

(iii) Small systems that are part of the State

Monitoring Plan

(A) Frequency

(B) Location

(C) Sampling deviations

(D) Sample kits

(E) Sampling instructions

(F) Duplicate samples

(G) Sampling forms

(H) Sample submission

(f) What additional requirements must I

follow if my system is selected as an

Index system?

(g) What must I do if my system is selected

for the Screening Survey or Pre-Screen

Testing?

(h) What is a violation of this rule?

2. Requirements for State and Tribal

Participation

(a) How can I as the director of a State or

Tribal drinking water program

participate in unregulated contaminant

monitoring, including the State

Monitoring Plan for small systems, and

the Screening Survey and Pre-Screen

Testing of all systems?

(b) What if I decide not to enter into an

MOA?

(c) Can I add contaminants to the

Unregulated Contaminant Monitoring

List?

(d) Can I waive monitoring requirements?

C. Appendix A—Quality Control

Requirements for Testing All Samples

Collected

D. § 142.15—Reports by States

E. § 142.16—Special primacy requirements

VIII. General Issues From Public Comment

and EPA Response

A. Data Quality

B. EPA Funding for Small System Testing

C. Lab Certification

D. Research

E. Regulation Format

F. Voluntary Data Submittal

IX. Other Changes Related to the Regulation

A. Implementation of the Rule

1. Setting an Effective Date.

2. Analytical Methods for the Testing

Program.

3. Testing Program for Large Systems.

4. Testing Program for Small Systems.

5. Continued Development of Analytical

Methods.

6. Determining the Representative National

Sample and State Monitoring Plans.
50558 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

7. Specifying the Vulnerable Monitoring

Period.

8. Conducting the Sampling.

9. Establishing Sampling Points.

10. Large Systems.

11. Systems in State Monitoring Plans.

12. Screening Survey.

13. Pre-Screen Testing.

14. Testing.

15. Reporting Requirements.

16. Record Keeping.

17. Previously Collected Data.

18. Modifying the Monitoring List.

B. Implementation in Indian Country

C. Performance-based Measurement

System

X. Guidance Manuals

XI Costs and Benefits of the Rule

A. Program Cost Estimates

1. Assumptions: Assessment Monitoring

2. Estimated Average Annual Cost for 5-

Year Program: Assessment Monitoring

Only

B. Estimated Net Costs

C. Benefits

XII. Administrative Requirements

A. Executive Order 12866—Regulatory

Planning and Review

B. Executive Order 13045—Protection of

Children From Environmental Health

Risks and Safety Risks

C. Unfunded Mandates Reform Act

D. Paperwork Reduction Act

E. Regulatory Flexibility Act

1. Full Assessment Monitoring

Implementation Scenario

2. Limited Implementation Scenario

F. National Technology Transfer and

Advancement Act

G. Executive Order 12898—Federal

Actions to Address Environmental

Justice in Minority Populations and LowIncome Populations

H. Federalism Executive Orders

I. Executive Order 13084—Consultation

and Coordination with Indian Tribal

Governments

J. Congressional Review Act

XIII. Public Involvement in Regulation

Development

XIV. References

Potentially Regulated Entities

The regulated entities are public

water systems. All large community and

non-transient non-community water

systems serving more than 10,000

persons are required to monitor. A

community water system (CWS) means

a public water system which serves at

least 15 service connections used by

year-round residents or regularly serves

at least 25 year-round residents. Nontransient non-community water system

(NTNCWS) means a public water system

that is not a community water system

and that regularly serves at least 25 of

the same persons over 6 months per

year. Only a national representative

sample of community and non-transient

non-community systems serving 10,000

or fewer persons would be required to

monitor. Transient non-community

systems (i.e., systems that do not

regularly serve at least 25 of the same

persons over six months per year)

would not be required to monitor.

States, Territories, and Tribes, with

primacy to administer the regulatory

program for public water systems under

the Safe Drinking Water Act sometimes

conduct analyses to measure for

contaminants in water samples and are

regulated by this action. Categories and

entities potentially regulated by this

action include the following:

Category Examples of potentially regulated entities SIC

State, Territorial and Tribal Governments .. States, Territories, and Tribes that analyze water samples on behalf of public water

systems required to conduct such analysis; States, Territories, and Tribes that

themselves operate community and non-transient non-community water systems

required to monitor.

9511

Industry ....................................................... Private operators of community and non-transient non-community water systems required to monitor.4941

Municipalities ............................................... Municipal operators of community and non-transient non-community water systems

required to monitor.

9511

This table is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

regulated by this action. This table lists

the types of entities that EPA is now

aware of that could potentially be

regulated by this action. Other types of

entities not listed in the table could also

be regulated. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed in the preceding FOR FURTHER

INFORMATION CONTACT section.

I. Statutory Authority

SDWA section 1445(a)(2), as amended

in 1996, requires EPA to establish

criteria for a program to monitor

unregulated contaminants and to

publish, by August 6, 1999, a list of

contaminants to be monitored. To meet

these requirements, today’s rule EPA

substantially revises the existing

Unregulated Contaminant Monitoring

(UCM) Program, which is codified at 40

CFR 141.40. This final rule revises the

regulations at 40 CFR 9.1, 141.35,

141.40, 142.16 and deletes and reserves

142.15(c)(3). The rule covers: (1) the

frequency and schedule for monitoring,

based on PWS size, water source, and

likelihood of finding contaminants; (2) a

new, shorter list of contaminants for

which systems will monitor; (3)

procedures for selecting and monitoring

a nationally representative sample of

small PWSs (those serving 10,000 or

fewer persons), and; (4) procedures for

entering the monitoring data in the

National Drinking Water Contaminant

Occurrence Data Base (NCOD), as

required under section 1445.

II. Major Program Revisions

Since its inception in 1988, the UCM

Program has collected occurrence data

to help EPA determine which

contaminants EPA should regulate

based on contaminant concentrations in

PWSs and the contaminants’ adverse

health effects levels. Today’s rule is

designed to improve and enhance this

program in several important ways:

(1) A statistical approach to select

only 800 representative systems for

monitoring from the national total of

65,600 small systems reduces the

monitoring burden of the water supply

industry; the burden on small systems is

significantly further reduced in that

EPA will pay for virtually all of the

costs associated with monitoring for the

small systems that are part of the

representative sample;

(2) A smaller number of contaminants

to be monitored also reduces the testing

and reporting burden of the water

industry overall;

(3) The required information to be

reported about each contaminant has

been refined to improve the data quality

for regulatory decisions; and

(4) Direct reporting of data for

regulatory determination and

development from systems to EPA

reduces State reporting burden, and the

opportunity for electronic reporting

reduces the potential for data entry and

submission.

A three-tier monitoring approach

allows monitoring to start promptly for

contaminants with approved analytical

methods, while accommodating the

need to delay implementation for

contaminants needing further methods

development. The rule also allows use

of a State-EPA Memorandum of
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50559

Agreement, providing direct

implementation in each State rather

than implementation through primacy

revisions, to address the three-tiered

approach of the UCMR.

This program is a cornerstone of the

‘‘sound science’’ approach to future

drinking water regulations, which is a

goal of the 1996 SDWA Amendments.

Data generated by this final rule will be

used to: (1) evaluate and prioritize

contaminants on the Contaminant

Candidate List (CCL) and refine the

CCL; (2) support the Administrator’s

determination of whether to regulate a

contaminant under the drinking water

program; and, (3) support the

development of drinking water

regulations.

In a related, cost-savings action, EPA

published a Direct Final Rule (64 FR

1494) on January 8, 1999, suspending

the monitoring requirements in effect

for small systems serving 10,000 or

fewer persons. The third round of

monitoring by small systems under the

existing list of unregulated

contaminants would have overlapped

with the monitoring required under this

final rule. The Direct Final Rule saved

small systems and States the cost of

unnecessary monitoring. EPA believes it

obtained sufficient data from the

previous monitoring rounds to make

decisions concerning the occurrence of

the unregulated contaminants on its

prior monitoring list for these systems.

Large systems were not included in this

Direct Final Rule since they had already

begun the third round of monitoring in

January 1998. This large system

monitoring will provide confirming

information on the occurrence of those

contaminants. However, this final

regulation cancels further monitoring by

large systems for the existing list of

contaminants effective January 1, 2001.

Until that date, large systems must

continue to monitor for the 48

contaminants listed in 40 CFR 141.40

(and also listed in Table 1 of ‘‘Revisions

to the Unregulated Contaminant

Monitoring Regulation for Public Water

Systems,’’ Federal Register, vol. 64, no.

83, April 30, 1999, p. 23401 (64 FR

23401)).

III. Regulatory Background

The requirements for unregulated

contaminant monitoring were first

established by the 1986 SDWA

Amendments. Under this law, EPA

implemented the drinking water

standards in phases, with each phase

having a set of contaminants for which

maximum contaminant levels in

drinking water were established. The

phases also included unregulated

contaminants for which more

information was needed before

decisions could be made regarding

regulation of the contaminants. EPA

included unregulated contaminant

monitoring requirements in the Phase I

chemical regulation, under 40 CFR

141.40(a)–(e). The Phase II regulation

later superceded the Phase I rule, and

some of the Phase I unregulated

contaminants became regulated under

Phase II. Additional contaminants were

also added to the list of unregulated

contaminants. The Phase V chemical

regulation further modified the list of

contaminants, as additional unregulated

contaminants became regulated.

The basic monitoring and reporting

requirements for unregulated

contaminants were the same under the

Phase I, Phase II, and Phase V

regulations. PWSs were required to

report their monitoring results to the

primacy agencies (either the State or

EPA), with States, in turn, reporting to

EPA. Only systems serving fewer than

150 service connections were exempt

from monitoring—provided they made

their facilities available for monitoring

by the States. Repeat monitoring was

required every 5 years.

Section 125 of the 1996 SDWA

Amendments substantially revised

unregulated contaminant monitoring

program. The new program includes: (1)

a new list of contaminants (i.e., the

Unregulated Contaminant Monitoring

Regulation (UCMR) (1999) List; (2) a

representative sample of PWSs serving

10,000 or fewer persons to monitor; (3)

placement of the monitoring data in the

NCOD, and; (4) notification of

consumers that the monitoring results

are available.

The 1996 amendments limit the

number of contaminants to be

monitored on the UCMR list to a

maximum of 30. The amendments

specify that only a representative

sample of small systems are required to

monitor, and that EPA must pay the

reasonable costs of analyzing the

samples taken by those systems. EPA

will use the data generated by this

monitoring effort in the development of

future drinking water regulations.

Today’s final rule will completely

replace the requirements of the existing

rule on the final rule’s effective date of

January 1, 2001. The existing

requirements of 40 CFR 141.35 and

141.40 still apply to large systems

serving more than 10,000 persons,

(since their third round of monitoring

had begun in January 1998) until

January 1, 2001, as noted above in II.

Major Program Revisions.

IV. Process of Preparing the Final Rule

EPA has been developing the final

revisions to the Unregulated

Contaminant Monitoring Regulation

(UCMR) for public water systems since

1997. In December, 1997, EPA’s UCMR

development workgroup held a

stakeholders meeting to obtain input

from the public on major issues and

options affecting the program and

emanating from the Safe Drinking Water

Act, as amended in 1996. EPA held a

second stakeholders meeting in May

1998, on options under serious

consideration for the UCMR. EPA

engaged eleven external expert

reviewers from March 1 through April

22, 1999 to examine and comment on

the technical aspects of the proposed

rule. These technical reviewers

evaluated and commented on the

chemical and microbiological

contaminant analytical methods and

reporting requirements, the statistical

approach for the representative sample

of small systems, and the sampling and

monitoring approach. The comments of

the technical reviewers were available

to the public through the official docket

and on the Internet through EPA’s

Office of Ground Water and Drinking

Water electronic homepage.

EPA published the proposed rule in

the Federal Register on April 30, 1999,

for public comment. The comment

period closed on June 14, with

submissions from 39 commenters

meeting the deadline and addressing all

major aspects of the proposed

regulation. EPA received one hundred

sixteen comments after the public

comment period closed, principally

concerning the inclusion of perchlorate

on the UCMR monitoring list. EPA

considered and addressed all comments

in the process of developing this final

regulation.

V. Concise Description of Today’s

Action

A. Which Systems Must Monitor

Owners and operators of community

and non-transient noncommunity water

systems must monitor for unregulated

contaminants if they serve more than

10,000 persons or if they are part of the

representative sample of small systems

serving 10,000 or fewer persons that

will be randomly selected to monitor for

these contaminants. Transient systems

are not required to monitor for

unregulated contaminants. Only

purchased water systems that are

identified by EPA or the State to sample

at locations of low disinfectant residual

or longest residence time are required to

monitor for distribution system

contaminants.
50560 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

B. System Monitoring Requirements

The contaminants included in this

action are: 2,4-dinitrotoluene, 2,6-

dinitrotoluene, DCPA mono acid

degradate, DCPA di acid degradate, 4,4′-

DDE, EPTC, molinate, MTBE,

nitrobenzene, terbacil, acetochlor, and

perchlorate. Systems must also analyze

for water quality parameters including,

for chemical contaminants: pH; and for

microbiological contaminants: pH,

temperature, turbidity, free disinfectant

residual and total disinfectant residual.

Surface water systems must monitor

during four consecutive quarters.

Ground water systems must monitor

two times five to seven months apart.

One sampling event for surface and

ground water systems must be during

the vulnerable time of May 1 to July 31,

or during an alternate vulnerable time

selected by the State. Monitoring must

be conducted at the entry point to the

distribution system, or at other sampling

locations previously specified by the

State for compliance monitoring, for

sampling points representative of each

principal, non-emergency water source

in use over the one year of monitoring.

Large and small systems must monitor

according to the quality control

procedures described. Laboratories that

are certified to use the indicated

methods for the contaminants listed are

automatically certified to analyze for

unregulated contaminants. Small

systems that are part of the

representative sample which become

part of State Monitoring Plans must

follow instructions given them for

unregulated contaminant sampling and

shipment to the designated laboratory.

C. System Reporting Requirements

After testing for the contaminants on

the monitoring list, the systems must

report the results electronically to, or in

an alternate format previously arranged

with, EPA within 30 days following the

month they receive the results. EPA will

report the results for the small systems

that are selected to be part of the State

Monitoring Plans. EPA will hold the

data for 60 days to allow for quality

control review by systems and States

before placing the data in the National

Drinking Water Contaminant

Occurrence Database.

Data required to be reported include:

Public Water System (PWS)

Identification Number; Sample

Identification Number; Sample

Collection Date; Contaminant/

Parameter; Analytical Results—Sign;

Analytical Result—Value; Analytical

Result—Unit of Measure; Analytical

Method Number; Public Water System

Facility Identification Number—Source,

Treatment Plant and Sampling Point;

Sample Analysis Type; Detection Level;

Detection Level Unit of Measure; Batch

Identification Number; Spiking

Concentration; Analytical Precision;

Analytical Accuracy; Presence/Absence.

A system can have a laboratory report

the results for it, but the system retains

the responsibility for reporting. A

system can report previously collected

data as long as the data meet the

requirements specified in 40 CFR

141.40(a) (3), (4), (5) and Appendix A

and include the applicable water quality

parameters and data listed previously

that are required to be reported.

D. State and Tribal Participation

States and Tribes can enter into a

Memorandum of Agreement (MOA)

with the EPA concerning the

implementation of the monitoring

program. The MOA must address the

following: accepting or modifying the

State Monitoring Plan for small systems,

determining an alternate vulnerable

time, modifying the timing of

monitoring, identifying sampling points

for small systems, notifying small and

large systems of their monitoring

responsibilities, and providing

instructions to systems. A State can

remove a system from the State

Monitoring Plan, after EPA review, as

long as removal is not based on prior

information on the occurrence or nonoccurrence of contaminants at the

system or the vulnerability of the system

to the contaminants. States can decide

not to participate in an MOA, in which

case the EPA will establish a State

Monitoring Plan. The governors of seven

or more States can petition EPA to add

contaminants to the monitoring list.

States can apply to EPA to waive

monitoring for large systems if they can

demonstrate that the contaminants for

which a monitoring waiver is sought

have not occurred in the State in the

past 15 years.

VI. Final Changes in the Unregulated

Contaminant Monitoring Program

A. Revised List of Unregulated

Contaminants To Be Monitored

1. Criteria for Selecting Contaminants

for the UCMR

(a) Revising the UCMR (1999) List

Section 1445(a)(2)(B) requires EPA to

list not more than 30 unregulated

contaminants to be monitored by public

water systems. EPA used the 1998

Contaminant Candidate List (CCL),

established under section 1412(b)(1)(B)

of SDWA, as the primary basis for

selecting contaminants for future

monitoring under the UCMR.

Development of the CCL is discussed in

the preamble to the proposed rule at 64

FR 23402. EPA believes, and nearly all

public commenters addressing the use

of the CCL as the basis for the UCMR

List indicated, that the CCL process

already uses the best available

information on contaminants of concern

and emerging contaminants that may

need regulation. SDWA section 1445

(a)(2)(B)(ii) provides for the governors of

seven or more States to petition the

Agency to add contaminants to the

UCMR List. This petition process allows

for the flexibility to include

contaminants that are emerging as

concerns between the five-year listing

cycles.

The CCL lists 26 chemical and 8

microbiological contaminants as

occurrence priorities because additional

data on their occurrence in drinking

water are needed to help decide

whether they should be regulated. The

proposed rule did not address the two

contaminants identified in the

preparation of the CCL as highly

localized in occurrence: perchlorate and

RDX (hexahydro-1,3,5-trinitro-1,3,5-

triazine). EPA now has information

indicating that the occurrence of these

contaminants is more widespread than

originally thought. In response to this

information, some of which was

provided in public comments, EPA has

added perchlorate and RDX to the final

UCMR (1999) List. Perchlorate was

added to the UCMR (1999) List because

EPA feels that there is enough

information on its occurrence in public

water systems to warrant its inclusion in

a national monitoring program. Since it

was not included on the proposed

UCMR (1999) List, EPA did not take

comment on its analytical method,

minimum reporting level, or sampling

location. EPA is currently engaged in

final validation of an analytical method

for perchlorate. This validation is

important because earlier analytical

methods did not make adjustments for

interferences from sulfate and chloride,

thus reducing or eliminating detected

concentrations. EPA feels that with this

validation, the analytical method should

be sufficiently ready for monitoring, and

thus EPA has included perchlorate on

the UCMR List 1. EPA plans to publish,

for public comment, the analytical

method, minimum reporting level, and

sampling location for perchlorate

shortly after the promulgation of this

final rule. RDX now appears on UCMR

(1999) List 2, indicating that additional

information is available, and initial

monitoring of occurrence in public

water systems should occur but that its

method needs further refinement.
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50561

Additionally, based on technical peer

review and public comments, EPA

moved Aeromonas from UCMR (1999)

List 1 to UCMR (1999) List 2 in Table

1, because its analytical method is not

expected to be validated until 2000 or

2001. Also, in response to public

comments that the Agency include as

many contaminants that could be tested

under the same multi-analyte method as

possible in Assessment Monitoring, EPA

moved acetochlor to List 1 from List 2.

This action is based on information that

only minor refinements are needed in

the method and those can be resolved

before the effective date of today’s rule.

As a result, the analytical method is

reserved until the details of the method

are resolved. EPA plans to publish a

revision to this final rule to approve an

analytical method for acetochlor shortly

after this rule’s promulgation. EPA will

likely publish a joint request for public

comment on the analytical methods for

perchlorate and acetochlor. EPA intends

to approve and publish the methods as

early as possible to allow monitoring to

begin on January 1, 2001, and to allow

for the reporting of any data obtained

prior to January 1, 2001 to meet the

requirements of this final Rule.

For the remaining contaminants on

the CCL Occurrence Priorities List, EPA

has evaluated the availability of

analytical methods published by EPA or

voluntary consensus standards

organizations, such as the American

Society for Testing and Materials

(ASTM) and Standard Methods (SM). In

addition, EPA prioritized analytical

methods development activities for

those compounds and microorganisms

for which suitable analytical methods

are not currently available. As listed in

List 1 of Table 1, EPA identified 10 of

the 12 listed chemical contaminants for

which analytical methods are now

available. UCMR (1999) List 1

contaminants are those for which

monitoring is required under today’s

Rule, with the added note that

analytical methods have yet to be

approved for perchlorate and

acetochlor. UCMR (1999) List 2 of Table

1 lists 16 contaminants for which

analytical methods are being refined: 14

chemical contaminants, Aeromonas (a

microorganism), and polonium-210

(discussed in Table 1). UCMR (1999)

List 3 of Table 1 identifies seven

microbiological contaminants and lead210 for which analytical methods are

being researched. Monitoring for

contaminants on UCMR (1999) Lists 2

and 3 is not required until EPA

promulgates revisions to this rule to

specify analytical methods and related

sampling requirements for them.

EPA requested comment on the

addition to the UCMR (1999) List of two

naturally occurring radionuclides with

health concerns at low levels, lead-210

(pb-210), and polonium-210 (po-210).

Both nuclides are in the uranium decay

series, which also includes radium-226

and radon-222. Lead-210, with a halflife of 22 years, and one of its

degradates, polonium-210, with a halflife of 138 days, have been found in

drinking water. EPA is aware of the

occurrence of these contaminants in

shallow aquifers in Florida (Harada, et

al., 1989; Upchurch, 1991), and in at

least two other States. Because of

potential occurrence, consequent health

risks, and in response to public

comments, EPA has added polonium210 and lead-210 to the UCMR (1999)

List and has placed them on Lists 2 and

3 respectively.

(b) Regulatory Approach for the UCMR

(1999) List

EPA establishes in § 141.40(a)(3) that

the contaminants listed in Lists 1–3

comprise the UCMR (1999) List,

categorized based on the availability of

analytical methods. UCMR (1999) List 1

is the basis for Assessment Monitoring.

Assessment Monitoring will occur at all

2,774 large community and nontransient non-community public water

systems serving more than 10,000

persons and at a representative sample

of approximately 800 systems serving

10,000 or fewer persons identified in

State Monitoring Plans. UCMR (1999)

List 2 will be the basis for two Screening

Surveys of approximately 300 systems

each, statistically selected from those

systems required to conduct Assessment

Monitoring. UCMR (1999) List 3 will be

used for Pre-Screen Testing at up to 200

systems selected because of their

potential vulnerability to the specific

contaminants. This monitoring

approach is described in detail under

Section VI.C, ‘‘Type of Monitoring

Required of Public Water Systems Based

on Listing Group.’’ Assessment

Monitoring (and associated ‘‘Index

system’’ monitoring) is the only

monitoring that would be required by

today’s action. This includes

contaminants for which EPA expects to

have developed analytical methods

before implementation: perchlorate and

acetochlor.

For contaminants on UCMR (1999)

List 2 for which analytical methods are

developed by the time of initial

monitoring in 2001, EPA will amend

this rule to require the first Screening

Survey to be conducted at selected

systems. For those contaminants on List

2 and List 3 that do not have well

developed methods by the time of initial

monitoring in 2001, EPA will issue a

revision to this regulation to activate

monitoring for them at the time when

the methods are considered

implementable, up to the limit of 30

contaminants to be monitored within

the five-year contaminant listing cycle.

Monitoring for those contaminants will

then begin at a date specified in that

prospective regulation. Therefore,

monitoring of contaminants on UCMR

(1999) Lists 2 and 3 is not required by

today’s action. Monitoring of these

contaminants will only occur when EPA

publishes a revision to this regulation

specifying the analytical methods to be

used and the period during which

monitoring is to be completed.

(c) Analytical Methods Applicable to

the UCMR (1999) List

The UCMR (1999) List development

process focuses primarily on the

availability of analytical methods for the

listed contaminants and the level of

information available for them at the

time of its development. The discussion

below highlights analytical method

considerations in listing the

contaminants for monitoring. Only the

contaminants identified on UCMR

(1999) List 1, will be monitored as a

result of today’s action, with the

exceptions of perchlorate and

acetochlor, for which analytical

methods have yet to be approved.

Contaminants on UCMR (1999) Lists 2

and 3 are included on the final UCMR

(1999) List, but will not be activated for

monitoring until EPA proposes and

promulgates analytical methods that can

be used to reliably measure their

occurrence in drinking water. At that

time, EPA will propose regulations for

the monitoring of UCMR (1999) List 2

and 3 contaminants.

(i) Chemical Analytical Methods

The ability to correctly identify a

chemical contaminant is directly related

to the type of chemical and the

analytical method used. Compounds

such as disinfection byproducts are far

less likely to be misidentified than

pesticides because they are typically

present at relatively high concentrations

in disinfected waters, while pesticides

are much less likely to occur, or occur

at lower concentrations. The analytical

method selected will determine the

accuracy of the qualitative

identification. In general, the most

reliable qualitative identifications will

come from methods that use mass

spectral data for contaminant

identification. However, these methods

are typically less sensitive than methods

that rely on less selective detectors.
50562 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

Before EPA establishes a Maximum

Contaminant Level (MCL), the Agency

relies on an analytical method suitable

for routine monitoring. It is likely that

analytical methods in general use by

laboratories performing drinking water

analyses may not exist for some of the

final compounds to be measured in the

UCMR program. Complex analytical

methods or methods requiring special

handling often require more

experienced laboratories than the

laboratories performing routine

compliance monitoring. Even when

analytical methods that are in general

use by analytical laboratories are

available, limiting the analyses to a

small number of laboratories operating

under strict quality control

requirements improves the precision

and accuracy of the analyses, thereby

increasing the usefulness of the data.

The option favored by many

stakeholders for conducting the

chemical laboratory analyses and made

final today by EPA is the following:

For PWSs serving more than 10,000

people, the PWS is responsible for

sample collection and analyses for

Assessment Monitoring. This

monitoring may be conducted at the

same time as the required compliance

monitoring, to the extent possible. For

Assessment Monitoring, however, EPA

requires in § 141.40(a)(3) and § 141.40

Appendix A, quality control procedures

for both sampling and testing to ensure

that the data collected under this

regulation are of sufficient quality to

meet the requirements of the related

regulatory decisions. Thus, today’s

action specifies the analytical methods

and procedures to be used in obtaining

these data. The sampling and associated

quality control requirements cover time

frame, frequency, sample collection and

submission, and review and reporting of

results. The laboratory analytical quality

control requirements address the use of

a certified laboratory, sample collection/

preservation, analytical methods,

method detection limits, calibration,

quality control samples, method

performance tests, detection

confirmation, and reporting. PWSs

serving 10,000 or fewer persons must

send their Assessment Monitoring

samples to laboratories designated by

EPA, since the Agency must pay for the

reasonable costs of testing.

The purpose of the quality control

requirements is to ensure that, since

EPA will only be able to obtain results

from 3,574 systems (2,774 large systems

and a representative sample of 800

systems from 65,600 systems serving

10,000 or fewer persons), the Agency

obtains the most reliable data possible.

EPA is specifying the use of certain

analytical methods that are currently

available for monitoring (see Table 3,

UCMR (1999) List, column 3). While

these methods are routinely used by

commercial and public water system

laboratories (including some that are

currently used for compliance

monitoring), they have not been

routinely used for the contaminants on

the UCMR (1999) List. Note that, as

shown in § 141.40(a)(3), Table 1,

methods other than those that EPA has

developed may be approved for use, but

quality control procedures must also be

followed, as specified in § 141.40(a)(3),

(4) and (5), and Appendix A.

For the compounds included in this

regulation, the following summary,

Table 1, Status of Analytical Methods

for Chemical Contaminants on the

UCMR (1999) List, presents a brief

overview of methods availability for

each chemical contaminant.

TABLE 1.—STATUS OF ANALYTICAL METHODS FOR CHEMICAL CONTAMINANTS ON THE UCMR (1999) LIST

CAS No. Analytical methods Status of availability

UCMR (1999) List 1—Chemical Contaminant

2,4-dinitrotoluene ..................... 121–14–2 EPA 525.2 ............................... Method is adequate for monitoring.

2,6-dinitrotoluene ..................... 606–20–2 EPA 525.2 ............................... Method is adequate for monitoring.

4,4’-DDE .................................. 72–55–9 EPA 508 ..................................

EPA 508.1 ...............................

EPA 525.2 ...............................

D5812–96 ...............................

AOAC 990.06 ..........................

Methods are adequate for monitoring.

Acetochlor ................................ 34256–82–1 In validation process ............... EPA anticipates that this compound can be added to the

scope of EPA Method 525.2.

DCPA di acid degradate ......... 2136–79–0 EPA 515.1 ...............................

EPA 515.2 ...............................

D5317–93 ...............................

AOAC 992.32 ..........................

No method is available to measure the mono and di acid

forms separately. All of the approved methods identify total

mono and di acid forms.

DCPA mono acid degradate ... 887–54–7 EPA 515.1 ...............................

EPA 515.2 ...............................

D5317–93 ...............................

AOAC 992.32 ..........................

No method is available to measure the mono and di acid

forms separately. All of the approved methods identify total

mono and di acid forms.

EPTC ....................................... 759–94–4 EPA 507 ..................................

EPA 525.2 ...............................

D5475–93 ...............................

AOAC 991.07 ..........................

Methods are adequate for monitoring.

Molinate ................................... 2212–67–1 EPA 507 ..................................

EPA 525.2 ...............................

D5475–93 ...............................

AOAC 991.07 ..........................

Methods are adequate for monitoring.

MTBE ....................................... 1634–04–4 EPA 524.2 ...............................

D5790–95 ...............................

SM6210D ................................

SM6200B ................................

Methods are adequate for monitoring.

Nitrobenzene ........................... 98–95–3 EPA 524.2 ...............................

D5790–95 ...............................

SM6210D ................................

SM6200B ................................

Methods are adequate for monitoring.
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50563

TABLE 1.—STATUS OF ANALYTICAL METHODS FOR CHEMICAL CONTAMINANTS ON THE UCMR (1999) LIST—Continued

CAS No. Analytical methods Status of availability

Perchlorate .............................. 14797–73–0 In validation process ............... EPA is currently conducting analytical methods development

to support the analyses of perchlorate. This new method

will be based on the currently available ion chromatography methods, but will include a criteria detailing when

a laboratory must perform a sample clean-up procedure to

minimize the impact of elevated concentrations of chloride,

sulfate or other dissolved solids.

Terbacil .................................... 5902–51–2 EPA 507 ..................................

EPA 525.2 ...............................

D5475–93 ...............................

AOAC 991.07 ..........................

Methods are adequate for monitoring.

UCMR (1999) List 2—

Chemical Contaminant

1,2-diphenylhydrazine ............. 122–66–7 In development ....................... Some methods evaluated but inadequate for monitoring. Priority for analytical method development. EPA anticipates

that contaminant will be added to the scope of EPA Method 525.2.

2,4,6-trichlorophenol ................ 88–06–2 In development ....................... EPA Method 552 evaluated but subject to false positives

from interferences of the derivitized byproduct of the contaminant. EPA anticipates that contaminant will be included

in a new SPE/GC/MS method currently under development.

2,4-dichlorophenol ................... 120–83–2 In development ....................... EPA Method 552 evaluated but subject to quantitative uncertainty due to inadequate derivatization of the contaminant.

EPA anticipates that contaminant will be included in a new

SPE/GC/MS method currently under development.

2,4-dinitrophenol ...................... 51–28–5 In development ....................... Some methods evaluated but inadequate for monitoring. EPA

anticipates that contaminant will be included in a new SPE/

GC/MS method currently under development.

2-methylphenol ........................ 95–48–7 In development ....................... Some methods evaluated but inadequate for monitoring. EPA

anticipates that contaminant will be included in a new SPE/

GC/MS method currently under development.

Alachlor ESA and degradation

byproducts of acetanilide

pesticides.

........................ To be determined ................... EPA is evaluating which specific contaminants will be included within this group of compounds. Analytical methods

will be determined for the targeted contaminants.

Diazinon ................................... 333–41–5 In development ....................... Diazinon is listed as a contaminant in several EPA and voluntary consensus standard organization methods but it is

subject to rapid aqueous degradation. Preservation research currently being conducted to develop a preservation technique that would permit adding this compound to

EPA Method 525.2.

Disulfoton ................................. 298–04–4 In development ....................... Disulfoton is listed as a contaminant in several EPA and voluntary consensus standard organization methods but it is

subject to rapid aqueous degradation. Preservation research currently being conducted to develop a preservation technique that would permit adding this compound to

EPA Method 525.2.

Diuron ...................................... 330–54–1 In development ....................... While this compound is included in the scope of NPS Method

4 (LLE/HLPC/UV) and EPA Method 553 (SPE/HPLC/MS),

these methods are not adequate for this monitoring. EPA

anticipates that this compound can be included in a new

SPE/HPLC/UV method currently being developed.

Fonofos .................................... 944–22–9 In development ....................... Fonofos is listed as a contaminant in several EPA and voluntary consensus standard organization methods but it is

subject to rapid aqueous degradation. Preservation research is currently being conducted to develop a preservation technique that would permit adding this compound to

EPA Method 525.2.

Linuron ..................................... 330–55–2 In development ....................... While this compound is included in the scope of NPS Method

4 (LLE/HLPC/UV) and EPA Method 553 (SPE/HPLC/MS),

these methods are not adequate for this monitoring. EPA

anticipates that this compound can be included in a new

SPE/HPLC/UV method currently being developed.

Polonium-210 (210Po) .............. 13981–52–7 In development ....................... Radiochemistry laboratory capacity is limited.
50564 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

TABLE 1.—STATUS OF ANALYTICAL METHODS FOR CHEMICAL CONTAMINANTS ON THE UCMR (1999) LIST—Continued

CAS No. Analytical methods Status of availability

Prometon ................................. 1610–18–0 In development ....................... Prometon is listed as a contaminant in several EPA and voluntary consensus standard organization methods but it is

subject to rapid aqueous degradation in non-acidified samples and is not readily extracted in acidified samples. Preservation research is currently being conducted to add neutralizing the pH of acidified samples just prior to extraction.

This would permit adding this compound to EPA Method

525.2.

RDX ......................................... 121–82–4 In development ....................... No EPA or consensus methods organization analytical methods for the analysis of RDX in water are currently available.

Terbufos .................................. 13071–79–9 In development ....................... Terbufos is listed as a contaminant in several EPA and voluntary consensus standard organization methods but it is

subject to rapid aqueous degradation. Preservation research is currently being conducted to develop a preservation technique that would permit adding this compound to

EPA Method 525.2.

UCMR (1999) List 3—

Chemical Contaminant

Lead-210 (210Pb) ..................... 14255–04–0 In development ....................... Method is time-consuming and expensive. Radiochemistry

laboratory capacity is limited.

(ii) Microbiological Analytical Methods

The discussion of data quality for

chemical analytical methods also

applies to microbiological testing when

analytical methods are developed for

CCL microorganisms. When

microorganisms were proposed for the

CCL, EPA recognized that analytical

methods were not well developed for

the majority of them. Because of the lack

of available analytical methods, some of

the CCL microorganisms were grouped

either into one category where

information was available about

methodologies indicating a need to

further refine them, or another category

where more research, including research

on detection methods and occurrence,

was needed. At the present time, and

based on technical peer review and

public comment, Aeromonas is the only

one of the microorganisms for which

more occurrence data are needed that

also has an analytical method likely to

be sufficiently developed for monitoring

in time for implementation of the

Screening Surveys. Three other

microorganisms have methods available,

but are in need of further methods

development. These microorganisms

(Cyanobacteria, Echoviruses, and

Coxsackieviruses) may be candidates for

the Screening Surveys if methods

development proceeds expeditiously

(§ 141.40(a)(3), Table 1, List 2), but are

currently identified for Pre-Screen

Testing (Table 1, List 3). The remaining

four microorganisms currently lack

satisfactory methods and will be

evaluated for Pre-Screen Testing.

Several microorganisms on the CCL

are actually groups of microorganism

taxa. In some cases, the taxa have so

many members that, given the limited

resources available for UCMR

monitoring, EPA may have to prioritize

which strains, species, or serotypes are

the most important to consider and

target those for monitoring or further

study. Decisions will have to be made

on the basis of health risk, disinfection

resistance, occurrence in water, and

other factors. To address the need to

prioritize which microorganisms should

be targeted for monitoring, EPA’s Office

of Research and Development is

assisting the Office of Ground Water and

Drinking Water in establishing a

research program for health effects,

treatment, and analytical methods.

TABLE 2.—STATUS OF ANALYTICAL METHODS FOR MICROBIOLOGICAL CONTAMINANTS ON THE UCMR (1999) LIST

Availability of analytical method Status of availability

List 2—Microbiological Contaminant

Aeromonas ....................................... Analytical method likely to be

available for monitoring.

Current modification and evaluation of a published membrane filtration method (Havelaar et al., 1987) indicates that this method will

be suitable for the monitoring program.

List 3—Microbiological Contaminant

Cyanobacteria (blue-green algae,

other freshwater algae and their

toxins).

Methods available but not standardized.Methods are available for counting cyanobacteria but new, standardized methods are needed for direct counts of targeted species with

filtration methods or a counting chamber. Standardized analytical

methods are also needed to detect the more important

cyanobacterial toxins.

Echoviruses ...................................... Methods available but not standardized.Echoviruses can be cultured on BGM cells and detected by the ICR

method but require supplemental methods such as serological typing to distinguish echoviruses from other viruses. Cost of cell culture assays plus serotyping can be high. RT/PCR methods are

subject to interferences and do not demonstrate infectivity. Combined cell culture and PCR, which demonstrates infectivity, may be

considered.
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50565

TABLE 2.—STATUS OF ANALYTICAL METHODS FOR MICROBIOLOGICAL CONTAMINANTS ON THE UCMR (1999) LIST—

Continued

Availability of analytical method Status of availability

Coxsackieviruses .............................. Methods available but not standardized.Group B coxsackieviruses are easy to grow in tissue culture but

group A coxsackievirus detection in cell culture is variable.

Culturable coxsackieviruses can be detected with the ICR method

but serological typing is needed to distinguish coxsackieviruses

from other viruses. RT/PCR methods are subject to interferences

and do not demonstrate infectivity. New, standardized methods are

needed. Combined cell culture and PCR methods may be considered.

Helicobacter pylori ............................ No suitable method currently

available.

Helicobacter pylori is difficult to cultivate because of its slow growth

rate and the need for a low oxygen environment. No selective medium exists that will discriminate H. pylori from background bacteria. A culture-based method that demonstrates viability is preferred. Methods are needed for selective growth and identification.

IMS has been used to concentrate Helicobacter pylori. Methods

using PCR alone have been used but have not been validated by

EPA. In general, PCR methods are not preferred due to interferences and their inability to demonstrate viability. A combined

cultural and molecular method may be considered.

Microsporidia .................................... No suitable method currently

available.

No methods are available for the monitoring of the two species of

human microsporidia which may have a waterborne route of transmission [Enterocytozoon bienuesi and Encephalitozoon (formerly

Septata) intestinalis]. Spores could possibly be detected by methods similar to those being developed for Cryptosporidium parvum.

Potential methods may utilize water filtration, clean-up with IMS,

and detection using microscopy with either fluorescent antibody or

gene probe procedures. Provided that procedures are validated by

EPA, reverse-transcriptase (RT)—PCR techniques may be considered for monitoring, although PCR methods in general are not preferred at this time due to interferences and their inability to demonstrate viability. Due to the small size of microsporidia, problems

could be encountered during filtration.

Adenoviruses .................................... No suitable method currently

available.

Adenoviruses serotypes 1 to 39 and 42 to 47 can be grown in tissue

culture but enteric adenoviruses 40 to 41 are difficult to grow. Several selective tissue culture methods and detection methods have

been reported. A selective, standardized method is needed for

monitoring. PCR methods are not preferred, as they are subject to

interferences and do not demonstrate infectivity. A combined cell

culture and PCR method may be considered.

Caliciviruses ...................................... No suitable method currently

available.

No tissue culture methods exist for the two genogroups of

caliciviruses on the CCL (the Norwalk-like and the Snow Mountainlike agents). No sensitive or fully developed detection methods

exist. PCR methods are not preferred, as they are subject to interferences and do not demonstrate infectivity. A combined cell culture and PCR method may be considered if a suitable cell line is

found.

2. List of Contaminants To Be

Monitored

(a) Final UCMR (1999) List

Section 141.40 (a)(3) Table 1,

Unregulated Contaminant Monitoring

Regulation (1999) List, presents EPA’s

list of unregulated contaminants for

monitoring under Section

1445(a)(2)(B)(i) of the 1996

Amendments for the first five-year

listing cycle. The monitoring program

for these contaminants is a three-tiered

approach based on the availability of

information about each contaminant

and the availability of analytical

methods for each contaminant. This

approach is described in Section C.,

Type of Monitoring Required of Public

Water Systems Based on Listing Group.

The final monitoring program divides

the listed unregulated contaminants into

three lists: List 1, for which Assessment

Monitoring will be required, List 2,

designated for the Screening Surveys;

and List 3, designated for Pre-Screen

Testing. Today’s final regulation only

requires Assessment Monitoring for

UCMR (1999) List 1 contaminants

beginning on January 1, 2001, with the

exceptions of perchlorate and

acetochlor, for which analytical

methods have not yet been approved

(but are planned to have monitoring

begin on that date, also, after

rulemaking to specify their analytical

methods). The monitoring for

contaminants on Lists 2 and 3 will only

be required after EPA promulgates

further rules.

Technical peer review and public

comments strongly supported the threetier approach of the UCMR program. As

a result, EPA requires in today’s action

Assessment Monitoring for the

contaminants on UCMR (1999) List 1,

because analytical methods for these

contaminants currently exist or will

shortly be validated. EPA will shortly

publish a request for public comment on

a revision to this final rule to implement

the analytical methods and other

sampling requirements for perchlorate

and acetochlor. Also, by future

rulemaking, EPA plans to implement

the Screening Survey (List 2) monitoring

in groups of contaminants, rather than

one contaminant at a time, to minimize

sampling and testing costs since some of

the contaminants may be tested by the
50566 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

same method. EPA intends to take a

similar approach with the contaminants

on List 3, the Pre-Screen Testing. EPA

plans to require, through future

rulemaking, Pre-Screen Testing for

contaminants for which EPA determines

that new analytical methods can

measure their existence in locations

where they are most likely to be found.

All analytical methods for contaminants

on Lists 2 and 3 would be peer

reviewed, following EPA’s policy for

peer review, before the Agency proposes

regulations which would require public

water systems to monitor for them.

In § 141.40 (a)(3), Table 1, UCMR

(1999) List 1 contaminants, for

Assessment Monitoring, are chemical

contaminants for which analytical

methods capable of generating the

quantity and quality of data required

under the UCMR are currently available,

or expected to be available shortly after

today’s final rule. Monitoring for these

contaminants is required under today’s

final UCMR, with the exceptions of

perchlorate and acetochlor, as noted.

UCMR (1999) List 2 contaminants (14

organic chemicals, one radiochemical

and one microorganism), for the

Screening Surveys, are those for which

EPA is currently refining analytical

methods. Development of these methods

should be sufficient for Screening

Surveys to be conducted in the first

three years of the listing cycle, but may

occur in the later years of the cycle.

These contaminants are characterized in

today’s final rule at § 141.40(a)(3), Table

1, Unregulated Contaminant Monitoring

Regulation (1999) List, List 2.

UCMR (1999) List 3 contaminants

(seven microbiological contaminants or

contaminant groups and one inorganic

chemical), for Pre-Screen Testing, are

those for which EPA has begun or

shortly will begin analytical methods

development, but completion of those

efforts is not expected prior to the

Assessment Monitoring required under

implementation of this regulation.

Instead, these contaminants will be

tested for in Pre-Screen Testing. These

contaminants are listed in today’s final

rule at § 141.40(a)(3) as Table 1,

Unregulated Contaminant Monitoring

List, List 3.

Tables 3 and 4, in IV.A.1.(c),

Analytical Methods Applicable to the

UCMR (1999) List, present a summary of

the status of the methods for all the

contaminants on this list.

EPA believes that this three-tiered

approach to the UCMR, which was

recommended by stakeholders, reflects a

balance between the implementability

of current analytical methods and the

need to obtain data in time frames that

are useful for responding to concerns

about the contaminants identified.

(b) Number of Contaminants on the

UCMR (1999) List

Thirty-six contaminants are on

today’s final UCMR (1999) List. SDWA

Section 1445 (a)(2)(B)(i) states that in

August 1999 and every five years

thereafter ‘‘the Administrator shall issue

a list of * * * not more than 30

unregulated contaminants to be

monitored by public water systems and

to be included in the national drinking

water occurrence data base * * *’’ EPA

interprets this to mean that the UCMR

list may contain more than 30

contaminants, as long as monitoring is

not required for more than 30

contaminants during a five-year listing

cycle. Public comments were split on

whether the monitoring list should have

more than 30 contaminants. EPA

believes that maintaining a monitoring

list with more than 30 contaminants,

while requiring monitoring for no more

than 30, is responsive to public

concerns about contaminants in

drinking water. This interpretation and

approach also supports EPA’s efforts to

respond to and encourage analytical

methods development for emerging

contaminants.

Any PWS may voluntarily submit

data to EPA, including data for

contaminants that a PWS may monitor

that are on the UCMR (1999) List of 36

contaminants, but that are not on the

final list of 30 contaminants actually

required for UCMR monitoring. EPA is

preparing a guidance document

specifying the procedures for future

voluntary submission of such data to the

National Drinking Water Contaminant

Occurrence Database (NCOD).

B. Public Water Systems Subject to the

UCMR

The monitoring in this final rule

focuses ultimately on determination of,

on a national basis, the occurrence or

likely occurrence of contaminants in

drinking water delivered by community

water systems (CWS) and non-transient

non-community water systems

(NTNCWS). For regulatory purposes,

public water systems are categorized as

‘‘community water systems,’’ or ‘‘noncommunity water systems.’’ Community

water systems (CWSs) are specifically

defined as ‘‘public water systems which

serve at least 15 service connections

used by year-round residents or

regularly serve at least 25 year-round

residents.’’ (40 CFR 141.2) A ‘‘noncommunity water system’’ means any

other public water system. Noncommunity water systems include

nontranisent non-community water

systems (NTNCWSs) and transient noncommunity water systems. Noncommunity water systems are available

to serve the public, but are not used on

a year-round basis in most cases. Nontransient systems regularly serve at least

25 of the same persons over six months

per year (e.g., schools). Transient

systems do not regularly serve at least

25 of the same persons over six months

per year. Additionally, some community

water systems purchase all or part of

their water supply from other water

systems. Purchased water systems may

be at the end of a distribution system

from the water system selling the water.

One of the factors considered in

establishing the UCMR program is the

number of persons served by a system.

With respect to size, about 2,774 large

systems (each serving more than 10,000

persons) provide drinking water to

about 80 percent of the U.S. population

served by public water systems. Under

today’s final regulation, all large

systems will be required to monitor the

unregulated contaminants specified in

§ 141.40(a)(3), List 1 of Table 1, UCMR

(1999) List, with the exception of

perchlorate and acetochlor for which

analytical methods have not been

promulgated. In response to public

comment on purchased water systems

representing the end of a distribution

system, purchased water systems are

also included in this monitoring

requirement for microbiological

contaminants that occur primarily in

distribution systems with maximum

residence times or low disinfectant

residuals which may allow

microorganisms that have human health

effects to survive and reproduce.

Section 1445(a)(2)(A) requires that the

UCMR ensure that only a representative

sample of systems serving 10,000 or

fewer persons (small systems) monitor

for unregulated contaminants. Small

community water systems and small

non-transient, non-community water

systems total 65,636 systems. From this

total number of small systems, EPA will

select a national representative sample

of 800 small systems. EPA is excluding

transient non-community systems from

UCMR requirements. The variation in

the 97,000 transient systems would be

difficult to reflect in a national

representative sample and would be

very costly to monitor. Furthermore,

projecting contaminant exposure results

from such systems would be complex

and inconclusive because of the

transient nature of the population that

uses them. The results from the very

small community and non-transient

non-community systems (NTNCWS) can

be extrapolated to the transient noncommunity systems. Public comments
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50567

supported not including these systems

in the representative sample. One

commenter suggested that transient

systems be the subject of a special

survey since they may be a pathway of

exposure for a specific segment of the

population. At this time, EPA is not

planning any special surveys of

transient systems because they are such

a large and diffuse category and it is

difficult to compile and evaluate

population exposure information for

this category of water systems.

EPA will pay for the reasonable costs

of monitoring by the small systems

selected for the representative sample,

as long as the systems are part of a State

Monitoring Plan. The EPA will select

systems to monitor through the use of a

random number generator according to

a national representative sample

selection plan developed primarily on

the basis of population served by PWSs

in each State. This detailed selection

plan is necessary to ensure that the

sample is statistically valid and

representative of all small water systems

nationally. This plan is also necessary

because EPA typically has the least

information about these systems and

needs a consistent base of data for

regulation development. EPA will use a

national sample of approximately 800

systems serving 10,000 or fewer persons

which the EPA will statistically draw

from all small CWSs and NTNCWSs

nationally. Section F, ‘‘Representative

Sample of Systems Serving 10,000 or

Fewer Persons,’’ provides the details of

the sample selection plan, including the

sample size. The number of systems

selected within each size category of

systems will be based on the proportion

of population served by that size

category. System selection will be

further allocated across water source

type and distributed across all states.

The State-based component of this

national representative sample, called a

State Monitoring Plan (or State Plan),

will include the list of systems

statistically selected for UCMR

monitoring. Other state responsibilities

will be defined in the Memorandum of

Agreement issued between the States

and EPA. The State can review, and

modify if necessary, the list of systems

in the State Plan. The resulting State

Plans will then be part of a national

sample framework, providing the

representative national sample requisite

to drawing national conclusions for

contaminant exposure.

To provide a more capable

understanding of contaminants and

conditions affecting small systems, and

to provide additional quality assurance,

EPA will randomly select up to 30 small

public water systems from the systems

in State Monitoring Plans as ‘‘Index’’

systems. Index systems must monitor

every year during the five year UCMR

listing cycle. These systems will also be

required to report information on

system operating conditions (such as

water source, pumping rates, and

environmental setting). This

information will assist EPA in more

fully evaluating small system operations

and future regulations of small systems.

EPA will conduct the sampling and

testing for Index systems. At the time of

sampling, EPA will also gather other

system information to characterize the

environmental setting affecting the

system including precipitation, land

and water resource use, and

environmental factors (such as soil type

and geology).

Also, up to 150 additional small

systems might be selected for the PreScreen Testing. The systems for the PreScreen Testing will be selected on the

basis of their representativeness of

systems most vulnerable to the

particular UCMR (1999) List 3

contaminants for which methods have

been refined. The statistical selection of

the 800 systems for the national

representative sample may not include

the systems determined to be most

vulnerable to these contaminants,

hence; the States and EPA may need to

select additional systems for this

targeted testing.

External expert peer review and

public comments supported the

statistical approach described to select

small systems for the national

representative sample and State

Monitoring Plans.

C. Type of Monitoring Required of

Public Water Systems Based on Listing

Group

At the UCMR Stakeholders Meeting

on June 3–4, 1998, a diverse group of

stakeholders suggested that the UCMR

Program be developed through a

progression of monitoring levels based

on contaminant group characteristics.

These characteristics reflect current

information about both the occurrence

of and method availability for the

contaminants. Occurrence information

and methods availability will determine

which phase, or tier, of monitoring the

contaminants will be placed. Both EPA

and stakeholders are also concerned

about contaminants that may be

‘‘emerging’’ as contaminants of concern.

These emerging contaminants have not

been monitored before, but have the

potential to be found near or in drinking

water supplies or recently have been

identified as potential health problems.

It is not likely that there exists approved

EPA analytical methods for the

‘‘emerging contaminants of concern’’.

Typically, ‘‘research’’ analytical

methods are used to detect such

emerging contaminants and may be

expensive. EPA will have to either

develop an approved method for

inclusion in a regulatory approach, or

perhaps substitute a regulatory

approach with a study using a single

laboratory and a ‘‘research’’ analytical

method. The resources needed to

develop an approved analytical method

will face competing resource demands

for other contaminants on the CCL that

also require analytical method

development. In recognition of these

considerations, as described above, the

final rule incorporates an approach with

three monitoring levels, or tiers, referred

to as ‘‘Assessment Monitoring,’’

‘‘Screening Survey,’’ and ‘‘Pre-Screen

Testing’’.

1. Assessment Monitoring

The first type of monitoring in the

three-tiered monitoring program of

today’s rule pertains to the group of

contaminants for which analytical

methods are currently available and are

specified in § 141.40(a)(3), Table 1,

UCMR (1999) List 1, Assessment

Monitoring Importantly, these

contaminants are ones for which initial

data for PWSs indicate that the

contaminants occur in at least two

States or ten public water systems and

should be monitored to assess national

occurrence through the UCMR. Based

on today’s rule, all contaminants in

§ 141.40(a)(3), Table 1, List 1 must be

monitored in the Assessment

Monitoring tier of the UCMR Program,

except perchlorate and acetochlor, for

which analytical methods are soon to be

finalized.

In § 141.40, EPA indicates that each

system must conduct UCMR

‘‘Assessment Monitoring’’ of List 1

contaminants for a twelve-month period

in the first three years (i.e., 2001

through 2003) of a five-year UCMR

contaminant listing cycle (i.e., 2001

through 2005). Large systems must

complete this monitoring in any twelvemonth period within the years 2001 to

2003. Small systems in State Monitoring

Plans must complete the monitoring

according to the scheduled monitoring

identified in those plans within the

period of 2001 to 2003. Section F,

‘‘Representative Sample of Systems

Serving 10,000 or fewer persons,’’

describes in detail the selection of the

subset of small systems required to

monitor. The State could specify in the

State Monitoring Plans a schedule that

would correlate with compliance

monitoring. This arrangement should

enable systems to complete UCMR
50568 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

sampling coincident with their

compliance monitoring for regulated

contaminants during one of the years

when compliance monitoring is

required. However, EPA recognizes that

some large systems may not be required

to monitor for any regulated

contaminants during the five-year

UCMR listing cycle. In that case, such

large systems could monitor for the

unregulated contaminants during any

twelve-month period within the three

years they choose. This approach, as

originally proposed, is responsive to

public comments that UCMR

monitoring be able to be conducted in

conjunction with compliance

monitoring.

EPA is requiring that surface water

systems monitor for four consecutive

quarters in the designated, or, in the

case of large systems, selected,

monitoring year, and that ground water

systems monitor two times

approximately five to seven months

apart in their monitoring year. Under

Assessment Monitoring, systems serving

more than 10,000 persons must conduct

and pay for their own sample collection

and testing. Small systems included in

State Monitoring Plans must collect the

samples with EPA-supplied equipment

and send the samples to EPA-specified

laboratories. EPA will pay for the testing

and reporting. Although the laboratory

may report the information directly to

EPA and provide a copy to the State, the

system still has final reporting

responsibility to ensure that results are

reported to EPA and copied to the State.

Frequency and location of monitoring

are discussed in section D, ‘‘Monitoring

Requirements under the Final UCMR.’’

2. Screening Surveys

The contaminants that EPA is

considering for the Screening Survey are

listed in § 141.40(a)(3), Table 1, List 2.

These contaminants are those for which

analytical methods are under

development and for which EPA has

less occurrence data than for the

contaminants on List 1. The purpose of

the Screening Survey is to analyze for

contaminants where the use of newly

developed, non-routine analytical

methods are required. To do this and

still maintain adequate quality of the

occurrence data, EPA will use only a

select, controlled group of laboratories.

In addition, the Screening Survey

approach might allow EPA to maximize

scientifically-defensible occurrence data

for emerging contaminants of concern

more quickly than could be obtained

through a more standard unregulated

contaminant monitoring effort. The

Screening Survey could, for example, be

useful where questions concerning

whether a contaminant of concern is in

fact occurring in drinking water and the

range of concentration of that

occurrence. The Screening Survey is

also intended to allow EPA to screen

contaminants to see if they occur at high

frequencies or concentrations that

justify inclusion in future unregulated

contaminant Assessment Monitoring or

at sufficiently low frequencies that do

not require further monitoring, but

allow the Agency to evaluate standard

development.

The contaminants in UCMR (1999)

List 2 will be monitored by a smaller,

statistically selected sample from all

(large and small) community and nontransient non-community water systems

(about 300 systems total). These systems

will be selected through a random

number generator. Systems will not

have to initiate Screening Surveys until

after EPA promulgates requirements for

Screening Surveys. The sample size

needed for estimating frequencies of

contaminant occurrence are smaller if

the actual occurrence frequencies are

close to 0 or to 100 percent. When a

contaminant is consistently present or

consistently absent it requires fewer

samples to determine its frequency with

adequate statistical confidence than if it

occurs about half the time. Only 300

PWSs are needed to determine if a

contaminant is present 5 percent of the

time or less frequently, at a 99 percent

confidence level and with a 3 percent

margin of error. (The same criteria

require 1,844 samples when the

frequency could be any number.) If the

contaminant occurrence findings are

above the thresholds established for the

Screening Survey, EPA will include the

contaminant in the next Assessment

Monitoring round (projected to begin in

2006) of the UCMR Program. The

statistical threshold for positive results

from this monitoring to determine if

further monitoring is warranted might

be 1 to 2 percent of systems with

detections. If the contaminant

occurrence were under the threshold,

then no further testing would be

required, and the contaminant may be

removed from the list in a future UCM

rulemaking. EPA requested public

comment on whether the statistical

threshold of 1 to 2 percent of systems

is adequate to make a determination that

further Assessment Monitoring should

be conducted to determine the extent of

contaminant occurrence, and, if not,

what percent should be used as the

threshold for such a determination. One

commenter suggested that EPA should

use a threshold of 3 to 5 percent, but did

not provide any rationale. EPA believes

that 1 to 2 percent is consistent with the

approach that this monitoring is a

Screening Survey to determine whether

the contaminant(s) are occurring in any

public water system. One to 2 percent

occurrence is equal to 3 to 6 systems for

the sample, but statistically this can be

extrapolated to 600 to 1,200 systems out

of all small systems that may have an

occurrence of the contaminants. For a

sample size of 300, occurrence of a

contaminant on the monitoring list in

any system would indicate that the

contaminant occurs at a frequency

greater than 0 (zero). Therefore, EPA

should give further consideration to the

occurrence and concentration of such a

contaminant and may evaluate the

extent of its occurrence nationally. EPA

considers this extent of occurrence to be

significant and to warrant more

extensive monitoring, perhaps even

through Assessment Monitoring.

Another commenter indicated that EPA

should evaluate other factors and not

just the extent of occurrence before

deciding to regulate a contaminant. EPA

agrees with this comment and will

continue to evaluate other factors.

The anticipated analytical methods

that might be used for Screening

Surveys are identified in § 141.40(a)(3),

Table 1, List 2, as ‘‘Analytical

Methods.’’ These methods are being

refined for the particular contaminants

on List 2 and are not expected to be

ready for use in an Assessment

Monitoring program. Therefore, as

analytical methods are developed for

groups of contaminants on List 2, EPA

will propose a rule modification for

public comment and will promulgate

analytical methods, minimum reporting

levels and the location and timeframe

for sampling for each contaminant.

Additionally, EPA requested public

comment on two potential outcomes

from the Screening Survey: (1) if the

contaminant is observed at very few or

no PWSs (i.e., less than the threshold of

1 to 2 percent of systems), then the

contaminant may be dropped from the

UCMR (1999) List 2 and no further

monitoring for it will occur; and, (2) if

the contaminant is observed extensively

(i.e., in a higher percentage of PWSs,

such as 5 to 10 percent) and EPA has

health effects data for the contaminant

that indicate a significant concern, then

that specific contaminant may move

directly to the regulation development

stage. In these cases, there may be no

Assessment Monitoring tier of

monitoring activity to provide

additional occurrence data for that

contaminant. One commenter expressed

concern that EPA would move directly

to regulation development after

obtaining results from Screening

Surveys for a contaminant and stated
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50569

that EPA should move the contaminant

up to Assessment Monitoring before

taking any action. EPA believes that an

occurrence of a contaminant in 5 or 10

percent of systems, for example, in the

screening survey may be sufficient to

determine whether or not to initiate

regulation development. EPA may

decide that it needs more information,

in which case, EPA could move the

contaminant to Assessment Monitoring

(List 1) for more extensive monitoring to

inform the regulatory process, but this

may not always be necessary.

With respect to funding the Screening

Survey, EPA will pay for the testing and

reporting (as described in Preamble

section V.G., Reporting of Monitoring

Results) for systems serving 10,000 or

fewer persons. Systems serving 10,000

or fewer persons will be responsible for

sample collection and preparing the

samples for shipment. EPA will pay for

the shipment of these samples to an

EPA-designated laboratory for testing

and for reporting of monitoring results

to EPA, with a copy to the State.

For large systems serving more than

10,000 persons, EPA requested public

comment on whether it should set

performance standards and allow

systems to conduct their own laboratory

analyses in compliance with the

standards, or should approve a limited

but sufficient number of laboratories to

do lab analyses for large systems,

providing for quality control across a

manageable number of laboratories

while allowing competitive pricing of

services. Most commenters, including

water system operators, favored EPA

approval of a limited number of

laboratories, but noted that a sufficient

number of laboratories were needed so

that competitive pricing would be

available.

EPA expects the Screening Surveys

will occur one or two times during the

five-year listing cycle of 2001 through

2005. EPA expects that this Screening

Survey monitoring will occur for groups

of contaminants, rather than for one

contaminant at a time, depending on

when the different methods are

promulgated and the timing of their

promulgation. Systems selected for the

Screening Surveys will monitor at the

same frequency as for contaminants

under Assessment Monitoring. Should

approval and implementation of the

analytical method for a particular

contaminant become delayed, the

contaminant might be moved into the

category of Pre-Screen Testing,

described next.

3. Pre-Screen Testing

The third tier of the final monitoring

program is ‘‘Pre-Screen Testing’’, which

will be conducted for contaminants

with analytical methods that are in an

early stage of development and at

systems that are determined to be most

vulnerable to the occurrence of

contaminants on the Pre-Screen Testing

list. Pre-Screen Testing means sampling,

testing, and reporting of the listed

contaminants that have newly emerged

as drinking water concerns and, in most

cases, for which methods are in an early

stage of development. Pre-Screen

Testing will be performed to determine

whether a listed contaminant occurs in

sufficient frequency in the most

vulnerable systems or sampling

locations to warrant its being included

in future Assessment Monitoring or

Screening Surveys. Pre-Screen Testing

will only be required after additional

rulemaking.

EPA will select a limited number of

systems (up to 200) to conduct PreScreen Testing, possibly using a random

number generator, selected from up to

25 of the most vulnerable systems

identified by each State, or by EPA if a

State decides not to participate in the

Pre-Screen Testing system selection

process. Up to 200 systems, a smaller

sample size than under the Screening

Survey or Assessment Monitoring, are

considered sufficient for this type of

monitoring because monitoring will

occur at systems determined to be

vulnerable to occurrence of the

contaminants, based on the

characteristics of the contaminants,

system operation, climatic conditions,

and land and water resource use. This

monitoring is to determine whether the

contaminant can be found in any public

water system under most likely

occurrence conditions specific to the

contaminant. This tier of monitoring is

not designed to determine the extent of

occurrence. A portion (e.g., 100 to 150)

of these 200 systems may be a different

subset of small systems serving 10,000

or fewer persons than those selected for

the national representative sample. The

reason for this different subset is that

States should identify the systems that

are representative of the most

vulnerable conditions for the

contaminants specified for Pre-Screen

Testing. These most vulnerable systems

may not be those conducting

Assessment Monitoring or the Screening

Survey. It is possible, though, that some

overlap of systems doing Assessment

Monitoring and those selected for PreScreen Testing could occur.

Under Pre-Screen Testing, EPA will

designate or approve a laboratory or

laboratories to conduct sample analysis.

The reason for this testing approach is

that the analytical methods expected to

be used will be emerging from research

development, and most laboratories will

not have any experience with them. For

these laboratories to utilize the new

methods could involve extensive

investment in equipment and training.

Rather than requiring this investment

for contaminants which have uncertain

occurrence in public water systems,

EPA will develop and promulgate

appropriate methods. EPA will also

require that these methods be used by

designated or approved laboratories.

Pre-Screen Testing analysis is

conducted at systems most likely to

have the contaminants to determine

whether further action is warranted and

additional method development is

needed.

Under this approach, once EPA has

developed methods and promulgated

the rule to test for List 3 contaminants,

it will request States to identify at least

5 and not more than 25 systems (based

on the population served by PWSs in

each State) most vulnerable to the listed

contaminants. States will select these

systems from all community and nontransient non-community systems of all

sizes. Selection criteria for these

systems include States’ determination of

systems most vulnerable to the specified

contaminants and numbers of systems

per State based on the population

served in each size category of system.

The States will send the list of systems,

any modification of their State

Monitoring Plans, and the reasons for

their list and modifications (considering

the characteristics of the contaminants,

precipitation, system operation, and

environmental conditions) to the EPA.

EPA will select up to 200 PWSs

nationwide, from the pool of Stateidentified vulnerable systems, that must

submit samples of the specified

contaminants. Some small systems

selected may not be part of the national

representative sample of 800 small

systems selected for Assessment

Monitoring. Hence, some small systems

may only be required to sample for PreScreen Testing. States or EPA will

provide instructions to the systems for

the necessary sampling and subsequent

shipping to the EPA laboratory. At this

time, EPA believes that the

contaminants for which Pre-Screen

Testing will likely be required are those

listed in the final rule at § 141.40(a)(3)

Table 1, List 3. Sampling and testing

done for Pre-Screen Testing will most

likely be required in the later years of

the five-year UCMR listing cycle. This

approach will assist EPA in refining the

methods for these contaminants. If EPA

finds any substantial frequency of

occurrence of Pre-Screen Testing

contaminants, the contaminants could
50570 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

become part of either the Screening

Survey or part of Assessment

Monitoring in future UCMR lists. Since

the methods for these contaminants will

have to be applied under highly

controlled analytical conditions, EPA

will pay for the shipping and analyses

of these samples for small systems

selected to participate. Large systems

will pay for the shipping and testing of

samples at EPA approved laboratories.

Public comments requested that EPA

provide guidance on the selection of

‘‘most vulnerable’’ systems and on

reporting requirements for Pre-Screen

Testing. EPA plans to provide this

guidance during the years 2001 and

2002, and obtain public comment before

the guidance is final.

D. Monitoring Requirements Under the

Final UCMR

1. Monitoring Frequency

(a) Systems Serving More Than 10,000

Persons

(i) Chemical Contaminants.

The number of persons served affects

exposure to contaminants and resources

necessary to monitor. The final UCMR

program requires large systems serving

more than 10,000 persons to monitor at

each entry point to the distribution

system, or other representative

compliance monitoring location

specified by the State, whether or not

the system applies treatment. If a system

applies treatment, then it must monitor

after treatment. In response to public

comment, EPA modified the rule to

allow alternative sampling points to be

used: sampling points identified by the

State for compliance monitoring under

40 CFR 141.24(f)(1), (2), and (3), and/or

source (raw) water sampling points, if

the State uses source water monitoring

as a more stringent monitoring

requirement. If monitoring at source

(raw) water sampling points indicates

detection of any of the contaminants on

the monitoring list, then the system in

most cases will be required to shift its

unregulated contaminant monitoring to

the entry point to the distribution

system. These flexibilities in the

sampling location should enable

systems and States to coordinate

compliance and unregulated

contaminant monitoring more

extensively.

The law requires EPA to consider the

source of water relative to unregulated

contaminant monitoring requirements

(SDWA Section 1445(a)(2)(A)). Over the

twelve-month period of monitoring, the

regulation requires that systems sample

from all entry points to the distribution

system, or other sampling points

specified, representing all principal,

non-emergency sources of water used

over the monitoring period. Surface

water-supplied systems will monitor

each of these points every three months

for a twelve-month period and ground

water-supplied systems will monitor

each of these points two times five to

seven months apart within a twelvemonth period. Today’s final monitoring

frequency for surface water systems is

the same as in the previous program.

For ground water systems, the two

sampling events must be approximately

six months apart, increasing the

frequency from one sample in five years

under the previous program to two. The

reasons for this increase are that while

ground water typically moves slowly,

one sample is insufficient to

characterize water quality at any

particular location and will not provide

evidence of any changes over a longer

period of time. Furthermore, some

ground water environments transmit

water more rapidly, potentially resulting

in changes in water quality over shorter

timeframes. From a statistical

standpoint, one sample is not

representative and will not allow the

data to be used for exposure assessment

which uses an average annual value.

This frequency applied to the average of

6.2 entry points to the distribution

system for systems serving more than

10,000 persons will provide sufficient

data for an adequate statistical analysis

of the varied conditions in which these

systems are located.

One of the monitoring events for both

surface water and ground water systems

must occur at the most vulnerable time

of year for the PWS. The rationale for

this approach is that it provides data

representing potential variation in

contaminant concentration over the

course of a year. This potential variation

in concentration is necessary to evaluate

exposure related to contaminant

occurrence. Some systems perform

compliance monitoring on a quarterly

basis and can collect UCMR samples

coincident with their compliance

samples, and therefore provide data on

the range of variation. Other systems

may only conduct compliance

monitoring once every third year and

will therefore have to collect additional

samples under the UCMR. While one

UCMR sample could be collected

coincident with this compliance

sample, EPA is requiring for ground

water-supplied systems to take a second

sample five to seven months later. This

requirement will provide the necessary

data on seasonal variation over a year to

allow consistent exposure assessments

to be done with a range of

concentrations. Stakeholders supported

this option. EPA originally proposed

that the second sample be collected

exactly six months later. State

commenters indicated a need to provide

flexibility to accommodate changes in

monitoring schedules. Therefore, EPA

modified the regulation to allow

monitoring five to seven months before

or after the initial vulnerable period

sampling event.

(ii) Microbiological Contaminants

For microbiological contaminants, the

sampling frequency will be two times

within one year, with samples collected

each time at two different locations after

treatment in the distribution system: a

site representative of water in the

distribution system received by the

general population that the system

serves and a site in the distribution

system representing the maximum

residence time or lowest disinfectant

residual, depending on the contaminant.

The frequency should capture the most

vulnerable time as well as a time five to

seven months later to provide an

average exposure. Furthermore,

precipitation patterns may be a major

factor in contaminant occurrence. Thus,

frequency of sampling should be

tailored to the most vulnerable times

because increased seasonal precipitation

may carry these contaminants at higher

concentrations than other times during

the year.

(b) Systems Serving 10,000 or Fewer

Persons

The final rule states that

approximately one third of the small

systems (serving 10,000 or fewer

persons) selected through the

representative sample, be sampled each

year over a three-year period at the

frequencies indicated in Section D,

‘‘Monitoring Requirements Under the

Final UCMR’’ (1)(a) above. This allows

a relatively even submission of samples

to be managed and tested by the EPA

laboratory. EPA will pay for the

reasonable costs of monitoring (i.e.,

containers, shipping, testing and

reporting) for this representative sample

of systems, including Assessment

Monitoring, Screening Survey, and PreScreen Testing, and will conduct the

analyses at its designated laboratories.

EPA, therefore will need to be able to

manage the number of samples being

received at any time to closely

correspond to the analytical capacity of

its laboratories. Some public

commenters suggested that sampling for

microbiological contaminants not occur

at the maximum residence time in the

distribution system, but at the point of

lowest disinfectant residual, since the
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50571

monitoring of concern is for

effectiveness of treatment and booster

disinfection stations that may be in use

in long distribution lines. In response,

EPA added another sampling point at

the ‘‘lowest disinfectant residual’’ in the

distribution system. However, EPA

maintained the original sampling point

location of ‘‘maximum residence time’’

because, given potential chemical

degradation over long periods of time in

a distribution system, such as for

disinfection byproducts, the location of

maximum residence time can often be

the location of lowest disinfectant

residual and, therefore, highest

likelihood of microbiological

contaminants.

Public comments also addressed the

flexibility in monitoring schedules to

allow for unforeseen events or factors in

field sampling. Specifically, States

asked that system sampling schedules

allow for sampling over a month within

a quarter, rather than exactly three

months later. EPA modified the final

rule to allow sampling by small and

large surface water systems to occur

within the same month in each quarter

and for small and large ground water

systems, to occur any time five to seven

months before or after the initially

selected month within the vulnerable

time.

2. Monitoring Time for Vulnerable

Period

Water quality studies and monitoring

throughout the United States have

clearly shown that contaminant

occurrence and/or concentration vary

over time, both seasonally as well as

from year to year. The seasonality of

occurrence, or period of peak

concentration of contaminants,

commonly varies with seasonal changes

in the hydrologic cycle in relation to the

source of contaminants and their fate

and transport characteristics.

Particularly for land-applied or landdisposed contaminants, the increased

flux of water mobilizes the

contaminants and moves them into

surface or ground water flow systems.

For the most vulnerable of water

systems, such as surface waters,

unconfined shallow ground water and

karst flow systems, for example, higher

levels of contaminant concentrations

typically occur during annual runoff

and recharge periods. For much of the

United States, east of the Rocky

Mountains, many studies have shown

that the season of greatest vulnerability

for contaminant occurrence is the latespring, early-summer runoff-recharge

period, particularly for contaminants

such as pesticides and nitrate (e.g.,

Larson et al., 1997; Barbash and Resek,

1996; Hallberg, 1989a,b). For deeper,

more confined ground water systems,

defining vulnerable periods is much

more difficult. The exact flow path and

time of travel are much greater and more

complex and are dependent upon many

factors unique to a particular well and

aquifer setting (e.g., Hallberg and

Keeney, 1993). There is no generality

that can be applied to these latter

settings.

Because occurrence may vary

seasonally, it is important to try to

capture these vulnerable periods in a

one-time survey of contaminant

occurrence such as the UCMR.

Statistical studies of sampling strategies

in surface water (e.g., Battaglin and Hay,

1996) have shown that incorporating

sampling during spring and early

summer runoff periods provides a more

accurate representation of annual

occurrence than random quarterly

sampling (that can avoid these months).

Ground water studies (e.g., Pinsky et al.,

1997) suggest that the more vulnerable

ground water settings also show peaks

during these periods. The default

vulnerable period for sampling for the

UCMR has been designated to coincide

with this period of peak vulnerability

for much of the United States: one

sample must be collected during May,

June, or July, unless the State has better

information to designate another period.

Also, for surface waters, three additional

samples will be collected throughout

the year, and for ground water systems,

one additional sample will be collected

five to seven months before or after the

vulnerable time. This additional

sampling will also capture the winter

recharge and runoff period that may be

more vulnerable in the western coastal

regions or warmer southern climates for

some contaminants. In the case of some

deeper ground water systems, States or

systems may have additional knowledge

of seasonal vulnerability patterns, in

which case the State can designate an

alternative period for sampling.

Public comments generally supported

monitoring in a vulnerable time, but

desired flexibility in establishing the

time and frequency. The rule already

provided flexibility in selecting a time

within the May to July period for a

sampling event. However, because the

statistical approach requires

consistency, today’s rule enables a State

to determine the alternate vulnerable

time for monitoring, rather than each

system using its own criteria for

choosing a vulnerable time. With

respect to frequency, the statistical

approach requires that systems monitor

with the same frequency so that a

national frequency distribution can be

developed. This precludes the State or

a system from establishing its own

monitoring frequency.

Two commenters indicated that

pumping rate and not hydrologic factors

accounted for variations in contaminant

concentration, with higher pumping

rates coinciding with higher

concentrations. No specific data were

offered in support of these comments.

EPA believes that many factors may

account for higher contaminant

concentrations during certain seasons.

While pumping rate may be a factor,

hydrologic factors are documented as

having a significant influence in

concentrations of pesticides and other

contaminants, as noted previously. A

State may use pumping rates as a basis

for designating an alternative vulnerable

time if determined appropriate.

3. Monitoring Location

In § 141.40(a)(3), today’s action

identifies entry points to the

distribution system (EPTDS) after any

treatment, or the sampling points

specified by the State for compliance

monitoring under 40 CFR 141.24(f)(1),

(2), and (3), representative of each

principal, non-emergency water source

in use over the twelve-month period of

Assessment Monitoring, as the sampling

locations for List 1 contaminants. Also,

two sites in the distribution system (a

site representative of water in the

distribution system received by the

general population that the system

serves and a site in the distribution

system representing the maximum

residence time or the lowest disinfectant

residual) are designated for

microbiological or distribution system

contaminants. Sampling at entry points

to the distribution system after any

treatment follows the existing regulatory

approach for currently regulated

contaminants and provides data for

exposure assessment.

(a) Chemical Contaminants

The chemicals in this final rule

(UCMR (1999) List 1) are all compounds

that can enter a public water supply

from the external environment (in

contrast to disinfection byproducts, for

example). The monitoring location is at

the entry point to the distribution

system after treatment, representative of

each principal non-emergency source of

water in use over the twelve-month

monitoring period, which will ensure a

nationally consistent data set and will

provide consistent data for exposure

assessment. In response to State and

water system commenters, EPA also

provided flexibility in the final rule to

allow sampling of source (raw) water

sampling points. However, if a listed

contaminant is detected through source
50572 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

water sampling and testing, then the

monitoring location must be shifted to

the entry point to the distribution

system (unless there is no treatment)

and follow the monitoring frequency

specified in the rule for the contaminant

and water source type.

(b) Microbiological Contaminants

The sampling locations for

microbiological contaminants are

different from those for chemical

contaminants because the most likely

locations with microbiological

contaminants may be in the distribution

system, or, for some systems, in source

water. Two sampling locations were

considered in the development of this

regulation and are included in the

reporting requirements under 40 CFR

141.35(d). No microbiological

contaminant is on List 1 for Assessment

Monitoring so the two sampling points

are not now required. When

microbiological contaminant monitoring

is required, one of the samples will be

at the site below a representative entry

point to the distribution system that is

used for taking total coliform samples;

this sample will represent general

exposure. The second sample will be in

the distribution system that has the

maximum residence time or lowest

disinfectant residual, representing the

extreme exposure of the population at

this point in the distribution system.

These sampling points were suggested

by stakeholders. EPA will consider

activating these sampling points for

microbiological contaminants when

their analytical methods are determined

to be ready for Assessment Monitoring,

Screening Survey or Pre-Screen Testing

through separate rulemaking. Over the

twelve-month period of monitoring,

systems would sample at locations

representing each principal, nonemergency source of water used over the

monitoring period, to the extent

possible. One commenter suggested that

distribution system samples be taken at

sites used for sampling total

trihalomethanes (TTHMs). EPA will

consider TTHM sites when it proposes

methods for microbiological

contaminants or other contaminants

likely to occur in distribution systems.

Currently, it is not possible to assess

whether or not all of the microbiological

contaminants (including those on List 3)

are likely to be found at any one

sampling location, or that one sampling

location is best to potentially identify all

microbiological contaminants. The

occurrence data needs may differ for

different contaminants. Different

portions of the water supply and

distribution system may be more likely

locations of particular microbiological

contaminants/occurrences. Therefore,

the sampling location for each

microbiological contaminant may need

to be contaminant-specific and related

to the likelihood of occurrence.

As a result, for the microbiological

contaminants on Lists 2 and 3 of the

rule today, EPA has not identified a

sampling location or locations. For some

of the microbiological contaminants,

source water may be the most

appropriate sampling location. EPA will

specify sampling locations at the time

public comment is requested on the

specific monitoring requirements for

microbiological contaminants.

4. Quality Control Procedures for

Sampling and Testing

To assure that the data collected

under this final regulation are of

sufficient quality to meet the

requirements of its intended uses, EPA

is requiring the use of the analytical

methods and procedures in

§ 141.40(a)(3), (4), and (5) and Appendix

A for monitoring. Also, additional

guidance for quality control and

analytical confirmation are specified in

the ‘‘UCMR Analytical Methods and

Quality Control Manual’’, available by

the time this rule is published. This

final regulation covers quality control

steps for all sampling and testing under

this program. Today’s final rule requires

that all monitored systems follow these

methods and procedures in organizing

and conducting their UCMR sampling

and testing. Systems must also ensure

that the laboratories they use to analyze

samples use these approved methods

and procedures. The specific quality

control requirements addressed in

§ 141.40(a)(3), (4) and (5) and Appendix

A of the final rule include: sample

collection/preservation; sample

transport; sample and sample extract

holding time and storage; sample

analyses/quality control requirements,

including quality control (QC)

requirements, calibration, calibration

verification, laboratory reagent (method)

blank, quality control sample, laboratory

duplicates, sample matrix spike and

matrix spike duplicate, internal

standard, surrogate standard, method

detection limit determination, minimum

reporting level; confirmation; and

reporting requirements. EPA believes

that specifying the quality control

requirements for UCMR sampling and

testing will enable the Agency to have

a high degree of confidence in

determining the extent and range of

concentrations for the contaminants on

the UCMR (1999) List, since they are not

regularly tested for nationally.

5. Monitoring of Routinely Tested Water

Quality Parameters

In addition to the contaminants to be

monitored, several chemical and

physical parameters are important

indicators of water quality and may

contribute to the likelihood of

contaminants being found in drinking

water. EPA requested public comment

on whether it should require the

monitoring and reporting of these

routinely tested parameters, usually

associated with water quality analyses,

to provide for a more thorough scientific

understanding of the occurrence of

unregulated contaminants. These

chemical and physical parameters are

not added to the UCMR (1999) List

because they are not contaminants, but

rather they provide supplementary data

about the sample results which will

facilitate their interpretation and use in

regulatory decisions. Public comments

indicated that for some systems and

States, these chemical and physical

parameters are routinely tested for, and

in others, they are not. One commenter

stated that temperature and pH were

important for chemical contaminant

occurrence and degradation. Another

commenter indicated that analyzing for

these water quality parameters is

essential to managing his system’s

water. In response, EPA has revised the

rule to require that for organic and

inorganic chemical samples, pH be

reported for the sampling event of each

sampling point. Since no supporting

information was provided, EPA

determined that while temperature may

be important for microorganisms, it is

not expected to affect the results for

chemical contaminants because the

storage and transit temperature

requirements in the approved methods

will minimize the loss of target

contaminants due to any physical,

chemical or biological processes. For

microbiological contaminants,

temperature, pH, free disinfectant

residual, and total disinfectant residual

must be reported. These required water

quality parameters are listed in § 141.40

(a)(4)(i) Table 2, Water Quality

Parameters To Be Monitored With

UCMR Contaminants. These water

quality parameters must be reported as

analytical results along with other

results and data elements.

6. Relation to Compliance Monitoring

Requirements

Currently, compliance monitoring for

regulated contaminants is coordinated

on a three-year cycle. All public water

systems that are required to monitor for

specific contaminants a minimum of

one year out of every three, six, or nine
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50573

years, depending on the contaminant

and its occurrence in the system. The

existing unregulated contaminant

monitoring requirements and the final

revised UCMR require monitoring

during one year out of every five years.

EPA provides flexibility in this final

UCMR so that public water systems: (a)

only have to monitor for unregulated

contaminants during one twelve-month

period every five years (unless the State,

at its discretion, determines that PWSs

should conduct more frequent

monitoring); (b) can use previously

State-specified compliance sampling

points, including source water sampling

points; and (c) choose a sampling time

within quarters or three-month periods

specified in the rule. Hence, the

compliance monitoring and the UCMR

monitoring can be coordinated, to the

extent practical, by conducting UCMR

monitoring during a coincident year

during which compliance monitoring is

required. The years within which the

unregulated contaminant monitoring are

required to occur are specified in

§ 141.40(a)(3), Table 1, Unregulated

Contaminant Monitoring List, column 6.

7. Previous Monitoring of the

Contaminants on the Final UCMR

(1999) List

Some PWSs may already have

monitored for or want to monitor before

the rule’s effective date of January 1,

2001, for some of the contaminants

identified on the final UCMR (1999) List

because of local or State concerns about

the possibility of those contaminants

occurring in drinking water. At the time

of proposal, EPA was concerned about

allowing systems to report monitoring

results for samples taken and tested

prior to promulgation of the UCMR.

EPA was concerned that such results

might not be comparable to results

obtained under this revised UCMR

Program because of differences in

sampling and analytical protocols, as

well as the sampling schedule. Other

factors thought to compound the

problem of comparability included: (1)

monitoring methods may have changed

or improved; (2) water quality changes

over time; and, (3) today’s action

requires reporting of a net increase of

seven additional data elements, which

will allow various, consistent

comparisons to be made and data to be

aggregated nationally based on current

sound-science and quality assurance/

quality control consistency. However,

EPA received comments recommending

that previously collected data should be

accepted for the unregulated

contaminants on the monitoring list as

long as they meet all the requirements

of this final rule. In response, EPA

reevaluated the circumstances under

which previously collected (also

referred to as ‘‘grandfathered’’ or

‘‘grandparented’’) data could be

accepted, given the statistical and

quality assurance/quality control

requirements of the UCMR Program.

EPA has modified the regulation to

allow previously collected data to be

reported, as long as the data meet the

sampling, testing and reporting

requirements specified in 40 CFR

141.35(d) and 141.40(a)(3), (4), (5) and

Appendix A. This change will allow for

early monitoring and reporting for

MTBE, as long as it meets the

requirements of the UCMR. By doing so,

EPA is responding to one of the

recommendations of the Blue Ribbon

Panel on Oxygenates in Gasoline, a

panel appointed by EPA Administrator

Browner, to evaluate the issues posed by

the use of MTBE in gasoline. This

recommendation consisted of

accelerating the implementation of the

UCMR, by allowing systems to sample

for MTBE prior to the implementation

date of January 1, 2001.

E. Waivers

1. Waivers for Systems Serving More

Than 10,000 Persons

Section 1445(a)(2)(F) of SDWA allows

a State to obtain a waiver of UCMR

monitoring for specific contaminants if

the State demonstrates that the UCMR

listing criteria do not apply in that State.

These criteria are:

(a) the criteria for listing a

contaminant in the occurrence priorities

list in the CCL or the regulatory process

identifying contaminant occurrence in

two or more States; and

(b) whether an analytical method

exists for the contaminant.

When a State makes such a

demonstration for a waiver of a specific

contaminant on the monitoring list, EPA

may waive monitoring for that

contaminant in that State for large

systems (serving more than 10,000

persons) only.

Stakeholders indicated that waiver

requirements should be sufficiently

stringent to obtain the most

representative national data possible,

including non-detections of

contaminants on the UCMR (1999) List.

Since only the UCMR listing criteria in

(a) are relevant to a State-specific waiver

and based on stakeholders’ concern that

the waiver be narrowly applied, EPA is

requiring that this waiver be applied

only where the State can demonstrate

that the contaminant has not been used,

applied, stored, disposed, released, or

detected in the source waters or

distribution systems in the State in the

past 15 years and that the contaminant

does not occur naturally (such as growth

in a system or air deposition) in the

State. Source Water Assessments

provided for under Sections 1453 and

1428(b) of SDWA may be used as the

basis for these waivers if the

assessments specifically address the

contaminant(s) on the UCMR List for

which a waiver is sought. Table 3, Uses

and Environmental Sources of

Contaminants for the Monitoring List,

presents the uses and sources of the

contaminants included for the final

UCMR (1999) List. A State can apply for

a waiver from monitoring for specific

contaminants, but must receive EPA

approval to waive the monitoring.

While some chemical contaminants

may only be discharged into the

environment in regional or local areas,

microbiological contaminants may be

ubiquitous. However, previous

monitoring results over time may

provide information useful to waiver

determinations for microbiological

contaminants.

Public comments on system-specific

waivers ranged from not allowing

waivers for any systems to providing

waiver procedures for individual

systems. EPA decided that such waivers

are not provided by the statute and

would be generally inconsistent with

the nature of a program that relies on

nationally representative data.

Detections and non-detections are

equally important in deciding whether

to regulate a contaminant. If waivers are

given to systems not expected to have

occurrence of a particular contaminant

or group of contaminants, then the

resulting data set will be biased toward

systems having detections, potentially

contributing to an incorrect conclusion

about contaminant occurrence and

regulation. EPA did not change the rule

to allow other circumstances under

which contaminant monitoring waivers

could be given.

2. Waivers for Small Systems in State

Plans

EPA is not allowing waivers to be

granted for small systems serving 10,000

or fewer persons in State Plans for the

national representative sample.

Stakeholders also supported this

position. The systems in State Plans will

be statistically selected with the

assumption that all systems in a

particular size category and water

source type have an equal probability of

being selected. Non-detections are just

as important as detections of

contaminants for national analysis.

Waiving contaminants to be monitored

in certain States not expecting to have

such contaminants biases the
50574 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

representative sample toward

detections. Selecting the small systems

to be included in the State Monitoring

Plans for the representative sample

through a statistical process effectively

waives ninety-seven percent of the

systems from the final monitoring

requirements (based on using 99 percent

confidence level with three percent

allowable error). Therefore, EPA

rejected waivers for systems serving

fewer than 10,000 persons because this

approach is contradictory to obtaining a

scientifically sound data set that

provides the basis for a scientific

statistical analysis. The rule was not

changed in this regard.

TABLE 3.—USES AND ENVIRONMENTAL SOURCES OF CONTAMINANTS FOR THE MONITORING LIST

Contaminant name CASRN Use or environmental source

Proposed Chemical Contaminants

1,2-diphenylhydrazine ............................... 122–66–7 Used in the production of benzidine and anti-inflammatory drugs.

2-methyl-phenol ........................................ 95–48–7 Released in automobile and diesel exhaust, coal tar and petroleum refining, and

wood pulping.

2,4-dichlorophenol .................................... 120–83–2 Chemical intermediate in herbicide production.

2,4-dinitrophenol ....................................... 51–28–5 Released from mines, metal, and petroleum plants.

2,4-dinitrotoluene ...................................... 121–14–2 Used in the production of isocyanate and explosives.

2,4,6-trichlorophenol ................................. 88–06–2 By-product of fossil fuel burning, used as bactericide and wood/glue preservative.

2,6-dinitrotoluene ...................................... 606–20–2 Used as mixture with 2,4-DNT (similar uses).

Acetochlor ................................................. 34256–82–1 Herbicide used with cabbage, citrus, coffee, and corn crops.

Alachlor ESA ............................................. ........................ Degradation product of alachlor, an herbicide used with corn, bean, peanut, and

soybean crops to control grasses and weeds.

DCPA di-acid degradate ........................... 2136–79–0 Degradation product of DCPA, an herbicide used on grasses and weeds with fruit

and vegetable crops.

DCPA mono-acid degradate ..................... 887–54–7 Degradation product of DCPA, an herbicide used on grasses and weeds with fruit

and vegetable crops.

DDE .......................................................... 72–55–9 Degradation product of DDT, a general insecticide.

Diazinon .................................................... 333–41–5 Insecticide used with rice, fruit, vineyards, and corn crops.

Disulfoton .................................................. 298–04–4 Insecticide used with cereal, cotton, tobacco, and potato crops.

Diuron ....................................................... 330–54–1 Herbicide used on grasses in orchards and wheat crops.

EPTC ........................................................ 759–94–4 Herbicide used on annual grasses, weeds, in potatoes and corn.

Fonofos ..................................................... 944–22–9 Soil insecticide used on worms and centipedes.

Lead-210 (Pb-210) .................................... 14255–04–0 Part of the uranium decay series, naturally occurring.

Linuron ...................................................... 330–55–2 Herbicide used with corn, soybean, cotton, and wheat crops.

Molinate .................................................... 2212–67–1 Selective herbicide used with rice, controls watergrass.

MTBE ........................................................ 1634–04–4 Octane enhancer in unleaded gasoline.

Nitrobenzene ............................................. 98–95–3 Used in the production of aniline, which is used to make dyes, herbicides, and

drugs.

Perchlorate ................................................ 14797–73–0 Oxygen additive in solid fuel propellant for rockets, missiles, and fireworks.

Polonium-210 (Po-210) ............................. 13981–52–7 Part of the uranium decay series, naturally occurring.

Prometon .................................................. 1610–18–0 Herbicide used on annual and perennial weeds and grasses.

RDX .......................................................... 121–82–4 Used in explosives; ammunition plants.

Terbacil ..................................................... 5902–51–2 Herbicide used with sugarcane, alfalfa, and some fruit, etc.

Terbufos .................................................... 13071–79–9 Insecticide used with corn, sugar beet, and grain sorghum crops.

Microbiological Contaminants

Adenoviruses ............................................ N/A Fecal sources; hand to mouth transmission.

Aeromonas ................................................ N/A Present in all freshwater and brackish water.

Cyanobacteria (Blue-green algae), other

freshwater algae and their toxins.

N/A Bloom in surface water bodies; produce toxins.

Caliciviruses .............................................. N/A Contaminated food and water, raw shellfish.

Coxsackieviruses ...................................... N/A Fecal sources; hand to mouth transmission.

Echoviruses .............................................. N/A Fecal sources; hand to mouth transmission.

Helicobacter pylori .................................... N/A Fecal sources; hand to mouth transmission.

Microsporidia ............................................. N/A Occur in rivers, ponds, lakes, and unfiltered water.

F. Representative Sample of Systems

Serving 10,000 or Fewer Persons

As required by section 1445(a)(2)(A)

and (C), the regulation requires that only

a representative sample of public water

systems serving 10,000 or fewer persons

must monitor for unregulated

contaminants. As previously explained,

only community and non-transient noncommunity systems are required to

monitor for unregulated contaminants

under this action. Therefore, the

representative sample will include only

community and non-transient noncommunity systems serving 10,000 or

fewer persons. The representative

sample must be of sufficient size to

gather the necessary information on

occurrence of unregulated contaminants

to determine whether or not to regulate

them, while not burdening every water

system with the expense of monitoring.

The number of systems selected within

each of three size ranges of small

systems will be based on the proportion

of the State’s population served by

systems in that size range. (An example

appears in Section 5.(a), ‘‘State Plans for

the Representative Sample’’.) The small

systems in the national representative

sample will be selected using a stratified

random sampling process. This process

will utilize a random number generator

to choose a statistically determined

number of systems in each State,

considering the proportion of the

population served by CWSs and

NTNCWSs by water source type (i.e.,

ground or surface water) and system
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50575

size category (i.e., 25 to 500 persons,

501 to 3,300, and 3,301 to 10,000)

within the water source type. The

regulation stipulates that the national

representative sample is the basis for the

State Monitoring Plan in each state. The

use of this statistical approach is

designed to take into account different

system sizes, types of systems, the

source of supply, contaminants likely to

be found, and geographic location. EPA

believes that the statistical process for

selecting systems to monitor must yield

data that are sufficient to answer

questions about occurrence of

contaminants on a national scale for use

in exposure assessments and technology

evaluations of alternative treatments at

a PWS and in its watershed. These data

should also be sufficient to answer

questions on a broad multi-state scale,

such as systems classified by size or

source of water, particularly when

combined with data for the 2,774 large

systems.

Under this action, small system

monitoring will be too sparse to answer

questions about occurrence at the scale

of a single State. The number of systems

required for evaluation of occurrence in

a single State is far greater than, and

thus more costly than, those needed for

the broader national evaluations

required under the Act to determine

whether or not to regulate a

contaminant and to assist in developing

future drinking water regulations.

1. System Size

Based on statistics reported in the

Safe Drinking Water Information System

(SDWIS) database, the following

numbers of systems (1997 data) by size

will approximate the universe from

which a representative sample of

systems serving 10,000 or fewer people

will be taken for the national

representative sample plan. These

system size categories are used in other

statutory and regulatory

characterizations of systems, and are

applied under the existing rule for

unregulated contaminant monitoring for

the scheduling of sampling. The

relevant system and population

information (1997) for systems serving

10,000 or fewer persons is:

No. of people served in PWS size range No. of PWSs

in size range

Population served nationally

CWS NTNCWS

25–500 ......................................................................................................................................... 48,100 5,249,577 2,379,034

501–3,300 .................................................................................................................................... 14,126 19,918,106 2,724,728

3,301–10,000 ............................................................................................................................... 3,410 25,236,059 401,579

Total ...................................................................................................................................... 65,636 50,403,742 5,505,341

Considering all community water

systems and nontransient noncommunity water systems that do not

purchase their water supplies, 65,636

PWSs are in the size range for small

systems as defined in Section 1445. In

response to public comments that

indicated the appropriateness of

including purchased water systems,

EPA revised this rule to cover systems

purchasing water from other systems if

their distribution systems are the

locations of the maximum residence

time or lowest disinfectant residual in

relation to the combined water sellerpurchaser distribution system.

Purchased water systems will not be

required to monitor for contaminants for

which the sampling location is specified

as the entry point to the distribution

system because they could bias results

by potentially causing double counting

of contaminant occurrence.

2. System Type

(a) Public Water System Monitoring

Under today’s action, all public water

systems serving 10,000 or fewer

persons, except transient noncommunity systems, will be considered

for monitoring, but only a subset will be

selected for the national representative

sample. Purchased water systems will

be excluded from UCMR monitoring for

contaminants where the sampling point

is identified as the entry point to the

distribution system. Public water

systems owned and/or operated on

Tribal lands by Tribes will have the

same probability of being selected for

the national representative sample as

any other system in its water sourcesystem size category. EPA will identify

the size of the representative sample

and the specific systems required to

monitor and send the list of systems to

the States for review and inclusion in

State Monitoring Plans (discussed in

Section V. F. 5).

(b) Nontransient Non-Community Water

Systems

Nontransient non-community water

systems (NTNCWSs) represent schools,

hospitals and other facilities in

communities that serve the resident

population but have their own water

supply systems. Approximately 20,000

systems of this type exist in the United

States. Today’s final regulation at

§ 141.40(a)(1)(iii) includes NTNCWSs as

a separate type of water system to be

included in the representative sample

for monitoring. Typically, these systems

are closely associated with a local

resident population and may be a

significant source of water consumed by

that population over a lifetime. The

selection of NTNCWSs will use the

same statistical process as for CWSs,

with systems grouped within a State by

water source type and size category.

NTNCWSs are considered separately to

avoid double-counting the population

served when conducting exposure

assessments of both small CWSs and

NTNCWSs, while allowing weighting of

lifetime water consumption by system

type.

(c) Transient Non-Community Systems

Transient non-community water

systems represent systems providing

drinking water to transient populations

such as at a restaurant in a rural location

or a highway roadside rest area. About

97,000 of these systems exist in the

United States; their location and type

are highly variable. It will be difficult to

extrapolate exposure from monitoring

results, given the very short-term nature

of the systems’ use by individuals who

may not be in the area for more than a

few hours or days. Because of problems

with implementation and cost for

sampling such a large and highly

variable set of typically very small

systems, EPA has excluded transient

systems from all unregulated

contaminant monitoring requirements

in this final rule. In this regard, this

action is consistent with the current

UCMR Program. Four of the five public

commenters addressing transient

systems supported exclusion of

transient systems from requirements for

unregulated contaminant monitoring.

3. Geographic Location

SDWA Section 1445 specifies that

State plans should consider ‘‘geographic

location’’ when selecting a

representative sample. This is
50576 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

accomplished at the broadest level by

selecting systems from each State.

However, within a State, the sources of

water may not be evenly distributed

across that State, especially surface

waters. Cities transfer water across

watershed boundaries, or move water

from one State to another. To best

represent water being consumed by

individuals, EPA defines ‘‘geographic

location’’ in the representative sample

for the final rule today as the location

of the source of water, rather than as an

even distribution of points across the

State. For example, if 40 percent of the

people in a State obtain their water from

one water source type (e.g., surface

water), 40 percent of the systems

selected for the representative state

sample should be from that source type,

even if this results in points unevenly

distributed across the State. This

distribution should be accommodated

by allocating systems based on the

population served nationally and in

each State stratified by water source and

system size category.

4. Likelihood of Finding Contaminants

Section 1445(a)(2)(A) requires that the

UCMR Program take into account the

likelihood of finding a contaminant in

establishing variable monitoring

requirements for systems. The final rule

allows the UCMR Program to focus on

monitoring for contaminants that are

expected to be found nationally or

within several regions of the United

States. Therefore, the expectation of

finding the contaminants nationally is

fundamental to the approach of the

representative sample and its statistical

method of selection. The ‘‘likelihood of

finding contaminants’’ factor is

accommodated by the step-wise threetiered approach of Pre-Screen Testing,

Screening Survey and Assessment

Monitoring.

5. State Plans for the Representative

Sample

As discussed previously, Section 1445

(a)(2)(C) allows States to develop State

Monitoring Plans (also referred to as

‘‘State Plans’’) to assess the occurrence

of unregulated contaminants for small

systems in the State. EPA believes that

the development of State Plans is

affected by two other considerations: (i)

the State plans must fit together into a

national representative sample so that it

is, in fact, nationally ‘‘representative,’’

and (ii) EPA will pay for the reasonable

costs of testing and laboratory analysis

necessary to carry out monitoring at

State Plans, pursuant to Section

1445(a)(2)(C)(ii).

(a) Representative State Plans

To have representativeness at the

national level while at the same time

allowing each State to develop a ‘‘State

Plan,’’ the testing for which EPA will

fund, the Agency will take the following

approach. Based on a statistical random

selection process applied to all CWSs

and NTNCWSs nationally using the

average population served by systems

and water source type (surface or

ground water to ensure geographic

coverage) within service-size categories

(25–500, 501–3,300, 3,301–10,000

persons), EPA will select at least twice

as many CWSs and NTNCWSs as

required for the national representative

sample. EPA will use a random number

generator to select these systems. These

systems will be divided into an ‘‘initial

plan’’ list and a ‘‘replacement list’’ to

allow for replacement of systems on the

list with systems from the replacement

list, by States. The representative

sample will be allocated on a State

basis, and then stratified by water

source type and then by service size

category within each water source type.

EPA will use the percentages of the

populations served in each water

source-system size category to further

allocate the systems in each State. The

‘‘initial plan’’ list of systems will

identify those systems tentatively

selected by EPA for each State. To

establish a State Plan for small system

monitoring, a State may enter into a

Memorandum of Agreement (MOA)

with EPA to take a partnership role in

the development and implementation of

the State Plan. By agreeing to participate

in the process for the State plan through

the MOA, the State must accept the

EPA-selected systems on the ‘‘initial

plan’’ as its plan, or review the list to

determine which systems should be

removed from the list because of such

factors as closure, merger, or water

purchase arrangement and submit a

modified plan. The State must replace

the system(s) they remove from the list

with the water system(s) from the

‘‘replacement list’’ in the order the

systems are listed in the replacement

list, thus creating a ‘‘modified plan.’’

The State, in either case, must inform

the EPA of the State’s choice of plan

(i.e., ‘‘initial’’ plan or ‘‘modified’’ plan)

along with reasons for removing and

replacing systems on the ‘‘initial plan’’

within 60 days of receiving the ‘‘initial

plan.’’ If the State decides not to enter

into an MOA with EPA for the State

Plan process, then the EPA will consult

with the State before the State adopts

the ‘‘initial plan’’ as its State Plan. In a

State with an MOA, the State Plan will

include a process for the State to inform

the public water systems of their

responsibility to monitor and report

results, their vulnerable time period,

other monitoring times, sampling

instructions, and of their participation

in the screening survey and pre-screen

testing. The EPA will inform systems of

their inclusion in the representative

sample if the State chooses not to enter

into an MOA for the State Plan. This

approach ensures a nationally

representative set of systems and allows

a State flexibility to modify EPA’s

‘‘initial plan’’ with minimal burden.

EPA will develop and provide initial

plans to States and Tribes in the first

half of year 2000 to allow sufficient time

for State/Tribal review and

modification, and for informing systems

selected for the State Plans.

Statistical Approach. Under today’s

action, the representative sample of

small public water systems will be

composed of a subset of systems which,

in the aggregate, represent the public

water systems of the three small system

size categories within the United States.

Within a State, public water systems

will need to be selected so that the

proportion of persons served by the

systems sampled is as close as possible

to the proportion of persons served by

that system size category within each

water source type for that State. The

portion of the national representative

sample within a State’s boundaries will

become that State’s Monitoring Plan,

after review and possible adjustment by

the State, and then EPA review.

For the small systems considered, a

representative sample size of

approximately 800 systems will provide

a confidence level of 99 percent with an

allowable error of plus or minus 1

percent. This number of systems is

statistically derived to allow population

weighting for exposure assessment.

Because of population weighting in the

selection of the representative sample,

systems are a surrogate for the number

of people being monitored for

unregulated contaminants in their

drinking water. Since population

exposure assessment is the principal use

of the data in the regulation

development process, the quantity of

interest is the fraction of people

exposed, rather than the fraction of

systems affected. However, the law

requires measuring contaminant

occurrence at systems and it is more

efficient to measure at systems. So the

population weighted plan allows EPA to

recognize systems providing drinking

water to their service population as a

surrogate for people. When the goal is

exposure assessment, then a population

weighted sampling plan for systems is

optimal. The results can also be used to
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50577

estimate the number of systems affected,

although the selected population

weighted plan is not optimal for this

purpose.

The results will also be useful for

analysis of contaminant occurrence at

small systems in national analyses by

water source and system size categories

or strata, with a confidence level of 95

percent and a one percent margin of

error. EPA will allocate systems to each

State, water source type and system size

category by: (1) estimating the

population served by all small CWSs in

each State, (2) dividing this population

into the population served in each water

source type-system size combination to

derive a percentage, and (3) multiplying

the percentage by the number of small

systems in the State, with the result

being the number of systems allocated

to each water source-system size

category. This allocation is a statistical

stratification of systems by water source

type and system size category. The

approach ensures that each State has

systems allocated to it for its State Plan.

To accomplish this allocation of systems

to each State, EPA will add a sufficient

number of small CWSs and NTNCWSs

to the statistically derived number for

the representative sample to allow each

State to have a plan that will then fit

into the national representative sample,

with each State having at least two

systems. Once monitored, the results of

the representative sample of small

systems will then be combined with

large system results in an overall

national analysis of contaminant

occurrence in systems. EPA believes

that this sample size will provide an

adequate level of confidence,

considering size, type (community and

non-transient non-community water

systems), geographic location (State),

and water source. EPA also believes that

this approach provides sufficient

information for the decision processes

drawing on UCMR monitoring data for

systems serving 10,000 or fewer

persons, while keeping testing costs at

a manageable level. This number of

systems should be sufficient to

statistically evaluate whether a

contaminant occurs in a specified

proportion, such as 2 or 3 percent of the

population (using systems as a

surrogate). This number of systems,

confidence level and allowable error

will enable EPA to: (1) evaluate the

statistical significance of contaminant

occurrence with low frequency and (2)

compute the percent of systems for

occurrence nationally, combining the

results of both small and large systems.

Further rationale for using a small

number of systems and small allowable

error (confidence interval) in calculating

the number of systems to be included in

the representative sample is provided in

the monitoring results from previous

unregulated contaminant monitoring

under the existing program. EPA has

results from over 28,000 systems from

the unregulated contaminant monitoring

activities of 1988 to 1992 (the first

round of unregulated contaminant

monitoring under the existing program)

that indicate that of the 34 contaminants

required to be monitored at that time, 30

occurred at less than 2 percent of

systems and, of those, 27 occurred at

less than 1 percent of systems. Ten of

these contaminants were selected for the

Contaminant Candidate List ‘‘Regulatory

Priorities’’ (see 64 FR 23403) and all of

the ten contaminants occurred at less

than 2 percent of systems and eight, at

less than 1 percent. Of the eight

contaminants occurring at less than one

percent of systems, four have health

effects values within the concentration

range of contaminant occurrence

(bromomethane [a pesticide], 1,3-

dichloropropene [a pesticide],

hexachlorobutadiene [a solvent], and

1,1,2,2-tetrachloroethane [a solvent]),

and consequently may be considered for

future regulation. These data point at

the need to focus at the low end of

occurrence. Using a small allowable

error minimizes the chance of EPA

incorrectly deciding whether or not to

regulate a contaminant based on

occurrence. Once EPA evaluates health

effects data, contaminant occurrence

among States and systems, contaminant

sources, treatment technologies, and

other relevant information, the small

allowable error allows EPA to make

regulatory determinations with a high

degree of confidence.

If, based on prior information (e.g.,

from a Screening Survey or Pre-screen

Testing), EPA determines that the listed

contaminants occur in a different

percent of systems at a different

statistical confidence level and/or

allowable error providing scientifically

defensible monitoring results, then EPA

may apply a different likely percent of

systems, confidence level, and/or

allowable error to determine a smaller

representative sample size. The

statistical approach for specifying the

number of systems by water source type

(ground water, surface water or ground

water under the direct influence of

surface water) and systems size is as

follows:

The number of systems, n, required in

the representative sample is determined

by the allowable error (±d) around the

estimate for p, the proportion of systems

(a population-weighted surrogate for

people) which exceed a criteria (e.g.,

detection level) of interest. Based on the

binomial distribution in statistics, the

number of systems n which must be

sampled for a likely proportion p of

people (systems as a surrogate) with

contaminant occurrence within the

allowable error d with confidence (1¥a)

is approximately:

n

z p p

d

a = ( / ) ( ) − ( ) 2

2

2

1

1

The number of systems to be sampled,

n, does not depend on the total number

of systems available. The number from

the standard normal distribution, z, is

obtained from a table of the standard

normal distribution, representing a

collection of data following a ‘‘bellshaped curve’’ which have a

(standardized) mean of zero and

standard deviation of one. The

significance level, a, is the chance of the

statistical interval of interest not

containing the true value of the number

being estimated, which, in this case, is

the percent of systems where

contaminants of concern on the UCMR

List occur. The true value for the

percentage of systems where

contaminants of concern occur can only

be known if all systems are sampled,

which is not a possibility since Section

1445(a)(2)(A) requires that only a

representative subset of small systems

be required to monitor for unregulated

contaminants. Using this equation (1),

the matrix below presents the required

sample sizes for several values of

allowable error margins and confidence

levels. For the national representative

sample, an allowable error of ±0.01 at a

confidence level of 99 percent and a

likely proportion of systems with

contaminant occurrence of 1 percent

was chosen. The possibilities for sample

size, confidence level and allowable

error considered in developing this

approach are:
50578 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

SAMPLE SIZES FROM A UNIVERSE OF 65,600 SYSTEMS BASED ON: CONFIDENCE LEVEL

Confidence Level (1-a)

d, Allowable Error

.03 .02 .01 .005

90% .......................................................................................................................................................................... 30 67 266 1,065

95% .......................................................................................................................................................................... 42 95 380 1,521

99% .......................................................................................................................................................................... 73 165 659 2,636

EPA believes that a representative

sample size of 659 systems to be

sufficient to draw conclusions about

contaminant occurrence for small

systems, based on 99 percent (.99)

confidence level, ± a 1 percent (.01)

allowable margin of error (confidence

interval), and target percent of

contaminant occurrence in 1 percent of

systems. EPA chose a confidence level

of 99 percent because it wanted high

confidence that the true proportion was

included in its sample results. A 5

percent chance that the window of error

did not include the true proportion was

considered too large, given the amount

of money invested in monitoring and

regulatory decisions. Based on the

monitoring program, a 1 percent risk

(100¥99 percent confidence) that EPA

missed the target was more acceptable.

A small allowable error (narrow

confidence interval), such as ±1 percent

(±0.01), is important for evaluating the

expected low percentages of

contaminant occurrence in systems

because EPA wants to be able to

determine when the monitoring results

show that the percent of systems is

distinguishable from zero or some other

small value close to zero. Determining

this outcome will help EPA decide

which contaminants should receive

primary focus for possible regulation

after the results are evaluated with

health effects data.

To further consider the implications

of the table above, suppose that after

sampling these 659 systems, the

proportion p which equaled or exceeded

a detection level was 4 percent (0.04).

The estimate of the true (unknown)

proportion will be 0.04±0.02, or 4 to 6

percent. This interval has a 99 percent

likelihood of containing the true

proportion of systems having an

occurrence of the contaminant of

concern. There is a 1 percent (0.01)

chance (a) that the true proportion is

outside this estimated interval. A larger

allowable error, d, (e.g., 3 percent)

results in a wider estimate window.

Knowing only that the proportion is

somewhere within a window of 6

percent (e.g., between 1 and 7 percent)

was too large a window of error if the

percent of systems having occurrence of

the UCMR (1999) List contaminants is

less than 3 percent, which may be

possible based on information from

previous unregulated contaminant

monitoring. In such a situation, it will

be difficult to determine whether the

percent of systems with contaminant

occurrence was significantly different

than zero or some small number.

For the purposes of data

interpretation in the future, EPA has

determined that, rather than using the

normal approximation to the binomial

distribution, the Agency should use the

Wilson score interval method

(Newcombe, 1998) which results in a

confidence interval around the estimate

of the percent of systems with

contaminant occurrence which is

narrower on the left or ‘‘zero’’ side of

the estimate and wider on the right side

of the estimate. One advantage to this

interval is that it does not include zero

whenever the estimated exposure is

non-zero.

Additionally, EPA will increase the

representative sample size of CWSs to

721 to increase the statistical power of

the smallest system category. EPA will

also add 79 systems to the NTNCWS

sample size (using the same approach of

applying the percentage of population

served by NTNCWSs in each State to

derive the number of systems allocated

to each State). A total of 800 CWSs and

NTNCWSs are included as the national

representative sample. This allocation

facilitates assigning systems to each

State in the representative sample,

allowing each State to have at least two

systems.

Technical peer review of the

statistical approach found it to be sound

for the purposes of estimating

contaminant occurrence to assess

population exposure to the

contaminants from Assessment

Monitoring. Both internal and external

peer review indicated the possibility of

using another statistical method (such

as the Poisson approximation to the

binomial distribution or Wilson score

interval method) to derive the number

of systems in the national representative

sample and to interpret the data at a

given confidence level and error once

they are reported. Additionally, the

public commenters supported the

statistical approach for deriving and

implementing the national

representative sample of small systems.

The representative sample of 721

small CWSs and 79 NTNCWSs will be

disaggregated to the State level, and

stratified by water source type (ground

water or surface water) and system size

(the three size categories of 25–500,

501–3,300, and 3,301–10,000 persons).

The stratification by State, water source

type and system size is described in the

following example.

Example. To determine the number of

PWSs (CWSs and NTNCWSs) randomly

selected for unregulated contaminant

monitoring as part of the national

representative sample, the following

figures are used as the starting point and

are approximations for the purposes of

example only:

US population: 265,000,000

US population served by small PWSs

serving ≤ 10,000 persons: 50,000,000

State A’s population served by small

PWSs serving 10,000 or fewer persons

equals 1,251,340 persons, which

divided by 50,000,000 persons served

nationally by small water systems

equals 2.5 percent, or the percent of

State A’s population served by small

systems of the national population

served by small systems. Multiplying

2.5 percent (0.025) times the 659

systems nationally equals 16.48,

rounded to 16, which is the number of

small systems allocated to State A for its

representative sample. Mathematically,

this can be expressed as:

1 340

50 000 000

659 ,251,

. ,

 persons i

 persons in U.S. systems in sample for U.S.= 16 systems in State A' s sample n State A

×
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50579

State A’s population served by small

PWSs supplied by surface water (SW) or

ground water under the direct influence

of surface water (GWUDI) equals

449,920 persons.

State A’s population served by small

PWSs supplied by ground water (GW)

equals 801,420 persons.

For each water source type (surface or

ground water), the population served by

small systems is further divided into the

size category. The next step is to divide

the population in each size category by

the population served by small systems

in State A (1,251,340 persons), and then

multiply that result by the number of

small systems allocated to State A (18

systems), to obtain the number of

systems in that size category for the

water source type that will be in the

State Plan (identified below as ‘‘State

Plan Allocation’’). For each water source

type, the example results for State A are:

SW/GWUDI SYSTEMS IN STATE A

[Numbers of systems rounded to nearest whole number]

System size (persons served) Population served by size category

Number of

persons

served in

state A

Systems allocated to

state A

State plan

allocation

10,000–3,301 ............................................. 281,200 persons ........................................ ÷ 1,251,340 × 16 = 4

3,300–501 .................................................. 154,660 persons ........................................ ÷ 1,251,340 × 16 = 2

500–25 ....................................................... 14,060 persons .......................................... ÷ 1,251,340 × 16 = 0

Total .................................................... .................................................................... .... .................... .... .................... .... 6 systems

GW SYSTEMS IN STATE A

[Numbers of systems rounded to nearest whole number]

System size (persons served) Population served by size category

Number of

persons

served in

state A

Systems allocated to

state A

State plan

allocation

10,000–3,301 ............................................. 421,800 persons ........................................ ÷ 1,251,340 × 16 = 5

3,300–500 .................................................. 239,020 persons ........................................ ÷ 1,251,340 × 16 = 3

500–25 ....................................................... 140,600 persons ........................................ ÷ 1,251,340 × 16 = 2

Total .................................................... .................................................................... .... .................... .... .................... .... 10 systems

The total of 6 surface water and 10

ground water systems equals 16

systems, the number to State A’s Plan.

The replacement list of systems will

also be developed and provided at this

level of detail.

Sampling Plan. The sampling plan

that EPA is considering is outlined here.

As shown in the first matrix of

confidence levels, the overall

confidence level is established at 99

percent (0.99). The small water systems

were allocated on the basis of

population served, except in the very

small strata, which EPA supplemented

to bring the statistical inferential ability

up to 95 percent in all cells of the

confidence level matrix.

System Size Category

Desired Confidence Levels by Source Type

Ground Water Surface Water All Sources

Very Small (25–500 persons) ...................................................................................................... 0.95 0.95 0.95

Small (501–3,300 persons) ......................................................................................................... 0.95 0.95 0.95

Medium (3,300–10,000 persons) ................................................................................................. 0.95 0.95 0.95

All System Categories ................................................................................................................. 0.95 0.95 0.99

SAMPLING PLAN

System Size Category

Planned national water system allocation by

source type

Ground water Surface water All sources

Very Small (25–500 persons) ...................................................................................................... 67 64 131

Small (501–3,300 persons) ......................................................................................................... 186 74 260

Medium (3,300–10,000 persons) ................................................................................................. 189 141 330

All System Categories Subtotal ................................................................................................... 442 279 721

NTNCWS Subtotal ....................................................................................................................... ........................ ........................ 79

Total ...................................................................................................................................... ........................ ........................ 800
50580 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

Both the very small ground water and

surface water systems categories

contained too few systems to have a

confidence level of 95 percent. The very

small ground water category needed 6

additional systems and the very small

surface water category needed 56

systems to bring them up to the 95

percent confidence level. These

numbers of systems will be allocated to

each State based on the number of

persons served in each subcategory

within the State. (Note that the example

presented above did not reflect an

additional allocation to the ‘‘very small’’

strata for surface or ground water

systems for State A. Such an outcome

would result because State A had a low

number of people in this category

relative to other States and would not be

allocated an additional system in this

plan.)

EPA has prepared a background

document titled ‘‘National

Representative Sample of Small Public

Water Systems: Statistical Design and

State Plans for the Unregulated

Contaminant Monitoring Regulation’’ to

describe in more detail this selection

process and its relation to the State

Plans. The background document is

available by calling the EPA Safe

Drinking Water Hotline at (800) 426–

4791, or by viewing it on EPA’s Internet

Homepage for the Office of Ground

Water and Drinking Water

(www.epa.gov/safewater).

EPA asked for public comment on

whether it should consider using a

targeted approach for selecting systems

in the national representative sample

based on prior knowledge of

contaminant use or occurrence, system

operation or other locational

information, rather than this stratified

random selection approach. Internal and

external peer reviewers and public

commenters agreed that a targeted

approach would bias the national

results.

Several aspects of potential bias are of

concern to EPA: (1) prior information on

targeted use of a contaminant may not

be perfect which may lead to missing

the target zone; (2) targeting leads to

biased results that would be expected to

have a larger percentage of detections,

potentially overstating occurrence of the

contaminant; (3) targeting areas of

known or expected contaminant use or

occurrence for monitoring does not

provide a representative national

picture of occurrence, because both

detections and nondetections of

contaminants are equally important in

determining national occurrence in the

decision process of whether or not to

regulate a contaminant; and (4) targeting

areas of known or expected use or

occurrence does not take into account

that surface waters can carry the

contaminant out of the targeted area.

The State Monitoring Plans will also

include a representative sample of small

systems that will be combined with a set

of randomly selected large systems for

Screening Survey monitoring of UCMR

(1999) List 2 contaminants. The number

of small systems, selected through the

same statistical process from the

systems used to conduct Assessment

Monitoring, will be smaller (perhaps

150 to 200 systems out of a total number

of about 300 small and large systems)

because the purpose of the Screening

Survey is to test for contaminant

presence in systems rather than testing

for concentrations in an established

percentage (such as 2 or 3 percent) of

systems, as is the case for Assessment

Monitoring. If a contaminant occurs in

a small percent (e.g., 0.5 percent) of

systems, then the contaminant will be

considered to occur at a level that will

indicate that it should be included in

the next round of Assessment

Monitoring.

EPA needs to balance the number of

systems included in the national

representative sample required for

statistical validity with the cost of

paying for the testing. EPA believes that

the final rule’s approach balances the

number of systems to be tested with the

cost and also balances a nationally

representative sample with the

allowance for State plans. The final

approach also relieves States from

having to develop the statistical design

and specify the systems to be

monitored.

(b) Systems Selected for Pre-Screen

Testing

If a State enters into an MOA with

EPA, it can participate in the Pre-Screen

Testing program. States must specify

from 5 up to 25 systems as the systems

most vulnerable to the contaminants on

UCMR (1999) List 3. EPA will determine

the number of systems to be selected in

any State based on the population

served by CWSs and NTNCWSs in a

State. The States must modify their

State Plans to identify the small systems

selected for Pre-Screen Testing and

notify the EPA of their addition to those

Plans.

(c) Tribal Water Systems

Public water systems serving less than

10,000 persons that are located on

Tribal lands in Indian country will be

treated as an individual stratum for the

representative sample. The stratified

random selection process described

previously allocates systems within

water source and size category by

population served. A PWS in Indian

country will have the same probability

of being selected as any other water

system in another State based on the

proportion of the population served by

water source and system size category.

Because no State has jurisdiction over

such systems, EPA will consult with the

appropriate tribal government

concerning whether any initially

selected system should be replaced due

to merger, closure, or purchase of water

from another system. The resulting set

of systems will be the ‘‘State Plan’’ for

Indian country.

Public comments relative to Tribal

water systems requested that Tribal

systems be specified through a stratified

random selection process like the other

systems in the national representative

sample to avoid biasing the results. EPA

agrees and plans to identify Tribal

systems through the same stratified

random selection process that is applied

to the other systems.

(d) ‘‘Index’’ Systems

EPA generally has less information

about systems serving 10,000 or fewer

persons than about systems serving

more than 10,000 persons. This lack of

information on these systems and their

operation affects EPA’s ability to tailor

regulations to systems of this size. To

provide an improved understanding of

small systems, EPA will select up to 30

small public water systems as ‘‘Index’’

systems and EPA will conduct

Assessment Monitoring at these systems

during each of the five years for which

the UCMR List and national

representative sample must be

established. EPA is requiring more

frequent monitoring from these systems

than the systems selected for

Assessment Monitoring. Index systems

must be selected from the systems

designated in State Monitoring Plans

using a random number generator. EPA

will pay for this monitoring, including

provision of sample equipment,

shipment of samples, testing, and

reporting. EPA will help Index systems

collect samples by sending a field

technician to each Index system to

obtain the samples. Index system

sampling is being conducted to: ensure

sample collection quality for the 30

systems; provide information of

temporal variation encountered during

the monitoring cycle; and better

understand the needs of small public

water systems in future regulations. The

Index system sampling program is

designed to ensure that future

regulations better reflect the conditions

under which small systems operate.

Owners/operators of Index systems are

required to assist EPA in identifying
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50581

appropriate sampling locations and

provide information on wells and

intakes in use at the time of sampling,

well casing and screen depth (if known)

for those wells, and the pumping rates

of each well or intake at the time of

sampling. The monitoring results for the

Index systems will be used to

characterize the UCMR results to other

small systems in the national

representative sample with this

frequency and for this additional

information. EPA or its representative

will also collect information on

precipitation, land use and other

environmental factors (e.g., soils and

geology) to provide the Agency with

information on other conditions

potentially affecting drinking water

quality of small systems. This Index

system monitoring will facilitate

extrapolation of Assessment Monitoring

results nationally for systems of this

size. A description of the selection

process for Index systems using a

random number generator will be

presented in the background document,

noted above, titled ‘‘National

Representative Sample of Small Public

Water Systems: Statistical Design and

State Plans for the Unregulated

Contaminant Monitoring Regulation.’’

Public comments received concerning

Index systems were generally

supportive of the approach to provide

additional information to tailor future

regulations to small systems.

(e) Other State Data

Some States may sample and test

additional systems beyond those

included in the State Monitoring Plan.

Any additional systems sampled by

States should not be combined with

those of the State Monitoring Plan for

the purpose of computing national

estimates of contamination. While

providing useful information for

protecting the health of persons using

drinking water from these systems, this

additional data will bias the results of

the national representative sample if

included. However, if the State wants to

report the results of such monitoring,

EPA could receive the data through the

Safe Drinking Water Information System

(SDWIS) for input to the NCOD. EPA

plans to develop acceptance criteria to

allow such data to be placed in the

NCOD. Public comments supported

EPA’s position that any data from

additional systems not in the State

Monitoring Plan should not be

combined with data from the

representative sample of small systems

because it would bias the national

results.

G. Reporting of Monitoring Results

Today’s final regulation replaces the

reporting requirements at 40 CFR 141.35

to make the reported occurrence results

more useful for sound scientific

analyses.

1. Reporting Requirements (Data

Elements)

UCMR data are one of four types of

data that will potentially be reported to

the NCOD as required by Section

1445(g). The other types of data that

may be included in the NCOD are: (1)

regulated contaminant occurrence data

below the maximum contaminant level

(MCL) but above the minimum reporting

level (MRL) (a regulation may be

developed to obtain this data during

2000); (2) source water monitoring data;

and (3) other data from special studies

and research. Since these data will come

from varying sources, they may have

different reporting requirements. The

PWS data from unregulated

contaminant monitoring may have the

smallest number of data elements to be

reported because of the greater level of

control over the quality of the data

through the laboratory certification

programs and the monitoring and

quality control requirements in the final

rule today.

EPA engaged in an extensive process

of stakeholder and technical review

when developing the NCOD to identify

information reporting requirements that

allow data from different sources to be

adequately evaluated, compared, and

interpreted. The NCOD information

requirements process identified

additional data elements that must be

considered for UCMR reporting with

unregulated contaminant sample test

results. These data elements are

especially important because many of

the contaminants may not be routinely

tested for and will need sample test data

quality indicators to assist in

interpreting the results. These

additional data elements for the

unregulated contaminants, and the

reasons EPA adds them to the previous

reporting requirements in this rule, are

explained briefly in the following table.

EPA requested public comment on these

additional reporting requirements

identified in Table 4, Final Additional

Data Elements for the UCMR. The only

comments EPA received, other than

support for the additional data elements

to be reported, were to clarify Minimum

Reporting Level and Method Detection

Level reporting and their difference

from Instrument Detection Level and

Estimated Detection Level and to use

‘‘presence/absence’’ for microbiological

contaminants only. A technical peer

reviewer also suggested that spiking

concentration be added to the reporting

requirements to allow evaluation of the

methods being used, since the methods

are still being refined. The reader is

referred to the document titled, ‘‘Public

Comment and Response Summary’’ for

the Unregulated Contaminant

Monitoring Regulation for a discussion

of these comments. The complete list of

data elements for the UCMR appears in

the rule at § 141.35(d), Table 1.

TABLE 4.—FINAL ADDITIONAL DATA ELEMENTS FOR THE UCMR

Final data element Definition Reason for reporting

Public Water System Facility Identification Number—Source, Treatment Plant

and Sampling Point.

An identification number established by the State,

or, at the State’s discretion, the PWS, that is

unique to the system for an intake for each

source of water, a treatment plant and a sampling point. Within each PWS, each intake,

treatment plant and sampling point must receive a unique identification number, including,

for intake; surface water intake, ground water

well or wellfield centroid; and including, for

sampling point; entry points to the distribution

system, wellhead (or wellfield), intake, or locations within the distribution system. The same

identification number must be used consistently

throughout the history of unregulated contaminant monitoring to represent the facility.

Identify source water, treatment plant and sampling location for use in evaluating contaminant

source controls in regulation development. The

source intake/well identification number can be

related to latitude and longitude for use in geographic analysis of land use, soils, geology and

precipitation for alternative treatment and control analysis. Treatment plant identification

number can be related to treatment information

for that plant to use in analysis of alternative

treatments. Sampling point identification number will allow the sample test result to be consistently associated with the same sample location over time for trend analysis.
50582 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

TABLE 4.—FINAL ADDITIONAL DATA ELEMENTS FOR THE UCMR—Continued

Final data element Definition Reason for reporting

Sample Analysis Type ............................. The type of sample collected. Permitted values

include: (a) Field Sample—sample collected

and submitted for analysis under this rule. (b)

Batch Spike/Spike Duplicate Samples—Samples associated with a batch for calculating analytical precision and accuracy. A batch is a

collection of 22 samples analyzed together, of

which two are the spike and spike duplicate

samples, that are tested for analyte concentrations.

Indicates field and spiked sample to ensure that

the sample test result is used for the appropriate analysis (e.g., contaminant concentration

trends, sample test performance, etc.).

Detection Level ........................................ ‘‘Detection level’’ refers to the detection limit applied to both the method and equipment. Detection limits are the lowest concentration of a

target contaminant that a given method or

piece of equipment can reliably ascertain and

report as greater than zero (i.e., Instrument

Detection Limit, Method Detection Limit, Estimated Detection Limit).

Indicates lowest quantifiable measurement level

applied through the method to the sample to

allow comparison with other sample test results.

Detection Level Unit of Measure ............. The unit of measure to express the concentration, count, or other value of a contaminant

level for the detection level reported.

(e.g., μg/L, colony forming units/mL (CFU/mL),

etc.).

Indicates the reporting unit for the detection limit.

Batch Identification Number .................... A unique number assigned by the laboratory analyzing samples to a specific batch of samples.

The number comprises 9 digits for the laboratory identification number, 4 digits for the year,

2 digits for the month, 2 digits for the day, and

2 digits for the batch of samples.

Allows calculation and comparison of precision

and accuracy among batches of samples and

association of precision and accuracy with

each sample in a batch to sort results based

on data quality.

Spiking Concentration .............................. The concentration of method analytes added to a

sample to be analyzed for calculating analytical

precision and accuracy.

Allows calculation of precision and accuracy for a

batch of samples and an evaluation of the

method.

Analytical Precision .................................. For purposes of the UCMR, Analytical Precision

is defined as the relative percent difference

(RPD) between spiked matrix duplicates. The

RPD for the spiked matrix duplicates analyzed

in the same batch of samples as the analytical

result being reported is to be entered in this

field. Precision is calculated as RPD between

spiked matrix duplicates using, RPD =

[(X1¥X2) / {(X1 + X2)/2}] x 100.

Indicates variability among laboratory results as

measured by testing replicate field or duplicate

spiked samples, and is a key measure of sample test performance.

Analytical Accuracy .................................. For the purposes of the UCMR, accuracy is defined as the percent recovery of the contaminant in the spiked matrix sample analyzed in

the same analytical batch as the sample result

being reported and calculated using;.

% recovery = [(amt. found in Spiked sample—

amt. found in sample) / amt. spiked] x 100.

Indicates whether test results are within a group

of measurements corresponding to the true

value of the results, and is a key measure of

sample test performance.

Presence/Absence ................................... Chemicals: Presence—a response was produced

by the analysis (i.e., greater than or equal to

the MDL but less than the MRL)/Absence—no

response was produced by the analysis (i.e.,

less than the MDL).

Microbiologicals: Presence—indicates a response

was produced by the analysis/Absence—indicates no response was produced by the analysis.

Chemicals: Indicates results that do not have a

quantifiable value and whether, for a positive

result, the chemical concentration is between

the MRL and the MDL to allow more thorough

assessment of the method’s capability to identify the contaminant.

Microbiologicals: Allows measure under conditions and for microorganisms that are not able

to be counted.

Note that EPA deleted ‘‘composite’’

from the proposed set of data elements

since the final rule does not allow

compositing. Since this program is

designed to measure actual occurrence

of contaminants, compositing (the

combining of samples from several

sampling points of a water system) will

dilute concentrations of contaminants to

be measured. Stakeholders supported

the deletion of compositing, and

believed it to be contrary to the

objectives of the UCMR. No public

comments were received on this subject.

Also note that ‘‘Public Water System

Facility Source Intake Identification

Number’’ must currently be reported

under existing reporting requirements

for SDWIS under 40 CFR 142.15(b)(1).

The UCMR will expand this

requirement to include the unique

identification numbers for treatment

plant and sampling point, which may

not change over time. EPA is not

requiring, through today’s action, the

reporting of treatment data (treatment

objectives and processes) since these

data are already required to be reported

by January 1, 2000, for all systems. (Safe

Drinking Water Information System
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50583

FACT SHEET, Revised Inventory

Reporting Requirements, June 1998)

The rationale for including these data

elements is that EPA needs the detailed

information concerning the sample test,

location, and treatment that will allow

the results to be used in making a

determination of whether or not to

regulate the contaminant and to develop

regulations. The specific reasons are

identified in Table 4. To avoid duplicate

and costly resampling efforts, EPA

believes that systems should obtain and

report the most complete information

the first time a sample is tested.

The information requirements process

for development of the NCOD identified

technical questions that need to be

answered in the regulatory process that

the UCMR is to support. These data

elements are associated with these

questions. While the list of data

elements will increase by five (from 12

to 17) in today’s final UCMR (as

compared to the existing UCMR),

reporting them the first time precludes

the need to obtain the information

through another process. Because the

1996 SDWA Amendments expanded the

determinations and types of analyses

that need to be conducted to develop a

rule, including these data elements is

responsive to the new regulatory

environment in which drinking water

regulations must be developed.

These new data elements will not be

a major burden for a PWS. Only four of

the elements must be supplied by the

PWS: the PWS ID; the Facility ID; the

sample number; and sample collection

date. All other elements can be supplied

by the laboratory.

States commented that EPA should

not require system inventory data if

those data are required under another

reporting arrangement in 40 CFR

142.15(b)(1). As a result, EPA modified

this final rule eliminating inventory

data elements that are required for other

reporting. Today’s rule requires that

Public Water System Facility ID be

reported. Coupled with the PWS ID, the

facility ID can be linked to sampling site

information and locational data

necessary for thorough analyses of the

data.

As explained earlier, EPA also

requires owners/operators of Index

systems that are part of State Plans for

the national representative sample to

provide data concerning well casing,

screen depths and pumping rates at

each well or intake at the time of

monitoring. This reporting will allow

EPA to tailor regulations to systems

serving 10,000 or fewer persons by

relating sample test results to conditions

that affect capture of contaminants by

ground water and surface water

supplied systems.

2. Reporting to the Primacy Agency

Today’s rule changes reporting

relationships for unregulated

contaminant monitoring data. The

statute requires that the results be

reported to the primary enforcement (or

‘‘primacy’’) authority for the system.

Many States and systems raised

questions about the necessity and utility

of requiring State primacy for the

UCMR. In response to these comments,

EPA has decided to directly implement

the UCMR, while allowing States to

participate in State Plan review and

implementation through MOAs rather

than through State primacy. Some States

noted that UCMR data will primarily be

used by EPA to make regulatory

determinations, and that such data are

not required by the State to assess

compliance for public health. The States

however, need these data for their

program records and implementation. In

response to these comments, EPA is not

requiring the State to report the data,

but is requiring the PWS to report the

data electronically to EPA, unless

otherwise arranged, with a copy to the

State. EPA will issue guidance on the

process of reporting to EPA

electronically or in other formats and

providing a copy of the results to the

State. Since EPA is paying for small

systems’ testing and reporting, the

Agency will set up an electronic

reporting system for these systems that

are required to report. EPA will report

the data to the States for these small

systems. EPA will hold the data of small

and large systems for 60 days to allow

systems and States to review the data

before placing the data in the NCOD, as

required by SDWA. EPA encourages

States to review the data as time allows

because their review is critical to

identifying drinking water quality issues

that may not be obvious at the national

level. This review provides an

additional level of data quality control

before EPA uses the data in regulatory

decisions.

3. Timing of Reporting

In response to public comments from

States and systems requesting more time

to report these data, EPA modified the

rule at § 141.35(c) to require large PWSs

to report their monitoring results within

thirty days, rather than ten days, after

the month in which they receive the

results from the laboratory. This

requirement provides additional time

for systems to review the UCMR results

before reporting them to EPA.

4. Method of Reporting

SDWA Section 1445 (a)(2)(D) states

that each PWS that monitors for

unregulated contaminants must provide

the monitoring results to the primacy

authority for the system. Today’s final

rule requires electronic reporting by

PWSs to EPA, while providing a copy of

the results to the State (§ 141.35(e)). The

rule also allows EPA to specify another

method for reporting by a PWS, if

necessary. Public commenters

supported allowing an alternate

reporting method for PWSs if they could

not report electronically. Note that EPA

will pay for the testing and laboratory

analysis of samples for small systems in

State Monitoring Plans. Since EPA plans

to establish electronic recordkeeping of

the results from systems in State Plans,

electronic reporting for these systems

will be done through the assistance of

EPA. EPA might consider specifying

another method for reporting when a

system serving over 10,000 persons has

not developed the capability to report

electronic results. However, most

laboratories have this capability and

could probably provide this service for

the PWS.

5. Public Notification of Availability of

Results

SDWA Section 1445 (a)(2)(E) requires

notification of the results of the UCMR

program to be made available to persons

served by the system. The results of

UCMR monitoring for CWSs will be

reported through annual Consumer

Confidence Reports (CCR), as required

by § 141.153 (d). For NTNCWSs, UCMR

monitoring results will be reported

according to requirements of the revised

public notification rule as proposed

May 13, 1999 at 64 FR 25963. Failure to

monitor for unregulated contaminants

required through the UCMR will also be

reportable under the public notification

rule.

The results that will be reported

through the CCR and public notification

rules should be based on the same

monitoring data that the States will

receive under the UCMR and will be

required to be reported to the NCOD.

Information in the NCOD will be

available to the public.

VII. Section-by-Section Analysis of

Public Comment and EPA Response

This portion of the preamble is

devoted to highlighting major changes

in the specific sections and paragraphs

of the revisions to the Unregulated

Contaminant Monitoring Regulation,

including 40 CFR 141.35, 141.40,

142.15(c), and 142.16, in the order that

they appear in the Code of Federal
50584 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

Regulations and are promulgated here as

a final rule today. The details of the peer

review and public comments and EPA’s

responses can be found in two

background documents: External Peer

Reviews of the Unregulated

Contaminant Monitoring Regulation,

and Public Comment and Response

Summary for the Unregulated

Contaminant Monitoring Regulation.

A. Section 141.35—Reporting of

Unregulated Contaminant Monitoring

Results

1. Does this reporting apply to me?

This paragraph notes that § 141.35

applies to the owner or operator of any

PWS required to monitor for

unregulated contaminants under

§ 141.40. Exceptions to the reporting

requirements are also noted. The

majority of comments received on this

topic suggested that water systems using

purchased water should be required to

monitor for contaminants occurring in

distribution lines, such as

microbiological contaminants. Like the

proposed rule, today’s final rule states

that small systems serving 10,000 or

fewer persons need not report their

results to EPA because EPA will pay

and arrange for testing and reporting of

the results. To improve the logical flow

of the rule, EPA moved this exception

to this paragraph from the paragraph

immediately below it.

In response to these comments, EPA

has modified this section, noting that

water systems that purchase all of their

water will be included in the UCMR for

contaminants having distribution

system sampling points, including

points of maximum residence time or

points of lowest disinfectant residual.

A few commenters suggested it was

inappropriate for only the small systems

selected as part of the national

representative sample to report UCMR

results and not other small systems. In

response, EPA notes that Section

1445(a)(2)(D) of the SDWA states that all

systems required to conduct

unregulated contaminant monitoring

must report the results. Because only a

nationally representative sample of

small systems will be required to

monitor under the UCMR, only those

systems will have to report the results.

2. To whom must I report?

This section explains the reporting

requirements for systems that will

monitor for unregulated contaminants.

Under today’s rule, a system must

report the results of unregulated

contaminant monitoring to EPA and

provide a copy to the State. This is a

change from the proposal and is based

on EPA’s decision, in response to public

comment, to implement this rule

through MOAs with State agencies

rather than through the primacy

process. EPA will hold the data for 60

days to allow systems and States time to

conduct a quality control review before

entering the data into the NCOD. This

is discussed in more detail in IX.A.

Implementation of the Rule. The system

also must notify the public of the

monitoring results as provided in

Subpart O (Consumer Confidence

Reports) and proposed Subpart Q

(Public Notification) of this part.

Even though small systems do not

report their results because EPA will do

that for them, small systems must still

comply with the public notification

requirements for these results.

3. When do I report monitoring results?

This section specifies that a PWS

must report the results of unregulated

contaminant monitoring within thirty

days following the month in which they

receive the results from the laboratory.

Today’s final rule is slightly different

from that of the proposed rule. Rather

than reporting within 10 days of

receiving monitoring results, it extends

the deadline for reporting results to

thirty days after the month in which the

results are received from the laboratory.

This change provides more time for the

system to review the data before

reporting. This is in response to

comments received indicating that the

requirement that systems report results

within 10 days after receiving results

from the laboratory is too short a period.

Additionally, commenters were

concerned with adequate time to review

and understand the data before

reporting them to EPA. Also, as noted

previously, EPA will wait 60 days

before placing the data in the National

Drinking Water Contaminant

Occurrence Database (NCOD) to allow

additional time for systems, States and

EPA to ensure quality control of the

data.

Consistent with the decision to not

require States to adopt this rule as part

of primacy, EPA has also clarified that

EPA, not the State primacy agency, will

specify the required monitoring period.

A commenter was concerned with the

costs associated with reporting UCMR

results quarterly and requested that

PWSs be allowed to report data in an

annual batch. EPA is maintaining the

requirement of quarterly reporting

because EPA does not believe that

annual reporting would allow EPA to

use the data as input to the next round

of the CCL and UCMR lists, which is a

principal objective of the rule. Also,

large PWSs already report quarterly.

Additionally, EPA plans to evaluate the

data early to determine whether

modifications are needed in the

analytical methods.

4. What information must I report?

This section lists and defines the data

elements that must be reported. In

addition to analytical results and quality

control, EPA is requiring information on

the PWS from which the analyzed

sample was taken.

Today’s rule modifies somewhat the

unregulated contaminant monitoring

reporting requirements in the proposed

rule (Table 8 of ‘‘Revisions to the

Unregulated Contaminant Monitoring

Regulation for Public Water Systems,’’

Federal Register, vol. 64, no. 83, April

30, 1999, pages 23426 to 23428) and

reorders the sample data elements. For

example, for microbiological

monitoring, future requirements may

specify either a sampling point in the

distribution system that has the

maximum residence time or, under

today’s rule, the lowest disinfectant

residual, in response to comments

concerning systems using disinfectant

booster stations where the disinfectant

residual is low. These sampling point

types were added to the data element

listing. Questions were raised as to how

the UCMR would accommodate water

systems that have mixed sources (i.e.,

use blended/mixed surface water and

ground water). In response, the data

element, Water Source Type, will be

modified in the Safe Drinking Water

Information System (SDWIS) Inventory

Reporting Requirements to address this

issue: the valid choices for this data

element will include purchased/nonpurchased blended/mixed water. See 40

CFR 141.35(d) Table 1 of the rule for

more information.

Sample collection date must be

reported as 4-digit year, 2-digit month,

and 2-digit day under the final rule to

ensure year 2000 compliance, and to

refine date records, as suggested by peer

reviewers. Also added to the sample

data elements is a sample batch

identification number, which is

assigned by the laboratory to each batch

of samples analyzed with the spike and

spike duplicate sample at the spiking

concentration to allow analysis of

method performance. The list of

permitted sample analysis types is

reduced to field sample and batch

spike/spike duplicate since these will be

the only required sample types reported

for unregulated contaminant

monitoring.

During the public comment period, a

comment was received suggesting that

inventory data elements should be

provided officially by the States through
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50585

the inventory data reporting process,

rather than by systems with their

sample results. EPA agrees that

inventory data elements are already

reported by a different mechanism.

Therefore, EPA has removed the data

elements that are or will be included in

the Safe Drinking Water Information

System (SDWIS) Inventory Reporting

Requirements: sampling point type,

water source type, public water system

facility type, latitude of the public water

system facility for source and treatment

plant, and longitude of the public water

system facility for source and treatment

plant. This change in data elements

under today’s rule provides for the

revision or addition in inventory data

reporting for the data elements not

included in the rule to address:

(A) for sampling point type, an

expansion of allowable choices to

include: raw/untreated water, finished

water from treatment system, finished/

treated water from entry point to the

distribution system after treatment,

finished/treated water from within the

distribution system, finished/treated

water from the distribution system at

the location of maximum residence time

or lowest disinfectant residual, finished/

treated water from the distribution

system at the location of lowest

disinfectant residual, finished/treated

water from household/drinking water

tap, finished/treated water from

unknown location, and other finished/

treated water;

(B) for water source type, to include

allowable choices of: surface water from

a stream or purchased surface water

from a stream, surface water from a lake

or reservoir, or purchased surface water

from a lake or reservoir, ground water

under the direct influence of surface

water or purchased ground water under

the direct influence of surface water,

ground water or purchased ground

water, and blended/mixed surface water

and ground water, or purchased

blended/mixed surface water and

ground water;

(C) for public water system facility

type, to include, for the purposes of

UCMR, the allowable choices of: intake

(for surface water sources), well or

wellfield (for ground water sources),

treatment plant, sampling point, entry

point to distribution system, reservoir,

booster station, and unknown;

(D) latitude of the public water system

facility for source and treatment plant;

and

(E) longitude of the public water

system facility for source and treatment

plant. Additionally, the SDWIS

inventory reporting requirements will

address associating the PWS facility

identification number of any sampling

point with the PWS facility

identification number of its respective

treatment plant. Furthermore, the reason

that the latitude and longitude of the

treatment plant should be reported is to

allow the association of other data, such

as health effects information, with a

point closest to the affected population,

since the ultimate use of the UCMR data

is for input to exposure assessment in

determining whether or not to regulate

a contaminant.

Comments were received suggesting

that EPA include the maximum

reporting level (MRL) in the data

elements. It is not necessary to include

the MRL in the data elements because

the MRL is specified in the rule in

§ 141.40(a)(3) Table 1. The rule wording

is clarified so that a particular

laboratory having the capability for

reliable lower detection may report

concentrations below the MRL.

Some commenters had concerns about

the inclusion of a presence/absence data

element. For microbiological

contaminants, this data element may be

needed because analytical methods do

not always allow for quantification of

the target organism in the sample and

may only allow for a qualitative

response, i.e., presence or absence. For

chemical contaminants it can be used

for reporting the detection of chemical

contaminants below the MRL but above

the MDL.

5. How must I report this information?

This section explains that the

unregulated contaminant monitoring

results must be reported in electronic or

in another format specified by EPA,

such as a template on paper that can be

scanned and entered into the NCOD

electronically.

A question was raised as to how EPA

will be able to accept electronic data

from diverse laboratory information

systems at the many laboratories that

may be reporting data. It was also

suggested that EPA work with States

and water suppliers to develop formats

to make electronic submission easier.

EPA is considering the development of

software that may be downloaded from

the EPA website to enable systems and

their laboratories to electronically report

data. This may be the same electronic

data form that allows PWSs to report

data to NCOD/SDWIS.

Some commenters indicated that the

State should have the option to specify

an alternate reporting method,

particularly with respect to small

systems. It was also suggested that EPA

should write the rule so as not to

preclude reporting directly to States and

EPA from the laboratories for small

systems, as well as for large systems.

The laboratory, whether EPA-approved

or an EPA-designated (i.e., contract)

laboratory, could report to systems,

States, and EPA. As noted previously,

EPA will report the data for small

systems.

As noted, the final rule is modified to

require systems to report to EPA. EPA

will require electronic reporting, unless

some other format must be used for a

particular system. This situation may be

established in consultation with the

State and described in subsequent

guidance that EPA will prepare on the

UCMR reporting process.

One commenter also expressed the

need for an electronic legal equivalency

of a signed hard copy of a laboratory

report. Since there is no requirement for

electronic reporting of a signed

laboratory report, EPA will not require

an electronic legal equivalency. Systems

may want a signed hard copy for their

own records.

6. Can the laboratory to which I send

samples report the results for me?

This section states that a laboratory

can report the sample results, so long as

it provides the system with a copy for

review and record keeping.

The Agency was asked to clarify that

it is the responsibility of the PWS

owner/operator to report data to EPA,

even if the laboratory reports the results.

In response to comments, the rule

wording has been clarified to stress that

the PWS is responsible for reporting

information and ensuring that the

laboratory provides the results to EPA

and the State.

7. Can I report previously collected data

to meet the testing and reporting

requirements for the contaminants in

§ 141.40(a)(3)?

This paragraph was added in response

to many comments received requesting

a provision for systems to report

relevant unregulated contaminant data

collected before implementation of

today’s rule, in lieu of allowing only

UCMR data collected after the rule’s

effective date. The general consensus

was that some large systems may

already have monitored for or want to

monitor before 2001 for these

contaminants, especially if it fits within

their monitoring cycle. This paragraph

specifies that, as long as systems meet

the requirements specified in

§ 141.40(a)(3), (4), (5) and Appendix A

for monitoring and in § 141.35 (d) for

reporting, the data collected before the

effective date of this rule can be

submitted to meet the testing and

reporting requirements for the

contaminants in § 141.40(a)(3).
50586 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

B. Section 141.40—Monitoring

Requirements for Unregulated

Contaminants

1. Requirements for Owners and

Operators of Public Water Systems

(a) Do I have to monitor for unregulated

contaminants?

This section eliminates unregulated

contaminant monitoring requirements

for owners and operators of transient,

non-community water systems. It also

specifies the monitoring requirements

for large systems that do and do not

purchase their entire water supply from

another system and for small systems

selected for the program that do and do

not purchase their entire water supply

from other systems.

Today’s rule describes specific

monitoring requirements for large and

small systems that purchase their entire

water supply from other systems. This

is in response to the many commenters

who indicated that PWSs using

purchased water should be included in

the UCMR for microbiological

contaminants, or other contaminants

that may arise in the distribution

system. As a result, EPA modified the

rule to require that water systems that

purchase all of their water will be

included in the UCMR for contaminants

having distribution system sampling

points.

(b) How would I be selected for the

monitoring under the State Monitoring

Plan, the screening survey, or the prescreen testing?

This section is basically unchanged

from the proposed rule since

commenters broadly supported the 3-

tier approach to the monitoring

program. It explains that only a

representative sample of small systems,

randomly selected by EPA, will be

required to conduct assessment

monitoring for unregulated

contaminants as part of a State

Monitoring Plan. A subset of these

systems will be randomly selected as

Index systems and required to submit

additional information. Each State will

have the opportunity to modify the list

of selected systems.

(c) For which contaminants must I

monitor?

The Unregulated Contaminant

Monitoring List is presented in this

section. It comprises List 1, the

chemical contaminants to be monitored

under Assessment Monitoring; List 2,

the chemical and microbiological

contaminants to be monitored under the

Screening Survey; and List 3, the

chemical and microbiological

contaminants to be monitored under

Pre-Screen Testing.

In response to many comments,

today’s rule makes changes in the

contaminant lists as presented in the

proposed rule. For List 1, the chemicals

perchlorate and acetochlor are added

and the microbiological contaminant

Aeromonas is removed and moved to

List 2. The analytical methods for

perchlorate and acetochlor are reserved.

The methods are expected to be ready

in the near future, at which time, a rule

revision will be published for comment

and promulgated to ensure these

contaminants can be monitored on or

before January 2001. Nitrobenzene, also

on List 1, has an approved method, but

it requires careful implementation.

Acetochlor (now on List 1) is removed

from List 2, and RDX and the

radionuclide polonium-210 are added to

List 2. The sampling locations for List

1 and 2 contaminants are Entry Points

to the Distribution System (EPTDS),

except for Aeromonas and polonium210, for which the sampling points are

reserved until the methods are further

validated and promulgated. The

radionuclide lead-210 is added to List 3.

Sampling locations for the

radionuclides and microogranisms are

reserved, as are the dates for the period

during which monitoring must be

completed. These dates will be

determined at a later time. To activate

monitoring for the contaminants on

Lists 2 and 3, the methods and related

sampling requirements must be

specified in future rulemaking revising

this regulation.

Many commenters indicated that it

would be premature to include

Aeromonas on List 1 since the specified

method has not been sufficiently field

tested. It was also suggested that the

rule should be clear about its focus on

Aeromonas the genus, not the species A.

hydrophila.

In response, EPA has moved

Aeromonas to List 2. The CCL specifies

Aeromonas hydrophila; however, the

proposed analytical method identifies to

the level of the Aeromonas hydrophila

complex, which is a group of about 7 to

12 Aeromonas species. To identify to

the species level would increase the cost

and complexity of the analysis and,

given funding considerations, would

limit the size of the Aeromonas

monitoring program that could be done.

Given the cost of the analyses and how

frequently Aeromonas has been found

in previous finished water surveys, a

panel of EPA scientists (CCL

Microbiology Meeting, Cincinnati, OH,

July 9, 1998) agreed that identifying to

the Aeromonas hydrophila complex

(rather than the species) level was

adequate for the purpose of the UCMR.

A final method has not yet been written

for Aeromonas. The current draft

analytical method for Aeromonas, draft

EPA Method 1602, does not include

verification tests since a final decision

on the inclusion of verification tests into

the method will be made after method

validation studies. Since the method

validation studies have not been

completed, EPA has placed Aeromonas

on List 2, to be monitored after the

method is ready.

In response to over 100 public

comments and peer review

considerations addressing the inclusion

of perchlorate in the UCMR, EPA has

added it to List 1. EPA did not originally

propose monitoring for perchlorate

under this portion of the regulation

based on three general concerns: its

apparent local/regional, rather than

nationwide, occurrence at the time EPA

assembled the monitoring list; current

analytical methods do not adequately

address potential interferences from

chloride, sulfate or other dissolved

solids; and no laboratories are certified

for performing analyses using the

methods for perchlorate. Based on many

comments that showed perchlorate

occurrence in many locations around

the nation, EPA placed perchlorate on

List 1. The analytical method for

perchlorate is listed as ‘‘reserved’’ in the

UCMR pending imminent conclusion of

EPA refinement and review of the

analytical method. Since EPA did not

initially include a perchlorate analytical

method in the proposal to this

regulation, it will be necessary for EPA

to issue an additional regulation to

formally propose and promulgate a

perchlorate analytical method prior to

initiating monitoring for perchlorate

under the UCMR.

Therefore, following promulgation of

the UCMR (including the ‘‘reserved’’

perchlorate method reference), EPA will

be proposing a new regulation

specifying both the approved analytical

method for the analyses of perchlorate,

and the implementation of a laboratory

approval system, where labs are

certified to test for perchlorate. EPA is

currently conducting analytical methods

development to support the analyses of

perchlorate. This new method will be

based on the currently available ion

chromatography methods, but will

include a criteria detailing when a

laboratory must perform a sample cleanup procedure to minimize the impact of

elevated concentrations of chloride,

sulfate or other dissolved solids. The

laboratory approval system will be

based upon previous certification of the

laboratory for the analyses of

compliance monitoring samples using
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50587

either EPA Method 300.0 or 300.1, and

the successful analyses of a perchlorate

performance evaluation sample.

EPA asked for comment on and a few

commenters recommended the addition

of RDX (hexahydro-1,3,5-trinitro-1,3,5-

triazine) to the UCMR. In response, EPA

has placed RDX on List 2, as its method

needs further refinement. EPA will

propose and promulgate an analytical

method for RDX prior to requiring

monitoring for RDX under the UCMR.

EPA also received comments

suggesting that it move acetochlor, 2,4-

dichlorophenol and 2,4,6-

trichlorophenol from List 2 to List 1,

and require systems to use EPA Method

525.2 to analyze for acetochlor and

either a new SPE/GC/MS method

modified for EPA Method 525.2 or a

modified EPA Method 552 to analyze

for the phenols. EPA has moved

acetochlor to List 1, since the analysis

of acetochlor using EPA Method 525.2

is expected to be approved prior to

UCMR implementation. The evaluation

of the use of EPA Method 525.2 will be

finalized after acetochlor preservation

studies have been completed. EPA will

propose and promulgate an analytical

method, likely EPA Method 525.2, for

acetochlor prior to requiring monitoring

for acetochlor under the UCMR.

EPA did not move 2,4-dichlorophenol

and 2,4,6-trichlorophenol to List 1 since

the progress of method development for

these contaminants is not equivalent to

that of acetochlor. EPA has determined

that the phenols are not compatible with

EPA Method 525.2 and expects to

require a separate SPE/GC/MS method

currently under development. A

modification to EPA Method 552 was

also suggested. The suggested

diazomethane modification to EPA

Method 552 is not an option permitted

in Method 552 as an EPA approved

method and must be evaluated,

reviewed and approved before allowing

it to be used as an EPA method.

As noted in this comment,

dichlorophenol and 2,4,6-

trichlorophenol can only be analyzed

using method 552, when the

diazomethane used is sufficiently

strong. This does not lead to the type of

reproducibility needed to approve this

method in a variety of analytical

laboratories that may produce

diazomethane of varying strengths. If

the diazomethane is not as strong as that

indicated in this comment, the recovery

of dichlorophenol can drop to 10%. In

addition, 2,4,6-trichlorophenol is

subject to interferences caused by the

derivatization product of 2,4-

dichlorophenol, regardless of the

strength of the diazomethane. Method

552 is not approved for the analyses of

any other UCMR analytes. Therefore,

use of Method 552 for these 2

compounds would then require the

laboratory to use a separate method for

the analyses of the other phenols

included in the UCMR. Instead of

requiring 2 methods for these analyses,

EPA is currently conducting the method

development necessary to provide a

solid phase extraction GC/MS method,

that does not require derivatization, for

the analyses of all of the phenols

included in the UCMR as well as other

phenols not currently listed. This will

provide a single solid phase extraction,

GC/MS method for the analyses of all of

the phenols included in the UCMR.

Therefore, 2,4-dichlorophenol and 2,4,6-

trichlorophenol will remain on List 2.

As suggested by several commenters,

EPA has added polonium-210 and lead210 to the UCMR Lists. New

information indicates that methods for

these contaminants may be easier to

conduct than originally envisioned.

However, EPA research and an external

expert reviewer with experience with

radionuclides note that the currently

available methods for lead-210 and

polonium-210 may be very time

consuming and will require an

experienced analyst. There are also

significant laboratory capacity and

capability concerns. Few, if any,

laboratories currently performing

compliance drinking water

radiochemistry have any experience

with polonium-210 or particularly lead210. The method for lead-210, in

particular, needs further refinement.

Therefore, EPA has added polonium210 to List 2 and lead-210 to List 3.

Before requiring monitoring for these

contaminants, EPA will need to address

issues related to radionuclide laboratory

capacity and certification.

The recommendation was also made

that the Agency add EPA Method 502.2

for the measurement of MTBE. Several

public comments suggested that EPA

Method 502.2 was reliable, and that if

it is not added, then there could be

added burden on PWSs using GC

methods. EPA considered the

commenters concerns; however, the

Agency is not allowing the use of EPA

Method 502.2 for MTBE. MTBE is not

included in EPA Method 502.2 because

MTBE cannot be reliably measured by

either of the detectors used in the

method, and its stability has not been

tested using the preservatives listed in

that method.

Some commenters also suggested the

use of EPA 525.2 for nitrobenzene since

they have problems using the methods

listed in this regulation. Nitrobenzene

will remain on List 1 with EPA Method

524.2, and voluntary consensus

standard methods D5790–95 and

SM6210D being approved for its

analysis. However, the commenters are

correct that some laboratories have had

problems measuring nitrobenzene using

these methods. When laboratories do

not use the three stage trap listed in the

method, nitrobenzene cannot be

detected at reasonable concentrations in

either standards or samples. Since they

will therefore clearly fail the quality

control requirements of the method,

data will only be generated by

laboratories that can provide useful data

based on full method implementation.

While the data provided by a

commenter and confirmed by current

EPA methods development research

demonstrate that nitrobenzene can be

analyzed using EPA Method 525.2, the

preservation of nitrobenzene using

Method 525.2 conditions has not been

demonstrated. The methods

development research needed to

determine that nitrobenzene can be

preserved using the sampling

procedures specified in EPA Method

525.2 is currently being conducted. If

nitrobenzene is compatible with this

method’s preservation requirements,

then EPA will propose and promulgate

an analytical method for nitrobenzene

prior to requiring monitoring for

nitrobenzene.

As for the use of EPA Method 525.2

for the analyses of nitrobenzene,

research recently conducted in the

OGWDW laboratory clearly indicated

that nitrobenzene cannot be accurately

analyzed using Method 525.2.

Recoveries of nitrobenzene were less

then 10% when samples were extracted

using the conditions specified in

method 525.2. In conversations with the

laboratory submitting this comment,

EPA was informed that the data

submitted in this comment was not

developed using the procedures

specified in EPA Method 525.2. In

addition, no analyte stability data is

available for the storage of nitrobenzene

in samples preserved as specified in

method 525.2 or in extracts generated

using method 525.2. Therefore, EPA

Method 525.2 will not be approved for

the analyses of nitrobenzene.

One commenter suggested that EPA

Method 632 is a simple method with

adequate sensitivity for measuring

diuron and linuron. EPA Method 632 is

a modification of the National Pesticide

Survey Method 4, which EPA has found

is not reliable for diuron and linuron.

One commenter requested that an

HPLC method that can measure each of

the two DCPA acid degradates

separately be approved for their

analyses. However, this method was

published in a journal not by EPA or
50588 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

any of the consensus methods

organizations. This method, to the best

of EPA’s knowledge, is only being used

in a limited number of laboratories and

therefore has not had the level of

validation necessary for use in this type

of occurrence data gathering effort. In

addition, since the methods that were

approved measure the two DCPA

degradates as a single analyte,

approving a method that measures them

differently would cause concern about

data reporting and interpretation.

(d) What general monitoring

requirements must I follow for List 1

monitoring?

This section specifies what is

generally required of all systems

participating in Assessment Monitoring.

It also details additional monitoring

requirements unique to large and to

small systems.

Several commenters expressed

support for collecting routine water

quality parameters (WQPs) and agreed

that WQPs provide useful information

and a solid framework within which to

explain and understand monitoring

results, especially for microbiological

contaminants. Several did not believe

that reporting or testing of WQPs is

necessary, noting that WQPs are not

routinely collected for all systems, and

expressing particular concern that small

ground water systems without treatment

do not collect information on chlorine

residuals.

Water quality parameters are

important for microbiological

contaminants and may affect

degradation of chemical contaminants.

However, EPA is limiting the set of

additional parameters, in response to

comments. EPA is requiring reporting of

additional parameters, as appropriate to

the contaminant type, including pH,

turbidity, temperature, and free and

total disinfectant residuals. In addition,

today’s rule specifies the contaminant

type and EPA Method, Standard

Method, or other voluntary consensus

standard that may be used to measure

these parameters. Small ground water

systems that do not disinfect would

have no residuals to measure or report,

so this will not be a burden.

Furthermore, for small systems serving

10,000 or fewer persons, EPA will pay

for the testing of these water quality

parameters as part of the testing

program for unregulated contaminants.

The monitoring requirements for large

systems remain unchanged from the

proposed rule. Text covering small

systems has been clarified (1) to indicate

that the State may inform small systems

of sampling arrangements other than

those listed in this section, (2) that EPAdesignated laboratories will provide

sampling equipment, and (3) the EPA

will specify sample collection times.

It was suggested that the Agency use

total trihalomethane (TTHM)

monitoring sites for the microbiological

contaminants. In general, commenters

requested that more explicit

designations be given for

microbiological sampling sites. EPA has

noted that it expects that system specific

sites of normal and maximum residence

time and normal and lowest chlorine

residual will be designated when

revisions to this final rule are made for

contaminants of concern in distribution

systems. These sites have been

designated for other rules, related to

total coliform and total trihalomethane/

disinfectant byproduct sampling.

Further, EPA will propose and

promulgate appropriate monitoring sites

for microbiological contaminants prior

to requiring monitoring for Aeromonas

and other contaminants of interest in

distribution systems. The TTHM

monitoring sites may be appropriate

and, if so, will be included in the future

rulemaking.

(e) What specific sampling and quality

control requirements must I follow for

monitoring of List 1 contaminants?

This section details the requirements

for all systems, including sample

collection, shipping time and reviewing

and reporting results. It also prohibits

compositing samples. Also provided in

this section are requirements unique to

large and small PWSs that are part of the

State Monitoring Plan.

Today’s text has been clarified to

indicate that the State or EPA may

inform all systems of sampling

arrangements other than those specified

in the rule. Other changes from the

proposed rule related to large systems

include clarifications on the frequency

of sampling for chemical and

microbiological contaminants

conducted by surface water and ground

water systems, as well as expanded

information on sampling locations.

Regarding small systems that are part

of a State Monitoring Plan, today’s rule

notes that the State or EPA may inform

the system of sampling arrangements

other than those specified in the

proposed rule. It also notes that EPA’s

laboratory will send additional

instructions for sampling if the first

sampling event was not properly

conducted.

(i) All systems

Overall requirements for all systems

relative to (A) sample collection and

shipping time, (B) no compositing of

samples, and (C) review and reporting of

results were not changed from the

proposed to final rule.

(ii) Large systems

Specific sampling requirements for

large systems are in this section.

(A) Timeframe

One commenter indicated that EPA

should adapt the UCMR process to the

3-year compliance monitoring cycle.

The rule already states that coordination

with the 3-year compliance monitoring

cycle is appropriate.

(B) Frequency

Many commenters were concerned

that requiring ground water samples 6

months apart was not flexible enough to

accommodate other monitoring

schedules. Several commenters also

suggested that systems using

groundwater only be required to collect

one sample per year because ground

water systems do not vary much in

water quality.

EPA has modified the rule to provide

flexibility to the system to pick one of

the three months in the vulnerable time

and then one of three months 5 to 7

months earlier or later than the

vulnerable time. This schedule should

preserve the longer time between

ground water samples desired for

calculating an average annual

concentration for exposure assessment.

EPA will maintain the two samples

for ground water systems. Ground water

systems encompass a wide range of

conditions and many utilize unconfined

settings that do exhibit temporal

variability. To assess exposure from a

one-year sampling activity, most experts

EPA consulted and most stakeholders

agreed that the program must try to

capture the range of contaminant

concentrations that occur to ensure

representativeness of the results over

time nationally. Two samples are the

minimum to estimate an average

exposure; one sample will be targeted

toward the season of elevated

concentrations (the vulnerable

monitoring time). Many experts and

reviewers suggested more frequent

sampling, but the current design was

deemed a reasonable compromise

between data needs and burden. The

UCMR frequency adds one additional

sample over five years for a ground

water site, not one every year. While

some systems may not exhibit much

variability, and some deep systems may

not exhibit any synthetic contaminants,

the UCMR must include the full range

of water system conditions to develop

an accurate estimate of national

occurrence and exposure. Additionally,

with the UCMR monitoring being
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50589

coordinated with compliance

monitoring (to the extent possible),

approximately one-third of systems

affected by the rule will monitor each

year. Therefore, UCMR Assessment

Monitoring is expected to be conducted

over a range of hydrologic patterns.

This wide range of ground water

conditions also effects the nature of

vulnerable periods. Some ground water

systems show clear seasonal patterns,

some show different scale of variability,

and some show no variations (for some

types of contaminants). For these new

contaminants, EPA set a default

vulnerable period (May, June, or July)

that would fit the majority of vulnerable

seasonal patterns around the United

States. Expert technical reviewers and

stakeholders concurred with this period.

However, the State can specify a

different period, based on their

knowledge of local conditions. EPA

decided not to allow systems to

establish vulnerable periods because of

the need for national consistency to

support a sound statistical approach.

Allowing each system to establish a

vulnerable time would introduce

significant variability in the program

implementation, contrary to the

consistency basis of the statistical

approach for an unbiased sample. EPA

decided that flexibility at the State level

to select an alternate vulnerable

monitoring time was the maximum

allowable variability that should be

incorporated into the implementation of

the program.

(C) Location

A few commenters suggested that EPA

allow source water monitoring,

particularly in States where source

water monitoring is used as a more

stringent location for compliance

monitoring. In related comments, the

Agency was asked to provide further

information about entry points to the

distribution system (EPTDS),

particularly with respect to groundwater

systems with multiple wellhead and/or

using multiple aquifers, suggesting that

representative samples might be

collected instead of from every entry

point.

The sampling location for chemical

contaminants is given on List 1 as the

EPTDS and is now further defined to

include the compliance monitoring

point specified by the State or EPA

under 40 CFR Part 141. In implementing

compliance monitoring, the States and

EPA have made determinations of

where representative samples are

collected, and this rule will incorporate

these determinations and be consistent

with ongoing monitoring. However, if

the compliance monitoring point

specified by the State is a source (raw)

water site, and a UCMR contaminant is

detected, then sampling must be

conducted at the EPTDS unless the State

or EPA determines that no treatment or

processing was in place that would

affect the measurement of the

contaminants. In that case, the

additional sampling at the EPTDS

would not be required.

(D) Sampling instructions

This section did not change and EPA

did not receive any comments on it.

(E) Testing and analytical methods

Several commenters raised questions

about the process for laboratory

certification under the rule. As noted in

the rule, laboratories are automatically

certified for the analysis of UCMR

chemicals if they are already certified to

conduct compliance monitoring for a

chemical included in the same method

being approved for UCMR analysis.

Since the Standard Methods, ASTM,

and AOAC methods approved in the

UCMR use the same technology as the

EPA method listed for the same analyte,

laboratories certified for compliance

monitoring using the EPA method may

also use any of these methods approved

for the same analyte. As the method to

be used for the analysis of perchlorate

will be based upon the currently

available single analyte methods for the

analysis of perchlorate, EPA will need

to conduct a performance evaluation

study of labs to approve them for

perchlorate monitoring before January

2001. Details of this approval system

will be included in a public notice and

comment period prior to conducting

approval for perchlorate analysis.

(F) Sampling deviations

This section did not change and EPA

did not receive any comments on it.

(G) Testing

This section did not change and EPA

did not receive any comments on it.

(iii) Small systems that are part of the

State Monitoring Plan

In the Preamble of the proposed rule,

EPA asked for public comment on

whether a random selection of small

systems across the nation was

appropriate for a representative sample

of small systems or a targeted sampling

approach based on prior information

about contaminant occurrence or use

should be applied. Most commenters,

and particularly expert technical

reviewers, addressing this issue

supported the random selection of

systems as an unbiased, scientifically

sound approach.

EPA determined after consulting

statisticians inside and outside EPA that

a targeted approach would increase

sampling errors unless the sample size

is increased. A random sample is

necessary to provide small system data

roughly equivalent to large system data.

Further stratification could introduce

non-random sampling errors unless the

sample size is increased. Targeted

monitoring may also miss the target area

if little is known about the actual

location of use of a contaminant or if the

contaminant is used beyond the

specified target area. Additionally,

surface waters will carry contaminants

beyond the target area to surface water

supplied drinking water systems

downstream that need to be considered

for UCMR monitoring. Also, targeting

would be very difficult with the number

of contaminants the UCMR is designed

to measure. Finally, stratified sampling

also requires extensive knowledge about

a variety of factors beyond the fate and

transport of a contaminant in the

environment.

(A) Frequency

Comments and EPA response were

addressed under (ii) Large Systems,

above.

(B) Location

Comments and EPA response were

addressed under (ii) Large Systems,

above.

(C) Sampling deviations

State commenters asked about

resampling if sampling errors occurred.

EPA modified this paragraph to include

provisions for resampling using

additional instructions from the State or

EPA.

(D) Sample kits

No comments were received on this

section. It is unchanged.

(E) Sampling instructions

States indicated that some flexibility

was needed within a month’s timeframe

to accommodate changes in sampling

schedules that could not be accounted

for up-front. In response, EPA changed

the specifications. The State Plan will

specify the year and day, plus or minus

2 weeks, to allow flexibility and/or to

account for changes related to the

State’s determination of an alternate

vulnerable sampling period. The State

may pick another year and day to

coincide with compliance monitoring.

(F) Duplicate samples

No comments were received on this

section. It is unchanged.
50590 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

(G) Sampling forms

No comments were received on this

section. It is unchanged.

(H) Sample submission

At least ten States expressed concerns

about the ability of small system owner/

operators to properly collect samples for

UCMR requirements, which would,

therefore, affect the quality of the UCMR

results. These States suggested that they

could collect UCMR samples for

systems in the State Monitoring Plans

since, in most States, the number of

small systems would be limited, and

some of them already conduct

compliance field sampling for small

systems.

The rule allows for States to sample.

States can address field sampling in

their Memorandum of Agreement

between the State and EPA. EPA would

welcome the assistance of States in

collecting samples from small systems

to ensure high quality data for future

decisions concerning whether or not to

regulate unregulated contaminants.

(f) What additional requirements must I

follow if my system is selected as an

Index system?

This section explains that systems

selected as Index systems must help

EPA or the State identify appropriate

sampling locations and provide

information on the wells and intakes

that are in use at the time of sampling,

on well casing and screen depths (if

known) for those wells, and the

pumping rate of each well or intake at

the time of sampling. However, EPA

will provide field technical support to

collect samples at index systems and

assist the systems with compilation of

this information, as well as reporting

these data.

Comments were supportive and no

substantive changes were made to this

section.

(g) What must I do if my system is

selected for the Screening Survey or PreScreen Testing?

This section explains what is required

of large and small systems selected to

participate in the Screening Survey or in

Pre-Screen Testing. Today’s rule notes

that large systems must report test

results to States and EPA. EPA will be

developing guidance for this reporting

process.

(h) What is a violation of this rule?

EPA added a new § 141.40(a)(8) that

clarifies violations of this rule. This

clarification will help public water

systems understand the consequences of

a failure to monitor. The changes state

that any failure to monitor or report will

be a monitoring or reporting violation.

2. Requirements for State and Tribal

Participation

(a) How can I as the director of a State

or Tribal drinking water program

participate in unregulated contaminant

monitoring, including the State

Monitoring Plan for small systems, and

the Screening Survey and Pre-Screen

Testing of all systems?

Today’s final rule incorporates a

variety of changes from the proposed

rule in response to public comments.

Many comments were received

requesting that EPA directly implement

the UCMR, rather than require States to

obtain primacy. In response to these

comments, adoption of this rule is no

longer a condition of maintaining PWS

primacy. EPA will proceed with direct

implementation. However, EPA

recognizes the important role of the

States in this program and has modified

the rule to encourage States and EPA to

enter into Memoranda of Agreement

(MOA) to facilitate State participation

and implementation. EPA also

recognizes that, in the absence of the

option for an MOA, the three-tier

monitoring approach of the UCMR

would require States to apply for

primacy revisions under this program

three separate times (separately for each

of the three lists) over five years;

moreover, the primacy application

period extends beyond the start of

monitoring for each of the three tiers.

Through the MOA, EPA and the State

may also address other aspects of this

final rule’s implementation, including

compliance tracking and enforcement.

This section explains that the director

of a State or Tribal drinking water

program can complete an MOA with

EPA that describes the State’s or Tribe’s

activities in accepting or modifying the

initial monitoring plan, determining an

alternative vulnerable time for

sampling, modifying the timing of

monitoring, identifying sampling points

for small systems, notifying large and

small systems of their monitoring

responsibilities, providing instructions

to systems that are part of the State

Monitoring Plan, and participating in

the Screening Survey and Pre-Screen

Testing.

Regarding the initial plan, EPA will

specify the small systems, rather than

just their number, and the year and day

plus or minus two weeks—rather than

the week, month, and year in the

proposed rule—that each small system

must monitor for List 1 contaminants. A

State can request that a system which

purchases all its water from another

system, as clarified in today’s rule, be

removed from the initial monitoring list,

except if it is required to monitor for

contaminants in the distribution system.

Public comments also suggested that

States be allowed to remove systems

from the monitoring list for justifiable

and compelling reasons. States may

remove systems from the plan if the

systems have closed, merged, or

purchase all of their water from another

system. However, in response to

comments, purchased water systems

may be selected to monitor

contaminants in the distribution system,

since purchased water systems tend to

have locations furthest from the

treatment plant. In these cases, they

would be added to the plan as sampling

points in the distribution system for the

systems first selected. In a change from

the proposed rule, States may now

remove systems from the list for other

reasons, subject to review by EPA, as

long as the decision to remove systems

from the list is not based on

contaminant occurrence, nonoccurrence, or potential vulnerability of

a system to a contaminant. Not

removing systems based on prior or

presumed information about

contaminants preserves the statistical

principle of an unbiased sample.

A State must explain in the State Plan

sent to EPA why it believes a system

should be removed, but the final

decision rests with EPA, as EPA is

responsible for ensuring the integrity of

the national representative sample.

Systems are expected to monitor

between May 1 and July 31, as the

default vulnerable period, but today’s

rule allows a State to determine if there

is a different period when any of the

small systems in the initial plan, or any

of the large systems that must monitor,

are more vulnerable to contamination. If

so, a State must notify the affected

systems of when they are to take

samples. If a State changes the

vulnerable time for monitoring, the rule

now indicates, in response to

comments, that the State should also

consider that the effects on modifying

the timing of monitoring. The States

would notify EPA of their determination

through the submission of their revised

Plan to EPA.

The proposed rule required States to

provide EPA with plans for notifying

each PWS selected in the initial or

modified monitoring plan of their

responsibilities and to provide them

with instructions for monitoring. Under

today’s rule, establishing the State role

of informing systems of their

responsibilities is part of the State-EPA

MOA.
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As was the case under the proposed

rule, a State entering an MOA with EPA

must provide instructions to systems

that are part of the State Monitoring

Plan implementation; EPA will provide

guidance on the instructions. Today’s

final rule adds new language requiring

a State to inform EPA at least 6 months

before the first monitoring is to occur if

the State plans to do the sampling or to

make alternative arrangements for the

sampling at systems in the plan. The

State also must address the alternative

monitoring arrangements in the MOA

with EPA. These alternative monitoring

arrangements could include the State

sampling at small systems, a change

from, but not precluded in, the

proposed rule.

Today’s rule enables States, through a

State-EPA MOA, to participate in

Screening Survey monitoring by small

systems as well as large systems. To

participate, a State must review its State

Monitoring Plan to ensure that no

systems have closed, merged, or

purchase water from other systems

(unless the system is to conduct

microbiological monitoring) and then

make any necessary changes. States also

must notify selected systems of the

Screening Survey requirements.

Under today’s rule, States may

participate in Pre-Screen Testing in two

ways. First, within 60 days of receiving

EPA’s letter concerning the initiation of

Pre-Screen Testing for specific

contaminants, a participating State must

identify between 5 and 25 systems

determined to be representative of the

systems most vulnerable to the List 3

contaminants. Second, if Pre-Screen

Testing is part of the MOA, a State now

must notify each selected system’s

owner or operator of the Pre-Screen

Testing requirements.

Today’s rule also notes that if a State

decides not to prepare an MOA with

EPA to develop the State Monitoring

Plan for small systems, the initial plan

provided by EPA will become the State

Monitoring Plan for a State or Tribe.

Under the proposed rule, the initial plan

became the State plan if a State did not

accept the initial plan or submit a

request to EPA to modify the initial plan

within 60 days.

A commenter raised concerns about

whether Tribal systems would be

selected in a random manner to avoid

bias toward selecting vulnerable

systems. EPA will select Tribal systems

at random. The rule treats Tribal

systems the same as other systems with

equal probability of selection.

A commenter was concerned about

who would inform systems of their

responsibility to monitor. As noted

above, the State still plays a critical role

in the successful implementation of the

program, including informing the

systems. If the State elects not to enter

into an MOA, EPA will inform systems

of their responsibilities.

Several commenters asked whether

States should review List 2 systems in

the representative sample at a later date

to check the status of the systems prior

to the Screening Survey. A provision

has been made for later State review of

List 2 systems in the State Plan to check

system status that may have changed

since the initial review.

(b) What if I decide not to enter into an

MOA?

This is a new section not included in

the proposed rule, although it responds

to the previous recognition in the

proposed rule that a State may not

desire to engage in the process of

preparing a State Monitoring Plan. This

section indicates that EPA will carry out

the functions that the State could have

conducted.

(c) Can I add contaminants to the

Unregulated Contaminant Monitoring

List?

This section explains how seven or

more State governors can petition the

EPA Administrator to add one or more

contaminants to the Unregulated

Contaminant Monitoring List.

Except for the numbering of this

subsection, it is unchanged from the

proposed rule.

(d) Can I waive monitoring

requirements?

This section explains that monitoring

requirements can be waived only with

EPA approval and only under very

limited conditions.

Except for the numbering of this

subsection, it is unchanged from the

proposed rule.

A few commenters inquired as to

whether EPA would allow individual

systems to be waived from monitoring.

The statute only provides for State-wide

waivers.

C. Appendix A—Quality Control

Requirements for Testing All Samples

Collected Under § 141.40

This appendix specifies the

requirements that a system must follow

to control the quality of samples

collected and submitted under § 141.40.

Areas covered are sample collection/

preservation, method detection limit,

calibration, reagent blank analysis,

quality control sample, matrix spike and

duplicate, internal standard calibration,

method performance test, detection

confirmation, and reporting.

In response to public comments, a few

minor technical modifications have

been made to the Appendix, modifying

specifications for calibration, matrix

spikes and matrix spike duplicates, and

the number of significant digits

specified for MRLs.

D. Section 142.15—Reports by States

Section 142.15(c)(3) is replaced in its

entirety by the term ‘‘Reserved’’ in

today’s final regulation because States

will not go through a primacy revision

process but may be reviewing the data

for quality control purposes before EPA

places them in the NCOD. The wording

in the proposed rule is, therefore, not

included.

E. Section 142.16—Special Primacy

Requirements

Section 142.16(e) is revised to delete

references to § 141.40 that are no longer

relevant.

VIII. General Issues From Public

Comment and EPA Response

Several additional issues were raised

during the technical peer review and

public comment processes. They are

summarized and addressed next.

A. Data Quality

One commenter indicated that data

quality objectives should determine

confidence bounds for occurrence and

exposure estimates and that resulting

DQOs should be maintained for all

system sizes. Many data quality

specifications, such as confidence levels

for the representative sample, are

presented in F., Representative sample

of systems serving 10,000 persons or

fewer. EPA will publish other Data

Quality Objectives for the UCMR in the

Quality Assurance Project Plan for the

program.

Commenters indicated that EPA

should give balanced attention to both

false negatives and false positives in

establishing analytical methods and

quality control procedures for the

contaminants on the UCMR List. The

Agency has evaluated analytical

methods developed by both EPA and

other voluntary consensus standards

organizations that publish analytical

methods, such as Standard Methods and

the American Society for Testing and

Materials. The Agency has not approved

analytical methods published only in

analytical journals or methods that use

techniques that cannot routinely be

used by all drinking water analysis

laboratories (e.g., acid, base/neutral

fractionation, or packed column gas

chromatography). Because control of

‘‘false negatives’’ is essential to the

quality of the data collected under this
50592 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

final regulation, documentation of the

contaminants’ stability under the

sample and extract holding conditions

specified in the analytical method were

also evaluated.

B. EPA Funding for Small System

Testing

Commenters were concerned about

small system testing for which EPA is to

pay the costs. They suggested that if

there is reduced funding, then EPA

should reduce the list, sampling

frequency or number of systems

sampled. EPA currently has sufficient

funds for this rule. If for some reason,

funds are reduced, EPA will consider a

range of options to respond to this

circumstance, but in all cases would

ensure that the rule would not impose

a significant economic impact on small

entities.

C. Lab Certification

Commenters were concerned that EPA

needs to identify steps and procedures

necessary to maintain certification for

unregulated contaminant analysis and

clarify how States are to certify

laboratories in time for implementation

of the rule. EPA will maintain the

process for laboratory certification as it

is. The rule provides an automatic

certification of laboratories that are

certified for the same methods applied

to at least one other contaminant. No

separate certification is required under

the current UCMR.

D. Research

Commenters indicated that EPA

should commit research funds for

Aeromonas and preservation process

studies. EPA is developing a detailed

research agenda with its Office of

Research and Development in support

of the contaminants on the CCL.

E. Regulation Format

Some State commenters indicated that

they may not be able to incorporate this

regulation by reference because it is in

question-and-answer format. EPA is no

longer requiring States to have primacy

to implement the UCMR, so the States

will not have to incorporate the UCMR

into their regulations. However, States

will still be able to participate in the

State Monitoring Plan as specified in a

Memorandum of Agreement between

the State and EPA.

F. Voluntary Data Submittal

One commenter indicated that EPA

should encourage voluntary source

water data if standardized methods were

utilized to substantiate treatment needs.

EPA will pursue obtaining data from

other reliable sources since additional

data will help inform decision

processes. Source water data are

available from other agencies.

IX. Other Changes Related to the

Regulation

A. Implementation of the Rule

Implementation issues addressed in

today’s final rule include setting an

effective date, instituting a

memorandum of agreement (MOA)

process with interested States;

establishing the laboratory testing

program; continuing research on

methods development; determining the

representative national sample and

associated State Plans; conducting the

sampling, analysis, and reporting; and

allowing previously collected

monitoring data. The UCMR program, as

revised by today’s final rule, is

illustrated in Figure 1, ‘‘Unregulated

Contaminant Monitoring Approach.’’ A

critical part of this program is funding

the testing of samples from the national

representative sample of small systems.

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1. Setting an Effective Date

EPA has testing methods which are

expected to give reliable and

reproducible results for 10 of the

contaminants on the UCMR Monitoring

List to be tested for under Assessment

Monitoring. These methods are widely

used in the drinking water industry,

although not necessarily for the listed

contaminants. Testing for these

contaminants, and other information

about them, will help EPA determine

whether to regulate them. Results of the

UCMR testing should be available before

the next revision of the CCL, in

February 2003. Additionally, prior to

initiation of the monitoring resulting

from this rule, EPA must establish

laboratory analysis contracts with

laboratories that will do the testing and

associated activities (including setting

up a database and electronic reporting

process) establish Memoranda of

Agreement with States to implement the

rule, and develop the national

representative sample and send each

State its allocation for review.

Therefore, EPA has set January 1, 2001,

as the effective date of the UCMR

program, approximately16 months from

the promulgation of this final rule.

Shortly after this rule is promulgated,

EPA will issue another rulemaking for

public comment to add methods for

perchlorate and acetochlor which were

not previously on List 1. This action

will allow these contaminants to be

tested in 2001 and may allow data

collected prior to the effective date to be

used to meet the requirements of this

final rule.

The 16-month period will enable

States to enter into MOAs with EPA to

provide support for the implementation

of this final rule, to review the initial

State Monitoring Plans, and to inform

small PWSs of their selection and their

responsibilities for monitoring. EPA will

use this time to establish its laboratory

program to test samples from small

systems. Analytical methods are already

in use for the contaminants to be tested

for under Assessment Monitoring, so 16

months should be sufficient for

laboratories that serve large systems to

organize and implement the testing

program, especially given the assistance

provided by the methods and quality

control manual. EPA is working to

ensure that the manual and the

contaminant occurrence reporting

guidance documents are available to

allow the program’s implementation at

that time. The requirements for small

systems and the sampling and quality

control procedures for all systems are

specified in § 141.40(a)(3), (4), and (5)

and in Appendix A. Figure 2 shows the

timing of the major components and

activities supporting the UCMR

program.

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2. Analytical Methods for the Testing

Program

The required methods are identified

in today’s rule at § 141.40(a)(3), Table 1,

‘‘Assessment Monitoring.’’ Additional

sampling and quality control

requirements can be found in

§ 141.40(a)(4) and (5) and in Appendix

A. Large systems are required to follow

the methods and procedures in

§ 141.40(a)(3), (4), (5) and Appendix A.

Laboratories that test samples from

small systems will also have to comply

with § 141.40(a)(3), (4), (5), and

Appendix A.

EPA has prepared guidance

documents to help large systems

organize and conduct their unregulated

contaminant testing programs. The

Agency’s draft sampling guidance,

‘‘UCMR Guidance for Operators of

Systems Serving 10,000 or Fewer

Persons’’ provides details on sampling

requirements. The Agency’s

‘‘Unregulated Contaminant Monitoring

Regulation Analytical Methods and

Quality Control Manual’’ provides

detailed guidance on specific method

requirements related to the unregulated

contaminants on the monitoring list and

on quality control for all testing under

this program.

3. Testing Program for Large Systems

Implementation of today’s rule will

result in Assessment Monitoring for List

1 contaminants only (including

perchlorate and acetochlor, for which

methods will be addressed in a separate

rulemaking shortly). Analytical methods

are in use for these contaminants, and

EPA plans to review laboratories’

procedures for their testing during

Assessment Monitoring because of this

program’s stringent data-quality

requirements.

The Agency anticipates that the

contaminants on List 2, for the

Screening Survey, may be monitored

during the 5-year listing cycle through

a separate rulemaking. EPA will select

a statistically valid random sample of

about 150 large systems to provide

samples to a limited number of EPAapproved laboratories. The Agency’s

approval will depend on a variety of

factors, including its evaluation of (1)

laboratory capability, (2) test results of

blind samples, (3) experience with

similar methodologies, (4) willingness

to accept samples from any PWS

required to monitor under this

regulation, and (5) provision of the

testing for List 2 (and List 3)

contaminants at a reasonable cost to

large systems required to monitor.

Large systems selected for the

Screening Survey (or Pre-Screen Testing

for List 3 contaminants) will be notified

by the State or EPA before the dates

established for collecting and

submitting samples to determine the

presence of contaminants on List 2. For

List 2 and 3 contaminants, large systems

must send samples to laboratories

approved by EPA.

4. Testing Program for Small Systems

Based on a competitive selection

process, EPA will designate one to five

laboratories that will test Assessment

Monitoring samples from approximately

800 small systems in the State

Monitoring Plans and, from the index

systems, over the program’s 5-year

cycle. The laboratories will need to be

able to provide all necessary sampling

equipment to these systems, complete

yet easy-to-follow instructions on the

equipment’s use, and appropriate

sample preservation and testing

services. They also will have to report

electronically the test results to EPA

and, in an alternate format specified by

EPA if necessary, the PWSs, and

provide a copy to the States, according

to the reporting requirements of today’s

rule.

EPA will review and evaluate

laboratory procedures to ensure that

sufficient testing and data quality

standards are met. Today’s requirements

and the final ‘‘UCMR Analytical

Methods and Quality Control Manual’’

would be part of the testing contracts

that EPA expects to sign with the

selected laboratories.

Once a future rule is finalized to

implement the Screening Survey for List

2 contaminants, EPA will select a

statistically valid random sample of 150

small systems to provide samples

during the two to three years in the

middle of the 5-year cycle. The

laboratories that test for List 1

contaminants for small systems will also

test for contaminants on List 2.

5. Continued Development of Analytical

Methods

EPA has yet to establish analytical

methods for List 2 and List 3

contaminants that can be used widely

and at reasonable cost. The Agency is

establishing, through its Office of

Research and Development, a research

program to identify such methods. As

analytical methods for the List 2 and

List 3 contaminants are developed, EPA

will propose and promulgate them as a

revision to today’s rule and solicit

public comments on them. In addition

to specifying the analytical methods to

be used, these future revisions will

establish sampling locations, minimum

reporting levels applicable to the

contaminants, and the dates sampling is

to occur.

6. Determining the Representative

National Sample and State Monitoring

Plans

EPA requires only a representative

sample of up to 800 small systems to

monitor for the presence of unregulated

contaminants in their drinking water.

No later than 6 months prior to the start

of Assessment Monitoring, EPA will

identify, through a statistical selection

process using a random number

generator, up to 800 small systems (from

approximately 65,600 community and

non-transient non-community water

systems) and at least 800 alternate

systems in case replacements are

needed. Each system will have an

approximately equal chance of being

selected based on its source water type

(ground water or surface water) and size

category (25 to 500, 501 to 3,300, or

3,301 to 10,000 persons served). EPA

will notify each State, tribe, and

territory of the selected systems or the

systems themselves (i.e., the initial State

Monitoring Plan) and the alternates

within its jurisdiction.

Each State, tribe and territory can

enter into a Memorandum of Agreement

(MOA) with EPA to participate in the

monitoring program, which will include

development and implementation of the

State Monitoring Plan. Each State, Tribe,

and Territory will have 60 days to

review its initial plan and (1) accept the

plan as its State Monitoring Plan and

inform EPA of that; (2) propose to EPA

deletions from and additions to the

initial plan, and explain the reasons for

the changes, in order to create the State

Monitoring Plan; or (3) choose not to

participate in an MOA to develop the

State Monitoring Plan, in which case,

the initial plan sent to the State will

become the final State Monitoring Plan.

A State, Tribe, or Territory that

chooses option 1 or 2 must also inform

EPA of how and when it will notify the

selected systems of their responsibilities

for monitoring, along with any

necessary modifications to the timing of

sampling related to vulnerable period

determinations or to coordinate with

compliance monitoring, at the State’s

discretion. A State may also choose an

alternative ‘‘most vulnerable time’’ for

its systems to sample if systems are

most vulnerable to contamination by

unregulated contaminants during a

period other than May through July, as

specified in today’s rule. States that

choose option 3 may still elect to notify

the selected systems and provide the

necessary information about their

monitoring responsibilities as long as

EPA is notified 6 months prior to the
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50597

first unregulated contaminant

monitoring.

The systems randomly chosen by EPA

to be index systems will also be

specified in each State’s initial plan.

Any required replacements for the index

systems will come from a list of

randomly selected alternates included

in the plan. EPA expects to provide,

through the laboratories selected to test

for unregulated contaminants,

contractor support in collecting,

shipping, and testing samples and in

gathering additional information to

support these index systems.

The Agency’s procedures for selecting

index systems is described in a

technical document, ‘‘National

Representative Sample and State Plans

for Unregulated Contaminant

Monitoring at Public Water Systems

Serving 10,000 or Fewer Persons.’’

Although monitoring for List 2

contaminants is not required by today’s

rule, EPA will provide with the initial

State Monitoring Plans a list of systems

that would monitor for List 2

contaminants once a future rule

implementing the Screening Survey is

promulgated. The Agency will select

randomly about 180 small systems and

120 large systems when it prepares the

initial plans. States will review these

systems at the same time they review

their initial plans. EPA believes that the

analytical methods for List 2

contaminants will be ready for use

during the first 3 years of the 5-year

listing cycle and that the Screening

Survey will be undertaken during that

period.

For the Pre-Screen Testing, each State

may specify 5 to 25 systems that are

representative of systems most

vulnerable to the contaminants on List

3. EPA will determine the exact number

of systems to be selected in each State

based on the population served by

community and non-transient noncommunity water systems. Each State

must add to its monitoring plan any

small systems selected for Pre-Screen

Testing and will notify EPA of their

addition.

7. Specifying the Vulnerable Monitoring

Period

Each State may modify the vulnerable

monitoring period specified in

§ 141.40(a)(5)(ii)(B) for a single system,

a group of systems, or all systems

selected to perform monitoring. In

changing the vulnerable period, the

State may consider environmental,

precipitation, and system-specific

factors. For small systems in the State

Monitoring Plan, changes in the

vulnerable time must be included in the

Plan.

8. Conducting the Sampling

All selected systems must monitor for

the unregulated contaminants on List 1

and should coordinate, at State

discretion and to the extent practical,

with their compliance monitoring

schedule for regulated chemicals. For

small systems in State Monitoring Plans,

States may also select an alternative

year and day, plus or minus two weeks,

within the 3 year monitoring time frame

for Assessment Monitoring as long as

approximately one-third of the systems

in the State Monitoring Plan monitor in

each year of the 3 year period. Surface

water-supplied systems must monitor

for chemical contaminants every 3

months during a 12-month period, and

ground water-supplied systems must

monitor for them once approximately

every 6 months during a 12-month

period of every 5-year testing cycle

beginning in the years indicated in

column 6 of UCMR Table 1, List 1,

§ 141.40(a)(3). One sample must be

taken at each post-treatment distribution

system entry point or other

representative sampling point

designated by the State for compliance

monitoring under 40 CFR 141.24(f)

representing all principal, nonemergency water sources in use during

the 12-month period, or at each

distribution sampling point, during May

to July unless the State identifies a

period when one, some, or all of its

systems are more vulnerable to

contamination by List 1 chemicals.

For microbiological contaminants, a

PWS must monitor at a site in the

distribution system that represents the

water supplied to the system’s

customers and at a site in the

distribution system that has the

maximum residence time or lowest

disinfectant residual, depending on the

contaminant. This also would apply to

PWS that purchase their water supply

from another system. One set of samples

must be taken during the system’s most

vulnerable time, defined as May 1

through July 31 in today’s final rule, or

at a time designated by the State as the

must vulnerable period, and another set

of samples must be taken approximately

5–7 months before or after.

The 5-year unregulated contaminant

listing cycle can be coordinated with the

3-year compliance monitoring schedule

by starting the next 5-year monitoring

round in January 2001 and taking UCM

samples when compliance sampling is

performed, regardless of where the 3-

year cycle is in a particular State.

Sampling in the rest of the State would

occur during the next 2 years, following

the State’s compliance monitoring

schedule. Even though a system is not

sampled for regulated contaminants

during the 5-year UCMR listing cycle, it

may be required to monitor for

unregulated contaminants during that

time.

9. Establishing Sampling Points

Today’s rule specifies that sampling

must be done at entry points to the

distribution system, or at sampling

points designated by the State to be

representative compliance monitoring

sites under 40 CFR 141.24 (f)(1), (2), or

(3). For systems that are required to

monitor source (raw) water for

compliance purposes, the UCMR

program accommodates these

compliance sites in the following way:

If sampling and testing at source water

compliance sampling points results in

detection of any UCMR List 1

contaminants, then Assessment

Monitoring must shift to entry points to

the distribution system for unregulated

contaminants unless there is no

treatment.

10. Large Systems

For Assessment Monitoring, large

systems will follow the sampling

requirements in § 141.40. They are

explained further in the draft methods

and quality control manual.

11. Systems in State Monitoring Plans

EPA’s ‘‘UCMR Guidance for Operators

of Public Water Systems Serving 10,000

or Fewer Persons’’ explains the

responsibilities of PWSs that are part of

the representative sample and State

Monitoring Plan. It also explains further

the requirements for operators of small

systems, which are found at

§ 141.40(a)(3), (4), (5) and Appendix A,

and addresses sampling including

frequency and location, receipt and use

of sampling equipment, shipping

samples to laboratories, reviewing the

results, and reporting. States can use the

guidance to give monitoring schedules

and instructions to systems when

informing them of their responsibility to

participate in the representative sample

and State Monitoring Plan.

Small systems that are part of a State

Monitoring Plan must sample at the

locations specified in the regulation,

similar to the other systems described

previously. EPA will inform the

competitively selected laboratories

about which systems are included in the

State Monitoring Plans and should

therefore receive sampling equipment.

Ten percent of the systems in the

State Monitoring Plans will be randomly

selected to collect duplicate samples for

quality control purposes. These samples

will be collected using the same
50598 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

procedures as those for the first sample

collection.

12. Screening Survey

The Screening Survey is not part of

today’s rule. Today’s rule only

publishes the UCMR (1999) List 2

contaminants that systems will monitor

for once the necessary analytical

methods are developed, peer reviewed,

proposed, and promulgated. When the

methods are ready, EPA will issue a rule

requiring large and small PWSs to

collect water samples and submit them

for testing to determine the presence of

specified contaminants. EPA will pay

for the shipping and testing of samples

collected by small systems in State

Monitoring Plans.

13. Pre-Screen Testing

Except for publishing the List 3

contaminants as part of the revised

UCMR (1999) list, Pre-Screen Testing is

not part of today’s rule. Once analytical

methods for these contaminants are

developed, peer reviewed, proposed and

promulgated. EPA will promulgate a

rule specifying the sample locations and

dates, analytical methods to be used,

and minimum reporting levels.

Pre-Screen Testing will be a limited

sampling and testing effort, conducted

under controlled conditions. EPA will

ask States to identify, within 90 days of

the request, 5 to 25 large and small

systems vulnerable to List 3

contaminants so that EPA will have a

national set of up to 200 systems to

collect samples. The Agency intends to

use the results of this testing to

determine whether a more

representative monitoring effort should

be made through Assessment

Monitoring or a Screening Survey.

Although the samples will come from

the most vulnerable systems in the

country’and not from a statistically

valid, randomly selected group of

systems’EPA could decide to regulate

one or more of the List 3 contaminants

if monitoring and other available

information shows a clear and present

threat to public health.

Persons taking samples to be tested

for certain contaminants may require

specific training and skills to ensure the

integrity of the samples. In such cases,

EPA may contract for sampling services,

and the PWS owner/operator would be

required only to provide access to the

sampling locations.

The Agency will pay for shipping and

testing samples from small systems

participating in the Pre-Screen Testing.

EPA will forward testing results for

review by the PWSs and States before

posting them on the NCOD where the

public can access them. Large systems

will pay for sampling, shipping, and

testing at EPA-approved laboratories,

and they will report the results to EPA

and provide a copy to the State. EPA

will enter the data into the NCOD.

14. Testing

As explained previously, EPA has

prepared a methods and quality control

manual for taking samples and

analyzing them for contaminants on the

monitoring list. The manual covers the

requirements found in § 141.40(a)(3),

(4), and (5) and Appendix A. EPA will

make the manual available to systems,

States and other interested parties in

hard copy and on the Internet.

Laboratories testing for unregulated

contaminants at the request of PWSs

will need to follow the requirements of

§ 141.40 and Appendix A. EPA plans to

establish a program to review methods

implementation and performance of the

participating laboratories.

For small PWSs in State Monitoring

Plans, EPA will identify through

competitive bids one to five laboratories

that will test their water samples for the

presence of unregulated contaminants.

The Agency is doing this so it can pay

for the testing of samples from small

PWSs. Later this year, EPA will seek

bids from laboratories that wish to be

considered for this effort. The first

samples are expected to be available for

testing after January 1, 2001.

For large systems required to test for

contaminants on Lists 2 and 3, EPA will

open a process to approve on a

competitive basis, a limited number of

laboratories for these analyses. This

approval process will occur as EPA

specifies methods for Lists 2 and 3

contaminants.

15. Reporting Requirements

The results of contaminant testing

will have to be reported along with the

17 data elements identified in today’s

rule. Inventory data about systems

(including PWS facility identification

numbers allowing association of

treatment plants to sampling points, and

latitude and longitude of treatment

plants) reported by States will be

addressed separately in Safe Drinking

Water Information System Inventory

Reporting Requirements. PWSs are

responsible for reporting electronically

to EPA, unless EPA specifies alternative

reporting requirements, such as a

standard paper form that can be

electronically scanned to make the data

available in electronic format for

computer storage, retrieval, and use.

The PWSs must also provide a copy of

the results to their States.

Small systems listed in State

Monitoring Plans and large systems will

have to report five data elements to the

laboratory testing its samples: PWS

identification number; PWS facility

identification number for source (intake,

well or wellfield), treatment plant, and

sampling points; water source type;

sample identification number; and

sample collection date. The remaining

data elements will be provided by the

laboratory. If systems have not

previously reported PWS facility

identification number for sources,

treatment plants and sampling points

prior to their first UCMR report, then

they must do so at the time of the first

report. This information must be

reported so that each sampling point

used for UCMR sampling must be able

to be associated with its treatment

plant(s) and source(s) in use at the time

the sampling occurred.

For systems demonstrating that they

are not able to report electronically, EPA

may specify an alternative reporting

format that will allow EPA to enter the

system’s data into the National Drinking

Water Contaminant Occurrence

Database. EPA will use the

‘‘Unregulated Contaminant Monitoring

Reporting Guidance’’ to guide the

development of this alternative

reporting format.

16. Record Keeping

Today’s rule does not change PWSs’

responsibility for keeping records of

data from unregulated contaminant

monitoring, which are presented in

§ 141.33, for PWSs.

17. Previously Collected Data

Public water systems that have

previously collected data on List 1 may

submit this information. However, this

data must meet the specific testing and

reporting requirements as described in

today’s final rule.

18. Modifying the Monitoring List

As required under SDWA Section

1445, EPA will modify the Unregulated

Contaminant Monitoring List, Table 1,

every 5 years to include the

contaminants of greatest concern at that

time. If EPA still requires additional

data for some previously listed

contaminants, they may remain on the

list. Within each 5-year listing cycle,

EPA will also modify the monitoring list

to include the analytical methods for

Lists 2 and 3 contaminants and their

related sampling requirements. These

modifications will occur through future

rulemaking, with opportunity for public

comment.

Funding for Testing of Samples for

Systems in State Monitoring Plans and

for Pre-Screen Testing. EPA will pay the

cost of testing samples taken from small
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50599

systems pursuant to a State Monitoring

Plan. These payments will be made

directly to EPA-approved laboratories

that meet the requirements of

§ 141.40(a)(3), (4), (5), and Appendix A,

which are further described in the

methods and quality control manual.

The Agency expects to minimize costs

of testing and take advantage of

economies of scale through this

approach, rather than reimbursing 800

systems for analytical costs at up to 800

different laboratories. Administrative

costs will be less with this approach and

contracted testing costs for a larger

volume of samples should be less.

Two funding sources are available to

pay for testing of these small system

samples to carry out the provisions of

SDWA Section 1445(a)(2)(C). Since FY

1998, EPA has been required to reserve

annually $2 million from funds

appropriated for the Drinking Water

State Revolving Fund (DWSRF) to pay

for unregulated contaminant testing.

SDWA Section 1445(a)(2)(H) authorizes

$10 million each year through FY 2003

to carry out all aspects of the UCMR

program, including paying to test

samples from small systems under State

Monitoring Plans. Currently, $2 million

from the DWSRF set-aside for FY 1998

and FY 1999 are available to support

unregulated contaminant monitoring for

small systems. EPA will use this setaside in future years to pay for this

testing and for the testing of samples

drawn from small systems participating

in the Screening Survey and Pre-Screen

Testing. If funding for the UCMR

program changes, however, EPA will

need to consider how to accommodate

reduced funding. The Agency could, for

example, recalculate the representative

sample size to a lower confidence level

commensurate with available resources.

B. Implementation in Indian Country

Several provisions of this rule apply

to State governments, and this preamble

section clarifies how they will apply in

Indian country.

As explained earlier, EPA intends to

include all small systems in Indian

country in a single, separate group. Like

small systems in each State, small

systems anywhere in Indian country

may be selected at random to participate

in the UCM program. EPA will not,

however, notify the State of the systems

selected and allow the State to select

alternatives for systems that have

closed, merged, or that purchase their

water from other systems. Instead, EPA

will contact the appropriate tribal

governments for that purpose. The

resulting group of systems will compose

the single ‘‘State Plan’’ for Indian

country. The EPA will notify selected

systems of their UCMR responsibilities.

Tribes with ‘‘treatment as a State’’

status may enter into an MOA with EPA

to provide support in implementing the

UCMR for small systems monitoring

plans. For systems on tribal lands of

Tribes not having ‘‘treatment as a State’’

status, EPA will serve as the point of

contact with the system and will

implement the UCMR with the tribe. In

either case, the steps of implementation

would be the same as those described

previously.

C. Performance-based Measurement

System

EPA’s Office of Water plans to

implement a performance-based

measurement system (PBMS) that would

allow the option of using either

performance criteria or reference

methods in its drinking water regulatory

programs, removing the requirement

that only EPA-specified and approved

analytical methods be used in SDWA

regulatory programs. The requirement to

use approved methods for SDWA

regulatory programs would, however, be

maintained for certain method-defined

analytes (e.g., Total Coliform and

asbestos), and for data gathering

prospective to regulation, such as the

contaminant monitoring in this rule.

As noted above, many of the

contaminants of interest for the

Unregulated Contaminant Monitoring

(UCM) program can be classified as

‘‘emerging’’ and thus do not have

existing performance criteria or

reference methods. In addition to

collecting information about

contaminant occurrence, the UCM

program will enable the development of

reference methods and performance

criteria. UCM testing will provide data

to assist the Agency in developing

performance criteria that would be

proposed with the MCL, monitoring

requirements, etc. for an analyte. For

these reasons, the Agency is specifying

the method to be used for UCM testing.

Once, however, a contaminant proceeds

to regulation development as an

NPDWR, EPA expects to have sufficient

data and method development

information to be able to propose both

performance criteria and a validated

reference method, either of which could

be used for compliance monitoring of

the contaminant.

X. Guidance Manuals

EPA will provide a guidance manual

to further explain the quality control

measures that laboratories will need to

perform for all unregulated contaminant

monitoring. For systems that are part of

State Plans for representative samples,

the sampling guidance, ‘‘UCMR

Guidance for Operators of Public Water

Systems Serving 10,000 or Fewer

Persons’’, will be available. Commenters

asked for additional time to review the

guidances for implementing this

regulation. EPA will provide additional

time for review and comment on the

guidances: (1) UCMR Guidance for

Operators of Public Water Systems

Serving 10,000 or Fewer Persons; (2)

UCMR Integrated Guidance; (3) UCMR

Reporting Guidance; (4) Contaminant

Selection, Methods, and Sampling:

Technical Background Information for

the UCMR. The guidance and manual

‘‘UCMR Analytical Methods and Quality

Control Manual’’ and ‘‘National

Representative Sample of Small Public

Water Systems: Statistical Design and

State Plans for the UCMR’’ will be

available through the EPA Safe Drinking

Water Hotline at 800–426–4791, or

through EPA’s Office of Ground Water

and Drinking Water Homepage at

www.epa.gov/safewater at the time of

promulgation of this rule. EPA would

apply these same testing and quality

control procedures to the samples of all

monitored systems. These final

procedures are discussed in more detail

in Section D. ‘‘Monitoring Requirements

Under the Final UCMR’’.

XI. Costs and Benefits of the Rule

A. Program Cost Estimates

Today’s final rule requires that only

Assessment Monitoring for List 1

contaminants (12 chemical

contaminants) be conducted over a 3-

year period by all 2,774 large PWSs and

a randomly selected representative

sample of 800 small systems.

Perchlorate and acetochlor monitoring

will be activated under List 1 shortly

after today’s rule, by a separate

regulation that will add the methods for

those contaminants. Monitoring for

contaminants on Lists 2 and 3 will wait

until EPA promulgates rules to initiate

the Screening Survey and Pre-Screen

Testing.

Labor costs pertain to systems, State

primacy agencies, and EPA. They

include activities such as reading the

regulation, notifying systems selected to

participate, sample collection, reporting,

record keeping, and data analysis.

Non-labor costs will be incurred

primarily by EPA and by large PWSs.

They include the cost of shipping

samples to laboratories for testing and

the cost of the actual laboratory

analyses. The Agency also will incur

non-labor costs in procuring services to

conduct quality assurance surveys at

contract laboratories and in collecting
50600 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

samples at a select number of Index

systems.

Laboratory analysis accounts for

almost 70 percent of the national cost

for a program such as this one. These

costs generally are calculated as follows:

the number of systems multiplied by the

number of sampling points is multiplied

by the sampling frequency and then

multiplied by the cost of laboratory

analysis. (This calculation is repeated

for each separate analytical method).

Shipping is added to the calculated

costs to derive the total direct analytical

non-labor costs. Instead of assuming

that large systems will pay the full

analytical costs for Assessment

Monitoring, EPA assumes they will pay

smaller ‘‘incremental’’ analytical costs

because UCMR monitoring will coincide

with ongoing Phase II/V compliance

monitoring. In some cases, UCMR

analyses use the laboratory analytical

methods required for ongoing

compliance monitoring. Therefore,

when unregulated contaminant

monitoring and Phase II/V monitoring

are conducted concurrently, only

incremental fees are charged for the

analysis of additional UCMR

compounds. Of course, if analyzing

samples for some unregulated

contaminants requires testing methods

that are not currently in use, no cost

savings can be realized. Note that, since

the methods for perchlorate and

acetochlor have a ‘‘Reserved’’ status in

this rule promulgation, costs for these

contaminants will be estimated when

the rule revisions for these methods are

published.

The details of EPA’s cost assumptions

and estimates can be found in the

Information Collection Request (ICR)

prepared for this rule (ICR No. 1882.01),

which presents estimated costs and

burden for the 1999–2001 period. It was

sent to the Office of Management and

Budget (OMB) on April 15, 1999. A

background cost document, ‘‘Burden

and Cost Calculation for the

Unregulated Contaminant Monitoring

Regulation,’’ is attached as an appendix

to the ICR. It presents the total and the

estimated annual cost and burden for

the final rule’s first 5-year cycle (from

2001 to 2005). Some of the costs EPA

estimated are associated with program

start-up and may not recur in future

monitoring cycles. Although some of

these start-up costs might be incurred

before 2001, they are included and

averaged as part of the 5-year program

costs to simplify the calculations;

systems will incur costs only during the

5-year monitoring cycle. Copies of the

ICR may be obtained from Sandy Farmer

by mail at: Office of Policy Regulatory

Information Division; U.S.

Environmental Protection Agency

(2137); 401 M St., S.W.; Washington, DC

20460, by email at:

farmer.sandy@epa.gov, or by calling:

(202) 260–2740. A copy may also be

downloaded from the Internet at: http:/

/www.epa.gov/icr.

In preparing the UCMR ICR, EPA

relied on standard assumptions and data

sources used in the preparation of other

drinking water program ICRs. These

include the public water system

inventory, number of entry points per

system, and labor rates. To estimate the

labor burden for State and some system

activities, the Agency used its standard

State Resource Model, which is

documented in the Resource Analysis

Computer Program for State Drinking

Water Agencies (January 1993). Other

assumptions are discussed next.

1. Assumptions: Assessment Monitoring

EPA’s estimated cost of Assessment

Monitoring is based on the following

assumptions:

• Surface water systems will sample

4 times during 1 year and ground water

systems will sample twice during 1 year

in the 5-year UCMR program cycle.

• EPA will pay the testing costs for

the representative sample of 800 small

systems, which will be performed by

selected laboratories.

• Large systems will pay for their

own testing, which will be performed by

laboratories of their choice (in

accordance with UCMR program quality

control requirements).

• All systems will, to the extent

practical, conduct their chemical

sampling along with their standard

compliance monitoring to reduce labor

burden and analytical costs where

possible.

In addition, various quality assurance

and quality control measures (e.g., 10

percent duplicate samples from the

representative systems) will be in effect.

Water samples also will be taken from

a group of 30 small ‘‘Index systems’’ (a

subset of the national representative

sample of small systems) during all 5

years of the monitoring cycle to assess

any trends in temporal occurrence,

other data variability, or program

problems.

2. Estimated Average Annual Cost for 5-

Year Program: Assessment Monitoring

Only

EPA estimates that the average annual

cost of nationwide Assessment

Monitoring is approximately $8.4

million, as follows:

• EPA: $3.1 million, including $2.0

million in testing costs for small

systems.

• States: $461,500.

• Small systems: $16,440.

• Large systems: $4.8 million.

The estimated average annual cost

(labor plus non-labor) is approximately

$21 per participating small system and

$1,735 per large system.

These average annual costs do not

represent the peak costs expected to be

encountered during program

implementation. Most of the

monitoring, and hence most of the costs,

are expected to occur over a 3-year

period, allowing for follow-up work and

data review, reporting, and analysis.

EPA’s peak year costs (during the 3 core

years of Assessment Monitoring

primarily for the representative sample)

are estimated to be $3.6 million for

Assessment Monitoring. Peak year costs

for large systems are projected to be

about $8.0 million for Assessment

Monitoring.

B. Estimated Net Costs

EPA estimated the UCMR program’s

net cost by comparing the new program

costs, with the estimated costs of the

unrevised program (i.e., the baseline

costs). The standard labor rates and

activities used to estimate the new

program costs were also used to

determine the baseline costs, and the

same water inventory numbers were

used for the comparison. A simplifying

assumption with respect to the

baseline’that all systems serving more

than 500 persons monitor during the

same 5-year interval—was also made.

The Agency also had to address

several differences between the two

programs. The regulation replaced by

today’s rule did not require systems

serving 150 or fewer service connections

to monitor for unregulated contaminants

unless requested to do so by the State.

Data in the drinking water program

information system suggest that State

required about one-third of the systems

serving 500 or fewer people to monitor;

thus one-third of systems serving 150 or

fewer service connections were

included in EPA’s baseline estimates.

Another significant difference

between the previous program and the

new one is the list of contaminants for

which monitoring is required. The

previous regulations required

monitoring for 48 chemicals included in

Table 1 of the Proposed Rule Preamble

(64 FR 23401). (Although monitoring for

14 of the chemicals was discretionary,

their associated costs were derived from

the analytical method required for the

other unregulated contaminants and the

regulated volatile organic compounds

[VOCs]. Consequently, they do not make

a substantive difference in the cost

estimates.) Although the previous

program required monitoring for more
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50601

contaminants than does the program

implemented by today’s final rule,

monitoring requirements of the previous

UCMR program were derived from

fewer analytical methods, and all were

derived from standard methods used for

routine compliance samples. Hence, the

analytical costs were relatively lower.

Given the above assumptions and full

implementation over 5 years, the

revised UCMR program will save small

drinking water systems an estimated

$35.8 million over the estimated

baseline. The annual costs for each

small system participating in

unregulated contaminant monitoring are

reduced an estimated $190. Small

systems will realize this saving because,

unlike the previous program, the new

program does not require any of them to

pay for the analysis of water samples to

determine the presence of unregulated

contaminants. Only small systems

chosen for the representative national

sample will incur any costs, and they

will be labor costs only.

Under the UCMR Assessment

Monitoring program, large systems will

face a $10.2 million increase in costs,

primarily from the increase in

laboratory analytical costs. Average

annual large system costs are estimated

to increase by approximately $730

under the new UCMR program.

EPA estimated the baseline costs to

the States at $7.5 million over the 2001–

2005 monitoring cycle, plus year 2000

start-up costs. Total estimated saving to

States under the revised UCMR program

is an estimated $5.2 million. This saving

will be primarily in labor costs because

the States will have oversight

interactions with only 800 small water

systems, far fewer than previously were

involved in unregulated contaminant

monitoring.

EPA estimated that it would have cost

the Agency $1.9 million to run the

previous monitoring program over the

2001–2005 monitoring period, plus

start-up costs. The Agency’s costs are

estimated to almost double under the

revised Assessment Monitoring program

primarily because it will fund sample

shipment and analysis for small

systems.

The cost reductions also can be

attributed to the ‘‘Suspension of

Unregulated Contaminant Monitoring

Requirements for Small Public Water

Systems (Direct Final Rule),’’ which was

published in the Federal Register on

January 8, 1999. It suspended the

requirement for small systems to

perform another round of monitoring for

unregulated contaminants because it

would have overlapped with the revised

UCMR program. Approximately twothirds of the systems between 3,300 and

10,000 persons will save the cost of

monitoring in 1999 and 2000 by the

action of the Direct Final Rule, resulting

in a savings of about $5.3 million for

these systems.

C. Benefits

Today’s rule significantly reduces

burden, especially for small water

systems. The original UCMR program,

initiated in 1988, required all

community water systems (CWSs) to

monitor for 48 contaminants. States

could waive the requirement for systems

serving 150 or fewer service

connections, although these systems

had to be available for monitoring under

the regulation. Analysis of the first

round of data, from 1988 to 1993,

indicates that well over 25,000 PWSs

were involved in the original

monitoring program. The revised

program will involve only 3,574 to

3,724 systems: 2,774 large systems and

up to 800 small systems.

The systems that will be regulated

under today’s rule will monitor for

fewer contaminants than was the case

under the original UCMR program. EPA

will pay the small systems’ costs of

testing, keeping their burden to a

minimum and limiting it to collecting

the samples and contacting a shipping

service to pick them up for delivery to

a laboratory. The Agency also will

manage the laboratory testing program

for these systems, minimizing the time

they interact with the laboratories. The

laboratories contracted by EPA to

perform the analyses also will provide

electronic reporting services for small

systems that lack this capability.

Consequently, the costs borne by the

selected 800 systems will be

substantially reduced under the revised

program.

Regarding the full UCMR program,

cost savings can be attributed to the use

of a small sample of small and large

systems in the Screening Surveys and

Pre-Screen Testing. The two Screening

Surveys of 300 systems each and the

Pre-Screen Testing of up to 200 systems

will allow statistically valid, targeted

approaches to be applied to emerging

contaminants. These early screening

efforts will help EPA determine whether

contaminants are already in public

water systems and whether they should

be monitored for in the subsequent 5-

year monitoring cycle. This approach—

rather than requiring Assessment

Monitoring for all 30 contaminants at all

monitored systems—is projected to save

large water systems and EPA more than

$50 million in annual Assessment

Monitoring costs.

State burden also will be reduced. A

substantial portion of State burden

depends on the number of systems that

a State must manage. Although the

revised UCMR program introduces some

new elements, fewer systems are

involved so State oversight activity (e.g.,

system notification and record keeping)

will be reduced.

Today’s final rule increases the

number of data elements that must be

reported from 12 to 17. These data must

be reported with each sample to make

the monitoring data more useful for

analysis. However, the additional

burden on systems is minimal, because

most of the data elements will be

reported to EPA by laboratories which

already routinely record many of them.

The long-term benefits of the revised

UCMR program are:

• Contaminants whose occurrence in

drinking or source water is not

widespread will be identified early,

which will enable evaluations and

decisions to minimize further the

monitoring and resources that would

otherwise be committed to those

contaminants.

• Contaminants whose occurrence in

drinking water is widespread will

trigger additional research on health

effects and treatment as soon as

practical to protect the health of

sensitive persons.

• The use of a representative sample

of small systems (which comprise the

majority of PWSs) can provide a

scientifically sound, statistically valid

data set that can be used for improved

analysis and program decisions at

reduced cost.

XII. Administrative Requirements

A. Executive Order 12866—Regulatory

Planning and Review

Under Executive Order 12866 (58 FR

51735, October 4, 1993), the Agency

must determine whether a 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
50602 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

(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.

It has been determined that this rule

is not a ‘‘significant regulatory action’’

under the terms of Executive Order

12866 and is therefore not subject to

OMB review.

B. Executive Order 13045—Protection of

Children From Environmental Health

Risks and Safety Risks

Executive Order 13045, ‘‘Protection of

Children from Environmental Health

Risks and Safety Risks’’ (62 FR 19885,

April 23, 1997), applies to any rule that

(1) is determined to be ‘‘economically

significant’’ as defined under 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.

This rule is not subject to E.O. 13045

because it is not ‘‘economically

significant’’ as defined under E.O.

12866. Further, EPA interprets E.O.

13045 as applying only to those

regulatory actions that are based on

health or safety risks, such that the

analysis required under section 5–501 of

the Order has the potential to influence

the regulation. This final rule is not

subject to E.O. 13045 because it does not

establish an environmental standard

intended to mitigate health or safety

risks. For the most part, this rule

establishes procedures for monitoring of

unregulated contaminants on the

Agency’s CCL. Given EPA’s interest in

protecting children’s health, however,

as part of the provisions in the rule

allowing State governors and Indian

tribes to petition EPA to add

contaminants to the Unregulated

Contaminant Monitoring List, EPA asks

them specifically to include any

information that might be available

regarding disproportional risks to the

health or safety of children. Such

information would help inform EPA’s

decision making regarding future lists.

This final rule is part of the Agency’s

overall strategy for deciding whether to

regulate the contaminants on the CCL

(63 FR 10273). Its purpose is to ensure

that EPA has data on the occurrence of

contaminants on the CCL where those

data are lacking. EPA is also taking steps

to ensure that the Agency will have data

on the health effects of these

contaminants on children through its

research program. The Agency will use

these occurrence and health effects data

to decide whether to regulate any of

these contaminants.

C. Unfunded Mandates Reform Act

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA), Pub L.

104–4, establishes requirements for

Federal agencies to assess the effects of

their regulatory actions on State, local,

and tribal governments and the private

sector. Under 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 a rule for which a written

statement is needed, UMRA section 205

generally requires EPA to identify and

consider a reasonable number of

regulatory alternatives and adopt the

least costly, most cost-effective, or least

burdensome alternative that achieves

the objectives of the rule. The

provisions of section 205 do not apply

when they are inconsistent with

applicable law. Moreover, section 205

allows EPA to adopt an alternative other

than the least costly, most cost-effective,

or least burdensome alternative if the

Administrator publishes with the final

rule an explanation of why that

alternative was not adopted. Before EPA

establishes any regulatory requirements

that may significantly or uniquely affect

small governments, including tribal

governments, it must have developed

under UMRA section 203 a small

government agency plan. The plan must

provide for notifying potentially

affected small governments, enabling

officials of affected small governments

to have meaningful and timely input in

the development of EPA regulatory

proposals with significant Federal

intergovernmental mandates, and

informing, educating, and advising

small governments on compliance with

the regulatory requirements.

EPA has determined that this rule

does not contain a Federal mandate that

may result in expenditures of $100

million or more for State, local, and

tribal governments, in the aggregate, or

for the private sector in any one year.

Total annual costs of today’s rule for

State, local, and Tribal governments and

the private sector, are estimated to be

$7.3 million, of which EPA will pay

$2.0 million, or 27 percent. Thus,

today’s rule is not subject to the

requirements of UMRA sections 202 and

205.

EPA has determined that this rule

contains no regulatory requirements that

might significantly or uniquely affect

small governments because EPA will

pay for the reasonable costs of sample

testing for the small PWSs required to

sample and test for unregulated

contaminants under this rule, including

those owned and operated by small

governments. The only costs that small

systems will pay are the costs attributed

to (1) the labor associated with reading

the regulations, guidance, and

instructions to implement the

monitoring requirements, (2) collecting

the samples and packing them for

shipping to the laboratory (EPA will pay

for shipping), and (3) reporting and

record keeping. These costs are not

significant. Thus, today’s rule is not

subject to the requirements of UMRA

section 203.

D. 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 2040–0208. An

Information Collection Request (ICR)

document which presents estimated

costs and burdens for the 1999–2001

period has been prepared by EPA (ICR

No. 1882.02). A background cost

document, ‘‘Burden and Cost

Calculations for the Unregulated

Contaminant Monitoring Regulation,’’ is

attached as an appendix to the ICR and

presents the estimated costs and

burdens for the first 5-year cycle of the

final rule. A copy of these may be

obtained from Sandy Farmer by mail at

OP Regulatory Information Division;

U.S. Environmental Protection Agency

(2137); 401 M St., S.W.; Washington, DC

20460; by email at:

farmer.sandy@epa.gov; or by calling:

(202) 260–2740. A copy may also be

downloaded from the Internet at:

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

The information to be collected under

today’s rule is to fulfill the statutory

requirements of section 1445(a)(2) of the

Safe Drinking Water Act, as amended in

1996. The data to be collected will

describe the source water, location, and

test results for samples taken from

PWSs. The concentrations of any

identified UCMR contaminants will be

evaluated regarding health effects and

will be considered for future regulations

accordingly. Reporting is mandatory.

The data are not subject to

confidentiality protection.

Burden is defined as the total time,

effort, or financial resources expended

by persons to generate, maintain, retain,
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50603

or disclose or provide information to or

for a Federal agency. This includes the

time needed to review instructions;

develop, acquire, install, and use

technology and systems to collect,

validate, verify, process, maintain,

disclose, and provide 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.

The annual burden and cost estimates

described below are for the

implementation assumptions put forth

in this Rule, which includes only the

Assessment Monitoring component of

the UCMR Program. For Assessment

Monitoring, the respondents are 800

small water systems (in the national

representative sample of systems

serving 10,000 or fewer people), 2,774

large public water systems, and 56

States and primacy agents (3,630 total

respondents). The frequency of response

varies across respondents and years.

System costs (particularly laboratory

analytical costs) vary depending on the

number of entry or sampling points.

For the three-year ICR period 1999–

2001, small systems will sample and

report an average of 2.7 times for the

entire period. The burden for small

systems is estimated to be an average of

1.5 hours annually per system, with an

annual cost of $31. Large systems will

sample and report an average of 2.9

times for the entire period, and are

estimated to have a 3.3 hour per system

annual burden, with a labor cost of $93

per year. Non-labor costs per year for

these systems is estimated at $2,798 per

system. On average, States are assumed

to report quarterly during each UCMR

implementation year. It is estimated that

each State will incur 141 hours of

burden per year, with an annual labor

cost of $5,647 for the ICR period 1999–

2001. Non-labor costs for States were

assumed to be minimal, with 10 percent

of the States incurring a one-time

$25,000 contractor cost for the optional

upgrading of their drinking water

databases; an average of $833 per year

per State for the ICR period. In

aggregate, the average respondent (i.e.,

small systems, large systems, and the

States) incurs an average annual burden

of 9.0 hours and a labor plus non-labor

cost of $2,400. Because the actual

implementation period of the UCMR

does not begin until 2001, most of the

costs presented here occur during that

year. Average annual costs reflect the

fact that the UCMR program

implementation only overlaps with one

of the three ICR years (1999–2001).

The burden and cost per response for

the three ICR years for Assessment

Monitoring are estimated to be 1.7 hour

burden at $35 per response for small

systems; 3.4 hours at $95 for labor and

$2,847 in analytical costs for large

systems; and 52.9 hours at $2,116 for

labor for States. In aggregate, the average

response (i.e., responses from small

systems, large systems, and the States)

is associated with a burden of 8.7 hours,

with a labor plus non-labor cost of

$2,213 per response over the three-year

ICR period.

Over the ICR period, the Agency is

estimated to incur an annual burden of

9,150 hours, with an average annual

cost for labor of $366,000. Non-labor

costs for EPA, which are primarily

comprised of the analytical and

shipping costs for representative set of

small systems, and other contractor

costs, are estimated at $1.3 million per

year over the period 1999–2001. Nonlabor costs are primarily attributed to

the cost of sample testing for small

systems.

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 on its ICR. 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

the final rule.

E. 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 (SBREFA),

EPA generally is required to conduct a

regulatory flexibility analysis describing

the impact of the regulatory action on

small entities as part of 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, the Agency is not required to

prepare a regulatory flexibility analysis.

Pursuant to RFA section 605(b), 5 U.S.C.

605(b) and for the reasons set forth

below, I certify that this rule will not

have a significant economic impact on

a substantial number of small entities.

For purposes of RFA analyses for

SDWA rulemakings, the Agency defines

small entities as systems serving 10,000

or fewer customers because this is the

size of system specified in SDWA as

requiring special consideration with

respect to small system flexibility. This

alternative definition was established

for all drinking water rules in the

Consumer Confidence Reports

rulemaking (63 FR 44511–44536

[August 19, 1998]). EPA also consulted

with the Small Business Administration

about the alternative definition as it

relates to small businesses. For further

information on the establishment of this

definition of small entities, see the

referenced Federal Register notice.

EPA has determined that the UCMR

will affect small water utilities, since it

is applicable to a subset of small

community and non-transient

noncommunity water systems.

However, the affected systems are

limited to a representative sample of

approximately 800 small PWSs, or 1.2

percent of systems serving 10,000 or

fewer persons. These systems will be

required to conduct monitoring, as

specified in the UCMR (i.e., collect and

prepare samples for shipping). EPA will

assume all costs for testing of the

samples and for shipping the samples

from these systems to certified

laboratories throughout the United

States. EPA has set aside $2 million

from the DWSRF in Fiscal Years 1998

and 1999, and plans to do so into the

future with its authority to set aside

DWSRF monies to implement this

SDWA provision.

EPA has estimated the impact of

today’s rule and concludes that the rule

will not have a significant economic

impact on a substantial number of small

entities. The rationale for this

conclusion is that EPA plans to pay the

full costs of shipping and testing

samples for small systems and does not

plan, under any scenario, to ask systems

to pay these costs. (The costs to these

systems will be limited to the labor

hours associated with collecting a

sample and preparing it for shipping.)

EPA evaluated the cost to small

entities under two scenarios. Under

either scenario, EPA will assume the

cost of shipping and testing samples for

small systems. The ‘‘full

implementation’’ scenario assumes full

funding from the DWSRF set-aside

through the year 2005, with the full

Assessment Monitoring program being

implemented. The ‘‘limited

implementation’’ scenario assumes that

EPA will pay for testing with the funds

already set aside for this program.

Under either scenario, this rule will not

have a significant economic impact on

a substantial number of small entities,

and EPA certifies that fact. Cost

summaries for both scenarios are

provided below.
50604 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

1. Full Assessment Monitoring

Implementation Scenario

EPA analyzed separately the impact

on small privately and publicly owned

water systems because of the different

economic characteristics of these

ownership types. For publicly owned

systems, EPA used the ‘‘revenue test,’’

which compares a system’s annual costs

attributed to the rule with the system’s

annual revenues. EPA used a ‘‘sales

test’’ for privately owned systems,

which involves the analogous

comparison of UCMR-related costs to a

privately owned system’s sales. EPA

assumes that the distribution of the

national representative sample of small

systems will reflect the proportions of

publicly and privately owned systems

in the national inventory. The estimated

distribution of the representative

sample, categorized by ownership type,

source water, and system size, is

presented below in Table 5.

TABLE 5.—NUMBER OF PUBLICLY AND PRIVATELY OWNED SYSTEMS TO PARTICIPATE IN ASSESSMENT MONITORING

Size category

Publicly owned systems Privately owned systems

Total—all

Non-index systems

systems Index systems Non-indexsystems Index systems

Ground Water Systems:

500 and under .............................................................. 20 1 76 2 99

501 to 3,300 ................................................................. 146 6 67 3 222

3,301 to 10,000 ............................................................ 144 7 40 2 193

Subtotal ................................................................. 310 14 183 7 514

Surface Water Systems:

500 and under .............................................................. 18 0 49 0 67

501 to 3,300 ................................................................. 51 2 23 1 77

3,301 to 10,000 ............................................................ 106 5 30 1 142

Subtotal ................................................................. 175 7 102 2 286

Total ...................................................................... 485 21 285 9 800

The basis for the UCMR RFA

certification under full Assessment

Monitoring program implementation is

as follows: the average annual

compliance costs of the rule represent

less than 1 percent of revenues/sales for

the 800 small water systems that will be

affected. The EPA estimates that EPA

and system costs for implementing

small system sampling for the full

UCMR Assessment Monitoring program

(2001–2005) will be approximately

$10.2 million. Since the Agency

specifically structured the rule to avoid

significantly affecting a substantial

number of small entities by assuming all

costs for laboratory analyses, shipping,

and quality control for small entities,

EPA costs comprise approximately 99

percent ($10.1 million) of the total costs.

(Note that EPA’s contribution to the

small system program is assumed to

include all small system analytical and

shipping costs, as well as all non-labor

program support costs.) Table 6 presents

the annual costs to small systems and to

EPA for the small system sampling

program, along with the number of

participating small systems during each

of the 5 years of the program.

TABLE 6.—EPA COSTS FOR SMALL SYSTEMS UNDER FULL IMPLEMENTATION OF UCMR ASSESSMENT MONITORING

Cost description 1 2001 2002 2003 2004 2005 Total

Costs to EPA for Small System Program: quality

assurance, ongoing coordination, data analysis, analytical costs, shipping costs, and

costs for contractor site visits to small Index

systems 2 .......................................................... $3,317,970 $2,647,790 $2,617,790 $856,890 $648,440 $10,088,880

Costs to Small Systems: additional labor for

monitoring or monitoring assistance ................ 26,796 25,840 25,840 1,861 1,861 82,198

Total Costs to EPA and Small

Systems for UCMR .................... 3,924,769 2,993,810 3,053,630 1,338,752 1,150,297 10,171,078

Number of Systems to be Monitoring each Year:

Non-Index and Index in 2001–2003, Index

only in 2004–2005 3

Public .................................................... 182 182 182 107 21 533

Private ................................................... 104 104 104 81 9 267

Total ............................................... 286 286 286 188 30 800

1AM = Assessment Monitoring.

2EPA costs during the year 2001 include some start-up costs that may actually be incurred during the year 2000.

3Total number of systems is 800. All 30 Index systems sample during each year 2001–2005. One-third of Non-Index systems sample during

each year from 2001–2003. The rows do not add across, because the same 30 Index systems sample during every year of 5-year implementation cycle.
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50605

System costs are attributed to the

labor required for reading State

notification letters, monitoring,

reporting, and record keeping.

Assuming that systems will efficiently

conduct UCMR sampling (e.g.,

coincident with other required

monitoring when feasible), the

estimated average annual per system

labor burden for full Assessment

Monitoring implementation will be $17

(0.8 hours) for ground water systems

and $27 (1.3 hours) for surface water

systems. In total, ground water and

surface water systems average 1.0 hours

of burden per year with an average

annual cost of $21. Average annual cost,

in all cases, is less than 0.2 percent of

system revenues/sales. Therefore, as

stated previously, the Administrator

certifies that this rule, as funded by

EPA, will not have a significant

economic impact on small entities.

Tables 7a and 7b below present the

estimated economic impacts in the form

of revenue/sales tests for publicly and

privately owned systems.

TABLE 7a.—UCMR FULL ASSESSMENT MONITORING IMPLEMENTATION SCENARIO: ANALYSIS FOR PUBLICLY-OWNED

SYSTEMS (2001–2005)

System size

Annual number of

systems affected 1

Average annual hours

per system

(2001–2005)

Average annual cost per

system

(2001–2005)

‘‘Revenue test’’ 2

(percent)

Number Percent of

US total Non-index Index Non-index Index Non-index Index

Ground Water Systems

500 and under .................................. 4.8 0.01 0.6 2.0 $9.03 $28.28 0.05 0.17

501 to 3,300 ..................................... 35.4 0.29 0.7 2.8 10.12 39.88 0.01 0.04

3,301 to 10,000 ................................ 35.8 1.49 0.9 3.6 24.02 100.80 0.01 0.02

Surface Water Systems

500 and under .................................. 3.5 0.18 1.1 0.0 16.39 0.00 0.06 0.00

501 to 3,300 ..................................... 12.2 0.67 1.2 4.2 18.03 60.90 0.01 0.03

3,301 to 10,000 ................................ 25.9 2.58 1.2 4.0 33.24 112.00 0.00 0.02

1 Calculated as 1⁄5 of the Non-Index sample, plus all Index systems for each year from 2001–2005; actual sampling for Non-Index systems

takes place over three years, while that of Index systems occurs over each of five years. 2The ‘‘Revenue Test’’ was used to evaluate the economic impact of an information collection on small government entities (e.g., publiclyowned systems); costs are presented as a percentage of median annual revenue in each size category.

TABLE 7b.—UCMR FULL ASSESSMENT MONITORING IMPLEMENTATION SCENARIO: ANALYSIS FOR PRIVATELY-OWNED

SYSTEMS (2001–2005)

System size

Annual number of

systems affected 1

Average annual hours

per system

(2001–2005)

Average annual cost per

system

(2001–2005) 1

‘‘Sales test’’ 2

(percent)

Number Percent of

US total Non-index Index Non-index Index Non-index Index

Ground Water Systems

500 and under .................................. 17.6 0.04 0.6 2.0 $9.03 $28.28 0.06 0.18

501 to 3,300 ..................................... 16.2 0.13 0.7 2.8 10.12 39.88 0.01 0.04

3,301 to 10,000 ................................ 10.1 0.42 0.9 3.6 24.02 100.80 0.00 0.02

Surface Water Systems

500 and under .................................. 9.7 0.51 1.1 0.0 16.39 0.00 0.07 0.00

501 to 3,300 ..................................... 5.6 0.31 1.2 4.2 18.03 60.90 0.01 0.04

3,301 to 10,000 ................................ 7.3 0.72 1.2 4.0 33.24 112.00 0.01 0.02

1 Calculated as 1⁄5 of the Non-Index sample, plus all Index systems for each year from 2001–2005; actual sampling for Non-Index systems

takes place over three years, while that of Index systems occurs over each of five years. 2The ‘‘Sales Test’’ was used to evaluate the economic impact of an information collection on small private entities (e.g., privately-owned systems); costs are presented as a percentage of median annual sales in each size category.

2. Limited Implementation Scenario

Despite the expected $2 million

annual budget, EPA recognizes that

funding levels vary from year to year

and thus the Agency cannot guarantee

the precise amount that will ultimately

be available to implement its UCMR

Assessment Monitoring Program

(although a considerable portion of

those funds are currently on hand). If an

amount commensurate with funding the

optimal UCMR Assessment Monitoring

Program (in terms of numbers of small

systems sampled and numbers of

contaminants analyzed) is not available,

the Agency will adjust the UCMR

program to accommodate the available

funds. This adjustment may necessitate

use of fewer sample sites, testing for

fewer contaminants, or both.

Although the Agency considers the

scenario of no additional funding to be

unlikely, EPA also evaluated the

scenario of ‘‘current funds only’’ for

purposes of this RFA analysis. In this

‘‘current available funds’’ scenario EPA

would receive no funding for small

system testing beyond the $4 million set

aside from the DWSRF in FY 1998 and

FY 1999. EPA anticipates funding this

program such that no small system

would incur testing costs, as intended in

the legislation. Small systems would be

responsible only for taking the sample.

By analyzing the small system impact

under this scenario, EPA can
50606 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

1Publicly- and privately-owned systems

allocations are estimated using data from the 1995

Community Water System Survey. Publicly-owned

systems are those that are owned by a city, town,

township, village, municipal government, State or

federal government, or any other publicly-owned or

operated system. Privately-owned systems include

those owned by private investors or homeowners’

associations.

demonstrate that, regardless of funding

levels, the UCMR will not have a

significant economic impact on a

substantial number of small entities.

Given the flexibility of the proposed

rule, EPA can ensure scientifically

defensible results, balanced with

available funding.

In the optimal program, the sample of

800 systems is derived by applying a 99

percent confidence level, with 1 percent

error tolerance. To accommodate a $4

million budget, the representative

sample of small systems would be

reduced to approximately 400 systems.

Although this smaller sample would be

less rigorous than the anticipated

sample of 800 systems, the sample error

would still remain within plus or minus

5 percent. These 400 systems would

incur only labor costs for collecting and

packing the samples, while EPA would

pay to ship and test these samples.

With the currently available $4

million, EPA will be able to fund

approximately 50 percent of the

planned Assessment Monitoring

program for small systems. To estimate

the costs under this scenario, EPA

assumed that only the Assessment

Monitoring component of the UCMR

would be implemented and that the

smaller representative sample would be

allocated across system size categories

in the same proportions as those in the

sample of 800 systems, with 10 of these

systems being Index sites, as seen in

Table 8. Finally, for the cost analysis of

this current funds scenario, EPA

assumed that the national representative

sample will reflect the proportions of

publicly and privately owned systems

in the national inventory of public water

systems.1 Because EPA’s statistical

approach uses a random selection

process for systems in the national

representative sample, publicly-and

privately-owned systems should be

selected in the same proportions for that

sample as they occur in the set of all

community and non-transient noncommunity water systems in the nation.

The Agency is concerned that a

reduced sample size will reduce the

statistical likelihood that the observed

contaminant occurrence levels will be

representative of actual occurrence

across the nation. Because of this, the

Agency will actively pursue funding for

the full program described in this

Preamble.

Table 8.—Number of Publicly- and Privately-Owned Systems To Participate in Assessment Monitoring, for Limited

Funding Program 1

Size category

Publicly-owned systems Privately-owned systems

Total—all

Non-index systems

systems Index systems Non-indexsystems Index systems

Ground Water Systems:

500 and under .............................................................. 10 0 39 1 50

501 to 3,300 ................................................................. 75 2 34 1 112

3,301 to 10,000 ............................................................ 73 2 21 1 97

Subtotal ground water systems ............................ 158 4 94 3 259

Surface Water Systems:

500 and under .............................................................. 9 0 24 0 33

501 to 3,300 ................................................................. 26 1 12 0 39

3,301 to 10,000 ............................................................ 54 2 15 0 71

Subtotal surface water systems ............................ 89 3 51 0 143

Total ...................................................................... 247 7 145 3 402

1The Limited Funding Program assumes that the only funds available to run the program are those that are currently in hand—$4 million of set

aside funds from Federal Fiscal Years 1998 and 1999. This is a ‘‘worst case’’ funding scenario.

Under the limited funding scenario,

EPA’s costs for Assessment Monitoring

would be incurred primarily from 2001

to 2003. Systems are assumed to sample

during 1 year of the 3-year period, with

one-third of systems sampling during

each year. However, Index Systems are

assumed to monitor during each of the

three Assessment Monitoring years. The

distribution of costs to EPA and small

systems over the entire 5 years is

presented in Table 9.

TABLE 9.—EPA COSTS FOR SMALL SYSTEMS—LIMITED $4 MILLION PROGRAM

Cost description 2001 2002 2003 2004 2005 Total

Costs to EPA for Assessment Monitoring Program: Quality assurance, ongoing coordination, data analysis, shipping costs, testing

costs, reporting and analysis costs, and costs

for contractor site visits to ‘‘Index’’ systems .... $1,367,947 $1,082,342 $1,082,342 $280,422 $186,948 $4,000,000

Costs to Small Systems (Assessment Monitoring): including additional labor for monitoring or monitoring assistance ....................... 13,162 11,527 11,527 0 0 36,216
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50607

TABLE 9.—EPA COSTS FOR SMALL SYSTEMS—LIMITED $4 MILLION PROGRAM—Continued

Cost description 2001 2002 2003 2004 2005 Total

Total Costs to EPA and Small Systems

for Assessment Monitoring ................... 1,381,109 1,093,869 1,093,869 280,422 186,948 4,036,216

Number of Systems each Year: Assessment

Monitoring and Index Systems in 2001–

2003: 1

Public ............................................................ 89 89 89 0 0 254

Private .......................................................... 51 51 51 0 0 148

Total .......................................................... 140 140 140 0 0 402

1 Rows do not add across because the 10 Index systems sample during each year 2001–2003. One-third of Non-Index systems sample during

each year from 2001–2003.

Under this limited $4 million

program, EPA’s costs represent

approximately 98 percent of the

national cost for the small system

sampling program. As in full UCMR

implementation, small system costs are

attributed to the additional labor

required for reading State letters,

monitoring, reporting, and record

keeping. It is estimated that under a

limited program of Assessment

Monitoring only the average annual per

system labor burden will be $14 (0.7

hours) for ground water systems and

$25 (1.2 hours) for surface water

systems. In total, ground water and

surface water systems average 0.9 hours

of burden per year, with an average

annual cost of $18.

Through revenue and sales tests,

determinations of economic impact are

presented in Tables 10a and 10b

respectively. Under this limited $4

million program, systems will be subject

to less required monitoring than in the

full UCMR program. For both full

Assessment Monitoring implementation

and the limited funding scenario,

average annual cost is in all cases lower

than 1 percent of annual sales/revenues.

Thus, even in this worst case, limited

implementation scenario, EPA certifies

that today’s final rule would not impose

a significant economic impact on small

entities.

TABLE 10a.—UCMR LIMITED IMPLEMENTATION SCENARIO: ANALYSIS FOR PUBLICLY-OWNED SYSTEMS (2001–2005)

System size

Annual number of

systems affected 1

Average annual hours

per system

(2001–2005)

Average annual cost per

system

(2001–2005)

‘‘Revenue test’’ 2

(percent)

Number Percent of

US total Non-index Index Non-index Index Non-Index Index

Ground Water Systems

500 and under .................................. 2.1 0.00 0.6 1.3 $8.06 $18.71 0.05 0.11

501 to 3,300 ..................................... 16.2 0.13 0.6 1.5 9.15 22.19 0.01 0.02

3,301 to 10,000 ................................ 16.1 0.67 0.8 2.0 22.16 57.12 0.00 0.01

Surface Water Systems

500 and under .................................. 1.7 0.09 1.1 0.0 15.41 0.00 0.05 0.00

501 to 3,300 ..................................... 5.6 0.31 1.2 2.6 17.07 38.28 0.01 0.02

3,301 to 10,000 ................................ 11.8 1.17 1.1 2.5 31.35 70.56 0.00 0.01

1 Calculated as 1⁄5 of publicly-owned Non-Index sample, plus all public Index systems for each year from 2001–2003; actual sampling for NonIndex takes place over 3 years, Index in each of 3 years. 2The ‘‘Revenue Test’’ was used to evaluate the economic impact of an information collection on small governments (e.g., publicly owned systems); costs are presented as a percentage of median annual revenue in each size category.

TABLE 10b.—UCMR Limited Implementation Scenario: Analysis for Privately-Owned Systems (2001–2005)

System size

Annual number of

systems affected 1

Average annual hours

per system

(2001–2005)

Average annual cost per

system

(2001–2005)

‘‘Revenue test’’ 2

(percent)

Number Percent of

US total Non-index Index Non-index Index Non-index Index

Ground Water Systems

500 and under .................................. 8.2 0.02 0.6 1.3 $8.06 $18.71 0.05 0.12

501 to 3,300 ..................................... 7.4 0.06 0.6 1.5 9.15 22.19 0.01 0.02

3,301 to 10,000 ................................ 4.5 0.19 0.8 2.0 22.16 57.12 0.00 0.01

Surface Water Systems

500 and under .................................. 4.8 0.25 1.1 0.0 15.41 0.00 0.07 0.00

501 to 3,300 ..................................... 2.5 0.14 1.2 2.6 17.07 38.28 0.01 0.03
50608 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

TABLE 10b.—UCMR Limited Implementation Scenario: Analysis for Privately-Owned Systems (2001–2005)—

Continued

System size

Annual number of

systems affected 1

Average annual hours

per system

(2001–2005)

Average annual cost per

system

(2001–2005)

‘‘Revenue test’’ 2

(percent)

Number Percent of

US total Non-index Index Non-index Index Non-index Index

3,301 to 10,000 ................................ 3.3 0.33 1.1 2.5 31.35 70.56 0.01 0.01

1 Calculated as 1⁄5 of the Non-Index sample, plus all Index systems for each year from 2001–2005; actual sampling for Non-Index systems

takes place over 3 years, while that of Index systems occurs during each of 3 years. 2The ‘‘Sales Test’’ was used to evaluate the economic impact of an information collection on small private entities (e.g., privately owned systems); costs are presented as a percentage of median annual sales in each size category.

F. National Technology Transfer and

Advancement Act

As noted in the proposed rule,

Section 12(d) of the National

Technology Transfer and Advancement

Act (NTTAA), Pub. L. No. 104–113,

§ 12(d) (15 U.S.C. 272 note) directs EPA

to use voluntary consensus standards in

its regulatory activities unless to do so

would be inconsistent with applicable

law or otherwise impractical. Voluntary

consensus standards are technical

standards (e.g., materials specifications,

test methods, sampling procedures, and

business practices) that are developed or

adopted by voluntary consensus

standards bodies. The NTTAA directs

EPA to provide Congress, through OMB,

explanations when the Agency decides

not to use available and applicable

voluntary consensus standards.

This rulemaking involves technical

standards. EPA has decided to use

consensus methods published by the

three major voluntary consensus

method organizations—Standard

Methods, AOAC International, and

American Society for Testing and

Materials (ASTM)—that would be

acceptable for compliance

determinations under SDWA for the

UCMR (1999) List 1. The voluntary

consensus methods found are listed in

§ 141.40(a)(3), Table 1, List 1. For the

Assessment Monitoring portion of the

final rule, EPA is approving the use of

all of the non-EPA analytical methods

adopted by these voluntary consensus

groups that are applicable to the

analyses of these unregulated

contaminants when used in conjunction

with the required quality-control

practices specified in the rule.

A few public comments suggested the

updating of consensus methods

approved in Table 1, List 1, or an

additional method to consider. To that

end, the Agency updated the consensus

methods listed to include those

identified in the most current (20th)

edition of Standard Methods (SM). SM

6200B, from the 20th edition, is also

approved for volatile analysis; SM

6210D remains on the list but only

appears in previous editions. A

commenter suggested use of SM 6640

for DCPA mono and di acids for List 1;

however, this method does not address

hydrolysis, a critical step in the analyses

of this contaminant, so EPA is not

including it on the list.

EPA conducted a search to identify

potentially applicable voluntary

consensus standards for chemical and

microbiological parameters included in

Lists 2 and 3 of this rule. EPA identified

and listed in the proposal some general

methods specifications that the Agency

believes may potentially be used to

reliably detect some of the contaminants

on List 2. However, EPA was unable to

find either an EPA or voluntary

consensus method applicable to the

monitoring required and none were

brought to our attention in comments on

the proposed rule. Commenters

suggested EPA also approve EPA

Method 632 for linuron and diuron,

which does not include confirmation or

preservation steps; and EPA Method 552

for the phenols, which has low

recoveries and interferences among the

compounds. For these reasons, EPA has

not included these EPA methods for the

respective contaminants. No other

voluntary consensus standards were

brought to the Agency’s attention in

comments on the proposed rule. EPA is

developing acceptable methods to

determine the presence of the

contaminants on Lists 2 and 3, and will

take additional public comment when

the rules are proposed for monitoring of

List 2 and 3 contaminants.

G. Executive Order 12898—Federal

Actions to Address Environmental

Justice in Minority Populations and

Low-Income Populations

Executive Order 12898, ‘‘Federal

Actions to Address Environmental

Justice in Minority Populations and

Low-Income Populations’’ (February 11,

1994), focuses federal attention on the

environmental and human health

conditions of minority and low-income

populations with the goal of achieving

environmental protection for all

communities.

By seeking to identify unregulated

contaminants that may pose health risks

via drinking water from all PWSs, the

unregulated contaminant monitoring

regulation furthers the protection of

public health for all citizens, including

minority and low-income populations

using public water supplies. Using a

statistically derived set of systems for

the national representative sample that

is population-weighted within each

system size category allocated across

States, the final rule ensures that no

group within the population is under

represented.

H. Federalism Executive Orders

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

OMB with a description of the extent of

EPA’s prior consultation with

representatives of affected State, local,

and tribal governments; the nature of

their concerns; 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 today’s rule

will create a mandate on local

governments that own or operate PWSs

and that the Federal government will

not provide the funds necessary to pay

all of the direct costs incurred by these

governments in complying with the

mandate. However, EPA will pay for the
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50609

sample testing costs of small systems

and has budgeted funds to do so.

In developing this rule, EPA

consulted with State, local, and tribal

governments to enable them to provide

meaningful and timely input in the

development of this rule. Prior to the

publication of the proposed rule, EPA

received input through its public

stakeholder process, by conducting

public meetings and through targeted

mailings. Additionally, EPA received

input through its public comment

process from 22 States, 13 public water

systems and local water agencies, and

130 other commenters, including nonprofit organizations, associations,

industry, and individuals. EPA also sent

out nearly 400 targeted mailings directly

to 360 Tribes, Tribal organizations, and

small water system organizations to

ensure that they were informed of the

proposed rule’s publication and had an

opportunity to comment. The principal

concerns raised were that: (1) States did

not want to go through the primacy

process; (2) EPA should include

perchlorate on the monitoring list; (3)

EPA should use multi-analyte methods

to the extent possible for testing; and (4)

EPA should allow previous monitoring

data for some of the contaminants on

the list. In response to these principal

concerns, EPA changed the

implementation steps for the regulation

from primacy revisions to a

Memorandum of Agreement with States.

Perchlorate is now on UCMR List 1

(1999) for early monitoring. EPA

incorporated as many additional

contaminants in List 1 using multianalyte methods as possible, specifically

moving acetochlor from List 2 to List 1.

Systems can submit previously

collected data to meet the UCMR, as

long as the requirements for sampling,

testing and reporting are met.

Finally, while there is a new

executive order on federalism,

Executive Order 13132, it will not go

into effect until November 3, 1999. In

the interim, under the current Executive

Order 12612 on federalism, this rule

does not have a substantial direct effect

upon States, upon the relationship

between the national government and

the States, or upon the distribution of

power and responsibilities among the

various levels of government. The final

rule allows States to decide whether

they want to enter a Memorandum of

Agreement (MOA) with EPA to

implement the monitoring program. If

they decide not to enter into an MOA,

then EPA will directly implement the

monitoring program, since the data are

for the purposes of deciding which

contaminants to regulate in the future at

the Federal level and will not have a

direct effect on public health protection

under current drinking water standards

implemented by States.

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 OMB, in a

separately identified section of the

preamble to the rule, a description of

the extent of EPA’s prior consultation

with representatives of affected Tribal

governments, a summary of the nature

of their concerns, and a statement

supporting the need to issue the

regulation. In addition, Executive Order

13084 requires EPA to develop an

effective process permitting elected

officials and other representatives of

Indian Tribal governments ‘‘to provide

meaningful and timely input in the

development of regulatory policies on

matters that significantly or uniquely

affect their communities.’’

Today’s rule does not significantly or

uniquely affect the communities of

Indian Tribal governments. Only one

Tribal water system serves more than

10,000 persons. All the other Tribal

water systems serve 10,000 or fewer

persons, and in today’s rule have an

equal probability of being selected in

the national representative sample of

small systems, for which EPA will pay

the costs of unregulated contaminant

testing. Thus, these Tribal water systems

will be treated the same as water

systems of a State and the impact of the

rule on them will not be significant.

This rule will not impose substantial

direct compliance costs on such

communities either because, with the

exception of the one large Tribal water

system, the Federal government will

provide most of the funds necessary to

pay the direct costs incurred by tribal

governments in complying with the

rule. Accordingly, the requirements of

section 3(b) of Executive Order 13084

do not apply to this rule. Nevertheless,

in developing this rule, EPA consulted

with representatives of Tribal

governments pursuant to both Executive

Order 12875 and Executive Order

13084. The extent of EPA’s consultation,

the nature of the governments’ concerns,

and EPA’s position supporting the need

for this rule, are discussed in the

preamble section that addresses

compliance with Executive Order

12875. Tribes were consulted and raised

issues concerning the utility of a

targeted, rather than a representative

random, sampling approach and the

applicability of ‘‘treatment as a State’’

under the final rule.

J. Congressional Review Act

The Congressional Review Act, 5

U.S.C. § 801 et seq., as added by the

Small Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and to the Comptroller General

of the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives, and

the Comptroller General of the United

States prior to publication of the rule in

the Federal Register. A major rule

cannot take effect until 60 days after it

is published in the Federal Register.

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

defined by U.S.C. § 804(2). This rule

will be effective January 1, 2001.

XIII. Public Involvement in Regulation

Development

EPA’s Office of Ground Water and

Drinking Water has developed a process

for stakeholder involvement in its

regulatory activities to provide early

input to regulation development.

Activities related to the UCMR included

meetings for developing the CCL and

the information requirements of the

NCOD, as well as specific meetings

focused on revising the UCMR

monitoring list. During the development

of the UCMR, stakeholders from a wide

range of public and private entities

provided key perspectives.

Representatives from public water

systems, States, industry, and other

organizations attended two stakeholder

meetings to discuss options directly

related to the UCMR. An additional 17

meetings were held with stakeholders

and the public concerning issues related

to the UCMR. In total, 21 State health

and environmental agencies, 5 water

systems, 6 water associations, 6 health

associations, 5 industrial associations, 4

environmental organizations, 4

community and consumer

organizations, 29 companies, and 7

federal agency offices participated in

meetings that were instrumental in the

development of today’s final rule.

As noted previously, the CCL

identifies contaminants for which EPA
50610 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

may take regulatory action and for

which EPA needs additional data. The

UCMR list contains contaminants for

which additional data are needed before

EPA can determine their regulatory

status. The meetings to develop the CCL

included stakeholder meetings to

discuss the list broadly and meetings

focused on particular issues conducted

through the National Drinking Water

Advisory Council’s (NDWAC) Working

Group on Occurrence and Contaminant

Selection, as follows:

• December 2–3, 1996 Stakeholders

Meeting.

• April 3–4, 1997 NDWAC Working

Group.

• June 23, 1997 NDWAC Working

Group.

• July 17, 1997 NDWAC Working

Group.

• January 7, 1998 NDWAC

Conference Call.

These meetings resulted in the

Drinking Water Contaminant Candidate

List (63 FR 10274, March 2, 1998). The

contaminants in today’s rule for

unregulated contaminant monitoring are

taken in large part from the CCL

‘‘Occurrence Priorities.’’

The NCOD development activities

included 10 public meetings on

information requirements that should be

considered for inclusion in the database.

These meetings were held between

October 1997 and February 1998. The

work of the NCOD development team is

incorporated as the reporting

requirements for sample testing in

today’s unregulated contaminant

monitoring regulation. Several

documents concerning the NCOD

development which were used in the

public meetings are:

• Options for the National Drinking

Water Contaminant Occurrence Data

Base, Background Document (Working

Draft), EPA 815–D–97–001, May 1997.

• National Drinking Water

Contaminant Occurrence Data Base—

Development Strategy, Background

Document (Working Draft), EPA 815–D–

97–005, December 1997.

• Options for Design of the National

Drinking Water Contaminant

Occurrence Data Base, Background

Document (Working Draft), EPA 815–D–

98–001, January 1998.

EPA held its first stakeholder meeting

to discuss options for the development

of the Unregulated Contaminant

Monitoring Regulation on December 2

and 3, 1997, in Washington, DC. A

variety of stakeholders attended that

meeting, including representatives of

PWSs, States, industry, health and

laboratory organizations, and the public.

EPA prepared a background document

for the meeting, Options for Developing

the Unregulated Contaminant

Monitoring Regulation (Working Draft),

EPA 815–D–97–003, November 1997. A

summary of the meeting is also

available. EPA held a second

stakeholders meeting on June 3 and 4,

1998 to obtain input from interested

parties on significant issues evolving

from drafting the regulation, which

needed further public input. The

Agency prepared a public review

document for that meeting, Background

Information and Draft Annotated

Outline for a Proposed Unregulated

Contaminant Monitoring Regulation,

Background Document, (Working Draft),

May 1998. A meeting summary also is

available. EPA also sent special requests

for review of stakeholder documents to

more than 360 Tribes (exclusive of the

Alaskan native villages) and to small

systems organizations to obtain their

input.

In all, EPA held 17 public meetings

with stakeholders and interested parties

related directly or closely to the final

Unregulated Contaminant Monitoring

Regulation. Additionally, EPA received

39 comments by the public comment

date of June 14, 1999, from a range of

the public, including individuals, water

systems, States, environmental

organizations, and associations. EPA

also received 121 comments after the

comment period, primarily from

individuals concerned with perchlorate

being on the Monitoring List.

XIV. References

Barbash, J.E., and E.A. Resek. 1996.

Pesticides in Ground Water, volume two of

the series Pesticides in the Hydrologic

System. Ann Arbor Press, Inc., Chelsea,

Michigan.

Battaglin, W., and Hay, L. 1996. Effects of

sampling strategies on estimates of annual

mean herbicide concentrations in

Midwestern rivers. Environmental Science

and Technology, v. 30, p. 889–896.

Hallberg, G. 1989a. Pesticide pollution of

groundwater in the humid United States; In

Bouwer, H., and Bowman, R.S., eds., Effect

of Agriculture on Groundwater. Agriculture,

Ecosystems, and Environment, v. 26, p. 299–

367.

Hallberg, G.R. 1989b. Nitrate in

groundwater in the United States, In Follett,

R.F., ed., Nitrogen Management and

Groundwater Protection; Chapter 3, p. 35–74.

Elsevier Sci. Pub., Amsterdam, The

Netherlands.

Hallberg, G., and D. Keeney. 1993. Nitrate.

In Alley, W.A., Regional Ground-Water

Quality; Chapter 2, p. 297–322. Van Nostrand

Reinhold, New York, NY.

Harada, Koh, W.C. Burnett, P.A. LaRock,

and J.B. Cowart. 1989. Polonium in Florida

groundwater and its possible relationship to

the sulfur cycle and bacteria. Geochemica et

Cosmochimica Acta, v. 53, pp. 143–150.

Havelaar, A.H., M. During and J.F.

Versteegh. 1987. Ampicillin-dextrin agar

medium for the enumeration of Aeromonas

species in water by membrane filtration.

Journal of Applied Bacteriology. 62(3):279–

287.

Larson, S.J., P.D. Capel, and M.S.

Majewski. 1997. Pesticides in Surface Waters,

volume three of the series Pesticides in the

Hydrologic System. Ann Arbor Press, Inc.,

Chelsea, Michigan.

Newcombe, R.G. 1998. Two-Confidence

Intervals for the Single Proportion:

Comparison of Seven Methods. Statistics in

Medicine, vol. 17, p. 857–872.

Pinsky, P., M. Lorber, K. Johnson, B. Kross,

L. Burmeister, A. Wilkins, and G. Hallberg.

1997. A study of the temporal variability of

atrazine in private well water. Environmental

Monitoring and Assessment, v. 47, p. 197–

221.

Upchurch, S.B. 1991. Radiochemistry of

Uranium-Series Isotopes in Groundwater.

Florida Institute of Phosphate Research

(Report No. 05–022–092).

List of Subjects

40 CFR Part 9

Environmental protection, Reporting

and recordkeeping requirements.

40 CFR Part 141

Environmental protection, Analytical

methods, Chemicals, Incorporation by

Reference, Intergovernmental relations,

Microorganisms, Monitoring, Water

supply.

40 CFR Part 142

Environmental protection, Analytical

methods, Chemicals, Intergovernmental

relations, Microorganisms, Monitoring,

Water supply.

Dated: August 30, 1999.

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—OMB APPROVALS UNDER

THE PAPERWORK REDUCTION ACT

1. The authority citation for part 9

continues to read as follows:

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

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

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

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

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

(e); 1361; 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. Section 9.1 is amended by

removing the entry for ‘‘141.33–141.35’’;

revising the entry for ‘‘141.40’’; and by

adding in numerical order under the

indicated heading new entries ‘‘141.33–

141.34’’ and ‘‘141.35’’ to read as follows:
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50611

§ 9.1 OMB approvals under the Paperwork

Reduction Act.

* * * * *

40 CFR Citation OMB control

No.

National Primary Drinking Water

Regulations

141.33–141.34 ...................... 2040–0090

141.35 ................................... 2040–0208

141.40 ................................... 2040–0208

* * * * *

PART 141—NATIONAL PRIMARY

DRINKING WATER REGULATIONS

1. The authority citation for part 141

continues to read as follows:

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

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

300j–9, and 300j–11.

2. Section 141.35 is revised to read as

follows:

§ 141.35 Reporting of unregulated

contaminant monitoring results.

(a) Does this reporting apply to me?

(1) This section applies to any owner or

operator of a public water system

required to monitor for unregulated

contaminants under § 141.40. This

section requires you to report the results

of this monitoring.

(2) Exception. You do not need to

report results if you are a system serving

a population of 10,000 or less, since

EPA will arrange for testing and

reporting of the results. However, you

will still need to comply with consumer

confidence reporting and public

notification requirements for these

results.

(b) To whom must I report? You must

report the results of unregulated

contaminant monitoring to EPA and

provide a copy to the State. You must

also notify the public of the monitoring

results as provided in Subpart O

(Consumer Confidence Reports) and

Subpart Q (Public Notification) of this

part.

(c) When must I report monitoring

results? You must report the results of

unregulated contaminant monitoring

within thirty (30) days following the

month in which you received the results

from the laboratory . EPA will place the

data in the national drinking water

contaminant occurrence database sixty

(60) days after you report the data to

allow for quality control review by

systems and States.

(d) What information must I report?

You must report the information

specified in the following table for each

sample, and for each spiked sample and

spike duplicate sample analyzed for

quality control purposes and associated

with each sample and its sample batch:

TABLE 1.—UNREGULATED CONTAMINANT MONITORING REPORTING REQUIREMENTS

Data element Definition

1. Public Water System (PWS) Identification

Number.

The code used to identify each PWS. The code begins with the standard two-character postal

State abbreviation; the remaining seven characters are unique to each PWS.

2. Public Water System Facility Identification

Number—Source, Treatment Plant, and Sampling Point.

An identification number established by the State, or, at the State’s discretion, the PWS, that

is unique to the system for an intake for each source of water, a treatment plant and a sampling point. Within each PWS, each intake, treatment plant and sampling point must receive

a unique identification number, including, for intake; surface water intake, ground water well

or wellfield centroid; and including, for sampling point; entry points to the distribution system,

wellhead, intake, locations within the distribution system, or other representative sampling

point specified by the State. The same identification number must be used consistently

throughout the history of unregulated contaminant monitoring to represent the facility.

3. Sample Collection Date .................................. The date the sample is collected reported as 4-digit year, 2-digit month, and 2-digit day.

4. Sample Identification Number ........................ A numeric value assigned by the PWS or laboratory to uniquely identify a specific sampling

occurrence.

5. Contaminant/Parameter .................................. The unregulated contaminant or water quality parameter for which the sample is being analyzed.

6. Analytical Results—Sign ................................ An alphanumeric value indicating whether the sample analysis result was:

(a) (<) ‘‘less than’’ means the contaminant was not detected or was detected at a level ‘‘less

than’’ the MRL.

(b) (=) ‘‘equal to’’ means the contaminant was detected at a level ‘‘equal to’’ the value reported

in ‘‘Analytical Result—Value.’’

7. Analytical Result—Value ................................ The actual numeric value of the analysis for chemical and microbiological results, or the minimum reporting level (MRL) if the analytical result is less than the specified contaminant’s

MRL

8. Analytical Result—Unit of Measure ................ The unit of measurement for the analytical results reported. [e.g., micrograms per liter, (μg/L);

colony-forming units per milliliter, (CFU/mL), etc.]

9. Analytical Method Number ............................. The identification number of the analytical method used.

10. Sample Analysis Type .................................. The type of sample collected. Permitted values include:

(a) Field Sample—sample collected and submitted for analysis under this rule.

(b) Batch Spike/Spike Duplicate—Samples associated with a batch used for calculating analytical precision and accuracy. A batch is defined as the set of field samples plus one spiked

sample and one spiked duplicate sample analyzed for contaminant concentrations

11. Sample Batch Identification Number ............ A number assigned by the laboratory to the batch of samples analyzed with the spiked sample

(at the spiking concentration reported), to be reported as 9-digit laboratory number (assigned by the State or EPA), 4-digit year, 2-digit month, 2-digit day and 2-digit batch number.

12. Detection Level ............................................. ‘‘Detection level’’ refers to the detection limit applied to both the method and equipment. Detection limit is the lowest concentration of a target contaminant that a given method or piece

of equipment can reliably ascertain and report as greater than zero ( e.g., Instrument Detection Limit, Method Detection Limit, or Estimated Detection Limit).

13. Detection Level Unit of Measure .................. The unit of measure to express the concentration, count, or other value of a contaminant level

for the detection level reported.

(e.g., μg/L, colony forming units/mL (CFU/mL), etc.)
50612 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

TABLE 1.—UNREGULATED CONTAMINANT MONITORING REPORTING REQUIREMENTS—Continued

Data element Definition

14. Analytical Precision ...................................... Precision is the degree of agreement among a set of repeated measurements and is monitored through the use of replicate samples or measurements. For purposes of the Unregulated Contaminant Monitoring Regulation (UCMR), Analytical Precision is defined as the relative percent difference (RPD) between spiked matrix duplicates. The RPD for the spiked

matrix duplicates analyzed in the same batch of samples as the analytical result being reported is to be entered in this field. Precision is calculated as Relative Percent Difference

(RPD) between spiked matrix duplicates using,

RPD = [(X1–X2) / (X1 + X2)/2] × 100

15. Analytical Accuracy ...................................... Accuracy describes how close a result is to the true value measured through the use of

spikes, standards, surrogates or performance evaluation samples. For purposes of unregulated contaminant monitoring, accuracy is defined as the percent recovery of the contaminant in the spiked matrix sample analyzed in the same analytical batch as the sample result

being reported and calculated using;

% recovery = [(amt. found in spiked sample—amt. found in sample) / amt. spiked] × 100

16. Spiking Concentration .................................. The concentration of method analytes added to a sample to be analyzed for calculating analytical precision and accuracy where the value reported use the same unit of measure reported

for Analytical Results

17. Presence/Absence ........................................ Chemicals: Presence—a response was produced by the analysis (i.e., greater than or equal to

the MDL but less than the MRL)/Absence—no response was produced by the analysis (i.e.,

less than the MDL).

Microbiologicals: Presence—indicates a response was produced by the analysis /Absence—indicates no response was produced by the analysis.

(e) How must I report this

information? You must report this

information in the electronic or other

format specified by EPA.

(f) Can the laboratory to which I send

samples report the results for me? Yes,

as long as the laboratory sends you a

copy for review and recordkeeping.

However, you are responsible for the

reporting of this information and

ensuring that the laboratory reports

these results to EPA, with a copy to the

State, on time.

(g) Can I report previously collected

data to meet the testing and reporting

requirements for the contaminants

listed in § 141.40(a)(3)? Yes, as long as

the data meet the specific requirements

of § 141.40(a)(3), (4), (5), and Appendix

A of § 141.40 and you report the data

with the information specified in

paragraph (d) of this section.

3. Section 141.40 is revised to read as

follows:

§ 141.40 Monitoring requirements for

unregulated contaminants.

(a) Requirements for owners and

operators of public water systems. (1) Do

I have to monitor for unregulated

contaminants?

(i) Transient systems. If you own or

operate a transient non-community

water system, you do not have to

monitor for unregulated contaminants.

(ii) Large systems not purchasing their

entire water supply from another

system. If you own or operate a

wholesale or retail public water system

(other than a transient system) that

serves more than 10,000 persons, as

determined by the State, and do not

purchase your entire water supply from

another public water system, you must

monitor as follows:

(A) You must monitor for the

unregulated contaminants on List 1 of

Table 1, Unregulated Contaminant

Monitoring Regulation (1999) List, in

paragraph (a)(3) of this section.

(B) You must monitor for the

unregulated contaminants on List 2 of

Table 1, Unregulated Contaminant

Monitoring Regulation (1999) List, in

paragraph (a)(3) of this section, if

notified by your State or EPA that you

are part of the Screening Surveys.

(C) You must monitor for the

unregulated contaminants on List 3 of

Table 1, Unregulated Contaminant

Monitoring Regulation (1999) List, in

paragraph (a)(3) of this section, if

notified by your State or EPA that you

are part of the Pre-Screen Testing.

(iii) Large systems purchasing their

entire water supply from another

system. If you own or operate a public

water system (other than a transient

system) that serves more than 10,000

persons and purchase your entire water

supply from a wholesale public water

system, you must monitor as follows:

(A) You must monitor for the

unregulated contaminants on List 1 of

Table 1, Unregulated Contaminant

Monitoring Regulation (1999) List, in

paragraph (a)(3) of this section, that

have a ‘‘sampling location’’ indicated as

‘‘distribution system’’.

(B) You must monitor for the

unregulated contaminants on List 2 of

Table 1, Unregulated Contaminant

Monitoring Regulation (1999) List, in

paragraph (a)(3) of this section, that

have a ‘‘sampling location’’ indicated as

‘‘distribution system’’ if notified by your

State or EPA that you are part of the

Screening Surveys.

(C) You must monitor for the

unregulated contaminants on List 3 of

Table 1, Unregulated Contaminant

Monitoring Regulation (1999) List, in

paragraph (a)(3) of this section, that

have a ‘‘sampling location’’ indicated as

‘‘distribution system’’ if notified by your

State or EPA that you are part of the PreScreen Testing.

(iv) Small systems not purchasing

their entire water supply from another

system. If you own or operate a public

water system (other than a transient

system) that serves 10,000 or fewer

persons and do not purchase your entire

water supply from another public water

system, you must monitor as follows:

(A) You must monitor for the

unregulated contaminants on List 1 of

Table 1, Unregulated Contaminant

Monitoring Regulation (1999) List, in

paragraph (a)(3) of this section, if you

are notified by your State or EPA that

you are part of the State Monitoring

Plan for small systems.

(B) You must monitor for the

unregulated contaminants on List 2 of

Table 1, Unregulated Contaminant

Monitoring Regulation (1999) List, in

paragraph (a)(3) of this section, if you

are notified by your State or EPA that

you are part of the Screening Surveys.

(C) You must monitor for the

unregulated contaminants on List 3 of

Table 1, Unregulated Contaminant

Monitoring Regulation (1999) List, in

paragraph (a)(3) of this section, if you

are notified by your State or EPA that

you are part of the Pre-Screen Testing.

(v) Small systems purchasing their

entire water supply from another
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50613

system. If you own or operate a public

water system (other than a transient

system) that serves 10,000 or fewer

persons and purchase your entire water

supply from a wholesale public water

system, you must monitor as follows:

(A) You must monitor for the

unregulated contaminants on List 1 of

Table 1, Unregulated Contaminant

Monitoring Regulation (1999) List, in

paragraph (a)(3) of this section, that

have a ‘‘sampling location’’ indicated as

‘‘distribution system’’ if you are notified

by your State or EPA that you are part

of the State Monitoring Plan for small

systems.

(B) You must monitor for the

unregulated contaminants on List 2 of

Table 1, Unregulated Contaminant

Monitoring Regulation (1999) List, in

paragraph (a)(3) of this section, that

have a ‘‘sampling location’’ indicated as

‘‘distribution system’’ if you are notified

by your State or EPA that you are part

of the Screening Surveys.

(C) You must monitor for the

unregulated contaminants on List 3 of

Table 1, Unregulated Contaminant

Monitoring Regulation (1999) List, in

paragraph (a)(3) of this section, that

have a ‘‘sampling location’’ indicated as

‘‘distribution system’’ if you are notified

by your State or EPA that you are part

of the Pre-Screen Testing.

(2) How would I be selected for the

monitoring under the State Monitoring

Plan, the Screening Surveys, or the PreScreen Testing? (i) State Monitoring

Plan. Only a representative sample of

small systems must monitor for

unregulated contaminants. EPA will

select a national representative sample

of small public water systems in each

State through the use of a random

number generator. Selection will be

weighted by population served within

each system water source type (surface

or ground water) and system size

category (systems serving 25–500, 501–

3,300, and 3,301–10,000 persons). EPA

may allocate additional systems to water

source types or system size categories to

increase the statistical inferential ability

for those categories. EPA will also select

a small group of systems to be ‘‘Index

systems.’’ Systems selected as Index

systems are required to provide

information about their site and

operation that will serve to allow

extrapolation of their results to other

systems of similar size, rather than

collecting detailed information at every

small system. Each State will have the

opportunity to make some modifications

to the list of small systems that EPA

selects. You will be notified by the State

or EPA if your system is part of the final

State Monitoring Plan.

(ii) Screening Surveys. The purpose of

the Screening Surveys is to determine

the occurrence of contaminants in

drinking water or sources of drinking

water for which analytical methods

have recently been developed for

unregulated contaminant monitoring.

EPA will select up to 300 systems to

participate in each survey by using a

random number generator. You will be

notified by the State or EPA if your

system is selected for monitoring under

the Screening Surveys.

(iii) Pre-screen Testing. The purpose

of Pre-Screen Testing is to determine the

occurrence of contaminants for which

EPA needs to evaluate new analytical

methods in locations where the

contaminants are most likely to be

found. EPA will select up to 200

systems to participate in this testing

after considering the characteristics of

the contaminants, precipitation, system

operation, and environmental

conditions. You will be notified by the

State or EPA that your system has been

selected for monitoring under the PreScreen Testing program.

(3) For which contaminants must I

monitor? Lists 1, 2 and 3 of unregulated

contaminants are listed in the following

table:

TABLE 1.—UNREGULATED CONTAMINANT MONITORING REGULATION (1999) LIST

List 1—Assessment Monitoring Chemical Contaminants

1-Contaminant 2-CAS registry number 3-Analytical methods 4-Minimum reporting

level 5-Sampling location

6-Period during which

monitoring to be completed

2,4-dinitrotoluene ........ 121–14–2 .................. EPA 525.2 a ............... 2 μg/L e ...................... EPTDSf ..................... 2001–2003

2,6-dinitrotoluene ........ 606–20–2 .................. EPA 525.2 a ............... 2 μg/L e ...................... EPTDSf ..................... 2001–2003

Acetochlor .................. 34256–82–1 .............. Reserved m ................ Reserved m ................ EPTDSf ..................... 2001–2003

DCPA mono-acid

degradate.

887–54–7 .................. EPA 515.1 a ...............

EPA 515.2 a

D5317–93 b

AOAC 992.32 c

1 μg/L e ...................... EPTDSf ..................... 2001–2003

DCPA di-acid

degradate.

2136–79–0 ................ EPA 515.1 a ...............

EPA 515.2 a

D5317–93 b

AOAC 992.32 c

1 μg/L e ...................... EPTDSf ..................... 2001–2003

4,4’-DDE ..................... 72–55–9 .................... EPA 508 a ..................

EPA 508.1 a

EPA 525.2 a

D5812–96 b

AOAC 990.06 c

0.8 μg/L e ................... EPTDSf ..................... 2001–2003

EPTC .......................... 759–94–4 .................. EPA 507 a ..................

EPA 525.2 a

D5475–93 b

AOAC 991.07 c

1 μg/L e ...................... EPTDSf ..................... 2001–2003

Molinate ...................... 2212–67–1 ................ EPA 507 a ..................

EPA 525.2 a

D5475–93 b

AOAC 991.07 c

0.9 μg/L e ................... EPTDSf ..................... 2001–2003

MTBE ......................... 1634–04–4 ................ EPA 524.2 a ...............

D5790–95b

SM 6210D d

SM 6200Bd

5 μg/L g ...................... EPTDSf ..................... 2001–2003
50614 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

TABLE 1.—UNREGULATED CONTAMINANT MONITORING REGULATION (1999) LIST—Continued

List 1—Assessment Monitoring Chemical Contaminants

1-Contaminant 2-CAS registry number 3-Analytical methods 4-Minimum reporting

level 5-Sampling location

6-Period during which

monitoring to be completed

Nitrobenzene .............. 98–95–3 .................... EPA 524.2 a ...............

D5790–95 b

SM6210D d

SM6200Bd

10 μg/L g .................... EPTDSf ..................... 2001–2003

Perchlorate ................. 14797–73–0 .............. Reserved m ................ Reserved m ................ EPTDSf ..................... 2001–2003

Terbacil ....................... 5902–51–2 ................ EPA 507 a ..................

EPA 525.2 a

D5475–93 b

AOAC 991.07 c

2 μg/L e ...................... EPTDSf ..................... 2001–2003

List 2—Screening Survey Chemical Contaminants

To Be Sampled After Notice of Analytical Methods Availability

1-Contaminant 2-CAS registry number 3-Analytical methods 4-Minimum reporting

level 5-Sampling location

6-Period during which

monitoring to be completed

1,2-diphenylhydrazine 122–66–7 .................. EPA 525.2 i ............... Reserved h ................. EPTDSf ..................... Reserved h

2-methyl-phenol .......... 95–48–7 .................... SPE/GC/MSl ............. Reserved h ................. EPTDSf ..................... Reserved h

2,4-dichlorophenol ...... 120–83–2 .................. SPE/GC/MSl ............. Reserved h ................. EPTDSf ..................... Reserved h

2,4-dinitrophenol ......... 51–28–5 .................... SPE/GC/MSl ............. Reserved h ................. EPTDSf ..................... Reserved h

2,4,6-trichlorophenol ... 88–06–2 .................... SPE/GC/MSl ............. Reserved h ................. EPTDSf∼ ................... Reserved h

Alachlor ESA .............. TBD h ......................... TBD h ......................... Reserved h ................. EPTDSf ..................... Reserved h

Diazinon ..................... 333–41–5 .................. EPA 525.2 k ............... Reserved h ................. EPTDSf ..................... Reserved h

Disulfoton ................... 298–04–4 .................. EPA 525.2 k ............... Reserved h ................. EPTDSf ..................... Reserved h

Diuron ......................... 330–54–1 .................. SPE/HPLC/ UVj ........ Reserved h ................. EPTDSf ..................... Reserved h

Fonofos ...................... 944–22–9 .................. EPA 525.2 i ............... Reserved h ................. EPTDSf ..................... Reserved h

Linuron ....................... 330–55–2 .................. SPE/HPLC/UVj ......... Reserved h ................. EPTDSf ..................... Reserved h

Polonium-210 ............. 13981–52–7 .............. Reserved h ................. Reserved h ................. Reserved h ................. Reserved h

Prometon .................... 1610–18–0 ................ EPA 525.2 k ............... Reserved h ................. EPTDSf ..................... Reserved h

Terbufos ..................... 13071–79–9 .............. EPA 525.2 k ............... Reserved h ................. EPTDSf ..................... Reserved h

RDX ............................ 121–82–4 .................. Reserved h ................. Reserved h ................. EPTDSf ..................... Reserved

List 2—Screening Survey Microbiological Contaminants

To Be Sampled After Notice of Analytical Methods Availability

1-Contaminant 2-Identification number 3-Analytical methods 4-Minimum reporting

level 5-Sampling location

6-Period during which

monitoring to be completed

Aeromonas ................. Reserved h ................. Reserved h ................. Reserved h ................. Reserved h ................. Reserved

List 3—Pre-Screen Testing Radionuclides

To Be Sampled After Notice of Analytical Methods Availability

1-Contaminant 2-CAS registry number 3-Analytical methods 4-Minimum reporting

level 5-Sampling location

6-Period during which

monitoring to be completed

Lead-210 .................... 14255–04–0 .............. Reserved h ................. Reserved h ................. Reserved h ................. Reserved
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50615

List 3—Pre-Screen Testing Microorganisms

To Be Sampled After Notice of Analytical Methods Availability

1-Contaminant 2-Identification number 3-Analytical methods 4-Minimum reporting

level 5-Sampling location

6-Period during which

monitoring to be completed

Cyanobacteria (bluegreen algae, other

freshwater algae

and their toxins).

Reserved h ................. Reserved h ................. Reserved h ................. Reserved h ................. Reserved h

Echoviruses ................ Reserved h ................. Reserved h ................. Reserved h ................. Reserved h ................. Reserved h

Coxsackieviruses ....... Reserved h ................. Reserved h ................. Reserved h ................. Reserved h ................. Reserved h

Helicobacter pylori ...... Reserved h ................. Reserved h ................. Reserved h ................. Reserved h ................. Reserved h

Microsporidia .............. Reserved h ................. Reserved h ................. Reserved h ................. Reserved h ................. Reserved h

Calciviruses ................ Reserved h ................. Reserved h ................. Reserved h ................. Reserved h ................. Reserved h

Adenoviruses .............. Reserved h ................. Reserved h ................. Reserved h ................. Reserved h ................. Reserved h

Column headings are:

1-Chemical or microbiological contaminant: the name of the contaminants to be analyzed.

2–CAS (Chemical Abstract Service Number) Registry No. or Identification Number: a unique number identifying the chemical contaminants.

3-Analytical Methods: method numbers identifying the methods that must be used to test the contaminants.

4-Minimum Reporting Level: the value and unit of measure at or above which the concentration or density of the contaminant must be measured using the Approved Analytical Methods.

5-Sampling Location: the locations within a PWS at which samples must be collected.

6-Years During Which Monitoring to Be Completed: The years during which the sampling and testing are to occur for the indicated contaminant.

The procedures shall be done in accordance with the documents listed below. The incorporation by reference of the following documents listed

in footnotes b-d was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the documents may be obtained from the sources listed below. Information regarding obtaining these documents can be obtained from the Safe Drinking

Water Hotline at 800–426–4791. Documents may be inspected at EPA’s Drinking Water Docket, 401 M Street, SW., Washington, DC 20460

(Telephone: 202–260–3027); or at the Office of Federal Register, 800 North Capitol Street, NW., Suite 700, Washington, DC. aThe version of the EPA methods which you must follow for this Rule are listed at 40 CFR 141.24 (e).

bAnnual Book of ASTM Standards, 1996 and 1998, Vol. 11.02, American Society for Testing and Materials. Method D5812–96 is located in

the Annual Book of ASTM Standards, 1998, Vol. 11.02. Methods D5790–95, D5475–93, and D5317–93 are located in the Annual Book of ASTM

Standards, 1996 and 1998, Vol 11.02. Copies may be obtained from the American Society for Testing and Materials, 100 Barr Harbor Drive,

West Conshohocken, PA 19428. bOfficial Methods of Analysis of AOAC (Association of Official Analytical Chemist) International, Sixteenth Edition, 4th Revision, 1998, Volume

I, AOAC International, First Union National Bank Lockbox, PO Box 75198, Baltimore, MD 21275–5198. 1–800–379–2622. dSM 6210 D is only found in the 18th and 19th editions of Standard Methods for the Examination of Water and Wastewater, 1992 and 1995,

American Public Health Association; either edition may be used. SM 6200 B is only found in the 20th edition of Standard Methods for the Examination of Water and Wastewater, 1998. Copies may be obtained from the American Public Health Association, 1015 Fifteenth Street NW, Washington, DC 20005. e Minimum Reporting Level determined by multiplying by 10 the least sensitive method’s minimum detection limit (MDL=standard deviation

times the Student’s T value for 99% confidence level with n-1 degrees of freedom), or when available, multiplying by 5 the least sensitive method’s estimated detection limit (where the EDL equals the concentration of compound yielding approximately a 5 to 1 signal to noise ratio or the

calculated MDL, whichever is greater). fEntry Points to the Distribution System (EPTDS), After Treatment, representing each non-emergency water source in routine use over the

twelve-month period of monitoring; sampling must occur at the EPTDS, unless the State has specified other sampling points that are used for

compliance monitoring 40 CFR 141.24 (f)(1), (2), and (3). See 40 CFR 141.40(a)(5)(ii)(C) for a complete explanation of requirements, including

the use of source (raw) water sampling points. g Minimum Reporting Levels (MRL) for Volatile Organic Compounds (VOC) determined by multiplying either the published Method Detection

Limit (MDL) or 0.5 μg/L times 10, whichever is greater. The MDL of 0.5 μg/L (0.0005 mg/L) was selected to conform to VOC MDL requirements

of 40 CFR 141.24(f)(17)(i)(E). hTo be Determined at a later time

i Compound currently not listed as a contaminant in this method.

j Methods development currently in progress to develop a solid phase extraction/high performance liquid chromatography/ultraviolet method for

the determination of this compound. k Compound listed as being a contaminant using EPA Method 525.2; however, adequate sample preservation is not available. Preservation

studies currently being conducted to develop adequate sample preservation. l Methods development currently in progress to develop a solid phase extraction/gas chromatography/mass spectrometry method for the determination of this compound. m If not determined by regulation by December 31, 2000, this contaminant will become part of List 2.

(4) What general requirements must I

follow for monitoring List 1

contaminants? (i) All systems. You

must:

(A) Collect samples of the listed

contaminants in accordance with

paragraph (a)(5) of this section and

Appendix A of this section and any

other specific instructions provided to

you by the State or EPA,

(B) Analyze the additional parameters

specified below in Table 2. ‘‘Water

Quality Parameters to be Monitored

with UCMR Contaminants’’ for each

relevant contaminant type. You must

analyze the parameters for each

sampling event of each sampling point,

using the method indicated, and report

using the data elements 1 through 10 in

Table 1, § 141.35(d), Unregulated

Contaminant Monitoring Reporting

Requirements;

(C) Review the laboratory testing

results to ensure reliability; and

(D) Report the results as specified in

§ 141.35.
50616 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

TABLE 2.—WATER QUALITY PARAMETERS TO BE MONITORED WITH UCMR CONTAMINANTS

Parameter Contaminant type

Methodology

EPA method Standard methods 1 Other

pH ....................................................... Chemical; ............................................

Microbiological ....................................

2 150.1

2 150.2

4500-H ∂ B ASTM D1293–84 3

ASTM D1293–95 3

Turbidity .............................................. Microbiological .................................... 4,5180.1 2130 B4 GLI Method 2 4,6

Temperature ....................................... Microbiological .................................... ........................ 2550

Free Disinfectant Residual ................. Microbiological .................................... ........................ 4500-Cl D

4500-Cl F

4500-Cl G

4500-Cl H

4500-ClO2 D

4500-ClO2 E

4500-O3 B

ASTM D 1253–86 3

Total Disinfectant Residual ................. Microbiological .................................... ........................ 4500-Cl D

4500-Cl E4

4500-Cl F

4500-Cl G 4

4500-Cl I

ASTM D 1253–86 3

The procedures shall be done in accordance with the documents listed below. The incorporation by reference of the following documents was

approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the documents may be obtained from the sources listed below. Information regarding obtaining these documents can be obtained from the Safe Drinking Water Hotline at

800–426–4791. Documents may be inspected at EPA’s Drinking Water Docket, 401 M Street, SW., Washington, DC 20460 (Telephone: 202–

260–3027); or at the Office of Federal Register, 800 North Capitol Street, NW., Suite 700, Washington, DC. 1The 18th and 19th Editions of Standard Methods for the Examination of Water and Wastewater, 1992 and 1995. Methods 2130 B; 2550;

4500-Cl D, E, F, G, H, I; 4500-ClO2 D, E; 4500-H∂ B; and 4500-O3 B in the 20th edition Standard Methods for the Examination of Water and

Wastewater, 1998, American Public Health Association, 1015 Fifteenth St. NW, Washington D.C., 20005. 2 Methods 150.1 and 150.2 are available from US EPA, NERL, 26 W. Martin Luther King Dr., Cincinnati, Ohio 45268. The identical methods

are also in ‘‘Methods for Chemical Analysis of Water and Wastes,’’ EPA–600/4–79–020, March 1983, available from the National Technical Information Service (NTIS), U.S. Department of Commerce, 5285 Port Royal Rd., Springfield, Virginia 22161, PB84–128677. (Note: NTIS toll-free

number is 800–553–6847.) 3Annual Book of ASTM Standards, Editions 1994 and 1996,Volumes 11.01, American Society for Testing and Materials, 100 Barr Harbor

Drive, West Conshohocken, PA 19428. Version D1293–84 is located in the Annual Book of ASTM Standards, 1994, Volumes 11.01. Version

D1293–95 is located in the Annual Book of ASTM Standards, 1996, Volumes 11.01. 4 ‘‘Technical Notes on Drinking Water,’’ EPA–600/R–94–173, October 1994, Available at NTIS, PB95–104766.

5 ‘‘Methods for the Determination of Inorganic Substances in Environmental Samples,’’ EPA–600/R–93–100, August 1993. Available at NTIS,

PB94–121811 6GLI Method 2, ‘‘Turbidity,’’ November 2, 1992, Great Lakes Instruments Inc., 8855 North 55th St., Milwaukee, Wisconsin 53223.

(ii) Large systems. In addition to

paragraph (a)(4)(i) of this section, you

must arrange for testing of the samples

according to the methods specified for

each contaminant in Table 1,

Unregulated Contaminant Monitoring

Regulation (1999) List, in paragraph

(a)(3) of this section, and in Appendix

A of this section.

(iii) Small systems. Unless directed

otherwise by the State or EPA, in

addition to paragraph (a)(4)(i) of this

section , you must:

(A) Properly receive, store, maintain

and use the sampling equipment sent to

you from the laboratory designated by

EPA;

(B) Sample at the times specified by

the State or the EPA;

(C) Collect and pack samples in

accordance with the instructions sent to

you by the laboratory designated by

EPA; and

(D) Send the samples to the laboratory

designated by EPA.

(5) What specific sampling and

quality control requirements must I

follow for monitoring of List 1

contaminants? (i) All systems. Unless

the State or EPA informs you of other

sampling arrangements, you must

comply with the following

requirements:

(A) Sample collection and shipping

time. If you must ship the samples for

testing, you must collect the samples

early enough in the day to allow

adequate time to send the samples for

overnight delivery to the laboratory

since some samples must be processed

at the laboratory within 30 hours of

collection. You must not collect samples

on Friday, Saturday or Sunday because

sampling on these days would not allow

samples to be shipped and received at

the laboratory within 30 hours.

(B) No compositing of samples. You

must not composite (that is, combine,

mix or blend) the samples. You must

collect, preserve and test each sample

separately.

(C) Review and reporting of results.

After you have received the laboratory

results, you must review and confirm

the system information and data

regarding sample collection and test

results. You must report the results as

provided in § 141.35.

(ii) Large systems. In addition to

paragraph (a)(5)(i) of this section, you

must comply with the following:

(A) Timeframe. You must collect the

samples in one twelve-month period

during the years indicated in column 6

of Table 1, Unregulated Contaminant

Monitoring Regulation (1999) List.

(B) Frequency. You must collect the

samples within the timeframe and

according to the following frequency

specified by contaminant type and

water source type:
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50617

TABLE 3.—MONITORING FREQUENCY BY CONTAMINANT AND WATER SOURCE TYPES

Contaminant type Water source type Timeframe Frequency

Chemical .............................. Surface water .................... Twelve (12) months ........... Four quarterly samples taken as follows: Select either

the first, second, or third month of a quarter and

sample in that same month of each of four (4) consecutive quarters a to ensure that one of those sampling events occurs during the vulnerable time.b

Ground water ..................... Twelve (12) months ........... Two (2) times in a year taken as follows: Sample during one (1) month of the vulnerable time b and during one (1) month five (5) to seven (7) months earlier or later.c

Microbiological ..................... Surface and ground water Twelve (12) months ........... Two (2) times in a year taken as follows: Sample during one (1) month of the vulnerable time b and during one (1) month five (5) to seven (7) months earlier or later.c

a ‘‘Select either the first, second, or third month of a quarter and sample in that same month of each of four (4) consecutive quarters’’ means

that you must monitor during each of the four (4) months of either: January, April, July, October; or February, May, August, November; or March,

June, September, December. b ‘‘Vulnerable time’’ means May 1 through July 31, unless the State or EPA informs you that it has selected a different time period for sampling

as your system’s vulnerable time. c ‘‘Sample during one (1) month of the vulnerable time and during one (1) month five (5) to seven (7) months earlier or later’’ means, for example, that if you select May as your ‘‘vulnerable time’’ month to sample, then one (1) month five (5) to seven (7) months earlier would be either

October, November or December of the preceding year, and one (1) month five (5) to seven (7) months later would be either, October, November, or December of the same year.

(C) Location. You must collect

samples at the location specified for

each listed contaminant in column 5 of

the Table 1, UCMR (1999) List, in

paragraph (a)(3) of this section. The

sampling location for chemical

contaminants must be the entry point to

the distribution system or the

compliance monitoring point specified

by the State or EPA under 40 CFR

141.24(f)(1), (2), and (3). If the

compliance monitoring point as

specified by the State is for source (raw)

water and any of the contaminants in

paragraph (a)(3) of this section are

detected, then you must also sample at

the entry point to the distribution

system at the frequency indicated in

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

with the following exception: If the

State or EPA determines that sampling

at the entry point to the distribution

system is unnecessary because no

treatment was instituted between the

source water and the distribution

system that would affect measurement

of the contaminants listed in paragraph

(a)(3) of this section, then you do not

have to sample at the entry point to the

distribution system.

(D) Sampling instructions. You must

follow the sampling procedure for the

method specified in column 3 of List 1

of Table 1, Unregulated Contaminant

Monitoring Regulation (1999) List, in

paragraph (a)(3) of this section, for each

contaminant.

(E) Testing and analytical methods.

For each listed contaminant, you must

use the analytical method specified in

column 3 of List 1 of Table 1,

Unregulated Contaminant Monitoring

Regulation (1999) List, in paragraph

(a)(3) of this section, the minimum

reporting levels in column 4 of List 1 of

Table 1, Unregulated Contaminant

Monitoring Regulation (1999) List, in

paragraph (a)(3) of this section, and the

quality control procedures specified in

Appendix A of this section.

(F) Sampling deviations. If you do not

collect a sample according to the

procedures specified for a listed

contaminant, you must resample within

14 days of observing the occurrence of

the error (which may include

notification from the laboratory that you

must resample) following the

procedures specified for the method.

(This resampling is not for confirmation

sampling but to correct the sampling

error.)

(G) Testing. You must arrange for the

testing of the contaminants by a

laboratory certified under § 141.28 for

compliance analysis using the EPA

analytical methods listed in column 3

for each contaminant in Table 1,

Unregulated Contaminant Monitoring

Regulation (1999) List, in paragraph

(a)(3) of this section, whether you use

the EPA analytical methods or non-EPA

methods listed in Table 1.

(iii) Small systems that are part of the

State Monitoring Plan. Unless directed

otherwise by the State or EPA, in

addition to paragraph (a)(5)(i) of this

section, you must comply with the

following:

(A) Timeframe and frequency. You

must collect samples at the times

specified for you by the State or EPA,

within the timeframe specified in

paragraph (a)(5)(ii)(A) of this section

and according to the frequency specified

in paragraph (a)(5)(ii)(B) of this section

for the contaminant type and water

source type.

(B) Location. You must collect

samples at the locations specified for

you by the State or EPA.

(C) Sampling deviations. If you do not

collect a sample according to the

instructions provided to you for a listed

contaminant, then you must report the

deviation on the sample reporting form

that you send to the laboratory with the

samples. You must resample following

instructions that you will be sent from

EPA’s designated laboratory or the State.

(D) Sample kits. You must store and

maintain the sample collection kits sent

to you by EPA’s designated laboratory in

a secure place until used for sampling.

You should read the instructions for

each kit when you receive it. If

indicated in the kit’s instructions, you

must freeze the cold packs. The sample

kit will include all necessary containers,

packing materials and cold packs,

instructions for collecting the sample

and sample treatment (such as

dechlorination or preservation), report

forms for each sample, contact name

and telephone number for the

laboratory, and a prepaid return

shipping docket and return address

label. If any of the materials listed in the

kit’s instructions are not included or

arrive damaged, you must notify EPA’s

designated laboratory which sent you

the sample collection kits.

(E) Sampling instructions. You must

comply with the instructions sent to you

by the State or EPA concerning the use

of containers, collection (how to fill the

sample bottle), dechlorination and/or

preservation, and sealing and preparing

the sample and shipping containers for
50618 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

shipment. You must also comply with

the instructions sent to you by EPA’s

designated laboratory concerning the

handling of sample containers for

specific contaminants.

(F) Duplicate samples. EPA will select

systems in the State Monitoring Plan

that must collect duplicate samples for

quality control. If your system is

selected, you will receive two sample

kits that you must use. You must use the

same sampling protocols for both sets of

samples, following the instructions in

the duplicate sample kit.

(G) Sampling forms. You must

completely fill out the sampling forms

sent to you by the laboratory, including

the data elements 1 through 6 listed in

§ 141.35(d) for each sample. You must

sign and date the sampling forms.

(H) Sample submission. Once you

have collected the samples and

completely filled in the sampling forms,

you must send the samples and the

sampling forms to the laboratory

designated in your instructions.

(6) What additional requirements

must I follow if my system is selected as

an Index system? If your system is

selected as an Index system in the State

Monitoring Plan, you must assist the

State or EPA in identifying appropriate

sampling locations and provide

information on which wells and intakes

are in use at the time of sampling, well

casing and screen depths (if known) for

those wells, and the pumping rate of

each well or intake at the time of

sampling.

(7) What must I do if my system is

selected for the Screening Surveys or

Pre-Screen Testing? (i) Large systems. If

your system serves over 10,000 persons,

you must collect and arrange for testing

of the contaminants in List 2 and List 3

of Table 1, Unregulated Contaminant

Monitoring Regulation (1999) List, in

paragraph (a)(3) of this section, in

accordance with the requirements set

out in paragraphs (a)(4) and (5) of this

section. You must send the samples to

one of the laboratories designated by

EPA in your notification. You must

report the test results to EPA, and

provide a copy to the State, as specified

in 40 CFR 141.35.

(ii) Small systems. If your system

serves 10,000 or fewer persons, you

must collect samples in accordance with

the instructions sent to you by the State

or EPA, or, if informed by the State or

EPA that the State or EPA will collect

the sample, you must assist the State or

EPA in identifying the appropriate

sampling locations and in taking the

samples. EPA will report the test results

to you and the State.

(8) What is a violation of this Rule? (i)

Any failure to monitor in accordance

with § 141.40(a)(3) through (7) and

Appendix A is a monitoring violation.

(ii) Any failure to report in accordance

with § 141.35 is a reporting violation.

(b) Requirements for State and Tribal

Participation. (1) How can I, as the

director of a State or Tribal drinking

water program, participate in

unregulated contaminant monitoring,

including Assessment Monitoring

(which includes the State Monitoring

Plan for small systems), the Screening

Surveys, and Pre-Screen Testing of all

systems? You can enter into a

Memorandum of Agreement (MOA)

with the EPA that describes your State’s

or Tribe’s activities to:

(i) Accept or modify the initial plan.

EPA will first specify the systems

serving 10,000 or fewer persons by

water source and size in an initial State

Monitoring Plan for each State using a

random number generator. EPA will

also generate a replacement list of

systems for systems that may not have

been correctly specified on the initial

plan. This initial State Monitoring Plan

will also indicate the year and day, plus

or minus two (2) weeks from the day,

that each system must monitor for the

contaminants in List 1 of Table 1 of this

section, Unregulated Contaminant

Monitoring Regulation (1999) List. EPA

will provide you with the initial

monitoring plan for your State or Tribe,

including systems to be Index systems

and those systems to be part of the

Screening Surveys. Within sixty (60)

days of receiving your State’s initial

plan, you may notify EPA that you

either accept it as your State Monitoring

Plan or request to modify the initial

plan by removing systems that have

closed, merged or are purchasing water

from another system and replacing them

with other systems. Any purchased

water system associated with a nonpurchased water system must be added

to the State Monitoring Plan if the State

determines that its distribution line is

the location of the maximum residence

time or lowest disinfectant residual of

the combined distribution system. In

this case, the purchased water system

must monitor for the contaminants for

which the ‘‘distribution system’’ is

identified as the point of ‘‘maximum

residence time’’ or ‘‘lowest disinfectant

residual,’’ depending on the

contaminant, and not the community

water system selling water to it. You

must replace any systems you removed

from the initial plan with systems from

the replacement list in the order they

are listed. Your request to modify the

initial plan must include the modified

plan and the reasons for the removal

and replacement of systems. If you

believe that there are reasons other than

those previously listed for removing and

replacing one or more other systems

from the initial plan, you may include

those systems and their replacement

systems in your request to modify the

initial plan. EPA will review your

request to modify your State’s initial

plan. Please note that information about

the actual or potential occurrence or

non-occurrence of contaminants at a

system or a system’s vulnerability to

contamination is not a basis for removal

from or addition to the plan.

(ii) Determine an alternate vulnerable

time. Within 60 days of receiving the

initial State Monitoring Plan, you may

also determine that the most vulnerable

time of the year for any or all of the

systems in the plan, and for any of the

large systems that must monitor, is some

period other than May 1 through July

31. If you make this determination, you

must modify the initial plan to indicate

the alternate vulnerable time and to

which systems the alternate vulnerable

time applies. EPA will review these

determinations when you submit your

request to modify your State’s initial

monitoring plan to the EPA. You must

notify the small system(s) in your final

State Monitoring Plan and the large

system(s) of the most vulnerable time(s)

of the year that you have specified for

them to sample for one of their sampling

events. You must notify them at least 90

days before their first unregulated

contaminant sampling is to occur. You

may need to consider the timing of

monitoring in paragraph (b)(1)(iii) of

this section.

(iii) Modify the timing of monitoring.

Within sixty (60) days of receiving the

initial plan, you may also modify the

plan by selecting an alternative year and

day, plus or minus two (2) weeks,

within the years specified in column 6,

List 1 of Table 1, Unregulated

Contaminant Monitoring Regulation

(1999) List, in paragraph (a)(3) of this

section, for monitoring for each system

in the initial plan as long as

approximately one-third of the systems

in the State Plan monitor in each of the

three (3) years listed. This monitoring

may be coordinated with regulated

contaminant compliance monitoring at

your discretion. You must send the

modified plan to EPA.

(iv) Identify alternate sampling points

for small systems in the State

Monitoring Plan. All systems are

required to monitor for the

contaminants at the sampling locations

specified in column 5, List 1 of Table 1,

Unregulated Contaminant Monitoring

Regulation (1999) List, in paragraph

(a)(3) of this section, unless the State

specifies an alternate compliance

sampling point as the sampling location.
Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations 50619

If the compliance sampling points for

the small systems in the State

Monitoring Plan are different than those

specified in paragraph (a)(3) of this

section, then you must indicate these

sampling points in the plan. These

alternative sampling points must allow

proper sampling and testing for the

unregulated contaminants.

(v) Notify small and large systems of

their monitoring responsibilities. You

must provide notification to systems in

the plan and, where appropriate, the

large systems, at least ninety (90) days

before sampling must occur.

(vi) Provide instructions to systems

that are part of the final State

Monitoring Plan. You must send a

monitoring schedule to each system

listed in the State Monitoring Plan and

instructions on location, frequency,

timing of sampling, use of sampling

equipment, and handling and shipment

of samples based on these regulations.

EPA will provide you with guidance for

these instructions. If you perform the

sampling or make alternative

arrangements for the sampling at the

systems in the plan, you must inform

EPA at least six (6) months before the

first monitoring is to occur and address

the alternative monitoring arrangements

in the MOA.

(vii) Participate in monitoring for the

Screening Surveys for small and large

systems. Within 120 days prior to

sampling, EPA will notify you which

systems have been selected to

participate in the Screening Surveys, the

sampling dates, the designated

laboratory for testing, and instructions

for sampling. You must review the small

systems that EPA selected for the State

Monitoring Plan to ensure that the

systems are not closed, merged or

purchasing water from another system

(unless the system is to conduct

microbiological contaminant

monitoring), and then make any

replacements in the plan, as described

in paragraph (b)(1)(i) of this section.

You must notify the selected systems in

your State of these Screening Surveys

requirements. You must provide the

necessary Screening Surveys

information to the selected systems at

least ninety (90) days prior to the

sampling date.

(viii) Participate in monitoring for

Pre-Screen Testing for small and large

systems. You can participate in PreScreen Testing in two ways.

(A) First, within ninety (90) days of

EPA’s letter to you concerning initiation

of Pre-Screen Testing for specific

contaminants, you can identify from

five (5) up to twenty-five (25) systems in

your State that you determine to be

representative of the most vulnerable

systems to these contaminants, modify

your State Monitoring Plan to include

these most vulnerable systems if any

serve 10,000 or fewer persons, and

notify EPA of the addition of these

systems to the State Plan. These systems

must be selected from all community

and non-transient noncommunity water

systems. EPA will use the Stateidentified vulnerable systems to select

up to 200 systems nationally to be

monitored considering the

characteristics of the contaminants,

precipitation, system operation, and

environmental conditions.

(B) Second, within 120 days prior to

sampling, EPA will notify you which

systems have been selected, sampling

dates, the designated laboratory for

testing of samples for systems serving

10,000 or fewer persons and approved

laboratories for systems serving more

than 10,000 persons, and instructions

for sampling. You must notify the

owners or operators of the selected

systems in your State of these PreScreen Testing requirements. At least

ninety (90) days prior to the sampling

date, you must provide the necessary

Pre-Screen Testing information to the

owners or operators of the selected

systems and then inform EPA that you

took this action to allow sufficient time

for EPA to ensure laboratory readiness.

(ix) Revise system’s treatment plant

location(s) to include latitude and

longitude. For reporting to the Safe

Drinking Water Information System,

EPA already requires reporting of either

the latitude and longitude or the street

address for the treatment plant location.

If the State enters into an MOA, the

State must report each system’s

treatment plant location(s) as latitude

and longitude (in addition to street

address, if previously reported) by the

time of the system’s reporting of

Assessment Monitoring results to the

National Drinking Water Contaminant

Occurrence Database.

(2) What if I decide not to participate

in an MOA? If you decide not to enter

into an MOA with EPA to develop the

State Monitoring Plan for small systems,

the initial monitoring plan that EPA

sent you will become the final State

Monitoring Plan for your State or Tribe.

In that case, you may still notify each

public water system of its selection for

the plan and instructions for monitoring

as long as you notify EPA that you will

be undertaking this responsibility at

least six (6) months prior to the first

unregulated contaminant monitoring.

(3) Can I add contaminants to the

Unregulated Contaminant Monitoring

List? Yes, the SDWA allows Governors

of seven (7) or more States to petition

the EPA Administrator to add one or

more contaminants to the Unregulated

Contaminant Monitoring Regulation

(1999) List, in paragraph (a)(3) of this

section. The petition must clearly

identify the reason(s) for adding the

contaminant(s) to the monitoring list in

paragraph (a)(3) of this section,

including the potential risk to public

health, particularly any information that

might be available regarding

disproportional risks to the health and

safety of children, the expected

occurrence documented by any

available data, any analytical methods

known or proposed to be used to test for

the contaminant(s), and any other

information that could assist the

Administrator in determining which

contaminants present the greatest public

health concern and should, therefore, be

included on the Unregulated

Contaminant Monitoring Regulation

(1999) List, in paragraph (a)(3) of this

section.

(4) Can I waive monitoring

requirements? Only with EPA approval

and under very limited conditions.

Conditions and procedures for obtaining

the only type of waiver available under

these regulations are as follows:

(i) Application. You may apply to

EPA for a State-wide waiver from the

unregulated contaminant monitoring

requirements for public water systems

serving more than 10,000 persons. To

apply for such a waiver, you must

submit an application to EPA that

includes the following information:

(A) the list of contaminants on the

Unregulated Contaminant Monitoring

List for which you request a waiver, and

(B) documentation for each

contaminant in your request

demonstrating that the contaminants

have not been used, applied, stored,

disposed of, released, naturally present

or detected in the source waters or

distribution systems in your State

during the past 15 years, and that it does

not occur naturally in your State.

(ii) Approval. EPA will notify you if

EPA agrees to waive monitoring

requirements.

Appendix A to § 141.40—Quality Control

Requirements for Testing All Samples

Collected

Your system must ensure that the quality

control requirements listed below for testing

of samples collected and submitted under

§ 141.40 are followed:

(1) Sample Collection/Preservation. Follow

the sample collection and preservation

requirements for the specified method for

each of the contaminants in Table 1, UCMR

(1999) List, in paragraph (a)(3) of this section.

These requirements specify sample

containers, collection, dechlorination,

preservation, storage, sample holding time,

and extract storage and/or holding time that

the laboratory must follow.
50620 Federal Register / Vol. 64, No. 180 / Friday, September 17, 1999 /Rules and Regulations

(2) Method Detection Limit. Calculate the

laboratory method detection limit (MDLs) for

each contaminant in Table 1, Unregulated

Contaminant Monitoring Regulation (1999)

List, of paragraph (a)(3) of this section using

the appropriate specified method according

to procedures in 40 CFR Part 136, Appendix

B with the exception that the contaminant

concentration used to fortify reagent water

must be less than or equal to the minimum

reporting level (MRL) for the contaminants as

specified in column 4, Table 1, UCMR (1999)

List, in paragraph (a)(3) of this section. The

calculated MDL is equal to the standard

deviation times the Student’s T value for

99% confidence level with n-1 degrees of

freedom. (The MDL must be less than or

equal to one-half of the MRL.)

(3) Calibration. Follow the initial

calibration requirements as specified in the

method utilized. Calibration must be verified

initially with a low-level standard at a

concentration at or below the MRL for each

contaminant. Perform a continuing

calibration verification following every 10th

sample. The calibration verification must be

performed by alternating low-level and midlevel calibration standards. The low-level

standard is defined as a concentration at or

below the MRL with an acceptance range of

±40%. The mid-level standard is in the

middle of the calibration range with an

acceptance range of ±20%.

(4) Reagent Blank Analysis. Analyze one

laboratory reagent (method) blank per sample

set/batch that is treated exactly as a sample.

The maximum allowable background

concentration is one-half of the MRL for all

contaminants. A field reagent blank is

required only for EPA Method 524.2 (or

equivalent listed methods, D5790.95,

SM6210D, and SM6200B).

(5) Quality Control Sample. Obtain a

quality control sample from an external

source to check laboratory performance at

least once each quarter.

(6) Matrix Spike and Duplicate. Prepare

and analyze the sample matrix spike (SMS)

for accuracy and matrix spike duplicate

(MSD) samples for precision to determine

method accuracy and precision for all

contaminants in Table 1, Unregulated

Contaminant Monitoring Regulation (1999)

List, in paragraph (a)(3) of this section. SMS/

MSD samples must be prepared and analyzed

at a frequency of 5% (or one SMS/MSD set

per every 20 samples) or with each sample

batch whichever is more frequent. In

addition, the SMS/MSD spike concentrations

must be alternated between a low-level spike

and mid-level spike approximately 50% of

the time. (For example: a set of 40 samples

will require preparation and analysis of two

SMS/MSD sets. The first set must be spiked

at either the low-level or mid level, and the

second set must be spiked with the other

standard, either the low-level or mid-level,

whichever was not used for the initial SMS/

MSD set). The low-level SMS/MSD spike

concentration must be within ±20% of the

MRL for each contaminant. The mid-level

SMS/MSD spike concentration must be

within ±20% of the mid-level calibration

standard for each contaminant, and should

represent, where possible, an approximate

average concentration observed in previous

analyses of that analyte. The spiking

concentrations must be reported in the same

units of measure as the analytical results.

(7) Internal Standard Calibration. As

appropriate to a method’s requirements to be

used, test and obtain an internal standard for

the methods for each chemical contaminant

in Table 1, Unregulated Contaminant

Monitoring Regulation (1999) List, in

paragraph (a)(3) of this section, a pure

contaminant of known concentration, for

calibration and quantitation purposes. The

methods specify the percent recovery or

response that you must obtain for acceptance.

(8) Method Performance Test. As

appropriate to a method’s requirements, test

for surrogate compounds, a pure contaminant

unlikely to be found in any sample, to be

used to monitor method performance. The

methods specify the percent recovery that

you must obtain for acceptance.

(9) Detection Confirmation. Confirm any

chemical contaminant detected above the

MRL by gas chromatographic/mass

spectrometric (GC/MS) methods. If testing

resulted in first analyzing the sample extracts

via specified gas chromatographic methods,

an initial confirmation by a second column

dissimilar to the primary column may be

performed. If the contaminant detection is

confirmed by the secondary column, then the

contaminant must be reconfirmed by GC/MS

using three (3) specified ion peaks for

contaminant identification. Use one of the

following confirming techniques: perform

single point calibration of the GC/MS system

for confirmation purposes only as long as the

calibration standard is at a concentration

within ± 50% of the concentration

determined by the initial analysis; or perform

a three (3) point calibration with single point

daily calibration verification of the GC/MS

system regardless of whether that verification

standard concentration is within ± 50% of

sample response. If GC/MS analysis confirms

the initial contaminant detection, report

results determined from the initial analysis.

(10) Reporting. Report the analytical results

and other data, with the required data listed

in 40 CFR 141.35, Table 1. Report this data

electronically to EPA, unless EPA specifies

otherwise, and provide a copy to the State.

Systems must coordinate with their

laboratories for electronic reporting to EPA to

ensure proper formatting and timely data

submission.

PART 142—NATIONAL PRIMARY

DRINKING WATER REGULATIONS

IMPLEMENTATION

1. The authority citation for part 142

continues to read as follows:

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

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

300j–9, and 300j–11.

§ 142.15 [Amended]

2. Section 142.15 is amended by

removing and reserving paragraph (c)(3).

3. Section 142.16 is amended by

revising paragraphs (e) introductory

text, (e)(1) introductory text, and

(e)(1)(i)(C) to read as follows:

§ 142.16 Special primacy requirements.

* * * * *

(e) An application for approval of a

State program revision which adopts the

requirements specified in §§ 141.11,

141.23, 141.24, 141.32, 141.61 and

141.62 must contain the following (in

addition to the general primacy

requirements enumerated elsewhere in

this part, including the requirement that

State regulations be at least as stringent

as the federal requirements):

(1) If a State chooses to issue waivers

from the monitoring requirements in

§§ 141.23 and 141.24, the State shall

describe the procedures and criteria

which it will use to review waiver

applications and issue waiver

determinations.

(i) * * *

(C) The State decision criteria,

including the factors that will be

considered in deciding to grant or deny

waivers. The decision criteria must

include the factors specified in

§§ 141.24(f)(8) and 141.24(h)(6).

* * * * *

[FR Doc. 99–23030 Filed 9–3–99; 12:35 pm]

BILLING CODE 6560–50–P