Thursday,

December 7, 2000

Part II

Environmental

Protection Agency

40 CFR Parts 9, 141, and 142

National Primary Drinking Water

Regulations; Radionuclides; Final Rule

76708 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 9, 141, and 142

[FRL–6909–3]

RIN 2040–AC98

National Primary Drinking Water

Regulations; Radionuclides; Final Rule

AGENCY: Environmental Protection

Agency.

ACTION: Final rule.

SUMMARY: Today, EPA is finalizing

maximum contaminant level goals

(MCLGs), maximum contaminant levels

(MCLs), and monitoring, reporting, and

public notification requirements for

radionuclides. Today’s rule is only

applicable to community water systems.

Today’s rule includes requirements for

uranium, which is not currently

regulated, and revisions to the

monitoring requirements for combined

radium-226 and radium-228, gross alpha

particle radioactivity, and beta particle

and photon radioactivity. Based on an

improved understanding of the risks

associated with radionuclides in

drinking water, the current MCL for

combined radium-226/-228 and the

current MCL for gross alpha particle

radioactivity will be retained. Based on

the need for further evaluation of the

various risk management issues

associated with the MCL for beta

particle and photon radioactivity and

the flexibility to review and modify

standards under the Safe Drinking

Water Act (SDWA), the current MCL for

beta particle and photon radioactivity

will be retained in this final rule, but

will be further reviewed in the near

future.

Some parts of EPA’s 1991 proposal,

including the addition of MCLGs and

the National Primary Drinking Water

Regulation (NPDWR) for uranium, are

required under the SDWA. Other

portions were intended to make the

radionuclides NPDWRs more consistent

with other NPDWRs, e.g., revisions to

monitoring frequencies and the point of

compliance. Lastly, some portions were

contingent upon 1991 risk analyses, e.g.,

MCL revisions to the 1976 MCLs for

combined radium-226 and -228, gross

alpha particle radioactivity, and beta

particle and photon radioactivity. The

portions required under SDWA and the

portions intended to make the

radionuclides NPDWRs more consistent

with other NPDWRs are being finalized

today. The portions contingent upon the

outdated risk analyses supporting the

1991 proposal are not being finalized

today, in part based on updated risk

analyses.

DATES: This regulation is effective

December 8, 2003. The incorporation by

reference of the publications listed in

today’s rule is approved by the Director

of the Federal Register as of December

8, 2003. For judicial review purposes,

this final rule is promulgated as of 1

p.m. Eastern Time on December 7, 2000.

ADDRESSES: The record for this

regulation has been established under

the docket name: National Primary

Drinking Water Regulations for

Radionuclides (W–00–12). The record

includes public comments, applicable

Federal Register notices, other major

supporting documents, and a copy of

the index to the public docket. The

record is available for inspection from 9

a.m. to 4 p.m., Eastern Standard Time,

Monday through Friday, excluding

Federal holidays, at the Water Docket,

401 M Street SW, East Tower Basement

(Room EB 57), Washington, DC 20460.

For access to the Docket materials,

please call (202) 260–3027 to schedule

an appointment.

FOR FURTHER INFORMATION CONTACT: For

technical inquiries, contact David

Huber, Standards and Risk Management

Division, Office of Ground Water and

Drinking Water, EPA (MC–4607), 1200

Pennsylvania Avenue, NW.,

Washington, DC 20460; telephone (202)

260–9566. For general inquiries, the

Safe Drinking Water Hotline is open

Monday through Friday, excluding

Federal holidays, from 9:00 a.m. to 5:30

p.m. Eastern Standard Time. The Safe

Drinking Water Hotline toll free number

is (800) 426–4791.

SUPPLEMENTARY INFORMATION:

Regulated Entities

Entities potentially regulated by this

rule are public water systems that are

classified as community water systems

(CWSs). Community water systems

provide water for human consumption

through pipes or other constructed

conveyances to at least 15 service

connections or serve an average of at

least 25 people year-round. Regulated

categories and entities include:

Category Examples of

regulated entities

Industry ..................... Privately-owned community water systems.

State, Tribal, Local,

and Federal Governments.

Publicly-owned community water systems.

This table is not intended to be

exhaustive, but rather, provides a guide

for readers regarding entities likely to be

regulated by this action. Other types of

entities not listed in the table could also

be regulated. To determine whether

your facility is regulated by this action,

you should carefully examine the

applicability criteria in

§§ 141.26(a)(1)(i), 141.26(a)(1)(ii),

141.26(b)(1), and 141.26(b)(2) of this

rule. 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.

Abbreviations and Acronyms Used in

This Document

ASTM: American Society for Testing and

Materials

AWWA: American Water Works Association

BAT: Best available treatment

BEIR: Biological effects of ionizing radiation

CFR: Code of Federal Regulations

CWS: Community water systems

EDE: Effective dose equivalent

EML: Environmental Measurements

Laboratory

FR: Federal Register

ICRP: International Commission on

Radiological Protection

IE: Ion exchange

kg: Kilogram

L/day: Liter per day

LET: Low energy transfer

LOAEL: Lowest observed adverse effect level

MCL: Maximum contaminant level

MCLG: Maximum contaminant level goal

mg/L: Milligram per liter

μg/L: Microgram per liter

mGy: MilliGray

mrem: Millirem

mrem/yr: Millirem per year

NBS: National Bureau of Standards

NDWAC: National Drinking Water Advisory

Committee

NIRS: National Inorganic and Radionuclide

Survey

NIST: National Institute of Standards and

Technology

NODA: Notice of Data Availability

NPDWRs: National Primary Drinking Water

Regulations

NRC: National Research Council

NTIS: National Technical Information

Service

NTNC: Non-transient, non-community

NTNCWS: Non-transient, non-community

water systems

pCi: Picocurie

pCi/L: Picocurie per liter

PE: Performance evaluation

PNR: Public Notification Rule

POE: Point-of-entry

POU: Point-of-use

PQL: Practical quantitation level

PT: Performance testing

RADRISK: A computer code for radiation risk

estimation

RfD: Reference dose

RO: Reverse osmosis

SM: Standard methods

SMF: Standardized monitoring framework

SSCTL: ‘‘Small Systems Compliance

Technology List’’

SWTR: Surface Water Treatment Rule

TAW: Technical Advisory Workgroup

UCMR: Unregulated Contaminant Monitoring

Rule

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76709

UNSCEAR: United Nations Scientific

Committee on the Effects of Atomic

Radiation

USDOE: United States Department of Energy

USEPA: United States Environmental

Protection Agency

USGS: United States Geological Survey

Table of Contents

I. Background and Summary of the Final

Rule

A. What did EPA propose in 1991?

B. Why did EPA propose changes to the

radionuclides drinking water regulations

in 1991?

C. What new information has become

available since 1991? Overview of the

2000 Notice of Data Availability (NODA).

D. What are the rationales for the

regulatory decisions being promulgated

today?

1. Retaining the Combined Radium-226

and Radium-228 MCL

a. Major Comments Regarding Retention of

the Combined Radium-226 and Radium228 MCL

2. The Final Uranium MCL

a. What is the final MCL for uranium and

the rationale for that regulatory level?

b. MCLG and Feasible Level for Uranium

c. Basis for 1991 Proposed MCL and Cancer

Risk from Uranium

d. Uranium Health Effects: Kidney Toxicity

e. New Kidney Toxicity Analyses

Announced in the NODA

f. Costs and Benefits from Regulating

Uranium in Drinking Water

g. Administrator’s Decision to Promulgate

MCL Higher than Feasible Level

h. California Drinking Water Regulation

i. Summary of Major Comments on the

Uranium Options

(1) Costs and Benefits of Uranium MCLs of

20, 40, and 80 μg/L or pCi/L

(2) The Calculation of the Safe Level for

Uranium in Water

(3) Compliance Options for Small Systems

for an MCL of 20 μg/L or pCi/L

(4) The Use of a Dual Standard for

Uranium

3. Retaining Beta Particle and Photon

Radioactivity MCL

a. Summary of Major Comments Regarding

the Decision to Retain the Current Beta

Particle and Photon Radioactivity MCL

4. Retaining the Current Gross Alpha

Particle Activity MCL

a. Summary of Major Comments Regarding

the Decision to Retain the Current

Definition of the (Adjusted) Gross Alpha

Particle Activity MCL

5. Further Study of Radium-224

a. Summary of Major Comments on

Radium-224

(1) The Use of a Short Gross Alpha Particle

Activity Sample Holding Time to

Measure Radium-224

(2) The Need to Regulate Radium-224

6. Entry Point Monitoring and the

Standardized Monitoring Framework

7. Separate Monitoring for Radium-228 and

Change to Systems Required to Monitor

for Beta Particle and Photon

Radioactivity

8. Future Actions Regarding the Regulation

of Radionuclides at Non-Transient NonCommunity Water Systems

a. Summary of Major Comments on

NTNCWSs and EPA Responses

E. What are the health effects that may

result from exposure to radionuclides in

drinking water?

1. Major Comments

a. Linear Non-threshold Model

b. Radium Carcinogenicity Threshold

c. ‘‘Beneficial Effects’’ of Radiation

F. Does this regulation apply to my water

system?

G. What are the final drinking water

regulatory standards for radionuclides

(Maximum Contaminant Level Goals and

Maximum Contaminant Levels)?

H. What are the best available technologies

(BATs) for removing radionuclides from

drinking water?

I. What analytical methods are approved

for compliance monitoring of

radionuclides?

1. Major Comments

a. Request for ICP-MS Method for Uranium

b. Detection Limit for Uranium

J. Where and how often must a water

system test for radionuclides?

1. Monitoring frequency for gross alpha,

radium 226, radium 228, and uranium:

2. Monitoring frequency for beta particle

and photon radioactivity:

3. Sampling points and data grandfathering

4. Does the rule allow compositing of

samples?

5. Interpretation of Analytical Results

K. Can my water system use point-of-use

(POU), point-of-entry (POE), or bottled

water to comply with this regulation?

L. What do I need to tell my customers?

1. Consumer Confidence Reports

2. Public Notification

M. Can my water system get a variance or

an exemption from an MCL under

today’s rule?

N. How were stakeholders involved in the

development of this rule?

O. What financial assistance is available for

complying with this rule?

P. How are the radionuclides MCLs used

under the Comprehensive Environmental

Response, Compensation, and Liability

Act (CERCLA)?

Q. What is the effective date and

compliance date for the rule?

R. Has EPA considered laboratory

approval/certification and laboratory

capacity?

1. Laboratory Approval/Certification

2. Laboratory Capacity: Laboratory

Certification and PT Studies

3. Summary of Major Comments Regarding

Laboratory Capacity and EPA Responses

a. Laboratory Certification, Availability of

PT Samples and Costs of PT Samples:

b. Laboratory Capacity:

II. Statutory Authority and Regulatory

Background

A. What is the legal authority for setting

National Primary Drinking Water

Regulations (NPDWRs)?

B. Is EPA required to finalize the 1991

radionuclides proposal?

III. Rule Implementation

A. What are the requirements for primacy?

B. What are the special primacy

requirements?

C. What are the requirements for record

keeping?

D. What are the requirements for reporting?

E. When does a State have to apply for

primacy?

F. What are Tribes required to do under

this regulation?

IV. Economic Analyses

A. Estimates of Costs and Benefits for

Community Water Systems

B. Background

1. Overview of the 1991 Economic

Analysis

2. Summary of the Current Estimates of

Risk Reductions, Benefits, and Costs

3. Uncertainties in the Estimates of

Benefits and Cost

a. Uncertainties in Risk Reduction and

Benefits Estimates

b. Uncertainty in Compliance Cost

Estimates

4. Major Comments

a. Retention of radium-226/-228 MCL of 5

pCi/L

b. Cost/Benefit Analysis Requirements

c. Cumulative Affordability

d. Disposal costs

e. Discounting of Costs and Benefits

f. Use of MCLs for Ground Water

Protection Needs to be Evaluated as Part

of this Rulemaking

V. Other Required Analyses and

Consultations

A. Regulatory Flexibility Act (RFA)

B. Paperwork Reduction Act

C. Unfunded Mandates Reform Act

1. Summary of UMRA Requirements

D. National Technology Transfer and

Advancement Act

E. Executive Order 12866: Regulatory

Planning and Review

F. Executive Order 12898: Environmental

Justice

G. Executive Order 13045: Protection of

Children from Environmental Health

Risks and Safety Risks

H. Executive Order 13084: Consultation

and Coordination with Indian Tribal

Governments

I. Executive Order 13132

J. Consultation with the Science Advisory

Board and the National Drinking Water

Advisory Council

K. Congressional Review Act

I. Background and Summary of the

Final Rule

A. What Did EPA Propose in 1991?

In 1991, EPA proposed a number of

changes and additions to the

radionuclides NPDWRs. Among other

things, EPA proposed to:

• Set a maximum contaminant level

goal (MCLG) of zero for all

radionuclides.

• Set a maximum contaminant level

(MCL) of 20 μg/L or 30 pCi/L for

uranium (with options of 5 pCi/L to 80

μg/L).

• Change the radium standard from a

combined limit for radium-226 and 228

of 5 pCi/L to separate standards at 20

pCi/L.

• Remove radium-226 from the

radionuclides included in the definition

76710 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

1The 1991 cancer risk estimates were based on

the now-outdated RADRISK model (see the NODA

and its Technical Support Document, USEPA 2000e

and h).

of gross alpha, while keeping the gross

alpha MCL at 15 pCi/L, since the

proposed radium-226 MCL was greater

than the gross alpha MCL.

• Change dose limit from critical

organ dose (millirems) to ‘‘weighted

whole body dose’’ (millirems-effective

dose equivalent).

• Require community water systems

which are determined by the State to be

vulnerable or contaminated to monitor

for beta particle and photon

radioactivity, rather than at all surface

water systems serving a population over

100,000 people (as under the current

1976 rule).

• Establish a monitoring framework

more in line with the standardized

monitoring framework used for other

contaminants.

• Exclude compositing for beta

particle and photon emitters.

• Include non-transient, noncommunity water systems (NTNCWSs)

in the regulation.

• Require that each entry point to the

distribution system be monitored to

ensure that each household in the

system received water protective at the

MCL.

B. Why Did EPA Propose Changes to the

Radionuclides Drinking Water

Regulations in 1991?

In 1976, National Interim Primary

Drinking Water Regulations were

promulgated for radium-226 and -228,

gross alpha particle radioactivity and

beta particle and photon radioactivity.

The health risk basis for the 1976

radionuclides MCLs was described in

the recent radionuclides Notice of Data

Availability (NODA), (65 FR 21575,

April 21, 2000). The 1986

reauthorization of the Safe Drinking

Water Act (SDWA) required EPA to

promulgate MCLGs and National

Primary Drinking Water Regulations

(NPDWRs) for the above radionuclides,

radon and uranium. Also in 1986, EPA

published an Advance Notice of

Proposed Rulemaking for the

radionuclides NPDWRs (EPA 1986),

which stated EPA’s intent to accomplish

this goal. In 1991, EPA proposed

changes to the current radionuclides

standards and new standards for radon

and uranium. EPA determined that both

combined radium-226 and -228 and

uranium could be analytically

quantified and treated to 5 pCi/L.

However, EPA concluded that, given the

much greater cost-effectiveness of

reducing risk through radon water

treatment relative to radium and

uranium, the feasible levels were 20

pCi/L each for radium-226 and -228 and

20 μg/L (or 30 pCi/L) for uranium.

Between 1986 and 1991, EPA made risk

estimates based on then-current models

and information, as described in the

NODA (EPA 2000e) and its Technical

Support Document (USEPA 2000h). The

1991 risk estimates 1 indicated that the

proposed MCL changes would result in

lifetime cancer risks within the risk

range of 10¥6 and 10¥4 (one in one

million to one in ten thousand) that EPA

considers in establishing NPDWRs. The

1991 proposed uranium MCL was based

on both kidney toxicity risk and cancer

risk. All MCLGs for radionuclides were

proposed as zero pCi/L, based on a

linear no-threshold cancer risk model

for ionizing radiation. A summary of the

difference between the 1976 rule and

the 1991 proposal are presented in

Table I–1. The detailed differences

between the 1976 rule and the 1991

proposal can be found in the record for

this rulemaking (EPA 1976; 1986; 1991;

2000a).

TABLE I–1.—COMPARISON OF THE 1976 RULE, 1991 PROPOSAL, AND 2000 FINAL RULE

Provision 1976 rule (current rule) 1991 proposal 2000 final rule

Affected Systems .... CWS ..................................................... CWS + NTNC ....................................... CSW.

MCLG for all radionuclides.No MCLG ............................................. MCLG of zero ....................................... MCLG of zero.

Radium MCL ........... Combined Ra-226 + Ra-228 MCL of

5pCi/L.

Ra-226 MCL of 20 pCi/L ......................

Ra-228 MCL of 20 pCi/L

Maintain current MCL based on the

newly estimated risk level associated with the 1991 proposed MCL.

Beta/Photon Radioactivity MCL.• ≤ 4 mrem/y to the total body or any

given internal organ

• Except for H-3 and Sr-90, derived

radionucide-specific activity concentrations yielding 4 mrem/y based

on NSB Handbood 69 and 2L/d

• H-3 = 20,000 pCi/L; Sr-90 = 8 pCi/L

• Total dose from co-occurring beta/

photon emitters must be ≤ 4 mrem/y

to the total body of any internal

organ

• 4 mrem/y effective dose equivalent

(ede)

• Re-derived radionuclide-specific activity concentrations yielding 4

mrem/y ede based on EPA

RADRISK code and 2 L/d

• Total dose from co-occurring beta/

photon emitters must be < 4 mrem/y

ede

Maintain current MCL based on the

newly estimated risk level associated with the 1991 proposed MCL.

This MCL will be reviewed within 2

to 3 years based on a need for further re-evaluation of risk management issues.

Gross alpha MCL .... 15 pCi/L excluding U and Rn, but including Ra-226.‘‘Adjusted’’ gross aplha MCL of 15 pCi/

L, excluding Ra-226, radon, and uranium.

Maintain current MCL based on the

newly estimated risk level associated with the 1991 proposed MCL.

Polonium-210 .......... Included in gross alpha ........................ Included in gross alpha ........................ Included under gross alpha, as in current rule. Monitoring required under

the UCMR rule. Further action may

be proposed at a later date.

Lead-210 ................. Not Regulated ...................................... Included in beta particle and photon

radioactivity; concentration limit proposed at 1 pCi/L.

No changes to current rule. Monitoring

required under the UCMR rule. Further action may be proposed at a

later date.

Uranium MCL .......... Not Regulated ...................................... 20 g/L or 30 pCi/L w/ option for 5 pCi/

L–80 g/L.

30 μ/L.

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76711

TABLE I–1.—COMPARISON OF THE 1976 RULE, 1991 PROPOSAL, AND 2000 FINAL RULE—Continued

Provision 1976 rule (current rule) 1991 proposal 2000 final rule

Ra-224 .................... Part of gross alpha, but sample holding time too long to capture Ra-224.Part of gross alpha, but sample holding time too long to capture Ra-224.No changes to current gross alpha

rule. Will collect national occurrence

information; further action may be

proposed at a later date.

Radium monitoring .. Ra-226 linked to Ra-228; measure Ra228 if Ra-226 > 3 pCi/L and sum.Measure Ra-226 and -228 separately Measure Ra-226 and -228 separately.

Monitoring baseline 4 quarterly measurements. ..................

Monitoring reduction based on results:

> 50% of MCL required 4 samples

every 4 yrs; < 50% of MCL reguired

1 sample every 4 yrs

Annual samples for 3 years; Std Monitoring Framework: > 50% of MCL required 1 sample every 3 years; <

50% of MCL enabled system to

apply for waiver to 1 sample every 9

years.

Implement Std Monitoring Framework

as proposed in 1991. Four initial

consecutive quarterly samples in

first cycle. If initial average level >

50% of MCL: 1 sample every 3

years; < 50% of MCL: 1 sample

every 6 years; Non-detect: 1 sample

every 9 years. (beta particle and

photon radioactivity has a unique

schedule—see section III, part—K)

States will have discretion in data

grandfathering for establishing initial

monitoring baseline.

Beta particle and

photon emitters

monitoring.

Surface water systems > 100,000 population Screen at 50 pCi/L/; vulnerable systems screen at 15 pCi/L.Ground and surface water systems

within 15 miles of source screen at

30 or 50 pCi/K.

CWSs determined to be vulnerable by

the State screen at 50 pCi/L.

Gross alpha monitoring.Analyze up to one year later ................ Six month holding time for gross alpha

samples; Annual compositing of

samples allowed.

As proposed in 1991.

Analytical Methods .. Provide methods .................................. Method updates proposed in 1991;

Current methods were updated in

1997.

Current methods with clarifications.

C. What New Information Has Become

Available Since 1991? Overview of the

2000 Notice of Data Availability

(NODA)

EPA published a Notice of Data

Availability (NODA) on April 21, 2000.

This NODA described the new

information that has become available

since the 1991 proposal and the basis

for today’s final regulatory decisions.

The most significant source of new

information is Federal Guidance Report13 (FGR–13) (USEPA 1999b), ‘‘Cancer

Risk Coefficients for Environmental

Exposure to Radionuclides,’’ which

provides the numerical factors used in

estimating cancer risks from low-level

exposures to radionuclides. The risk

coefficients in FGR–13 are based on

state-of-the-art methods and models and

are a significant improvement over the

risk coefficients that supported the 1991

radionuclides proposal. FGR–13 is the

latest report in a series of Federal

guidance documents that are intended

to provide Federal and State agencies

technical information to assist their

implementation of radiation protection

programs. FGR–13 was formally

reviewed by EPA’s Science Advisory

Board and was peer-reviewed by

academic and government radiation

experts. An interim version of the report

was published for public comment in

January of 1998. Comments were

provided by Federal Agencies,

including the Nuclear Regulatory

Commission and the Department of

Energy, State Agencies, and the public.

The final version (September 1999)

reflects consideration of all of these

comments. The risk analyses supporting

today’s regulatory decisions are

described in detail in the NODA (EPA

2000e) and its Technical Support

Document (USEPA 2000h).

The NODA also reported the results

from a June 1998 USEPA workshop held

to discuss non-cancer toxicity issues

associated with exposure to uranium

from drinking water. At this workshop,

a panel of experts reviewed and

evaluated new information regarding

kidney toxicity was examined. The

findings from this workshop can be

found in the NODA’s Technical Support

Document (USEPA 2000h).

Other important new information

includes the results from a 1998 U.S.

Geological Survey study which targeted

the occurrence of radium-224 and beta

particle/photon radioactivity (USEPA

2000e and h). Previously, it was

assumed that the alpha-emitting

radium-224 isotope rarely occurred in

drinking water. If present in drinking

water, because of its short half-life (3.6

days) and estimated low occurrence, it

was thought that sufficient time would

elapse to allow the isotope to decay to

low levels before entry into the

distribution system. Hence, radium-224

was not thought to appreciably occur in

drinking water. This new information

indicates that radium-224 significantly

(positively) correlates with both radium228 (correlation coefficient of 0.82) and

radium-226 (correlation coefficient of

0.69), suggesting that radium-224

should be evaluated as a potential

drinking water contaminant of national

concern (USEPA 2000h). The impact of

this and other information on decisions

regarding radium-224 is discussed in

part D of this section. In addition to the

radium-224 occurrence information, the

USGS study also determined that the

majority of the beta particle/photon

radioactivity in the samples collected

was due to the presence of radium-228

and potassium-40, both naturally

occurring contaminants. Since radium228 is regulated under the combined

radium-226/-228 standard and

potassium-40 is not regulated, this

suggests that most situations in which

the beta/photon screening level is

exceeded will not result in MCL

violations. Of more concern, minor

contributions from naturally occurring

lead-210 were also reported. Lead-210

occurrence will be studied under the

Unregulated Contaminant Monitoring

Rule (UCMR).

In addition to this new technical

information, the NODA also described

the 1996 changes to the statutory

framework for setting drinking water

NPDWRs. The SDWA, as amended in

1996, requires EPA to review and revise,

76712 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

2The actual relationship between mass

concentration (μg/L) and activity (pCi/L) varies

somewhat in drinking water sources, since the

relative amounts of the radioactive isotopes that

make up naturally occurring uranium (U–238, U–

235, and U–234) vary between drinking water

sources. The typical conversion factors that are

observed in drinking water range from 0.67 up to

1.5 pCi/μg.

as appropriate, each national drinking

water regulation at least once every six

years. The Act also requires that any

revision to an NPDWR ‘‘maintain, or

provide for greater, protection of the

health of persons’’ (section 1412(b)(9)).

Regarding the setting of new

NPDWRs, the SDWA as amended in

1996 gives EPA the flexibility to set an

MCL at a level less stringent than the

feasible level, if the Administrator

determines that the benefits do not

justify the costs at the feasible level. If

the Administrator makes this finding,

the Act directs EPA to set the MCL at

a level that ‘‘maximizes health risk

reduction benefits at a cost that is

justified by the benefits’’ (section

1412(b)(6)). This provision applies to

uranium only, since it is the only

contaminant for which a new MCL is

being established by today’s regulatory

action.

D. What Are the Rationales for the

Regulatory Decisions Being Promulgated

Today?

As previously discussed, EPA is

retaining the current MCLs for

combined radium-226 and 228, gross

alpha particle radioactivity, and beta

particle and photon radioactivity and is

promulgating a new standard for

uranium. The following is a discussion

of the rationales supporting these

decisions. In addition to the responses

to major comments in the following

section, responses to each individual

comment are in the comment response

document which is available for review

in the docket for this final rule.

1. Retaining the Combined Radium-226

and Radium-228 MCL

The 1991 proposed changes to the

MCLs for combined radium-226 and

radium-228 were premised on a costeffectiveness trade-off between radium

mitigation and radon mitigation (a

radon standard was also included in the

1991 proposal). This cost-effectiveness

argument was used to support a

proposal to raise the combined radium226/-228 MCL of 5 pCi/L to individual

MCLs of 20 pCi/L for each isotope. At

the time, it was thought that the risks

associated with 20 pCi/L of radium-226

and radium-228 were within the 10¥6 to

10¥4 risk range. However, current risk

analyses based on Federal Guidance

Report-13 (see Part C of this section)

indicate that these higher MCLs have

associated risks that are well above the

10¥6 to 10¥4 risk range. For details on

the basis and findings of this risk

analysis, see the NODA (USEPA 2000e)

and its Technical Support Document

(USEPA 2000h). Since this proposed

change would introduce higher risks

than envisioned in the original 1976

rule, approaching lifetime cancer risks

of one in one thousand (10¥3) for

occurrence at or near the 1991 proposed

MCLs, EPA believes that its decision to

retain the current combined radium226/-228 MCL of 5 pCi/L is justified.

Under the 1996 Amendments to the Safe

Drinking Water Act, EPA is required to

ensure that any revision to a drinking

water regulation maintains or provides

for greater protection of the health of

persons (section 1412(b)(9)).

a. Major Comments Regarding Retention

of the Combined Radium-226 and

Radium-228 MCL

The major comments and responses

concerning the retention of the

combined radium-226 and radium-228

MCL are summarized in part E of this

section (‘‘What are the health effects

that may result from exposure to

radionuclides in drinking water?’’).

2. The Final Uranium MCL

a. What Is the Final MCL for Uranium

and the Rationale for That Regulatory

Level?

With today’s rule, EPA is

promulgating a uranium MCL of 30 μg/

L. The SDWA generally requires that

EPA set the MCL for each contaminant

as close as feasible to the MCLG, based

on available technology and taking costs

to large systems into account. The 1996

amendments to the SDWA added the

requirement that the Administrator

determine whether or not the

quantifiable and non-quantifiable

benefits of an MCL justify the

quantifiable and non-quantifiable costs

based on the Health Risk Reduction and

Cost Analysis (HRRCA) required under

section 1412(b)(3)(C). The 1996 SDWA

amendments also provided new

discretionary authority for the

Administrator to set an MCL that is less

stringent than the feasible level if the

benefits of an MCL set at the feasible

level would not justify the costs (section

1412(b)(6)). This final rule establishing

an MCL for uranium of 30 μg/L is the

first time EPA has invoked this new

authority.

In conducting this analysis, EPA

considered all available scientific

information concerning the health

effects of uranium, including various

uncertainties in the interpretation of the

results, as well as all costs and benefits,

both quantifiable and non-quantifiable.

As discussed in more detail below, all

health endpoints of concern were

considered in this analysis. For some of

these, the risk can currently be

quantified (i.e., expressed in numerical

terms); and for some, it cannot.

Similarly, there are a variety of health

and other benefits attributable to

reductions in levels of uranium in

drinking water, some of which can be

monetized (i.e., expressed in monetary

terms) and others that cannot yet be

monetized. All were considered in this

analysis. A detailed discussion of each

of the principal factors considered

follows.

b. MCLG and Feasible Level for

Uranium

Since uranium is radioactive and EPA

uses a non-threshold linear risk model

for ionizing radiation, today’s rule sets

the MCLG (non-enforceable healthbased goal) for this contaminant at zero.

The Safe Drinking Water Act requires

EPA to set the MCL as close to the

MCLG as is feasible, where this is

defined as ‘‘feasible with the use of the

best technology, treatment techniques

and other means which the

Administrator finds, after examination

for efficacy under field conditions and

not solely under laboratory conditions,

are available (taking cost into

consideration) * * * ’’ [section

1412(b)(4)(D)]. EPA proposed a feasible

level of 20 μg/L in its 1991 proposal. In

doing so, EPA determined that uranium

may be treatable and quantifiable at

levels below 20 μg/L, however, levels

below 20 μg/L were not considered

feasible under the Safe Drinking Water

Act. EPA believes the feasible level is

still 20 μg/L.

c. Basis for 1991 Proposed MCL and

Cancer Risk from Uranium

EPA is required by the Safe Drinking

Water Act (section 1412(b)(2)) to

regulate uranium in drinking water. In

1991, EPA proposed a uranium MCL of

20 μg/L (‘‘mass concentration’’) based

on health effects endpoints of kidney

toxicity and carcinogenicity. In the

proposal, EPA estimated that 20 μg/L

would typically 2 correspond to 30 pCi/

L (‘‘activity’’), based on an assumed

mass:activity ratio of 1.5 pCi/μg. While

such values are known to occur in

ground water, this conversion factor

does not reflect our ‘‘best estimate’’

today. The best estimate of a geometric

average mass:activity ratio is 0.9 pCi/μg

for values near the MCL, based on data

from the National Inorganics and

Radionuclides Survey (see USEPA

2000h). Given the closeness of this

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76713

3This is mentioned since, for the sake of

simplicity, the reader may thus easily convert

between μg/L and pCi/L. However, in current

calculations, we use the geometric mean from the

NIRS data, which is 0.9 pCi/μg. We reiterate that

conversion factors ranging from 0.67 up to 1.5 pCi/

μg do occur in drinking water sources.

4The drinking water equivalent level (DWEL) (μg/

L) is the best estimate of the drinking water

concentration that results in the Reference Dose (μg/

kg/day), assuming a water ingestion rate of 2 L/day

and a body mass of 70 kg.

5The standard assumptions for the DWEL are

conservative, since the ingestion rate is at the 90th

percentile, while the body mass is more typical.

Conservative assumptions are used to ensure that

the resulting exposure level is protective of

individuals that consume significantly more water

than typical and children (low body masses).

value to unity (1 pCi/μg), the available

data suggests that, to a first

approximation 3, the mass:activity ratio

is 1:1 for typical systems. The 1991

proposed MCL of 20 μg/L was

determined, at that time, to correspond

to a ‘‘drinking water equivalent level’’

(DWEL 4) with respect to kidney toxicity

for a lifetime exposure. The

corresponding 30 pCi/L level (based on

the 1991 mass to activity conversion)

was estimated to have a lifetime cancer

risk of slightly below the 10¥4 level.

Because the kidney toxicity health

effects and the corresponding nonquantifiable kidney toxicity benefits are

a very important consideration in

setting the MCL, we first provide

background on these effects before

discussing the rationale for setting the

uranium MCL.

d. Uranium Health Effects: Kidney

Toxicity

Each kidney consists of over a million

nephrons, the filtration functional units

of the kidney. The nephron consists of

glomeruli, which filter the blood, and

renal tubules (proximal, distal,

collecting duct, etc.), which collect the

fluid that passes through the glomeruli

(the ‘‘filtrate’’). After the filtrate flows

into renal tubules, glucose, proteins,

sodium, water, amino acids, and other

essential substances are reabsorbed,

while wastes and some fraction of

electrolytes are left behind for later

excretion. The efficiency of this process

can be monitored by analyzing urine

(‘‘urinalysis’’), which reveals the

concentrations of the various

constituents making up the urine. For

example, protein or albumin in the

urine (proteinuria or albuminuria)

indicates reabsorption deficiency or

leakage of albumin, a class of proteins

found in blood and which are

responsible for maintaining fluid

balance between blood and body cells.

In the case of uranium toxicity, it is not

clear whether long-term exposure may

lead to marked albumin loss.

The level of proteinuria in urine is an

indication of the degree of kidney

toxicity: levels are divided into ‘‘trace’’,

‘‘mild’’, ‘‘moderate’’, or ‘‘marked’’,

which are defined by increasing levels

of proteinuria. Increased excretion of

protein in the urine could be the result

of tubular damage, inflammation, or

increased glomerular permeability. It

should be noted that a gradual loss of

nephrons is asymptomatic until the loss

is well advanced; the kidneys normally

have the ability to compensate for

nephron-loss. For example, chronic

renal failure occurs when there is

around 60% nephron loss. During the

gradual loss of functioning nephrons,

the remaining nephrons appear to adapt,

increasing their capacity for filtration,

reabsorption, and excretion.

Uranium has been identified as a

nephrotoxic metal (kidney toxicant),

exerting its toxic effects by chemical

action mostly in the proximal tubules in

humans and animals. However,

uranium is a less potent nephrotoxin

than the classical nephrotoxic metals

such as cadmium, lead, and mercury.

Uranium has an affinity for renal

proximal tubular cells and interferes

with reabsorption of proteins, as

previously described. Specifically,

uranium-induced renal tubular

dysfunction in humans is marked by

mild proteinuria, due to reduced

reabsorption in the proximal renal

tubules. Furthermore, the pathogenesis

of the kidney damage in short-term

animal studies indicates that

regeneration of the tubular cells may

occur upon discontinuation of exposure

to uranium. We do not know if

uranium-induced proteinuria is an

indicator of the beginning of an adverse

effect or whether it is a reversible effect

that does not typically result in kidney

disease. Based on the uncertainty

involved in the ultimate effects, the

scientists at our experts workshop

(discussed next) treated this effect as an

indicator of an incipient change in

kidney function that may lead

ultimately to frank adverse effects such

as breakdown of kidney tubular

function. For general information on

proteinuria, kidney function, and

kidney disease, see the fact sheets at

‘‘http://www.niddk.nih.gov/health/

kidney/pubs/ proteinuria/

proteinuria.htm’’, ‘‘http://

www.niddk.nih.gov/health/kidney/

pubs/yourkids/index.htm’’, and ‘‘http://

www.niddk.nih.gov/health/kidney/

kidney.htm’’ (NIH 2000a, NIH 2000b,

and NIH 2000c).

e. New Kidney Toxicity Analyses

Announced in the NODA

Since the 1991 radionuclides

proposal, EPA has re-evaluated the

available kidney toxicity data and,

based on the results of an experts

workshop (see the NODA, USEPA

2000e, for details), has estimated the

DWEL to be 20 μg/L. The DWEL is

derived from the Reference Dose (RfD),

which is an estimate of a daily ingestion

exposure to the population, including

sensitive subgroups, that is likely to be

without an appreciable risk of

deleterious effects during a lifetime. The

RfD (in μg of uranium per kg of body

mass per day; μg/kg/day) for uranium

was calculated from the Lowest

Observed Adverse Effects Level

(‘‘LOAEL’’), which is the lowest level at

which adverse effects were observed to

occur. The LOAEL is taken directly from

health effects data. The RfD is

calculated by dividing the LOAEL by a

numerical uncertainty factor which

accounts for areas of variability in

human populations because of

uncertainty in the uranium health

database. EPA followed the

recommended methodology of the

National Academy of Sciences in

estimating the uncertainty factor.

As described in the NODA, we

reported that our best-estimate of the

LOAEL is 60 μg/kg/day, based on rat

data. In support of this estimate of the

DWEL, EPA has some human data

which demonstrates that mild

proteinuria has been observed at

drinking water levels between 20 and

100 μg/L. In estimating the RfD, we have

used an uncertainty factor of 100

(rounded from the product of 3 for intraspecies variability, 10 for inter-species

variability, and 3 for the use of a

LOAEL). Using this uncertainty factor,

the RfD is calculated to be 0.6 μg/kg/

day. The estimated uncertainty in the

RfD spans an order of magnitude (a

factor of ten). The 20 μg/L DWEL is

calculated by using this RfD and

assuming that an adult with a body

mass of 70 kilograms drinks 2 liters of

water per day 5 and that 80% of

exposure to uranium is from water.

These calculations are described in

more detail in the NODA’s Technical

Support Document (USEPA 2000h).

The Agency believes that 30 μg/L is

protective against kidney toxicity. While

20 μg/L is the Agency’s best estimate of

the DWEL, there are several reasons, in

the Agency’s judgment, that

demonstrate that there is not a

predictable difference in health effects

due to exposure between the DWEL of

20 μg/L and a level of 30 μg/L. For

instance, variability in the normal range

for proteinuria in humans is very large

and there is additional variability in

proteinuria levels observed at uranium

76714 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

6Not incremental net benefits, but net benefits:

‘‘Benefits for an MCL in isolation’’—‘‘Cost of an

MCL in isolation’’.

7Annual net benefits for an MCL of 20 μg/L = $4

million—$93 million, which rounds to negative $90

million; annual net benefits for an MCL of 30 μg/

L = $3 million—$54 million, which rounds to

negative $50 million. See Table IV–1, ‘‘Summary of

Costs and Benefits for Community Water Systems

Predicted to Be Impacted by the Regulatory Options

Being Considered for Finalization’’, in today’s

notice and the supporting Economic Analysis

(USEPA 2000g) for more details.

exposures large enough to induce the

effect. In the existing few epidemiology

studies, each of which are based on

small study populations, there were

some persons exposed to over five times

the DWEL of 20 μg/L without the

observation of effects more serious than

mild proteinuria (within the high end of

the normal range). An MCL of 30 μg/L

represents a relatively small increase

over the DWEL compared to the over-all

uncertainty in the RfD and the

uncertainty in the importance of the

mild proteinuria observed for uranium

exposures from high drinking water

levels (keeping in mind that, as

discussed previously, the DWEL is

based on the RfD and is an estimate of

a no effect level for a population). While

it is assumed that risk of an effect (here

a mild effect) increases as exposure

increases over the RfD, it is not known

at what exposure an effect is likely.

Given that the uncertainty factor of 100

provides a relatively wide margin of

safety, the likelihood of any significant

effect in the population at 30 μg/L is

very small. EPA, thus, believes that the

difference in kidney toxicity risk for

exposures at 20 μg/L versus 30 μg/L is

insignificant.

f. Costs and Benefits From Regulating

Uranium in Drinking Water

As discussed in the NODA, EPA has

estimated the risk reductions,

monetized benefits, and costs associated

with compliance with an MCL of 20 μg/

L, 40 μg/L, and 80 μg/L. In the NODA,

EPA solicited comment on using its

statutory authority provided in section

1412(b)(6) of the Safe Drinking Water

Act to set the uranium MCL at a level

higher than the proposed level of 20 μg/

L, based on its analysis of costs and

benefits.

The monetized costs and benefits

associated with various MCL options are

discussed further in section IV of

today’s notice and in more detail in the

economic analysis support document

(USEPA 2000g). Table I–2 shows

incremental annual cancer risk

reductions, total national annual

compliance costs and monetized

benefits (excluding kidney toxicity

benefits), and the numbers of

community water systems predicted to

have MCL violations for MCLs of 80, 30,

and 20 μg/L (assuming the 0.9 pCi/μg

conversion factor for estimating cancer

risk reductions and benefits). Keeping in

mind that the monetized benefits and

risk reductions exclude kidney toxicity

benefits, several things can be noted

from the analysis. Focusing on the MCL

change from 30 μg/L to 20 μg/L (see

lower part of table I–2), one can see that

the incremental benefits for

implementing an MCL of 30 μg/L are

three times greater than the incremental

benefits for a lower MCL of 20 μg/L,

while the incremental annual costs are

much closer in magnitude ($54 million

vs. $39 million). In terms of incremental

cancer cases avoided, the estimated

number of cancer cases avoided for an

MCL of 30 μg/L is 0.8 annually, while

lowering the MCL to 20 μg/L would

result in an additional 0.2 cases avoided

annually (25% reduction) at an

additional cost of $39 million annually

(75% increase). Approximately 37% of

systems predicted to have MCL

violations occur between 30 μg/L and 20

μg/L, resulting in significant increases

in annual compliance costs (42% of

national compliance costs occur

between 30 μg/L and 20 μg/L), while the

number of cancer cases avoided

increases much less significantly (only

20% of cancer risk reduction occurs

between 30 μg/L and 20 μg/L).

Since the kidney benefits are not

quantified, this is an incomplete

picture, but EPA believes that the

uncertainties in the analysis of health

effects are such that it is not known

whether the risk of mild proteinuria are

appreciably different between 20 μg/L

and 30 μg/L. Assuming that there is a

risk increase, it would be expected to be

negligible compared to the risk increase

that occurs between the highest

uranium levels that occur in drinking

water (i.e., approximately 200 μg/L) and

an MCL of 30 μg/L. Considering only

cancer risk reduction benefits, the

annual net benefits 6 for a uranium MCL

of 20 μg/L are negative $90 million 7 and

for an MCL of 30 μg/L are negative $50

million. Since the cancer risk reduction

net benefits are higher at 30 μg/L than

at 20 μg/L and the non-quantified

kidney toxicity benefits are expected to

be substantially the same at 20 μg/L and

30 μg/L, EPA believes an MCL of 30 μg/

L maximizes the benefits at a cost

justified by the benefits. EPA does not

believe that uranium levels above 30 μg/

L are protective of kidney toxicity with

an acceptable margin of safety. (EPA

believes that the margin of safety

associated with a 30 μg/L are

comparable with those at 20 μg/L.)

Further, EPA believes that the net

kidney toxicity benefits of an MCL

greater than 30 μg/L would be less than

those at 30 μg/L. Finally, EPA believes

that 30 μg/L is protective of the general

population, including children and the

elderly.

TABLE I–2.—INCREMENTAL COSTS AND BENEFITS FOR URANIUM MCLS OF 80 μG/L, 30 μG/L, AND 20 μG/L

Uranium MCL Exposure

change

Incremental

annual cancer

cases avoided

Incremental

annual

compliance

costs

(in millions)

Incremental

annual monetized

cancer benefits

(kidney benefits not

monetized)

(in millions)

Incremental

number of

community water

systems

impacted

80 μg/L ............................................................ ∞–80 μg/L 0.5 $16 $2 100

30 μg/L ............................................................ 80–30 μg/L 0.4 38 1 400

20 μg/L ............................................................ 30–20 μg/L 0.2 39 1 290

Incremental Costs and Benefits for Uranium MCLs of 30 μg/L (μg/L) and 20 μg/L only

30 μg/L ............................................................ ∞–30 μg/L 0.8 54 3 500

20 μg/L ............................................................ 30–20 μg/L 0.2 39 1 290

Note: Numbers are rounded, so numbers resulting from addition and subtraction of the numbers shown may appear to yield incongruous results. However, the numbers shown are calculated using more significant figures and rounded after, which is the appropriate approach for numbers with large uncertainties.

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76715

g. Administrator’s Decision To

Promulgate MCL Higher Than Feasible

Level

Based on the relatively modest annual

cancer risk reductions and the expected

modest kidney toxicity risk reductions

between 30 μg/L and 20 μg/L (see Table

I–2) and the high annual compliance

costs for an MCL of 20 μg/L, the

Administrator has determined that the

benefits do not justify the costs at the

feasible level. Furthermore, as

previously described, the Administrator

has determined that an MCL of 30 μg/

L maximizes the health risk reduction

benefits at a cost justified by the

benefits. In summary, this finding is

based on the fact that potential uranium

MCLs lower than 30 μg/L have

substantially higher associated

compliance costs and only modest

additional cancer risk reduction and

kidney toxicity benefits. EPA has not

selected a higher MCL for several

reasons. Higher uranium MCLs would

still incur implementation and

monitoring costs, with benefits greatly

diminished because uranium does not

occur significantly at levels much

higher than 30 μg/L. Additionally, EPA

believes that a uranium MCL of 30 μg/

L is appropriate since it is protective of

kidney toxicity and cancer with an

adequate margin of safety. We do not

believe that MCL options higher than 30

μg/L afford a sufficient measure of

protection against kidney toxicity.

Assuming a conversion factor of 0.9

pCi/μg, an MCL of 30 μg/L will typically

correspond to 27 pCi/L, which has a

lifetime radiogenic cancer risk of

slightly less than one in ten thousand,

within the Agency’s target risk range of

one in one million to one in ten

thousand. EPA is aware that

circumstances may exist in which more

extreme conversion factors (> 1.5 pCi/

μg) apply. EPA does not have extensive

data on these ratios at local levels, but

believes these higher ratios to be rare. In

these rare circumstances, uranium

activities in drinking water may exceed

40 pCi/L. Although these concentrations

are still within EPA’s target risk ceiling

of 1×10¥4, EPA recommends that

drinking water systems subject to

extreme pCi/μg conversion factors

mitigate uranium levels to 30 pCi/L or

less, to provide greater assurance that

adequate protection from cancer health

effects is being afforded.

In today’s final rule, the

Administrator is exercising her

authority to set an MCL at a level higher

than feasible (section 1412(b)(6)), based

on the finding that benefits do not

justify the costs at the feasible level (20

μg/L) and that the net benefits are

maximized at a level (30 μg/L) that is

still protective of kidney toxicity and

carcinogenicity with an adequate

margin of safety. EPA believes that there

are considerable non-quantifiable

benefits associated with ensuring that

kidney toxicity risks are minimized and

has weighed these non-quantifiable

benefits in its decision to exercise its

discretionary authority under SDWA

section 1412(b)(6).

In invoking the discretionary

authority of section 1412(b)(6) to set an

MCL level higher than feasible, the

Agency is in compliance with the

provisions of section 1412(b)(6)(B). This

provision provides that the judgment

with respect to when benefits of the

regulation would justify the costs under

subparagraph (6)(A) is to be made based

on assessment of costs and benefits

experienced by persons served by large

systems and those other systems

unlikely to receive small system

variances (e.g. systems serving up to

10,000 persons). In effect, the costs to

systems likely to receive a small system

variance are not to be considered in

judging the point at which benefits

justify costs. Subparagraph (6)(B) also

provides, however, that this adjusted

assessment does not apply in the case of

a contaminant found ‘‘almost

exclusively’’ in ‘‘small systems eligible’’

for a small system variance. Because the

contaminants addressed in today’s rule

are found almost exclusively in small

systems and because the Agency has

identified affordable treatment

technologies for small systems that

would need to comply with today’s rule

(i.e., we do not contemplate granting

small system variances), the Agency has

not adjusted the proposed MCL

pursuant to subparagraph (B).

h. California Drinking Water Regulation

Approximately one-third of the

community water systems that are

expected to be impacted by the uranium

MCL are located in California. Thus,

current and likely future practices of

these systems is of particular interest.

The State of California currently has a

drinking water standard for uranium of

20 pCi/L (enforced as 35 μg/L), which it

adopted in 1989. EPA has used

comments and information from the

State of California in considering its

MCL for uranium. The California

standard is based on the California

Department of Health Services’ 1989

estimate of the DWEL for kidney

toxicity, 35 μg/L. While California has

recently proposed revising its nonenforceable public health goal for

uranium in drinking water, it is not

currently known what the final estimate

will be. In response to the NODA,

representatives of the California

Department of Health Services

commented that at uranium levels of 35

μg/L, most of its small water systems

were able to use alternate sources of

water (new wells) as a means of

complying with the standard, but that

20 μg/L would lead to many of these

small systems having to install

treatment, which, because of waste

disposal issues (i.e., inability to safely

dispose of hazardous radioactive

wastes), could lead to a significant

number of small systems being unable

to come into compliance through

treatment. EPA believes that these

comments lend support to the choice of

an MCL of 30 μg/L as being both

protective of kidney toxicity and a

standard that allows for significant use

of non-treatment options by small

systems, reducing the need for dealing

with radioactive waste handling and

disposal.

i. Summary of Major Comments on the

Uranium Options

(1) Costs and Benefits of Uranium

MCLs of 20, 40, and 80 μg/L or pCi/L:

Most commenters stated that the

benefits of an MCL of 20 μg/L or pCi/

L did not justify the costs and suggested

that EPA should exercise its authority

under SDWA section 1412(b)(6) to set

an MCL higher than the feasible level.

As discussed previously in this section,

EPA agrees that the benefits of an MCL

at 20 μg/L do not justify the costs and

has exercised its SDWA authority by

setting the uranium MCL at a level of 30

μg/L, a level at which EPA believes the

benefits do justify the costs.

(2) The Calculation of the Safe Level

for Uranium in Water: One commenter

suggested that the use of 70 kg as the

reference body mass with a ‘‘90th

percentile ingestion rate’’ of 2 L/day

will lead to a kidney toxicity DWEL that

is more protective than the 90th

percentile. EPA agrees that it is possible

that 20 μg/L is more protective than the

90th percentile value for the general

population. EPA has performed a

preliminary Monte Carlo analysis of the

safe level that replaces point estimates

for consumption rate and body mass

with distributions based on the

available data. Based on this analysis

the 90th percentile (for the general

population) equivalent level could be as

high as 30 μg/L.

(3) Compliance Options for Small

Systems for an MCL of 20 μg/L or pCi/

L: Several commenters stated that an

MCL of 20 μg/L or pCi/L would force

small systems to install water treatment,

rather than allowing other compliance

options like installing new wells or

blending water. The commenters

76716 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

8 4 mrem ede with a look-up table of

concentrations different from those calculated using

the current MCL and the methodology incorporated

by reference in the current rule.

9Six Year Review Process—Under the Safe

Drinking Water Act (SDWA), the U.S.

Environmental Protection Agency (EPA) must

periodically review existing National Primary

Drinking Water Regulations (NPDWRs) and, if

appropriate, revise them. This requirement is

contained in section 1412(b)(9) of SDWA, as

amended in 1996, which reads, ‘‘The Administrator

shall, not less often than every 6 years, review and

revise, as appropriate, each national primary

drinking water regulation promulgated under this

title. Any revision of a national primary drinking

water regulation shall be promulgated in

accordance with this section, except that each

revision shall maintain, or provide for greater,

protection of the health of persons.’’

suggested that an MCL of 20 μg/L or

pCi/L would pose a significant hardship

on small systems with little benefit,

including significant costs and technical

problems associated with waste

disposal. Commenters also suggested

that a higher MCL would allow a larger

fraction of small systems to use

compliance options other than

treatment, most notably, new well

installation. EPA agrees that a lower

MCL does decrease the probability that

some non-treatment options could be

used, including new well installation

and blending. EPA agrees that the

benefits of the MCL of 20 μg/L or pCi/

L do not justify the costs and thus has

chosen a higher MCL. EPA also believes

that an MCL of 30 μg/L should allow a

greater fraction of small systems to use

non-treatment options for compliance,

avoiding waste disposal issues and

excessive treatment costs.

(4) The Use of a Dual Standard for

Uranium: Commenters suggested that

the use of a dual standard for uranium

to ensure protectiveness of both kidney

toxicity and carcinogenicity, i.e., one in

μg/L and one in pCi/L, would be

unnecessarily complicated, since it

would require that both uranium

isotopic analyses and mass analyses be

performed by each water system. EPA

agrees that a dual standard would be

unnecessarily complicated and has

chosen a single standard expressed in

μg/L that is protective of both kidney

toxicity and carcinogenicity.

3. Retaining Beta Particle and Photon

Radioactivity MCL

With today’s rule, EPA is retaining the

existing MCL for beta and photon

emitters and the methodology for

deriving concentration limits for

individual beta and photon emitters that

is incorporated by reference. The

concentrations for these contaminants

were derived from a dosimetry model

used at the time the rule was originally

promulgated in 1976. When these risks

are calculated in accordance with the

latest dosimetry models described in

Federal Guidance Report 13, the risks

associated with these concentrations,

while varying considerably, generally

fall within the Agency’s current risk

target range for drinking water

contaminants of 10¥4 to 10¥6.

Accordingly, we are not changing the

MCL for beta particle and photon

radioactivity at this time.

We also are concerned that under the

regulatory changes for the beta particle

and photon radioactivity MCL proposed

in 1991 8) the concentrations of many

individual radionuclides have

associated lifetime cancer morbidity

(and mortality) risks that exceed the

Agency’s target risk range. A newly

proposed MCL expressed in mrem-ede

could result in a more consistent risk

level within the Agency’s target risk

range. However, in today’s final rule, we

are ratifying the current standard since

it is protective of public health. At the

same time, we believe a near future

review of the beta particle and photon

radioactivity MCL and the methods for

calculating individual radionuclide

concentration limits is appropriate. We

intend to reevaluate the MCL under the

authority of section 1412(b)(9) of the

SDWA to ensure that the MCL reflects

the best available science. This review

will be performed as expeditiously as

possible (expected to be 2 to 3 years).

Particular questions that we believe

warrant examination as part of such a

reevaluation process would include, but

are not limited to, the following:

• What additional beta and photon

emitters should be regulated?

• What is the appropriate aggregate

MCL expression for this category of

radionuclides?

• What new information concerning

occurrence, analytical methods, health

effects, treatment, costs, and benefits

would have a bearing on this

reevaluation?

• Is there an advantage to setting

individual radionuclide concentration

limits using a ‘‘uniform risk level

MCL’’?

• If the basis of the current MCL

changes, is there an advantage to and

legal basis for setting concentration

limits for individual beta particle and

photon emitters within a guidance

document that can be readily updated as

scientific understanding improves?

• To what degree, in keeping with the

provisions of sections 1412(b)(9) and

1412(b)(3)(A), can the existing

methodology for calculating the

concentration limits of individual beta

and photon emitters be adjusted in

accordance with the best available

scientific models and information and

still meet the requirement that revised

regulations provide ‘‘greater or

equivalent protection to the health of

persons’’?

• How would any adjustments be

reconciled with the requirement that

MCLs be set ‘‘as close as feasible’’ to

MCLGs?

Finally, we note that there should be

no assumption, from the outset of this

reevaluation, that the process will

necessarily lead to a different set of

individual beta and photon emitter

concentration limits than those that

result from the methodology

incorporated by reference in the current

and final rule. This reevaluation will

involve a complicated set of legal,

regulatory, and technical information

that will need to be carefully

considered.

a. Summary of Major Comments

Regarding the Decision To Retain the

Current Beta Particle and Photon

Radioactivity MCL

Of the 70 commenters who responded

to the April 21, 2000 NODA,

approximately 14 commented on the

MCL for beta particle and photon

radioactivity. The commenters

represented Federal agencies, State

governments, local governments, water

utilities, water associations, nuclear

institute representatives and public

interest groups. Seven commenters

support EPA’s proposal to retain the

current MCL and several of these

commenters agreed that it was

appropriate to review the standard

under the six year review process 9. The

commenters that supported EPA’s

proposal to maintain this MCL felt there

was no appreciable occurrence of manmade beta emitters in drinking water, so

it was not a pressing public health

concern to revise the MCL. Several of

these commenters also felt it was

appropriate to delay action on lead-210

until more occurrence information

becomes available.

Three of the 14 commenters objected

to EPA’s proposal to retain the current

standard and to defer re-evaluation to

the statutorily required six year process.

These commenters felt that the Agency

should propose to update the models

used as the basis for the MCL on a

shorter time-frame than the six year

review process. The commenters felt

that deferring the reevaluation of beta/

photons to the six year review process

would increase and perpetuate the

uncertainty involved with standards

which are used in waste management

and cleanup decisions. One commenter

pointed out that most DOE sites with

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76717

radiological contamination are moving

towards the final Record of Decision

(ROD) stage (as required as part of site

clean-up under the Superfund Program).

The commenter felt that delaying the reevaluation of this MCL until the next six

year review process (2002–2008) would

occur after most RODs were already in

place and it would be too late to

incorporate a new MCL into the RODs.

The commenter further stated that some

ROD commitments will be using clean

up standards based on the 1976 values

and if the standards are eventually

relaxed, the committed RODs (which

were based on the 1976 values) will be

extremely expensive and may not be

justifiable. EPA agrees that review of the

MCL for beta particle and photon

radioactivity is a priority and, as

previously discussed in this section, the

Agency intends to review this standard

within the general time frame

established for the U.S. Department of

Energy’s (DOE) submission of the

licensing application for the Yucca

Mountain site.

4. Retaining the Current Gross Alpha

Particle Activity MCL

In 1991, EPA proposed excluding

radium-226 from adjusted gross alpha

particle activity, which is currently

defined as the gross alpha particle

activity result minus the contributions

from uranium and radon (in practice, it

is not necessary to exclude radon, since

it volatilizes before analysis). The 1991

proposal to increase the combined

radium-226/-228 MCL from 5 pCi/L

combined to 20 pCi/L each made the

adjusted gross alpha definition

necessary, since the radium-226 MCL

exceeded the adjusted gross alpha

particle activity MCL. Besides

addressing this inconsistency, at the

time EPA believed that the unit risk

from radium-226 was small enough that

the change in the definition of adjusted

gross alpha particle activity would not

result in a significant change in health

protectiveness. As discussed in the

NODA, the 1991 risk analysis was based

on the EPA RADRISK model, which is

now outdated.

The most current risk analyses are

based on FGR–13, discussed previously

in today’s preamble and in detail in the

NODA and its Technical Support

Document. These new radionuclide

cancer risk coefficients greatly improved

health effects analyses indicate that the

unit risk from radium-226 is too

significant to exclude radium-226 from

adjusted gross alpha particle activity

without an appreciable loss in health

protectiveness. For this reason, today’s

rule does not change the definition of

adjusted gross alpha from the current

rule.

Also, as discussed in the NODA,

further occurrence data will be collected

for polonium-210 and radium-224

(discussed in more detail next) and,

based on findings, EPA may propose in

the future to address these and/or other

contaminants that contribute to gross

alpha particle activity through changes

to the definition of adjusted gross alpha

particle activity. Regardless of the

findings concerning polonium-210 and

radium-224 occurrence, the gross alpha

particle activity standard will be

reviewed under the required six year

regulatory review process.

a. Summary of Major Comments

Regarding the Decision to Retain the

Current Definition of the (Adjusted)

Gross Alpha Particle Activity MCL

Of the 70 commenters who responded

to the April 21, 2000 NODA,

approximately 23 commented on issues

regarding the gross alpha particle

activity MCL and/or whether or not to

regulate polonium-210 and/or radium224 separately. The summary of the

comments regarding radium-224 is

discussed further in the next section.

The commenters represented State

governments, local governments, water

associations, water utilities, associations

of elected officials and public interest

groups. Of these 23 commenters, 14

stated that EPA should not regulate

polonium-210 and/or radium-224

separately. Some commenters felt either

the occurrence of these radionuclides is

rare in water supplies or they felt that

not enough occurrence data was

available to warrant separate limits. EPA

agrees that occurrence information

should be collected before proposing

separate standards. Commenters felt that

occurrence information should be

gathered under an unregulated

contaminant monitoring mechanism,

which EPA is doing in the case of

polonium-210. Only one commenter

supported an immediate separate

standard for polonium-210 and quick

gross alpha particle activity analysis to

ensure that radium-224 was included in

gross alpha particle activity

measurement. EPA points out that a

proposal would be necessary for such

actions and that a proposal would

require adequate occurrence

information. Of those commenters who

commented on retaining the current

definition of the gross alpha particle

activity MCL, including radium-226,

most supported retaining the standard

as is. However, three commenters stated

that radium-226 should not be included

in the gross alpha particle activity MCL,

since it is already regulated in the

combined radium-226/-228 standard.

EPA points out that the contribution

from radium-226 to the over-all risk

from gross alpha particle activity is

significant and that removing it would

reduce the health protectiveness of the

gross alpha particle activity standard.

Also, two commenters felt that gross

alpha particle activity should only be

used as a screening tool (versus a

standard) since the commonly occurring

alpha emitting radionuclides are already

covered under other standards. EPA

points out polonium-210 is not

regulated under any other standard at

this time. The gross alpha particle

activity standard will be reviewed under

six year review and these and other

considerations will be taken into

account.

5. Further Study of Radium-224

As discussed in section I.C., recent

studies show that there is a positive

correlation between radium-228 and

radium-224 (correlation coefficient of

0.82, approximately 1:1). This

correlation means that in most

situations in which a system has high

radium-224 levels, it will also have high

radium-228 levels and, with a less

degree of certainty, high radium-226

levels. More details on this relationship,

including the summary statistics, can be

found in the NODA and its Technical

Support Document (USEPA 2000e and

2000h). The expected result of these

correlations is that high radium-224

levels will be mitigated by enforcement

of the combined radium-226/-228 MCL,

keeping in mind that treatment for

radium does not differentiate between

the different isotopes. Since radium-228

is estimated to be eight times more

radiotoxic than radium-224, it appears

that radium-224 may not be a pressing

public health concern compared to the

co-occurring regulated contaminant

radium-228. The Agency plans to collect

additional national occurrence

information for radium-224, which may

involve coordination with the USGS,

and will evaluate whether future

regulatory action or guidance is

necessary. Radium-224 occurrence data

collection activities are not as high a

priority as addressing other

radionuclide commitments such as the

review of the beta particle and photon

radioactivity MCL.

For several reasons, a change in the

gross alpha particle activity holding

time has been determined to be an

inappropriate regulatory solution. First,

the uncertainty in the national

occurrence data does not allow EPA to

determine the number of systems out of

compliance with the gross alpha particle

activity standard due to radium-224 if a

76718 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

48–72 hour holding time is required.

Since this change may result in a

significant number of systems out of

compliance with the current gross alpha

particle activity MCL, EPA would need

to issue a proposed amendment before

making such a change. Such a proposal

would require national level occurrence

data for radium-224 in drinking water.

Since EPA’s next course of action is to

collect such data to determine if a

proposal is needed, EPA believes that

this course of action is the appropriate

one.

a. Summary of Major Comments on

Radium-224

(1) The Use of a Short Gross Alpha

Particle Activity Sample Holding Time

to Measure Radium-224: Several

commenters stated that the use of a

short gross alpha sample holding time to

measure radium-224 would raise

technical difficulties and would be

costly. Several commenters stated that

there was not enough information to

warrant a change to the gross alpha

holding time or to regulate radium-224

separately. EPA agrees with this

comment and, as stated in the Notice of

Data Availability (NODA; USEPA

2000e), will not change the gross alpha

holding time or regulate radium-224

separately in today’s final rule. Some

commenters stated that it would not be

appropriate to change the holding time

or to issue a separate standard in the

final rule without a proposal. This is in

agreement with what the Agency stated

in the NODA.

(2) The Need to Regulate Radium-224:

One commenter suggested that the

radium-224 cancer mortality risk

coefficient from Federal Guidance

Report-13 (FGR–13) warranted a health

concern and warranted regulating

radium-224. While EPA agrees that

radium-224 is a health concern, the

radium-224 cancer mortality unit risk is

eight times less than the radium-228

cancer mortality unit risk. In other

words, it would take 40 pCi/L of

radium-224 to present an equal cancer

mortality risk as 5 pCi/L of radium-228.

Since the correlation between radium224 and radium-228 is approximately

one-to-one (1:1) in the areas known to

be of concern, one would typically

expect to find 5 pCi/L of radium-224

associated with 5 pCi/L of radium-228.

Since radium-226 and radium-228 also

significantly co-occur, EPA believes that

in most situations in which radium-224

occurs it would be present at levels

lower than 5 pCi/L for systems in

compliance with the combined radium226/-228 standard. Table I–3 shows the

predicted increase in risk for water

systems in areas in which radium-224 is

known to co-occur with radium-228,

assuming a 1:1 correlation. This table

shows that the presence of radium-224

increases the over-all combined radium

risk by 5%–13%, depending on the

relative contributions of radium-226 to

radium-228 to the MCL of 5 pCi/L. EPA

believes that this situation indicates that

radium-224 may be of concern in some

areas, but also believes that collecting

data to determine if radium-224 is of

national concern is the appropriate next

step for determining if radium-224

should be regulated separately.

TABLE 1–3.—TYPICAL INCREASE IN COMBINED RADIUM RISK DUE TO PRESENCE OF RA-224 FOR WATER SYSTEMS WITH

COMBINED RA-226/-228 LEVELS OF 5 PCI/L, ASSUMING A 1:1 CORRELATION OF RA-224 AND RA-228

Ra–226 (pCi/L) Ra–228 (pCi/L) Ra–224 (pCi/L) Percent increase in risk due to

presence of Ra–224

5 0 0 0%

4 1 1 5%

3 2 2 8%

2 3 3 10%

1 4 4 12%

0 5 5 13%

6. Entry Point Monitoring and the

Standardized Monitoring Framework

The changes to the existing

distribution system-based monitoring

scheme proposed in 1991 are

promulgated in today’s final rule. New

monitoring must be performed at entry

points to the distribution system, which

is meant to ensure that all customers are

protected by the radionuclides

NPDWRs. The 1976 monitoring scheme

ensured that ‘‘average customers’’ were

protected, but did not ensure that all

customers were served by water at or

below the MCL for the various

radionuclides.

While EPA is finalizing a change to

the point of compliance from a

representative distribution system

sampling point to all points of entry to

the distribution system, EPA realizes

that unless data grandfathering is

allowed, many systems will have to reestablish monitoring baselines that have

been established for many years. The

‘‘monitoring baseline’’ refers to the

average contaminant level analytical

result that is used for determining the

future monitoring frequency. For this

reason, EPA is allowing primacy entities

(States, Tribes, and other) the option of

developing data grandfathering plans

that are suited to their individual

situations (e.g., occurrence patterns,

water system configurations, and other

factors) as a part of their primacy

packages. This situation will allow

primacy entities flexibility to

grandfather historical data for

determining future monitoring

frequencies, while allowing EPA

oversight of the process to ensure that

the goal of having each entry point in

compliance with the MCLs is met. Since

future monitoring will be conducted at

each entry point, this approach will

ensure that compliance is achieved at

every entry point.

The new requirements for uranium

and radium-228 will mean that initial

monitoring baselines for determining

future monitoring frequencies will need

to be established. Only community

water systems that have gross alpha

particle activity screening levels greater

that 15 pCi/L will be required to

monitor for uranium. Thus, many

systems will be able to use historical

gross alpha data to determine future

monitoring frequency under the

uranium standard. And, since the

current monitoring requirements for

gross alpha particle activity already

require systems with gross alpha

particle activity levels greater than 15

pCi/L to quantify uranium levels (to

subtract out the uranium contribution to

the gross alpha particle activity), EPA

expects that many of these water

systems will also be able to grandfather

historical uranium data. Given this

situation, EPA does not expect uranium

monitoring requirements to be overly

burdensome to community water

systems or drinking water programs.

Community water systems without

historical radium-228 data (expected to

be those with gross alpha particle

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76719

activity levels less than 5 pCi/L and

radium-226 levels less than 3 pCi/L)

will need to establish an initial

monitoring baseline to determine future

monitoring frequency. Four consecutive

quarterly samples will be required to

establish this baseline. However, States

and Tribes may waive the last two

quarterly samples and determine the

initial monitoring baseline on the first

two samples if the results for the first

two samples are below the detection

limit (1 pCi/L), which would be

considered a non-detect and would be

reported as ‘‘zero’’ (this discussion

assumes that radium-226 levels are also

non-detects and are reported as zero).

Systems with non-detects for radium228 and radium-226 would have to

monitor once every nine years after the

initial monitoring period. Other

monitoring requirements are discussed

in section I.J.

7. Separate Monitoring for Radium-228

and Change to Systems Required To

Monitor for Beta Particle and Photon

Radioactivity

Separate monitoring for radium-228,

proposed in 1991, is promulgated in

today’s rule. The need for separate

monitoring of radium-228 is supported

by the occurrence studies supporting

the 1991 proposal and new occurrence

studies (USEPA 2000e and i), which

indicate that the 1976 radium-228

screens are not robust. Since the unit

risks for radium-228 are higher than for

radium-226 (described in the NODA and

its Technical Support Document,

USEPA 2000e and h), EPA believes that

separate monitoring for radium-228, as

proposed in 1991, is essential to

enforcing the combined radium-226/-

228 standard.

In addition, today’s rule eliminates

the previous requirement that all surface

water systems serving more than

100,000 persons must monitor for beta

particles and photon radioactivity. Beta

particle and photon radioactivity

monitoring will be performed only by

community water systems designated by

the State as ‘‘vulnerable’’ or

‘‘contaminated’’. In 1976, the Agency

was concerned about nuclear fallout

contaminating surface water sources.

The Agency anticipated that large

surface water systems (i.e. systems

serving greater than 100,000 persons)

would be vulnerable to becoming

contaminated by nuclear testing

activities. Therefore, the radionuclides

regulation required all surface water

systems serving more than 100,000

persons and any other systems

determined by the State to be vulnerable

to monitor for beta and photon emitters.

Since that time above-ground testing

of nuclear weapons has been banned,

and sources of man-made radiation are

not expected, thus, large surface water

systems are not automatically

vulnerable to beta and photon emitters.

As a result, the Agency has reevaluated

the 1975 approach, and in today’s rule,

as proposed in 1991, is removing the

requirement for all large surface water

systems to monitor for beta and photon

emitters, unless they have been

designated as vulnerable by the State.

The Agency believes that States are in

the best position to determine which

systems are vulnerable to beta and

photon emitters. The EPA is also

encouraging States to reevaluate a

system’s vulnerability to beta photon

emitters when conducting source water

assessments and provide immediate

notification to those systems that have

been deemed vulnerable.

8. Future Actions Regarding the

Regulation of Radionuclides at NonTransient Non-Community Water

Systems

EPA will not regulate NTNC water

systems with today’s rule, but may

propose to do so in the future. As

described in the NODA (USEPA 2000e),

EPA considered regulating non-transient

non-community (NTNC) water systems

for today’s final rule, as proposed in

1991. The NODA also described EPA’s

analysis of the risks faced by customers

of NTNC water systems, potential risk

reductions, and compliance costs. EPA

stated that several options were being

considered for finalization: (1) Not

regulating NTNC water systems; (2)

regulating all NTNC water systems

under the same requirements faced by

CWSs; (3) regulating targeted NTNC

water systems, based on occurrence

potential, typical lengths of exposure,

the age distribution of typical

customers, and other factors; (4) issuing

guidance recommending that States

require that targeted NTNC systems

monitor, and in some cases, mitigate to

acceptable levels.

EPA’s rationale for not regulating

NTNC water systems at this time is

based upon consideration of several

factors. EPA summarized the results of

a conservative Monte Carlo analysis of

risks at NTNC water systems in the

NODA and discussed the analysis in

more detail in its Technical Support

Document (USEPA 2000h). After

evaluating the available information and

the various comments on the NODA,

EPA does not believe that exposure to

radionuclides by consumers of water

from NTNC systems poses an

unacceptable health risk. This

conclusion is based on consideration of

the total pattern of exposure of

individuals, considering their

consumption of both NTNC water and

water from other types of water systems.

However, EPA’s information for these

radionuclides is limited and will be the

subject of additional future analyses and

reevaluation, together with any new

data that can be obtained.

In the immediate future and in

consultation with the National Drinking

Water Advisory Committee (NDWAC),

EPA will further evaluate various

approaches to regulating NTNCs

generally (including radionuclides).

This further analysis will involve

examination of additional data and

information and will include further

analysis of a full range of possible

options. In this evaluation, EPA will

consider risk analyses for adults and

children, occurrence patterns, the

national distribution of NTNC water

systems, and other factors. In

determining the appropriate action, EPA

will consider the issue of consistency

between the various regulations for

chronic contaminants applicable to

NTNC water systems, including future

rules.

a. Summary of Major Comments on

NTNCWSs and EPA Responses

Of the 70 commenters who responded

to the April 21, 2000 NODA,

approximately 31 commented on the

issue of NTNC water systems and the

options presented in the NODA. About

75 percent of these 31 commenters

oppose regulation of NTNC water

systems. While several of the

commenters felt that EPA should only

require targeted monitoring, many

commenters felt that monitoring of

NTNC water systems should be left to

the discretion of the States. A few

commenters felt that EPA should treat

NTNC water systems like CWSs and

require regulation and some

commenters felt partial coverage of

targeted NTNC water systems would be

appropriate.

Those opposed to the regulation of

NTNC water systems felt the cost/

benefit and risk analyses presented in

the NODA did not support a

requirement to regulate. Some of those

opposed to regulating NTNC water

systems believe EPA needs to gather

more information about the occurrence

of radionuclides, the amount and

percentage of water consumed, and the

duration of exposure at NTNC water

systems. Many commenters felt that

EPA should allow States the flexibility

or discretion to determine whether or

not to regulate NTNC water systems and

leave it to the States to target specific

NTNC water systems. Some commenters

76720 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

suggested that EPA issue guidance that

recommends targeted NTNC water

systems monitor and meet the CWS

MCLs. In addition, some commenters

stated that EPA should be consistent in

all their rules when considering

whether or not to regulate NTNC water

systems. EPA believes that all of these

comments have merit and that the

regulation of radionuclides at NTNC

water systems deserves further

evaluation along with an analysis of

additional data and information. If EPA

proposes to regulate NTNC water

systems in the future, stakeholders will

have future opportunity to comment.

Regarding State discretion, States may at

any time choose to regulate NTNC water

systems, either under a targeted rule or

otherwise.

E. What Are the Health Effects That May

Result From Exposure to Radionuclides

in Drinking Water?

Radioactive drinking water

contaminants differ from one another in

ways that determine their harmfulness.

Each radionuclide has a particular halflife and emits characteristic forms of

radiation (alpha particles, beta particles,

and/or photons). A radionuclide’s halflife and concentration determine its

radioactivity, i.e., the number of

radioactive ‘‘decay events’’ that occur in

a particular unit of time. These factors,

concentration, half-life, form of

radioactive decay, and radiation energy,

all determine a particular radionuclide’s

potential for impacting human health.

For a discussion of half-life and the

different forms of radioactive decay, see

Appendix I (‘‘Fundamentals of

Radioactivity in Drinking Water’’) to the

Radionuclides NODA’s Technical

Support Document (USEPA 2000h).

The potential for harmful health

effects from exposure to radioactive

compounds results from the ability of

ionizing radiation to chemically change

the molecules that make-up biological

tissues (e.g., stomach, liver, lung)

through a process called ‘‘ionization.’’

The radiation (alpha and beta particles

and photons) emitted by radionuclides

is called ‘‘ionizing radiation’’ because

the radiation has sufficient energy to

strip electrons from nearby atoms as

they travel through a cell or other

material. Ionization may result in

significant chemical changes to

biologically important molecules. For

example, ionizing radiation can damage

important molecules like DNA. DNA is

the elementary building block for genes

and the chemical that carries genetic

information involved in many

fundamental biological processes.

Damage to the DNA of an individual

gene may cause the gene to mutate,

changing a cell’s genetic code. Such

mutation can lead to cancer. Since

ionizing radiation may damage genes, it

can adversely affect individuals directly

exposed as well as their descendants.

While much of this cellular damage is

repaired by the body, restoring proper

biological functions, the net result of an

increase in exposure to ionizing

radiation is an increase in the risk of

cancer or harmful genetic mutations that

may be passed on to future generations.

(See, EPA’s fact sheets on ionizing

radiation and associated health effects at

http://www.epa.gov/radiation/

ionize.htm and in the record of this final

rulemaking; (USEPA 1998a and1998c)).

Alpha emitters and beta/photon

emitters differ in the magnitude of their

biological effects. Alpha particles

interact very strongly with matter (e.g.,

human tissues), transferring their energy

through these interactions. Beta

particles interact less strongly, which

allows them to travel further through

tissue before being absorbed. The

difference of interest is in the

concentration of tissue damage. Alpha

particles may damage many molecules

over a short distance, while beta

particles may damage molecules spread

out over a greater distance. The actual

number of potentially damaged

molecules depends upon the energy of

the alpha particle or beta particle

(which differs between individual alpha

emitters and beta emitters). Photon

emissions may also interact with

tissues, but they interact over much

longer distances (they can pass through

the body entirely). Exposure to any of

these forms of radiation increases the

risk of cancer.

All people are chronically exposed to

background levels of radiation present

in the environment. Many people also

receive additional chronic exposures,

including exposure to radionuclides in

drinking water, and/or relatively small

acute exposures, for example from

medical X-rays. For populations

receiving such exposures, the primary

concern is that radiation could increase

the risk of cancers or harmful genetic

effects.

The likelihood of developing cancer

or genetic mutations from short-term

exposure to the concentrations of

radionuclides found in drinking water

supplies is negligible. However, longterm exposures may result in increased

risks of genetic effects and other effects

such as cancer, precancerous lesions,

benign tumors, and congenital defects.

For example, an individual that is

exposed to relatively high levels of

radium-228 (e.g., 20 pCi/L) in drinking

water over the course of a lifetime is

projected to have a significantly

increased chance of developing fatal

cancer (roughly a one in one thousand

increased risk if exposed to radium-228

at 20 pCi/L over a lifetime of 70 years).

The probability of a radiation-caused

cancer or genetic effect is related to the

total amount of radiation accumulated

by an individual. Based on current

scientific models, it is assumed that any

exposure to radiation may be harmful

(or may increase the risk of cancer);

however, at very low exposures (e.g.,

drinking water exposures below the

MCL), the estimated increases in risk are

very small and uncertain. For this

reason, cancer rates in populations

receiving very low doses of radiation

may not show increases over the rates

for unexposed populations.

For information on effects at high

levels of exposure, scientists largely

depend on epidemiological data on

survivors of the Japanese atomic bomb

explosions and on people receiving

large doses of radiation for medical

purposes. These data demonstrate a

higher incidence of cancer among

exposed individuals and a greater

probability of cancer as the exposure

increases. In the absence of more direct

information, that data is also used to

estimate what the effects could be at

lower exposures. Where questions arise,

scientists extrapolate from information

obtained from cellular and molecular

studies, but these extrapolations are

acknowledged to be only estimates.

Professionals in the radiation protection

field prudently assume that the chance

of a fatal cancer from radiation exposure

increases in proportion to the

magnitude of the exposure.

In the case of uranium in drinking

water, we must consider not only

carcinogenic health effects but also

damage to the kidneys that may result

from ingestion. When uranium

radioactively decays in the body, it

results in increased cancer risks.

However, natural uranium isotopes have

long half-lives, which means that

uranium tends to persist in the body

until it is excreted or stored in tissue. As

discussed in detail in the Notice of Data

Availability (USEPA 2000e), its

Technical Support Document (USEPA

2000h), and the Toxicological Review of

Uranium (USEPA 2000b) this persistent

uranium may result in kidney toxicity.

See section I.D.2 for a brief summary of

kidney (renal) function and uranium

toxicity.

1. Major Comments

Most comments on Health Effects

related to three areas of risk estimation:

(1) The use of a linear, non-threshold

model, (2) not finding a threshold for

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76721

radium, and (3) not promoting claimed

beneficial effects of ionizing radiation.

a. Linear Non-threshold Model: Some

commenters suggested that the Agency

abandon the linear nonthreshold (LNT)

model it employs to estimate radiation

induced carcinogenesis. They suggest a

new paradigm should be used.

The Agency disagrees and believes its

position is based on weight of evidence

and support from national and

international groups of experts

interested in radiation protection. EPA

classifies all radionuclides as Group A

(known human) carcinogens. This

classification is based on the

considerable weight of epidemiological

evidence that exposure to high doses of

ionizing radiation causes cancer in

humans and on the fact that all

radionuclides emit ionizing radiation.

Radiation has been shown to induce

unique DNA damage, mutations, and

transformation of cells in culture. The

monoclonal nature of cancers is

evidence that a single ‘‘wild’’ cell can

give rise to a cancer. For alpha particles,

it has been shown experimentally that a

single alpha passing through a cell is

sufficient to induce a mutational event;

there are strong theoretical reasons to

expect that the same is true for low

energy transfer (LET) radiation such as

gamma rays. Since a single particle

traversal of a cell is the minimum event

for radiation exposure, a prudent

assumption is that there is no threshold

for radiation induced mutations.

To estimate radiogenic cancer risks

and to regulate low-dose radiation

exposures from continuous intakes of

radionuclides in environmental media,

EPA uses a linear, non-threshold (LNT)

dose-response model. The LNT model

permits direct extrapolation of low-dose

cancer risks from high-dose exposures—

allowing for adjustments, as needed, for

differences in radiation quality, dose

rate, and exposed populations,

including such factors as age at

exposure, time since exposure, baseline

cancer rates, and gender and assumes

that there is no threshold for effects; i.e.,

it is assumed that exposure to any

amount of radioactivity has a finite

potential to induce cancers in humans.

As noted above, support for the LNT

model comes in part from the linear

dose-response relationships observed

for most types of cancers in the

intermediate- to high-dose range for

atomic bomb survivors, and from results

of molecular and cellular studies.

Several such studies have shown that a

single radiation track traversing a cell

nucleus can cause unrepaired or

misrepaired DNA lesions and

chromosomal aberrations. Other studies

have shown that DNA lesions and

chromosomal aberrations can lead to

cancer. From these studies, it is

assumed that the probability of DNA

damage and carcinogenesis is linearly

proportional to the dose.

EPA’s application of the LNT model

to estimate and regulate cancer risks

from environmental exposures to

radionuclides is entirely consistent with

all past and current observations and

recommendations of the International

Commission on Radiological Protection

(ICRP), the National Council on

Radiation Protection and Measurements

(NCRP), the National Academy of

Sciences Committee on the Biological

Effects of Ionizing Radiation (BEIR), and

the United Nations Scientific Committee

on the Effect of Atomic Radiation

(UNSCEAR), and the National Radiation

Protection Board (NRBP). Citing the

recommendations of these national and

international advisory bodies, the U.S.

Department of Energy, the U.S. Nuclear

Regulatory Commission, and other

Federal and State agencies with

regulatory authority over radioactive

materials also apply the LNT model as

the basis for setting regulations and

guidelines for radiation protection.

However, to address these limitations

and the uncertainties associated with

this model and improve its radiation

risk assessments, EPA is actively

supporting national and international

studies of radiation dosimetry and dose

reconstruction, radionuclide

biokinetics, quantitative techniques for

uncertainty analyses, and long-term

follow-up epidemiological studies of

populations exposed chronically to lowdose radiation. The Agency also

continues to review its policies and

positions as new reports and data are

published so that the best science is

applied.

b. Radium Carcinogenicity Threshold:

Some commenters have suggested that

there is a threshold for radium

carcinogenicity. They generally base

this conclusion on the ‘‘Radium Dial

Painter’’ studies.

The Agency disagrees. While the

‘‘Radium Dial Painter’’ studies are

interesting, they are of limited value for

the estimation of risk. First, no one

knows the quantity of radium ingested

in those studies, so dose estimates are

speculative. The intake estimates are

based on the body burden the first time

the subjects were measured and backcalculated with biokinetics modeling.

Moreover, the quantities of radium

ingested by the subjects was great

enough to cause extensive skeletal

pathology and interfere with normal

bone metabolism. In addition to

problems of radium dosimetry, the high

mortality in some groups, and the small

numbers of subjects in all exposure

groups, would impair use of the data to

develop dose response relationships.

Only a small fraction of persons

known to have been exposed to radium

have been located and their radium

content at that time measured. Of 6,675

subjects identified above as being in the

data base and as having been exposed to

radium, 2,383 have been measured to

determine their radium-226 burden. (21

of the 85 osteosarcomas occurred in

subjects who had never been measured

for radium burden.) Since the radium

intake in dial painters is unknown, body

burden is known only from the date of

first radioassay (usually many years

after the radium intake), and

metabolism is estimated from other

sources, estimates of the radiation dose

must be based on a series of poorly

verified assumptions. In spite of these

inherent problems in the data set, efforts

have been made to use the radium dial

workers, or some subset of them, to

establish a ‘‘practical threshold’’ for

radium or other internal emitter

exposure.

The ‘‘practical threshold’’ concept is

derived from studies of chemical

carcinogenesis which include dose

levels causing extensive life shortening.

Plots of the mean age at tumor onset vs

dose indicates an increase in tumor

latency with decreasing dose.

Extrapolation of these curves to

environmental dose levels has led some

investigators to conclude at these dose

levels tumor latency would exceed the

human life span. This ‘‘practical

threshold’’ is as an argument for a

threshold and against LNT models. The

‘‘practical threshold’’ model has been

examined and rejected by experts at the

International Agency for Research on

Cancer (IARC). The IARC warned in

their discussion regarding mean tumor

latency or mean age at tumor onset that

‘‘care must be taken not to extrapolate

the observed tendency for the mean age

at onset to increase with decreasing

dose below the dose range in which

most animals get cancer. Failure to

observe this restriction has led to the

unjustified speculation that

progressively lower and lower human

doses of environmental contaminants

will produce cancers only at age 200 or

300 years; for refutation, see Peto

(1978).’’

Even if there were no problems with

intake, dose, metabolism, extensive

pathology, etc., as mentioned above, the

radium dial studies would be

uninformative on the subject of the dose

response relationship at environmental

exposure levels. The number of subjects

and their distribution in dose categories

is too small. The number of subjects

76722 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

needed to show a given risk increases as

the square of the decrease in dose. For

example, if 10 subjects are required to

show an radiogenic risk at dose level x,

250 would be needed to show the same

risk at dose level x/5, and 1000 at dose

level x/10. There just are not enough

subjects at lower dose levels to show the

risk, giving the illusion of a threshold.

The claims regarding a possible

‘‘practical threshold’’ addressed above

are based solely on the bone cancer

data. However, bone cancer constitutes

only a fraction of the estimated risk

from ingested radium. Radium-226 has

also been found to induce epithelial

cancers in sinuses in the head (due to

radon-222 released into the sinus air

spaces from the decay of radium-226 in

bone). The data in the dial painter study

is inadequate to develop a dose

response relationship for sinus cancers,

however the number of epithelial

cancers expected in the dial painters is

about the same as the number of bone

cancers. The number of bone cancers in

the Agency’s radium-226 risk model is

doubled to get an estimate of combined

bone and sinus cancers. In addition to

bone cancer, patients treated with

radium-224 were found to have

significant increases in breast cancer,

soft tissue sarcomas, liver cancer,

thyroid cancer, cancers of urinary

organs, and leukemia. Given our

understanding of radium metabolism

and the effects of alpha irradiation, it is

expected that ingestion of any of the

radium isotopes will increase the risks

for various types of cancer other than

bone. EPA’s risk estimates include all

these potential sites.

c. ‘‘Beneficial Effects’’ of Radiation:

One commenter suggests there are

beneficial effects of radiation,

‘‘Hormesis’’ (small doses of radiation are

good for you) and ‘‘Adaptive Response’’

(relatively small doses of radiation

protect against large doses of radiation).

The Agency finds that, based on

available scientific evidence, these

phenomena are not relevant to

environmental radiation protection.

Neither has been shown to occur at

environmental dose levels. Neither has

been shown to influence the dose

response for induction of radiation

induced cancer. Hormesis has not been

demonstrated in normal healthy active

populations of mammals, much less in

humans. Adaptive response may have

some application in radiotherapy (very

high radiation doses), but it is not

relevant to environmental exposure

levels.

Hormesis is a non-specific

phenomenon. Biological, chemical, or

physical agents may stimulate hormesis;

thus, cold, physical stress, toxic

chemicals, antibiotics, as well as

ionizing radiation, can be hormetins.

Hormesis originally was used to

describe a stimulatory effect, which was

not inherently good or bad. Recent

usage of the term ‘‘Radiation Hormesis’’

implies the discussion relates to

beneficial effects. It should not,

however, imply absence of radiation

carcinogenesis.

The ‘‘adaptive response’’ is also a

nonspecific response to stress, which

has been observed at the cellular level.

An ‘‘adaptive response’’ is observed

experimentally when a ‘‘conditioning’’

exposure is given, followed at some

later time by a ‘‘challenge’’ exposure,

and the response in the ‘‘conditioned’’

organism or cell culture is less than in

controls; that is, the conditioning

exposure was ‘‘protective’’ against the

challenge. In typical studies where cells

in culture are given a conditioning dose

of radiation in the range of 0.2 to 20 rad

(2 to 200 milliGray or mGy), a dose of

100 to 200 rad (1000 to 2000 mGy) given

later causes only about 50% as great an

effect as that observed in controls with

no conditioning exposure. However

several points are noteworthy: not all

cells respond, effects may be different

for cells at different stages in the cell

cycle, not all conditioning doses give

the same response (sometimes instead of

protection there is synergism between

doses), the ‘‘adaptive’’ effects are

transient, and the timing of the

challenge dose may be critical to

response. Given these limitations, EPA

does not believe it is appropriate at this

time to consider such an adaptive

response in its assessment of the risks

from environmental levels of radiation.

F. Does This Regulation Apply to My

Water System?

The NPDWRs for combined radium226 and radium-228, gross alpha

particle radioactivity, beta particle and

photon radioactivity, and uranium

apply to all community water systems.

G. What Are the Final Drinking Water

Regulatory Standards for Radionuclides

(Maximum Contaminant Level Goals

and Maximum Contaminant Levels)?

The maximum contaminant level

goals (non-enforceable health-based

target, MCLGs) and maximum

contaminant levels (enforceable

regulatory limits, MCLs) are listed in

table I–4. For the reasons already

described, EPA is retaining the existing

MCLs for combined radium-226 and

radium-228, gross alpha, and beta

particle and photon radioactivity. EPA

is finalizing an MCL of 30 μg/L for

uranium, based on kidney toxicity and

cancer risk endpoints. The final MCLGs

are zero for all radionuclides, based on

the no-threshold cancer risk model for

ionizing radiation.

TABLE I–4.—MCLGS AND MCLS FOR RADIONUCLIDES IN DRINKING WATER (OTHER THAN RADON)

Contaminant MCLG (pCi/L) MCL

Combined Radium-226 and Radium-228 ..................................................................... Zero ........................................................... 5 pCi/L.

Gross Alpha (Excluding radon and uranium) ............................................................... Zero ........................................................... 15 pCi/L.

Beta Particle and Photon Radioactivity ........................................................................ Zero ........................................................... 4 mrem/year.

Uranium ......................................................................................................................... Zero ........................................................... 30 μg/L.

H. What Are the Best Available

Technologies (BATs) for Removing

Radionuclides From Drinking Water?

Under the SDWA, EPA must specify

the best available technology (BAT) for

each MCL that is set. PWSs that are

unable to achieve an MCL may be

granted a variance if they use the BAT

and meet other requirements (see

section I.M for a discussion of variances

and exemptions). Table I–5 lists the best

available technologies (BATs) for

complying with the radionuclides

MCLs.

TABLE I–5.—BEST AVAILABLE TECHNOLOGIES (BATS) FOR RADIONUCLIDES IN DRINKING WATER

Contaminant BAT

Combined radium-226 and radium-228 ................................................... Ion Exchange, Lime Softening, Reverse Osmosis.

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76723

TABLE I–5.—BEST AVAILABLE TECHNOLOGIES (BATS) FOR RADIONUCLIDES IN DRINKING WATER—Continued

Contaminant BAT

Gross alpha (excluding radon and uranium) ............................................ Reverse Osmosis.

Beta particle and photon radioactivity ...................................................... Ion Exchange and Reverse Osmosis.

Uranium .................................................................................................... Ion Exchange, Lime Softening; Reverse Osmosis, Enhanced Coagulation/Filtration.

In addition to BATs, the SDWA, as

amended in 1996, requires EPA to list

small system compliance technologies

(the requirements are described in

section I.M). EPA published a list of

small systems compliance technologies

for the existing radionuclide MCLs in

1998 (63 FR 42032) and issued a

guidance document on their use

(USEPA 1998f). EPA took comment on

small system compliance technologies

for uranium in the NODA (USEPA

2000e; 65 FR 21576). Table I–6 is a

compilation of all of the small systems

compliance technologies for

radionuclides, including limitations,

required operator skill, raw water

quality ranges, and other considerations.

Table I–7 shows the small systems

compliance technologies listed for:

combined radium-226 and radium-228,

gross alpha particle radioactivity, beta

particle and photon radioactivity, and

uranium.

TABLE I–6.—LIST OF SMALL SYSTEMS COMPLIANCE TECHNOLOGIES FOR RADIONUCLIDES AND LIMITATIONS TO USE

Unit technologies Limitations

(see footnotes) Operator skill level required 1 Raw water quality range &considerations 1

1. Ion Exchange (IE) .............................. (a) Intermediate .......................................... All ground waters.

2. Point of Use (POU 2) IE ..................... (b) Basic ...................................................... All ground waters.

3. Reverse Osmosis (RO) ...................... (c) Advanced .............................................. Surface waters usually require pre-filtration.

4. POU 2 RO ........................................... (b) Basic ...................................................... Surface waters usually require pre-filtration.

5. Lime Softening ................................... (d) Advanced .............................................. All waters.

6. Green Sand Filtration ......................... (e) Basic ......................................................

7. Co-precipitation with Barium Sulfate (f) Intermediate to Advanced ..................... Ground waters with suitable water

quality.

8. Electrodialysis/Electrodialysis Reversal............................... Basic to Intermediate ............................ All ground waters.

9. Pre-formed Hydrous Manganese

Oxide Filtration.

(g) Intermediate .......................................... All ground waters.

10. Activated alumina ............................. (a), (h) Advanced .............................................. All ground waters; competing anion

concentrations may affect regeneration frequency.

11. Enhanced coagulation/filtration ........ (i) Advanced .............................................. Can treat a wide range of water qualities.

1 1 National Research Council (NRC). Safe Water from Every Tap: Improving Water Service to Small Communities. National Academy Press.

Washington, DC 1997. 2 2A POU, or ‘‘point-of-use’’ technology is a treatment device installed at a single tap used for the purpose of reducing contaminants in drinking

water at that one tap. POU devices are typically installed at the kitchen tap. See the April 21, 2000 NODA for more details.

Limitations Footnotes to Table I–6: Technologies for Radionuclides

aThe regeneration solution contains high concentrations of the contaminant ions. Disposal options should be carefully considered before

choosing this technology. bWhen POU devices are used for compliance, programs for long-term operation, maintenance, and monitoring must be provided by water utility to ensure proper performance. c Reject water disposal options should be carefully considered before choosing this technology. See other RO limitations described in the

SWTR Compliance Technologies Table. dThe combination of variable source water quality and the complexity of the water chemistry involved may make this technology too complex

for small surface water systems. e Removal efficiencies can vary depending on water quality.

fThis technology may be very limited in application to small systems. Since the process requires static mixing, detention basins, and filtration,

it is most applicable to systems with sufficiently high sulfate levels that already have a suitable filtration treatment train in place. gThis technology is most applicable to small systems that already have filtration in place.

h Handling of chemicals required during regeneration and pH adjustment may be too difficult for small systems without an adequately trained

operator. iAssumes modification to a coagulation/filtration process already in place.

TABLE I–7.—COMPLIANCE TECHNOLOGIES BY SYSTEM SIZE CATEGORY FOR RADIONUCLIDE NPDWRS

Contaminant

Compliance technologies 1 for system size categories

(population served) 3,300–10,000

25–500 501–3,300

Combined radium-226 and radium-228 .................. 1, 2, 3, 4, 5, 6, 7, 8, 9 ........... 1, 2, 3, 4, 5, 6, 7, 8, 9 ........... 1, 2, 3, 4, 5, 6, 7, 8, 9

Gross alpha particle activity .................................... 3, 4 ......................................... 3, 4 ......................................... 3, 4

Beta particle activity and phton activity ................... 1, 2, 3, 4 ................................ 1, 2, 3, 4 ................................ 1, 2, 3, 4

76724 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

TABLE I–7.—COMPLIANCE TECHNOLOGIES BY SYSTEM SIZE CATEGORY FOR RADIONUCLIDE NPDWRS—Continued

Contaminant

Compliance technologies 1 for system size categories

(population served) 3,300–10,000

25–500 501–3,300

Uranium ................................................................... 1, 2, 4, 10, 11 ........................ 1, 2, 3, 4, 5, 10, 11 ................ 1, 2, 3, 4, 5, 10, 11

Note: (1) Numbers correspond to those technologies found listed in the table I–6 above.

I. What Analytical Methods Are for

Compliance Monitoring of

Radionuclides?

The approved methods for

compliance monitoring of radionuclides

are listed in § 141.25. These methods are

shown in Table I–8. A large portion of

the approved methods for radionuclides

were added after the 1991 proposed rule

(56 FR 33050). There, the Agency

proposed to approve fifty-six methods

for the measurement of radionuclides in

drinking water (excluding radon). Fiftyfour of the fifty-six were actually

promulgated in the March 5, 1997 final

methods rule (62 FR 10168). In addition

to these fifty-four, EPA also

promulgated 12 radiochemical methods

in the March 5, 1997 final methods rule,

which were submitted by commenters

after the 1991 proposed rule.

In the March 5, 1997 final methods

rule for radionuclides (62 FR 10168), the

Agency approved several methods for

the analysis of uranium. Specific

analysis for uranium can be performed

by radiochemical methods, alpha

spectrometry, fluorometric (mass), or

laser phosphorimetry (mass) (see Table

I–8). The radio-chemical method

separates and concentrates uranium

from potentially-interfering

radionuclides and non-radioactive

sample constituents. The resulting

concentrate, depending on the method,

can then be counted by gas flow

proportional counting, alpha

scintillation, or alpha spectrometry.

Results from proportional counting or

alpha scintillation counting accurately

determine the alpha emission rate from

total uranium in the sample; however,

the uranium isotope ratio (uranium-234/

uranium-238) cannot be determined and

the uranium mass cannot be estimated

unless an empirical conversion factor is

applied to the measured count rate. The

use of alpha spectrometry allows for the

determination of individual isotopes of

uranium and the accurate calculation of

the mass of uranium-238 present in the

sample. Additionally, the concentration

of uranium-234 can be accurately

measured, if necessary to assess the

radiotoxicity of this isotope.

Both the fluorometric and the laser

phosphorimetry methods measure the

mass of uranium-238 present in the

sample; a conversion factor must be

used to convert the mass measurement

to an approximate radioactivity

concentration in picoCuries. The

computed radioactivity is only

approximate because the ratio of

uranium isotopes must be assumed. The

use of mass-type methods is acceptable

provided a conversion factor of 0.67

pCi/μg is used to convert the

fluorometric or laser phosphorimetry

uranium-238 mass result from

micrograms to picoCuries. This

conversion factor is conservative and is

based on a 1:1 ratio of uranium-234 to

uranium-238 in uranium-bearing

minerals. The scientific literature

indicates that the activity ratio varies in

ground water from region to region

(typically from 0.67 to 1.5 pCi/μg).

EPA recognizes that the mass

conversion factor is conservative in that

the calculated uranium alpha emission

rate based on the mass measurement

may be biased low (i.e.,

underestimated). The use of this

conversion factor may result in a larger

net gross alpha (gross alpha less the

calculated uranium gross alpha

contribution), which may require

additional testing to resolve.

Conversely, the calculated mass of

uranium based on gross alpha could be

biased high and result in an

overestimation, which may require

additional testing to resolve. Both

situations are protective in that the bias

requires additional testing to resolve

when the uranium concentration in a

sample is near the proposed MCL

regardless of which method is used to

measure the uranium.

1. Major Comments

a. Request for ICP-MS Method for

Uranium: In response to the NODA,

several commenters asked EPA to

consider the approval of an Inductively

Coupled Plasma Mass Spectrometry

(ICP-MS) method for uranium analysis

(a mass method). Many commenters

stated that the ICP-MS method (i.e., EPA

200.8 or SM 3125) is more cost-effective,

less labor-intensive and offers greater

sensitivity than some of the currently

approved methods for uranium analysis.

EPA is currently reviewing the ICP-MS

method for uranium and will publish a

proposal and a final in a future

rulemaking.

b. Detection Limit for Uranium: In

1976, the NPDWRs defined the

‘‘detection limit’’ (DL) as the

‘‘concentration which can be counted

with a precision of plus or minus 100

percent at the 95 percent confidence

level (1.96 σ, where σ is the standard

deviation of the net counting rate of the

sample).’’ The detection limits for gross

alpha, radium-226, radium-228, gross

beta and other radionuclides are listed

at § 141.25 and reproduced in Table I–

9. In the NODA, EPA stated that it

would maintain the use of detection

limits as the required measures of

sensitivity for radiochemical analysis,

instead of using the method detection

limit (MDL), the practical quantitation

level (PQL) and acceptance limits, as

was proposed in 1991. Although no

comments were submitted about EPA’s

decision to maintain the use of the

detection limits listed in § 141.25,

several commenters submitted

comments about the appropriate

measure of sensitivity for uranium.

Since uranium was not previously

regulated, no detection limit is listed in

the CFR and none was proposed in

1991. In 1991, the Agency only

proposed a PQL (5 pCi/L) and an

acceptance limit (±30%) for uranium.

Because the NODA was not the

appropriate mechanism to propose a

detection limit for uranium, the Agency

stated that it ‘‘may have to adopt the

PQL for uranium until a detection limit

is proposed.’’ Several commenters

disagreed with the use of a PQL and

acceptance limits for uranium. They felt

that EPA should be consistent with

other regulated radionuclides and set a

detection limit for uranium as the

required measure of sensitivity. The

Agency agrees with the commenters and

will propose a detection limit for

uranium in a future rulemaking before

the compliance date of this rule to be

consistent with the sensitivity measures

used for other radionuclides.

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76725

TABLE I–8.—ANALYTICAL METHODS APPROVED BY EPA FOR RADIONUCLIDE MONITORING (§ 141.25)

Contaminant Methodology

Reference (method or page number)

EPA1 EPA2 EPA3 EPA4 SM 5 ASTM 6 USGS7 DOE8 Other

Naturally occurring:

Gross alpha 11 and beta ... Evaporation .............................. 900.0 p 1 00–01 p 1 302, 7110 B R–1120–76

Gross alpha 11 ................... Co-precipitation ........................ ............ 00–02 7110 C

Radium 226 ....................... Radon emanation ..................... 903.1 p 16 Ra-04 p 19 7500-Ra C D 3454–91 R–1141–76 Ra-05 N.Y. 9

Radiochemical .......................... 903.0 p 13 Ra-03 304, 305, 7500-Ra B D 2460–90 R–1140–76

Radium 228 ....................... Radiochemical .......................... 904.0 p 24 Ra-05 p 19 304, 7500-Ra D R–1142–76 N.Y. 9

N.J. 10

Uranium 12 ......................... Radiochemical .......................... 908.0 7500-U B

Fluorometric ............................. 908.1 7500-U C (17th Ed.) D 2907–91 R–1180–76

R–1181–76

U-04

Alpha spectrometry .................. ............ 00–07 p 33 7500-U C (18th or

19th Ed.)

D 3972–90 R–1182–76 U-02

Laser phosphorimetry .............. ............ D 5174–91

Man-made:

Radioactive cesium ........... Radiochemical .......................... 901.0 p 4 7500-Cs B D 2459–72 R–1111–76

Gamma ray spectrometry ........ 901.1 p 92 7120 D 3649–91 R–1110–76 4.5.2.3

Radioactive iodine ............. Radiochemical .......................... 902.0 p 6

p 9

7500–1 B

7500–1 C

7500–1 D

D 3649–91

Gamma ray spectrometry ........ 901.1 p 92 7120 (19th Ed.) D 4785–88 4.5.2.3

Radioactive Strontium 89,

90.

Radiochemical .......................... 905.0 p 29 Sr-4 p. 65 303, 7500-Sr B R–1160–76 Sr-01

Sr-02

Tritium ............................... Liquid scintillation ..................... 906.0 p 34 H-2 p. 87 306,7500–3H B D 4107–91 R–1171–76

Gamma emitters ............... Gamma ray spectrometry ........ 901.1

902.0

901.0

p 92 7120 (19th Ed.)

7500-Cs B

7500-I B

D 3649–91

D 4785–88

R–1110–76 4.5.2.3

1 ‘‘Prescribed Procedures for Measurement of Radioactivity in Drinking Water,’’ EPA 600/4–80–032 , August 1980. Available at U.S. Department of Commerce, National Technical Information

Service, 5285 Port Royal Road, Springfield, VA 22161 (Telephone 800–553–6847), PB 80–224744. 2 ‘‘Interim Radiochemical Methodology for Drinking Water,’’ EPA 600/4–75–008 (revised), March 1976. Available at NTIS, ibid. PB 253258. 3 ‘‘Radiochemistry Procedures Manual’’, EPA 520/5–84–006, December 1987. Available at NTIS, ibid. PB 84–215581.

4 ‘‘Radiochemical Analytical Procedures for Analysis of Environmental Samples,’’ U.S. Department of Energy, March 1979. Available at NTIS, ibid. EMSL LV 053917. 5Standard Methods for the Examination of Water and Wastewater, 13th, 17th, 18th, 19th Editions, 1971, 1989, 1992, 1995. Available at American Public Health Association, 1015 Fifteenth

Street N.W., Washington, D.C. 20005. Methods 302, 303, 304, 305 and 306 are only in the 13th edition. Methods 7110B, 7110 C, 7500-Ra B, 7500-Ra C, 7500-Ra D, 7500-U B, 7500-Cs B,

7500-I B, 750–9I C, 7500–D, 7500-Sr B, 7500–3H B are in the 17th, 18th and 19th editions. Method 7500-U C Fluorometric Uranium is only in the 17th Edition, and 7500-U C Alpha spectrometry is only in the 18th and 19th editions. Method 7120 is only in the 19th edition. Methods 302, 303, 304, 305 and 306 are only in the 13th edition. 6Annual Book of ASTM Standards, Vol. 11.02, 1994; American Society for Testing and Materials; any year containing the cited version of the method may be used. Copies may be obtained

from the American Society for Testing and Materials, 100 Barr Harbor Drive, West Conshohocken, PA 19428. 7 ‘‘Methods for Determination of Radioactive Substances in Water and Fluvial Sediments,’’ Chapter A5 in Book 5 of Techniques of Water-Resources Investigations of the United States Geological Survey, 1977. Available at U.S. Geological Survey Information Services, Box 25286, Federal Center, Denver, CO 80225–0425. 8 ‘‘EML Procedures Manual’’, 27th Edition, Volume 1, 1990. Available at the Environmental Measurements Laboratory, U.S. Department of Energy (DOE), 376 Hudson Street, New York, NY

10014–3621. 9 ‘‘Determination of Ra-226 and Ra-228 (Ra-02),’’ January 1980; Revised June 1982. Available at Radiological Sciences Institute Center for Laboratories and Research, New York State Department of Health, Empire State Plaza, Albany, NY 12201. 10 ‘‘Determination of Radium 228 in Drinking Water,’’ August 1980. Available at State of New Jersey, Department of Environmental Protection, Division of Environmental Quality, Bureau of Radiation and Inorganic Analytical Services, 9 Ewing Street, Trenton, NJ 08625. 11 Natural uranium and thorium-230 are approved as gross alpha-particle activity calibration standards for the gross alpha co-precipitation and evaporation methods; americium-241 is approved for use with the gross alpha co-precipitation methods. 12 If uranium (U) is determined by mass-type methods (i.e., fluorometric or laser phosphorimetry), a 0.67 pCi/μg uranium conversion factor must be used. This conversion factor is conservative

and is based on the 1:1 activity ratio of U-234 to U-238 that is characteristic of naturally-occurring uranium in rock.

TABLE I–9.—REQUIRED REGULATORY

DETECTION LIMITS FOR THE VARIOUS RADIOCHEMICAL CONTAMINANTS (§ 141.25)

Contaminant

Detection

Limit

(pCi/L)

Gross Alpha .............................. 3

Gross Beta ................................ 4

Radium-226 .............................. 1

Radium-228 .............................. 1

Cesium-134 ............................... 10

Strontium-89 ............................. 10

Strontium-90 ............................. 2

Iodine-131 ................................. 1

Tritium ....................................... 1,000

Other Radionuclides and Photon/Gamma Emitters.

1⁄10th of the

rule.

J. Where and How Often Must a Water

System Test for Radionuclides?

1. Monitoring Frequency for Gross

Alpha, Radium 226, Radium 228, and

Uranium

The monitoring scheme being

finalized today provides for more

frequent, but less sample-intensive (on a

per compliance site basis), monitoring

for systems with a demonstrated

inherent vulnerability and reduced

monitoring for systems with low

contaminant levels, which will apply to

most systems. Instead of the current

monitoring framework for radionuclides

of four samples every four years for

results above 50% of the MCL and one

sample every 4 years for those at or

below 50% (at State discretion), the

revised rule calls for one sample every

three years for compliant systems with

average contaminant levels above 50%

of the MCL but at or below the MCL,

one sample every 6 years for systems

with levels above the detection limit

and at or below 50% of the MCL, and

every 9 years for systems with levels

below the detection limit.

2. Monitoring Frequency for Beta

Particle and Photon Radioactivity

Beta particle and photon radioactivity

monitoring will be performed only by

community water systems designated by

the State as ‘‘vulnerable’’ or

‘‘contaminated’’. A community water

systems (both surface and ground water)

designated by the State as vulnerable

must collect quarterly samples for beta

emitters and annual samples for tritium

and strontium-90 at each entry point to

the distribution system, beginning

within one quarter after being notified

by the State. Systems already designated

by the State must continue to sample

until the State reviews and either

reaffirms or removes the designation. If

the gross beta particle activity minus the

naturally occurring potassium-40 beta

particle activity at a sampling point has

a running annual average less than or

equal to 50 pCi/L (screening level), the

system may reduce the frequency of

monitoring at that sampling point to

once every 3 years.

Community water systems (both

surface and ground water) designated by

the State as utilizing waters

contaminated by effluents from nuclear

facilities must collect quarterly samples

for beta emitters and iodine-131 and

annual samples for tritium and

strontium-90 at each entry point to the

distribution system, beginning within

one quarter after being notified by the

State. Systems already designated by the

State as systems using waters

contaminated by effluents from nuclear

facilities must continue to sample until

the State reviews and either reaffirms or

removes the designation. If the gross

76726 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

beta particle activity beta minus the

naturally occurring potassium-40 beta

particle activity at a sampling point has

a running annual average less than or

equal to 15 pCi/L (screening level), the

system may reduce the frequency of

monitoring at that sampling point to

every 3 years.

For CWS in the vicinity of a nuclear

facility, the State may allow the CWS to

utilize environmental surveillance data

collected by the nuclear facility in lieu

of monitoring at the system’s entry

point(s), where the State determines if

such data is applicable to a particular

water system. Community water

systems designated by the State to

monitor for beta particle and photon

radioactivity can not apply to the State

for a waiver from the monitoring

frequencies.

Several USGS studies, including the

study entitled Gross-beta Activity in

Ground Water: Natural Sources and

Artifacts of Sampling and Laboratory

Analysis, have found that Potassium-40

and Radium-228 appear to be the

primary sources of beta activity in

ground water. EPA recognizes that

naturally occurring potassium could

trigger many systems into conducting

expensive beta speciation analysis due

to exceedance of the screening level.

Therefore, as noted above, naturally

occurring Potassium-40 analyzed from

the same or equivalent sample used for

the gross beta analysis may be

subtracted from the total gross beta

activity to determine if the screening

level is exceeded. The potassium-40

beta particle activity must be calculated

by multiplying elemental potassium

concentrations (in mg/L) by a factor of

0.82. If the gross beta particle activity

minus the naturally occurring

potassium-40 beta particle activity

exceeds the screening level, an analysis

of the sample must be performed to

identify the major radioactive

constituents present in the sample and

the appropriate doses must be

calculated and summed to determine

compliance with § 141.66(d). Doses

must also be calculated and combined

for measured levels of tritium and

strontium to determine compliance.

The regulatory language in

§ 141.26(b)(6) of today’s rule requires

systems to monitor monthly at sampling

points which exceed the maximum

contaminant levels in § 141.66(d)

beginning in the next month after the

exceedance occurred. There are many

circumstances that may arise from this

requirement such as collecting and

obtaining the results in two separate

months, however, the EPA intended this

to require all systems to collect the

initial monthly sample no later than 30

days following the collection date of the

initial MCL exceedance.

The EPA believes that States have

evaluated the vulnerability of systems to

potential beta emitting sources under

the existing rule. Therefore, States

should use the existing vulnerability

assessments to notify systems of their

status and monitoring requirements if

they have not provided that notification

previously. The EPA is also encouraging

States to reevaluate a systems

vulnerability to beta photon emitting

sources when conducting a systems

source water assessment and provide

immediate notification to those systems

that have been deemed vulnerable.

3. Sampling Points and Data

Grandfathering

Because the current radionuclide

NPDWRs have been in effect for almost

25 years, States have much historical

distribution system data for the

regulated radionuclides at most

community water systems and have data

regarding occurrence patterns at various

scales. The monitoring scheme is an

attempt to balance two opposing goals:

first, to ensure that every entry point is

in compliance, and second, to allow

States and drinking water systems to

make maximal use of the existing

distribution system historical data.

To meet the first goal, today’s final

rule requires that all new monitoring be

at the entry point to the distribution

system. This will ensure that all entry

points are in compliance with the MCLs

from now on. But, rather than narrowly

prescribing specific criteria for

grandfathering existing distribution

system data, today’s rule provides

flexibility to States to devise a

grandfathering plan applicable to their

own circumstances. In particular, States

may devise a plan for determining

which systems will need to analyze new

samples from each entry point to

establish initial monitoring baselines for

the currently regulated radionuclides

and which can rely on the existing

distribution system data for the same

purpose (including existing uranium

data). EPA had considered more

prescriptive options, such as allowing

grandfathering for systems with fewer

than three entry points, systems serving

fewer than 3,300 persons, systems

drawing from aquifers of certain

characteristics, etc. However, the many

competing variables present at the local

level make generalizations impractical

at the national level. Since the

grandfathering plans will be a part of

the primacy packages approved by the

EPA Regions, EPA will have oversight

over these plans. EPA expects that the

plans would allow grandfathering only

for situations in which it is to be

expected that every entry point is in

compliance with the MCLs. For

example, if a system with five entry

points (all of significant flows) has gross

alpha monitoring data from a

representative point in the distribution

system and the result is 75% of the MCL

(11 pCi/L), EPA expects that this data

would not be grandfathered, since it can

not be ruled out that at least one of the

entry points has a contaminant level

greater than the MCL. On the other

hand, if the distribution system sample

baseline result is below the detection

limit and the State determines that,

based on aquifer and other

characteristics, the entry points are

expected to have fairly uniform

contaminant levels, then a State could

reasonably determine that this water

system should be able to grandfather its

distribution system data. EPA will

provide an Implementation Guidance to

further explain this issue after today’s

rule is final.

4. Does the Rule Allow Compositing of

Samples?

Compositing allows a system to have

combined samples analyzed to reduce

the costs of monitoring. Compositing of

samples is done in the laboratory. The

1976 rule allowed compositing for gross

alpha and allowed (but did not

recommend) some compositing for beta/

photon emitters. Compositing is

essentially an issue for the initial round

of monitoring for systems without data

to grandfather. Once decreased

monitoring is in effect, only a single

sample will be required and

compositing will not be an issue. In

general, there are three kinds of

compositing: combining samples taken

from the same sampling point from

different quarters (temporal

compositing), samples taken in the same

quarter from different sampling points

within a system (spatial compositing),

and samples taken from different water

systems each having one well (intersystem compositing). Inter-system and

spatial compositing are not allowed in

today’s rule, since this kind of

compositing defeats the purpose of

monitoring at each entry point to the

distribution system.

Because compositing lessens the

burden on systems and allows for

adequate monitoring reliability in some

situations, temporal compositing is

allowed under circumstances in which

the detection limit is low compared to

the MCL. In particular, temporal

compositing is allowed for uranium,

gross alpha radium-226 (provided a DL

of 1 pCi/L is met) and radium-228

(provided a DL of 1 pCi/L is met). While

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76727

10Point-of-entry (POE) treatment units treat all of

the water entering a household or other building,

with the result being treated water from any tap.

Point-of-use (POU) treatment units treat only the

water at a particular tap or faucet, with the result

being treated water at that one tap, with the other

taps serving untreated water. POE and POU

treatment units often use the same technological

concepts employed in the analogous central

treatment processes, the main difference being the

much smaller scale of the device itself and the

flows being treated.

compositing is allowed under these

circumstances, compositing of several

samples taken at different times

provides less information than

individual analysis of the samples. For

example, if contaminant levels vary

appreciably with pumping rates and

pumping rates are seasonal, compositing

will hide this potentially significant

variance. Additionally, if a State allows

a system with low contaminant levels to

base compliance on two results from

different quarters, compositing may not

be desirable. If a State wishes to be more

stringent and use the highest result of

four initial samples to set future

monitoring frequency, compositing is

not appropriate. However, under some

conditions, States may wish to allow

water systems to have their samples

composited before analysis.

Commenters generally agreed that

spatial monitoring was impractical,

since it would provide limited

information on contaminant levels at

individual entry points. Some

commenters suggested that the six

month holding time for gross alpha

would necessitate compositing twice,

two samples in the first six months and

two in the second six months. Although

this type of compositing would be

allowed, EPA disagrees that this is

necessary, since, for statistical reasons,

analysis of four composited samples

taken in four different quarters will

achieve results of comparable quality

(assuming that the analysis is done

within the same year that the first

sample is taken) to individual analyses

of four samples using six month holding

times. For this reason, annual

compositing at a single entry point is

allowed for gross alpha. While several

commenters were desirous of maximum

compositing flexibility, the technical

limitations described rule out some

types of compositing, specifically

spatial and inter-system compositing.

5. Interpretation of Analytical Results

The Agency recognizes that States

have interpreted radionuclide analytical

results in a variety of ways, including

adding or subtracting standard

deviations from the analytical results.

The Agency believes that compliance

and reduced monitoring frequencies

should be calculated based on the

‘‘analytical result(s)’’ as stated in

§ 141.26(c)(3). It is EPA’s interpretation

that the analytical result is the number

that the laboratory reports, not

including (i.e. not adding or subtracting)

the standard deviation. For example, if

a laboratory reports that the gross alpha

measurement for a sampling point is 7

± 2 pCi/L, then compliance and reduced

monitoring would be calculated using a

value of 7 pCi/L.

K. Can My Water System Use Point-ofUse (POU), Point-of-Entry (POE) 10, or

Bottled Water To Comply With This

Regulation?

EPA has listed: (1) POU ion exchange

and POU reverse osmosis as small

system compliance technologies for

combined radium-226 and radium-228,

and beta particle and photon

radioactivity; and (2) POU reverse

osmosis as a small systems compliance

technology for gross alpha particle

activity (63 FR 42032; on August 6,

1998, also see Table I–6 and I–7)). While

these POU technologies are not

considered BAT for large systems, they

may be used as BAT under sections

1412 and 1415 of the Act for systems

serving 10,000 persons or fewer.

Guidance documents were published to

support the small systems compliance

technology lists (‘‘Small System

Compliance Technology List for the

Non-Microbial Contaminants Regulated

Before 1996,’’ USEPA 1998f). The small

system compliance technology list

described in section I.H., table I–6, of

today’s final rule is identical to the 1998

list, with the exception of the addition

of small systems compliance

technologies for uranium. See section

I.H. for details about the lists. POE

technologies are not being listed as

small systems compliance technologies

since they are considered emerging

technologies and due to concerns

regarding waste disposal and costs. POE

technologies (and other technologies)

may be added in the future through

small system compliance technology

updates.

The authority for listing POU

technologies as small system

compliance technologies comes from

section 1412(b)(4)(e)(ii) of the SDWA,

which identifies both Point-of-Entry

(POE) and Point-of-Use (POU) treatment

units as options for compliance

technologies. The SDWA identifies

requirements that must be met when

POU or POE units are used by a water

system to comply with an NPDWR.

Section 1412(b)(4)(e)(ii) stipulates that

‘‘point-of-entry and point-of-use

treatment units shall be owned,

controlled, and maintained by the

public water system or by a person

under contract with the public water

system to ensure proper operation and

maintenance and compliance with the

MCL or treatment technique and

equipped with mechanical warnings to

ensure that customers are automatically

notified of operational problems.’’ Other

conditions in this section of the SDWA

include the following: ‘‘If the American

National Standards Institute has issued

product standards applicable to a

specific type of POE or POU treatment

unit, individual units of that type shall

not be accepted for compliance with a

MCL or treatment technique unless they

are independently certified in

accordance with such standards.’’

In order to list POU treatment units as

compliance technologies, EPA had to

withdraw the part of § 141.101 that

prohibited POU devices being used to

comply with an MCL. To this end, a

final rule was published in the Federal

Register on June 11, 1998 (EPA 1998g).

For more details on POU and POE

devices, see the supporting guidance

document for the small system

compliance technology lists (USEPA

1998f).

Public water systems are not allowed

to use bottled water to comply with an

MCL (63 FR 31932; June 11, 1998).

Bottled water may only be used on a

temporary basis to avoid unreasonable

risks to health, e.g., as negotiated with

the State or other primacy agency as

part of the compliance schedule period

for an exemption or variance.

L. What Do I Need To Tell My

Customers?

1. Consumer Confidence Reports

On August 19, 1998, EPA issued

Subpart O, the final rule requiring

community water systems to provide

annual reports on the quality of water

delivered to their customers (63 FR

44512). The first Consumer Confidence

Reports (CCRs) were to be made

available to customers by October 19,

1999, and now they are due each year

by July 1 (§ 141.152(a)). In these reports,

systems must provide, among other

things, the levels and sources of all

detected contaminants and a description

of the potential health effects of any

contaminant found at levels that violate

EPA or State rules, as part of a broader

description of the violation and efforts

to remedy it. For MCL or treatment

technique violations, specific ‘‘health

effects language’’ in Appendix A of

Subpart O must be included verbatim in

the report. Today’s rule updates the

Appendix to include health effects

language and ‘‘likely source’’

76728 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

information for uranium. This language

is consistent both with previously

published health effects language for

other radionuclides and with the

language now required by the Public

Notification Rule. Table I–10 shows the

health effects language required for the

radionuclides for the purposes of CCR

and public notification.

TABLE I–10.—STANDARD HEALTH EFFECTS LANGUAGE FOR CCR AND PUBLIC NOTIFICATION

Contaminant Standard health effects language for CCR and public notification

Beta/photon emitters ....................... Certain minerals are radioactive and may emit forms of radiation known as photons and beta radiation.

Some people who drink water containing beta and photon emitters in excess of the MCL over many

years may have an increased risk of getting cancer.

Alpha Emitters ................................. Certain minerals are radioactive and may emit a form of radiation known as alpha radiation. Some people

who drink water containing alpha emitters in excess of the MCL over many years may have an increased risk of getting cancer.

Combined Radium (–226 & –228) .. Some people who drink water containing radium 226 or 228 in excess of the MCL over many years may

have an increased risk of getting cancer.

Uranium ........................................... Some people who drink water containing uranium in excess of the MCL over many years may have an increased risk of getting cancer and kidney toxicity.

2. Public Notification

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

SDWA, as amended in 1996, require

that public water systems notify their

customers when they are in violation of

NPDWRs. In the case of the

radionuclides NPDWRs, this only

applies to community water systems.

On May 4, 2000, EPA revised the

minimum requirements that public

water systems must meet for public

notification of violations of EPA’s

drinking water standards and other

situations that pose a risk to public

health from the drinking water. These

revisions were promulgated under the

Public Notification Rule (PNR), under

40 CFR Part 141, Subpart Q. Water

systems must begin to comply with the

new regulations on October 31, 2000 (if

they are in jurisdictions where the

program is directly implemented by

EPA), or on the date a primacy State

adopts the new requirements (but not

later than May 6, 2002). Until the

effective date of the new requirements,

water systems must continue to comply

with the requirements under § 141.32.

Subsequent EPA drinking water

regulations that affect public

notification requirements will amend

the PNR as a part of each individual

rulemaking.

Public notification of drinking water

violations is an important part of the

‘‘public right to know’’ provisions of the

1996 Amendments to the Safe Drinking

Water Act. The PNR sets the

requirements that public water systems

must follow regarding the form, manner,

frequency, and content for public

notifications. These requirements apply

to owners and operators of, in the case

of the radionuclides NPDWRs,

community water systems. The PNR

requires that any regulated system

notify its customers when: (1) A

violation of a NPDWR occurs; (2) the

system obtains a variance or an

exemption from a NPDWR; or (3) the

system is facing another situation

posing a significant risk to public

health.

Depending on the severity of the

situation, water suppliers have from 24

hours to one year to notify their

customers after a violation occurs. EPA

specifies three categories, or tiers, of

public notification. Depending under

which tier a violation situation falls,

water systems have different amounts of

time to distribute and ways to deliver

the notice:

• Immediate Notice (Tier 1): Any time

a situation occurs where there is the

potential for human health to be

immediately impacted, water suppliers

have 24 hours to notify people who may

drink the water of the situation. Water

suppliers must use media outlets such

as television, radio, and newspapers,

post their notice in public places, or

personally deliver a notice to their

customers in these situations.

• Notice ‘‘as soon as possible’’ (Tier

2): Any time a water system provides

water with levels of a contaminant that

exceed EPA or State standards or that

hasn’t been treated properly, but that

does not pose an immediate risk to

human health, the water system must

notify its customers as soon as possible,

but within 30 days of the violation.

Notice may be provided via the media,

posting, or through the mail.

• Annual Notice (Tier 3): When water

systems violate a drinking water

standard that does not have a direct

impact on human health (for example,

failing to take a required sample on

time) the water supplier has up to a year

to provide a notice of this situation to

its customers. The extra time gives

water suppliers the opportunity to

consolidate these notices and send them

with annual water quality reports

(consumer confidence reports (CCR)), if

the CCR meets the PNR timing, content,

and distribution requirements.

The PNR lists the currently regulated

radionuclides (combined radium-226

and radium-228, gross alpha, and beta

particle and photon radioactivity) as

being subject to ‘‘Tier 2’’ public notice

requirements for MCL violations and

‘‘Tier 3’’ public notice requirements for

violations of the monitoring and testing

procedure requirements. Today’s rule

does not change this designation for the

currently regulated radionuclides and

adds uranium to the list of contaminants

subject to Tier 2 requirements for MCL

violations and Tier 3 requirements for

violations of the monitoring and testing

procedure requirements.

The elements to be included in each

public notice are specified under

§ 141.205(a). All notices must include:

• A description of the violation that

occurred, including the potential health

effects (as specified in appendix B to

subpart Q for MCL violations and the

standard language under § 141.205(d)(2)

for monitoring violations);

• The population at risk and if

alternate water supplies need to be

used;

• What the water system is doing to

correct the problem;

• Actions consumers can take;

• When the violation occurred and

when the system expects it to be

resolved;

• How to contact the water system for

more information; and

• Standard language encouraging

broader distribution of the notice.

The standard health effects language

used for public notification is the same

as that for CCR, which is provided in

Table I–10.

The public notice requirements under

40 CFR 141.203(b)(1) are such that the

public water system must provide a Tier

2 public notice to persons served as

soon as practical, but no later than 30

days after the system learns of the

violation. Posted notices are required to

remain in place for as long as the

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76729

violation or situation persists, but in no

case for less than seven days, even if the

violation or situation is resolved. The

PNR under § 141.203(b)(2) also requires

the public water system to repeat the

notice every three months for as long as

the violation persists. In contrast, the

current rule requires a newspaper notice

within 14 days, a notice mailed to all

bill-payers within forty-five days, and a

repeat notice mailed every three months

thereafter until the violation is resolved.

The public notification requirement

gives the primacy agency discretion, in

appropriate circumstances, to extend

the time period allowed for the Tier 2

notice from 30 days to up to three

months for the initial notice and to

allow repeat notice less frequently than

every three months (but no less than

once per year). Permission must be

granted in writing. Although the

discretion given to the primacy agency

is fairly broad, the rule specifically

disallows extensions of the 30-day

deadline for the initial public notice for

any unresolved violation. The PNR also

does not allow primacy agencies to

establish regulations or policies that

automatically give ‘‘across-the-board’’

extensions or reductions in the repeat

notice frequency for all the other

violations.

For the most up-to-date version of the

CCR and PNR tables that will be

published in the July edition of the

Code of Federal Regulations (appendix

A to subpart O, and appendices A and

B to subpart Q of 40 CFR part 141), visit

EPA’s Office of Ground Water and

Drinking Water’s website at ‘‘http://

www.epa.gov/safewater/tables.html.’’

These on-line tables incorporate

changes on an on-going basis.

M. Can My Water System Get a Variance

or an Exemption From an MCL Under

Today’s Rule?

There are two kinds of variances

applicable to public water systems:

‘‘regular variances,’’ which are usually

referred to simply as ‘‘variances,’’ and

‘‘small systems variances.’’ The

currently regulated radionuclides are

already subject to the provisions for

variances and exemptions and nothing

in today’s rule changes these provisions.

The regular variances and exemptions

provisions will be discussed later in this

section.

As discussed in the NODA, the

‘‘Small Systems Compliance

Technology List’’ (SSCTL) for combined

radium-226 and -228, gross alpha

particle activity, and beta particle/

photon emitter radioactivity was

published in the Federal Register on

August 6, 1998 (63 FR 42032), as

required by the amended SDWA. The

SSCTL list for uranium was published

for comment in the radionuclides

NODA.

The 1996 SDWA identifies three

categories of small drinking water

systems, those serving populations

between 25–500, 501–3,300, and 3,301–

10,000. In addition to BAT

determinations, the SDWA directs EPA

to make technology assessments for

each of the three small system size

categories in all future regulations

establishing an MCL or treatment

technique. Two classes of small systems

technologies are identified for future

NPDWRs: small system compliance

technologies and small system variance

technologies.

Small system compliance

technologies (‘‘compliance

technologies’’) may be listed for

NPDWRs that promulgate MCLs or

treatment techniques. In the case of an

MCL, ‘‘compliance technology’’ refers to

a technology or other means that is

affordable for the appropriate small

systems (if applicable) and that achieves

compliance. Possible compliance

technologies include packaged or

modular systems and point-of-entry

(POE) or point-of-use (POU) treatment

units, as described previously.

Small system variance technologies

(‘‘variance technologies’’) are only

specified for those system size/source

water quality combinations for which

no technology meets all of the criteria

for listing as a compliance technology

(section 1412(b)(15)(A)). Thus, the

listing of a compliance technology for a

size category/source water combination

prohibits the listing of variance

technologies for that combination.

While variance technologies may not

achieve compliance with the MCL or

treatment technique requirement, they

must achieve the maximum reduction

that is affordable considering the size of

the system and the quality of the source

water. Variance technologies must also

achieve a level of contaminant

reduction that is ‘‘protective of public

health’’ (section 1412(b)(15)(B)). The

process for determining small system

compliance technologies and small

system variance technologies is

described in more detail in the guidance

document, ‘‘Small System Compliance

Technology List for the Non-Microbial

Contaminants Regulated Before 1996’’

(USEPA 1998f).

In the case of the currently regulated

radionuclides, i.e., combined radium226 and -228, gross alpha particle

activity, and total beta particle and

photon radioactivity, there are no

variance technologies allowable since

the SDWA (section 1415(e)(6)(A))

specifically prohibits small system

variances for any MCL or treatment

technique which was promulgated prior

to January 1, 1986. The Variance and

Exemption Rule describes EPA’s

interpretation of this section in more

detail (see 63 FR 19442; April 20, 1998).

Stakeholders provided input

regarding the small system compliance

technologies for combined radium-226

and -228, gross alpha emitters, and beta

particle and photon radioactivity, and

uranium that are listed in section I.H.

The small system compliance

technologies for the radionuclides

regulated since 1976 were listed and

described in the Federal Register on

August 6, 1998 (63 FR 42032) and in an

accompanying guidance manual (EPA

1998b). Small systems compliance

technologies for uranium were

evaluated subsequent to the 1998 list,

and presented in the Small Systems

Compliance Technology List for the

Radionuclides Rule (USEPA 1999a).

Small systems compliance technologies

for uranium were evaluated in terms of

each technology’s removal capabilities,

contaminant concentration applicability

ranges, other water quality concerns,

treatment costs, and operational/

maintenance requirements. This list was

published for comment in the April 21,

2000, Notice of Data Availability

(USEPA 2000e). No comments were

received.

Small system compliance technology

lists are technology specific, but not

product (manufacturer) specific.

Product specific lists were determined

to be inappropriate due to the potential

resource intensiveness involved.

Information on specific products will be

available through another mechanism.

EPA’s Office of Research and

Development has a pilot project under

the Environmental Technology

Verification (ETV) Program to provide

treatment system purchasers with

performance data from independent

third parties.

The currently regulated radionuclides

are already subject to the provisions for

‘‘regular variances’’ and exemptions.

Uranium will be subject to the same

provisions. Variances generally allow a

system to provide drinking water that

may be above the maximum

contaminant level on the condition that

the quality of the drinking water is still

protective of public health. The SDWA

(1415(a)) requires that any system

obtaining a variance must enter into a

compliance schedule with the primacy

entity as a condition of the variance. An

exemption, on the other hand, is

intended to allow a system with

compelling circumstances an extension

of time before the system must comply

with applicable SDWA requirements.

76730 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

An exemption is limited to three years

after the otherwise applicable

compliance date, although extensions

up to a total of six additional years may

be available to small systems under

certain conditions.

N. How Were Stakeholders Involved in

the Development of This Rule?

EPA has consulted with a broad range

of stakeholders and technical experts.

EPA held a two-day stakeholders

meeting on the radionuclides rule in

Washington, DC on December 11–12,

1997. The meeting was announced in

the Federal Register and open to any

one interested in attending in person or

by phone. During the meeting, EPA

discussed a range of regulation

development issues with the

stakeholders, including the statutory

requirements, the stipulated agreement,

MCLs for each of the radionuclides, new

scientific information on health effects,

occurrence, analytical methods,

treatment technologies, and the current

and proposed monitoring framework.

The presentations generated useful

discussion and provided feedback to

EPA regarding technical issues,

stakeholder concerns and possible

regulatory options. Participants in EPA’s

stakeholder meeting included

representatives from the Association of

Metropolitan Water Agencies (AMWA),

Association of State Drinking Water

Administrators (ASDWA), American

Water Works Association (AWWA),

National Association of Water

Companies, State departments of

environmental protection, State health

department, State drinking water

programs, Federal agencies,

environmental groups, and local water

systems. The public docket for this final

rulemaking contains the meeting

summary for EPA’s stakeholder meeting

on radionuclides in drinking water.

In addition, during the regulation

development process, EPA gave

presentations on the radionuclides

regulation at meetings of the AWWA,

ASDWA and EPA State/Regional

conferences, and met with States from

Regions 2, 3, 7, and 8 regarding

radionuclides issues and the upcoming

final rule. EPA participated in AWWA’s

Technical Advisory Workgroup (TAW),

which meets annually to discuss

technical issues including treatment,

occurrence, and health risks. State

public health departments and drinking

water program representatives of both

large and small drinking water districts

participated in TAW meetings. EPA also

held frequent conference calls with

interested State drinking water

programs about the development of the

rule. In addition, EPA made

presentations and received input at

Tribal meetings in Nevada, Alaska, and

California. Finally, EPA held a one-day

meeting with associations that represent

State, county, and local government

elected officials on May 30, 2000, and

discussed five upcoming drinking water

regulations, including radionuclides.

See section V.I ‘‘Executive Order 13132’’

for more information about the meeting.

The Agency utilized the feedback

received from the stakeholders during

all these meetings in developing today’s

final rule.

O. What Financial Assistance Is

Available for Complying With This

Rule?

Various Federal programs exist to

provide financial assistance to State,

local, and Tribal governments to

administer and comply with this and

other drinking water rules. The Federal

government provides funding to States

and Tribes that have a primary

enforcement responsibility for their

drinking water programs through the

Public Water Systems Supervision

(PWSS) Grants program. Additional

funding is available from other

programs administered either by EPA or

other Federal agencies. These include

the Drinking Water State Revolving

Fund (DWSRF) and Housing and Urban

Development’s Community

Development Block Grant Program. For

example, the SDWA authorizes the

Administrator of the EPA to award

capitalization grants to States, which in

turn can provide low cost loans and

other types of assistance to eligible

public water systems. The DWSRF

assists public water systems with

financing the costs of infrastructure

needed to achieve or maintain

compliance with SDWA requirements.

Each State has considerable flexibility to

determine the design of its program and

to direct funding toward its most

pressing compliance and public health

protection needs. States may also, on a

matching basis, use up to ten percent of

their DWSRF allotments for each fiscal

year to assist in running the State

drinking water program.

Under PWSS Program Assistance

Grants, the Administrator may make

grants to States to carry out public water

system supervision programs. States

may use these funds to develop primacy

programs. States may ‘‘contract’’ with

other State agencies to assist in the

development or implementation of their

primacy program. However, States may

not use program assistance grant funds

to contract with regulated entities (i.e.,

water systems). PWSS Grants may be

used by States to set-up and administer

a State program which includes such

activities as: public education, testing,

training, technical assistance,

developing and administering a

remediation grant and loan or incentive

program (excludes the actual grant or

loan funds), or other regulatory or nonregulatory measures.

P. How Are the Radionuclides MCLs

Used Under the Comprehensive

Environmental Response,

Compensation, and Liability Act

(CERCLA)?

The framework for the

Comprehensive Environmental

Response, Compensation, and Liability

Act (CERCLA) and the National Oil and

Hazardous Substances Pollution

Contingency Plan (NCP) includes the

expectation that contaminated ground

waters will be returned to beneficial

uses whenever practicable (see

§ 300.430(a)(1)(iii)(F)). Section 121(d) of

CERCLA requires on-site remedial

actions to attain MCLGs and water

quality standards under CWA when

relevant and appropriate. The NCP

(§ 300.430(e)(2)(i)(B) and (C) clarify that

MCLs or non-zero MCLGs established

under SDWA will typically be

considered relevant and appropriate

cleanup levels for ground waters that

are a current or potential source of

drinking water.

EPA’s guidance on complying with

these requirements are contained in an

EPA document entitled ‘‘Presumptive

Response Strategy and Ex-Situ

Treatment Technologies for

Contaminated Ground Water at CERCLA

Sites, Final Guidance,’’ (October 1996.

OSWER Directive 9283.1–12). A

discussion of the flexibility of EPA’s

guidance under CERCLA on the

attainment of drinking waters in ground

water is contained in section 2.6 ‘‘Areas

of Flexibility in Cleanup Approach’’ (pp

15–19) of the 1996 OSWER directive.

The discussion in the 1996 OSWER

directive regarding monitored natural

attenuation and determining beneficial

uses of groundwater has been updated

by the following EPA guidance

documents: (1) ‘‘Use of Monitored

Natural Attenuation at Superfund,

RCRA Corrective Action, and

Underground Storage Tank Sites’’ (April

1999. Final OSWER Directive 9200.4–

17P), and (2) ‘‘The Role of CSGWPPs in

EPA Remediation Programs’’ (April 4,

1997, OSWER Directive 9283.1–09).

Q. What Is the Effective Date and

Compliance Date for the Rule?

Much of today’s rule will involve

retaining current elements of the

radionuclides NPDWR. Those portions

of the final rule that are unaffected by

the upcoming regulatory changes are

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76731

already in effect. MCLs for gross alpha,

beta particle and photon radioactivity,

and combined radium-226 and -228 will

be unchanged and are already in effect.

Regarding water systems that are

currently out of compliance with the

existing NPDWRs for gross alpha,

combined radium-226 and -228, and/or

beta particle and photon radioactivity,

States with primacy and EPA will

renegotiate, as necessary, enforcement

actions that put systems on compliance

schedules as expeditiously as possible.

Under the Safe Drinking Water Act,

the final rule becomes effective three

years after promulgation December 8,

2003. Under the Standard Monitoring

Framework (SMF), systems usually have

three years to complete the initial

monitoring cycle of four consecutive

quarterly samples. In order to

synchronize the monitoring periods for

radionuclides with the Standardized

Monitoring Framework and alleviate

potential laboratory capacity problems,

the end of the initial monitoring period

will be December 31, 2007. EPA expects

that States will phase-in monitoring

over this period and determine

compliance upon completion of each

water system’s initial monitoring

schedule. For example, the fraction of

water systems that begin monitoring in

the first year would have compliance

determinations made at the end of the

first year, based upon the average results

of the four quarterly samples. New

monitoring includes initial monitoring

for uranium, the new monitoring

requirements for radium-228, and new

initial monitoring under the

requirements for entry points. Data

grandfathering discretion for existing

monitoring data to determine future

monitoring schedules is discussed in

sections I.D and I.J. Combined radium226 and radium-228 MCL violations

which result from the new requirement

for separate radium-228 monitoring will

be treated as ‘‘new violations’’ and will

be on the same schedule as other new

violations (e.g. uranium). Water systems

with existing monitoring data for

radium-228 and uranium that

demonstrate that they are not in

compliance with the MCL will be out of

compliance on the effective date of the

rule.

R. Has EPA Considered Laboratory

Approval/Certification and Laboratory

Capacity?

The ultimate effectiveness of the

approved regulations depends upon the

ability of laboratories to reliably analyze

contaminants at relatively low levels.

The Drinking Water Laboratory

Certification Program is intended to

ensure that approved drinking water

laboratories analyze regulated drinking

water contaminants within acceptable

limits of performance. The Certification

Program is managed through a

cooperative effort between EPA’s Office

of Ground Water and Drinking Water

and the Office of Research and

Development. The program stipulates

that laboratories analyzing drinking

water compliance samples must be

certified by U.S. EPA or the State. The

program also requires that certified

laboratories must analyze Proficiency

Testing (PT) samples [formerly called

Performance Evaluation (PE) samples],

use approved methods and pass

periodic on-site audits.

1. Laboratory Approval/Certification

As discussed in the April 21, 2000

NODA, EPA recently privatized the PT

program, including the Water Supply

(WS) studies. The decision to privatize

the PT studies programs was announced

in the Federal Register on June 12, 1997

(62 FR 32112). The notice indicated that

in the future the EPA would issue

standards for the operation of the

program, while the National Institute of

Standards and Technology (NIST)

would develop standards for private

sector PT suppliers and would evaluate

and accredit PT suppliers. The private

sector would develop and manufacture

PT samples and conduct PT studies.

2. Laboratory Capacity: Laboratory

Certification and PT Studies

The availability of laboratories is also

dependent on laboratory certification

efforts in the individual States with

regulatory authority for their drinking

water programs. Until June of 1999, a

major component of many of these

certification programs was their

continued participation in the current

EPA Water Supply (WS) PT program. As

discussed previously, NIST is

administering the program to accredit a

provider for PT samples for

radionuclides. States also have the

option of approving their own PT

sample providers. The extent to which

the PT program will affect short-term

and long-term laboratory capacity for

radionuclides will be assessed after PT

providers are approved by NIST or the

States. However, EPA anticipates that

radionuclide PT samples will be

available in time to allow for laboratory

certification before compliance

monitoring is required.

3. Summary of Major Comments

Regarding Laboratory Capacity and EPA

Responses

In the April 21, 2000 NODA, the

Agency stated that it is difficult to

ascertain how and if externalization of

the PT program will affect

radiochemical laboratory capacity and

the cost of radiochemical analyses. In

the absence of definitive information,

the Agency solicited public comments

on this subject. The Agency stated in the

NODA that it recognized that PT

externalization may be an

implementation issue for at least three

reasons:

• The externalization of the

radionuclides PT studies program may

cause short-term disruption in

laboratory accreditation;

• Requiring NTNCWSs to monitor

under the Standard Monitoring

Framework will add approximately

20,000 systems to the universe of

systems that are already required to

monitor;

• And the radon rule will be

implemented at approximately the same

time as the radionuclides rule.

To alleviate potential laboratory

capacity problems that could result, the

Agency solicited comments on whether

or not to extend the initial monitoring

period to four years (instead of three

years). Of the 70 commenters who

provided comments on the

radionuclides NODA, 15 commented on

laboratory externalization and its related

issues. The major concerns raised by the

commenters and the Agency’s responses

to them are provided below.

a. Laboratory Certification,

Availability of PT Samples and Costs of

PT Samples: Several commenters noted

there is currently no certification

process through which laboratories can

receive State certification for

radionuclide analyses due to the lack of

availability of PT samples. Some

commenters noted that only one PT

provider has volunteered to provide PT

samples for radionuclides and based on

their inquiries, PT sample costs are too

high. Commenters believe the high costs

of PT samples will affect the resulting

costs of the radiochemical analyses (by

increasing operational costs). Several

commenters felt EPA should reconsider

the privatization of PT program.

Commenters stated that EPA must

ensure that an adequate number of

laboratories are available to perform

accurate measurements and provide

data of good quality for compliance and

enforcement efforts.

After evaluating public comment,

EPA published its final decision about

the externalization of the PT Program in

the June 12, 1997 final notice (62 FR

32112). Currently, the PT program for

radionuclides is being privatized, i.e.,

operated by an independent third party

provider accredited by the National

Institute of Standards and Technology

(NIST). EPA believes this program will

76732 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

ensure the continued viability of the

existing PT programs, with EPA

maintaining oversight. NIST is in the

process of approving a provider for PT

samples for radionuclides. To alleviate

concerns about the costs of PT samples,

States have the option to approve PT

sample provider(s) themselves. The

Agency anticipates that radionuclide PT

samples will be available in time to

allow for laboratory certification before

compliance monitoring is required.

b. Laboratory Capacity: Commenters

stressed the impact that the

externalization of the PT program, this

regulation and the radon regulation

would have on laboratory capacity and

workloads of the laboratories. Some

commenters felt the externalization and

high costs of PT samples would

decrease the number of radiochemical

laboratories and in affect decrease

laboratory capacity. Also, commenters

felt that if EPA required 48–72 hour turn

around times for gross alpha (to catch

the alpha particle contribution from

radium-224) or monitoring of regulated

radionuclides by NTNCWSs,

radiochemical laboratories would not be

able to address the additional demand

for analytical services. EPA agrees that

laboratory capacity could be effected by

the externalization of the PT program. In

an effort to alleviate potential laboratory

capacity problems, EPA has agreed to

extend the initial monitoring period

from three to four years. Extending the

initial monitoring period will spread the

burden on the laboratories as well as the

costs associated with the monitoring. In

addition, EPA is allowing systems to

grandfather existing data on currently

regulated radionuclides and composite

under certain circumstances (for more

information on compositing and

grandfathering, see section I.J. In

addition, because EPA has decided not

to require a 48 to 72 hour turn around

time for gross alpha particle activity nor

to regulate NTNCWSs, the potential

burden on laboratory capacity should be

alleviated.

II. Statutory Authority and Regulatory

Background

A. What Is the Legal Authority for

Setting National Primary Drinking

Water Regulations (NPDWRs)?

The SDWA requires EPA to

promulgate regulations pertaining to

public water systems. Specifically,

section 1412(b)(4) requires that EPA set

a health-based goal called a maximum

contaminant level goal (MCLG) as a

target for setting an enforceable

standard, the maximum contaminant

level (MCL). The MCLG is determined

by studies of the health effects of

contaminants on animals under

laboratory conditions or humans via

epidemiological studies. The MCLG is

the level at which no known or

anticipated adverse effects on the health

of persons occur and which allows an

adequate margin of safety. The Safe

Drinking Water Act requires EPA to set

the MCL as close to the MCLG as is

‘‘feasible,’’ which is defined as ‘‘feasible

with the use of the best technology,

treatment techniques and other means

which the Administrator finds, after

examination for efficacy under field

conditions and not solely under

laboratory conditions, are available

(taking cost into consideration) * * *’’

[section 1412(b)(4)(D)]. Additionally,

section 1412(b)(6) provides that if the

Administrator determines that at the

feasible level, the benefits do not justify

the costs, EPA can set a standard which

maximizes the health risk reduction

benefits at a cost that is justified by the

benefits. In today’s rule, EPA is

invoking these authorities with respect

to the uranium standard. Section 1412

(b)(9) requires that any revisions to

NPDWRs maintain or provide for greater

protection of the health of persons.

B. Is EPA Required To Finalize the 1991

Radionuclides Proposal?

The SDWA requires that EPA issue

MCLGs for the currently regulated

radionuclides in drinking water and

establish a NPDWR for uranium. When

EPA failed to finalize the 1991 proposal,

a citizen group brought suit to establish

a schedule for finalizing the appropriate

portions of the proposal. Following the

1996 amendments to the SDWA, the

plaintiffs and EPA agreed on a schedule

for completing the revisions to the

radionuclides rulemaking by either

finalizing applicable parts of the 1991

proposal or affirming the validity of the

current rule with an explanation of why

the current rule is preferable. With

respect to uranium, EPA has no current

rule, and is required to finalize a

uranium regulation on the same

schedule as gross alpha particle activity,

combined radium-226 and -228, and

beta particle and photon radioactivity.

This agreement was reflected in a

stipulation of the parties in litigation in

U.S. District Court in Oregon.

III. Rule Implementation

A. What Are the Requirements for

Primacy?

This section describes the regulations

and other procedures and policies

primacy entities have to adopt, or have

in place, to implement today’s final

rule. States must continue to meet all

other conditions of primacy in 40 CFR

part 142.

Section 1413 of the SDWA establishes

requirements that primacy entities

(States or Indian Tribes) must meet to

maintain primary enforcement

responsibility (primacy) for its public

water systems. These include:

(1) Adopting drinking water

regulations that are no less stringent

than Federal NPDWRs in effect under

sections 1412(a) and 1412(b) of the Act,

(2) Adopting and implementing

adequate procedures for enforcement,

(3) Keeping records and making

reports available on activities that EPA

requires by regulation,

(4) Issuing variances and exemptions

(if allowed by the State) under

conditions no less stringent than

allowed by sections 1415 and 1416, and

(5) Adopting and being capable of

implementing an adequate plan for the

provision of safe drinking water under

emergency situations.

40 CFR part 142 sets out the specific

program implementation requirements

for States to obtain primacy for the

Public Water Supply Supervision

Program, as authorized under section

1413 of the Act. In addition to adopting

the basic primacy requirements, States

may be required to adopt special

primacy provisions pertaining to a

specific regulation. These regulationspecific provisions may be necessary

where implementation of the NPDWR

involves activities beyond those in the

generic rule. States are required by

§ 142.12 to include these regulationspecific provisions in an application for

approval of their program revisions.

These State primacy requirements apply

to today’s final rule, along with the

special primacy requirements discussed

below.

To implement today’s final rule,

States are required to adopt revisions to

§ 141.25—Analytical methods for

radioactivity; § 141.26—Monitoring

frequency and compliance requirements

for radioactivity in community water

systems; appendix A to subpart O—

Regulated contaminants; appendix A to

subpart Q—NPDWR violations and

other situations requiring public notice;

appendix B to subpart Q—Standard

health effects language for public

notification; § 142.16—Special primacy

requirements; and new requirements

§ 141.55—Maximum contaminant level

goals for radionuclides; and § 141.66—

Maximum contaminant levels for

radionuclides.

B. What Are the Special Primacy

Requirements?

In addition to adopting drinking water

regulations at least as stringent as the

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76733

Federal regulations listed above, EPA

requires that States adopt certain

additional provisions related to this

regulation to have their program

revision application approved by EPA.

The State’s request for approval must

contain the following:

(1) If a State chooses to use

grandfathered data in the manner

described in § 141.26(a)(2)(ii)(C) of this

chapter, then the State must describe

the procedures and criteria which it will

use to make these determinations

(whether distribution system or entry

point sampling points are used).

(i) The decision criteria that the State

will use to determine that data collected

in the distribution system are

representative of the drinking water

supplied from each entry point to the

distribution system. These

determinations must consider:

(A) All previous monitoring data.

(B) The variation in reported activity

levels.

(C) Other factors affecting the

representativeness of the data (e.g.

geology).

(2) A monitoring plan by which the

State will assure all systems complete

the required monitoring within the

regulatory deadlines. States may update

their existing monitoring plan or use the

same monitoring plan submitted for the

requirements in § 142.16(e)(5) under the

National Primary Drinking Water

Regulations for the inorganic and

organic contaminants (i.e. the Phase II/

V Rules). States may note in their

application any revision to an existing

monitoring plan or note that the same

monitoring plan will be used. The State

must demonstrate that the monitoring

plan is enforceable under State law.

There are many ways that a State may

satisfy the special primacy

requirements. The Agency intends to

issue guidance regarding ways to satisfy

these requirements, but States have the

flexibility to develop individual

programs appropriate for the

circumstances within each State.

C. What Are the Requirements for

Record Keeping?

The current regulations in § 142.14

require States with primacy

enforcement responsibility to keep

records of analytical results to

determine compliance, system

inventories, sanitary surveys, State

approvals, vulnerability determinations,

monitoring requirements, monitoring

frequency decisions, enforcement

actions, and the issuance of variances

and exemptions. These records include:

(1) Any determination of a system’s

vulnerability to contamination by beta

and photon emitters (§ 142.14(d)(4));

and

(2) Any determination that a system

can reduce or increase monitoring

frequency for gross alpha particle

activity, gross beta particle and photon

radioactivity, uranium, radium-226 and

228. The records must include the basis

for the decision, and the repeat

monitoring frequency (§ 142.14(d)(5)).

Since these requirements are

generally included in § 142.14(d)(4) and

(5), revisions to the rule are not

necessary.

D. What Are the Requirements for

Reporting?

Currently, States must report to EPA

information under § 142.15 regarding

violations, variances and exemptions,

enforcement actions and general

operations of State public water supply

programs. These reporting requirements

remain unchanged and apply to the

radionuclides as with any other

regulated contaminant.

E. When Does a State Have To Apply for

Primacy?

The State must submit a request for

approval of program revisions that

adopts the uranium MCL, implementing

regulations, and other revisions

promulgated in today’s final rulemaking

within two years of the publication date

of today’s rule unless EPA approves an

extension per § 142.12(b). To maintain

primacy for the Public Water Supply

Supervision (PWSS) Program and to be

eligible for interim primacy enforcement

authority for future regulations, States

must adopt today’s rule. Interim

primacy enforcement authority allows

States to implement and enforce

drinking water regulations once State

regulations are effective and the State

has submitted a complete and final

primacy revision application. To obtain

interim primacy, a State must have

primacy with respect to each existing

NPDWR. Under interim primacy

enforcement authority, States are

effectively considered to have primacy

during the period that EPA is reviewing

their primacy revision application.

F. What Are Tribes Required To Do

Under This Regulation?

Currently, no federally recognized

Indian tribes have primacy to enforce

any of the drinking water regulations.

EPA Regions implement the rules for all

Tribes under section 1451(a)(1) of

SDWA. Tribes would need to submit a

primacy application in order to have the

authority to implement the

radionuclides NPDWRs. Tribes with

primacy for drinking water programs are

eligible for grants and contract

assistance (section 1451(a)(3)). Tribes

are also eligible for grants under the

Drinking Water State Revolving Fund

Tribal set aside grant program

authorized by SDWA section 1452(i) for

public water system expenditures.

IV. Economic Analyses

Under Executive Order 12866,

Regulatory Planning and Review, EPA

must estimate the costs and benefits of

the finalized changes to the

Radionuclides NPDWRs and submit the

impact analysis to the Office of

Management and Budget (OMB) as part

of the rulemaking process. EPA has

prepared an Economic Analysis (USEPA

2000g) to comply with the requirements

of this Order. This section provides a

summary of the information from the

economic analysis regarding estimates

of the costs and benefits related to the

changes to the existing radionuclides

NPDWRs and the uranium NPDWR

being finalized today. The economic

analysis is an update to the Health Risk

Reduction and Cost Analysis (USEPA

2000f) announced in the NODA (USEPA

2000e) and summarized in the NODA’s

Technical Support Document (USEPA

2000h). The updates to the economic

analysis reflect comments received on

the NODA. This section will not repeat

all of the material presented in the

NODA and in some cases will refer back

to that notice. Changes made in

response to comments will be

highlighted.

A. Estimates of Costs and Benefits for

Community Water Systems

Two requirements under today’s rule

are expected to incur costs and benefits:

the adoption of the uranium MCL of 30

μg/L and the requirement for separate

monitoring of radium-228, which is

expected to result in additional systems

in violation of the combined radium226/-228 MCL of 5 pCi/L. EPA estimates

that these requirements will result in

annual compliance costs of $81 million

in 1999 dollars, with $25 million of this

annual cost being due to mitigation of

systems newly in violation of the

radium-226/-228 standard due to new

monitoring requirements, $51 million

due to mitigation of systems in violation

of a uranium MCL of 30 μg/L, $ 4.9

million due to monitoring and reporting

by CWSs, and $ 0.06 million due to new

implementation costs for States. While

these represent new compliance costs,

most water systems will experience

reduced compliance costs in the longterm because of reduced monitoring

frequency for systems with low

contaminant levels under the

Standardized Monitoring Framework.

The basis for these estimates, and

76734 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

11The monitoring deficiency is corrected by

requiring the separate analysis of radium-228 for

systems with gross alpha levels below 5 pCi/L and

radium-226 levels below 3 pCi/L.

12The Agency has agreed to consider the July 27,

2000 recommendations of its Science Advisory

Board (SAB) concerning discounting of benefits in

future drinking water regulations. In particular, the

SAB recommended that quantitative adjustments to

benefits be considered with respect to timing of risk

(e.g., consideration of a lag or latency period before

the resulting cancer fatality) and income growth.

The SAB also recommended that other possible

adjustments to benefits estimates be considered in

a qualitative manner. We have not made any such

adjustments to the benefits associated with today’s

rule since the principal benefits are nonquantifiable (avoidance of kidney toxicity due to

reductions in exposure to uranium). We do not

alternate cost estimates using different

assumptions are described later in this

section.

State implementation and CWS start

up costs are estimated to be $10 million

annually for the first three years. Of this

$10 million, approximately $ 0.25

million are State start up costs with the

remainder being comprised by CWS

start up costs (USEPA 2000d). Over the

first twenty-three year period, the

implementation costs for States and

CWSs are estimated to be $ 4.9 million

annually (included in the annual

compliance costs reported previously).

These costs include preparation of the

primacy application, training, planning,

and other compliance preparations, and

monitoring and reporting costs for

PWSs.

The treatment/non-treatment

compliance unit costs and national

costing assumptions used in the

Economic Analysis (USEPA 2000g) are

standard and are consistent with those

used for estimating the costs of

compliance the other recently proposed

drinking water rules. The updated

Technologies and Costs document

(USEPA 2000i) provides unit capital

and ‘‘operations & maintenance’’ costs

for water treatment plants, including

residuals disposal costs. Typical model

small system treatment costs ranged

from $ 0.25 to $ 3 per kilogallon of

water treated, with associated annual

per household costs ranging from $20 to

$250, with the value depending upon

water system size and water quality.

Large system model unit costs ranged

from $0.17 to $ 0.28 per kilogallon

treated, with associated annual per

household costs ranging from $14 to

$23.

For various reasons (see the NODA’s

Technical Support Document for

details, USEPA 2000h), the estimate of

monetized benefits associated with

compliance of today’s rule are more

uncertain than the costs estimates. In

the case of the requirement for separate

monitoring for radium-228, cancer risk

reduction benefits of $1.7 million

annually are expected. While the net

benefits for this monitoring change are

expected to be negative, this monitoring

change is essential for enforcing the

combined radium-226/-228 standard. In

the case of the uranium standard, the

benefits are difficult to monetize, since

the number of kidney toxicity cases

avoided cannot be estimated using

current risk models. For this reason, the

uranium kidney toxicity benefits are

considered to be ‘‘non-quantified

benefits’’ for this rule. As discussed in

detail in part D of section I (‘‘Rationale

for the Final Uranium MCL’’), we

consider these non-quantified kidney

benefits to be a significant part of this

assessment of costs and benefits.

The uranium cancer risk reduction

benefits are estimated to be $3 million

annually, which, we reiterate, do not

include the non-quantified kidney

toxicity risk reduction benefits. As

discussed in the NODA, there are

significant uncertainties associated with

any estimate of drinking water benefits,

including uncertainties in the unit risks

used to estimate risk reductions and the

various health endpoints that cannot yet

be fully quantifitied.

Other non-quantified benefits include

those related to the technologies used to

remove radium and uranium from

ground water (e.g., water softening

technologies like ion exchange, lime

softening, and membrane softening and

iron removal technologies like green

sand filtration and oxidation/filtration).

EPA does not have enough information

to estimate these benefits, but believes

that they could be significant. Examples

of benefits related to water softening

include reductions in excessive calcium

and manganese carbonate scaling in

distribution systems, water heaters, and

boilers and reductions in soap and

detergent use. Examples of benefits

related to iron removal include

improvements in color and taste and

reduction in staining of clothes, sinks,

and basins.

B. Background

1. Overview of the 1991 Economic

Analysis

Many of the options proposed in 1991

economic analysis are not being

finalized today. Today’s discussion will

focus on the analysis of costs and

benefits of the options that are being

finalized: a final uranium standard and

separate monitoring for radium-228. The

1991 economic analysis (USEPA 1991)

estimated the annual cost of compliance

with a uranium MCL of 20 μg/L to be

$55 million, affecting approximately

1,500 systems, the vast majority of them

being small systems. The 1991 estimate

of the annual cost of compliance with a

uranium MCL of 40 μg/L was $23

million. The current estimate of the cost

of compliance with a uranium MCL of

20 μg/L is $93 million, impacting 900

systems, most of them small.

2. Summary of the Current Estimates of

Risk Reductions, Benefits, and Costs

Table IV–1 shows the summarized

results for EPA’s analysis of risk

reductions, benefits valuations, and

costs of compliance (see USEPA 2000g

for more detailed break-downs of the

risk reductions, costs, and benefits by

system size). The risk reductions and

cost estimates are based on the

estimated range of numbers of

community water systems predicted to

be out of compliance with the uranium

MCL of 30 μg/L and the systems that are

predicted to be out of compliance with

the current combined radium-226/-228

standard of 5 pCi/L because of the new

requirement for separate radium-228

monitoring. The best estimate values

shown are the midpoints from ranges

that are based on the two occurrence

model methodologies described in the

NODA (USEPA 2000e), the ‘‘direct

proportions’’ and ‘‘lognormal model’’

approaches. As described in the NODA,

these two approaches are expected to

serve as ‘‘low-end’’ and ‘‘high-end’’

occurrence estimates, respectively.

Eliminating the combined radium226/-228 monitoring deficiency 11 is

predicted to lead to 295 (range of 270 to

320) systems out of compliance with an

MCL of 5 pCi/L, affecting 420,000

persons (range 380,000 to 460,000). A

uranium MCL of 30 μg/L is predicted to

impact 500 systems (range 400 to 590),

affecting 620,000 persons (range 130,000

to 1,100,000). The estimates of

occurrence and risk reductions for a

uranium MCL of 30 μg/L are based on

the assumption that the activity-to-mass

ratio in drinking water is 0.9 μg/pCi.

Based on the available information, the

average activity-to-mass ratio for the

various uranium isotopes in drinking

water typically varies from 0.7 to 1.5

pCi/μg.

The estimated cancer morbidity risk

reduction for the option addressing the

combined radium monitoring deficiency

is 0.4 (0.3 to 0.5) cancer cases avoided

annually, with an associated annual

monetized benefit of $1.7 million (range

of $1.2 to $2.2 million). The annual

cancer morbidity risk reduction

estimated for a uranium MCL of 30 μg/

L is 0.9 cases/year (range 0.1 to 1.6). The

associated annual monetized benefit

related to uranium cancer risk reduction

is $3 million (range from $0.2 to $6

million) 12. The risk reductions and

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76735

believe that adjustments to these monetized cancer

avoidance benefits estimates for either timing or

income growth would materially affect our benefits

assessment or decisions resulting from overall

consideration of the benefits and costs of the

regulatory standard.

benefits shown for uranium do not

include those related to kidney toxicity,

which are non-quantifiable (cases

avoided cannot be estimated). As

discussed in section I.D.2 of today’s

final rule, these non-quantifiable

benefits are projected to be preventing a

series of adverse affects on the

functioning of the kidney such as

proteinuria (e.g., reabsorption

deficiency or leakage of albumin), that

could ultimately lead to a more

widespread breakdown in kidney

tubular function. Such effects on tubular

function would be manifested by an

impaired ability of the kidneys to filter

and reabsorb nutrients and to excrete

urine.

Annual compliance costs are

estimated to be $25 million (range $16

to $35 million) for the option addressing

the combined radium monitoring

deficiencies. Annual compliance costs

for the uranium NPDWR are predicted

to be $51 million (range from $9 to $92

million). In addition to these mitigation

related compliance costs, water systems

are expected to incur $4.9 million

annually in monitoring and reporting

costs. As demonstrated by this analysis

the estimated range of central-tendency

annual compliance costs exceed the

ranges of central-tendency annual

monetized benefits for both provisions

finalized today.

TABLE IV–1.—SUMMARY OF COSTS AND BENEFITS FOR COMMUNITY WATER SYSTEMS PREDICTED TO BE IMPACTED BY

THE REGULATORY OPTIONS BEING CONSIDERED FOR FINALIZATION

Options

Numbers of systems impacted 1

(population exposed above MCL)

Estimated lifetime

radiogenic cancer

morbidity risk at

MCL 2, 3, 4

Total cancer cases avoided

annually (fatal cases)

Best-estimate value of

avoided cancer cases, in

millions of

$/year)

Best-estimate of

annual compliance costs, in

millions of

$/year)

Systems predicted to be impacted by corrections to the monitoring deficiencies for combined radium-226 and -228

Eliminate combined

radium monitoring

deficiency.

295 systems (420

K persons).

1×10¥4 ................. 0.4 ........................................

(0.3)

1.7 ........................................ 25

Systems predicted to be out of compliance with proposed options for uranium MCL

Uranium at 30 μg/L 500 systems (620

K persons).

1×10¥4 (assumes

30 pCi/).

0.9 ........................................

(0.6)

(Total Number of kidney toxicity cases cannot be accurately estimated, but expected to be substantial)

3.0 ........................................

Kidney toxicity benefits

range from prevention of

mild proteinurea to possible more serious impaired kidney tubular function

51

Notes: Compliance costs do not include monitoring and reporting costs, which comprise an additional $5 million annually. Ranges based on

directly proportional versus lognormal distribution approach. 1 Compared to the initial baseline (i.e., occurrence data are adjusted to eliminate existing MCL violations) for combined radium. Occurrence

data is unadjusted for uranium options. 2 1×10 is equivalent to ‘‘one in ten thousand’’, EPA’s usual upper limit of acceptable cancer incidence (morbidity) risk for contaminants in drinking water. 3These risk estimates are based on several simplifying assumptions and are only meant to be illustrative. The reported combined radium risk

is based on an ‘‘occurrence weighted average’’ for radium-226 and radium-228 (2.3×10¥5 per pCi/L). The ‘‘best-estimate’’ for a particular situation would depend on the actual levels of Radium226 and Radium228 that comprise the combined level of 5 pCi/L. Regarding uranium risks,

since the individual uranium isotopes that make up naturally-occurring uranium have cancer morbidity risks that are similar in magnitude (6.4 to

7.1×10¥11 per pCi), the assumptions about isotopic prevalence are not important. Here, we assumed that the simple average applied (3.83×10¥6

per pCi/L). 4Kidney toxicity is not considered in this estimate of risk or monetized benefits.

3. Uncertainties in the Estimates of

Benefits and Cost

The models used to estimate costs and

benefits related to regulatory measures

have uncertainty associated with the

model inputs. The types and

uncertainties of the various inputs and

the uncertainty analyses for risks,

benefits, and costs are qualitatively

discussed in this section.

a. Uncertainties in Risk Reduction and

Benefits Estimates

For each individual radionuclide,

EPA developed a central-tendency risk

coefficient that expresses the estimated

probability that cancer will result in an

exposed individual per unit of

radionuclide activity (e.g., per pCi/L)

over the individual’s lifetime (assumed

to be 70 years). Two types of risks are

considered, cancer morbidity, which

refers to any incidence of cancer (fatal

or non-fatal), and cancer mortality,

which refers to a fatal cancer illness. For

this analysis, we used the draft

September 1999 risk coefficients

developed as part of EPA’s revisions to

Federal Guidance Report 13 (FGR–13,

EPA 1999e). FGR–13 compiled the

results of several models predicting the

cancer risks associated with

radioactivity. The cancer sites

considered in these models include the

esophagus, stomach, colon, liver, lung,

bone, skin, breast, ovary, bladder,

kidney, thyroid, red marrow (leukemia),

as well as residual impacts on all

remaining cancer sites combined.

There are substantial uncertainties

associated with the risk coefficients in

FGR–13 (EPA 1999e): researchers

estimate that some of the coefficients

may change by a factor of more than 10

if plausible alternative models are used

to predict risks. While the report does

not bound the uncertainty for all

radionuclides, it estimates that the

central-tendency risk coefficients for

uranium-234 and radium-226 may

change by a factor of seven depending

on the models employed to estimate

76736 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

13Table 2.4, Uncertainty Categories for Selected

Risk Coefficients. Federal Guidance Report 13

(1999).

14 It is difficult to estimate these costs due to

recent efforts by many CWSs to comply with the

current radium rule, however, we would expect

approximately 200–400 systems would spend in the

range of $18–36 million annually to comply with

the current standard. (Low estimate in range is

based on recent SDWIS data; high estimate is based

on 1984 NIRS occurrence database.)

risk.13 Ranges that reflect uncertainty

and variability in the risk coefficients

have been used to conduct a sensitivity

analysis of risk reductions and benefits,

the results of which are reported in

Economics Analysis (USEPA 2000g).

Since the available occurrence data do

not provide information on the

contribution of individual radionuclides

or isotopes to the total activities of gross

alpha or uranium, there is uncertainty

involved in the assumptions about

isotopic ratios. These and other

uncertainties related to occurrence

information (e.g., uncertainty in

extending the NIRS database results to

the national level) also contribute to

uncertainty in the estimates of impacts.

Other inputs that were used in the

sensitivity analysis of risk reductions

and benefits are the age- and genderdependent distributions of water

ingestion, which are used in estimating

lifetime exposure, and the credible

range for the ‘‘value of a statistical life.’’

b. Uncertainty in Compliance Cost

Estimates

Regarding uncertainty in the

compliance cost estimates, these

estimates assume that most systems will

install treatment to comply with the

MCLs, while recent research suggests

that water systems usually select

compliance options like blending

(combining water from multiple

sources), developing new ground water

wells, and purchasing water (USEPA

2000g). As discussed in the NODA,

preliminary data (202 compliance

actions from 14 States) on nitrate

violations suggest that only around a

quarter (25%) of those systems taking

action in response to a nitrate violation

installed treatment, while roughly a

third developed a new well or wells.

The remainder either modified the

existing operations (10–15%), blended

(15%), or purchased water (15–20%).

Similar data for radium violations from

the State of Illinois (77 compliance

actions) indicate that around a quarter

of systems taking action installed

treatment, while the majority (50–55%)

purchased water, with the remainder

(20–25%) either installing a new well,

blending, or stopping production from

the contaminated well or wells. EPA

will continue to gather information

regarding the prevalence of treatment

versus non-treatment options for

compliance for other contaminants. At

this time, this data is considered

preliminary and will be used for

comparisons only.

To evaluate the potential variability in

the compliance cost estimates, EPA has

performed a sensitivity analysis for

uncertainties in the decision tree by

varying the assumed percentages for the

modeled compliance options. Since per

system costs are much higher for very

large systems, the assumptions used in

the large water system size categories

can be expected to dominate the

variability in national costs. The

sensitivity analysis results are reported

in the Economic Analysis (USEPA

2000g).

4. Major Comments

Following is a summary of the major

comments received on the analysis of

costs and benefits for the finalization of

the radionuclides rule.

a. Retention of radium-226/-228 MCL

of 5 pCi/L: Several commenters

suggested that the costs and benefits of

compliance with the existing radium226/-228 MCL should be included in the

analysis of the costs and benefits of the

finalization of today’s rule, because

‘‘systems currently in non-compliance

with the combined radium MCL are in

that situation because of EPA’s

proposed rule changes in 1991.’’ EPA

disagrees with this comment since all of

MCLs for the currently regulated

radionuclides, including radium-226/-

228 have been fully enforceable since

1976. While some may argue that the

radionuclides rules were ‘‘National

Interim Primary Drinking Water

Regulations’’ (NIPDWRs) between 1976

and 1986, NIPDWRs were fully

enforceable. In addition, six years

elapsed between the re-authorization of

the Safe Drinking Water Act (1986),

which finalized all NIPDWRs, and the

1991 proposal. Given the fact that 25

years have elapsed since this MCL

became an enforceable standard, EPA

believes that it is appropriate to

consider only the costs and benefits of

the changes that are being made in the

current standards. In view of the fact

that 25 years have elapsed since this

MCL became an enforceable standard,

EPA believes that is appropriate to

consider only the costs and benefits of

the changes that are made to the current

radium standards as a cost of today’s

rule. EPA further believes that any costs

incurred by facilities that are required to

comply with the 1976 rule represent

deferred costs that those facilities

elected not to expend until now.14

b. Cost/Benefit Analysis

Requirements: One commenter

suggested that the analysis of costs and

benefits, as presented in the Notice of

Data Availability (USEPA 2000e)

omitted some information required

under section 1412(b)(4)(C) of the 1996

SDWA. EPA disagrees with this

comment. All of the required

information relevant to the analysis of

costs and benefits for the options

considered are found in the draft Health

Risk Reduction and Cost Analysis

(HRRCA, USEPA 2000f), which was

announced by and described in the

NODA. In the HRRCA, EPA did meet

the requirements of the Safe Drinking

Water Act for performing analyses of

costs and benefits. For compliance with

each regulatory option being

considered, EPA updated the analysis

supporting the 1991 radionuclides

proposal, including estimates of

quantifiable and non-quantifiable health

risk reduction benefits, quantifiable and

non-quantifiable health risk reduction

benefits likely to occur from reductions

in co-occurring contaminants (excluding

those associated with compliance with

other proposed or promulgated

regulations), quantifiable and nonquantifiable costs, the incremental costs

and benefits for the uranium options,

the effects of the contaminant on the

general population and on sensitive

groups within the population (e.g.,

children), and other relevant factors. In

addition to the HRRCA, EPA is

supporting today’s final actions with a

Economic Analysis (USEPA 2000g) that

builds on the HRRCA, including some

changes made in response to comments

received.

c. Cumulative Affordability: Several

commenters suggested that EPA

consider the cumulative impact of its

regulations on the affordability of water

service, as opposed to looking at

affordability one regulation at a time.

EPA agrees that it would be best to look

at ‘‘cumulative affordability,’’ since this

is the only realistic indicator of

affordability. For this reason, EPA

includes a ‘‘water bill baseline’’ in its

affordability assessments, which

includes cumulative impacts from

existing regulations. When a rule is

promulgated, the water bill baseline

increases and the estimate of

affordability decreases, the details of

which depend on the percentages of

systems impacted and the estimates of

the annual per household costs

associated with the regulation. The

affordability assessment supporting the

uranium small systems compliance

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76737

technology list is based on the current

baseline, which is described in

‘‘Variance Technology Findings for

Contaminants Regulated Before 1996’’,

which can be downloaded at ‘‘http://

www.epa.gov/OGWDW/standard/

varfd.pdf.’’ As future rules are

promulgated that impact small water

systems (including this one), this

baseline will be revised.

d. Disposal costs: One commenter

suggested that EPA ‘‘did not adequately

address the disposal of waste stream

residuals’’ in the NODA and that waste

disposal costs are a ‘‘significant factor’’

in estimating costs. EPA agrees that

waste disposal considerations are very

important when considering the

implementation of this rule. Since the

only MCL that EPA is finalizing today

is the uranium MCL (the others are

existing regulations), this is the only

MCL that could be impacted by this

consideration. In estimating the

compliance costs for today’s actions,

EPA did include waste disposal costs in

its estimate of treatment costs, including

estimated waste-related capital costs,

operations and maintenance costs, and

residuals disposal. EPA believes that its

estimate of residuals disposal are

adequate and are based on the best

available information.

e. Discounting of Costs and Benefits:

One commenter stated that it is

‘‘appropriate and standard practice to

ensure that costs and benefits be

evaluated on the same basis to avoid

apples and oranges comparison,’’

further stating that EPA should discount

both or neither. EPA agrees that costs

and benefits should be evaluated in

such a way that they can be compared.

One approach to accomplish this is to

annualize the costs and benefits of the

regulation. In such instances, the capital

costs, paid up front, need to be spread

out across the life of the equipment. To

do that, one needs to reflect the time

value of resources. The analyst must ask

the question: What is the annual

payment that could finance the capital

investment? Such a calculation would

reflect the social discount rate. Annual

operations and maintenance (O&M)

costs would not have to be annualized,

since these costs are assumed to be

accrued on a continual basis each year.

Ideally, the analysis would also

annualize the benefits using the same

techniques. As noted previously, we

have not made any such adjustments to

the benefits associated with today’s rule

for uranium since the principal benefits

are non-quantifiable (avoidance of

kidney toxicity due to reductions in

exposure to uranium). We do not

believe that adjustments to these

benefits estimates for either timing or

income growth would materially affect

our benefits assessment or decisions

resulting from overall consideration of

the benefits and costs of the regulatory

standard.

f. Use of MCLs for Ground Water

Protection Needs to be Evaluated as Part

of this Rulemaking: One commenter

stated that, since linkages are made

between drinking water standards and

‘‘clean-up standards’’ for radioactively

contaminated sites, the costs and

benefits of applying drinking water

standards to clean-up efforts should be

evaluated as part of this rulemaking.

EPA disagrees that clean-up costs and

benefits should be used to influence the

setting of drinking water MCLs. EPA

does, however, agree that cross-program

costs and benefits should be considered

when appropriate. In this case, it is

inappropriate to consider clean-up and

ground water protection costs since

MCLs are set specifically and solely

with drinking water exposures in mind.

If another program or Agency applies

these MCLs for other purposes (e.g.,

clean-up standards), then the costs and

benefits of that application should be

considered when evaluating that

application.

V. Other Required Analyses and

Consultations

A. Regulatory Flexibility Act (RFA)

The RFA, as amended by the Small

Business Regulatory Enforcement

Fairness Act of 1996 (SBREFA), 5 USC

601 et seq., generally requires an agency

to prepare a regulatory flexibility

analysis of any rule subject to notice

and comment rulemaking requirements

under the Administrative Procedure Act

or any other statute unless the agency

certifies that the rule will not have a

significant economic impact on a

substantial number of small entities.

Small entities include small businesses,

small organizations, and small

governmental jurisdictions.

The RFA provides default definitions

for each type of small entity. It also

authorizes an agency to use alternative

definitions for each category of small

entity, ‘‘which are appropriate to the

activities of the agency’’ after proposing

the alternative definition(s) in the

Federal Register and taking comment. 5

U.S.C. sec. 601(3)–(5). In addition to the

above, to establish an alternative small

business definition, agencies must

consult with SBA’s Chief Counsel for

Advocacy.

For purposes of assessing the impacts

of today’s rule on small entities, EPA

considered small entities to be CWSs

serving fewer than 10,000 persons. This

is the cut-off level specified by Congress

in the 1996 Amendments to the Safe

Drinking Water Act for small system

flexibility provisions. Because this

definition does not correspond to the

definitions of ‘‘small’’ for small

businesses, governments, and non-profit

organizations, EPA requested comment

on an alternative definition of ‘‘small

entity’’ in the preamble to the proposed

Consumer Confidence Report (CCR)

regulation (63 FR 7620, February 13,

1998). Comments showed that

stakeholders support the proposed

alternative definition. EPA also

consulted with the Small Business

Administration’s Office of Advocacy on

the definition as it relates to small

business analysis. In the preamble to the

final CCR regulation (63 FR 4511,

August 19, 1998), EPA expressed its

intention to use this alternative

definition for regulatory flexibility

assessments under the RFA for all

drinking water regulations and has thus

used it in this final rulemaking.

In accordance with section 603 of the

RFA, EPA prepared an initial regulatory

flexibility analysis (IRFA) for the 1991

proposed rule (see 56 FR 33050). Since

the proposed rule (July 18, 1991) predated the 1996 Amendments to the

RFA, EPA did not convene a Small

Business Advocacy Review Panel for

this rule.

We also prepared a final regulatory

flexibility analysis (FRFA) for today’s

final rule. The FRFA addresses the

issues raised by public comments on the

IRFA, which was part of the proposal of

this rule. The FRFA is available for

review in the docket and is summarized

below.

The RFA requires EPA to include the

following when completing an FRFA:

(1) A succinct statement of the need

for, and objectives of the rule;

(2) A summary of the significant

issues raised by the public comments on

the IRFA, and a summary of the

assessment of those issues, and a

statement of any changes made to the

proposed rule as a result of those

comments;

(3) A description of the types and

number of small entities to which the

rule will apply and the impact they will

experience, or an explanation why no

estimate is available;

(4) A description of reporting, record

keeping, and other compliance

requirements of the rule, including an

estimate of the classes of small entities

which will be subject to the rule and the

type of professional skills necessary for

preparation of reports or records; and

(5) A description of the steps the

Agency has taken to minimize the

significant impact on small entities

consistent with the stated objectives of

76738 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

the applicable statutes, including a

statement of the factual, policy, and

legal reasons why we selected the

chosen alternative in the final rule and

why the other significant alternatives to

the rule were rejected.

EPA has considered and addressed all

of the requirements. The following is a

summary of the FRFA. The need for and

objectives for the rule are discussed in

sections I.A, I.B, I.C and II.A of this

preamble. Requirements ‘‘2’’ through

‘‘4’’ are addressed in the subsections

that follow. The fifth requirement is

discussed in sections I.D and I.J., which

provide information about steps EPA

has taken that will lessen impacts on

small systems, including: (1) The

selection of the less stringent uranium

MCL, (2) overall reduced monitoring

frequencies for systems with

radionuclides levels less than the MCL,

(3) allowance of grandfathering of data

and State monitoring discretion for

determining initial monitoring baseline,

and (4) exclusion of NTNCWS from the

regulation. Sections I.C. and I.B provide

the rationale for the retention of the

MCLs for radium-226 and -228, gross

alpha, and photon/beta emitters.

The significant issues raised in public

comments were the high cost of

compliance for small systems and high

cumulative costs for water contaminant

testing. EPA understands these concerns

and has made several changes to the

proposed rule that will reduce cost

impacts to small systems. In addition,

commenters disagreed with the proposal

to include NTNC water systems in the

rule. Based on several factors, including

these comments and the analyses of

risks faced by NTNC customers, risk

reductions, benefits, and costs, EPA has

decided that additional future analyses

and reevaluation, together with any new

data that can be obtained is needed

before regulating radionuclides at NTNC

drinking water systems (see section

I.D.8. for further discussion). This

information will be collected and future

regulatory action will be assessed under

the regulatory review process. A

complete summary of comments

received and EPA’s responses can be

obtained from the docket (USEPA

2000a).

For many small entities, today’s final

rule will reduce long-term monitoring

costs because the rule provides for less

frequent follow-up monitoring (relative

to the 1976 rule) for systems if they have

radionuclides levels (e.g., gross alpha

and radium-226 and -228) below the

MCLs (most small systems). For

example, under the 1976 rule, a system

with a gross alpha level less than the

MCL but greater than 1⁄2 MCL is

required to monitor four times in a four

year period. The revised monitoring

scheme will allow this system to reduce

the monitoring frequency to one sample

every three years or less. In addition,

EPA is giving States discretion in using

historical monitoring data

(grandfathering) to determine the initial

monitoring baseline for systems.

Therefore, systems with sufficient data

may not be required to take four

quarterly samples for the initial

monitoring period and may immediately

begin reduced monitoring (e.g., one

sample per three years, six years, or

nine years) after the rule is effective

(e.g., three years after the rule is

promulgated). See sections I.D ‘‘How

has this new information impacted the

regulatory decisions being promulgated

today?’’ and I.J ‘‘Where and how often

must a water system test for

radionuclides?’’ for additional

information about monitoring. A small

percentage (<1.5%) of systems are

expected to exceed the radium-226 and228 and uranium MCLs and will be

required to take action to come into

compliance.

The number of small entities subject

to today’s rule is shown in Table V–1.

TABLE V–1.—SUMMARY OF ANALYSIS RESULTS

From the ‘‘Economic Analysis of the Radionuclides NPDWR’’ (USEPA 2000g)

Community

water

system

size

class

(25 to

10,00)

Ground water systems Surface water systems

Combined radium loophole Uranium (20μg/L) Uranium (40 μg/L) Uranium (20 μg/L) Uranium (40 μg/L)

Number of

systems

Cost/

Revenue 1

Number of

systems

Cost/

Revenue 1

Number of

systems

Cost/

Revenue 1

Number of

systems

Cost/

Revenue 1

Number of

systems

Cost/

Revenue 1

Total ..... 270–310 2 1–2 820–900 2 1–3 300–400 2 1–3 < 10–40 2 1–3 0–20 2 0–3

Notes:

1As reported in the economic analysis support document (USEPA 2000g), the revenue portion of the cost per revenue estimates are based on

data collected the 1992 Census of Governments. The Agency then estimated average revenues for small governments.

The reported ranges represent results using the directly proportional approach followed by results using the lognormal distribution approach.

‘‘0’’ indicates that no systems in this category are expected to be out of compliance with the MCL.

Revenue estimates are taken from Exhibit 6–3 of the economic analysis support document (USEPA 2000g).

See Appendix G of the economic analysis support document (USEPA 2000g) for information regarding the number of affected for the 25 to

10,000 size class and the associated costs. Detail does not add to totals due to rounding. 2Percent.

Small systems are also required to

provide information in the Consumer

Confidence Report or other public

notification if the system exceeds one of

the MCLs. As is the case for other

contaminants, required information on

radionuclides levels must be provided

by affected systems and is not

considered to be confidential. The

professional skills necessary for

preparing reports are the same skill

level required by small systems for

current reporting and monitoring

requirements for other drinking water

standards.

In addition to the public comments on

the proposal, the Agency considered

comments received through an outreach

process that obtained input from small

entities, including a Stakeholders

meeting, Tribal consultations, and other

consultations. After considering all the

input from stakeholders as well as its

own analyses, the Agency has included

several measures in today’s rule that

should reduce the burden on small

drinking water systems: (1) A revised

monitoring scheme with long-term

monitoring reduction for most small

systems; (2) State discretion for

grandfathering existing monitoring data;

(3) the decision not to regulate nontransient, non-community water

systems, which are generally very small

water systems; and (4) the selection of

a uranium MCL that is less stringent

than the 1991 proposed feasible level.

The uranium MCL is still protective of

public health with an adequate margin

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76739

of safety, but will impact fewer small

systems, reducing the number of

systems that may face waste disposal

issues, and increasing the likelihood

that non-treatment options for achieving

compliance may be used. These items

are discussed in more detail in sections

I.D and I.J.

EPA also is preparing a small entity

compliance guide to help small entities

comply with this rule. Small entities

will be able to access a copy of this

guide at: http://www.epa.gov/sbrefa/ (to

be available within 60 days of the

publication of the rule in the Federal

Register).

B. Paperwork Reduction Act

The Office of Management and Budget

(OMB) has approved the information

collection requirements contained in

this rule under the provisions of the

Paperwork Reduction Act, 44 U.S.C.

3501 et seq. and has assigned OMB

control number—2040–0228

Under this rule, respondents to the

monitoring, reporting, and

recordkeeping requirements include the

owners and operators of community

water systems and State officials that

must report data to the Agency.

Monitoring for radium-228, uranium,

and beta and photon emitters will be

required at each entry point to the

distribution system under the final

radionuclides rule. States will have

discretion in grandfathering existing

data for determining initial monitoring

baselines for the currently regulated

contaminants, combined radium-226/-

228, gross alpha particle activity, and

beta particle and photon radioactivity.

EPA has estimated the burden

associated with the specific information

collection, record keeping and reporting

requirements of the proposed rule in the

accompanying Information Collection

Request (ICR). The ICR for today’s final

rule compares the current requirements

to the revised requirements for

information collection, reporting and

record-keeping. There are several

activities that the State and the CWSs

must perform in preparing to comply

with the revised Radionuclides Rule.

Start-up activities include reading the

final rule to become familiar with the

requirements and training staff to

perform the required activities.

For PWSs, the number of hours

required to perform each activity may

vary by system size. This rule only

applies to community water systems. As

shown in Table V–2, there are

approximately 53,121 CWSs and 56

States and territories considered in this

ICR (a total of 53,177 respondents).

During the first three years after

promulgation of this rule, the average

burden hours per respondent per year is

estimated to be 6 hours for PWSs and

115 hours for States. During this period,

the total burden hour per year for the

approximately 53,177 respondents

covered by this rule is estimated to be

342,873 hours to prepare to comply

with this revised Radionuclide Rule.

There are no new monitoring, recordkeeping, reporting or equipment costs

for CWSs during the first three-year

period, hence no responses are expected

from the CWSs. The average number of

responses for the States is expected to

be 37 per year during the first three year

period. Total annual labor costs during

this first 3 year period are expected to

be about $10 million per year for CWS.

TABLE V–2.—AVERAGE BURDEN, RESPONDENTS, AND RESPONSES DURING THE THREE-YEAR ICR APPROVAL PERIOD

CWSs States Total

(each year)

Average Burden Hours per Year ................................................................................................. 336,433 6,440 342,873

Average Respondents per Year .................................................................................................. 53,121 56 53,177

Average Burden Hours per Respondent per Year ...................................................................... 6 115 121

Average Responses per Year ..................................................................................................... 1 0 33 33

Average Burden Hours per Response per Year ......................................................................... 1 0 17 17

Average Responses per Respondent per Year .......................................................................... 1 0 2 .66 .66

1Preparation only.

2Two over 3-year period.

TABLE V–3.—SUMMARY OF BURDEN AND COSTS FOR THE RADIONUCLIDES RULE FOR THE ICR APPROVAL PERIOD

Respondent Category

Number of

respondents

annually

Number of

responses

annually

Total annual

burden

(hours)

Total annual

labor costs

($ dollars)

Total annual

capital cost

Total annual

O&M cost

CWSs ....................................................... 53,121 (1) 336,433 $9,925,042 0 0

States ....................................................... 56 2 37 (2 per

respondent

over 3 year

period)

6,440 247,905 0 0

Total .................................................. 53,177 33 342,873 10,172,947 0 0

1Preparation only.

2Two per respondent over 3-year period.

Three years after the promulgation

date, community water systems will

begin collecting mandatory monitoring

data as described earlier in this section.

As reported in the ICR (using a 7%

discount rate over a 23 year period),

EPA estimates that today’s revisions to

monitoring will result in a national

annual monitoring, reporting and record

keeping burden of $ 4.85 million

(25,197 hours) for all CWSs and an

average annual programmatic burden of

$63,723 (4,170 hours) for States (total

for all 56 jurisdictions) over the first 23

years after promulgation of this rule (see

Table V–4).

76740 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

TABLE V–4.—SUMMARY OF BURDEN AND COSTS FOR THE RADIONUCLIDES RULE FOR THE POST-ICR APPROVAL PERIOD

Respondent category

Number of

respondents

annually

Number of

responses

annually

Total annual

burden

(hours)

Total annual

labor costs

Total annual

capital cost

Total annual

O&M cost

(monitoring)

CWSs ....................................................... 53,121 50,394 25,197 $537,574 0 $4,855,439

States ....................................................... 56 224 4,170 63,723 0 63,723

Total .................................................. 53,177 50,618 29,367 601,297 0 4,919,162

Burden means the total time, effort, or

financial resources expended by persons

to generate, maintain, retain, or disclose

or provide information to or for a

Federal agency. This includes the time

needed to review instructions; develop,

acquire, install, and utilize technology

and systems for the purposes of

collecting, validating, and verifying

information, processing and

maintaining information, and disclosing

and providing information; adjust the

existing procedures to comply with any

previously applicable instructions and

requirements; train personnel to be able

to respond to a collection of

information; search data sources;

complete and review the collection of

information; and transmit or otherwise

disclose the information.

An agency may not conduct or

sponsor, and a person is not required to

respond to, a collection of information

unless it displays a currently valid OMB

control number. The OMB control

numbers for EPA’s regulations are listed

in 40 CFR part 9 and 48 CFR chapter 15.

EPA is amending the table in 40 CFR

part 9 of the currently approved ICR

control numbers issued by OMB for

various regulations to list the

information requirements contained in

this final rule.

C. Unfunded Mandates Reform Act

1. Summary of UMRA Requirements

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA), 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 an EPA rule, for which a

written statement is needed, section 205

of the UMRA generally requires EPA to

identify and consider a reasonable

number of regulatory alternatives and

adopt the least costly, most costeffective or least burdensome alternative

that achieves the objectives of the rule.

The provisions of section 205 do not

apply when they are inconsistent with

applicable law. Moreover, section 205

allows EPA to adopt an alternative other

than the least costly, most cost-effective

or least burdensome alternative if the

Administrator publishes 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 section 203 of

the UMRA, a small government agency

plan. The plan must provide for

notifying potentially affected small

governments, enabling officials of

affected small governments to have

meaningful and timely input in the

development of EPA regulatory

proposals with significant Federal

intergovernmental mandates and

informing, educating, and advising

small governments on compliance with

the regulatory requirements.

EPA has determined that this rule

does not contain a Federal mandate that

may result in expenditures of $100

million or more for State, local, and

tribal governments, in the aggregate, or

the private sector in any one year. The

estimated total annual compliance costs

of the final rule is 83 million (See

section IV. Economic Analyses for

additional information). Thus, today’s

rule is not subject to the requirements

of sections 202 and 205 of the UMRA.

This rule will establish requirements

that affect small community water

systems. EPA has determined that this

rule may contain regulatory

requirements that significantly or

uniquely affect small governments. As

described in part A of this section, EPA

has provided all public water systems

(including small systems) with

opportunities to provide input into the

development of this rule and to be

informed about the requirements for

compliance.

D. National Technology Transfer and

Advancement Act

Section 12(d) of the National

Technology Transfer and Advancement

Act of 1995 (NTTAA), (Pub. L. 104–113,

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

directs EPA to use voluntary consensus

standards in its regulatory activities

unless to do so would be inconsistent

with applicable law or otherwise

impractical. Voluntary consensus

standards are technical standards (e.g.,

material specifications, test methods,

sampling procedures, business

practices) that are developed or adopted

by voluntary consensus standard bodies.

The NTTAA directs EPA to provide to

Congress, through OMB, explanations

when the Agency decides not to use

available and applicable voluntary

consensus standards.

Today’s rule does not establish any

technical standards, thus, NTTAA does

not apply to this rule. It should be

noted, however, that systems complying

with this rule need to use previously

approved technical standards already

included in § 141.25. Currently, a total

of 89 radiochemical methods are

approved for compliance monitoring of

radionuclides in drinking water. Of

these methods, twenty-four (24) are

approved by the Standard Methods

Committee and are described in the

‘‘Standard Methods for the Examination

of Waste and Wastewater (13th, 17th,

18th, and 19th editions),’’ which was

prepared and published by the

American Public Health Association. In

addition, twelve of the approved

radiochemistry methods are from the

American Society for Testing and

Materials (ASTM) and are described in

the Annual Book of ASTM Standards.

These methods and their references are

provided in Table I–8 (shown in section

I of this preamble).

E. Executive Order 12866: Regulatory

Planning and Review

Under Executive Order 12866, [58 FR

51735 (October 4, 1993)] the Agency

must determine whether the regulatory

action is ‘‘significant’’ and therefore

subject to OMB review and the

requirements of the Executive Order.

The Order defines ‘‘significant

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76741

regulatory action’’ as one that is likely

to result in a rule that may:

(1) Have an annual effect on the

economy of $100 million or more or

adversely affect in a material way the

economy, a sector of the economy,

productivity, competition, jobs, the

environment, public health or safety, or

State, local, or tribal governments or

communities;

(2) Create a serious inconsistency or

otherwise interfere with an action taken

or planned by another agency;

(3) Materially alter the budgetary

impact of entitlements, grants, user fees,

or loan programs or the rights and

obligations of recipients thereof; or

(4) Raise novel legal or policy issues

arising out of legal mandates, the

President’s priorities, or the principles

set forth in the Executive Order.’’

Pursuant to the terms of Executive

Order 12866, it has been determined

that this rule is a ‘‘significant regulatory

action.’’ As such, this action was

submitted to OMB for review. Changes

made in response to OMB suggestions or

recommendations will be documented

in the public record.

F. Executive Order 12898:

Environmental Justice

Executive Order 12898 ‘‘Federal

Actions To Address Environmental

Justice in Minority Populations and

Low-Income Populations,’’ (59 FR 7629,

February 16, 1994) establishes a Federal

policy for incorporating environmental

justice into Federal agency missions by

directing agencies to identify and

address disproportionately high and

adverse human health or environmental

effects of its programs, policies, and

activities on minority and low-income

populations. The Agency has

considered environmental justicerelated issues concerning the potential

impacts of this action and has consulted

with minority and low-income

stakeholders by convening a stakeholder

meeting via video conference

specifically to address environmental

justice issues.

As part of EPA’s responsibilities to

comply with E.O. 12898, the Agency

held a stakeholder meeting via video

conference on March 12, 1998, to

highlight components of pending

drinking water regulations and how

they may impact sensitive subpopulations, minority populations, and

low-income populations. Topics

discussed included treatment

techniques, costs and benefits, data

quality, health effects, and the

regulatory process. Participants

included national, State, tribal,

municipal, and individual stakeholders.

EPA conducted the meeting by video

conference call between eleven cities.

This meeting was a continuation of

stakeholder meetings that started in

1995 to obtain input on the Agency’s

Drinking Water programs. The major

objectives for the 1998 meeting were:

(1) Solicit ideas from Environmental

Justice (EJ) stakeholders on known

issues concerning current drinking

water regulatory efforts;

(2) Identify key issues of concern to EJ

stakeholders; and

(3) Receive suggestions from EJ

stakeholders concerning ways to

increase representation of EJ

communities in OGWDW regulatory

efforts.

In addition, EPA developed a plainEnglish guide specifically for this

meeting to assist stakeholders in

understanding the multiple and

sometimes complex issues surrounding

drinking water regulations. A meeting

summary for the March 12, 1998

Environmental Justice stakeholders

meeting (USEPA 1998J) is available in

the public docket for this final

rulemaking.

The radionuclides rule applies to all

community water systems, which will

provide equal health protection for all

minority and low-income populations

served by systems regulated under this

rule from exposure to radionuclides.

G. Executive Order 13045: Protection of

Children From Environmental Health

Risks and Safety Risks

Executive Order 13045: ‘‘Protection of

Children from Environmental Health

Risks and Safety Risks’’ (62 FR 19885,

April 23, 1997) applies to any rule that:

(1) Was initiated after April 21, 1997, or

for which a Notice of Proposed

Rulemaking was published after April

21, 1998; (2) is determined to be

‘‘economically significant’’ as defined

under E.O. 12866, and (3) 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 all three

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 final rule is not subject to the

Executive Order because EPA published

a notice of proposed rulemaking before

April 21, 1998. However, EPA’s policy

since November 1, 1995 is to

consistently and explicitly consider

risks to infants and children in all risk

assessments generated during its

decision making process including the

setting of standards to protect public

health and the environment.

Today’s action primarily involves

retaining the current MCLs for the

regulated radionuclides, rather than

adopting the less stringent 1991

proposed MCLs for the regulated

radionuclides. In addition, an MCL for

uranium, currently unregulated, is

promulgated in today’s rule. Since

today’s rule involves the decision to

retain the more stringent current MCLs

and to adopt a uranium MCL that is

protective of both kidney toxicity and

radiological carcinogenicity, today’s

action is consistent with greater

protection of children’s health.

The cancer risks estimated and

presented in today’s final rule explicitly

account for differential cancer risks to

children. In the case of uranium kidney

toxicity, there is no information that

suggests that children are a sensitive

subpopulation. However, as discussed

in the Notice of Data Availability

(USEPA 2000e), the Agency does have

reason to believe that radionuclides in

drinking water present higher unit risks

to children than to adults, since there is

evidence that children are more

sensitive to radiation than adults.

Because of this, we have explicitly

considered the risks to children in

evaluating the lifetime risks associated

with the current MCLs and 1991

proposed MCLs. In other words, the

lifetime risks that are reported for each

MCL are integrated over the entire

lifetime of the individual and include

the risks incurred during childhood.

In more detail, the per unit dose risk

coefficients used to estimate lifetime

risks are age-specific and organ-specific

and are used in a lifetime risk model

that applies the appropriate age-specific

sensitivities throughout the calculation.

The model also includes age-specific

changes in organ mass and metabolism,

which further incorporates age-specific

effects pertinent to age sensitivity. The

risk estimate at any age is the best

estimate of risk for an individual of that

age, so the summation of these agespecific risk estimates over all ages is

best estimate of the lifetime risk for an

individual. In developing the lifetime

risks, the model calculates the risks over

an age distribution for a stationary

population to simulate the lifetime risk

of an individual. The model also

accounts for competing causes of death

and age-specific survival rates. These

adjustments make the lifetime risk

estimate more realistic. At the same

time, consumption rates of food, water

and air are different between adults and

children. The lifetime risk estimates for

radionuclides in water use age-specific

water intake rates derived from average

76742 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

national consumption rates when

calculating the risk per unit intake.

While radiation protection

organizations have developed the

concept of committed dose, the dose to

an organ or tissue from time of intake

to end of life, there is no equivalent for

risk. If we define ‘‘committed risk’’ as

the lifetime risk from a given intake,

then it will be easier to compare the

risks of intakes at different times of life.

In Table V–5, the ‘‘committed risk’’ is

given for 5 isotopes and 5 periods of life

and continuous lifetime exposure. If the

radionuclide concentration in the water

is kept constant, the fraction of the

lifetime risk committed during any age

interval will also remain constant.

Unless the intake is restricted in an agespecific manner, the fraction of the

lifetime risk contributed by any age

interval is a constant.

TABLE V–5.—LIFETIME RISKS AND FRACTIONS OF LIFETIME RISK PER AGE GROUP

Age (yrs) 0–6 6–18 18–30 30–70 70–110 0–110

Lifetime risk for intake of water containing 1 Bq/L during several different age intervals

Ra-224 ..................................................................................................... 2.3e–05 3.3e–05 1.1e–05 1.5e–05 9.8e–07 8.4e–05

Ra-226 ..................................................................................................... 2.9e–05 8.6e–05 5.0e–05 5.1e–05 2.9e–06 2.2e–04

Ra-228 ..................................................................................................... 1.1e–04 2.6e–04 1.2e–04 1.1e–04 5.1e–06 6.1e–04

U-238 ....................................................................................................... 6.7e–06 1.2e–05 6.1e–06 9.8e–06 3.7e–07 3.4e–05

H-3 ........................................................................................................... 3.9e–09 8.5e–09 6.2e–09 9.6e–09 6.7e–10 2.9e–08

Percentage of lifetime risk committed for water intake during the age interval

Ra-224 ..................................................................................................... 28 40 13 18 1 100

Ra-226 ..................................................................................................... 13 39 23 23 1 100

Ra-228 ..................................................................................................... 17 43 20 19 1 100

U-238 ....................................................................................................... 19 33 18 28 1 100

H-3 ........................................................................................................... 13 29 21 33 2 100

In summary, today’s decision to retain

the current more stringent MCLs for

radionuclides and to establish an MCL

for uranium in drinking water is

consistent with the protection of

children’s health. In making this

decision, EPA evaluated the lifetime

radiogenic cancer risks associated with

the current and final MCLs, which are

based on age-specific cancer risk models

that explicitly consider children’s

higher per unit dose risks.

H. 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 if it significantly or

uniquely affects the communities of

Indian tribal governments and 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 if EPA consults with those

governments. If EPA complies by

consulting, Executive Order 13084

requires EPA to provide to the Office of

Management and Budget, in a separately

identified section of the preamble to the

rule, a description of the extent of EPA’s

prior consultation with representatives

of affected tribal governments, a

summary of the nature of their concerns,

and a statement supporting the need to

issue the regulation. In addition,

Executive Order 13084 requires EPA to

develop an effective process permitting

elected officials and other

representatives of Indian tribal

governments ‘‘to provide meaningful

and timely input in the development of

regulatory policies on matters that

significantly or uniquely affect their

communities.’’

EPA does not believe that today’s rule

significantly or uniquely affect the

communities of Indian tribal

governments nor does it impose

substantial direct compliance costs on

these communities. The provisions of

today’s rules apply to all community

water systems. Tribal governments may

be owners or operators of such systems,

however, nothing in today’s provisions

uniquely affects them. EPA believes that

the final rule will not significantly

burdens most Tribal systems, and in

some cases, will be less burdensome

than the current radionuclides rule.

Accordingly, the requirements of

section 3(b) of Executive Order 13084

do not apply to this rule.

Nonetheless, EPA did inform and

involve Tribal governments in the

rulemaking process. EPA staff attended

the 16th Annual Consumer Conference

of the National Indian Health Board on

October 6–8, 1998 in Anchorage,

Alaska. Over nine hundred attendees

representing Tribes from across the

country were in attendance. During the

conference, EPA conducted two

workshops for meeting participants. The

objectives of the workshops were to

present an overview of EPA’s drinking

water program, solicit comments on key

issues of potential interest in upcoming

drinking water regulations, and to

solicit advice in identifying an effective

consultative process with Tribes for the

future.

EPA, in conjunction with the Inter

Tribal Council of Arizona (ITCA), also

convened a Tribal consultation meeting

on February 24–25, 1999, in Las Vegas,

Nevada to discuss ways to involve

Tribal representatives, both Tribal

council members and tribal water utility

operators, in the stakeholder process.

Approximately twenty-five

representatives from a diverse group of

Tribes attended the two-day meeting.

Meeting participants included

representatives from the following

Tribes: Cherokee Nation, Nezperce

Tribe, Jicarilla Apache Tribe, Blackfeet

Tribe, Seminole Tribe of Florida, Hopi

Tribe, Cheyenne River Sioux Tribe,

Menominee Indian Tribe, Tulalip

Tribes, Mississippi Band of Choctaw

Indians, Narragansett Indian Tribe, and

Yakama Nation.

The major meeting objectives were to:

(1) Identify key issues of concern to

Tribal representatives;

(2) Solicit input on issues concerning

current OGWDW regulatory efforts;

(3) Solicit input and information that

should be included in support of future

drinking water regulations; and

(4) Provide an effective format for

Tribal involvement in EPA’s regulatory

development process.

EPA staff also provided an overview

on the forthcoming radionuclides rule at

the meeting. The presentation included

the health concerns associated with

radionuclides, EPA’s current position

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76743

on radionuclides in drinking water, and

specific issues for Tribes. The following

questions were posed to the Tribal

representatives to begin discussion on

radionuclides in drinking water:

(1) What are the current radionuclides

levels in your water systems?

(2) Are you treating for radionuclides

if they exceed the MCL? Is it effective

and affordable?

(3) What are Tribal water systems

affordability issues in regard to

radionuclides?

(4) Would in home treatment units be

an acceptable alternative to central

treatment?

(5) What level of monitoring is

reasonable?

The summary for the February 24–25,

1999 meeting was sent to all 565

Federally recognized Tribes in the

United States.

EPA also conducted a series of

workshops at the Annual Conference of

the National Tribal Environmental

Council which was held on May 18–20,

1999 in Eureka, California.

Representatives from over 50 Tribes

attended all, or part, of these sessions.

The objectives of the workshops were to

provide an overview of forthcoming

EPA regulations affecting water systems;

discuss changes to operator certification

requirements; discuss funding for Tribal

water systems; and to discuss

innovative approaches to regulatory cost

reduction. Meeting summaries for EPA’s

Tribal consultations are available in the

public docket for this rulemaking

(USEPA 1999c, USEPA 1999d).

I. Executive Order 13132

Executive Order 13132, entitled

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

1999), requires EPA to develop an

accountable process to ensure

‘‘meaningful and timely input by State

and local officials in the development of

regulatory policies that have federalism

implications.’’ ‘‘Policies that have

federalism implications’are defined in

the Executive Order to include

regulations that have ‘‘substantial direct

effects on the States, on the relationship

between the national government and

the States, or on the distribution of

power and responsibilities among the

various levels of government.’’

This final rule does not have

federalism implications. It will not have

substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132. Thus, Executive

Order 13132 does not apply to this rule

Although Executive Order 13132 does

not apply to this rule, EPA did consult

with representatives of State and local

elected officials in the process of

developing this final regulation. On May

30, 2000, EPA held a one-day meeting

in Washington, DC with representatives

of elected State and local officials to

discuss how upcoming drinking water

regulations may affect State, county, and

local governments. The rules discussed

were: Arsenic, Radon, Radionuclides,

Long Term 1 Enhanced Surface Water

Treatment and Filter Backwash Rule,

and the Ground Water Rule. EPA

invited associations which represent

elected officials, including National

Governors’ Association (NGA), National

League of Cities (NLC), Council of State

Governments (CSG), U.S. Conference of

Mayors, International City/County

Management Association (ICMA),

National Association of Counties

(NACO), National Association of Towns

and Townships, and National

Conference of State Legislators (NCSL).

EPA also invited the National

Association of Attorneys General

(NAAG), the Association of State and

Territorial Health Officials (ASTHO),

the Environmental Council of States

(ECOS), and the Southern Govenors’

Association (SGO). With the invitation

letter, EPA provided an agenda and

background information about the five

upcoming drinking water rules,

including today’s rule.

Ten representatives of elected officials

participated in the one-day meeting,

which included State of Florida—

Governor Bush’s Office, State of OhioGovernor Taft’s Office, NGA, NACO,

NAAG, NLC, ECOS, ICMA, SGO, and

ASTHO. The meeting encompassed

presentation and discussion about each

of the five rules. The purpose of the

meeting was to:

• Provide information about the five

upcoming drinking water regulations;

• Consult on the expected

compliance and implementation costs of

these rules for State, county, and local

governments; and

• Gain a better understanding of

State, county, and local governments’

and their elected officials’ views.

Following the meeting, EPA sent the

materials presented and distributed at

the meeting to the organizations that

were not able to attend, in order to

provide them additional information

about the upcoming regulations. EPA

has prepared a meeting summary which

provides in more detail the participants’

concerns and questions regarding each

rule. This summary is available in the

public docket supporting this

rulemaking (USEPA 2000c).

This meeting was not held sooner due

to the relatively recently signed

Executive Order and the need to

consider how to best comply with its

terms and conditions. Thus, many of the

issues associated with today’s

rulemaking were in relatively advanced

stages of development by the time of the

May 30, 2000 meeting. Nevertheless, we

endeavored to accommodate each of the

comments received from elected

officials or their representatives to the

maximum extent possible, within the

constraints imposed by our statutory

mandate to protect public health

through the promulgation of drinking

water standards.

The principal concerns of these

officials were the overall burden of the

rule and the potentially high costs of

compliance with its provisions. In

particular, they expressed concerns

about the affordability for the rule for

small systems and costs for disposal of

treatment residues that may be

considered hazardous due to

radioactivity. In response, we took

several steps to address these particular

concerns as well as actions in response

to the generalized concern about the

overall burden of the rule.

EPA believes that today’s regulatory

action is necessary to reduce kidney

toxicity and cancer health risks from

uranium, as well as to maintain public

health protection resulting from the

current radionuclide National Primary

Drinking Water Regulations. The

Agency understands the officials’

concerns about regulatory burden and

have addressed them in several ways.

First, EPA selected a less stringent MCL

for uranium of 30 μg/L by invoking the

discretionary authority for the

Administrator to set an MCL less

stringent than the feasible level if the

benefits of an MCL set at the feasible

level would not justify the costs (section

1412(b)(6)). As a result, fewer water

systems will be in violation of the

uranium MCL, reducing the number of

systems that may face radioactive waste

disposal issues, and resulting in the

ability of a higher percentage of water

systems to use non-treatment options for

achieving compliance (e.g., new wells,

blending of water sources, modifying

existing operations, etc.).

To further mitigate impacts on water

systems and State drinking water

programs, EPA is allowing State

discretion in grandfathering data for

determining initial monitoring

frequency. Since the data grandfathering

plan will be a part of a State’s primacy

package, EPA will have oversight over

the data grandfathering process. EPA

believes that this approach provides

flexibility for States to consider their

76744 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

particular circumstances, while

allowing EPA to ensure that goals are

met. Under this approach, many

systems will be able to use existing

monitoring data to establish initial

monitoring baselines, which will be

used to determine future monitoring

frequency under the Standardized

Monitoring Framework. Water systems

that do not have adequate data to

grandfather will be required to follow

the requirements for new monitoring.

The details of these requirements can be

found in part J of section I, ‘‘Where and

how often must a water system test for

radionuclides?’’ EPA expects that there

will be overall reduced monitoring

burden in the long-term, with

monitoring relief being targeted towards

those water systems that have low

radionuclide levels. Today’s final rule

will not apply to non-transient, noncommunity water systems (e.g., schools,

state parks, nursing homes), which are

primarily small ground water systems.

EPA will provide guidance to small

water systems on complying with

today’s rule. This will include

information on monitoring, treatment

technology and other compliance

options, including information on the

disposal of water treatment residuals.

Regarding the cost of treatment, EPA

agrees that treatment technologies can

be expensive for small water systems.

However, EPA expects that many small

water systems will rely on other

compliance options, e.g., alternate

source, purchasing water, and point-ofuse devices. In cases in which small

water systems have no other option and

cannot afford to install treatment, they

may apply to the State for exemptions

(see part M of section I, ‘‘Can my water

system get a variance or an

exemption?’’), which gives them extra

time. An exemption is limited to three

years after the otherwise applicable

compliance date, although extensions

up to a total of six additional years may

be available to small systems under

certain conditions. If a water system has

very high contaminant levels and no

compliance options other than

treatment, the water system can apply

for a variance, under the requirements

described in part M of section I. In

addition, there are various sources of

funding for State and local governments,

including the Drinking Water State

Revolving Fund, which is described in

part M of section I, ‘‘What financial

assistance is available for complying

with the rule?’’

J. Consultation With the Science

Advisory Board and the National

Drinking Water Advisory Council

In accordance with section 1412(d)

and (e) of SDWA, EPA consulted with

the Science Advisory Board and

National Drinking Water Advisory

Council and considered their comments

in developing this rule. See the OW

Docket for additional information.

K. 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 rule is not a ‘‘major rule’’ as

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

will be effective December 8, 2003.

VI. References

NIH 2000a. ‘‘Kidney Diseases: Publications

On-Line.’’ National Institute of Diabetes

and Digestive and Kidney Diseases

(NIDDK). June 2000. National Institutes of

Health.

NIH 2000b. ‘‘Proteinuria.’’ National Kidney

and Urologic Diseases Information

Clearinghouse. June 2000. National

Institutes of Health.

NIH 2000c. ‘‘Your Kidneys and How They

Work.’’ National Kidney and Urologic

Diseases Information Clearinghouse. June

2000. National Institutes of Health.

USEPA 1991. ‘‘Regulatory Impact Analysis of

Proposed National Primary Drinking Water

Regulations for Radionuclides (Draft dated

June 14, 1991). Prepared by Wade Miller

Associates.

USEPA 1994. Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income Populations,

59 FR 7629, February 16, 1994.

USEPA 1998a. ‘‘A Fact Sheet on the Health

Effects from Ionizing Radiation.’’ Prepared

by the Office of Radiation & Indoor Air,

Radiation Protection Division. EPA 402–F–

98–010. May 1998.

USEPA 1998b. Announcement of Small

System Compliance Technology Lists for

Existing National Primary Drinking Water

Regulations and Findings Concerning

Variance Technologies, 63 FR 42032,

August 6, 1998.

USEPA 1998c. ‘‘Ionizing Radiation Series No.

1.’’ Prepared by the Office of Radiation &

Indoor Air, Radiation Protection Division.

EPA 402–F–98–009. May 1998.

USEPA 1998d. National Primary Drinking

Water Regulations: Consumer Confidence;

Proposed Rule 63 FR 7605, February 13,

1998.

USEPA 1998e. National Primary Drinking

Water Regulation: Consumer Confidence

Reports; Final Rule, 63 FR 44511, August

19, 1998.

USEPA 1998f. ‘‘Small System Compliance

Technology List for the Non-Microbial

Contaminants Regulated Before 1996.’’

EPA–815–R–98–002. September 1998.

USEPA 1999a. ‘‘Small Systems Compliance

Technology List for the Radionuclides

Rule.’’ Prepared by International

Consultants, Inc. Draft. April 1999.

USEPA 1999b. Cancer Risk Coefficients for

Environmental Exposure to Radionuclides,

Federal Guidance Report No. 13. US

Environmental Protection Agency,

Washington, DC, 1999.

USEPA 1999c. ‘‘Inter Tribal Council of

Arizona, Inc.: Ground Water and Drinking

Water Tribal Consultation Meeting.’’

Executive Summary. February 24–25, 1999.

USEPA 1999d. ‘‘OGWDW Tribal

Consultations: Workshops at the Annual

Conference of the National Tribal

Environmental Council.’’ May 18–20, 1999.

USEPA 2000a. ‘‘Comment/Response

Document for the Radionuclides Notice of

Data Availability and 1991 Proposed

Rule.’’ Prepared by Industrial Economics,

Inc. for EPA. November 2000.

USEPA 2000b. ‘‘Draft Toxicological Review

of Uranium.’’ Prepared by the Office of

Science and Technology. Draft. June 6,

2000.

USEPA 2000c. Government Dialogue on U.S.

EPA’s Upcoming Drinking Water

Regulations. Meeting Summary. May 30,

2000.

USEPA 2000d. ‘‘Information Collection

Request for National Primary Drinking

Water Regulations: Radionuclides’’.

Prepared by ISSI Consulting Group, for

EPA. September 22, 2000.

USEPA 2000e. National Primary Drinking

Water Regulations; Radionuclides; Notice

of Data Availability; Proposed Rule. 65 FR

21577. April 21, 2000.

USEPA 2000f. ‘‘Preliminary Health Risk

Reduction and Cost Analysis: Revised

National Primary Drinking Water

Standards for Radionuclides.’’ Prepared by

Industrial Economics, Inc. for EPA. Draft.

January 2000.

USEPA 2000g. ‘‘Economic Analysis of the

Radionuclides National Primary Drinking

Water Regulations.’’ Prepared by Industrial

Economics, Inc. for EPA. November 2000.

USEPA 2000h. ‘‘Technical Support

Document for the Radionuclides Notice of

Data Availability.’’ Draft. March, 2000.

USEPA 2000i. ‘‘Technologies and Costs for

the Removal of Radionuclides from Potable

Water Supplies.’’ Draft. Prepared by

Malcolm Pirnie, Inc. June, 2000.

List of Subjects

40 CFR Part 9

Reporting and recordkeeping

requirements.

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76745

40 CFR Part 141

Environmental protection, Chemicals,

Indians-lands, Incorporation by

reference, Intergovernmental relations,

Radiation protection, Reporting and

recordkeeping requirements, Water

supply.

40 CFR Part 142

Environmental protection,

Administrative practice and procedure,

Chemicals, Indians-lands,

Intergovernmental relations, Radiation

protection, Reporting and recordkeeping

requirements, Water supply.

Dated: November 21, 2000.

Carol M. Browner,

Administrator.

For reasons set out in the preamble,

40 CFR parts 9, 141, and 142 are

amended as follows:

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, 1324, 1344, 1345 (d) and

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

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

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

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

300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq.,

6901–6992k, 7401–7671q, 7542, 9601–9657,

11023, 11048.

2. In § 9.1 the table is amended by:

(a) Removing the entry for 141.25–

141.30 and adding new entries for

141.25(a)–(e), 141.26 (a)–(b), and

141.27–141.30;

(b) Removing the entry for 142.14(a)–

(d)(7) and adding new entries for

142.14(a)–(d)(3), 142.14(d)(4)–(5), and

142.14(d)(6)–(7); and

(c) Removing the entry for

142.15(c)(5)–(d) and adding new entries

for 142.15(c)(5), 142.15(c)(6)–(7), and

142.15(d).

The additions read as follows:

§ 9.1 OMB approvals under the Paperwork

Reduction Act.

* * * * *

40 CFR citation OMB

control No.

*****

National Primary Drinking

Water Regulations

*****

141.25(a)–(e) .......................... 2040–0090

141.26(a)–(b) .......................... 2040–0228

141.27–141.30 ........................ 2040–0090

40 CFR citation OMB

control No.

*****

National Primary Drinking Water

Regulations Implementation

 

142.14(a)–(d)(3) ...................... 2040–0090

142.14(d)(4)–(5) ...................... 2040–0228

142.14(d)(6)–(7) ...................... 2040–0090

** ***

142.15(c)(5) ............................ 2040–0090

142.15(c)(6)–(7) ...................... 2040–0228

142.15(d) ................................ 2040–0090

* * * * *

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.

Subpart B—[Amended]

§§ 141.15 and 141.16 [Removed]

2. Sections 141.15 and 141.16 are

removed.

Subpart C—[Amended]

3. Section 141.25 is amended by:

a. Revising paragraph (a) introductory

text (the table remains unchanged),

b. Revising paragraph (c)(1),

c. Revising paragraph (c)(2) and

redisgnating Table B in paragraph (c)(2)

as Table C and

d. Revising paragraph (d).

The revisions read as follows:

§ 141.25 Analytical methods for

radioactivity.

(a) Analysis for the following

contaminants shall be conducted to

determine compliance with § 141.66

(radioactivity) in accordance with the

methods in the following table, or their

equivalent determined by EPA in

accordance with § 141.27.

* * * * *

(c) * * *

(1) To determine compliance with

§ 141.66(b), (c), and (e) the detection

limit shall not exceed the

concentrations in Table B to this

paragraph.

TABLE B.—DETECTION LIMITS FOR

GROSS ALPHA PARTICLE ACTIVITY,

RADIUM 226, RADIUM 228, AND

URANIUM

Contaminant Detection

limit

Gross alpha particle activity ....... 3 pCi/L.

Radium 226 ................................ 1 pCi/L.

Radium 228 ................................ 1 pCi/L.

Uranium ...................................... Reserve

(2) To determine compliance with

§ 141.66(d) the detection limits shall not

exceed the concentrations listed in

Table C to this paragraph.

* * * * *

(d) To judge compliance with the

maximum contaminant levels listed in

§ 141.66, averages of data shall be used

and shall be rounded to the same

number of significant figures as the

maximum contaminant level for the

substance in question.

* * * * *

4. Section 141.26 is revised to read as

follows:

§ 141.26 Monitoring frequency and

compliance requirements for radionuclides

in community water systems

(a) Monitoring and compliance

requirements for gross alpha particle

activity, radium-226, radium-228, and

uranium.

(1) Community water systems (CWSs)

must conduct initial monitoring to

determine compliance with § 141.66(b),

(c), and (e) by December 31, 2007. For

the purposes of monitoring for gross

alpha particle activity, radium-226,

radium-228, uranium, and beta particle

and photon radioactivity in drinking

water, ‘‘detection limit’’ is defined as in

§ 141.25(c).

(i) Applicability and sampling

location for existing community water

systems or sources. All existing CWSs

using ground water, surface water or

systems using both ground and surface

water (for the purpose of this section

hereafter referred to as systems) must

sample at every entry point to the

distribution system that is

representative of all sources being used

(hereafter called a sampling point)

under normal operating conditions. The

system must take each sample at the

same sampling point unless conditions

make another sampling point more

representative of each source or the

State has designated a distribution

system location, in accordance with

paragraph (a)(2)(ii)(C) of this section.

(ii) Applicability and sampling

location for new community water

systems or sources. All new CWSs or

CWSs that use a new source of water

76746 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

must begin to conduct initial monitoring

for the new source within the first

quarter after initiating use of the source.

CWSs must conduct more frequent

monitoring when ordered by the State in

the event of possible contamination or

when changes in the distribution system

or treatment processes occur which may

increase the concentration of

radioactivity in finished water.

(2) Initial monitoring: Systems must

conduct initial monitoring for gross

alpha particle activity, radium-226,

radium-228, and uranium as follows:

(i) Systems without acceptable

historical data, as defined below, must

collect four consecutive quarterly

samples at all sampling points before

December 31, 2007.

(ii) Grandfathering of data: States may

allow historical monitoring data

collected at a sampling point to satisfy

the initial monitoring requirements for

that sampling point, for the following

situations.

(A) To satisfy initial monitoring

requirements, a community water

system having only one entry point to

the distribution system may use the

monitoring data from the last

compliance monitoring period that

began between June 2000 and December

8, 2003.

(B) To satisfy initial monitoring

requirements, a community water

system with multiple entry points and

having appropriate historical

monitoring data for each entry point to

the distribution system may use the

monitoring data from the last

compliance monitoring period that

began between June 2000 and December

8, 2003.

(C) To satisfy initial monitoring

requirements, a community water

system with appropriate historical data

for a representative point in the

distribution system may use the

monitoring data from the last

compliance monitoring period that

began between June 2000 and December

8, 2003, provided that the State finds

that the historical data satisfactorily

demonstrate that each entry point to the

distribution system is expected to be in

compliance based upon the historical

data and reasonable assumptions about

the variability of contaminant levels

between entry points. The State must

make a written finding indicating how

the data conforms to the these

requirements.

(iii) For gross alpha particle activity,

uranium, radium-226, and radium-228

monitoring, the State may waive the

final two quarters of initial monitoring

for a sampling point if the results of the

samples from the previous two quarters

are below the detection limit.

(iv) If the average of the initial

monitoring results for a sampling point

is above the MCL, the system must

collect and analyze quarterly samples at

that sampling point until the system has

results from four consecutive quarters

that are at or below the MCL, unless the

system enters into another schedule as

part of a formal compliance agreement

with the State.

(3) Reduced monitoring: States may

allow community water systems to

reduce the future frequency of

monitoring from once every three years

to once every six or nine years at each

sampling point, based on the following

criteria.

(i) If the average of the initial

monitoring results for each contaminant

(i.e., gross alpha particle activity,

uranium, radium-226, or radium-228) is

below the detection limit specified in

Table B, in § 141.25(c)(1), the system

must collect and analyze for that

contaminant using at least one sample at

that sampling point every nine years.

(ii) For gross alpha particle activity

and uranium, if the average of the initial

monitoring results for each contaminant

is at or above the detection limit but at

or below 1⁄2 the MCL, the system must

collect and analyze for that contaminant

using at least one sample at that

sampling point every six years. For

combined radium-226 and radium-228,

the analytical results must be combined.

If the average of the combined initial

monitoring results for radium-226 and

radium-228 is at or above the detection

limit but at or below 1⁄2 the MCL, the

system must collect and analyze for that

contaminant using at least one sample at

that sampling point every six years.

(iii) For gross alpha particle activity

and uranium, if the average of the initial

monitoring results for each contaminant

is above 1⁄2 the MCL but at or below the

MCL, the system must collect and

analyze at least one sample at that

sampling point every three years. For

combined radium-226 and radium-228,

the analytical results must be combined.

If the average of the combined initial

monitoring results for radium-226 and

radium-228 is above 1⁄2 the MCL but at

or below the MCL, the system must

collect and analyze at least one sample

at that sampling point every three years.

(iv) Systems must use the samples

collected during the reduced monitoring

period to determine the monitoring

frequency for subsequent monitoring

periods (e.g., if a system’s sampling

point is on a nine year monitoring

period, and the sample result is above

1⁄2 MCL, then the next monitoring

period for that sampling point is three

years).

(v) If a system has a monitoring result

that exceeds the MCL while on reduced

monitoring, the system must collect and

analyze quarterly samples at that

sampling point until the system has

results from four consecutive quarters

that are below the MCL, unless the

system enters into another schedule as

part of a formal compliance agreement

with the State.

(4) Compositing: To fulfill quarterly

monitoring requirements for gross alpha

particle activity, radium-226, radium228, or uranium, a system may

composite up to four consecutive

quarterly samples from a single entry

point if analysis is done within a year

of the first sample. States will treat

analytical results from the composited

as the average analytical result to

determine compliance with the MCLs

and the future monitoring frequency. If

the analytical result from the

composited sample is greater than 1⁄2

MCL, the State may direct the system to

take additional quarterly samples before

allowing the system to sample under a

reduced monitoring schedule.

(5) A gross alpha particle activity

measurement may be substituted for the

required radium-226 measurement

provided that the measured gross alpha

particle activity does not exceed 5

pCi/l. A gross alpha particle activity

measurement may be substituted for the

required uranium measurement

provided that the measured gross alpha

particle activity does not exceed 15

pCi/l.

The gross alpha measurement shall

have a confidence interval of 95%

(1.65σ, where σ is the standard

deviation of the net counting rate of the

sample) for radium-226 and uranium.

When a system uses a gross alpha

particle activity measurement in lieu of

a radium-226 and/or uranium

measurement, the gross alpha particle

activity analytical result will be used to

determine the future monitoring

frequency for radium-226 and/or

uranium. If the gross alpha particle

activity result is less than detection, 1⁄2

the detection limit will be used to

determine compliance and the future

monitoring frequency.

(b) Monitoring and compliance

requirements for beta particle and

photon radioactivity.

To determine compliance with the

maximum contaminant levels in

§ 141.66(d) for beta particle and photon

radioactivity, a system must monitor at

a frequency as follows:

(1) Community water systems (both

surface and ground water) designated by

the State as vulnerable must sample for

beta particle and photon radioactivity.

Systems must collect quarterly samples

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76747

for beta emitters and annual samples for

tritium and strontium-90 at each entry

point to the distribution system

(hereafter called a sampling point),

beginning within one quarter after being

notified by the State. Systems already

designated by the State must continue to

sample until the State reviews and

either reaffirms or removes the

designation.

(i) If the gross beta particle activity

minus the naturally occurring

potassium-40 beta particle activity at a

sampling point has a running annual

average (computed quarterly) less than

or equal to 50 pCi/L (screening level),

the State may reduce the frequency of

monitoring at that sampling point to

once every 3 years. Systems must collect

all samples required in paragraph (b)(1)

of this section during the reduced

monitoring period.

(ii) For systems in the vicinity of a

nuclear facility, the State may allow the

CWS to utilize environmental

surveillance data collected by the

nuclear facility in lieu of monitoring at

the system’s entry point(s), where the

State determines if such data is

applicable to a particular water system.

In the event that there is a release from

a nuclear facility, systems which are

using surveillance data must begin

monitoring at the community water

system’s entry point(s) in accordance

with paragraph (b)(1) of this section.

(2) Community water systems (both

surface and ground water) designated by

the State as utilizing waters

contaminated by effluents from nuclear

facilities must sample for beta particle

and photon radioactivity. Systems must

collect quarterly samples for beta

emitters and iodine-131 and annual

samples for tritium and strontium-90 at

each entry point to the distribution

system (hereafter called a sampling

point), beginning within one quarter

after being notified by the State.

Systems already designated by the State

as systems using waters contaminated

by effluents from nuclear facilities must

continue to sample until the State

reviews and either reaffirms or removes

the designation.

(i) Quarterly monitoring for gross beta

particle activity shall be based on the

analysis of monthly samples or the

analysis of a composite of three monthly

samples. The former is recommended.

(ii) For iodine-131, a composite of five

consecutive daily samples shall be

analyzed once each quarter. As ordered

by the State, more frequent monitoring

shall be conducted when iodine-131 is

identified in the finished water.

(iii) Annual monitoring for strontium90 and tritium shall be conducted by

means of the analysis of a composite of

four consecutive quarterly samples or

analysis of four quarterly samples. The

latter procedure is recommended.

(iv) If the gross beta particle activity

beta minus the naturally occurring

potassium-40 beta particle activity at a

sampling point has a running annual

average (computed quarterly) less than

or equal to 15 pCi/L, the State may

reduce the frequency of monitoring at

that sampling point to every 3 years.

Systems must collect all samples

required in paragraph (b)(2) of this

section during the reduced monitoring

period.

(v) For systems in the vicinity of a

nuclear facility, the State may allow the

CWS to utilize environmental

surveillance data collected by the

nuclear facility in lieu of monitoring at

the system’s entry point(s), where the

State determines if such data is

applicable to a particular water system.

In the event that there is a release from

a nuclear facility, systems which are

using surveillance data must begin

monitoring at the community water

system’s entry point(s) in accordance

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

(3) Community water systems

designated by the State to monitor for

beta particle and photon radioactivity

can not apply to the State for a waiver

from the monitoring frequencies

specified in paragraph (b)(1) or (b)(2) of

this section.

(4) Community water systems may

analyze for naturally occurring

potassium-40 beta particle activity from

the same or equivalent sample used for

the gross beta particle activity analysis.

Systems are allowed to subtract the

potassium-40 beta particle activity value

from the total gross beta particle activity

value to determine if the screening level

is exceeded. The potassium-40 beta

particle activity must be calculated by

multiplying elemental potassium

concentrations (in mg/L) by a factor of

0.82.

(5) If the gross beta particle activity

minus the naturally occurring

potassium-40 beta particle activity

exceeds the screening level, an analysis

of the sample must be performed to

identify the major radioactive

constituents present in the sample and

the appropriate doses must be

calculated and summed to determine

compliance with § 141.66(d)(1), using

the formula in § 141.66(d)(2). Doses

must also be calculated and combined

for measured levels of tritium and

strontium to determine compliance.

(6) Systems must monitor monthly at

the sampling point(s) which exceed the

maximum contaminant level in

§ 141.66(d) beginning the month after

the exceedance occurs. Systems must

continue monthly monitoring until the

system has established, by a rolling

average of 3 monthly samples, that the

MCL is being met. Systems who

establish that the MCL is being met

must return to quarterly monitoring

until they meet the requirements set

forth in paragraph (b)(1)(ii) or (b)(2)(i) of

this section.

(c) General monitoring and

compliance requirements for

radionuclides.

(1) The State may require more

frequent monitoring than specified in

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

may require confirmation samples at its

discretion. The results of the initial and

confirmation samples will be averaged

for use in compliance determinations.

(2) Each public water systems shall

monitor at the time designated by the

State during each compliance period.

(3) Compliance: Compliance with

§ 141.66 (b) through (e) will be

determined based on the analytical

result(s) obtained at each sampling

point. If one sampling point is in

violation of an MCL, the system is in

violation of the MCL.

(i) For systems monitoring more than

once per year, compliance with the MCL

is determined by a running annual

average at each sampling point. If the

average of any sampling point is greater

than the MCL, then the system is out of

compliance with the MCL.

(ii) For systems monitoring more than

once per year, if any sample result will

cause the running average to exceed the

MCL at any sample point, the system is

out of compliance with the MCL

immediately.

(iii) Systems must include all samples

taken and analyzed under the

provisions of this section in determining

compliance, even if that number is

greater than the minimum required.

(iv) If a system does not collect all

required samples when compliance is

based on a running annual average of

quarterly samples, compliance will be

based on the running average of the

samples collected.

(v) If a sample result is less than the

detection limit, zero will be used to

calculate the annual average, unless a

gross alpha particle activity is being

used in lieu of radium-226 and/or

uranium. If the gross alpha particle

activity result is less than detection, 1⁄2

the detection limit will be used to

calculate the annual average.

(4) States have the discretion to delete

results of obvious sampling or analytic

errors.

(5) If the MCL for radioactivity set

forth in § 141.66 (b) through (e) is

exceeded, the operator of a community

water system must give notice to the

76748 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

State pursuant to § 141.31 and to the

public as required by subpart Q of this

part.

Subpart F—[Amended]

5. A new § 141.55 is added to subpart

F to read as follows:

§ 141.55 Maximum contaminant level goals

for radionuclides.

MCLGs for radionuclides are as

indicated in the following table:

Contaminant MCLG

1. Combined radium-226 and radium228.Zero.

2. Gross alpha particle activity (excluding radon and uranium).Zero.

3. Beta particle and photon radioactivity.Zero.

4. Uranium ......................................... Zero.

Subpart G—National Primary Drinking

Water Regulations: Maximum

Contaminant Levels and Maximum

Residual Disinfectant Levels

6. The heading of subpart G is revised

as set out above.

7. A new § 141.66 is added to subpart

G to read as follows:

§ 141.66 Maximum contaminant levels for

radionuclides.

(a) [Reserved]

(b) MCL for combined radium-226 and

-228. The maximum contaminant level

for combined radium-226 and radium228 is 5 pCi/L. The combined radium226 and radium-228 value is determined

by the addition of the results of the

analysis for radium-226 and the analysis

for radium-228.

(c) MCL for gross alpha particle

activity (excluding radon and uranium).

The maximum contaminant level for

gross alpha particle activity (including

radium-226 but excluding radon and

uranium) is 15 pCi/L.

(d) MCL for beta particle and photon

radioactivity. (1) The average annual

concentration of beta particle and

photon radioactivity from man-made

radionuclides in drinking water must

not produce an annual dose equivalent

to the total body or any internal organ

greater than 4 millirem/year (mrem/

year).

(2) Except for the radionuclides listed

in table A, the concentration of manmade radionuclides causing 4 mrem

total body or organ dose equivalents

must be calculated on the basis of 2 liter

per day drinking water intake using the

168 hour data list in ‘‘Maximum

Permissible Body Burdens and

Maximum Permissible Concentrations

of Radionuclides in Air and in Water for

Occupational Exposure,’’ NBS (National

Bureau of Standards) Handbook 69 as

amended August 1963, U.S. Department

of Commerce. This incorporation by

reference 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 this document are available

from the National Technical Information

Service, NTIS ADA 280 282, U.S.

Department of Commerce, 5285 Port

Royal Road, Springfield, Virginia 22161.

The toll-free number is 800–553–6847.

Copies may be inspected at EPA’s

Drinking Water Docket, 401 M Street,

SW., Washington, DC 20460; or at the

Office of the Federal Register, 800 North

Capitol Street, NW., Suite 700,

Washington, DC. If two or more

radionuclides are present, the sum of

their annual dose equivalent to the total

body or to any organ shall not exceed

4 mrem/year.

TABLE A.—AVERAGE ANNUAL CONCENTRATIONS ASSUMED TO PRODUCE: A TOTAL BODY OR ORGAN DOSE OF 4 MREM/YR

1. Radionuclide ................................................... Critical organ .................................................... pCi per liter

2. Tritium ............................................................ Total body ........................................................ 20,000

3. Strontium-90 ................................................... Bone Marrow .................................................... 8

(e) MCL for uranium. The maximum

contaminant level for uranium is 30 μg/

L.

(f) Compliance dates. (1) Compliance

dates for combined radium-226 and

-228, gross alpha particle activity, gross

beta particle and photon radioactivity,

and uranium: Community water systems

must comply with the MCLs listed in

paragraphs (b), (c), (d), and (e) of this

section beginning December 8, 2003 and

compliance shall be determined in

accordance with the requirements of

§§ 141.25 and 141.26. Compliance with

reporting requirements for the

radionuclides under appendix A to

subpart O and appendices A and B to

subpart Q is required on December 8,

2003.

(g) Best available technologies (BATs)

for radionuclides. The Administrator,

pursuant to section 1412 of the Act,

hereby identifies as indicated in the

following table the best technology

available for achieving compliance with

the maximum contaminant levels for

combined radium-226 and -228,

uranium, gross alpha particle activity,

and beta particle and photon

radioactivity.

TABLE B.—BAT FOR COMBINED RADIUM-226 AND RADIUM-228, URANIUM, GROSS ALPHA PARTICLE ACTIVITY, AND BETA

PARTICLE AND PHOTON RADIOACTIVITY

Contaminant BAT

1. Combined radium-226 and radium-228 ............................................... Ion exchange, reverse osmosis, lime softening.

2. Uranium ................................................................................................ Ion exchange, reverse osmosis, lime softening, coagulation/filtration.

3. Gross alpha particle activity (excluding Radon and Uranium) ............ Reverse osmosis.

4. Beta particle and photon radioactivity .................................................. Ion exchange, reverse osmosis.

(h) Small systems compliance

technologies list for radionuclides.

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76749

TABLE C.—LIST OF SMALL SYSTEMS COMPLIANCE TECHNOLOGIES FOR RADIONUCLIDES AND LIMITATIONS TO USE

Unit technologies

Limitations

(see footnotes)Operator skill level required 1 Raw water quality range and

considerations.1

1. Ion exchange (IE) ................................. (a) Intermediate .............................................. All ground waters.

2. Point of use (POU 2) IE ........................ (b) Basic ......................................................... All ground waters.

3. Reverse osmosis (RO) ......................... (c) Advanced .................................................. Surface waters usually require pre-filtration.

4. POU2 RO .............................................. (b) Basic ......................................................... Surface waters usually require pre-filtration.

5. Lime softening ...................................... (d) Advanced .................................................. All waters.

6. Green sand filtration ............................. (e) Basic.

7. Co-precipitation with Barium sulfate ..... (f) Intermediate to Advanced ......................... Ground waters with suitable water quality.

8. Electrodialysis/electrodialysis reversal .................... Basic to Intermediate ................................ All ground waters.

9. Pre-formed hydrous Manganese oxide

filtration.

(g) Intermediate .............................................. All ground waters.

10. Activated alumina ............................... (a), (h) Advanced .................................................. All ground waters; competing anion concentrations may affect regeneration frequency.

11. Enhanced coagulation/filtration ........... (i) Advanced .................................................. Can treat a wide range of water qualities.

1 National Research Council (NRC). Safe Water from Every Tap: Improving Water Service to Small Communities. National Academy Press.

Washington, D.C. 1997. 2A POU, or ‘‘point-of-use’’ technology is a treatment device installed at a single tap used for the purpose of reducing contaminants in drinking

water at that one tap. POU devices are typically installed at the kitchen tap. See the April 21, 2000 NODA for more details.

Limitations Footnotes: Technologies for Radionuclides: aThe regeneration solution contains high concentrations of the contaminant ions. Disposal options should be carefully considered before

choosing this technology. bWhen POU devices are used for compliance, programs for long-term operation, maintenance, and monitoring must be provided by water utility to ensure proper performance. c Reject water disposal options should be carefully considered before choosing this technology. See other RO limitations described in the

SWTR Compliance Technologies Table. dThe combination of variable source water quality and the complexity of the water chemistry involved may make this technology too complex

for small surface water systems. e Removal efficiencies can vary depending on water quality.

fThis technology may be very limited in application to small systems. Since the process requires static mixing, detention basins, and filtration,

it is most applicable to systems with sufficiently high sulfate levels that already have a suitable filtration treatment train in place. gThis technology is most applicable to small systems that already have filtration in place.

h Handling of chemicals required during regeneration and pH adjustment may be too difficult for small systems without an adequately trained

operator. iAssumes modification to a coagulation/filtration process already in place.

TABLE D.—COMPLIANCE TECHNOLOGIES BY SYSTEM SIZE CATEGORY FOR RADIONUCLIDE NPDWR’S

Contaminant

Compliance technologies 1 for system size categories

(population served) 3,300–10,000

25–500 501–3,300

1. Combined radium-226 and radium-228 ...................... 1, 2, 3, 4, 5, 6, 7, 8, 9 ....... 1, 2, 3, 4, 5, 6, 7, 8, 9 ....... 1, 2, 3, 4, 5, 6, 7. 8, 9.

2. Gross alpha particle activity ........................................ 3, 4 .................................... 3, 4 .................................... 3, 4.

3. Beta particle activity and photon activity ..................... 1, 2, 3, 4 ............................ 1, 2, 3, 4 ............................ 1, 2, 3, 4.

4. Uranium ....................................................................... 1, 2, 4, 10, 11 .................... 1, 2, 3, 4, 5, 10, 11 ........... 1, 2, 3, 4, 5, 10, 11.

Note: 1 Numbers correspond to those technologies found listed in the table C of 141.66(h).

Subpart O—[Amended]

8. The table in appendix A to subpart

O is amended under the heading

‘‘Radioactive contaminants’’ by revising

the entries for ‘‘Beta/photon emitters

(mrem/yr)’’, ‘‘Alpha emitters

(pCi/l)’’, and ‘‘Combined radium (pCi/

l)’’ and adding a new entry for

‘‘Uranium (pCi/L)’’ to read as follows:

76750 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

Appendix A to Subpart O—Regulated Contaminants

Contaminant units Traditional MCL

in mg/L

To convert for

CCR,

multiply

by

MCL in

CCR

units

MCLG Major sources in

drinking water Health effects language

*******

Radioactive contaminants:

Beta/photon

emitters

(mrem/yr).

4 mrem/yr ......... ¥ 4 0 Decay of natural and

man-made deposits.

Certain minerals are radioactive and may

emit forms of radiation known as photons and beta radiation. Some people

who drink water containing beta particle and photon radioactivity in excess

of the MCL over many years may have

an increased risk of getting cancer.

Alpha emitters

(pCi/L).

15 pCi/L ............ ¥ 15 0 Erosion of natural

deposits.

Certain minerals are radioactive and may

emit a form of radiation known as

alpha radiation. Some people who

drink water containing alpha emitters in

excess of the MCL over many years

may have an increased risk of getting

cancer.

Combined radium (pCi/L).5 pCi/L .............. ¥ 5 0 Erosion of natural

deposits.

Some people who drink water containing

radium-226 or -228 in excess of the

MCL over many years may have an increased risk of getting cancer.

Uranium (pCi/L) 30 μg/L ............. ¥ 30 0 Erosion of natural

deposits.

Some people who drink water containing

uranium in excess of the MCL over

many years may have an increased

risk of getting cancer and kidney toxicity.

*******

Subpart Q—[Amended]

9. Appendix A to subpart Q under I.F.

‘‘Radioactive contaminants’’ is amended

by:

a. Revising entries 1, 2, and 3;

b. Adding entry 4;

c. Redesignating endnotes 9 through

17 as endnotes 11 through 19; and

d. Adding new endnotes 9 and 10.

Appendix A to Subpart Q—NPDWR Violations and Other Situations Requiring Public Notice 1

Contaminant

MCL/MRDL/TT Violations 2 Monitoring and testing

procedure violations

Tier of public notice

required

Citation Tier of public notice

required

Citation

I. Violations of National Primary Drinking Water Regulations (NPDWR) 3

*******

F. Radioactive contaminants

1. Beta/photon emitters .................................................................................................... 2 141.66(d) 3 141.25(a)

141.26(b)

2. Alpha emitters .............................................................................................................. 2 141.66(c) 3 141.25(a)

141.26(a)

3. Combined radium (226 and 228) ................................................................................. 2 141.66(b) 3 141.25(a)

141.26(a)

4. Uranium ........................................................................................................................ 9 2 141.66(e) 10 3 141.25(a)

141.26(a)

*******

Appendix A—Endnotes

* * * * *

1. Violations and other situations not listed

in this table (e.g., reporting violations and

failure to prepare Consumer Confidence

Reports), do not require notice, unless

otherwise determined by the primary agency.

Primacy agencies may, at their option, also

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76751

require a more stringent public notice tier

(e.g., Tier 1 instead of Tier 2 or Tier 2 instead

of Tier 3) for specific violations and

situations listed in this Appendix, as

authorized under Sec. 141.202(a) and Sec.

141.203(a).

2. MCL—Maximum contaminant level,

MRDL—Maximum residual disinfectant

level, TT—Treatment technique.

3. The term Violations of National Primary

Drinking Water Regulations (NPDWR) is used

here to include violations of MCL, MRDL,

treatment technique, monitoring, and testing

procedure requirements.

* * * * *

9. The uranium MCL Tier 2 violation

citations are effective December 8, 2003 for

all community water systems.

10. The uranium Tier 3 violation citations

are effective December 8, 2000 for all

community water systems.

* * * * *

10. Appendix B to Subpart Q is amended

by:

a. Redesignating entries 79 through 84 and

86 through 88 as 80 through 85 and 87

through 89, respectively, and entries 85a and

85b as 86a and 86b, respectively;

b. Adding a new entry 79 for uranium

under ‘‘G. Radioactive contaminants’’;

c. Redesignating endnote entries 16

through 21 as 17 through 22; and

d. adding a new endnote 16.

Appendix B to Subpart Q—Standard Health Effects Language for Public Notification

Contaminant MCLG1 mg/L MCL2 mg/L Standard health effects language for public notification

National Primary Drinking

Water Regulations (NPDWR)

*******

G. Radioactive contaminants

*******

79. Uranium16 ............................. Zero ............. 30 μg/L ......... Some people who drink water containing uranium in excess of the MCL over

many years may have an increased risk of getting cancer and kidney toxicity.

*******

Appendix B—Endnotes

1. MCLG—Maximum contaminant level

goal

2. MCL—Maximum contaminant level

* * * * *

16. The uranium MCL is effective

December 8, 2003 for all community water

systems.

* * * * *

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.

Subpart B—Primary Enforcement

Responsibility

2. Section 142.16 is amended by

adding and reserving paragraphs (i), (j),

and (k) and adding a new paragraph (l)

to read as follows:

§ 142.16 Special primacy requirements.

* * * * *

(i)–(k) [Reserved]

(l) An application for approval of a

State program revision for radionuclides

which adopts the requirements

specified in § 141.26(a)(2)(ii)(C) of this

chapter must contain the following (in

addition to the general primacy

requirements enumerated in this part,

including that State regulations be at

least as stringent as the Federal

requirements):

(1) If a State chooses to use

grandfathered data in the manner

described in § 141.26(a)(2)(ii)(C) of this

chapter, then the State must describe

the procedures and criteria which it will

use to make these determinations

(whether distribution system or entry

point sampling points are used).

(i) The decision criteria that the State

will use to determine that data collected

in the distribution system are

representative of the drinking water

supplied from each entry point to the

distribution system. These

determinations must consider:

(A) All previous monitoring data.

(B) The variation in reported activity

levels.

(C) Other factors affecting the

representativeness of the data (e.g.

geology).

(ii) [Reserved]

(2) A monitoring plan by which the

State will assure all systems complete

the required monitoring within the

regulatory deadlines. States may update

their existing monitoring plan or use the

same monitoring plan submitted for the

requirements in § 142.16(e)(5) under the

national primary drinking water

regulations for the inorganic and organic

contaminants (i.e. the phase II/V rules).

States may note in their application any

revision to an existing monitoring plan

or note that the same monitoring plan

will be used. The State must

demonstrate that the monitoring plan is

enforceable under State law.

Subpart G—[Amended]

3. Section 142.65 is added to read as

follows.

§ 142.65 Variances and exemptions from

the maximum contaminant levels for

radionuclides.

(a)(1) Variances and exemptions from

the maximum contaminant levels for

combined radium-226 and radium-228,

uranium, gross alpha particle activity

(excluding Radon and Uranium), and

beta particle and photon radioactivity.

(i) The Administrator, pursuant to

section 1415(a)(1)(A) of the Act, hereby

identifies the following as the best

available technology, treatment

techniques, or other means available for

achieving compliance with the

maximum contaminant levels for the

radionuclides listed in § 141.66(b), (c),

(d), and (e) of this chapter, for the

purposes of issuing variances and

exemptions, as shown in Table A to this

paragraph.

76752 Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations

TABLE A.—BAT FOR RADIONUCLIDES LISTED IN § 141.66

Contaminant BAT

Combined radium-226 and radium-228 ................................................... Ion exchange, reverse osmosis, lime softening.

Uranium .................................................................................................... Ion exchange, reverse osmosis, lime softening, coagulation/filtration.

Gross alpha particle activity (excluding radon and uranium) ................... Reverse osmosis.

Beta particle and photon radioactivity ...................................................... Ion exchange, reverse osmosis.

(ii) In addition, the Administrator

hereby identifies the following as the

best available technology, treatment

techniques, or other means available for

achieving compliance with the

maximum contaminant levels for the

radionuclides listed in § 141.66(b), (c),

(d), and (e) of this chapter, for the

purposes of issuing variances and

exemptions to small drinking water

systems, defined here as those serving

10,000 persons or fewer, as shown in

Table C to this paragraph.

TABLE B.—LIST OF SMALL SYSTEMS COMPLIANCE TECHNOLOGIES FOR RADIONUCLIDES AND LIMITATIONS TO USE

Unit technologies

Limitations

(see footnotes)Operator skill level required 1 Raw water quality range &

considerations 1

1. Ion exchange (IE) ................................. (a) Intermediate .............................................. All ground waters.

2. Point of use (POU 2 ) IE ........................ (b) Basic ......................................................... All ground waters.

3. Reverse osmosis (RO) ......................... (c) Advanced .................................................. Surface waters usually require pre-filtration.

4. POU 2 RO ............................................. (b) Basic ......................................................... Surface waters usually require pre-filtration.

5. Lime softening ...................................... (d) Advanced .................................................. All waters.

6. Green sand filtration ............................. (e) Basic.

7. Co-precipitation with barium sulfate ..... (f) Intermediate to Advanced ......................... Ground waters with suitable water quality.

8. Electrodialysis/electrodialysis reversal Basic to Intermediate ................................ All ground waters.

9. Pre-formed hydrous manganese oxide

filtration.

(g) Intermediate .............................................. All ground waters.

10. Activated alumina ............................... (a), (h) Advanced .................................................. All ground waters; competing anion concentrations may affect regeneration frequency.

11. Enhanced coagulation/filtration ........... (i) Advanced .................................................. Can treat a wide range of water qualities.

1 National Research Council (NRC). Safe Water from Every Tap: Improving Water Service to Small Communities. National Academy Press.

Washington, D.C. 1997. 2A POU, or ‘‘point-of-use’’ technology is a treatment device installed at a single tap used for the purpose of reducing contaminants in drinking

water at that one tap. POU devices are typically installed at the kitchen tap. See the April 21, 2000 NODA for more details.

Limitations Footnotes: Technologies for Radionuclides:

aThe regeneration solution contains high concentrations of the contaminant ions. Disposal options should be carefully considered before

choosing this technology. bWhen POU devices are used for compliance, programs for long-term operation, maintenance, and monitoring must be provided by water utility to ensure proper performance. c Reject water disposal options should be carefully considered before choosing this technology. See other RO limitations described in the

SWTR compliance technologies table. dThe combination of variable source water quality and the complexity of the water chemistry involved may make this technology too complex

for small surface water systems. e Removal efficiencies can vary depending on water quality.

fThis technology may be very limited in application to small systems. Since the process requires static mixing, detention basins, and filtration,

it is most applicable to systems with sufficiently high sulfate levels that already have a suitable filtration treatment train in place. gThis technology is most applicable to small systems that already have filtration in place.

h Handling of chemicals required during regeneration and pH adjustment may be too difficult for small systems without an adequately trained

operator. iAssumes modification to a coagulation/filtration process already in place.

TABLE C.—BAT FOR SMALL COMMUNITY WATER SYSTEMS FOR THE RADIONUCLIDES LISTED IN § 141.66

Contaminant

Compliance technologies 1 for system size categories (population served)

25–500 501–3,300 3,300–10,000

Combined radium-226 and radium-228 .......................... 1, 2, 3, 4, 5, 6, 7, 8, 9 ....... 1, 2, 3, 4, 5, 6, 7, 8, 9 ....... 1, 2, 3, 4, 5, 6, 7, 8, 9.

Gross alpha particle activity ............................................ 3, 4 .................................... 3, 4 .................................... 3, 4.

Beta particle activity and photon activity ......................... 1, 2, 3, 4 ............................ 1, 2, 3, 4 ............................ 1, 2, 3, 4.

Uranium ........................................................................... 1, 2, 4, 10, 11 .................... 1, 2, 3, 4, 5, 10, 11 ........... 1, 2, 3, 4, 5, 10, 11.

1 Note: Numbers correspond to those technologies found listed in the table B to this paragraph.

(2) A State shall require community

water systems to install and/or use any

treatment technology identified in Table

A to this section, or in the case of small

water systems (those serving 10,000

persons or fewer), Table B and Table C

Federal Register / Vol. 65, No. 236 / Thursday, December 7, 2000 / Rules and Regulations 76753

of this section, as a condition for

granting a variance except as provided

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

after the system’s installation of the

treatment technology, the system cannot

meet the MCL, that system shall be

eligible for a variance under the

provisions of section 1415(a)(1)(A) of

the Act.

(3) If a community water system can

demonstrate through comprehensive

engineering assessments, which may

include pilot plant studies, that the

treatment technologies identified in this

section would only achieve a de

minimus reduction in the contaminant

level, the State may issue a schedule of

compliance that requires the system

being granted the variance to examine

other treatment technologies as a

condition of obtaining the variance.

(4) If the State determines that a

treatment technology identified under

paragraph (a)(3) of this section is

technically feasible, the Administrator

or primacy State may require the system

to install and/or use that treatment

technology in connection with a

compliance schedule issued under the

provisions of section 1415(a)(1)(A) of

the Act. The State’s determination shall

be based upon studies by the system

and other relevant information.

(5) The State may require a

community water system to use bottled

water, point-of-use devices, point-ofentry devices or other means as a

condition of granting a variance or an

exemption from the requirements of

§ 141.66 of this chapter, to avoid an

unreasonable risk to health.

(6) Community water systems that use

bottled water as a condition for

receiving a variance or an exemption

from the requirements of § 141.66 of this

chapter must meet the requirements

specified in either § 142.62(g)(1) or

§ 142.62(g)(2) and (g)(3).

(7) Community water systems that use

point-of-use or point-of-entry devices as

a condition for obtaining a variance or

an exemption from the radionuclides

NPDWRs must meet the conditions in

§ 142.62(h)(1) through (h)(6).

[FR Doc. 00–30421 Filed 12–6–00; 8:45 am]

BILLING CODE 6560–50–U