National Primary Drinking Water Regulations; Arsenic and Clarifications to Compliance and New Source Contaminants Monitoring

Federal RegisterJan 22, 2001

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9, 141 and 142

[WH-FRL-6934-9]

RIN 2040-AB75

National Primary Drinking Water Regulations; Arsenic and Clarifications to Compliance and New Source Contaminants Monitoring

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

Today EPA is establishing a health-based, non-enforceable Maximum Contaminant Level Goal (MCLG) for arsenic of zero and an enforceable Maximum Contaminant Level (MCL) for arsenic of 0.01 mg/L (10 μg/L). This regulation will apply to non-transient non-community water systems, which are not presently subject to standards on arsenic in drinking water, and to community water systems.

In addition, EPA is publishing clarifications for monitoring and demonstration of compliance for new systems or sources of drinking water. The Agency is also clarifying compliance for State-determined monitoring after exceedances for inorganic, volatile organic, and synthetic organic contaminants. Finally, EPA is recognizing the State-specified time period and sampling frequency for new public water systems and systems using a new source of water to demonstrate compliance with drinking water regulations. The requirement for new systems and new source monitoring will be effective for inorganic, volatile organic, and synthetic organic contaminants.

DATES:

This rule is effective March 23, 2001, except for the amendments to §§ 141.23(i)(1), 141.23(i)(2), 141.24(f)(15), 141.24(h)(11), 141.24(h)(20), 142.16(e), 142.16(j), and 142.16(k) which are effective January 22, 2004.

The compliance date for requirements related to the clarification for monitoring and compliance under §§ 141.23(i)(1), 141.23(i)(2), 141.24(f)(15), 141.24(f)(22), 141.24(h)(11), 141.24(h)(20), 142.16(e), 142.16(j), and 142.16(k) is January 22, 2004. The compliance date for requirements related to the revised arsenic standard under §§ 141.23(i)(4), 141.23(k)(3), 141.23(k)(3)(ii), 141.51(b), 141.62(b), 141.62(b)(16), 141.62(c), 141.62(d), and 142.62(b) is January 23, 2006. For purposes of judicial review, this rule is promulgated as of January 22, 2001.

ADDRESSES:

Copies of the public comments received, EPA responses, and all other supporting documents are available for review at the U.S. EPA Water Docket (4101), East Tower B-57, 401 M Street, SW, Washington DC 20460. For an appointment to review the docket, call 202-260-3027 between 9 a.m. and 3:30 p.m. and refer to Docket W-99-16.

FOR FURTHER INFORMATION CONTACT:

The Safe Drinking Water Hotline, phone: (800) 426-4791, or (703) 285-1093, e-mail: hotline.sdwa@epa.gov for general information about, and copies of, this document and the proposed rule. For technical inquiries, contact: Jeff Kempic, (202) 260-9567, e-mail: kempic.jeffrey@epa.gov for treatment and costs, and Dr. John B. Bennett, (202) 260-0446, e-mail: bennett.johnb@epa.gov for benefits.

SUPPLEMENTARY INFORMATION:

Regulated Entities

A public water system (PWS), as defined in 40 CFR 141.2, provides water to the public for human consumption through pipes or “other constructed conveyances, if such system has at least fifteen service connections or regularly serves an average of at least twenty-five individuals daily at least 60 days out of the year.” A public water system is either a community water system (CWS) or a non-community water system (NCWS). A community water system, as defined in § 141.2, is “a public water system which serves at least fifteen service connections used by year-round residents or regularly serves at least twenty-five year-round residents.” The definition in § 141.2 for a non-transient non-community water system (NTNCWS) is “a public water system that is not a [CWS] and that regularly serves at least 25 of the same persons over 6 months per year.” EPA has an inventory totaling over 54,000 community water systems and approximately 20,000 non-transient non-community water systems nationwide. Entities potentially regulated by this action are community water systems and non-transient non-community water systems. The following table provides examples of the regulated entities under this rule.

Table of Regulated Entities

Category

Examples of regulated entities

Industry

Privately owned/operated community water supply systems using ground water, surface water, or mixed ground water and surface water.

State, Tribal, and Local Government

State, Tribal, or local government-owned/operated water supply systems using ground water, surface water, or mixed ground and surface water.

Federal Government

Federally owned/operated community water supply systems using ground water, surface water, or mixed ground water and surface water.

The table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that EPA is now aware could potentially be regulated by this action. Other types of entities not listed in this table could also be regulated. To determine whether your facility is regulated by this action, you should carefully examine the applicability criteria in §§ 141.11 and 141.62 of the rule. If you have any questions regarding the applicability of this action to a particular entity, consult the general information contact listed in the section listing contacts for further information.

Abbreviations used in this rule

<—less than

≤—less than or equal to

>—greater than

≥—greater than or equal to

±—plus or minus

§ —section

σ—σ, Greek letter, in statistics represents standard deviation

μg—Microgram, one-millionth of a gram (3.5 × 10

−

8

of an ounce)

μg/L—micrograms per liter

AA—Activated alumina

AIC—Akaike Information Criterion

ACWA—Association of California Water Agencies

AMWA—Association of Metropolitan Water Agencies

APHA—American Public Health Association

ARARs—Applicable or relevant and appropriate requirements

As (III)—Trivalent arsenic. Common inorganic form in water is arsenite

As (V)—Pentavalent arsenic. Common inorganic form in water is arsenate

ASDWA— Association of State Drinking Water Administrators

AsH

3

—Arsine

ASTM—American Society for Testing and Materials

ATSDR—Agency for Toxic Substances and Disease Registry, U.S. Department of Health & Human Services

AWWA—American Water Works Association

AWWARF—American Water Works Association Research Foundation

BAT—Best available technology

BV—Bed volume

CCR—Consumer Confidence Report

CERCLA—Comprehensive Environmental Response, Compensation, and Liability Act administered by EPA for hazardous substances

C/F—Modified coagulation/filtration

CFR—Code of Federal Regulations

CSFII—Continuing Survey of Food Intakes by Individuals

CWA—Clean Water Act administered by EPA for surface waters of the U.S.

CWS—Community water system

CWSS—Community Water System Survey

DMA—Dimethyl arsinic acid, cacodylic acid, (CH

3

)

2

HAsO

2

DNA—Deoxyribonucleic acid

DWSRF—Drinking Water State Revolving Fund

EA—Economic analysis

EDR—Electrodialysis reversal

EEAC—Environmental Economics Advisory Committee

e.g.—

exempli gratia,

Latin for “for example”

EPA—U.S. Environmental Protection Agency

et al.—

et alia,

Latin for “and others”

FACA—Federal Advisory Committee Act

FR—Federal Register

FRFA—Final Regulatory Flexibility Analysis

FSIS—Federalism Summary Impact Statement

GDP—Gross Domestic Product

GFAA—Graphite furnace atomic absorption

GHAA—Gaseous hydride atomic absorption

GI—Gastrointestinal

GW—Ground water

GWR—Ground Water Rule

HRRCA—Health Risk Reduction and Cost Analysis

ICP-AES—Inductively coupled plasma-atomic emission spectroscopy

ICP-MS—Inductively coupled plasma mass spectroscopy

ICR—Information collection request

i.e.—

id est,

Latin for “that is”

IOCs—Inorganic contaminants

ISCV—Intra-system coefficient of variation

IX—Ion exchange

L—Liter, also referred to as lower case “l” in older citations

LD

50

—The dose of a chemical taken by mouth or absorbed by the skin which is expected to cause death in 50% of the test animals

LS—Modified lime softening

LT1/FBR—Long Term 1 Enhanced Surface Water Treatment and Filter Backwash Recycling Rule

MCL—Maximum contaminant level

MCLG—Maximum contaminant level goal

MDL—Method detection limit

mg—Milligrams, one-thousandth of a gram, 1 milligram=1,000 micrograms

mg/kg—Milligrams arsenic per kilogram body weight or soil weight

mg/L—Milligrams per liter

MHI—Mean household income

MMA—Monomethyl arsenic, arsonic acid, CH

3

H

2

ASO

3

NAOS—National Arsenic Occurrence Survey

NAS—National Academy of Sciences

NAWQA—National Ambient Water Quality Assessment, USGS

NCI—National Cancer Institute

NCWS—Non-community water system

NDWAC—National Drinking Water Advisory Council for EPA

NIRS—National Inorganic and Radionuclide Survey done by EPA

NODA—Notice of Data Availability

NOMS—National Organic Monitoring Survey done by EPA

NPDES—National Pollutant Discharge Elimination System for CWA

NPDWR—National primary drinking water regulation

NR—Not reported

NRC—National Research Council, the operating arm of NAS

NTNCWS—Non-transient non-community water system

NTTAA—National Technology Transfer and Advancement Act

NWIS—National Water Information System of USGS

OGWDW—Office of Ground Water and Drinking Water in EPA

OMB—Office of Management and Budget

PE—Performance evaluation, studies to certify laboratories for EPA drinking water testing

pH—Negative log of hydrogen ion concentration

PNR—Public Notification Rule

POE—Point-of-entry treatment devices

POTWs—Publicly owned treatment works, treat wastewater

POU—Point-of-use treatment devices

ppb—Parts per billion

ppm—Parts per million

PQL—Practical quantitation level

PRA—Paperwork Reduction Act

psi—Pounds per square inch

PT—Performance testing

PUC—Public utilities commission

PWS—Public water systems

QALYs—Quality adjusted life years

RCRA—Resource Conservation and Recovery Act

REF—Relative exposure factors

RFA—Regulatory Flexibility Act

RIA—Regulatory Impact Analysis

RO—Reverse osmosis

RUS—Rural Utilities Service

RWS—Rural Water Survey

SAB—Science Advisory Board

SBAR—Small Business Advocacy Review

SBREFA—Small Business Regulatory Enforcement Fairness Act

SD—Standard deviation

SDWA—Safe Drinking Water Act

SDWIS—Safe Drinking Water Information System

SEER—Surveillance, Epidemiology, and End Results

SM—Standard Method for Examination of Water and Wastewater

SMF—Standardized monitoring framework

SMRs—Standardized mortality ratios

SO4—Sulfate

SOCs—Synthetic organic contaminants

STP-GFAA—Stabilized temperature platform graphite furnace atomic absorption

SW—Surface water

TBLLs—Technically based local limits

TC—Toxicity Characteristic, RCRA hazardous waste

TCLP—Toxicity Characteristic Leaching Procedure, tests for hazardous waste

TDS—Total dissolved solids

TMF—Technical, managerial, financial capacity

TOC—Total organic carbon

UMRA—Unfunded Mandates Reform Act

URTH—Unreasonable risk to health

U.S.—United States

USDA—US Department of Agriculture

USGS—US Geological Survey

UV—Ultraviolet

VOCs—Volatile organic contaminants

VSL—Value of statistical life

VSLY—Value of statistical life year

WHO—World Health Organization

WS—Water supply

WTP—Willingness-to-pay

Table of Contents

I. Background and Summary of the Final Rule

A. What Did EPA Propose?

B. Overview of the Notice of Data Availability (NODA)

C. Does This Regulation Apply to My Water System?

D. What are the Final Drinking Water Regulatory Standards for Arsenic (Maximum Contaminant Level Goals and Maximum Contaminant Levels)?

E. Will There be a Health Advisory?

F. What are the Best Available Technologies For Removing Arsenic From Drinking Water?

1. BAT technologies

2. Preoxidation

3. Factors affecting listing technologies

4. Other technologies evaluated, but not designated as BAT

5. Waste disposal

G. Treatment Trains Considered For Small Systems

1. Can my water system use point-of-use (POU), point-of-entry (POE), or bottled water to comply with this regulation?

2. What are the affordable treatment technologies for small systems?

3. Can my water system get a small system variance from an MCL under today's rule?

H. Can My System Get a General Variance or Exemption from the MCL Under Today's Rule?

I. What Analytical Methods are Approved for Compliance Monitoring of Arsenic and What are the Performance Testing Criteria for Laboratory Certification?

1. Approved analytical methods

2. Performance testing criteria for laboratory certification

J. How Will I Know if My System Meets the Arsenic Standard?

1. Sampling points and grandfathering of monitoring data

2. Compositing of samples

3. Calculation of violations

4. Monitoring and compliance schedule

K. What do I Need To Tell My Customers?

1. Consumer Confidence Reports

a. General requirements

b. Special informational statement

2. Public Notification

L. What Financial Assistance Is Available for Complying With This Rule?

M. What is the Effective Date and Compliance Date for the Rule?

N. How Were Stakeholders Involved in the Development of This Rule?

II. Statutory Authority

III. Rationales for Regulatory Decisions

A. What is the MCLG?

B. What is the Feasible Level?

1. Analytical measurement feasibility

2. Treatment

C. How Did EPA Revise Its National Occurrence Estimates?

1. Summary of occurrence data and methodology

2. Corrections and additions to the data

3. Changes to the methodology

4. Revised occurrence results

D. How Did EPA Revise Its Risk Analysis?

1. Health risk analysis

a. Toxic forms of arsenic

b. Effects of acute toxicity

c. Non-cancer effects associated with arsenic.

d. Cancers associated with arsenic

e. How does arsenic cause cancer?

f. What is the quantitative relationship between exposure and cancer effects that may be projected for exposures in the U.S.?

g. Is it appropriate to assume linearity for the dose-response assessment for arsenic at low doses given that arsenic is not directly reactive with DNA?

2. Risk factors/bases for upper- and lower-bound analyses

a. Water consumption

b. Relative Exposure Factors

c. Arsenic occurrence

d. Risk distributions

e. Estimated risk reductions

f. Lower-bound analyses

g. Cases avoided

3. Sensitive subpopulations

4. Risk window

E. What are the Costs and Benefits at 3, 5, 10, and 20 μg/L?

1. Summary of cost analysis

a. Total national costs

b. Household costs

2. Summary of benefits analysis

a. Primary analysis

b. Sensitivity analysis on benefits valuation

c. SAB recommendations

d. Analytical approach

e. Results

3. Comparison of costs and benefits

a. Total national costs and benefits

b. National net benefits and benefit-cost ratios

c. Incremental costs and benefits

d. Cost-per-case avoided

4. Affordability

F. What MCL Is EPA Promulgating and What Is the Rationale for This Level?

1. Final MCL and overview of principal considerations

2. Consideration of health risks

3. Comparison of benefits and costs

4. Rationale for the final MCL

a. General considerations

b. Relationship of MCL to the feasible level (3 μg/L)

c. Reanalysis of proposed MCL and comparison to final MCL

d. Consideration of higher MCL options

e. Conclusion

IV. Rule Implementation

A. What are the Requirements for Primacy?

B. What are the Special Primacy Requirements?

C. What are the State Recordkeeping Requirements?

D. What are the State Reporting Requirements?

E. When does a State Have to Apply for Primacy?

F. What are Tribes Required To Do Under This Regulation?

V. Responses to Major Comments Received

A. General Comments

1. Sufficiency of information and adequacy of procedural requirements to support a final rule

2. Suggestions for development of an interim standard

3. Public involvement and opportunity for comment

4. Relation of MCL to the feasible level

5. Relationship of MCL to other regulatory programs

6. Relation of MCL to WHO standard

7. Regulation of non-transient non-community water systems (NTNCWSs)

8. Extension of effective date for large systems

B. Health Effects of Arsenic

1. Epidemiology data

2. Dose-response relationship

3. Suggestions that EPA await further health effects research

4. Sensitive subpopulations

5. EPA's risk analysis

6. Setting the MCLG and the MCL

C. Occurrence

1. Occurrence data

2. Occurrence methodology

3. Co-occurrence

D. Analytical Methods

1. Analytical interferences

2. Demonstration of PQL (includes acceptance limits)

3. Acidification of samples

E. Monitoring and Reporting Requirements

1. Compliance determinations

2. Monitoring of POU devices

3. Monitoring and reporting for NTNCWSs

4. CCR health language and reporting date

5. Implementation guidance

6. Rounding analytical results

F. Treatment Technologies

1. Demonstration of technology performance

2. Barriers to technology application

3. Small system technology application

4. Waste generation and disposal

a. Anion exchange

b. Activated alumina

c. Reverse osmosis

5. Emerging technologies

G. Costs

1. Disparity of costs

a. What is EPA's response to major comments on the decision tree for the proposed rule?

b. What is EPA's response to comments on system level costs?

c. What is EPA's response to comments that state the report “Cost Implications of a Lower Arsenic MCL” (Frey et al., 2000), be used as a basis for reflecting more realistic national costs than EPA's estimates?

2. Affordability

3. Combined cost of new regulations

4. Projected effects of the new standard on other regulatory programs.

H. Benefits of Arsenic Reduction

1. Timing of benefits accrual (latency)

2. Use of the Value of Statistical Life (VSL)

3. Use of alternative methodologies for benefits estimation

4. Comments on EPA's consideration of nonquantifiable benefits

5. Comments on EPA's assumption of benefits accrual prior to rule implementation

I. Risk Management Decision

1. Role of uncertainty in decision making

2. Agency's interpretation of benefits justify costs provision

3. Alternative regulatory approaches

4. Standard for total arsenic vs. species-specific standards

J. Health Risk Reduction and Cost Analysis (HRRCA)

1. Notice and comment requirement

2. Conformance with SDWA requirements

VI. Administrative and Other Requirements

A. Executive Order 12866: Regulatory Planning and Review

B. Regulatory Flexibility Act (RFA), as Amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et seq.

C. Unfunded Mandates Reform Act (UMRA) of 1995

a. Authorizing legislation

b. Cost-benefit analysis

c. Financial assistance

d. Estimates of future compliance costs and disproportionate budgetary effects

e. Macroeconomic effects

f. Summary of EPA's consultation with State, Tribal, and local governments

g. Nature of State, Tribal, and local government concerns and how EPA addressed these concerns

h. Regulatory alternatives considered

i. Selection of the regulatory alternative

D. Paperwork Reduction Act (PRA)

E. National Technology Transfer and Advancement Act (NTTAA)

F. Executive Order 12898: Environmental Justice

G. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks

H. Executive Order 13132: Federalism

I. Executive Orders 13084 and 13175: Consultation and Coordination with Indian Tribal Governments

J. Plain Language

K. Congressional Review Act

L. Consultations with the Science Advisory Board, National Drinking Water Advisory Council, and the Secretary of Health and Human Services

M. Likely Effect of Compliance With the Arsenic Rule on the Technical, Financial, and Managerial Capacity of Public Water Systems

VI. References

List of Tables

Table I.F-1.—Best Available Technologies and Removal Rates

Table I.G-1.—Treatment Technology Trains

Table I.G-2.—Baseline Values for Small Systems Categories

Table I.G-3.—Available Expenditure Margin for Affordable Technology Determinations

Table I.G-4.—Design and Average Daily Flows Used for Affordable Technology Determinations

Table I.G-5.—Affordable Compliance Technology Trains for Small Systems with population 25-500

Table I.G-6.—Affordable Compliance Technology Trains for Small Systems with populations 501-3,300 and 3,301 to 10,000

Table I.I-1.—Approved Analytical Methods (40 CFR 141.23) for Arsenic at the MCL of 0.01 mg/L

Table III.C-1.—Summary of Occurrence Databases for the Proposed and Final Rules

Table III.C-2.—Alaska PWS Inventories: Baseline Handbook and Corrected

Table III.C-3.—National Occurrence Exceedance Probability Estimates

Table III.C-4.—Parameters of Lognormal Distributions Fitted to National Occurrence Distributions

Table III.C-5.—Regional Occurrence Exceedance Probability Estimates

Table III.C-6.—Statistical Estimates of Numbers of Systems with Average Finished Arsenic Concentrations in Various Ranges

Table III.C-7.—Estimated Intra-System Coefficients of Variation

Table III.C-8.—Comparison of National Arsenic Occurrence Estimates

Table III.D-1.—Life-Long Relative Exposure Factors

Table III.D-2(a).—Cancer Risks for U.S. Populations Exposed At or Above MCL Options, after Treatment

1,2

(Without Adjustment for Arsenic in Food and Cooking Water)

Table III.D-2(b).—Cancer Risks for U.S. Populations Exposed At or Above MCL Options, after Treatment

1,2

(With Adjustment for Arsenic Exposure in Food and Cooking Water)

Table III.D-2(c).—Cancer Risks for U.S. Populations Exposed At or Above MCL Options, after Treatment

1

(Lower Bound With Food and Cooking Water Adjustment, Upper Bound Without Food and Cooking Water Adjustment)

Table III.D-3.—Annual Total (Bladder and Lung) Cancer Cases Avoided from Reducing Arsenic in CWSs and NTNCWS

Table III.E-1.—Total Annual National System and State Compliance Costs

Table III.E-2.—Mean Annual Costs per Household

Table III.E-3.—Estimated Benefits from Reducing Arsenic in Drinking Water

Table III.E-4.—Sensitivity of the Primary VSL Estimate to Changes in Latency Period Assumptions, Income Growth, and Other Adjustments

Table III.E-5.—Sensitivity of Combined Annual Bladder and Lung Cancer Mortality Benefits Estimates to Changes in VSL Adjustment Factor Assumptions

Table III.E-6.—Sensitivity of Combined Annual Bladder and Lung Cancer Mortality Benefits Estimates to Changes in VSL Adjustment Factor Assumptions

Table III.E-7.—Estimated Annual Costs and Benefits from Reducing Arsenic in Drinking Water

Table III.E-8 Summary of National Annual Net Benefits and Benefit-Cost Ratios, Combined Bladder and Lung Cancer Cases

Table III.E-9 Estimates of the Annual Incremental Risk Reduction, Costs, and Benefits of Reducing Arsenic in Drinking Water

Table III.E-10. Annual Cost Per Cancer Case Avoided for the Final Arsenic Rule—Combined Bladder and Lung Cancer Cases

TABLE V.F-4.1 Treatment Trains in Final Versus Proposed Arsenic Rule Decision Tree

Table V.F-4.2 New or Revised Treatment Trains

Table VI.B-1. Profile of the Universe of Small Water Systems Regulated Under the Arsenic Rule

I. Background and Summary of the Final Rule

A. What Did EPA Propose?

On June 22, 2000, the

Federal Register

published EPA's proposed arsenic regulation for community water systems and non-transient non-community water systems (65 FR 38888; EPA, 2000i). EPA proposed a health-based, non-enforceable goal, or Maximum Contaminant Level Goal (MCLG), of zero micrograms per liter (μg/L) and a Maximum Contaminant Level (MCL) of 5 μg/L. The Agency also requested comment on alternate MCL levels of 3 μg/L, 10 μg/L, and 20 μg/L. (In the proposed rule EPA expressed arsenic concentration in milligrams per liter (mg/L) or parts per million, which matches the units of the former and current standard for arsenic. Except as noted, the Agency will refer to arsenic concentration in micrograms per liter (μg/L) in this preamble.)

EPA based the June 2000 proposal on extensive analysis including a careful consideration of the following issues: a nonzero MCLG; occurrence of arsenic in public water systems; our approach for estimating national occurrence and co-occurrence; acceptance limits used to establish the practical quantitation level (PQL); rounding of measured values for compliance purposes; extending compliance by two years for systems serving under 10,000 people in order to add capital improvements; dates for reporting changes in the consumer confidence reports and public notification; appropriateness of the national affordability criteria; affordable technologies for small systems; implementation issues for point-of-use (POU) and point-of-entry (POE) treatments; appropriateness of non-hazardous residual costing; our overall analysis of costs; adjusting benefits estimates (

e.g.

, for factors such as latency); our approach for considering uncertainties that affected risk; use of the authority to set an MCL at a level other than the feasible MCL; expression of the MCL as total arsenic; approaches to regulation of NTNCWSs; State program revisions; selenium levels as an attenuation factor in arsenic toxicity; impacts on small entities; use of consensus analytical methods; methods to address environmental justice concerns; and comments on use of plain

language. We asked commenters to submit data and comments on these issues, as well as any other issues raised in the proposal.

The proposal reflected several types of technical evaluations, including analytical methods performance and laboratory capacity; the likelihood of different size water systems choosing treatment technologies based on source water characteristics; and the national occurrence of arsenic in drinking water supplies. Furthermore, the Agency assessed the quantifiable and nonquantifiable costs and health risk reduction benefits likely to occur at the treatment levels considered, and the effects of arsenic on sensitive subpopulations.

The proposed MCL was consistent with the Agency's use of the new benefit/cost provisions of the Safe Drinking Water Act (SDWA), as amended in 1996 (see section II. of this preamble for additional information about this provision). EPA proposed 3 μg/L as the feasible MCL, after considering treatment costs and efficiency under field conditions as well as considering the appropriate analytical methods. Because EPA determined that the benefits of regulating arsenic at the feasible level would not justify the costs, the Agency proposed an MCL of 5 μg/L, while requesting comment on MCL options of 3 μg/L (the feasible level), 10 μg/L, and 20 μg/L.

We based our estimates of large system compliance costs primarily on costs for coagulation/filtration and lime softening, although we consider several other technologies to be appropriate as best available technology (BAT) technologies. (See Table I.F-1.) For small-system (systems serving 10,000 people and less) compliance costs, we considered the costs for ion exchange, activated alumina, reverse osmosis, and nanofiltration. EPA proposed extending the effective date to five years after the final rule issuance for small community water systems and maintaining the effective date at three years after promulgation for all other community water systems. EPA proposed that States applying to adopt the revised arsenic MCL may use their most recently approved monitoring and waiver plans or note in their primacy application any revisions to those plans. EPA proposed that NTNCWSs monitor for arsenic and report exceedances of the MCL.

The Agency also clarified the procedure used for determining compliance after exceedances for inorganic, volatile organic, and synthetic organic contaminants in §§ 141.23(i)(2), 141.24(f)(15)(ii), and 141.24(h)(11)(ii), respectively. Finally, EPA proposed that new systems and systems using a new source of water be required to demonstrate compliance with the MCLs using State-specified time frames. The clarified new source and new system compliance regulations require that States establish initial sampling frequencies and compliance periods for inorganic, volatile organic, and synthetic organic contaminants in §§ 141.23(c)(9), 141.24(f)(22), and 141.24(h)(20), respectively.

B. Overview of the Notice of Data Availability (NODA)

In the proposed rule, EPA quantified the risk reduction and benefits of avoiding bladder cancer and noted that a peer-reviewed quantification of lung cancer risk from arsenic exposure would probably be available in time to consider for the final rule (65 FR 38888 at 38899; EPA, 2000i). Relying upon a discussion in the National Research Council (NRC) report (NRC, 1999, pg. 8) about the qualitative risks of lung cancer (65 FR 38888 at 38944; 2000i), EPA provided a “What-If” estimate of lung cancer benefits (65 FR 38888 at 38946, 2000i) in the proposed rule. On October 20, 2000, the

Federal Register

published EPA's Notice of Data Availability (NODA) containing a revised risk analysis for bladder cancer and new risk information concerning lung cancer (65 FR 63027; EPA, 2000m), and identified a correction to Table 4 on October 27, 2000 (65 FR 64479; EPA, 2000n). The NODA also provided information concerning the availability of cost curves used to develop the costs published in the proposal.

EPA used new risk information for lung and bladder cancer from a peer-reviewed article written by Morales

et al.

(2000). In the NODA, EPA explained that the authors used several alternative statistical models to estimate cancer risk. EPA explained its reasons for selecting “Model 1” with no comparison population for further analysis. We used daily water consumption (EPA, 2000c) reported by gender, region, age, economic status, race, and separately for pregnant women, lactating women, and women in childbearing years combined with weight data to derive exposure factors for the U.S. We used these exposure factors, our occurrence estimate (EPA 2000g) of populations exposed to arsenic at different concentrations, and the risk distributions from the Morales

et al.

(2000) paper in Monte Carlo simulations to estimate the upper bound of risks faced by the U.S. population. The NODA compared the bladder cancer risks derived for the proposal against the bladder cancer risks derived from the Morales

et al.

(2000) study. EPA also derived lung cancer risks using the same approach and the risk model contained in the Morales

et al.

(2000) study.

EPA also used the newly calculated risks to estimate a lower bound risk in the U.S. This calculation took into account the amount of additional arsenic people in Taiwan were likely to have ingested from water used in food preparation. EPA showed the effects on risks for the U.S. population at both the mean and 90th percentile levels for various arsenic levels in drinking water. Based on the revised risk assessment, we updated our assessment of the relative risk of lung cancer as compared to bladder cancer. The NODA indicated that instead of being 2 to 5 times as many fatal lung cancer cases as bladder cancer cases (as was cited in NRC's Executive Summary, NRC, 1999, pg. 8 as a qualitative estimate), the combined risk of excess lung and bladder cancer were thought to be only about twice that of bladder cancer risk. EPA noted that, while the new risks were higher than the bladder cancer risk in the proposal, the monetized benefits of lung cancer would fall within the lung cancer benefits range estimated using the “What-If” analysis (

e.g.

, $19.6 million—$224 million yearly for an MCL of 10 μg/L) in the proposal (65 FR 38888 at 38959; EPA, 2000m).

In the NODA, EPA also explained that the docket for the proposed rule had the November 1999 version (EPA, 1999o) of “Technologies and Costs for the Removal of Arsenic from Drinking Water” rather than the April 1999 version of the document that was the primary source for the treatment technology cost equations used to generate the national cost estimate. The national cost estimate was presented in the “Proposed Arsenic in Drinking Water Rule Regulatory Impact Analysis” (EPA, 2000h). The NODA therefore announced the availability of the “Technologies and Costs for the Removal of Arsenic from Drinking Water,” dated April 1999 (EPA,1999b). The NODA also noted that commenters interested in reproducing the waste disposal curves should consult the “Small Water System Byproducts Treatment and Disposal Cost Document” (EPA, 1993a) and “Water System Byproducts Treatment and Disposal Document (EPA, 1993b).” In addition to placing these documents in the docket, the NODA also specified that an electronic copy of the treatment technology and waste disposal equations used in the development of the RIA could be found in the docket.

EPA made the April 1999 version of the document, “Technologies and Costs for the Removal of Arsenic from Drinking Water” (EPA,1999b) available on its arsenic webpage.

The cost methodology and cost estimates were clearly stated and explained in the proposal for public review and consideration. Through a technical oversight, we incorrectly attributed the source for the cost curves to the November version of the document placed in the docket (EPA, 1999o). As a result, people could not replicate the precise analysis we did, should a commenter desire to do so. More specifically, although the inputs, assumptions, and model methodology were clearly explained, we incorrectly cited the sources of an intermediate step of deriving specific cost curves from those assumptions. Based upon the proposal's detailed discussion of inputs, assumptions and associated methodology, EPA believes the public was fully able to review, understand, and comment on the Agency's estimate of potential impacts. EPA discusses the cost curves further in section III.E.1 of this preamble.

C. Does This Regulation Apply to My Water System?

The final regulation on arsenic in drinking water promulgated today applies to all CWSs and NTNCWSs. The regulation not only establishes an MCLG and MCL for arsenic, but also lists feasible technologies and affordable technologies for small systems that can be used to comply with the MCL. However, systems are not required to use the listed technologies in order to meet the MCL.

D. What are the Final Drinking Water Regulatory Standards for Arsenic (Maximum Contaminant Level Goals and Maximum Contaminant Levels)?

In today's rule, the MCLG is 0 μg/L, and the enforceable MCL is 0.01 mg/L, which is the same as 10 micrograms per liter (μg/L) or 10 parts per billion (ppb). EPA based the MCL on total arsenic, because drinking water contains almost entirely inorganic forms, and the analytical methods for total arsenic are readily available and capable of being performed by certified laboratories at an affordable cost.

E. Will There be a Health Advisory?

A health advisory for arsenic is not part of today's rulemaking. EPA will be considering whether or not to issue a health advisory after evaluating the recommendations of the Science Advisory Board (SAB) (EPA, 2000q). The purpose of an advisory would be to provide useful information to water providers between issuance and implementation of this rule.

F. What are the Best Available Technologies For Removing Arsenic From Drinking Water?

Section 1412(b)(4)(E) of the Safe Drinking Water Act states that each National Primary Drinking Water Regulation (NPDWR) which establishes an MCL shall list the technology, treatment techniques, and other means that the Administrator finds to be feasible for purposes of meeting the MCL. Technologies are judged to be a best available technology (BAT) when the following criteria are satisfactorily met:

(1) The capability of a high removal efficiency;

(2) A history of full-scale operation;

(3) General geographic applicability;

(4) Reasonable cost based on large and metropolitan water systems;

(5) Reasonable service life;

(6) Compatibility with other water treatment processes; and

(7) The ability to bring all of the water in a system into compliance.

EPA identified BATs in this section using the listed criteria. Their removal efficiencies and a brief discussion of the major issues surrounding the usage of each technology are also given in this section. More details about the treatment technologies and costs can be found in “Technologies and Costs for the Removal of Arsenic From Drinking Water” (EPA, 2000t).

1. BAT technologies

EPA reviewed several technologies as BAT candidates for arsenic removal, e.g., ion exchange, activated alumina, reverse osmosis, nanofiltration, electrodialysis reversal, coagulation assisted microfiltration, modified coagulation/filtration, modified lime softening, greensand filtration, conventional iron and manganese removal, and several emerging technologies. The Agency determined that, of the technologies capable of removing arsenic from source water, only the technologies in Table I.F-1 fulfill the requirements of SDWA for BAT determinations for arsenic. The maximum percent of arsenic removal that can be reasonably obtained from these technologies is also shown in the table. These removal efficiencies are for arsenic (V) removal.

Table I.F-1.— Best Available Technologies and Removal Rates

Treatment Technology

Maximum Percent Removal

1

Ion Exchange (sulfate ≤ 50 mg/L)

95

Activated Alumina

95

Reverse Osmosis

>95

Modified Coagulation/Filtration

95

Modified Lime Softening (pH > 10.5)

90

Electrodialysis Reversal

85

Oxidation/Filtration (20:1 iron:arsenic)

80

1

The percent removal figures are for arsenic (V) removal. Pre-oxidation may be required.

2. Preoxidation

In water, the most common valence states of arsenic are As (V), or arsenate, and As (III), or arsenite. As (V) is more prevalent in aerobic surface waters and As (III) is more likely to occur in anaerobic ground waters. In the pH range of 4 to 10, As (V) species (H

2

AsO

4

−

and H

2

AsO

4

2

−

) are negatively charged, and the predominant As (III) compound (H

3

AsO

3

) is neutral in charge. Removal efficiencies for As (V) are much better than removal of As (III) by any of the technologies evaluated because the arsenate species carry a negative charge and arsenite is neutral under these pH conditions. To increase the removal efficiency when As (III) is present, pre-oxidation to the As (V) species is necessary.

As (III) may be converted through pre-oxidation to As (V) using one of several oxidants. Data on oxidants indicate that chlorine, potassium permanganate, and ozone are effective in oxidizing As (III) to As (V). Pre-oxidation with chlorine may create undesirable concentrations of disinfection byproducts and membrane fouling of subsequent treatments such as reverse osmosis. EPA has completed research on the chemical oxidants for As (III) conversion, and is presently investigating ultraviolet light disinfection technology (UV) and solid oxidizing media. For POU and POE devices, central chlorination may be required for oxidation of As (III).

3. Factors affecting listing technologies

Ion Exchange

(IX) can effectively remove arsenic using anion exchange resins. It is recommended as a BAT primarily for sites with low sulfate because sulfate is preferred over arsenic. Sulfate will compete for binding sites resulting in shorter run lengths. Due to much shorter run lengths than activated alumina, anion exchange must be

regenerated because it is not cost effective to dispose of the resin after one use. Column bed regeneration frequency is a key factor in the cost of the process and affects the volume of waste produced by the process. The proposed rule preamble noted that anion exchange may be practical up to approximately 120 mg/L of sulfate (Clifford, 1994). The upper-bound sulfate concentration for the final rule is 50 mg/L. The selection of this upper bound is based on several factors, including cost and the ability to dispose of the brine stream.

The proposed rule listed three mechanisms to dispose of the brine stream used for regeneration. The options were: sanitary sewer, evaporation pond, and chemical precipitation. Many comments on the proposed rule were based on the assumption that the waste streams generated would be considered hazardous waste. Waste streams containing less than 0.5% solids are evaluated against the toxicity characteristic directly to determine if the waste is hazardous. Arsenic in the regeneration brine will likely exceed 5 mg/L for most systems with arsenic above 10 μg/L and sulfate below 50 mg/L. Since the brine stream would likely be considered hazardous, EPA eliminated the evaporation pond and the chemical precipitation options from the decision tree as options for disposal of anion exchange wastes. The Agency retained discharge to a sanitary sewer because domestic sewage and any mixture of domestic sewage and other wastes that pass through a sewer system to a publicly owned treatment works (POTW) for treatment is excluded from consideration as solid waste (40 CFR 261.4). Domestic sewage means untreated sanitary wastes that pass through a sewage system. Discharges meeting the previously stated criteria are excluded from regulation as hazardous waste. However, these assumptions were reviewed to substantially reduce projections of brine wastes going to POTWs from those that were used in support of the proposed rule.

Discharge to a sanitary sewer can be limited by technically based local limits (TBLLs) for arsenic or total dissolved solids. Since anion exchange is regenerated more frequently than activated alumina, the total dissolved solids increase can be significant. Many comments indicated that significant increases in total dissolved solids would be unacceptable, especially in the Southwest where water resources are scarce. Salt is used for regeneration of anion exchange resins. The upper bound of 50 mg/L sulfate for anion exchange is based on projected increases of total dissolved solids using the quantity of salt needed for regeneration and the frequency of regeneration (based on sulfate). The sulfate upper bound for the final rule is significantly lower than the upper bound from the proposed rule. Due to the potential for an increase in total dissolved solids, anion exchange would be favored in areas other than the Southwest where the volume of brine is very small relative to the total volume of wastewater being treated at the POTW. Systems that need to treat only a few entry points or can blend a significant portion of the water to meet the MCL may produce a smaller brine stream to allow the brine to be discharged to a POTW. Water systems should check with the POTW to ensure that the brine stream will be accepted before selecting this option.

Activated Alumina

(AA) is an effective arsenic removal technology; however, the capacity of activated alumina to remove arsenic is very pH sensitive. High removals can be achieved over a broad range of pH, but shorter run lengths will be observed at higher pH. Activated alumina can be operated in one of two ways. The activated alumina can either be disposed of or regenerated after the media is exhausted. Under the regeneration option, strong acids and bases are used to remove arsenic from the media so that it can be used again to remove arsenic. Because arsenic is strongly adsorbed to the media, only about 50-70% of the adsorbed arsenic is removed. The brine stream produced by the regeneration process then requires disposal. The proposed rule listed discharge to a sanitary sewer as the disposal mechanism for the brines. Many comments on the proposed rule noted that TBLLs for arsenic or total dissolved solids might restrict discharge of brine streams to the sanitary sewer. Since activated alumina run lengths (i.e., number of bed volumes (BV) per run) are much longer than anion exchange, the arsenic concentrations in the brine stream would likely be much higher. Regeneration of activated alumina media is not recommended for larger systems because: (1) Disposal of the brine may be difficult, (2) the regeneration process is incomplete which reduces subsequent run lengths, and (3) for most systems it will be cheaper to replace the media rather than regenerate it. The option of replacing the spent media with new media is called disposable activated alumina.

The disposable activated alumina option can be operated both at the optimal pH of 6 and at higher natural water pH values. It is expected that larger systems would adjust pH to take advantage of the longer run lengths. EPA developed several disposable activated alumina options for the final rule. Two options were based on operating the process at the natural pH of the water (no pH adjustment). These options are intended primarily for smaller systems, although larger systems may also be able to operate at the natural pH if it is low enough to get sufficiently long run lengths. Two options where the pH was adjusted to pH 6 were also examined. The longer run length is based on using sulfuric acid to lower the pH. However, sulfate can compete for adsorption sites with arsenic. It was recommended that hydrochloric acid be used to obtain a longer run length (Clifford et al., 1998). When pH is adjusted to pH 6, post-treatment corrosion control will be necessary.

In our analysis, we assumed that spent media could be safely disposed of in a non-hazardous landfill. The preamble to the proposed rule described results from testing of activated alumina media used to remove arsenic in drinking water systems with arsenic above 50 μg/L. The results from the Toxicity Characteristic Leaching Procedure (TCLP) on these samples was typically less that 50 μg/L. The current toxicity characteristic (TC) regulatory level for designating arsenic as a hazardous waste under the Resource Conservation and Recovery Act (RCRA) is 5 mg/L (5000 μg/L) and is listed in 40 CFR 261.24(a). The TC regulatory level is one hundred times higher than the results from the activated alumina samples.

Reverse Osmosis

(RO) can provide removal efficiencies of greater than 95% when operating pressure is ideal. Water rejection (on the order of 20-25%) may be an issue in water-scarce regions and may prompt systems employing RO to seek greater levels of water recovery. Water recovery is the volume of drinking water produced by the process divided by the influent stream (product water/influent stream). Increased water recovery is often more expensive, since it can involve recycling of water through treatment units to allow more efficient separation of solids from water. This can also produce more concentrated solid wastes. However, the waste stream will generally not be as concentrated as anion exchange brines, so it should be easier to dispose of. Based on the cost of the process, it is unlikely that reverse osmosis would be installed solely for arsenic removal. Blending a treated portion with an untreated portion and

still meeting the MCL would make reverse osmosis more cost effective. If blending is not an option, post-treatment corrosion control would be necessary. Since a large portion of the water is wasted, water quantity could be an issue, especially in the Western U.S. It should be noted that while reverse osmosis is listed as a BAT, it was not used to develop national costs because other options are more cost effective and have much smaller waste streams.

Modified Coagulation/Filtration

(C/F) is an effective treatment process for removal of As (V) according to laboratory, pilot-plant, and full-scale tests. The type of coagulant and dosage used affects the efficiency of the process. Below a pH of approximately 7, removals with alum or ferric sulfate/chloride are similar. Above a pH of 7, removals with alum decrease dramatically (at a pH of 7.8, alum removal efficiency is about 40%). Other coagulants are also less effective than ferric sulfate/chloride. Systems may need to lower pH or add more coagulant to achieve higher removals.

Modified Lime Softening

(LS), operated within the optimum pH range of greater than 10.5 is likely to provide a high percentage of As removal. Systems operating lime softening at lower pH will need to increase the pH to achieve higher removals of arsenic.

Coagulation/Filtration and Lime Softening are unlikely to be installed solely for arsenic removal. Systems considering installation of one of these technologies should design the process to operate in the optimal pH range if high removal efficiencies are needed for compliance.

Electrodialysis Reversal

(EDR) can produce effluent water quality comparable to reverse osmosis. EDR systems are fully automated, require little operator attention, and do not require chemical addition. EDR systems, however, are typically more expensive than nanofiltration and reverse osmosis systems. These systems are often used in treating brackish water to make it suitable for drinking. This technology has also been applied in the industry for wastewater recovery and typically operates at a recovery of 70 to 80%. Since a large portion of the water is wasted, water quantity could be an issue, especially in the Western U.S. It should be noted that while electrodialysis reversal is listed as a BAT, it was not used to develop national costs because other options are more cost effective and have much smaller waste streams.

Oxidation/Filtration

(including greensand filtration) has an advantage in that there is not as much competition with other ions. Arsenic is co-precipitated with the iron during iron removal. Sufficient iron needs to be present to achieve high arsenic removals. One study recommended a 20:1 iron to arsenic ratio (Subramanian et al., 1997). Removals of approximately 80% were achieved when iron to arsenic ratio was 20:1. When the iron to arsenic ratio was lower (7:1), removals decreased below 50%. The presence of iron in the source water is critical for arsenic removal. If the source water does not contain iron, oxidizing and filtering the water will not remove arsenic. When the arsenic is present as As(III), sufficient contact time needs to be provided to convert the As(III) to As(V) for removal by the oxidation/filtration process. An additional pre-oxidation step is not required for this process as long as there is sufficient contact time. In developing national cost estimates, EPA assumed that systems would opt for this type of technology only if more than 300 μg/L of iron was present. The Agency assumed a removal percentage of 50% when estimating national costs because the 20:1 ratio could not be verified due to limitations in the co-occurrence database. However, EPA assumed a removal percentage of 80% as part of a sensitivity analysis. At proposal EPA indicated that oxidation filtration was not being listed as BAT because it has a low removal efficiency, which might not be appropriate for an MCL of 5. However, the Agency also noted that this technology may be appropriate for systems that do not require high arsenic removal and had high iron in their source water. Because this is an inexpensive technology that is particularly effective for high-iron, low-arsenic waters, EPA is listing oxidation/filtration as a BAT with a footnote that the iron-to-arsenic ratio must be at least 20:1. Systems with greater than 300 μg/L of iron will also see benefits in the aesthetic quality of the water as the iron can be reduced below the secondary standard. EPA's inclusion of oxidation/filtration as a BAT in today's final rule is based upon further evaluation of all available information and studies as well as on public comments.

4. Other technologies evaluated, but not designated as BAT

Coagulation Assisted Microfiltration.

The coagulation process described previously can be linked with microfiltration to remove arsenic. The microfiltration step essentially takes the place of a conventional gravity filter. The University of Houston recently completed pilot studies at Albuquerque, New Mexico on iron coagulation followed by a direct microfiltration system. The results of this study indicated that iron coagulation followed by microfiltration is capable of removing arsenic (V) from water to yield concentrations that are consistently below 2 μg/L. Critical operating parameters are iron dose, mixing energy, detention time, and pH (Clifford, 1997). Coagulation and microfiltration as separate processes have both been installed full scale, but the combined coagulation/microfiltration process does not have a full-scale operation history. Since a full-scale operation history is one of the requirements to list a technology as a BAT, it is not presently being listed as one. It could be designated as such in the future if the technology meets that requirement. EPA used this option in developing the national cost estimate because we believe coagulation/microfiltration is an appropriate technology that will be used by certain water systems to comply with this rule, even though it is not currently listed as BAT for the reasons mentioned.

Granular ferric hydroxide

is a technology that may combine very long run length without the need to adjust pH. The technology has been demonstrated for arsenic removal full scale in England (Simms et al., 2000). A pilot-scale study for activated alumina was also conducted on that water and showed run lengths much longer than observed in pilot-scale studies in the United States. Due to the lack of published data showing performance for a range of water qualities, granular ferric hydroxide was not designated a BAT. In addition, there is little published information on the cost of the media, so it is difficult to evaluate cost. Granular ferric hydroxide is being investigated in several ongoing studies and may be an effective technology for removing arsenic. Systems may wish to investigate it and other adsorption technologies such as modified activated alumina and other iron-based media. Many of these other new adsorptive media are also being investigated in several ongoing studies.

5. Waste disposal

Waste disposal will be an important issue for both large and small drinking water plants. Costs for waste disposal have been added to the costs of the treatment technologies (in addition to any pre-oxidation and corrosion control costs), and form part of the treatment trains that are listed in Tables I.G-1, I.G-5, and I.G-6.

The preamble to the proposed rule summarized toxicity characteristic leaching procedure (TCLP) data on residuals from different arsenic removal

technologies. The arsenic concentrations in TCLP extracts from alum coagulation, activated alumina, lime softening, iron/manganese removal, and coagulation-microfiltration residuals were below 0.05 mg/L, which is two orders of magnitude lower than the current TC regulatory level. The TCLP data for iron coagulation were mixed—the residuals from an arsenic removal plant were below 0.05 mg/L, but the residuals from another iron coagulation plant were above 1 mg/L. However, this is still below the TC regulatory level of 5 mg/L. Based on these data, EPA does not believe that drinking water treatment plant residuals would be classified as hazardous waste. The TCLP data also indicate that most residuals could meet a much lower TC regulatory level. Options where the brine stream could be hazardous were eliminated from the final decision tree. For the purposes of the national cost estimate, it was assumed that solid residuals would be disposed of at nonhazardous landfills.

G. Treatment Trains Considered For Small Systems

1. Can my water system use point-of-use (POU), point-of-entry (POE), or bottled water to comply with this regulation?

Section 1412(b)(4)(E)(ii) of SDWA, as amended in 1996, requires EPA to issue a list of technologies that achieve compliance with MCLs established under the Act that are affordable and applicable to typical small drinking water systems. These small public water systems categories are: (1) population of more than 25 but less than or equal to 500; (2) population of more than 500, but less than or equal to 3,300; and (3) population of more than 3,300, but less than or equal to 10,000. Owners and operators may choose any technology or technique that best suits their conditions, as long as the MCL is met.

The technologies examined for BAT determinations were also evaluated as small system compliance technologies. Several other alternatives that are solely small system options were also evaluated as compliance technologies. Central treatment is not the only option available to small systems. One of the provisions included in the SDWA Amendments of 1996 allows the use of POU and POE devices as compliance technologies for small systems. SDWA stipulates that POU/POE treatment systems:

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 (§ 1412(b)(4)(E)).

Whole-house, or POE treatment, is necessary when exposure to the contaminant by modes other than consumption is a concern; this is not the case with arsenic. Single faucet, or POU treatment, is preferred when treated water is needed only for drinking and cooking purposes. POU devices are especially applicable for systems that have a large flow and only a minor part of that flow directed for potable use such as at many NTNCWSs. POE/POU options include reverse osmosis, activated alumina, and ion exchange processes. POU systems are easily installed and can be easily operated and maintained. In addition, these systems generally offer lower capital costs and may reduce engineering, legal, and other fees associated with centralized treatment options. However, there will be higher administrative costs associated with POU and POE options. For POU options, the trade-off is lower treatment cost since only 1% of the water is treated, but higher administrative and monitoring costs occur. Centrally managed POU options, even with the higher monitoring and administrative costs, are less expensive than central treatment for populations up to 150 to 250 people depending upon the technology and number of households.

Using POU/POE devices introduces some new issues. Adopting a POU/POE treatment system in a small community requires more record-keeping to monitor individual devices than does central treatment. POU/POE systems may require special regulations regarding customer responsibilities as well as water utility responsibilities. The water system or person under contract to the system is responsible for maintaining the devices in customers' homes. This responsibility cannot be delegated to the customer. Use of POU/POE systems does not reduce the need for a well-maintained water distribution system. Increased monitoring may be necessary to ensure that the treatment units are operating properly. Monitoring POU/POE systems is also more complex because compliance samples need to be taken after each POU or POE unit rather than at the entry point to the distribution system to be reflective of treatment.

EPA examined three technologies as POU and POE devices for the proposed rule. EPA assumed that systems would more likely choose to use POU activated alumina (AA) or reverse osmosis (RO), and POE AA in the proposed rule. POU and POE ion exchange (IX) and POE RO were considered, but not included as compliance technologies in the proposed rule. Activated alumina and ion exchange units face a breakthrough issue. If the activated alumina is not replaced on time, there is a potential for significantly reduced arsenic removal. However, if the anion exchange resin is not replaced or regenerated on time, the previously removed arsenic can be driven off the resin by sulfate. Tap water arsenic concentrations can be higher than the source water. This is called chromatographic peaking. Due to the potential for chromatographic peaking and run lengths that would typically be less than six months, anion exchange was not listed as a compliance technology in the proposed rule. POE ion exchange also may present problems with total dissolved solids since the resin would need to be regenerated. Since all sites within the system would need treatment, the total dissolved solids increase from a centrally managed POE ion exchange system would be similar to that from a central treatment ion exchange system. EPA did not list POE RO units as compliance technologies because it could create corrosion control problems. In addition, water recovery would be no higher than central treatment, so water quantity issues associated with central treatment reverse osmosis would be applicable to POE RO.

The proposed rule included POE AA as a small system compliance technology. Arsenic removal by AA is very sensitive to the pH. The finished water pH will typically be higher than the optimal pH of 6 to meet the corrosion control requirements of the lead and copper rule. A finished water pH for many systems would be in the range of pH 7 to pH 8. Using data on activated alumina run length and pH, it was determined that viable run lengths were likely only when the finished water pH was at or below pH 7.5 (Kempic, 2000). Even in this pH range, the media may need to be replaced more frequently than once a year, which would make the option very expensive especially compared to the POU AA option. The run length data used for this analysis were from a site with very little competing ions (Simms and Azizian, 1997). Studies at other sites with higher levels of competing ions have much lower run lengths (Clifford et al., 1998). Based on the limited finished water pH range where POE AA might be effective and the fact that the POU media needs replacing much less frequently due to lower water demand, POE AA has not been listed as a compliance technology

in the final rule. POE devices utilizing media that are less sensitive to pH adjustment may be listed as compliance technologies in the future once data on their performance are generated.

The effect of pH was also examined on POU AA. Under the POU AA option, the volume of water requiring treatment is much smaller. The unit will be installed at the kitchen tap and only the water being used for cooking and consumption is being treated for arsenic removal. Since the ratio of the daily volume of water being treated to the size of the unit is much smaller, POU units can be operated for longer periods of time before the media needs to be replaced. The replacement frequency assumed for the costs is every six months. Viable run lengths for the POU option were greater than one year up to pH 8 (Kempic, 2000). This analysis assumed a large daily usage volume of 24 liters per day. The average consumption per person per day is just over 1 liter. Even if competing ions reduced the run length significantly, systems with tap water at or below pH 8 should meet the MCL of 10 μg/L using a six-month replacement frequency for the media. POU AA is a compliance technology when the tap water pH is at or below pH 8.

POU RO was listed as a compliance technology in the proposed rule and it is being listed as a compliance technology in the final rule as well. Several comments indicated that water rejection would be an issue with POU devices. Since only about 1% of the total water used in the household is being treated, POU RO is unlikely to create water quantity problems. If the water rejection rate was 10:1, this would only increase the total household water demand by about 10 percent. Where availability of additional water is limited, systems may want to consider other alternatives to meet the MCL.

In order to be consistent with 1996 SDWA Amendments, EPA issued a

Federal Register

notice on June 11, 1998 (EPA, 1998f) that deleted the prohibition on the use of POU devices as compliance technologies. This prohibition was in 40 CFR 141.101. This section now states that public water systems shall not use bottled water to achieve compliance with an MCL. Bottled water may be used on a temporary basis to avoid unreasonable risk to health. Therefore, bottled water cannot be used as a compliance technology for the arsenic rule.

Likely treatment trains are shown in Table I.G-1. These trains represent a wide variety of solutions, including BATs, that small systems may consider when complying with the proposed arsenic MCL. Not all solutions may be viable for a given system. For example, only those systems with coagulation/filtration in place will be able to modify their existing treatment system. The treatment trains include BATs, waste disposal, and when necessary, pre-oxidation and corrosion control. While systems could install lime softening at pH > 10.5 or optimized coagulation/filtration solely for arsenic removal, EPA does not view this as a likely option. Reverse osmosis and electrodialysis reversal are also not included in this table because other options are more cost effective for arsenic removal and do not reject a large volume of water like these two technologies. RO and EDR may be cost-effective options if removal of other contaminants is needed and water quantity is not a concern.

Table I.G-1.— Treatment Technology Trains for Consideration by Small Systems in Complying With Final Rule Including BATs

Train #

Treatment Technology Trains for Consideration by Small Systems

1

Add pre-oxidation [if not in-place] and modify in-place Lime Softening (pH > 10.5) and modify corrosion control.

2

Add pre-oxidation [if not in-place] and modify in-place Coagulation/Filtration and modify corrosion control.

3

Add pre-oxidation [if not in-place] and add Anion Exchange and add POTW waste disposal. Sulfate level ≤ 20 mg/L.

4

Add pre-oxidation [if not in-place] and add Anion Exchange and add POTW waste disposal. Sulfate level: 20 mg/L < sulfate ≤ 50 mg/L.

5

Add pre-oxidation [if not in-place] and add Coagulation Assisted Microfiltration with corrosion control and add mechanical dewatering/non-hazardous landfill waste disposal.

6

Add pre-oxidation [if not in-place] and add Coagulation Assisted Microfiltration with corrosion control and add non-mechanical dewatering/non-hazardous landfill waste disposal.

7

Add Oxidation/Filtration (Greensand) (20:1 iron: arsenic) and add POTW for backwash stream.

8

Add pre-oxidation [if not in-place] and add Activated Alumina and add non-hazardous landfill (for spent media) waste disposal. pH 7 ≤ pH < pH 8.

9

Add pre-oxidation [if not in-place] and add Activated Alumina and add non-hazardous landfill (for spent media) waste disposal. pH 8 ≤ pH ≤ pH 8.3.

10

Add pre-oxidation [if not in-place] and add Activated Alumina with pH adjustment (to pH 6) and corrosion control and add non-hazardous landfill (for spent media) waste disposal. Run length = 23,100 BV.

11

Add pre-oxidation [if not in-place] and add Activated Alumina with pH adjustment (to pH 6) and corrosion control and add non-hazardous landfill (for spent media) waste disposal. Run length = 15,400 BV.

12

Add pre-oxidation [if not in-place] and add POU Reverse Osmosis.

13

Add pre-oxidation [if not in-place] and add POU Activated Alumina. (Finished water pH ≤ pH 8.0)

Pre-oxidation costs are given as a separate component because they will be incurred only by some systems. In estimating national costs, it was assumed that only systems without pre-oxidation in place would need to add the necessary equipment. It is expected that no surface water systems will need to install pre-oxidation for arsenic removal and that fewer than 50% of the ground water systems may need to install pre-oxidation for arsenic removal. Ground water systems without pre-oxidation should ascertain if pre-oxidation is necessary by determining if the arsenic is present as As (III) or As (V). Ground water systems with predominantly As (V) will probably not need pre-oxidation to meet the MCL.

2. What are the affordable treatment technologies for small systems?

The 13 treatment trains listed in Table I.G-1 were compared against the national-level affordability criteria to determine the affordable treatment trains. The Agency's national-level affordability criteria were published in the August 6, 1998

Federal Register

(EPA, 1998h). In this notice, EPA discussed the procedure for affordable

treatment technology determinations for the contaminants regulated before 1996.

The preamble to the proposed arsenic rule described the derivation of the national-level affordability criteria (65 FR 38888 at 38926; EPA, 2000i). A very brief summary follows: First an “affordability threshold” (

i.e.

, the total annual household water bill that would be considered affordable) was calculated. The total annual water bill includes costs associated with water treatment, water distribution, and operation of the water system. In developing the threshold of 2.5% median household income, EPA considered the percentage of median household income spent by an average household on comparable goods and services and on cost comparisons with other risk reduction activities for drinking water such as households purchasing bottled water or a home treatment device. The complete rationale for EPA's selection of 2.5% as the affordability threshold is described in “Variance Technology Findings for Contaminants Regulated Before 1996” (EPA, 1998l).

The Variance Technology Findings document also describes the derivation of the baselines for median household income, annual water bills, and annual household consumption. Data from the Community Water System Survey (CWSS) were used to derive the annual water bills and annual water consumption values for each of the three small system size categories. The Community Water System Survey data on zip codes were used with the 1990 Census data on median household income to develop the median household income values for each of the three small-system size categories. The median household-income values used for the affordable technology determinations are not based on the national median income. The value for each size category is a national median income for communities served by small water systems within that range. Table I.G-2 presents the baseline values for each of the three small-system size categories. Annual water bills and median household income are based on 1995 estimates.

Table I.G-2.—Baseline Values for Small Systems Categories

System size category

(population served)

Annual household consumption

(1000 gallons/yr)

Annual water bills

($/yr)

Median household income

($)

25-500

72

$211

$30,785

501-3,300

74

184

27,058

3,300-10,000

77

181

27,641

For each size category, the threshold value was determined by multiplying the median household income by 2.5%. The annual household water bills were subtracted from this value to obtain the available expenditure margin. Projected treatment costs will be compared against the available expenditure margin to determine if there are affordable compliance technologies for each size category. The available expenditure margin for the three size categories is presented in Table I.G-3.

Table I.G-3.—Available Expenditure Margin for Affordable Technology Determinations

System size category

(population served)

Available expenditure margin

($/household/year)

25-500

559

501-3,300

492

3,301-10,000

510

The size categories specified in SDWA for affordable technology determinations are different than the size categories typically used by EPA in the Economic Analysis. A weighted average procedure was used to derive design and average flows for the 25-500 category using design and average flows from the 25-100 and 101-500 categories. A similar approach was used to derive design and average flows from the 501-1000 and 1001-3300 categories for the 501-3300 category. The Variance Technology Findings document (EPA, 1998l) describes this procedure in more detail. Table I.G-4 lists the design and average flows for the three size categories.

Table I.G-4.— Design and Average Daily Flows Used for Affordable Technology Determinations

System size category

(population served)

Design flow

(mgd)

Average flow

(mgd)

25-500

0.058

0.015

501-3,300

0.50

0.17

3,301-10,000

1.8

0.70

Capital and operating and maintenance costs were derived for each treatment train using the flows listed previously and the cost equations in the Technology and Cost Document. Several conservative assumptions were made to derive the costs. The influent arsenic concentration was assumed to be 50 μg/L, which was the MCL for arsenic prior to this rule. The treatment target was 8 μg/L, which is 80% of the MCL. Thus, little blending could be performed to reduce costs. Capital costs were amortized using the 7% interest rate preferred by OMB for benefit-cost analyses of government programs and regulations rather than a 3% interest rate.

The annual system treatment cost in dollars per year was converted into a rate increase using the average daily flow. The annual water consumption values listed in Table I.G-2 were multiplied by 1.15 to account for water lost due to leaks. Since the water lost to leaks is not billed, the water bills for the actual water used were adjusted to cover this lost water by increasing the household consumption. The rate increase in dollars per thousand gallons used was multiplied by the adjusted annual consumption to determine the annual cost increase for the household for each treatment train. Several comments on affordability presented household cost increases that were

derived by dividing the annual system cost by the number of households. That is an inappropriate method because residential customers would not only be paying for the water that they use, but also all the water used by non-residential customers of the system..

Of the 13 treatment trains in Table I.G-1, the ones identified in Table I.G-5 are deemed to be affordable for systems serving 25-500 people as the annual household cost was below the available expenditure margin. The two trains using coagulation-assisted microfiltration are not affordable for this size category. All 13 treatment trains are deemed to be affordable for systems serving 501-3,300 and 3,301-10,000 people and are presented in Table I.G-6. Centralized compliance treatment technologies include ion exchange, activated alumina, modified coagulation/filtration, modified lime softening, and oxidation/filtration (e.g. greensand filtration) for source waters high in iron. In addition, POU and POE devices are also compliance technology options for the smaller systems.

Table I.G-5.— Affordable Compliance Technology Trains for Small Systems With Population 25-500

Train No.

Treatment Technology Trains

1

Add pre-oxidation [if not in-place] and modify in-place Lime Softening (pH > 10.5) and modify corrosion control.

2

Add pre-oxidation [if not in-place] and modify in-place Coagulation/Filtration and modify corrosion control.

3

Add pre-oxidation [if not in-place] and add Anion Exchange and add POTW waste disposal. Sulfate level ≤ 20 mg/L.

4

Add pre-oxidation [if not in-place] and add Anion Exchange and add POTW waste disposal. Sulfate level: 20 mg/L < sulfate ≤ 50 mg/l.

7

Add Oxidation/Filtration (Greensand) (20:1 iron: arsenic) and add POTW for backwash stream.

8

Add pre-oxidation [if not in-place] and add Activated Alumina and add non-hazardous landfill (for spent media) waste disposal. pH 7 ≤pH < pH 8.

9

Add pre-oxidation [if not in-place] and add Activated Alumina and add non-hazardous landfill (for spent media) waste disposal. pH 8 ≤ pH ≤ pH 8.3.

10

Add pre-oxidation [if not in-place] and add Activated Alumina with pH adjustment (to pH 6) and corrosion control and add non-hazardous landfill (for spent media) waste disposal. Run length = 23,100 BV.

11

Add pre-oxidation [if not in-place] and add Activated Alumina with pH adjustment (to pH 6) and corrosion control and add non-hazardous landfill (for spent media) waste disposal. Run length = 15,400 BV.

12

Add pre-oxidation [if not in-place] and add POU Reverse Osmosis.

13

Add pre-oxidation [if not in-place] and add POU Activated Alumina. (Finished water pH ≤ pH 8.0)

Table I.G-6.— Affordable Compliance Technology Trains for Small Systems With Populations 501-3,300 and 3,301 to 10,000

Train No.

Treatment Technology Trains

1

Add pre-oxidation [if not in-place] and modify in-place Lime Softening (pH > 10.5) and modify corrosion control.

2

Add pre-oxidation [if not in-place] and modify in-place Coagulation/Filtration and modify corrosion control.

3

Add pre-oxidation [if not in-place] and add Anion Exchange and add POTW waste disposal. Sulfate level ≤ 20 mg/L.

4

Add pre-oxidation [if not in-place] and add Anion Exchange and add POTW waste disposal. Sulfate level: 20 mg/L < sulfate ≤ 50 mg/l.

5

Add pre-oxidation [if not in-place] and add Coagulation Assisted Microfiltration with corrosion control and add mechanical dewatering/non-hazardous landfill waste disposal.

6

Add pre-oxidation [if not in-place] and add Coagulation Assisted Microfiltration with corrosion control and add non-mechanical dewatering/non-hazardous landfill waste disposal.

7

Add Oxidation/Filtration (Greensand) (20:1 iron: arsenic) and add POTW for backwash stream.

8

Add pre-oxidation [if not in-place] and add Activated Alumina and add non-hazardous landfill (for spent media) waste disposal. pH 7 ≤pH < pH 8.

9

Add pre-oxidation [if not in-place] and add Activated Alumina and add non-hazardous landfill (for spent media) waste disposal. pH 8 ≤ pH ≤ pH 8.3.

10

Add pre-oxidation [if not in-place] and add Activated Alumina with pH adjustment (to pH 6) and corrosion control and add non-hazardous landfill (for spent media) waste disposal. Run length = 23,100 BV.

11

Add pre-oxidation [if not in-place] and add Activated Alumina with pH adjustment (to pH 6) and corrosion control and add non-hazardous landfill (for spent media) waste disposal. Run length = 15,400 BV.

12

Add pre-oxidation [if not in-place] and add POU Reverse Osmosis.

13

Add pre-oxidation [if not in-place] and add POU Activated Alumina. (Finished water pH ≤ pH 8.0)

3. Can My Water System Get a Small System Variance From an MCL Under Today's Rule?

Section 1415(e)(1) of SDWA allows States to grant variances to small water systems (i.e., systems having 10,000 customers or less) in lieu of complying with an MCL if EPA determines that there are no nationally affordable compliance technologies for that system size/water quality combination. The system must then install an EPA-listed variance treatment technology (section 1412(b)(15)) that makes progress toward the MCL, if not necessarily reaching it. EPA has determined that affordable technologies exist for all three system size categories and has therefore not identified a variance technology for any system size or source water quality combination. Small system variances are not available for the final arsenic MCL.

H. Can My System Get a General Variance or Exemption From the MCL Under Today's Rule?

General variances may be granted in accordance with section 1415(a)(1)(A) of SDWA and EPA's regulations. General variances are available to public water systems that have installed or agree to install the BAT but, due to source water quality, are or will be unable to comply with the national primary drinking water standard. The general variance

provisions of SDWA are narrowly focused on addressing those rare circumstances where some unusual characteristic of the source water available to a system will result in less effective performance of the BAT. Exemptions may be granted in accordance with section 1416(a) of SDWA and EPA's regulations. Exemptions are designed to provide a system facing compelling circumstances, such as economic hardship, additional time to come into compliance.

Under section 1415(a)(1)(A) of the SDWA, a State that has primary enforcement responsibility (primacy), or EPA as the primacy agency, may grant variances from MCLs to those public water systems of any size that cannot comply with the MCLs because of characteristics of the water sources. The primacy agency may grant general variances to a system on condition that the system install the best available technology, treatment techniques, or other means, and provided that alternative sources of water are not reasonably available to the system. At the time this type of variance is granted, the State must prescribe a schedule for compliance with its terms and may require the system to implement additional control measures. Furthermore, before EPA or the State may grant a general variance, it must find that the variance will not result in an unreasonable risk to health (URTH) to the public served by the public water system.

Under section 1413(a)(4), States that choose to issue general variances must do so under conditions, and in a manner, that are no less stringent than section 1415. Of course, a State may adopt standards that are more stringent than the EPA's standards. EPA specifies BATs for general variance purposes. EPA may identify as BAT different treatments under section 1415 for variances other than the BAT under section 1412 for MCLs. The BAT findings for section 1415 may vary depending on a number of factors, including the number of persons served by the public water system, physical conditions related to engineering feasibility, and the costs of compliance with MCLs. In this final rule, EPA is not specifying different BAT for variances under section 1415(a).

Under section 1416(a), EPA or a State may exempt a public water system from any requirements related to an MCL or treatment technique of an NPDWR if it finds that: (1) Due to compelling factors (which may include a variety of “compelling” factors, including economic factors such as qualification of the PWS as serving a disadvantaged community), the PWS is unable to comply with the requirement or implement measure to develop an alternative source of water supply; (2) the exemption will not result in an URTH; (3) the PWS was in operation on the effective date of the NPWDR, or for a system that was not in operation by that date, only if no reasonable alternative source of drinking water is available to the new system; and (4) management or restructuring changes (or both) cannot reasonably result in compliance with the Act or improve the quality of drinking water.

If EPA or the State grants an exemption to a public water system, it must at the same time prescribe a schedule for compliance (including increments of progress or measures to develop an alternative source of water supply) and implementation of appropriate control measures that the State requires the system to meet while the exemption is in effect. Under section 1416(b)(2)(A), the schedule prescribed shall require compliance as expeditiously as practicable (to be determined by the State), but no later than 3 years after the compliance date for the regulations established pursuant to section 1412(b)(10). For public water systems serving 3,300 people or less and needing financial assistance for the necessary improvements, EPA or the State may renew an exemption for one or more additional two-year periods, but not to exceed a total of six years, if the system establishes that it is taking all practicable steps to meet certain requirements specified in the statute. Thus, the maximum possible duration of a small systems exemption is nine years beyond the 5-year compliance schedule specified in today's rule.

A public water system shall not be granted an exemption unless it can establish that either: (1) The system cannot meet the standard without capital improvements that cannot be completed prior to the date established pursuant to section 1412(b)(10); (2) in the case of a system that needs financial assistance for the necessary implementation, the system has entered into an agreement to obtain financial assistance pursuant to section 1452 or any other Federal or State program; or (3) the system has entered into an enforceable agreement to become part of a regional public water system.

EPA believes that exemptions will be an important tool to help States address the number of systems needing financial assistance to achieve compliance with the arsenic rule (and other rules) with the available supply of financial assistance. About 2,300 CWSs and about 1,100 NTNCWSs will need to install treatment to achieve compliance with today's final rule. CWSs and not-for-profit NTNCWSs are eligible for assistance from the Drinking Water State Revolving Fund (DWSRF). Between its inception in Federal Fiscal Year 1997 and June 2000, the DWSRF program has provided assistance to about 1,100 systems. Given the many competing demands being placed on financial assistance programs, the ability to extend the period of time available for a system to receive financial assistance will provide important flexibility for States and systems. Exemptions provide an opportunity to extend the period of time during which a system can achieve compliance, thus providing needy systems with additional time to qualify for financial assistance. Under today's action, all systems have 5 years to achieve compliance. Exemptions for an additional 3 years can be made available to qualified systems. For those qualified systems serving 3,300 persons or less, up to 3 additional 2-year extensions to the exemption are possible, for a total exemption duration of 9 years. When added to the 5 years provided for compliance by the rule, this allows up to 14 years for small systems serving up to 3,300 people to achieve compliance.

EPA will issue guidance in the near future on considerations involved in granting exemptions under the arsenic rule, including making findings of no URTH where exemptions are offered.

I. What Analytical Methods are Approved for Compliance Monitoring of Arsenic and What are the Performance Testing Criteria for Laboratory Certification?

1. Approved Analytical Methods

Today's rule lists four analytical technologies that are approved for compliance determinations of arsenic at the MCL of 0.01 mg/L (see Table I.I-1). As noted in the June 22, 2000 proposed rule (65 FR 38888, EPA, 2000i), the methods listed in Table I.I-1 are the same analytical technologies that were approved for arsenic when the MCL was 0.05 mg/L, with the exception of the methods that use Inductively Coupled Plasma Atomic Emission Spectroscopy (ICP-AES) measurement technology. EPA is withdrawing two ICP-AES methods (EPA Method 200.7 and SM 3120B) because their detection limits (0.008 mg/L and 0.050 mg/L respectively) are too high to reliably determine compliance with an MCL of 0.01 mg/L. In the June 2000 proposed rule, EPA noted that the ICP-AES methods were rarely used to obtain laboratory certification when analyzing

low level challenge samples for arsenic. Therefore, we believe withdrawal of the availability of the ICP-AES methods for compliance determinations of arsenic in drinking water will not affect laboratory capacity. EPA did not receive any adverse comment on the proposal to withdraw approval of these two methods, and today's final rule amends the CFR to effect this withdrawal.

Table I.I-1.—Approved Analytical Methods (40 CFR 141.23) for Arsenic at the MCL of 0.01 mg/L

Methodology

Reference method

Inductively Coupled Plasma Mass Spectroscopy (ICP-MS)

200.8 (EPA)

Stabilized Temperature Platform Graphite Furnace Atomic Absorption (STP-GFAA)

200.9 (EPA)

Graphite Furnace Atomic Absorption (GFAA)

3113B (SM) D-2972-93C (ASTM)

Gaseous Hydride Atomic Absorption (GHAA)

3114B (SM) D-2972-93B (ASTM)

2. Performance Testing Criteria for Laboratory Certification

For purposes of drinking water laboratory certification, the Agency specifies pass/fail (acceptance) limits for a successful analysis of the required annual challenge sample, i.e., a performance evaluation (PE) or performance testing (PT) sample. These acceptance limits have been historically derived using one of two different approaches:

(a) Variable acceptance limits uniquely derived for each PE study from a regression analysis of the performance of all laboratories that participate in that PE-study, or

(b) Fixed acceptance limits derived from a regression analysis of the laboratory PE sample analysis results in several PE studies.

Variable acceptance limits are analogous to “grading on a curve” which means that the pass/fail limit can vary from PE study to study depending on the quality and experience of the laboratories participating in the study. These limits are specified in the CFR as plus or minus two sigma (2 ) where sigma is the standard deviation of the analytical results reported in the PE study. EPA specifies variable acceptance limits when a method or measurement technology is new enough that an insufficient number of experienced laboratories have participated in the PE studies or when only a few PE studies have been conducted.

EPA prefers the fixed acceptance limits approach because it is the better indicator of laboratory performance averaged over time and several different concentrations of the target analyte. Fixed limits also provide the same pass/fail benchmark in each PE study. As discussed in the proposed rule, EPA has a large base of PE-study data from which to derive a practical quantitation limit (PQL) and a fixed PE-study acceptance limit for arsenic. Thus, as proposed in the June 2000 rule, today's final rule amends § 141.23(k)(3)(ii) to specify an acceptance limit of ±30% in PE (now known as PT) samples spiked with arsenic at the PQL of 0.003 mg/L or greater. For a brief discussion of the derivation of the PQL for arsenic, see section III.B.1, What is the feasible level?

J. How Will I Know if My System Meets the Arsenic Standard?

This section summarizes changes to the arsenic monitoring and compliance determination requirements. The Agency is also changing the methods used by a system to determine if it is in violation of an MCL for all of the regulated inorganic contaminants (IOCs), synthetic organic contaminants (SOCs), and volatile organic contaminants (VOCs). See section I.J.3. for more information regarding violation determinations.

1. Sampling Points and Grandfathering of Monitoring Data

In today's rule, the Agency is moving the requirements associated with arsenic into § 141.23(c) making it consistent with the requirements for IOCs regulated under the standardized monitoring framework. All CWS and NTNCWSs must monitor for arsenic at each entry point to the distribution system. In some cases, § 142.11(1) allows States to establish regulations that “vary from comparable regulations set forth in part 141 of this chapter, and demonstrate that any different State regulation is at least as stringent as the comparable regulation contained in part 141.” Using this authority, States may allow systems to collect samples at an alternative location (e.g., the first point of drinking water consumption in the distribution system) if the State justifies in its primacy program that the alternative location is equally or more protective. States could implement the change in sampling location once the primacy package is approved.

The MCL compliance elements of the rule become effective in 2006. Some ground water systems will collect samples to comply with the sampling requirements for all regulated IOCs (including arsenic) in 2005 in accordance with the State monitoring plan. This sampling event will satisfy the monitoring requirements for the 2005-2007 compliance period, but the revised arsenic MCL will not become effective until 2006. Ground water systems may use grandfathered data collected after January 1, 2005 to satisfy the sampling requirements for the 2005-2007 compliance period. The grandfathered data must report results from analytical methods approved for use by this final rule (e.g., the method detection limit must be substantially less than the revised MCL of 10 μg/L). Data collected using unacceptably high detection levels (e.g. using ICP-AES technology) will not be eligible for grandfathering. If the grandfathered data are used to comply with the 2005-2007 compliance period and the analytical result is greater than 10 μg/L, that system will be in violation of the revised MCL on the effective date of the rule. If systems do not use grandfathered data, then surface water systems must collect a sample by December 31, 2006 and ground water systems must collect a sample by December 31, 2007 to demonstrate compliance with the revised MCL.

2. Compositing of Samples

Compositing of samples is allowed under the standardized monitoring framework. The States that allow compositing of samples use the methodology in the Phase II/V regulations as specified in § 141.23(a)(4). In today's rule, CWSs and NTNCWSs will still be allowed to composite samples; however, if arsenic is detected above one-fifth of the revised MCL (2 μg/L), then a follow-up sample must be taken within 14 days at each sampling point included in the composite as described in § 141.23(a)(4). Compliance determinations must be based on the follow up sample result. Water systems may composite samples (temporally and spatially) until a

contaminant (arsenic or any other contaminant regulated in the Phase II/V regulations) is detected. Once a contaminant has been detected in a composited sample at concentrations greater than one-fifth of the MCL, the system(s) must discontinue the practice of compositing samples for all future monitoring.

3. Calculation of Violations

In today's rule, the Agency is clarifying the compliance determination section for the IOCs (including arsenic), the SOCs, and the VOCs in §§ 141.23(i), 141.24(f)(15), and 141.24(h)(11), respectively.

Systems will determine compliance based on the analytical result(s) obtained at each sampling point. If any sampling point is in violation of an MCL, the system is in violation. For systems monitoring more than once per year, compliance with the MCL is determined by a running annual average at each sampling point. Systems monitoring annually or less frequently whose sample result exceeds the MCL for any inorganic contaminant in § 141.23(c), or whose sample results exceeds the trigger level for any organic contaminant listed in § 141.24(f) or § 141.24(h), must revert to quarterly sampling for that contaminant the next quarter. Systems are only required to conduct quarterly monitoring at the entry point to the distribution system at which the sample was collected and for the specific contaminant that triggered the system into the increased monitoring frequency. Systems triggered into increased monitoring will not be considered in violation of the MCL until they have completed one year of quarterly sampling. If any sample result will cause the running annual average to exceed the MCL at any sampling point (i.e., the analytical result is greater than four times the MCL), the system is out of compliance with the MCL immediately. Systems may not monitor more frequently than specified by the State to determine compliance unless they have applied to and obtained approval from the State. 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 annual average of the samples collected. If a sample result is less than the method detection limit, zero will be used to calculate the annual average. States have the discretion to delete results of obvious sampling or analytic errors.

States still have the flexibility to require confirmation samples for positive or negative results. States may require more than one confirmation sample to determine the average exposure over a 3-month period. Confirmation samples must be averaged with the original analytical result to calculate an average over the 3-month period. The 3-month average must be used as one of the quarterly concentrations for determining the running annual average. The running annual average must be used for compliance determinations.

The rule requires that monitoring be conducted at all entry points to the distribution system. However, the State has discretion to require monitoring and determine compliance based on a case-by-case analysis of individual drinking water systems. The Agency cannot address all of the possible outcomes that may occur at a particular water system; therefore, EPA encourages drinking water systems to inform State regulators of their individual circumstances. Some systems have implemented elaborate plans including targeted, increased monitoring that is more representative of the average annual contaminant concentration to which individuals are being exposed (some States use a time-weighted or flow-weighted averaging approach to determine compliance).

Some States require that systems collect samples from wells that only operate for one month out of the year regardless of whether they are operating during scheduled sampling times. The State may determine compliance based on several factors including, but not limited to, the quantity of water supplied by a source, the duration of service of the source, and contaminant concentration.

4. Monitoring and Compliance Schedule

Systems must begin complying with the clarified monitoring and compliance determination provisions of today's rule effective January 22, 2004 for inorganic, volatile organic, and synthetic organic contaminants. These requirements clarify that for §§ 141.23(i)(2), 141.24(f)(15)(ii), and 141.24(h)(11)(ii) compliance will be determined based on the running annual average of the initial MCL exceedance and any subsequent State-required confirmation samples. In addition, the clarifications address calculation of compliance when a system fails to collect the required number of samples. Compliance (determined by the average concentration) will be based on the total number of samples collected. Some systems have purposely not collected the required number of quarterly samples and only incurred monitoring and reporting violations for the uncollected samples. Any systems that avoid required sampling will calculate MCL violations by dividing the summed samples by the actual number of samples taken. This clarification did not change §§ 141.23(i)(1) and 141.24(h)(11)(i) which allow systems to use zero for all non-detects when calculating MCL violations. In addition, if any one sample would cause the annual average to be exceeded, the system is out of compliance immediately.

Also in today's rule, the Agency is moving the arsenic monitoring and compliance requirements from §§ 141.23(l) to (q) to the standardized monitoring framework in § 141.23 for other IOCs. States may grant systems nine-year monitoring waivers using the conditions in § 141.23(c) for arsenic. The criteria for developing a State waiver program were published in the Phase II/V rules, and as noted in section IV.B. of this rule, the Agency is not modifying the waiver criteria in today's rulemaking. However, the revised arsenic rule is not effective until January 23, 2006 (see section I.M. for a more detailed discussion regarding the effective date of the rule.). States and utilities supported moving arsenic into the standardized monitoring framework.

To use compliance data after the effective date of the 10 μg/L MCL, systems must use an approved method with a method detection limit substantially less than the revised arsenic MCL of 10 μg/L. This means that after December 31, 2006 and December 31, 2007 all surface water systems and groundwater systems, respectively, may not use analytical methods using the ICP-AES technology, because the detection limits for these methods are 8 μg/L or higher. This restriction means that two ICP-AES methods that were approved when the MCL was 50 μg/L may not be used for compliance determinations at the revised MCL of 10 μg/L. The two methods are EPA Method 200.7 and SM 3120B. Prior to 2005, systems may have compliance samples analyzed with these less sensitive methods. However, EPA advises systems to have compliance samples analyzed and reported at the laboratory minimum detection limit.

If sampling demonstrates that arsenic exceeds the MCL, a CWS will be triggered into quarterly monitoring for that sampling point “in the next quarter after the violation occurred.” The State may allow the system to return to the routine monitoring frequency when the State determines that the system is reliably and consistently below the MCL. However, the State cannot make a determination that the system is reliably and consistently below the MCL until a

minimum of two consecutive ground water, or four consecutive surface water samples, have been collected (§ 141.23(c)(8)).

The Agency is not promulgating a reduced monitoring approach similar to the revised radionuclides final rule published on December 7, 2000 (65 FR 76708; EPA, 2000p). As noted above, all systems have to collect IOC samples once a year or once every three years, depending on the source water, unless they have a waiver. The Agency believes that very few States issue waivers for IOCs because the analysis is relatively inexpensive and most IOCs are naturally occurring elements that may be found in concentrations above the method detection limit. Therefore, the majority of systems must collect routine samples for the regulated IOCs; and most of the methods used for analysis of these contaminants will measure arsenic as well as antimony, beryllium, cadmium, chromium, copper, and nickel.

K. What do I Need to tell My Customers?

1. Consumer Confidence Reports

a. General requirements.

In 1998, EPA promulgated the Consumer Confidence Report Rule (CCR) (codified at 40 CFR part 141, subpart O), a final rule requiring community water systems to issue annual water quality reports to their customers (63 FR 44512; EPA, 1998i). The reports are due each year by July 1, and provide a snapshot of water quality over the preceding calendar year. The reports include information on levels of detected contaminants and if the system has violated an MCL or a treatment technique, must also include information on the potential health effects of contaminants from appendix A to subpart O. When they have such violations, systems must also include in their report an explanation of the violation and remedial measures taken to address it. The arsenic health effects language is currently required when arsenic levels exceed 25 μg/L, one-half the existing MCL of 50 μg/L, required under § 141.154(b).

EPA is today retaining the health effects language for arsenic issued with the final CCR Rule and updating appendix A to subpart O to include the MCL and MCLG as revised in this rule, together with special arsenic-specific reporting requirements.

In addition to the standard reporting of arsenic detects and arsenic MCL violations, EPA is today finalizing a requirement (proposed at § 141.154(b); finalized at § 141.154(f)) that CWSs that detect arsenic between the revised and existing MCL (i.e., above 10 μg/L and up to and including 50 μg/L) prior to the effective date for compliance with the revised MCL, include the CCR Rule health effects language in their reports. This action is required even though, technically, the systems are not in violation of the regulations. This requirement will be effective for the five years after promulgation, when systems are not yet required to comply with the revised MCL. Then, beginning January 23, 2006, systems out of compliance must report violations of the revised arsenic MCL under § 141.153(d)(6) to the public.

Based on stakeholder and commenter input, the Agency decided in the final CCR Rule that it would use authority granted in SDWA section 1414(c)(4)(B)(vi) to require inclusion of health effects language for arsenic exceedances before the compliance date. That section allows the Administrator to require inclusion of health effects language for “not more than three regulated contaminants” other than those found to violate an MCL. The Agency used this authority for total trihalomethanes in the Stage 1 Disinfectants and Disinfection Byproducts Rule (63 FR 69390). The Agency is now using this same authority for arsenic, because it believes that it is important to provide customers with the most current understanding of the risk presented by this contaminant as soon as possible after establishing a new standard. This provision provides systems the flexibility to put this health effects information into context and to explain to customers that the system is complying with existing standards.

EPA modified the language it proposed on June 22, 2000 to reflect the MCL promulgated today and to clarify what language a system must include in its report. Systems subject to § 141.154(f) must begin including the arsenic health effects language in the report due by July 1, 2002.

b. Special informational statement.

In addition, in the CCR Rule, the Agency decided to require that CCRs include additional information about certain contaminants, one of which was arsenic. As explained in the preamble to the CCR Rule (63 FR 44512 at 44514; EPA, 1998i), because of commenters' concerns about the adequacy of the current MCL, EPA decided that systems that detect arsenic between 25 μg/L and the current MCL must include some information regarding the arsenic standard (§ 141.154(b)). This informational statement is different from the health effects language required for an MCL violation. EPA noted in the CCR rule and in the arsenic proposal that the informational statement requirement would be deleted upon promulgation of a revised MCL.

In view of the fact that EPA is today finalizing an MCL somewhat higher than the technologically feasible MCL, and that some commenters expressed concern about the risk that a higher-than-feasible MCL might present to certain consumers, EPA is today retaining and revising an existing § 141.154(b) requirement that systems which find arsenic below the MCL must provide additional information to their customers. EPA believes that consumers should be aware of the uncertainties surrounding the risks presented even by very low levels of arsenic. While EPA addressed many of the sources of uncertainty in its risk analysis of arsenic in support of the final rule, several sources of uncertainty remain. Chief among these is the mode of action (i.e., the shape of the dose-response curve). EPA continues to research the effects of arsenic (according to an arsenic research plan required by the 1996 SDWA Amendments and submitted to Congress) and should have a better understanding of these effects as the relevant research is completed. EPA believes that this uncertainty adequately justifies retaining the existing requirement to provide consumers with information about low levels of arsenic.

The existing § 141.154(b) requirement is today updated in two ways. First, the arsenic level that triggers the additional information is reset from 25 μg/L (half the existing MCL) to 5 μg/L (half the revised MCL). In the preamble to the CCR Rule, we explained that “[many] commenters agreed that half the MCL would be an appropriate threshold for requiring additional risk-related information.” EPA continues to believe that half the MCL is an appropriate trigger for special information about certain contaminants. Beginning with the report due by July 1, 2002, CWSs that find arsenic above 5 μg/L and up to and including 10 μg/L must include § 141.154(b) special health information about arsenic in their consumer confidence reports.

Second, the suggested text of the special information is updated. Rather than stating that “EPA is reviewing the drinking water standard for arsenic . . .,” the statement announces clearly that the consumer's water meets EPA's new standard while also noting the cost-benefit trade-off involved in setting that standard. The suggested text further notes that there are uncertainties (described in section III.F of this notice) surrounding the risks of low levels of arsenic. Systems retain the flexibility, as defined in the existing requirement, to

adjust this language in consultation with the Primacy Agency.

2. Public Notification

On May 4, 2000, EPA issued the final Public Notification Rule (PNR) to revise the minimum requirements that public water systems must meet for public notification of violations of EPA's drinking water standards (65 FR 25982; EPA, 2000e). Water systems must begin to comply with the revised PNR 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 (not to exceed May 6, 2002). EPA's drinking water regulation on arsenic affects public notification requirements and amends the PNR as part of its rulemaking.

Today's final rule will require CWSs and NTNCWSs to provide a Tier 2 public notice for arsenic MCL violations and to provide a Tier 3 public notice for violations of the monitoring and testing procedure requirements. The new arsenic MCL will become effective January 23, 2006. CWSs and NTNCWSs must provide public notification to consumers for any violations after the effective date of the revised arsenic MCL. The PNR requires owners and operators of public water systems to give notice to persons they serve for all violations when they are operating under a variance or exemption (or violate conditions of the variance or exemption).

L. What Financial Assistance is Available for Complying With This Rule?

There are two major sources of Federal financial assistance available for water systems: the Drinking Water State Revolving Fund (DWSRF) and the Water and Waste Disposal Loan and Grant Program of the Rural Utilities Service (RUS) of the U. S. Department of Agriculture.

The 1996 SDWA Amendments authorized (

i.e.

, approved spending) $9.6 billion for the DWSRF program. To date, Congress has appropriated (

i.e.

, provided) $4.2 billion, which includes $825 million for the program in Fiscal Year 2001. By the end of September 2000, States had been awarded $3.2 billion in capitalization grants and, from that, had provided more than $2.8 billion in assistance to eligible drinking water systems. The Federal capitalization grant, together with State matching funds, is currently making available about $1 billion per year. States have considerable discretion in designing their DWSRF program, and have the option of offering special assistance to systems that the State considers to be disadvantaged. Special assistance may include principal forgiveness, a negative interest rate, an interest rate lower than that charged to non-disadvantaged systems, and extended repayment periods of up to 30 years. Federal law allows DWSRF assistance to be provided to water systems of both public ownership and private ownership, although some States are unable or choose not to provide assistance to privately owned systems.

EPA recognizes that public water systems and States face a significant challenge in implementing new requirements that are needed to ensure the continued provision of safe drinking water. While the DWSRF program is proving to be a significant source of funding, it cannot be viewed as the only source of funding. It will take a concerted effort on the part of Federal, State and local governments, private business, and utilities to address the significant infrastructure needs identified by public water systems. In order to ensure that the DWSRF program is used to focus attention on the highest priority needs, all States must give priority to those drinking water infrastructure improvement projects that will have the greatest public health benefit or ensure compliance with SDWA. State DWSRF programs are currently making loans available to the highest ranked projects on their lists and are also using a portion of the grants to support other important drinking water program activities.

The RUS program is focused on providing a safe, reliable water supply and wastewater treatment to residents of rural America. The program offers a combination of low interest loans and grants to systems serving rural areas and cities and towns of up to 10,000 persons and which are publicly owned (including Native American systems) or operated as not-for-profit corporations. In recent years the RUS program has typically offered assistance totaling about $1.3 billion per year, about 60% of which is directed to drinking water projects. Thus, about $780 million per year is available for rural drinking water systems from this program. Together with the approximately $1 billion per year being made available through the DWSRF, this results in a total of about $1.78 billion per year of Federal financial assistance available for drinking water.

Other Federal financial assistance programs exist that may help systems with SDWA compliance related expenditures. However, these other programs are not generally as large or focused on drinking water as are the DWSRF and RUS programs. EPA's Environmental Financial Advisory Board has developed a “Guidebook of Financial Tools” (EPA, 1999c), which offers a comprehensive summary of public and private programs and mechanisms for paying for drinking water and other environmental systems. The handbook is available through EPA's web site at:

http://www.epa.gov/efinpage/guidbk98/index.htm

.

The Federal financial assistance programs described previously clearly face numerous, competing demands on their resources. EPA's 1995 Drinking Water Infrastructure Needs Survey (EPA, 1997a) identified a total 20-year need for all systems of $138.4 billion. The single largest category of need (accounting for over half of the total need) is installation and rehabilitation of transmission and distribution systems. Treatment needs constitute the second largest category of need, accounting for over

1/4

of total needs. Storage and source rehabilitation and development constitute the remaining major categories of needs. Thus, systems seeking financial assistance for installation of arsenic treatment are competing for resources with systems seeking assistance for compliance with other rules and with systems seeking resources for basic infrastructure repair and replacement. In seeking to meet these numerous and competing needs, the Agency recognizes the importance of priority setting for financial assistance programs. Systems having the financial capability to secure funding through the capital markets should do so, leaving the Federal financial assistance programs to assist the truly needy systems. Since the demand for assistance will likely outstrip the supply of assistance, States may wish to consider exemptions, which will provide additional time for systems to secure financial assistance.

M. What is the Effective Date and Compliance Date for the Rule?

In the proposed rule, EPA made a finding that all small systems (

i.e.

, systems serving 10,000 people or less) would be granted a 2-year capital improvement extension which extends the MCL effective date for purposes of compliance with the new MCL to January 23, 2006. EPA proposed the 2-year capital improvement extension for small systems because of the time required for systems to plan, finance, design and construct new treatment systems.

Large systems were not provided this additional time because of the greater resources these systems have to perform

capital improvements in a timely manner. However, upon consideration of information submitted by commenters, EPA has determined that large systems will also require an additional 2 years to complete the capital improvements necessary to comply with the arsenic MCL. While large systems (

i.e.

, systems serving more than 10,000 people) do have greater resources to implement capital improvements, (

e.g.

, engineering and construction management staff to manage the projects), these systems generally also have more entry points to the distribution system that will require treatment.

A number of treatment technologies are listed as BAT for the proposed rule: ion exchange, activated alumina, reverse osmosis, modified coagulation/filtration, modified lime softening and electrodialysis reversal. There are also several emerging technologies for arsenic removal, such as nanofiltration and granular ferric hydroxide. To ensure cost effective compliance with the arsenic MCL, systems will need to evaluate their treatment technology options as a first step. This planning step may include pilot studies with potential treatment systems, or it may be limited to an evaluation of the raw water characteristics. Systems choosing to conduct pilot testing may take a year or more to contract with vendors and to perform pilot testing.

Once the planning step is completed systems must design and construct the treatment systems. Design and permitting of the treatment systems can take an additional year, and construction of the treatment system can take another year. Because systems will also need time to: obtain funding, obtain local government approval of the project, or acquire the land necessary to construct these technologies, it is likely that most large systems will need additional time beyond the three-year effective date for compliance with the new MCL that EPA proposed.

Based upon these considerations, EPA determined, in accordance with section 1412(b)(10) of SDWA, that the compliance date for the new arsenic MCL, regardless of system size, will be 5 years from the date of promulgation of the standard. See section I.H. for more information regarding variance and exemptions.

N. How Were Stakeholders Involved in the Development of This Rule?

EPA met extensively with a broad range of groups during the development of the arsenic proposal, both at EPA-sponsored meetings and at other organizations' meetings. The

Federal Register

published notices about EPA's arsenic meetings, and we made conference call lines available for those who chose not to attend in person. In addition, EPA notified people about regulatory actions via the three

Federal Register

notices (proposal, notice of data availability, and correction notice), by mail and e-mail. Over 600 people asked to be on the mailing list during the regulatory development period.

EPA held arsenic stakeholders meetings September 11-12, 1997 in Washington, DC; February 25, 1998 in San Antonio, Texas; May 5, 1998 in Monterey, California; June 2-3, 1999 in Washington, DC; and August 9, 2000 in Reno, Nevada. For each of these meetings we invited representatives of States, tribal groups, associations, utilities and environmental groups. The docket for the proposed rule (W-99-16) contains the meeting discussion papers, agendas, participants lists, presentation materials, and executive meeting summaries. All the meeting materials, except the presentations and attendance list, are also available on EPA's arsenic in drinking water web page,

www.epa.gov/safewater/arsenic.html.

EPA also presented sessions on drinking water regulations (including arsenic) at the National Indian Health Board Annual Conference in Anchorage, Alaska in September 1998. The Inter-tribal Council of Arizona hosted a consultation for EPA with Tribes February 24-25, 1999 in Las Vegas, NV at which an overview of the proposed arsenic regulation was presented. EPA also conducted a series of workshops at the Annual Conference of the National Tribal Environmental Council May 18-20, 1999 in Eureka, California. The Council distributed materials and gathered comments on EPA's drinking water regulations from all recognized Tribal governments.

In addition to the general stakeholder meetings, EPA also had targeted meetings with States' representatives. In May 1999, State regulatory representatives from California, Nevada, Michigan, Illinois, Texas, Indiana, New Mexico, and Louisiana joined EPA in a discussion on the development of the cost of compliance decision tree. In August 1999, State regulatory representatives from Illinois, Indiana, New Mexico, and Texas joined EPA workgroup members in a discussion of the NRC study use, review of the occurrence work, treatment technology update, and regulatory changes. The interaction from these meetings with State colleagues improved the regulatory language and the preamble.

In May 2000, EPA presented a summary of the rule to the National Governors' Association. In May 2000, EPA held a dialogue in Washington, DC with State officials and the associations that represent elected officials. Presentations on arsenic and other drinking water rules under development were given to representatives of the National Association of Towns and Townships, National Governors' Association, National Association of Counties, National League of Cities, Association of State Drinking Water Administrators, Environmental Council of the States, Florida Department of Environmental Protection, Drinking Water Section, Association of State and Territorial Health Officials, and the International City/County Management. The purpose of the dialogue was to consult on the expected compliance and implementation costs of these rules for State, county, and local governments and gain a better understanding of the views of representatives of State, county, and local governments and their elected officials. The meeting materials are in the docket for the proposed rule.

In addition to the various special meetings and discussions mentioned previously, EPA representatives delivered arsenic regulatory development presentations at a variety of meetings held by other organizations. These included the American Water Works Association (AWWA) Inorganic Contaminants Meetings in February, 1998 in San Antonio, TX and in February, 2000 in Albuquerque, NM; meetings of the Association of State Drinking Water Administrators (ASDWA) in February and October 1998, March and October 1999, and in October 2000; meetings of the Association of Metropolitan Water Agencies (AMWA) in January and March 1998; and a meeting of the Association of California Water Agencies in March 1998. EPA also gave several technical presentations and regulatory updates at the AWWA annual meetings as well as at the AWWA Water Quality and Technology Conferences in 1998, 1999, and 2000. EPA participated in the Society of Toxicology arsenic workshop in Philadelphia, PA in March 2000. Finally, EPA co-sponsored and participated in the four International Conferences on Arsenic Exposure and Health Effects in July 1993, June 1995, July 1998, and June 2000.

After the proposal was published in the

Federal Register

, EPA notified all persons on its electronic mailing list for the arsenic rule of its availability and sent information. The Regulatory Impact Analysis went on the arsenic web page a week after the proposal publication. Similarly, EPA also notified the individuals and organizations on this

mailing list about the NODA and the correction notice.

II. Statutory Authority

Section 1401 of SDWA requires a “primary drinking water regulation” to specify a MCL if it is economically and technically feasible to measure the contaminant and to include testing procedures to insure compliance with the MCL and proper operation and maintenance. An NPDWR that establishes an MCL also lists the technologies that are feasible to meet the MCL, but systems are not required to use the listed technologies (section 1412(b)(3)(E)(i)). As a result of the 1996 amendments to SDWA, when issuing a NPDWR, EPA must also list affordable technologies that achieve compliance with the MCL or treatment technique for three categories of small systems: those serving 10,000 to 3301 persons, 3300 to 501 persons, and 500 to 25 persons. EPA can list modular (packaged) and POE and POU treatment units for the three small system sizes, as long as the units are maintained by the public water system or its contractors. Home units must contain mechanical warnings to notify customers of problems (section 1412(b)(4)(E)(ii)).

In section 1412(b)(12)(A) of SDWA, as amended August 6, 1996, Congress directed EPA to propose a national primary drinking water regulation for arsenic by January 1, 2000 and issue the final regulation by January 1, 2001. At the same time, Congress directed EPA to develop a research plan by February 2, 1997 to reduce the uncertainty in assessing health risks from low levels of arsenic and conduct the research in consultation with the NAS, other Federal agencies, and interested public and private entities. The amendments allowed EPA to enter into cooperative agreements for research. On October 27, 2000, Public Law 106-377, the bill which included Fiscal Year 2001 appropriations for EPA, amended the statutory deadline to direct EPA to promulgate a final arsenic standard by no later than June 22, 2001.

Section 1412(a)(3) requires EPA to propose an MCLG simultaneously with the NPDWR. The MCLG is defined in section 1412(b)(4)(A) as “the level at which no known or anticipated adverse effects on the health of persons occur and which allows an adequate margin of safety.” Section 1412(b)(4)(B) specifies that each NPDWR will specify an MCL as close to the MCLG as is feasible, with two exceptions added in the 1996 amendments. First, the Administrator may establish an MCL at a level other than the feasible level if the treatment to meet the feasible MCL would increase the risk from other contaminants or the technology would interfere with the treatment of other contaminants (section 1412(b)(5)). Second, if benefits at the feasible level would not justify the costs, EPA may propose and promulgate an MCL “that maximizes health risk reduction benefits at a cost that is justified by the benefits” (section 1412(b)(6)).

When proposing an MCL, EPA must publish, and seek public comment on, the health risk reduction and cost analyses (HRRCA) of each alternative maximum contaminant level considered (section 1412(b)(3)(C)(i)). This includes the quantifiable and nonquantifiable benefits from reductions in health risk, including those from removing co-occurring contaminants (not counting benefits resulting from compliance with other proposed or final regulations), costs of compliance (not counting costs resulting from other regulations), any increased health risks (including those from co-occurring contaminants) that may result from compliance, incremental costs and benefits of each alternative MCL considered, and the effects on sensitive subpopulations (e.g., infants, children, pregnant women, elderly, seriously ill, or other groups at greater risk). EPA must analyze the quality and extent of the information, the uncertainties in the analysis, and the degree and nature of the risk. As required by the statute, EPA issued a HRRCA for arsenic (EPA, 2000i) as section XIII of the June 22, 2000 arsenic proposal (65 FR 38888 at 38957).

The 1996 amendments also require EPA to base its action on the best available, peer-reviewed science and supporting studies and to present health effects information to the public in an understandable fashion. To meet this obligation, EPA must specify, among other things,

peer-reviewed studies known to the Administrator that support, are directly relevant to, or fail to support any estimate of public health effects and the methodology used to reconcile inconsistencies in the scientific data (section1412(b)(3)(B)(v)).

Section 1413(a)(1) allows EPA to grant States primary enforcement responsibility (primacy) for NPDWRs when EPA has determined that the State has adopted regulations that are no less stringent than EPA's. States must adopt comparable regulations within two years of EPA's promulgation of the final rule, unless a two-year extension is granted. State primacy also requires, among other things, adequate enforcement (including monitoring and inspections) and reporting. EPA must approve or deny State applications within 90 days of submission (section 1413(b)(2)). In some cases, a State submitting revisions to adopt an NPDWR has primacy enforcement authority for the new regulation while EPA action on the revision is pending (section 1413(c)). Section 1451(a) allows EPA to grant primacy enforcement responsibility to Federally recognized Indian Tribes, providing grant and contract assistance, using the procedures applied to States.

III. Rationales for Regulatory Decisions

A. What Is the MCLG?

The proposed rule suggested that an MCLG of zero be established for arsenic in view of the fact that we are currently unable to specify a safe threshold level due to uncertainty about the mode of action for arsenic. Today's rule establishes a final MCLG for arsenic of zero. After full consideration of public comments, EPA continues to believe that the most scientifically valid approach, given the lack of critical data, is to use the linear approach to assessing the mode of action. This approach results in an MCLG of zero. In the proposal and the NODA, EPA noted that the available data point to several potential carcinogenic modes of action for arsenic (EPA also requested additional data on the mode of action). However, which mode(s) of action is operative is unknown. For this reason, while the Agency recognizes that the dose-response relationship may be sublinear, the data do not provide any basis upon which EPA could reasonably construct this relationship. Thus, EPA has no basis upon which to depart from its assumption of linearity. The NRC report noted that available data that could help determine the shape of the dose-response curve are inconclusive and do not meet EPA's stated criteria for departure from the default assumption of linearity (NRC, 1999). See section III.D.1 for a thorough discussion of the dose-response assessment.

Because the postulated mode of action for arsenic cannot specifically be described and the key events are unknown, the Agency lacks sufficient available, peer-reviewed information to estimate quantitatively a non-linear mode of action. The Agency has thus decided not to depart from the assumption of linearity in selecting an MCLG of zero.

B. What Is the Feasible Level?

1. Analytical Measurement Feasibility

In the development of a drinking water regulation, EPA derives a practical quantitation limit (PQL) to estimate or evaluate the minimum,

reliable quantitation level (concentration) that most laboratories can be expected to meet during day-to-day operations. The PQL accounts for the limits of current measurement technologies and the laboratories that use the methods written around these analytical technologies. The PQL was defined in a November 13, 1985 rule (50 FR 46906, EPA, 1985b) as “the lowest concentration of an analyte that can be reliably measured within specified limits of precision and accuracy during routine laboratory operating conditions.” A PQL is determined either through use of interlaboratory studies or, in absence of sufficient studies, through the use of a multiplier of 5 to 10 times the method detection limit (MDL). Interlaboratory data are obtained from water supply (WS) studies that are conducted by EPA to certify drinking water laboratories. The WS studies require a candidate laboratory to measure the concentration of the target analyte within specified limits (e.g., ±30%) of the amount spiked into a PE (now called PT) challenge sample. Using graphical or linear regression analysis of the WS data, the Agency sets a PQL at a concentration where at least 75% of experienced laboratories (generally EPA and State laboratories) could perform within this acceptable limit for accuracy, e.g., ±30%.

As discussed in the June 22, 2000 proposed rule for arsenic, the Agency determined that the PQL (i.e., the feasible level of measurement) for arsenic in drinking water is 0.003 mg/L with an acceptance limit of ±30%. The derivation of the PQL for arsenic is consistent with the process used to determine PQLs for other metal contaminants regulated under SDWA and takes into consideration the recommendations from EPA's SAB (EPA, 1995). Using acceptance limits of ±30% and linear regression analysis of six recent WS studies, EPA derived a PQL of 0.00258 mg/L for arsenic, which was rounded to 0.003 mg/L at the ±30%. While the PQL represents a relatively stringent target for laboratory performance, based on the WS data used to derive the PQL for arsenic, the Agency believes most laboratories (using appropriate quality assurance and quality control procedures) can achieve this level on a routine basis.

2. Treatment Feasibility

EPA has determined that 3 μg/L is technologically feasible for large systems based on peer-reviewed treatment information. EPA has listed seven BATs for arsenic in the final rule. They are: ion exchange when sulfate ≤50 mg/L, activated alumina, reverse osmosis, modified coagulation/filtration, modified lime softening at pH >10.5, electrodialysis reversal, and oxidation/filtration when the iron to arsenic ratio is at least 20:1. Bench, pilot and full-scale data were examined to determine the capabilities of the treatment processes. The treatment performance data are summarized in “Technologies and Costs for the Removal of Arsenic from Drinking Water” (EPA, 2000t).

C. How Did EPA Revise its National Occurrence Estimates?

1. Summary of Occurrence Data and Methodology

Our data and methodology for estimating arsenic occurrence are substantially the same as in the proposed rule (65 FR 38888 at 38903; EPA, 2000i). The data and methodology are described in detail in (EPA, 2000r). Following is a summary of our method. All of the elements of this summary are the same as in the proposed rule, except where noted.

Our occurrence database consists of arsenic compliance monitoring samples of finished drinking water, submitted voluntarily by drinking water agencies in 25 States. The 25 States are distributed throughout the U.S., with at least one located in each of the seven geographic regions that we used in our analysis (65 FR 38888 at 38906; EPA, 2000i; EPA, 2000r). In some States we used data only from a subset of years in which detection limits were lowest. For each PWS in our database, we estimated the mean arsenic concentration over time in finished water, by first “filling in” non-detected concentrations, using one of two statistical methods (EPA, 2000r), then averaging the detected and filled-in observations from that system. Next, we collected the system mean estimates into State distributions, then merged the State distributions into regional and then national distributions. In combining the regional distributions into a national distribution, we weighted each region by the total number of systems in the region, not just the number of systems in the States in our database. This procedure has the same effect as assigning the regional distributions to the 25 States for which we have no observations in our database.

In addition to the distributions of system means, we estimated nationwide intra-system coefficients of variation (ISCV). For a given water system, the ISCV quantifies the variation of mean arsenic levels at the system's entry points to the distribution system (i.e., sampling points of individual wells and treatment points) around the overall system mean. We estimated a separate ISCV for each ground water (gw) CWS, surface water (sw) CWS, and, unlike in the proposed rule, ground water NTNCWS. Each of these ISCVs is assumed to be constant throughout the U.S.

2. Corrections and Additions to the Data

Some public commenters asked whether our data might have errors in the classification of water samples as treated or untreated. If that were the case, then including untreated samples in our database could cause us to overestimate occurrence in finished water. In order to determine whether and to what extent these problems exist, we solicited additional data sets from drinking water agencies in six States (Alabama, California, Illinois, New Mexico, North Carolina, and Texas) from whom we already had data in our draft data set. All six States responded to our request by submitting additional data, including additional identifiers of untreated observations, as well as some new observations not contained in our draft data base. In California, once the newly identified untreated observations were removed from the data set, the number of surface water observations decreased from 2,488 in the draft data set to 1,280 in the final data set. For ground water, on the other hand, the number of samples in California increased from 5,622 to 9,494. The increase resulted in part from the additional data, and in part because we changed our methodology, as we describe below, to include samples from both treated and untreated ground water in our ground water estimates. Changes in the other five States were of smaller size.

We also updated our data set from Utah. The latest data from Utah include more observations and covers the years 1980 to 1999. The total number of observations from Utah in our data set increased from 2,447 to 4,684.

Table III.C-1 compares the number of observations, systems, and States in our database, by system type and source water type, in the proposed and final rules. Note that our complete database is larger than shown in Table III.C-1, but in some States we excluded data from some years in which analytical detection limits were highest. Table III.C-1 counts only the data from the years that we used to estimate occurrence.

Table III.C-1.—Summary of Occurrence Databases for the Proposed and Final Rules

System type

Source water

Proposed rule

# of

observations

# of

systems

# of

States

Final rule

# of

observations

# of

systems

# of

States

CWS

GW

44,502

15,640

25

53,307

15,931

25

CWS

SW

15,892

2,360

25

16,212

2,228

25

NTNCWS

GW

* 6,420

* 4,662

* 18

7,045

4,382

17

NTNCWS

SW

* 420

* 150

* 14

* 409

* 118

* 15

All

All

67,234

22,812

25

76,973

22,659

25

* Data not used in estimating occurrence.

We also updated our baseline inventory of the public water systems in the U.S. and the populations they serve, by type of system, type of source water, and State. We use this inventory to estimate the numbers of systems and people affected by different MCL options, by multiplying the number of people or systems in a given category by the estimated fraction of systems in that category with mean arsenic greater than the levels of interest. In the proposed rule, the occurrence and regulatory impact analyses used different sets of baseline estimates: occurrence took baseline estimates from EPA's 4th quarter 1997 Safe Drinking Water Information System (SDWIS) database, while the proposal's regulatory impact analysis (RIA) used 4th quarter 1998 SDWIS. The result, as some public commenters pointed out, was that the proposed rule contained two inconsistent sets of estimates of the numbers of people and systems affected by different MCL options (65 FR 38888; EPA, 2000i, Table V-3; EPA, 2000h, Exhibit 4-11). The two estimates of total numbers of systems affected at various MCLs differed by up to 27%. We corrected this inconsistency by adopting, with one modification, the baseline inventory in EPA's Drinking Water Baseline Handbook (EPA, 2000b) throughout this preamble and all supporting documents for the final rule. The inventory in the Baseline Handbook is taken from EPA's 4th quarter 1998 SDWIS database, or the same that was used in the proposed RIA. The only modification we made to the inventory was in Alaska where the Baseline Handbook lists zero NTNCWS and zero population served by NTNCWS. Following public comment from the Alaska Department of Environmental Conservation, we corrected the inventory of NTNCWS in Alaska. The Baseline Handbook and corrected Alaska inventories are shown in Table III.C-2.

Table III.C-2.—Alaska PWS Inventories: Baseline Handbook and Corrected

System type

Source water

Baseline handbook

No. of systems

Population served

Corrected

No. of systems

Population served

CWS

GW

508

227,874

344

175,367

CWS

SW

160

317,155

121

260,792

NTNCWS

GW

0

0

161

51,909

NTNCWS

SW

0

0

35

56,013

All

All

668

545,029

661

544,081

The revised estimates of numbers of systems affected at different arsenic concentrations are shown in Table III.C-6. Since the proposed and final Economic Analysis use the same set of baseline estimates (except for the small correction in Alaska), changes in Table III.C-6 compared to the proposed RIA (EPA, 2000h, Exhibit 4-11) are due to changes in the occurrence estimates in Table III.C-3, which follows. Changes in Table III.C-6 compared to the proposed occurrence analysis (65 FR 38888; EPA, 2000i, Table V-3) are due to changes in occurrence estimates and also correction of the baseline.

3. Changes to the Methodology

In September 1999, EPA sponsored a peer review of our occurrence data and methodology by three independent experts in geochemistry and statistics. In response to that review and public comments, we have made minor revisions to our methodology for estimating occurrence in two ways since the proposed rule.

First, we now estimate the occurrence distribution for ground water NTNCWSs separately from CWSs. In the proposed rule, we used the CWSs distribution as a surrogate for NTNCWSs, for both ground and surface water systems. We now estimate occurrence in ground water NTNCWSs separately, using the same method as for CWSs, as described previously. For ground water NTNCWSs we have data from 17 States, compared to 25 States for CWSs, so there are on average fewer States with data in each region. Moreover we have no data about NTNCWSs from any States in the Southeast region (Alabama, Florida, Georgia, Mississippi, and Tennessee). We therefore used the occurrence distribution for ground water CWSs as a surrogate for ground water NTNCWSs in the Southeast. The revised occurrence estimates for ground water NTNCWSs are shown in Table III.C-3.

We still do not estimate a separate occurrence distribution for surface water NTNCWSs. For surface water NTNCWSs, we did not believe that the 118 systems for which data were provided for NTNCWSs formed as strong a basis for estimating occurrence as the much larger CWS surface water data base, especially in the concentration range of interest. In addition, there is less reason to believe that surface water NTNCWSs will differ from surface water CWSs. We thus believe the surface water CWS estimates provide the soundest basis for estimating impacts given the types of data available.

Second, we have improved our method for estimating intra-system

variability. In the proposed rule, we estimated the ISCV by measuring the total amount of variability of arsenic concentrations around the system mean within each system. The problem with that approach is that it fails to distinguish between-source variability (variability of sampling-point means around the system mean) from within-source variability (variability of observations at each sampling point around the sampling-point mean). Within-source variability includes variations in concentrations through time at a source, and analytical variability caused by imprecision of the analytical methods used to measure arsenic in water samples. The ISCV is intended to describe only between-source variability within a system. Following the recommendations of the peer review, we corrected our model of intra-system variation to include separate terms for between-source and within-source variability. As a result, our estimates of the ISCVs decreased, since we separate out the within-source variability. The revised ISCV estimates are shown in Table III.C-7.

A third change to our methodology is that, for ground water systems, we now include observations on both treated and untreated ground water in our analysis. With the exception of iron removal technologies, most treatment in ground water systems has little effect on arsenic, so one might expect arsenic concentrations to be similar in treated and untreated samples. This turns out to be the case in our data: estimates that included untreated samples were either slightly higher or lower than estimates with only treated samples. We therefore decided to include both treated and untreated samples in our ground water occurrence estimates. For surface water estimates, we still use only samples from treated water.

4. Revised Occurrence Results

Table III.C-3 shows our revised estimates of the national distribution of arsenic occurrence, by system type and source water type. The distributions are stated in terms of “exceedance probabilities,” that is, the fraction of systems with mean arsenic equal to or greater than the given concentration, in finished water. The “weighted point estimate” is the combination of State distributions into a national distribution, as described previously. We consider the weighted point estimate to be our best estimate. The “lognormal fit” is the result of fitting a lognormal distribution to the weighted point estimates. The lognormal fit is an approximation to the weighted point estimate, which we use in our cost and benefit analyses (sections III.E and III.F). The lognormal approximation simplifies the simulation studies that we use to derive costs and benefits, by allowing each distribution to be summarized in terms of only two parameters. Table III.C-4 lists the parameters of the fitted lognormal distributions.

Table III.C-3.—National Occurrence Exceedance Probability Estimates

Percent of systems with mean finished arsenic exceeding concentrations (μg/L) of:

3

5

10

20

50

Ground Water CWS

Weighted point estimate

19.9

12.1

5.3

2.0

0.43

95% confidence interval

1

[19.3,21.9]

[11.7,13.0]

[5.2,5.9]

[1.9,2.3]

[0.38,0.52]

Lognormal fit

19.7

12.0

5.3

2.0

0.43

Surface Water CWS

Weighted point estimate

5.6

3.0

0.80

0.32

0.10

95% confidence interval

1

[4.8,20.6]

[1.8,9.7]

[0.52,1.6]

[0.13,0.82]

[0.02,0.59]

Lognormal fit

5.6

3.0

1.1

0.37

0.067

Ground Water NTNCWS

Weighted point estimate

24.2

15.6

5.3

2.1

0.47

95% confidence interval

1

Lognormal fit

23.4

14.2

6.1

2.2

0.42

1

Brackets indicate confidence intervals which were computed for the proposed rule and have not been updated. No confidence intervals were computed for NTNCWS.

Table III.C-4.—Parameters of Lognormal Distributions Fitted to National Occurrence Distributions

System type

Source water

Log-mean

1

Log-SD

2

CWS

GW

−0.25

1.58

CWS

SW

−1.68

1.74

NTNCWS

GW

0.03

1.47

1

Log-mean = mean of natural logarithm of arsenic concentrations (μg/L).

2

Log-SD = standard deviation of natural logarithm of arsenic concentrations (μg/L).

Table III.C-3 lists separate distribution estimates for ground and surface water CWS and for ground water NTNCWSs. As we said previously, we believe surface water CWSs provide a more sound basis for estimation.

For CWSs, the estimates in Table III.C-3 have changed only slightly since the proposed rule. For ground water CWSs, the largest change is an increase at 10 μg/L from 5.3% exceedance to 5.4%. For surface water CWSs, the largest change is a decrease at 3 μg/L from 6.0% in the proposed rule to 5.6% in Table III.C-3. This decrease is as expected, since, as we explained previously, our revised database excludes some observations on untreated water that were included in the draft database. Our surface water

occurrence estimates did increase slightly at 5 μg/L, however, as Table III.C-8 shows.

For ground water NTNCWSs, our estimated exceedance probabilities increased from 19.9% to 24.2% at 3 μg/L, and from 12.1% to 15.6% at 5 μg/L. The estimates at higher concentrations changed by at most 0.1% point. The estimates changed because we now estimate a separate distribution for ground water NTNCWSs, as we described previously.

The confidence intervals listed in Table III.C-3 were computed for the proposed rule, using a computationally intensive resampling procedure, as described in (EPA, 2000r). Since our data set and point estimates have changed only minimally for the final rule, we did not recompute the confidence intervals.

Table III.C-5 shows occurrence distributions in seven geographic regions presented in the proposal and developed by Frey and Edwards (1997). (The States and names of these geographic regions in Table III.C-5 are based directly on the authors' designations.) As in the proposed rule, we find concentrations to be generally highest in the West, and generally lowest in the Southeast and Mid-Atlantic. In regions where analytical reporting limits in our database were mostly higher than 3 μg/L or 5 μg/L, we did not attempt to estimate occurrence at the lowest concentrations. These cases are indicated by dashes in Table III.C-5. In some regions, we were able to estimate occurrence in fewer States at the lowest concentrations, and this sometimes led to inconsistencies in our estimates. For example, for New England surface water CWSs, we estimated occurrence at 3 μg/L using only Maine, and at 5 μg/L using Maine, New Hampshire, and New Jersey. The introduction of more States at higher concentrations led to inconsistent estimates of 6.2% and 11.7% of New England surface water CWSs with arsenic exceeding 3 μg/L and 5 μg/L, respectively. We did not try to resolve these inconsistencies at the regional level, but note that the national occurrence distributions, listed in Table III.C-3, are consistent.

Table III.C-5.—Regional Occurrence Exceedance Probability Estimates

Percent of systems with mean finished arsenic exceeding concentrations (μg/L) of:

3

5

10

20

Ground Water CWS

Mid-Atlantic

(

2

)

*0.4

0.7

0.0

Midwest

21.2

13.8

6.2

2.4

New England

21.7

20.8

7.0

2.9

North Central

21.3

13.1

6.0

2.4

South Central

18.6

9.7

3.6

1.1

Southeast

0.9

0.4

0.1

0.0

West

31.5

25.2

12.5

5.0

Surface Water CWS

Mid-Atlantic

(

2

)

0.1

0.0

0.0

Midwest

3.0

1.6

0.7

0.3

New England

1

6.2

11.7

1.0

0.4

North Central

9.1

3.2

0.6

0.1

South Central

3.8

0.9

0.2

0.1

Southeast

0.2

0.1

0.0

0.0

West

12.7

8.2

3.4

1.4

Ground Water NTNCWS

Mid-Atlantic

(

2

)

(

2

)

1.4

0.5

Midwest

26.2

17.1

8.2

3.3

New England

(

2

)

(

2

)

2.1

0.6

North Central

29.8

22.8

15.0

9.3

South Central

24.0

14.4

5.9

1.9

Southeast

0.9

0.4

0.1

0.0

West

34.3

21.9

10.5

4.2

1

Estimate is inconsistent with estimate at the next higher concentration. See text for explanation.

2

Means not enough data to form an estimate. See text for explanation.

Table III.C-6 shows our estimates of the numbers of systems with mean finished arsenic concentrations in various ranges, by system type and size. As in the proposed rule, we find no evidence of any consistent difference in mean arsenic among systems of different sizes. We conclude that the occurrence distributions shown in Table III.C-3 apply to all categories of system size. In Table III.C-6, therefore, the estimated numbers of systems are computed by multiplying the baseline inventory of all systems of the given size and type, by the corresponding probability of falling within the given range, computed from Table III.C-3 and shown in the “% of systems” rows. The estimates for surface water NTNCWSs were computed by applying the occurrence distribution for surface water CWSs to the baseline inventory of surface water NTNCWSs.

Table III.C-6.—Statistical Estimates of Numbers of Systems With Average Finished Arsenic Concentrations in Various Ranges

System size (population served)

Number of systems with mean arsenic concentration (μg/L) in the range of:

>3 to 5

>5 to 10

>10 to 20

>20

Ground Water CWS

25 to 500

2,272

1,980

961

584

501 to 3,300

811

706

343

208

3,301 to 10,000

192

167

81

49

10,001 to 50,000

95

83

40

24

>50,000

15

13

6

4

All

3,384

2,949

1,432

870

% of systems

7.8%

6.8%

3.3%

2.0%

Surface Water CWS

25 to 500

76

68

14

10

501 to 3,300

92

81

17

12

3,301 to 10,000

47

41

9

6

10,001 to 50,000

41

36

8

5

>50,000

15

13

3

2

All

270

239

51

34

% of systems

2.5%

2.2%

0.5%

0.3%

Ground Water NTNCWS

25 to 500

1,440

1,713

545

348

501 to 3,300

230

274

87

56

3,301 to 10,000

5

6

2

1

10,001 to 50,000

1

1

0

0

>50,000

0

0

0

0

All

1,677

1,995

635

405

% of systems

8.6%

10.3%

3.3%

2.1%

Surface Water NTNCWS

25 to 500

14

13

3

2

501 to 3,300

5

4

1

1

3,301 to 10,000

1

1

0

0

10,001 to 50,000

0

0

0

0

>50,000

0

0

0

0

All

20

17

4

2

% of systems

2.5%

2.2%

0.5%

0.3%

Numbers do not add up to totals in some cases due to rounding.

Our proposed and final estimates of intra-system coefficients of variation are shown in Table III.C-7. The revised estimates are lower, since, as we described previously, we now better separate out within-source (time and analytical) variability from the variability of source means within a system. The ISCV estimate for ground water NTNCWSs also has changed because we now estimate it separately from that of ground water CWSs.

Table III.C-7.—Estimated Intra-System Coefficients of Variation (ISCV)

System type

Source water

Proposed rule

ISCV (percent)

Final rule

ISCV (percent)

95% confidence interval

CWS

GW

62.9

37.1

[33.1,40.8]

CWS

SW

68.4

52.6

[31.4,69.6]

NTNCWS

GW

62.9

25.2

[9.6,34.7]

Table III.C-8 compares our proposed and final national occurrence estimates to estimates from three other studies: the National Arsenic Occurrence Survey (NAOS) (Frey and Edwards, 1997), National Inorganics and Radionuclides Survey (NIRS) (Wade Miller Associates, 1992), and U.S. Geological Survey (USGS) (USGS, 2000). All of the studies in Table III.C-8 evaluated drinking water except for USGS, which evaluated ambient ground water, some of which came from non-drinking water sources. Wade Miller used surface water estimates from the 1978 Community Water System Survey, which we consider now to be out of date, so those estimates are not shown. Note that Frey and Edwards (1997) found significantly different occurrence distributions for small and large systems, so the NAOS

estimates are reported separately for small and large systems. The NAOS included samples from all 50 States, but it was a much smaller study (468 samples, compared to about 77,000 in our database), and it analyzed unfinished water samples. Frey and Edwards (1997) applied estimated efficiencies for the treatments known to be in place at the sampling locations, to predict the concentrations in finished water.

Table III.C-8.—Comparison of National Arsenic Occurrence Estimates

Study

Type of water

System types

Population served

% of systems with mean arsenic exceeding concentrations (μg/L) of:

2

3

5

10

20

Ground Water Systems

EPA-proposed

raw + finished

CWS

all

27.2

19.9

12.1

5.4

2.1

EPA-final

raw + finished

CWS

all

27.3

19.9

12.1

5.3

2.0

NAOS-small

finished

1

PWS

≤ 10,000

23.5

NR

12.7

5.1

NR

NAOS-large

finished

1

PWS

> 10,000

28.8

NR

15.4

6.7

NR

NIRS

finished

CWS

all

17.4

11.9

6.9

2.9

1.1

USGS

raw

PWS

all

25.0

NR

13.6

7.6

3.1

Surface Water Systems

EPA-proposed

finished

CWS

all

9.9

6.0

2.9

0.8

0.3

EPA-final

finished

CWS

all

9.8

5.6

3.0

0.8

0.3

NAOS-small

finished

1

PWS

≤ 10,000

6.2

NR

1.8

0.0

NR

NAOS-large

finished

1

PWS

> 10,000

7.5

NR

1.3

0.6

NR

NR = not reported.

1

Predicted from raw water, using estimated efficiency of treatment in place.

Table III.C-8 shows that our proposed and final occurrence estimates are only slightly different, with the possible exception of surface water occurrence estimates at 3 μg/L, where our estimate decreased from 6.0% to 5.6% exceedance for the final rule. The difference is explained by the identification and exclusion of samples of untreated water from our database for the final rule, as we described previously. For ground water, our estimates fall within the range reported in the other three studies. For surface water, our estimates are somewhat higher than those of the NAOS.

D. How Did EPA Revise its Risk Analysis?

1. Health Risk Analysis

a. Toxic forms of arsenic.

Humans are exposed to many forms of arsenic that have different toxicities. For example, the metallic form of arsenic (0 valence) is not absorbed from the stomach and intestines and does not exert adverse effects. On the other hand, a volatile compound such as arsine (AsH

3

) is toxic, but is not present in water or food. Moreover, the primary organic forms (arsenobetaine and arsenocholine) found in fish and shellfish seem to have little or no toxicity (Sabbioni

et al.,

1991). Arsenobetaine quickly passes out of the body in urine without being metabolized to other compounds (Vahter, 1994). Little is known about the various arsenic species in vegetables, grains, and oils (NRC, 1999). Arsenite (+3) and arsenate (+5) are the most prevalent toxic forms of inorganic arsenic found in drinking water. In general, the inorganic forms of arsenic have been considered to be more toxic than the organic forms. In toxicity tests, the inorganic forms were reported to be more toxic than the organic forms (NAS, 1977) and the trivalent form was more toxic than the pentavalent one (Szinicz and Forth, 1988).

In animals and humans, inorganic pentavalent arsenic is converted to trivalent arsenic that is methylated (

i.e.,

chemically bonded to a methyl group, which is a carbon atom linked to three hydrogen atoms) to monomethyl arsenic (MMA) and dimethyl arsinic acid (DMA), which are organic arsenicals. The primary route of excretion for these four forms of arsenic is i

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