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ARSENIC IN DRINKING WATER:
AN UPDATE ON THE SCIENCE,
BENEFITS AND COST
HEARING
BEFORE THE
SUBCOMMITTEE ON ENVIRONMENT, TECHNOLOGY,
AND STANDARDS
COMMITTEE ON SCIENCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTH CONGRESS
FIRST SESSION
OCTOBER 4, 2001
Serial No. 107–32
Printed for the use of the Committee on Science
ARSENIC IN DRINKING WATER: AN UPDATE ON THE SCIENCE, BENEFITS AND COST
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75–564PS
2001
ARSENIC IN DRINKING WATER:
AN UPDATE ON THE SCIENCE,
BENEFITS AND COST
HEARING
BEFORE THE
SUBCOMMITTEE ON ENVIRONMENT, TECHNOLOGY,
AND STANDARDS
COMMITTEE ON SCIENCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTH CONGRESS
FIRST SESSION
OCTOBER 4, 2001
Serial No. 107–32
Printed for the use of the Committee on Science
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Available via the World Wide Web: http://www.house.gov/science
COMMITTEE ON SCIENCE
HON. SHERWOOD L. BOEHLERT, New York, Chairman
LAMAR S. SMITH, Texas
CONSTANCE A. MORELLA, Maryland
CHRISTOPHER SHAYS, Connecticut
CURT WELDON, Pennsylvania
DANA ROHRABACHER, California
JOE BARTON, Texas
KEN CALVERT, California
NICK SMITH, Michigan
ROSCOE G. BARTLETT, Maryland
VERNON J. EHLERS, Michigan
DAVE WELDON, Florida
GIL GUTKNECHT, Minnesota
CHRIS CANNON, Utah
GEORGE R. NETHERCUTT, JR., Washington
FRANK D. LUCAS, Oklahoma
GARY G. MILLER, California
JUDY BIGGERT, Illinois
WAYNE T. GILCHREST, Maryland
W. TODD AKIN, Missouri
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TIMOTHY V. JOHNSON, Illinois
MIKE PENCE, Indiana
FELIX J. GRUCCI, JR., New York
MELISSA A. HART, Pennsylvania
J. RANDY FORBES, Virginia
RALPH M. HALL, Texas
BART GORDON, Tennessee
JERRY F. COSTELLO, Illinois
JAMES A. BARCIA, Michigan
EDDIE BERNICE JOHNSON, Texas
LYNN C. WOOLSEY, California
LYNN N. RIVERS, Michigan
ZOE LOFGREN, California
SHEILA JACKSON LEE, Texas
BOB ETHERIDGE, North Carolina
NICK LAMPSON, Texas
JOHN B. LARSON, Connecticut
MARK UDALL, Colorado
DAVID WU, Oregon
ANTHONY D. WEINER, New York
BRIAN BAIRD, Washington
JOSEPH M. HOEFFEL, Pennsylvania
JOE BACA, California
JIM MATHESON, Utah
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STEVE ISRAEL, New York
DENNIS MOORE, Kansas
MICHAEL M. HONDA, California
Subcommittee on Environment, Technology, and Standards
VERNON J. EHLERS, Michigan, Chairman
CONSTANCE A. MORELLA, Maryland
CHRISTOPHER SHAYS, Connecticut
CURT WELDON, Pennsylvania
NICK SMITH, Michigan
GIL GUTKNECHT, Minnesota
CHRIS CANNON, Utah
FELIX J. GRUCCI, JR., New York
MELISSA A. HART, Pennsylvania
WAYNE T. GILCHREST, Maryland
J. RANDY FORBES, Virginia
SHERWOOD L. BOEHLERT, New York
JAMES A. BARCIA, Michigan
LYNN N. RIVERS, Michigan
ZOE LOFGREN, California
MARK UDALL, Colorado
ANTHONY D. WEINER, New York
BRIAN BAIRD, Washington
JOSEPH M. HOEFFEL, Pennsylvania
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JOE BACA, California
JIM MATHESON, Utah
RALPH M. HALL, Texas
JOHN MIMIKAKIS Subcommittee Staff Director
MIKE QUEAR Democratic Professional Staff Member
BEN WU Professional Staff Member
ERIC WEBSTER Professional Staff Member
CAMERON WILSON Professional Staff Member/Chairman's Designee
MARTY SPITZER Professional Staff Member
MARY DERR Majority Staff Assistant
MARTY RALSTON Democratic Staff Assistant
C O N T E N T S
October 4, 2001
Witness List
Hearing Charter
Opening Statements
Statement by Representative Vernon Ehlers, Chairman, Subcommittee on Environment, Technology, and Standards, U.S. House of Representatives
Written Statement
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Statement by Representative James Barcia, Minority Ranking Member, Subcommittee on Environment, Technology, and Standards, U.S. House of Representatives
Written Statement
Written Statement by Representative Nick Smith, Member, Subcommittee on Environment, Technology, and Standards, U.S. House of Representatives
Written Statement by Representative J. Randy Forbes, Member, Subcommittee on Environment, Technology, and Standards, U.S. House of Representatives
Panel
Dr. Robert A. Goyer, Chair, NRC Subcommittee to Update the 1999 Arsenic in Drinking Water Report, Committee on Toxicology; Professor Emeritus, University of Western Ontario, Ontario, Canada. Report Title: ''Arsenic in Drinking Water 2001 Update.''
Written Statement
Dr. Maureen L. Cropper, Chair, EPA Science Advisory Board, Arsenic Rule Benefits Review Panel; Lead Economist, The World Bank; Professor of Economics, University of Maryland. Report Title: ''Arsenic Rule Benefits Analysis: An SAB Review.''
Written Statement
Mr. John P. Scheltens, National Drinking Water Advisory Council, Arsenic Cost Working Group; City Engineer, Public Works Director, Hot Springs, South Dakota. Report Title: ''Report on the Arsenic Cost Working Group to the National Drinking Water Advisory Committee.''
Written Statement
Dr. Barbara D. Beck, Principal, Gradient Corporation, representing the Environmental Arsenic Research Council, the National Wood Preservers Institute, and the National Rural Water Association
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Written Statement
Mr. Scott J. Rubin, Attorney & Consultant
Written Statement
Mr. Erik Olson, Senior Attorney, Natural Resources Defense Council
Written Statement
Discussion
Point of Entry Technology
Other Delivery Systems for Drinking Water
The Utah Study
Increasing Municipal Water Cost and Well Water as an Alternative
Arsenic Removal Technology and Its Effects on Other Contaminants
Purposeful Contamination
Cost-Benefit Ratio
Scope and Scale of Arsenic Contamination
Cancer at Current Exposure Levels
Different Research Perspectives
10 ppb Standard
How Americans Perceive Risk
Wood Preservation
Appendix 1: Biographies, Financial Disclosures, and Reports
Dr. Robert A. Goyer, Chair, NRC Subcommittee to Update the 1999 Arsenic in Drinking Water Report, Committee on Toxicology; Professor Emeritus, University of Western Ontario, Ontario, Canada
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Financial Disclosure
Report: ''Arsenic in Drinking Water: 2001 Update''
Dr. Maureen L. Cropper, Chair, EPA Science Advisory Board, Arsenic Rule Benefits Review Panel; Lead Economist, The World Bank; Professor of Economics, University of Maryland
Presentation Visuals
Biography
Financial Disclosure
Report: ''Arsenic Rule Benefits Analysis: An SAB Review''
Mr. John P. Scheltens, National Drinking Water Advisory Council, Arsenic Cost Working Group; City Engineer, Public Works Director, Hot Springs, South Dakota
Biography
Financial Disclosure
Letter from the United States Environmental Protection Agency
Report: ''Report on the Arsenic Cost Working Group to the National Drinking Water Advisory Committee''
Dr. Barbara D. Beck, Principal, Gradient Corporation, representing the Environmental Arsenic Research Council, the National Wood Preservers Institute, and the National Rural Water Association
Biography
Financial Disclosure
Mr. Scott J. Rubin, Attorney & Consultant
Biography
Financial Disclosure
Mr. Erik Olson, Senior Attorney, Natural Resources Defense Council
Biography
Financial Disclosure
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Appendix 2: Additional Material for the Record
Dr. George E. Parris, Director of Environmental and Regulatory Affairs, American Wood Preservers Institute
Submitted Testimony
Biography
Report: ''Arsenic: Biochemistry and Dose-Response of a Threshold Carcinogen''
Submitted Testimony of the Office of Advocacy, U.S. Small Business Administration
Submitted Testimony of the National Rural Water Association
Letter from Physicians for Social Responsibility, U.S. Public Interest Research Group, Friends of the Earth, National Association of People With AIDS, Consumer Federation of America, Clean Water Action, Mineral Policy Center, Sierra Club, American Rivers, and the American Public Health Association
Letter from the Association of California Water Agencies
ARSENIC IN DRINKING WATER: AN UPDATE ON THE SCIENCE, BENEFITS AND COST
THURSDAY, OCTOBER 4, 2001
House of Representatives,
Subcommittee on Environment, Technology, and Standards,
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Committee on Science,
Washington, DC.
The Subcommittee met, pursuant to call, at 10:08 a.m., in Room 2318 of the Rayburn House Office Building, Hon. Vernon J. Ehlers [Chairman of the Subcommittee] presiding.
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HEARING CHARTER
SUBCOMMITTEE ON ENVIRONMENT, TECHNOLOGY, AND STANDARDS
COMMITTEE ON SCIENCE
U.S. HOUSE OF REPRESENTATIVES
Arsenic in Drinking Water: An Update
on the Science, Benefits and Cost
THURSDAY, OCTOBER 4, 2001
10:00 A.M.–12:00 P.M.
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2318 RAYBURN HOUSE OFFICE BUILDING
I. Purpose
On Thursday, October 4, 2001 the House Subcommittee on Environment, Technology, and Standards will hold a hearing to receive testimony on three reports recently submitted to the Environmental Protection Agency that update the state of knowledge on the science, benefits and cost of regulating arsenic in drinking water. The subcommittee is interested in the latest findings that will inform EPA as it sets the maximum contaminant level for arsenic in drinking water, due to be published in February 2002.
The subcommittee will hear testimony from a panel the following witnesses:
Robert Goyer, (Chair) NRC Subcommittee to Update the 1999 Arsenic in Drinking Water Report, Committee on Toxicology; (Professor Emeritus) University of Western Ontario, Ontario, Canada. Report Title: ''Arsenic in Drinking Water: 2001 Update.''
Maureen Cropper, (Chair) EPA Science Advisory Board, Arsenic Rule Benefits Review Panel; Lead Economist, The World Bank; Professor of Economics, University of Maryland. Report Title: ''Arsenic Rule Benefits Analysis: An SAB Review.''
John Scheltens, National Drinking Water Advisory Council, Arsenic Cost Working Group; City Engineer, Public Works Director, Hot Springs, South Dakota. Report Title: ''Report on the Arsenic Cost Working Group to the National Drinking Water Advisory Committee.''
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Barbara Beck, Ph.D., Principal, Gradient Corporation representing the National Mining Association, the National Wood Preservers Institute, and the National Rural Water Association.
Scott Rubin, Attorney & Consultant, presenting research on water system affordability that he conducted for the National Rural Water Association.
Erik Olson, Senior Attorney, Natural Resources Defense Council.
Background
Arsenic is a widely distributed, naturally occurring element present in trace amounts in all living organisms. Arsenic concentrations in drinking water come largely from natural sources. Arsenic also enters water sources because of its use as a wood preservative, and from semi-conductor, paint, agriculture and mining operations. It is known to cause lung, bladder, and skin cancer, and increasingly is thought to cause other health problems such as high blood pressure, diabetes, and heart disease.
Higher levels of arsenic tend to be found more frequently in ground water than in surface water. Because small water systems typically rely on wells for drinking water, while the largest systems typically rely on surface-water sources, arsenic tends to occur in higher levels more often in water used by small communities. Compared to the rest of the United States, western states have more water systems with levels exceeding 10 parts per billion (ppb), and, in some instance levels exceeding 50 ppb. Parts of the Midwest and New England also have some water systems with arsenic levels exceeding 10 ppb. (See the following USGS web site for a chart of the distribution of arsenic exposure in the United States, http://co.water.usgs.gov/trace/pubs/fs-063-00/fig1.gif.)
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Statutory and Regulatory History
The current federal drinking water standard for arsenic, 50 ppb, was set by the U.S. Public Health Service in 1942. EPA adopted that level when it issued an interim drinking water regulation for arsenic in 1975 that is still in effect. In the intervening years, several deadlines set by Congress and in judicial consent orders for a revised arsenic standard have come and gone—in 1989, 1995, and again in 2001. Throughout these years, EPA, the Agency's Science Advisory Board and the National Academy of Sciences (NAS) conducted extensive analyses of the science, risks, and costs, and benefits of regulating arsenic.
The most recent deadline was set in the 1996 Amendments to the Safe Drinking Water Act (SDWA), which directed the EPA to promulgate a final standard by January 1, 2001. Congress also directed EPA to conduct scientific analysis in consultation with the National Academy of Sciences. The National Research Council (NRC), the research arm of the NAS, recommended in 1999 that the standard be reduced but did not recommend a particular level. The NRC reported that available data provided ample evidence for EPA's classification of inorganic arsenic as a human carcinogen (particularly for lung and bladder cancer), but that EPA's assessment of the risks associated with different levels of arsenic (dose response curve), which was based on a Taiwan study, deserved closer scrutiny.
Recent Regulatory History
In June 2000, EPA proposed revising the arsenic standard from the current level of 50 ppb to 5 ppb and requested comment on options of 3 ppb, 10 ppb, and 20 ppb. EPA stated that the proposal relied primarily on the previous NRC analysis, augmented with other recently published research, and that it would further assess arsenic's cancer risks before issuing the final rule. Congress extended the deadline for the final rule from January 1, to June 22, 2001, in EPA's FY2001 appropriations. EPA Administrator Carol Browner signed the final rule, which set the standard at 10 ppb, on January 16, 2001, and the rule was published in the Federal Register on January 22. The rule's general effective date was 60 days after publication; however, public water systems were given until 2006 to comply. On March 23, EPA Administrator Christine Todd Whitman delayed the rule for 60 days, citing concerns about the science supporting the rule and its estimated cost to communities. On May 22, EPA extended the previous delay of the rule's effective date to February 22, 2002 but did not change the compliance date for systems.
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Recent Studies
EPA commissioned three studies as part of its reassessment of the January 22 rule: the NRC undertook an expedited review of EPA's arsenic risk analysis and recent health effects research, the National Drinking Water Advisory Council reassessed the rule's cost, and the agency's Science Advisory Board reviewed its benefits. In July 2001, while these reviews were taking place, EPA requested public comment on whether the data and technical analyses for the January rule support setting the standard at 3, 5, 10, or 20 ppb; comments are due by October 31, 2001.
The risk, cost, and benefits reviews are now complete, and EPA is summarizing the new information to publish in the Federal Register for public comment this fall. The Agency then plans to issue a proposed final rule in November and request additional comment, with a goal of issuing a final rule in February.
Pending Legislative proposals
Various legislative proposals have emerged in response to this rule. Both the House and Senate approved arsenic amendments to the FY2002 appropriations bills for EPA (H.R. 2620). The House bill states that EPA may not use funds to delay the January rule or to issue a rule that sets the standard above 10 ppb. The Senate bill directs EPA to put into effect immediately an arsenic standard that: (1) protects sensitive subpopulations and (2) lifts the suspension of the January rule's effective date for the community right to know requirements included in the January rule. These requirements compelled certain water systems to provide additional risk information beginning next year, even though they were not required to meet the new standard until 2006. In addition to appropriations language, members have introduced a range of other bills.
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Regulatory Requirements
Standard Setting Process. Under the SDSWA, EPA is required to set a nonenforceable maximum contaminant level goal (MCLG) at a level which no known or anticipated adverse health effects occur and that allows an adequate margin of safety (typically zero for carcinogens like arsenic). EPA must then set an enforceable standard, the MCL, as close to the MCLG as is ''feasible'' using the best technology, treatment, or other means available (taking costs into consideration). EPA's determination of whether a standard is ''feasible'' typically is based on costs to systems serving more than 50,000 people. Less than 2% of community water systems (753 of the 54,352 systems) are this large, but they serve roughly 56% of all people served by community systems.
Temporary Exemptions. States or EPA may grant temporary exemptions from the standard if, due to certain compelling factors (including cost), a system cannot comply on time. All systems are required to comply with the new standard in 5 years; small systems serving up to 3,300 people may qualify for exemptions up to a maximum of 9 years, thereby allowing up to 14 years to achieve compliance. In the final rule in January 2001, EPA noted that exemptions would be an important tool to help states address the number of systems needing financial assistance.
Balancing Costs and Benefits. Another 1996 SDWA provision requires that, when proposing a rule, EPA must publish a determination as to whether the benefits of the standard justify the costs. In its January 22 arsenic rule, EPA determined that the ''feasible'' level (for systems serving more than 50,000 people) was 3 ppb, but that the benefits of this level would not justify the costs. Consequently, EPA first proposed a standard of 5 ppb. In finally setting the standard at 10 ppb, EPA cited SDWA, stating that this level ''maximizes health risk reduction benefits at a cost that is justified by the benefits.''
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Small System Costs. Regarding the cost of meeting the 10 ppb standard, EPA estimated that, for small systems (serving fewer than 10,000 people), the average annual cost per household would range from $38 to $327. For large systems, water cost increases range from $0.86 to $32 per household. A variety of organizations, including the Science Advisory Board, municipalities, water systems and the American Water Works Association, suggested that EPA's assumptions were not realistic and that various costs seemed to be excluded.
EPA's statistical estimates indicate that 3,000 (5.5%) of the 54,000 community water systems, and 1,100 (5.5%) of the 20,000 other water systems would need to take measures to meet the new standard. Most of these systems serve fewer than 500 people.
Applicability to Superfund. Drinking water standards (MCLs) established under SDWA are also legally ''applicable or relevant and appropriate'' requirements under Superfund (CERCLA); the result is that the arsenic MCL and certain other SDWA requirements apply to Superfund cleanups.
Results of the Three Reviews Requested by EPA
1. Health Effects and Risk Review: National Research Council
On September 13, the NRC released its new report, Arsenic in Drinking Water: 2001 Update, an update of the 1999 study. Of the 9 members on the most recent NRC review panel, 5 served on the original 1999 panel.
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The NRC asked the Subcommittee to examine whether there was adequate data to estimate the health impacts of arsenic; whether the Taiwanese studies remained the best data to assess dose-response; whether the EPA appropriately accounted for population differences, including diet, when extrapolating from the Taiwanese study population to the U.S. population; whether EPA understood how arsenic causes adverse effects; and whether EPA's risk estimates were consistent with available scientific information. The panel was not asked by EPA to recommend a specific level of arsenic to regulate.
Key Findings:
Consistent with its 1999 findings, the NRC concludes that chronic arsenic exposure is associated with increases in bladder and lung cancer and may be associated with additional health impacts. ''There is a sound database on the carcinogenic effects of arsenic in humans that is adequate for the purposes of a risk assessment'' (p. 9). While the NRC states that bladder and lung cancer continue as the primary concern, the subcommittee also finds evidence of non-cancer effects: ''There is increasing evidence that chronic exposure to arsenic in drinking water may be associated with an increased risk of [high blood pressure] and diabetes'' (p.180). Without further research the non-cancer risks cannot be quantified.
Taiwanese studies of arsenic exposure are adequate to determine risk. The subcommittee reaffirms its 1999 assessment that the early data from Southwestern Taiwan ''remain appropriate for use in dose-response assessment of arsenic in drinking water.'' The panel also considered four new epidemiological studies from Chile, Northeastern Taiwan, southwestern Taiwan and Utah. The Utah study was the only one that did not show an association between arsenic exposure from drinking water and cancer, and the subcommittee found several limitations in the study that ''preclude[d] its use in a quantitative risk assessment'' (p.4).
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Risks are greater than previously estimated and are above levels that EPA usually accepts. The panel estimates risks more than 10 times greater than EPA normally accepts and greater than those EPA originally estimated for the rule. EPA normally assumes an acceptable risk at 1 in 10,000. At exposure to 10 ppb of arsenic in drinking water, the panel estimates an increased cancer risk of between 30 and 40 per 10,000 people, depending on gender. At 5 ppb the risk is approximately 15 in 10,000 and at 3 ppb the risk is approximately 10 in 10,000. These estimates were developed by factoring in background levels for bladder and lung cancer in the United States, rates that are higher than those in Taiwan. However, because the panel was split on whether to use U.S. or Taiwanese background levels, they also present the risk estimates based on Taiwanese background levels. Using these levels, the cancer risk estimates drop to approximately 15, 7 and 4 per 10,000 people, levels still well above those considered acceptable by EPA (p. 184). (If risk estimates were based on recent Chilean data, the risk estimates would be higher than those based on U.S. background levels.) Why are there differences in EPA's and the subcommittee's risk estimates? EPA and the subcommittee differed in (1) methods to adjust for arsenic in food, (2) different assumptions regarding water intake in the United States and Taiwanese populations; (3) different statistical methods for estimating lifetime excess cancer risk, (4) different comparison populations, and (5) different background incidence data (p. 11).
Although the committee cannot say definitively how arsenic causes cancer, it believes that cancer effects are present at doses lower than 10 ppb. ''Although a large amount of research is available on arsenic's mode of action [how it causes adverse effects], the exact nature of the carcinogenic action of arsenic is not yet clear.'' As a result it is difficult to determine precisely either the shape of the dose-response curve or a safe threshold level of exposure. ''In the absence of definitive information on the shape of the curve, EPA's general policy is to assume a linear extrapolation.'' The panel also finds evidence for cellular effects of arsenic at very low exposures and points out that the shape of the curve will vary from one health end point to another and may vary from one individual to another. The panel concludes that ''even if the curve is sublinear (e.g., if a threshold exists), . . .any hypothetical threshold would likely occur below concentrations that are relevant to U.S. populations'' (p. 6) (p. 96–98) (p. 180–181).
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Risk of arsenic should be understood in a public health context. Because of uncertainty in the cancer risks estimated by the subcommittee, the results should be interpreted in a public-health context that uses an appropriate risk-management framework. As a result, public health policy choices will need to be made because the science alone is not definitive.
2. Benefits Analysis: Science Advisory Board
At the request of EPA, the SAB reviewed EPA's analysis of benefits associated with the arsenic drinking water rule. In addition, EPA asked the panel to evaluate whether the components, methodology, criteria and estimates reflected in EPA's benefits analysis were reasonable and appropriate. Specifically, EPA asked for an assessment of (1) how the latency period (the time between exposure and harm) should be addressed; (2) how health impacts other than cancer should be addressed; (3) whether reduction of exposure should be evaluated as a separate benefit; (4) how total and incremental benefits and costs should be addressed; and (5) how uncertainty should be addressed.
Key Findings:
EPA did not adequately include or measure the impacts of latency (the time between initiation of exposure and the increase in risk) or cessation-lag (the period between cessation of exposure and the reduction in risk) in its benefits analysis. As a result, the analysis does not adequately capture the risks as they increase from exposure or decrease when exposure declines due to the regulation.
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EPA should discount the value of each human life saved when monetizing and comparing benefits and costs. The panel also recommends that if the benefits of lives saved are to be monetized, then following ''conventional economic practices,'' the values should be discounted. (Discounting is a concept that reflects the idea that a dollar today is worth more than a dollar tomorrow.) While it is standard practice to discount capital and other hard costs, discounting the value of a life has been controversial.
EPA should assess risks and count benefits from other health effects besides cancer. The panel believes that it should be possible to quantify risk to other health endpoints such as heart disease, diabetes, high blood pressure and skin cancer. It also recommends that there should be efforts to quantify benefits from reductions in prostate cancer, and other illnesses, even though the evidence linking these illnesses to arsenic is not as strong. (Note, the NRC did not estimate these risks quantitatively, suggesting that more research would be required to do so.)
EPA should present it findings of benefits and costs on a water system and system size basis to make it easier to see differences between small and large water systems. The panel commends EPA for presenting the costs and benefits associated with various potential arsenic levels. However, it also points out that EPA should calculate the ''benefits and costs on a water supply basis'' and present the data by system size. This form of presentation would make it easier to see that the net benefits differ substantially among small and large water systems, allowing decision makers to evaluate a range of alternative strategies rather than a one-size-fits-all approach. EPA should report benefits in terms of both the incidence of disease and death avoided (by age) as well as monetary terms to allow consideration of ''alternatives to monetizing benefits''.
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EPA properly addresses uncertainties, but should state its assumptions more clearly. Benefits-cost analyses of drinking water regulations entail uncertainties in a) exposure measurement, b) dose-response measurement, c) heath effects valuation, and d) cost measurement. The sources of the uncertainties include uncertainty about the level of arsenic in tap water or the amount consumed, and uncertainty about which model to use to describe the relationship between dose and response at low doses. In addressing these uncertainties, EPA correctly used sensitivity analysis. However, according to the panel, EPA should spell out clearly the assumptions underlying each analysis.
3. National Cost Estimate Review: National Drinking Water Advisory Council
EPA asked the National Drinking Water Advisory Council (NDWAC) to review the cost estimates associated with the regulatory options EPA considered. The charge to the working group was to review the costing methodologies, assumptions, and information underlying the system-size as well as the aggregated national estimate of system costs underlying the January 2001 arsenic rule. NDWAC was not asked to develop its own estimate. The information generated by NDWAC was intended to help EPA develop more accurate cost estimates.
The NDWAC review was particularly important because industry estimates of the cost of the rule were much higher than EPA's. EPA estimated that the national annual cost of an arsenic standard of 10 ppb would be approximately $181 million. Yet, the American Water Works Association Research Foundation (AwwaRF) in a report issued in October 2000 titled, Cost Implications of a Lower Arsenic MCL, estimated that the cost of compliance for the new standard would be $590 million annually with capital costs of $4.5 billion. The AwwaRF attributed the difference between the estimates to various factors including assumptions about choice of technology, cost of residuals handling and waste disposal, and need for systems to purchase land. EPA's Science Advisory Board also questioned EPA's cost assumptions and concluded that certain assumptions may not have been realistic.
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After five public meetings, the working group presented its conclusions to the NDWAC on August 14, 2001. The NDWAC submitted the report to Administrator Whitman on August 23, with two minor modifications.
Key Findings and Recommendations:
EPA produced ''a credible estimate'' of the cost of compliance with the rule given the present constraints of rulemaking, data gathering, and cost models. It also acknowledged that the AwwaRF study was useful to evaluate the national cost estimate.
Although significant uncertainties underlie EPA's and AwwaRF's national cost estimates, the working group agreed that if EPA and AwwaRF implemented NDWAC's recommendations the costs estimates of the rule would improve.
The differences between EPA's and AwwaRF's national cost estimate are not as great as it would appear. The differences in estimates tend to narrow considerably if the assumptions of one model are plugged in to the other model.
Estimates should be presented as a range given the great uncertainty. All estimates should be presented with a low and high range of plus or minus 50%. The working group recognized the practical limitations of improving the underlying information that feeds the estimates and acknowledged that EPA would need ''authority, resources, and cooperation from other entities'' to improve future estimates.
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Several assumptions have the greatest impact on cost estimates. EPA needs to reexamine and update the sources of information to determine the number of systems and the entry points to the systems. Additional key assumptions include the selection of arsenic control technologies, unit cost models developed for selected technologies, residual handling and the cost methodology.
EPA generally used the appropriate technologies for arsenic removal. However, the group recommended more than 15 ''important changes in the costing approach. . .for these technologies.''
EPA should consider that the cost of residual handling and disposal might vary in states with more stringent hazardous waste regulations. The disposal of residual solids generated at arsenic treatment facilities will impact the cost of compliance. Under current federal requirements, EPA has determined that these arsenic contaminated residuals will not be hazardous wastes. The working group concurs. However, more stringent state requirements (e.g., California) may make these residuals hazardous wastes, which could lead to higher disposal costs.
EPA should assess where Point of Use (POU) technologies would be most cost effective. Because the working group is concerned about the ability of all regulators to obtain 100% access to homes, (the place where the technologies would be installed), it recommends that EPA specify steps to be taken by communities to achieve compliance.
The working group recommends that the NDWAC convene a working group to review EPA's methodology and assumptions for determining national affordability for regulations. The working group notes that EPA's national compliance cost estimates cannot be used to assess local challenges that may be faced by small water systems and their customers. In addition, a number of small systems and populations will be unable to afford compliance with the arsenic rule and future SDWA rules. The panel identifies various approaches that could be considered as potential solutions for system and ratepayer affordability.
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Arsenic in Drinking Water: An Update on the Science, Benefits and Cost
Chairman EHLERS. Just a brief announcement. The witching hour has arrived, but under the House Rules, we do not begin until a member of the minority party shows up. And so as soon as someone arrives, we will begin.
With the permission of the minority staff, we will begin the process and allow opening statements from the minority when they arrive. I now call the Committee on Environment and Technology and Standards to order. I am very pleased to welcome everyone here for this important hearing.
This hearing will review the latest and most up-to-date research on the science, benefits, and costs of regulating arsenic in drinking water. This subject has been more than a little controversial. However, at the beginning of this Congress, Chairman Boehlert stated that this Committee would not shrink from controversial issues if exploring them served the public and the members of this body.
In this case, I believe the Committee's review, evaluating the science of the risk of arsenic in drinking water is important, relevant, and timely, not only because arsenic has received so much public attention, but also because it highlights the importance of using science as the basis of important public health and environmental decisions.
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Arsenic is a widely distributed, naturally occurring element, present in all living organisms. The food we eat and the water we drink contain it. Everyone knows arsenic in large quantities is incredibly poisonous. Even Agatha Christie knew that and wrote a very entertaining book about it. But what we are examining here is the danger of arsenic in extremely minute amounts, equivalent to one teaspoon of arsenic in about 1.3 million gallons of water.
How much of a risk is the key question, and that brings us here today. We are reviewing this issue because we want to know what is the risk that arsenic poses to Americans? What does science tell us about this risk? And what is the best way to protect Americans from this risk?
Last spring, EPA Administrator, Christine Todd Whitman, delayed the arsenic drinking water standard, which had been issued by EPA in the waning days of the last Administration. At that time, she stated that she wanted to be sure that the conclusions about arsenic and the rule are supported by the best available science. In addition, she wanted to review the benefits and costs of implementing the new standard. I concurred fully with her decision.
By carrying out an expeditious review of new information and maintaining the rule's original implementation schedule, Administrator Whitman demonstrated her commitment to protecting the public health of Americans and to making well-informed decisions.
I am a strong supporter of using well-established science and risk analysis as cornerstones of EPA's policy and regulatory process. We have to use science to judge how we should allocate scarce resources to save and protect the most human lives. The risks associated with arsenic and drinking water provide a real world example of how we must collect, review, and assess the best information available before we make important policy decisions.
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It also highlights that it is sometimes not possible to know everything we would like to know. In fact, that is frequently true. And that it is still EPA's responsibility to fulfill its mission to protect public health and the environment even in the face of uncertainty.
Today, we will hear testimony from a Panel of distinguished witnesses who will present the major findings and recommendations of three reports commissioned by Governor Whitman.
The National Research Council, which is the research arm of the National Academy of Sciences, and has informally become the science advisory to Congress, I might add, updated a previous study reviewing the science and risks associated with arsenic exposure. EPA's Scientific Advisory Board, which is comprised of outside scientific and economic experts, evaluated EPA's estimates of the benefits of reducing arsenic in drinking water. The National Drinking Water Advisory Council, which consists of outside experts from state and local water utilities, reviewed the cost estimates of implementing the rule. As you can see, we have assembled a good core of expert testimony.
We will also hear testimony from several outside scientific, economic, and environmental experts on their views of the studies, including their areas of both agreement and disagreement with the reports. EPA is currently reviewing these reports and taking public comment on them. My understanding is that the Agency plans to complete its review and re-propose the rule some time this fall, publishing a final rule by its originally promised date of February 22, 2002.
I look forward to hearing from our witnesses today and also to EPA's final decision on this issue. And I am gratified by the work you have done, which will enable both us and the EPA to make better decisions on this topic. I would now like to recognize the Subcommittee's Ranking Member, Mr. Barcia.
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[The prepared statement of Vernon Ehlers follows:]
PREPARED STATEMENT OF CHAIRMAN VERNON J. EHLERS
Good morning!
Welcome to today's hearing which will review the latest and most up-to-date research on the science, benefits and costs of regulating arsenic in drinking water.
This subject has been more than a little controversial lately. However, at the beginning of this Congress, Chairman Boehlert stated that this Committee would not shrink from controversial issues if exploring them served the public and the Members of this body. In this case, I believe the Committee's review evaluating the science of the risk of arsenic in drinking water is important, relevant and timely. Not only because arsenic has received so much public attention, but also because it highlights the importance of using science as the basis of important public health and environmental decisions.
Arsenic is a widely distributed, naturally occurring element present in all living organisms. The food we eat and the water we drink contain it. Everyone knows arsenic in large quantities is incredibly poisonous. But what we are examining here is the danger from arsenic in extremely minute amounts, equivalent to one teaspoon of arsenic in about 13 million gallons of water. How much of a risk is the key question that brings us here today. We are reviewing this issue because we want to know: What is the risk that arsenic poses to Americans? What does science tell us about this risk? And what is the best way to protect Americans from this risk?
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Last Spring, EPA Administrator Christine Todd Whitman delayed the arsenic drinking water standard which had been issued by EPA in the waning days of the last Administration. At that time, she stated that she ''wanted to be sure that the conclusions about arsenic in the rule are supported by the best available science.'' In addition, she wanted to review the benefits and costs of implementing the new standard. I concurred fully with her decision.
By carrying out an expeditious review of new information, and maintaining the rule's original implementation schedule, Administrator Whitman demonstrated her commitment to protecting the public health of Americans, and to making well-informed decisions.
I am a strong supporter of using well established science and risk analysis as cornerstones of EPA's policy and regulatory process. We have to use science to judge how we should allocate scarce resources to save and protect the most human lives. The risks associated with arsenic in drinking water provide a real-world example of how we must collect, review and assess the best information available before we make important policy decisions. It also highlights that it is sometimes not possible to know everything we would like to know, and that it is still EPA's responsibility to fulfill its mission to protect public health and the environment even in the face of uncertainty.
Today we will hear testimony from a panel of distinguished witness who will present the major findings and recommendations of three reports commissioned by Administrator Whitman. The National Research Council, which is the research arm of the National Academy of Sciences, updated a previous study reviewing the science and risks associated with arsenic exposure. EPA's Science Advisory Board, which is comprised of outside scientific and economic experts, evaluated EPA's estimates of the benefits of reducing arsenic in drinking water. The National Drinking Water Advisory Council, which consists of outside experts from state and local water utilities, reviewed the cost estimates of implementing the rule.
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We will also hear testimony from several outside scientific, economic and environmental experts on their views of the studies, including their areas of agreement and disagreement with the reports.
EPA is currently reviewing these reports, and taking public comment on them. My understanding is that the agency plans to complete its review and re-propose the rule sometime this fall, publishing a final rule by its originally promised date of February 22, 2002.
I look forward to hearing from our witnesses today and also to EPA's final decision on this issue.
Mr. BARCIA. Thank you, Mr. Chairman. Good morning. And I want to join Chairman Ehlers in welcoming our distinguished Panel to this morning's hearing. When Congress first passed the Clean Water Act and the Safe Drinking Water Act more than 25 years ago, it sent a strong message to the American people that clean and safe water is not a luxury, but that all Americans, regardless of geography or income level, deserve clean drinking water.
As we learn more, we must continually review and revise our clean water regulations. This is the current case with arsenic. Most have agreed that arsenic in drinking water results in an increased threat of cancer, and everyone seems to agree that any change to the arsenic standard must be based on the best scientific information available.
However, there appears to be some disagreement on the scientific evidence about what constitutes a safe level of arsenic. This is a key issue as the Environmental Protection Agency considers whether to go forward with reducing the allowable levels of arsenic from 50 parts per billion to a level of 10 parts per billion or even lower. As complex as this decision is, agreeing on the allowable level of arsenic in our drinking water is only half of the battle.
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As some of our witnesses will highlight in their testimony, the impact of any changes to the arsenic standard will be significant to local communities. There is likely to be a heavy financial burden, especially to smaller communities who typically rely on wells for drinking water and experience higher levels of arsenic than the ten parts per billion rule under consideration.
For example, in my district, there is a small city called Bad Axe, with a population of 3,471. Bad Axe relies on groundwater for its water supply and has no purification facilities. The groundwater in this area has very high levels of arsenic, as well as other harmful minerals, such as barium and iron. To remedy this, construction has begun on a pipeline which will draw water from Lake Huron, purify it, and pipe it 17 miles to Bad Axe, where a new microfiltration water treatment plant and a raw water intake line will need to be built.
Eventually, up to 15 other communities, who are experiencing similar problems, will be able to draw water from this pipeline. When completed, this important project is expected to cost $20 million. Bad Axe has received some federal funding, but local officials face an uphill battle to secure the additional funds necessary to complete this water project, and this still does not address the funds needed to operate the new facility. This is a case where the citizens cannot afford to pay to have clean and safe drinking water.
I believe there are many communities nationwide who face challenges similar to those of the community of Bad Axe. I very much hope that our witnesses this morning will discuss not only the science behind developing safe drinking water standards, but also how to ensure that our small communities can afford the costs associated with achieving those safe drinking water goals.
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I would like to thank our witnesses for taking time from their busy schedules to share their expertise with us this morning, and I look forward to their testimony. And, once again, in conclusion, I thank the Chairman and staff for scheduling this very timely and very important hearing on the issue of arsenic standards in our drinking water. Thank you, Mr. Chairman.
[The prepared statement of Mr. Barcia follows:]
PREPARED STATEMENT OF THE HONORABLE JIM BARCIA
Good morning, I would like to join Chairman Ehlers in welcoming our distinguished panel to this morning's hearing.
When Congress passed the Clean Water Act and the Safe Drinking Water Act more than 25 years ago, it sent a strong message to the American people that clean and safe water is not a luxury, but that all Americans, regardless of geography or income level, deserve clean water. As we learn more, we must continually review and revise our clean water regulations. This is the current case with arsenic. Most have agreed that arsenic in drinking water results in an increased threat to cancer and everyone seems to agree that any change to the arsenic standard must be based on the best scientific information available. However, there appears to be some disagreement on the scientific evidence about what constitutes a safe level of arsenic. This is a key issue as the Environmental Protection Agency considers whether to go forward with reducing the allowable levels of arsenic from 50 parts per billion to a level of 10 parts per billion or even lower.
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As complex as this decision is, agreeing on the allowable level of arsenic in our drinking water is only half of the battle. As some of our witnesses will highlight in their testimony, the impact of any changes to the arsenic standard will be significant to local communities. There is likely to be a heavy financial burden, especially to smaller communities who typically rely on wells for drinking water and experience higher levels of arsenic than the 10 parts per billion rule under consideration.
For example, in my district, there is a small city called Bad Axe with a population of 3,471. Bad Axe relies on ground water for its water supply and has no purification facilities. The ground water in this area has high levels of arsenic, as well as other harmful minerals such as barium and iron. To remedy this, construction has begun on a pipeline which will draw water from Lake Huron, purify it, and pipe it 17 miles to Bad Axe, where a new micro-filtration water treatment plant and a raw water intake line will need to be built. Eventually, up to 15 other communities who are experiencing similar problems will be able to draw water from this pipeline. When completed this important project is expected to cost $20 million. Bad Axe has received some Federal funding, but local officials face an uphill battle to secure the additional funds necessary to complete this water project and this still does not address the funds needed to operate this new facility. This is a case where the citizens can not afford to pay to have clean and safe drinking water.
I believe there are many communities nationwide who face challenges similar to those of Bad Axe. I very much hope that our witnesses this morning will discuss not only the science behind developing safe drinking water standards, but also how to ensure our small communities can afford the costs associated with achieving these safe drinking water goals.
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I would like to thank our witnesses for taking time from their busy schedules to share their expertise with us this morning and I look forward to their testimony.
Chairman EHLERS. Thank you, Mr. Barcia. I'm interested in your comments about Bad Axe. I didn't realize they had more problems than their name. But if we only had the time, and if it were appropriate, it would be interesting to hear the history of that, but we won't go into that. It is a fascinating story, and it is actually a very wonderful community.
If there is no objection, all additional opening statements submitted by the Subcommittee members will be added to the record. Without objection, so ordered.
[The prepared statement of Nick Smith follows:]
PREPARED STATEMENT OF CONGRESSMAN NICK SMITH
I want to thank the Subcommittee Chairman, Mr. Ehlers, and the Ranking Member, Mr. Barcia, for holding this hearing on the status of the science on the health effects of arsenic in drinking water.
I have been hearing a great deal from my constituents on this issue, and I can tell you that there is a lot of fear and misinformation out there. This hearing will allow us to be brought up to date on the status of the scientific evidence.
First, I think it is important to note that arsenic is naturally occurring element in the Earth's crust and that it is present in trace amounts in all living organisms. Studies back in the 1980's found that low levels of arsenic may be detoxified by the body. Yet we still do not know what the safe ''threshold'' level is. Studies have found a link between certain cancers and ingesting arsenic, but these studies were based on populations exposed to arsenic in concentrations of several hundreds of parts per billion (ppb) or more, well above the existing EPA standard of 50 ppb.
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As I have said, I have heard from many of my constituents who are concerned about the cancer risks associated with the existing EPA standard, but I have also heard from those who fear loosing their public water supply due to the cost of meeting the proposed EPA standard, a prospect that many rural areas may face.
Studies have shown that higher levels of arsenic tend to be found more frequently in ground water and wells than in surface water. According to the U.S. Geological Survey, approximately 42 million Americans rely on private wells and streams for their water. The EPA does not oversee the quality of this water. About half the population of my home state of Michigan currently depends on groundwater as their primary source of drinking water—many of them depend on private wells. All of the coverage about the proposed standard for arsenic has sent a wave of concern through my state. But just testing a well for contaminants can cost private well owners thousands of dollars. Once the tests are completed, the well owner is faced with interpreting the results.
Most people assume that scientists have a good understanding of the health effects of water contaminants. Unfortunately, this is not the case for many of the substances found in well water, including arsenic. As a result, well owners are often left with even more questions, and few answers, when interpreting test results. Accurate, up-to-date, accessible scientific information is critical if we are to make good decisions. I believe that the EPA has a responsibility to make its decision-making process as transparent as possible and to ensure that the very best scientific evidence is brought to the public so as to better inform the millions of private decisions that also effect the quality of drinking water in our country.
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Again, I thank the Chairman for holding this hearing and I look forward to the testimony of this distinguished panel.
[The prepared statement of J. Randy Forbes follows:]
PREPARED STATEMENT OF REPRESENTATIVE J. RANDY FORBES
Thank you, Mr. Chairman and Ranking Member, Mr. Barcia, for holding this hearing today. Though the furor in the papers and on the news programs since it first became a story earlier this year has died down, this issue is still important to my constituents and others across the nation.
Virginia's Fourth District has many very rural areas, and many communities that depend upon well water for their drinking supplies. Fortunately, this area also has a low-level of naturally occurring arsenic, and, therefore, concerns about arsenic in our drinking water are not as prominent as in other areas, particularly in the Southwest. However, arsenic is a powerful word, and it takes little for its utterance to make people apprehensive about the water that they and their families drink.
When EPA Administrator Whitman indicated that she would postpone the implementation of the Clinton Administration's rule reducing the permitted level of arsenic in drinking water in order to allow for more study on the related costs, benefits, and health effects, many people thought that this signaled a retreat. But, nothing could be further from the truth. I believe that the reports that we are hearing about today and the recent press reports of the EPA's preliminary reactions are proof of this.
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There are legitimate concerns that in those regions of the nation where there is a high natural occurrence of arsenic in the drinking water that setting the standard too low would inhibit the ability to provide low-cost water to the public. In turn, this would push more low- and middle-income families onto well-water systems, which would put them at an even higher risk than had they remained with municipal water treatment. The EPA needs to reach a balance, and these studies will help them to do so.
It is fitting that yesterday the full Science Committee reported out a bill that aims to strengthen the role of science in our environmental protection rules and laws. The roles of chemistry, biology, and economics are indisputable in the establishment of this rule.
I appreciate the witnesses for coming here today to share what they and their colleagues have learned through their studies. I look forward to continuing to work with the Chairman and my colleagues here today to address these issues.
Chairman EHLERS. At this time, I would like to formally introduce our witnesses. First, Dr. Robert Goyer is the Chair of the National Research Council Subcommittee that updated the 1999 Arsenic in Drinking Water Report. He is a Professor Emeritus at the University of Western Ontario in Canada, not too far from Bad Axe, and will present the findings from the report, ''Arsenic in Drinking Water, the 2001 Update.''
Dr. Maureen Cropper is the Chair of the Arsenic Rule Benefits Review Panel within the EPA Science Advisory Board. She is also a Lead Economist at the World Bank and Professor of Economics at the University of Maryland. She will present the findings from the report, ''Arsenic Rule Benefits Analysis: An SAB Review.''
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Mr. John Scheltens is a Member of both the National Drinking Water Advisory Council and its Arsenic Cost Working Group. He is also the City Engineer and Public Works Director for Hot Springs, South Dakota, not too far from where I was born. He will present the results of the report on, ''The Arsenic Cost Working Group to the National Drinking Water Advisory Committee.''
Dr. Barbara Beck is a Principal at Gradient Corporation, a consulting firm located in Boston, Massachusetts. Today is she is testifying on behalf of the Environmental Arsenic Research Council, The American Wood Preservers Institute, and the National Rural Water Association. I am also submitting for the record testimony that the American Wood Preservers Institute has submitted separately. And without objection, that will be entered into the record.
Mr. Scott Rubin is an Attorney and Consultant, based in Selinsgrove, Pennsylvania. He will present the findings of research he has done on water system affordability for the National Rural Water Association.
And, finally, Mr. Erik Olson is a Senior Attorney at the National Resources Defense Council and will comment on the three reports mentioned previously.
As our witnesses presumably have been instructed, spoken testimony is limited to five minutes each. And you have the little device in front of you which will show a green light during the first four minutes, a caution light, yellowish-green, during the 1-minute wrap-up time, and the red light when you should stop. If the red light is on for more than a few seconds, trap doors open, and bad things happen. So please try to limit your testimony to five minutes.
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After you have completed your testimony, each Committee member will be given five minutes to ask questions of you. We will start our testimony with Dr. Goyer. Dr. Goyer, would you turn on your microphone, please?
STATEMENT OF DR. ROBERT A. GOYER, CHAIR, NATIONAL RESEARCH COUNCIL (NRC) SUBCOMMITTEE TO UPDATE THE 1999 ARSENIC IN DRINKING WATER REPORT, COMMITTEE ON TOXICOLOGY; PROFESSOR EMERITUS, UNIVERSITY OF WESTERN ONTARIO, ONTARIO, CANADA
Dr. GOYER. Okay. Good morning, Mr. Chairman, and members of the Committee. I am Robert Goyer, M.D., Professor Emeritus of Pathology at the University of Western Ontario. And I am pleased to appear before you today on behalf of the National Research Council Subcommittee to Update the 1999 Arsenic in Drinking Water Report, which prepared the report, ''Arsenic in Drinking Water: 2001 Update,'' the current one, and was released in September 2001.
In addition to serving as Chair of the Subcommittee, I served as Chair of the Subcommittee on Arsenic in Drinking Water, which prepared the NRC report of ''Arsenic in Drinking Water,'' released in 1999, two reports. Following the release of the 1999 report, EPA reviewed its regulations for arsenic in drinking water. And on January 22, 2001, EPA issued a pending standard for arsenic in drinking water of ten micrograms per liter.
The pending standard was primarily based on dose response models and extrapolation from the cancer study of the Taiwanese population exposed to high concentrations of arsenic in its drinking water. On March 23, 2001, EPA published a notice that delayed the effective date of the arsenic rule pending further study of options for revising the MCL for arsenic. Now, to incorporate the most recent scientific research into its decision, EPA's Office of Water subsequently requested that the NRC independently review studies on the health effects of arsenic published since the 1999 report.
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Now, in response to EPA's request, the NRC assigned the project to the Committee on Toxicology and convened the Subcommittee to Update the 1999 Arsenic in Drinking Water Report. The members of that subcommittee were selected by the NRC from the academic community and other organizations for expertise and relevant scientific disciplines.
The 2001 subcommittee was charged with the task of preparing the report, updating the scientific analysis, uncertainties, and findings of the 1999 report on the basis of relevant toxicologic and health effects studies that have been published since the 1999 report, and then to evaluate the analysis, subsequently conducted by EPA, in support of its regulatory decision-making for arsenic in drinking water.
The subcommittee addressed only scientific topics relevant to the toxicologic risk and health effects of arsenic. It did not address questions of economics, cost benefit assessment, control technology, exposure assessment in the U.S. population, or regulatory decision-making. It did not comment or make recommendations on risk management or policy decisions.
Now, the subcommittee considered several hundred new scientific articles on arsenic that have been published since the 1999 report. It also heard presentations from the EPA Administrator, other EPA representatives, the EPA Science Advisory Board, other scientists with expertise in arsenic toxicity, federal, state, local government agencies, trade organizations, public interest groups, and concerned individuals.
The subcommittee concluded that there is a sound data base on the carcinogenic effect of arsenic in humans that is adequate for the purpose of risk assessment, and that the data indicate arsenic causes cancer in humans at doses that are close to drinking water concentrations that occur in the United States. Arsenic-induced lung and bladder cancers should continue to be the principal focus of arsenic risk assessment for regulatory decision-making.
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Unlike many other chemicals, arsenic data from human epidemiologic studies are sufficient so that there is no need to extrapolate from animals to humans or from high doses to low doses. Since the 1999 NRC report, additional studies have been published that strengthen the association between arsenic and cancer. There are four new major epidemiological studies—three studies that show a positive relationship between cancer, that is bladder and lung, and arsenic; and one study from Utah that does not show a relationship. However, the study from Utah has several limitations that make it insufficient for use in the quantitative risk assessment. The human data from southwestern Taiwan, used by EPA in its risk assessment, remain the most appropriate for determining quantitative lifetime cancer risks.
The major findings of the ''Arsenic in Drinking Water: 2001 Update,'' confirm the conclusion of the 1999 report that the chronic exposure to arsenic is associated with an increased incidence of bladder and lung cancer at arsenic concentrations below the current MCL. This conclusion was strengthened by the new epidemiologic studies.
The subcommittee confirmed that the southwestern Taiwanese study, which was the basis of the 1999 report, is the optimal study for determining the cancer risk from chronic exposure to arsenic. However, the present report suggests that the risks for bladder and lung cancer are greater than the risk estimates on which EPA based its January 2001 pending rule.
And the reasons for the increased risk estimate include the use of a different biostatistical model that provides a better fit to the available data, the use of an external, rather than internal, comparison population, improving assumptions for determining arsenic exposures, and, finally, relating the risks to the Taiwanese population to the U.S. cancer rate, which is higher than the Taiwanese.
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Estimates of risk from low-level arsenic exposures were based on a Poisson linear extrapolation from observed data. Now, available data on the mode of action do not provide evidence for a threshold or non-linear dose response. Several biochemical effects have been observed in cells in vitro—that is test tube laboratory studies—in concentrations that might exist in urine following ingestion of drinking water containing arsenic concentrations of 3, up to 50, micrograms per liter. This is the range that is currently the focus of low-dose estimates—low-dose risk assessments.
There are also numerous studies showing an association between non-cancer health outcomes for arsenic. And these include cardiovascular diseases, such as hypertension, diabetes mellitus, and there is more limited evidence even for reproductive effects.
The subcommittee identified a number of uncertainty factors and population variability that might influence the risk estimates, including genetic factors, age, sex, and simultaneous exposure to other cancer-causing compounds. There is also uncertainty regarding the possible interaction between arsenic ingestion and smoking in the causation of cancer.
Research should be conducted on a priority basis to reduce these uncertainties which are relevant to the risk assessment. More research is needed on the possible association between arsenic exposures in cancers other than skin, bladder, and lung, which have been well studied in the past, and, as well, non-cancer effects, particularly the impacts on the circulatory system, again, blood pressure and heart disease, and diabetes mellitus, and reproductive outcomes.
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Future studies of the relationships between arsenic ingestion and both non-cancer and cancer outcomes should be designed to have sufficient power, statistical power, to determine risks in potentially susceptible populations, including children. They should consider factors that like—for instance, smoking and diet and genetics—that could influence susceptibility to arsenic, and they should collect detailed exposure information, all in an effort to reduce uncertainty to the risk assessment.
In addition, more information is needed on the variability and metabolism of arsenic among individuals and the effect of that variability on the risk assessment. Laboratory and clinical research is also needed to define the mechanisms, mode of action, by which arsenic induces cancer to clarify these risks at lower levels. The theoretical lifetime excess risk for bladder and lung cancer, combined, is estimated to be approximately one in 1,000 at three micrograms per liter. That is the lowest level that—within the range that we studied.
Now, I would like now to ask that the full NRC report, which I have here, be put in the record. And I thank you for inviting me to testify before the House Science Committee. I would be happy to answer any questions you have.
[The prepared statement of Dr. Goyer follows:]
PREPARED STATEMENT OF ROBERT A. GOYER
Good morning Mr. Chairman and members of the Committee. I am Robert Goyer, Professor Emeritus of University of Western Ontario, and I am pleased to appear before you today on behalf of the National Research Council's (NRC) Subcommittee to Update the 1999 Arsenic in Drinking Water Report, which prepared the report Arsenic in Drinking Water: 2001 Update, released in September 2001. In addition to serving as chair of that subcommittee, I served as chair of the Subcommittee on Arsenic in Drinking Water, which prepared the NRC report Arsenic in Drinking Water released in 1999.
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Following the release of the 1999 report, EPA reviewed its regulations for arsenic in drinking water, and on January 22, 2001, EPA issued a pending standard for arsenic in drinking water of 10 mg/L. That pending standard was primarily based on dose-response models and extrapolation from a cancer study of a Taiwanese population exposed to high concentrations of arsenic in its drinking water. On March 23, 2001, EPA published a notice that delayed the effective date of the arsenic rule pending further study of options for revising the MCL for arsenic. To incorporate the most recent scientific research into its decision, EPA's Office of Water subsequently requested that the NRC independently review studies on the health effects of arsenic published since the 1999 NRC report.
In response to EPA's request, the NRC assigned the project to the Committee on Toxicology (COT) and convened the Subcommittee to Update the 1999 Arsenic in Drinking Water Report. The members of that subcommittee were selected by the NRC from the academic community and other organizations for expertise in relevant scientific disciplines. The 2001 subcommittee was charged with the task of preparing a report updating the scientific analyses, uncertainties, and findings of the 1999 report on the basis of relevant toxicological and health-effects studies published since the 1999 NRC report, and to evaluate the analyses subsequently conducted by EPA in support of its regulatory decision-making for arsenic in drinking water. The subcommittee addressed only scientific topics relevant to toxicological risk and health effects of arsenic. It did not address questions of economics, cost-benefit assessment, control technology, exposure assessment in U.S. populations, or regulatory decision-making. It did not comment or make recommendations on risk management or policy decisions.
The subcommittee considered several hundred new scientific articles on arsenic published since the 1999 NRC report. It also heard presentations from the EPA administrator; other EPA representatives; the EPA Science Advisory Board; other scientists with expertise in arsenic toxicity; federal, state, and local government agencies; trade organizations; public-interest groups; and concerned individuals.
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The subcommittee concluded that there is a sound database on the carcinogenic effects of arsenic in humans that is adequate for the purposes of a risk assessment, and that the data indicate that arsenic causes cancer in humans at doses that are close to drinking water concentrations that might occur in the United States. Arsenic-induced lung and bladder cancers should continue to be the principal focus of arsenic risk assessment for regulatory decision making. Unlike many other chemicals, arsenic data are sufficient so that there is no need to extrapolate from animals to humans or from very high doses to low doses. Since the 1999 NRC report, additional studies have been published that strengthen the association between arsenic and cancer. There are 4 new epidemiological studies: three studies that show a positive relationship between cancer (bladder and lung) and arsenic, and one study from Utah that does not show such a relationship. However, the study from Utah has several limitations that make it insufficient for use in a quantitative risk assessment. The human data from southwestern Taiwan used by EPA in its risk assessment remain the most appropriate for determining quantitative lifetime cancer risk estimates.
The major findings of the Arsenic in Drinking Water: 2001 Update confirmed the conclusion of the 1999 report that chronic exposure to arsenic is associated with an increase incidence of bladder and lung cancer at arsenic concentrations below the current MCL. This conclusion was strengthened by new epidemiological studies. The subcommittee confirmed that the southwestern Taiwanese study, which was the basis of the 1999 report, is the optimal study for determining the cancer risks from chronic exposure to arsenic. However, the present report suggests that risks for bladder and lung cancer are greater than the risk estimates on which EPA based its January 2001 pending rule. Reasons for the increased risk estimate include: (a) use of a different biostatistical model that provided a better fit to the available data, (b) use of an external rather than internal comparison population, (c) improved assumptions for determining arsenic exposures and, finally, (d) relating the risks to the Taiwanese population to U.S. cancer rates. Estimates of risks from low-level exposures were based on a Poisson linear extrapolation from observed data. Available data on the mode of action do not provide evidence for a threshold or non-linear dose-response. Several biochemical effects have been observed in cells in vitro at concentrations that might exist in urine following the ingestion of drinking water containing arsenic concentrations of 3–50 micrograms per liter, a range that is currently the focus of low-dose risk assessment.
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There are also numerous studies showing an association between noncancer health outcomes for arsenic, such as cardiovascular (hypertension) effects and diabetes mellitus, and more limited evidence for reproductive effects.
The subcommittee identified a number of uncertainty factors and population variability that might influence the risk estimates including genetic factors, age sex, and simultaneous exposure to other cancer causing compounds. There is also uncertainty regarding the possible interaction between arsenic ingestion and smoking in the causation of cancer. Research should be conducted on a priority basis to reduce those uncertainties which are relevant to arsenic risk assessment. More research is needed on the possible association between arsenic exposure cancers other than skin, bladder, and lung, as well as noncancer effects, particularly impacts on the circulatory system (high blood pressure, heart disease, and stroke), diabetes, and reproductive outcomes. Future studies of the relationships between arsenic ingestion and both noncancer and cancer outcomes should be designed to have sufficient power to determine risks in potentially susceptible subpopulations, including children; they should consider factors (e.g., smoking, diet, genetics) that could influence susceptibility to arsenic; and they should collect detailed exposure information, all in an effort to reduce uncertainty in the risk assessment. In addition, more information is needed on the variability in metabolism of arsenic among individuals and the effect of that variability on an arsenic risk assessment. Laboratory and clinical research is also needed to define the mechanisms by which arsenic induces cancer to clarify the risks at lower doses.
The theoretical lifetime excess risk for bladder and lung cancer combined is estimated to be approximately 1 in 1000 at 3 micrograms per liter.
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Thank you for inviting me to testify before the House Science Committee. I would be happy to answer any questions you have.
Chairman EHLERS. Thank you, Dr. Goyer. And without objection, the full report will be entered into the record, subject to the limitations of the printing requirements.(see footnote 1) And, again, I encourage everyone to try to summarize their remarks and stay within the 5-minute limit. Dr. Cropper.
STATEMENT OF DR. MAUREEN L. CROPPER, CHAIR, EPA SCIENCE ADVISORY BOARD, ARSENIC RULE BENEFITS REVIEW PANEL; LEAD ECONOMIST, THE WORLD BANK; PROFESSOR OF ECONOMICS, UNIVERSITY OF MARYLAND
Ms. CROPPER. Thank you. I am Maureen Cropper and I chair the Science Advisory Board's Arsenic Rule Benefits Review Panel. Our job was to comment on the soundness of the Benefit Cost Analysis that was done in support of the arsenic rule. So what I am going to talk about is really the economics of this and the economics of measuring the benefits and comparing them to the costs.
We have really made, I would say, about five major points here. The first one was that we thought not sufficient emphasis was given to breaking down the benefits and costs by system size. It is well-known, and we are going to hear more testimony about this, that the cost per household of treating drinking water is much higher in small systems. Typically, the ratio of benefits to cost is much lower in small systems. And we felt that this needed to be emphasized.
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There are really two policy issues here. I mean, it says under this Safe Drinking Water Act that you are supposed to have a uniform drinking water standard throughout the country. But in a situation where there are great differences in benefits and costs, at least from an efficiency perspective, you have to ask the question, should the standard really be uniform? Shouldn't it possibly vary from one community to another? When this is suggested, a lot of people will say, well, you know, should we consign people in small communities to drinking bad water? That is really not the issue.
And I also think that affordability is not really the issue here. You can deal with affordability by giving Federal subsidies to small communities. The question is, if you have just limited resources and you have a lot of health concerns in Bad Axe or in other places, are you getting the most bang for your buck by putting the money into drinking water treatment or taking arsenic out of drinking water? I mean, that is really the policy issue here. And, I think that there should be some consideration given to allowing standards to vary by community.
There is another issue, and that is that the Safe Drinking Water Act says that communities should be treating all of the water that goes into the house or that the household uses, whereas a very small percent of that is used for drinking and cooking. And so the question would be, if you break down these benefit-cost numbers by system size, maybe other regulatory options would be allowed, such as providing purer water for drinking and cooking than you are providing for people watering their lawns or washing their clothes.
A second point we made had to do with the way that you present the benefit estimates in a benefit-cost analysis. The people who are critical of benefit-cost analysis often object to assigning dollar values to avoided cases of illness and premature mortality. We emphasized that what should go in the executive summary of a report, such as the one that EPA presented, is actually the number of cases of premature mortality or, in the case of dealing primarily with cancers, of fatal and non-fatal cancers that you would expect to see reduced every year after you implement the new drinking water standard.
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So, you actually want to see what these numbers are. That way, people who object to the dollar weights that were used by EPA in the study, can supply their own. If they object to the way in which the future benefits were discounted, the rate that was used for that, they can do this themselves. And one other advantage of this is that you want to be looking at the cost per cancer case avoided of treating drinking water or reducing the MCL to 10 parts per billion versus other ways in which you could reduce cancers. And I think if you put the information in this format, it really encourages these kinds of questions to be asked.
Our third point had to do with what to do about these other health endpoints besides lung and bladder cancers. In a benefit-cost analysis, if you don't quantify something, people tend to think that it is worthless, unfortunately. And so, I mean—and so what happened here was, you know, we were asked, what should EPA have done about this list of 49 health effects that it puts in its report that could be associated with arsenic? I mean, there is a laundry list of effects.
When you look at it, you don't know whether—you know, you don't know how many studies support each of the different effects. You don't know at what levels effects were observed in the study, what kind of statistical association was made, or how large it was. There is no information really given to back up these other health effects that Dr. Goyer spoke of relating to heart disease and other kinds of cancers.
Now, I realize this goes a little bit at variance with the National Academy—the NRC report, but the health scientists on our panel believed that at least for some endpoints, for ischemic heart disease, hypertension, skin cancer, and diabetes, that it should be possible, allowing for the uncertainties in the estimates of dose response, to say something about the number of cases avoided for these health endpoints. So that was a recommendation of our study. I am not really the person to defend this since I am not an epidemiologist. But we certainly believe that there had to be more quantitative information provided to summarize the studies in the literature besides simply saying there are possibly these other effects, which is really what the reports says now.
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Another issue that we were asked to address—and I think this something that really goes beyond arsenic—was how do you deal with the timing of the health benefits. And this is the issue: You know, suppose somebody has been exposed to 30 parts per billion in their drinking water for their entire life, and then at the age of 50, the level goes down to ten parts per billion. The issue here is really how fast is the cancer risk going to be reduced for this person. How fast are they going to become equivalent to the person who was exposed to 10 parts per billion their entire lifetime?
When this was presented to us, people used the term latency, which is really not the right term. I mean, latency is the time between when somebody first begins to be exposed, and you start to see cancer—cancerous cells or cancer is diagnosed. And actually, in the NRC report, there is a chapter—in the new one, there is a chapter on latency. But it seems that, you know, the relevant concept here really is how fast these risks cease to exist once you stop exposure. So one of the things we recommended was actually that research needs to be done on this topic. I mean, from the data in Taiwan and from the data in Chile, where there was actually an improvement in drinking water, there has been enough time elapsed that one, I think, could actually look at the impact of where the time pattern of this cessation lag. Okay.
In the EPA report, a very extreme assumption was made in what I would call a primary analysis. And that was to say there is no cessation lag. The person who is exposed—whose exposure goes from 30 to 10, ultimate—you know, immediately becomes like the person who was exposed to 10 parts per billion their entire lifetime. This is all right to assume, as long as you identify it as giving you the upper bound to the cancer cases avoided.
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And one of the things that we thought should have been done was to realize that there is going to be a sort of gradual phasing in of these risk reductions and to make alternate realistic assumptions about how they would be phased in and to look at the implications of this for the time pattern of cancer. So that was another point.
And finally, in terms of, I guess, the way in which the valuation of benefits was done and benefits were actually computed in this study, we did think that the methodology there was sound. Even though we have these criticisms of, I guess, the number of endpoints that were—that could have been—quantified and how the time path should have been calculated, what the study did, given the assumption of number of cancer cases avoided, was to use standard economic procedures, use the value of a statistical life, which is measuring what people would pay for small risk reductions, to value the avoided fatal cancers. They discounted future benefits at the same rate that costs were discounted in the study, which was an appropriate thing to do. And we thought that that part of the study was done fine from the perspective of methodology.
[The prepared statement of Dr. Cropper follows:]
PREPARED STATEMENT OF MAUREEN CROPPER
Today I would like to summarize the main points made by the Arsenic Rule Benefits Review Panel (ARBRP) of the USEPA Science Advisory Board in its report, Arsenic Rule Benefits Analysis: An SAB Review. Our main points can be viewed as answers to the following four questions:
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1. How should benefits and costs be presented in an analysis of the Arsenic in Drinking Water Rule?
2. How should benefits other than avoided lung and bladder cancers be treated in the analysis?
3. How should the timing of benefits from arsenic reduction be handled in a benefit-cost analysis?
4. How should the benefits of reduced arsenic exposure be valued?
1. How should benefits and costs be presented in an analysis of the Arsenic in Drinking Water Rule?
The main issues here concern:
(a) whether emphasis should be placed on presenting the benefits and costs of a drinking water rule aggregated across all systems affected by the rule, or whether benefits and costs should be broken down by system size;
(b) to what extent emphasis should be placed on the dollar value of benefits or also on the number of cases of mortality and morbidity avoided. [''Placing emphasis'' means including these results in the Executive Summary of the report.]
The ARBRP recommended that benefits and costs be broken down by system size, before being aggregated to the national level, both in the primary analysis and in the Executive Summary of the report. Due to the large economies of scale in drinking water treatment, it is typically the case that the costs of drinking water treatment per household are larger in smaller systems and, hence, that benefit-cost ratios are smaller for small systems than for larger ones. One advantage of making this apparent to decision-makers is that it may suggest regulatory alternatives—such as smaller systems making bottled water available to their customers for drinking and cooking purposes, rather than treating all water to the level required by a standard. If the standard must remain uniform, a breakdown of benefits and costs by system size may suggest cases where financial aid (or an exception to the standard) might be desirable.
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The ARBRP also recommended that detailed information be presented on the time path of cases of morbidity and mortality avoided by the rule, as well as presenting information in monetary terms. Underlying any calculation of the present discounted value of benefits from reducing arsenic in drinking water is the estimated number of fatal and non-fatal cancers avoided each year, beginning in the year the rule is implemented. This information should be presented in tabular form in the primary analysis and in the Executive Summary. It allows readers who object to the monetary weights used in the analysis to apply their own, and/or to discount future benefits at the rate they prefer.
The Panel also stressed that avoided cases of illness and mortality should be broken down by age group, when possible. The epidemiological study that formed the basis for EPA's estimates of the number of cancer cases avoided by reducing arsenic in drinking water assumed that cancer risks associated with arsenic are proportional to baseline incidence of cancer. Since the baseline risks of bladder and lung cancer grow with age, the majority of fatal and non-fatal cancers avoided by the rule would occur among older people. In general, the age distribution of benefits from a regulation is important information to present to decision makers and the public.
2. How should benefits other than avoided lung and bladder cancers be treated in the analysis?
It appeared to the Panel that other health endpoints besides lung and bladder cancer could have been quantified in EPA's benefits analysis. There are studies in the peer-reviewed literature that present dose-response functions relating arsenic to ischemic heart disease, diabetes, skin cancer and hypertension. The issue is the precise shape of the dose response function at the levels of arsenic considered in the benefits analysis (3, 5, 10 and 20 ppb). [This issue is more serious for non-cancer endpoints, since protocols for extrapolating dose-response functions to low doses are better established in the case of cancer.] Uncertainty about the form of the dose-response function at low levels of exposure could be handled in an uncertainty analysis.
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In addition, the benefits analysis could present benchmark doses indicating the levels at which effects of arsenic (in addition to lung and bladder cancer) were found. A benchmark dose is the dose at which an effect was observed in a certain fraction of the population. For example, the ED01 (Effective Dose 01) is the dose at which an effect was observed in 1% of the population, implying a 1-in-100 risk. Comparing benchmark doses for outcomes other than lung and bladder cancer with benchmark doses for lung and bladder cancer allows one to determine whether other health effects occurred at doses similar to those for cancer endpoints.
The Panel also emphasized that a benefit analysis should include an appendix summarizing the peer-reviewed literature on the health effects of arsenic, in a format similar to the one included in our report. For each article it is imperative to indicate:
The nature of the study design
How exposure was measured
The range of exposures observed
What type of statistical analysis was conducted and what confounding factors were controlled for in the analysis
Measures of association (e.g., odds ratio) presented in the study and level of statistical significance of the association.
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This information should be much more useful in indicating the strength of the association observed and its relevance for a proposed regulation than a simple listing of possible health effects that might be associated with arsenic.
3. How should the timing of benefits from arsenic reduction be handled in a benefit-cost analysis?
When exposure to arsenic is reduced, say from 50 ppb to 10 ppb, persons whose exposure is reduced will eventually experience the same risks of cancer as persons exposed to 10 ppb their entire lifetime. How long this takes to occur depends on the cessation lag between reduction in exposure and reduction in risk. The length of the cessation lag in turn depends on the stage at which arsenic acts in the cancer formation process. If it acts primarily at a late stage, risk reductions will occur more rapidly than if it acts at an early stage. Moreover, since risk is a function of cumulative exposure, each person will experience a fraction of the total reduction in risk each year after the policy is implemented. For example, a person might enjoy 10% of the ultimate risk reduction one year after the policy is implemented, 60% five years after the policy is implemented, and 100% eight years after the policy is implemented. This information can be used to compute the expected number of cancer cases avoided each year following implementation of the policy.
When the exact length of the cessation lag is not known (as is the case for arsenic), alternate assumptions must be made and their implications for benefits traced out. Assuming a cessation lag of zero—the central assumption in the Arsenic Benefits analysis—is clearly an extreme assumption. It will yield an upper bound to the number of cancer cases avoided each year following implementation of the policy. Alternate assumptions about the percent of the ultimate risk reduction achieved each year should also be made. An extremely conservative assumption would be to assume that the cessation lag is equal to the latency period between initial exposure to arsenic and diagnosis of cancer, and that none of the ultimate reduction in risk is enjoyed until this period elapses. This is conservative for two reasons. First, the cessation lag for carcinogens is often shorter than the latency period, especially for late-stage carcinogens (consider the case of cigarette smoking and lung cancer). Second, it is unlikely that no cancer cases would be avoided until the end of this period.
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4. How should the benefits of reduced arsenic exposure be valued?
As the Report spells out in detail, assumptions about the timing of the relationship between exposure to arsenic and cancer risk will enable an analyst to compute the expected number of cancer cases avoided by reducing exposure to arsenic each year after the implementation of a policy. To value fatal cancer cases avoided according to standard economic practice, one would multiply the number of cases avoided in each year by the Value of a Statistical Life in that year. This would be repeated for each year the policy is in force, and the dollar value of benefits in each year would be discounted to the first year of the policy and summed. This number, the present discounted value of mortality benefits, would be added to the present discounted value of morbidity benefits (similarly computed) and the sum compared with the present discounted value of costs.
The ''Value of a Statistical Life'' (VSL) used to monetize avoided cancer cases, and the rationale for discounting the monetary value of avoided cancer cases, requires further discussion. The expected number of cancer cases avoided in any year, as a result of reducing the MCL for arsenic, is really the product of the change in fatal cancer risk per person (e.g., a 1-in-10,000 risk reduction) times the size of the relevant population. For this reason, we think of the lives saved as ''statistical lives.'' Reducing the risk of dying by 1-in-10,000 for each of 10,000 people will, on average, save one life, but we do not know whose life it is. Suppose we could estimate what each person would pay to reduce his risk of dying of cancer by 1-in-10,000. The VSL is the sum of people's willingnesses to pay for risk reductions that sum to one statistical life. (In this example, the VSL is the sum of 10,000 persons' willingnesses to pay for a 1-in-10,000 risk reduction.)
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Why discount these values? The present value of the cost of reducing arsenic in the year 2020 (e.g., $200 million) is the amount that would have to be invested today to yield $200 million in 2020. By the same token, the amount that people would have to invest today to yield the amount they would pay to reduce their risk of dying in 2020 is the present value of their willingness to pay in 2020. Failure to discount the value of future life-saving benefits from a regulation, while at the same time discounting the future costs of the regulation would make it appear profitable to postpone the regulation indefinitely. Postponing the regulation would lower the present value of its costs but, if monetary benefits were not discounted, would not diminish the present value of monetary benefits.
5. Issues Requiring Additional Research or a Change in Current Practice
The implications of our recommendations for future research and for benefit-cost analyses are as follows:
1. Studies should be conducted using data from Taiwan and Chile to estimate the length of the cessation lag between reduction in arsenic exposure and reduction in risk. Populations in Taiwan and Chile that have formed the basis for estimating the impacts of arsenic in drinking water on various health endpoints, including cancer and heart disease, have also experienced decreases in exposure that could be used to estimate how fast risks decline with reductions in exposure. In Taiwan, the water supply in exposed villages was changed in the early 1980's, thereby eliminating arsenic exposure. In Antofagasta, Chile water treatment beginning in 1970 reduced the arsenic concentration from 800 to 110 ppb and, over a few more years, to 40–50 ppb.
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2. In computing the time path of future benefits from reducing exposure to a carcinogen, the assumption of a zero cessation lag should be acknowledged as yielding an upper bound to benefits. Alternate assumptions about the percent of the ultimate risk reduction achieved each year should be made and their implications for the path of cancer cases avoided stated explicitly.
3. When dose response is calculated using a proportional hazard model, cancer cases avoided should be predicted by age group.
The underlying dose-response function used by EPA (Morales et al., 2000) allows the calculation of risk reductions by age group. It is important for policy makers and the public to know how many beneficiaries of a regulation are seven years old and low many are 70.
4. The literature on health endpoints other than lung and bladder cancer should be summarized in the Arsenic Rule benefits analysis and these benefits quantified to the extent possible, as indicated in point 2, above.
5. Benefit and costs should be presented for systems of different sizes both in the primary analysis and in the Executive Summary. Information on the time path of cancer cases and other health endpoints avoided should likewise appear in the primary analysis and Executive Summary, broken down by age when possible.
Chairman EHLERS. Thank you very much. Mr. Scheltens.
STATEMENT OF MR. JOHN P. SCHELTENS, NATIONAL DRINKING WATER ADVISORY COUNCIL, ARSENIC COST WORKING GROUP; CITY ENGINEER, PUBLIC WORKS DIRECTOR, HOT SPRINGS, SOUTH DAKOTA
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Mr. SCHELTENS. Mr. Chairman, members of the Committee, thank you very much for the opportunity to be here.
Chairman EHLERS. Is your microphone on?
Mr. SCHELTENS. Can you hear me now?
Chairman EHLERS. Yes.
Mr. SCHELTENS. Okay. I come to you here today really wearing two hats. I mean, I am the City Engineer of a small town in South Dakota, one of those people who will be at the receiving end of whatever decision is made to implement it. And the other hat that I wear is being a member of the Drinking Water Advisory Council and part of the Arsenic Workgroup that evaluated the cost methodology on how to—what the national cost will be.
Wearing the first hat from the Drinking Water Advisory Council and the Working Group, the recommendations in the report really center around three major recommendations. The first of which is by evaluating the methodology the EPA used, did they put in the correct assumptions into their model to produce a cost that is within the range of—a certain range of certainty. The Working Group did not—let me clarify—the Working Group did not do a cost estimate. That wasn't our job. Our job was to essentially evaluate the methodology that EPA used.
We made a number of recommendations to EPA on how to improve that cost estimate and the way that they did it. And the way they did it, they used computer models and cost curves to give projections as to what the national costs would be. This methodology is probably okay to get you in some sort of order of magnitude projection of what the cost will be nationwide, but it doesn't provide you sufficient detail or maybe enough accuracy to implement a rule that has a lot of impact on society. So depending on what the impact of the rule is on society, whether it is a financial impact or whatever, the way that it was done, you could argue whether or not that it does or does not provide you with sufficient detail.
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My argument would be—and this is my personal opinion, not EPA's or the Group's—that given the financial impact that this rule will have, particularly on small systems, that it may not be sufficient and detailed to be able to know what that impact is.
The—anyway, the report contains a number of recommendations on how EPA can improve the cost estimate using their current computer models and cost group technology. It is my understanding that they are doing that currently and, within 30 days, there will be a new number that will come from EPA on what the estimate of the national cost is. What may not be apparent from that national cost is the particular breakdown as to how it affects different sizes of systems.
Following up on what was already said, the cost to the big guys, the big systems can probably be absorbed and it probably will not be significant in terms of dollars and cents on user rates. What is obvious to most of us on the committee is that the impact to the small systems guys, which by the way, will be 95 percent of the systems affected by the arsenic rule, are small systems. So the cost and the burden of implementing this rule is going to fall very, very heavily on the small systems in the county. And there—that becomes a separate issue.
The second recommendation that came from the Working Group has to do with how to do future cost projections. If the rule, like I said, has a dramatic impact on economics or other sorts of social values—and there is a decision there that has to be made—but if it does, then a more detailed cost estimate needs to be done, more along the way an engineer would do an estimate on a project. We are doing, essentially, an aggregate of counties, cities, states, individual estimates that are accumulated and put together and put up to a national level what the total cost would be.
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Because there are so many uncertainties that go into it, to try to make an assumption at the national level is very difficult. Every system—there are 180,000 systems in this country. Every one has its own unique problems and concerns and whether it is how many entry points, where the water comes into the system, whether it is a mixed system, whether it comes from groundwater or surface water. There are so many variables that go into putting together a cost estimate that at the national level it is very hard to ball park that within a range of certainty that may not be adequate for rule making. So in the future, the second recommendation deals with recommendations on how to do cost methodologies when rules have a significant impact on society.
The third recommendation from the Working Group and the Council, deals with the affordability issue. And one of the things that we quickly realized in the Working Group is that this arsenic rule on small systems will probably have a dramatic financial impact. But we also realize that arsenic is only one of many contaminants that are regulated in the drinking water and also one of many that will probably either be additional—or additional contaminants will be regulated in the future, which will be added to that list. And existing contaminants on that list will probably be strengthened or the MCL, the maximum contaminant level, will fall or make it more difficult to do so.
So what the Council is recommending to EPA is that issue that now transcends the arsenic issue and really deals with the affordability of all drinking water regulations. We do two things, one of which is to conduct a—form a national panel of experts, a Working Group, in and of itself, dealing with the affordability issue—to raise that discussion to a national level so that we can discuss the issue of affordability, particularly on small systems.
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The second part of the recommendation, which is unique and is different, deals with proposing a sustainability fund. If we truly believe in this country that whatever standard we set for drinking water is of national public health interest, and that we want everybody in this country to come up to that standard, then we also must realize from a Federal Government standpoint, there is a financial obligation that goes with that.
Now, speaking as a City Engineer from a small town, what does that mean at my level? Financially, my hands are fairly well tied. My resources for income are limited to property tax and to user fees, is my primary source of income. I don't have access to Federal income taxes. I am also limited by property tax caps. In our state, there is a three percent maximum cap on our property.
You here deal with national priorities and what is important for the country and what resources are allocated. At the local level, I deal with the priorities at the local level and when those resources have to be—and I deal with a whole range of public health issues, not just drinking water. And we deal with solid waste and with waste water treatment. We also deal with—in fact, I would venture to say that 95 percent of what most people want from government every day is provided at the local level—education, law enforcement, water, sewer, streets, library, parks. All of that is locally funded and locally mandated and our resources are very, very limited.
So it is not to say that arsenic is not an important public health issue. It certainly may very well be. However, if I, at the local level, am required to implement a standard—and in my particular case, I will give you specific numbers. Population, 4,100 people—if the arsenic level—my—right now, the arsenic level in my system is 8.8. If it is set at 10, I really don't really need to do much of anything, other than notify people of that level. If it is set below that, it will cost approximately between one and two million dollars in capital costs up front to build that. It will cost additionally about $200,000 to $300,000 per year in annual O&M costs. The one thing that should be noted with this arsenic removal system is the high annual O&M costs.
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The SRF fund, which will help from the standpoint of providing capital to build the plant, is very important. And certainly under this arsenic rule, help to small systems will dramatically need to be increased. However, it doesn't go far enough. It doesn't finish the job. In many cases, you will be able to provide, through 100 percent grant, an arsenic treatment facility to a small town. Some small towns will not be able to afford the operation and maintenance.
So what needs to be created at the national level, if we truly believe that arsenic is a public health problem at those levels, and if that is the right thing to do, then also the right thing to do is to make sure that we enable every community to financially be able to afford that and to provide a sustainability fund that helps pay for that high cost of O&M year after year after year after year. And it falls on the burdens of the local rate.
In my particular community, our rates right now are about $22 a month for water service, and that is for wintertime consumption, no lawn watering type thing, for an average family of three. If I implement this particular standard, it would about triple that rate. It would bring it somewhere between $60 and $70 a month. I live in an area where the mean household is about $20,000 year. It is about $10,000 below the national average. How do I go to the people in my community—how do I go there and explain to them that this is something that they should do? And if they do this, what do I take the money away from so that we can afford doing this? So it is a matter of priorities and priorities at the national level. And then this gets charged at the local level. Thank you.
[The prepared statement of Mr. Scheltens follows:]
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PREPARED STATEMENT OF JOHN P. SCHELTENS
Arsenic Cost in Drinking Water
Mr. Chairman, distinguished members of the committee, my name is John Scheltens. I am the City Engineer for the City of Hot Springs, South Dakota. This is a small community in the southern end of the Black Hills serving a population of 4,100 people. I am a member of the National Drinking Water Advisory Council having served on the Council for nearly 6 years under both the Clinton and Bush Administrations. I was also a member of the Working Group that addressed the costs of implementing a new arsenic standard for drinking water.
Today I testify before you wearing two hats. First, as a representative of the NDWAC to report to you on the findings and conclusions of the costs associated with implementing a new arsenic standard. Secondly, as a 24 year+ public servant of a small rural community whose responsibility it is to implement the arsenic standard.
The NDWAC convened an Arsenic Cost Working Group which met five times around the country between May 29 and August 3, 2001. In addition, there have been numerous conference calls, e-mails, and subgroup meetings to review, edit, and refine the recommendations. After a conference call meeting held on August 22, 2001, the full Council voted unanimously to forward the Working Group's report to the Agency.
The report contains three major recommendations:
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1. How to improve the current national cost estimate.
2. How should future cost estimates be done.
3. Affordability of rule-making.
1. Improving the current national cost estimate:
There are always considerable uncertainties in the development of any national cost estimate. The Working Group believed that EPA did a credible and diligent effort in the cost analysis based on the limited data available to them and the limitations of using computer models. This method of costing produces generalized ''order-of-magnitude'' projections that may not produce the accuracy desired for certain rule-making. The Working Group identified several items in this approach that will improve the accuracy of this method. These specific recommendations include:
Use the most representative data bases available for community and non-community water systems when determining the national arsenic occurrence.
Re-evaluate the number of Entry Points to the Distribution System (EPDS) in its calculations.
Include the cost of land in its calculations.
Insure that unit costs be re-evaluated, undated, and validated.
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That mixed systems (i.e., those treating both surface and ground water) should be classified as ground water systems if more than 50 percent of the water they distribute is ground water.
Include new technologies in a revised national cost.
Capital cost multipliers should be 2.5 for systems under 10,000 population and 1.8 for systems above 10,000 population.
Re-examine labor costs to include process monitoring, routine maintenance, local administration, sampling and testing be included.
That additional pumping costs to overcome head loss in added treatment systems be included as well as higher energy costs.
Include on-site pilot testing costs of all technologies.
Include the costs of higher levels of operator training and certification required to operate more sophisticated technology.
Include administrative cost to states.
The Working Group also made a number of specific recommendations on various treatment technologies to include Activated Alumina, Enhanced Coagulation and Filtration, Coagulation Assisted Micro-filtration, and Point-of-Use Technologies, as well as for residual handling and disposal.
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It should be noted that the current national cost estimates are based on the premise that the arsenic laden residual of the treatment process is not considered, under current federal definition, as hazardous waste. However, some states, including California, use a test method referred to as the 'WET' test for arsenic. Results of this testing method may classify residuals of some facilities as hazardous waste. In response to this uncertainty, the NDWAC recommended that EPA include in the uncertainties section of the report, a discussion of the uncertainties in the cost of the disposal of waste that is considered hazardous or non-hazardous across the country. Disposal of non-hazardous waste is approximately $50/ton. It is my understanding that the disposal of hazardous waste is approximately $500/ton, but I'm sure this cost varies widely.
In order to make the cost of arsenic implementation easier to understand, the Working Groups further recommended that the final report of the revised national cost include tables that clearly indicate the number of systems affected for each of eight different population size categories, as well as the estimated capital and O&M costs for each category. And that a separate table be used for each MCL being considered.
2. Future Cost Estimates:
With the recommendations given above, we will get a better estimate, but one that may not yet be adequate for rule-making decisions. To do this EPA should use an approach based on a aggregate of county, regional and state costs coupled with extensive individual case analysis and better occurrence data bases. This takes considerably more time and resources. However, if a proposed rule is expected to have significant financial impact on the nation, then we should be behooved to do a better job in projecting it's impact. Resources expended in implementing a national cost estimate should be commensurate with the relative economic impact anticipated from a proposed drinking water rule.
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To accomplish this, EPA should be provided with additional and sufficient funds.
3. Affordability:
The cost of implementing of new arsenic standard to many small rural systems may be very expensive. Affected small systems will be generally going from little to no treatment to operating very sophisticated advanced treatment systems. Sort of like going from driving a pickup truck to flying a plane. The Working Group quickly realized the severe financial impact this could have on small systems. They also recognized that this problem transcends the Arsenic Rule as more and stricter standards are being set for drinking water. Each placing additional financial burdens on small systems. The Working Group made two recommendations:
That the NDWAC convene a national Working Group of recognized experts to review EPA's methodology and assumptions for determining national affordability.
That a ''Sustainability Fund'' be designed to assist small systems that have demonstrated no feasible alternatives to keep water user fees within the limits of affordability.
It should be noted that the second recommendation goes well beyond the SRF fund concept. The SRF fund will definitely need to be substantially increased to meet the costs for implementing a new arsenic standard. However, the SRF in and of itself will not be sufficient. Operating an arsenic removal treatment facility is very expensive for a small system that in the past was required to have little or no treatment. If the new arsenic standards are truly set for the best interest of the national public health, then many small systems will require continued and on-going financial assistance to meet these requirements. i.e., a ''Sustainability Fund''. This will be true for an arsenic standard today, as well as other additional and stricter water quality standards tomorrow.
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It should also be noted that the Working Group had considerable discussion on linking a ''Sustainability Fund'' with consolidation of treatment facilities, regionalized operation and/or management, central testing labs, and other methods to improve efficiency of operations where applicable.
Comments as a City Engineer from a small town:
(The following comments are from myself as a City Engineer in a small community and are not the opinions of the NDWAC or the Arsenic Working Group though some members may share the same or similar opinions.)
There are approximately 180,000 water systems in the United States. 90% of which are defined as small systems, i.e., serving less than 10,000 people (most serving less than 3,300). These systems serve approximately 10% of the population (@ 25 million people). Hot Springs has a population of @ 4,100 people; on the larger size of small. Right now my arsenic concentration is 8.8 ug/l. If I need to install arsenic removal treatment in our community. It will most likely cost between $1 to $2 million dollars in capital cost and an additional $2–3 hundred thousand dollars a year to operate. My annual operation and maintenance expenses right now are @ $400,000 per year. Without financial assistance, I would need to at least triple my water utility fees to meet this expense. Current monthly water fees for a typical household of three people is @ $22.80/month. This is during the winter or off season when they is no outdoor watering taking place. This amount would escalate to nearly $70/month. The City also charges residential users a $14.20/Month Sewer Fee and a $17.55/ Solid Waste Fee.
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Needless to say, this is a tremendous financial burden to a small community in rural South Dakota where per capita and family incomes are some of the lowest in the nation. However, if it needs to be done, then we need to figure a way of how to do it.
Today we are having testimony on national health affects, national costs, and national cost/benefit relationships. However, we should also have a discussion on priorities. Priorities of a nation—and priorities of a small town. It is your job to decide how to allocate our national resources to achieve the most good and the best protection of public health. It is my job to help decide how to best allocate the scarce financial resources of a small town to meet to our many community needs. Our goals are the same although our priorities probably differ.
This is not to say that arsenic levels in drinking water are not a public health concern. But it is important to realize that small towns are confronted with an array of serious problems that must also be dealt with.
In general, people receive more than 95% of there daily government needs from local government. Local government is responsible for law enforcement, education, water treatment and distribution, sewer collection and disposal, solid waste collection and disposal, storm drainage, streets, libraries, parks and many other services. The vast majority of this is funded through local property taxes and user fees and, unfortunately, not federal or state income tax.
If the federal government places certain mandatory requirements on local government, then the federal government needs to be sensitive on how the implementation of one federal requirement may impact the services of other local services including those that affect public health. My financial hands are very much tied. In South Dakota, we have a state property tax cap of no more that a 3% per year. If I need to increase funding for water treatment, then either rates have to skyrocket or something else is funded less.
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When the federal government sets water quality standards that have been determined to be in our nations best public health interest, then the federal government also needs to provide financial mechanisms to enable all communities to meet that standard and sustain it, especially those that cannot financially do it by themselves.
In 1996, the amendments to the Safe Drinking Water Act established the Drinking Water State Revolving Fund. This was a great step forward in financial assistance. In the wake of new arsenic and other impending water quality standards, this fund will need to be dramatically increased. However, it does not go far enough. SRF provides only low interest loan money (and some grant funds) for capital construction. It helps get the treatment plant built, but it provides no long term commitment to keep the plant operational. In fact, there will be some small communities, that you could give them the treatment plant and they would not be able to afford to operate it.
If certain water qualities are determined to be in the nations best public health interest, then the federal government needs to enable all of us to meet those standards by assisting those communities that require some sort of continued assistance. A separate fund (or an extension of the SRF fund) needs to be created called the ''Sustainability Fund''. This fund, a ''Sustainability Fund'', would be a source of continued revenue to needy small systems so they would be able to meet the drinking water quality standards established in this country. Creating a ''Sustainability Fund'' ultimately addresses the ability of the American Public to pay for the basic necessity of water service. By doing this, we enable all Americans to share in clean drinking water without placing undue financial burden on small community water systems.
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Chairman EHLERS. Thank you. Dr. Beck.
STATEMENT OF DR. BARBARA D. BECK, PRINCIPAL, GRADIENT CORPORATION, REPRESENTING THE NATIONAL MINING ASSOCIATION, THE AMERICAN WOOD PRESERVERS INSTITUTE, AND THE NATIONAL RURAL WATER ASSOCIATION
Dr. BECK. Thank you. Is this on?
Chairman EHLERS. I don't believe so.
Dr. BECK. Thank you, Mr. Chairman. Thank you the rest of the Committee. I am very pleased to be here. My name is Barbara Beck. I am a Toxicologist and Risk Assessor. And, again, my career in this field: a number of years ago at the Harvard School of Public Health, I was Regional Expert in Toxicology at Region I EPA where I first became acquainted with arsenic as a reviewer on EPA's first risk assessment forum panel report on arsenic, and have spent at least 15 years evaluating issues of toxicology and risks associated with arsenic.
I am here to provide comments on several of the recent evaluations of arsenic toxicity and risk, especially the NRC 2001 report. I will also provide some comments on the benefits review—the SAB benefits analysis, and, where appropriate, contrast some of those conclusions with those of the earlier NRC report.
First of all, I think the NRC subcommittee should be commended. They performed yeoman-like work in an incredibly short period of time. When one realizes that this report came out in only four months, it is really quite remarkable.
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To start off with, I think it is important to realize that here in the United States, we don't have any evidence of arsenic-related diseases at typical U.S. exposure levels. This is in contrast to situations outside the United States. And this is reflected in a number of studies, the study of Utah, as well as some earlier studies performed by academic researchers.
The key issue, which was highlighted at the very beginning by the Chair, is really what happens with low levels of arsenic concentrations in water that are typical of the U.S. situation. I believe that the evidence would indicate that these lower levels are relatively lower risk or perhaps no risk and that this is consistent with a nonlinear or a sub-linear dose response model.
The key conclusions of the NRC report, especially as reflected in the executive summary, I believe are not well supported by the scientific evidence, and, in some cases, are inconsistent with the body of the text. Specifically, the selection of a linear no-threshold model for extrapolating risks down to low levels, I believe was policy-based rather than science-based. In fact, there are other equally or perhaps more valid approaches that could have been used, the results compared and contrasted, and an evaluation of the uncertainties in the models could have been performed. In fact, such an approach is consistent with EPA's cancer risk assessment guidelines, which were proposed in '96, as well as in the original NRC report, which did explore the use of nonlinear models at low doses.
The statement in the executive summary implying that effects may be occurring at low levels in U.S. populations, is not, I believe, consistent with the text of the report. The text of the report, specifically the chapter on mechanisms, is really quite measured and highlights many of the uncertainties in extrapolating from results in cells to whole organisms. But it is very difficult to say that because an effect observed—is observed in a cell at a specific dose level that the same effect will occur in a whole organism.
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There are three main lines of evidence that I believe support a nonlinear dose response model. The first is that other models, in particular the Weibull model, used in the '99 NRC report, as well as the paper by Morales cited in the NRC 2001 report, fit the data as well and, in some cases, better than the linear models used.
The second is a qualitative argument from cell and animal studies. Arsenic does not interact directly with DNA. It is the interaction of chemicals directly with DNA that form the theoretical underpinning of the linear no-threshold model, a model which is not unanimously agreed upon by scientists in general.
The second is that there are qualitative differences between what happens at low doses versus high doses of arsenic in cells. It appears, in fact, that there may be induction of protective effects at low levels, such as DNA repair enzymes or antioxidant systems.
Finally, the epidemiology studies, I believe, do not find any consistent or convincing effects of arsenic at levels less than 100 micrograms per liter. One study by Ferreccio of Chilean-of individuals exposed in Chile to arsenic in water, is provided as qualitative support for effects at low levels and is used in quantitative manner. This study is highly problematic in terms of quantification of risks for a number of reasons, such as selection of control populations and how the doses were estimated.
I would like to just briefly touch on the issue of non-cancer effects. It is clear that arsenic at high levels is associated with non-cancer effects. No one would debate that. The NRC report, I believe, concludes appropriately that the information is not there to quantify these effects. The SAB report concludes that these effects can be quantified and implies that there may be effects at low levels. In fact, from what I can tell, the support for non-cancer effects at low levels is provided by a single, unpublished Ph.D. thesis which indicates increase in markers of cardiovascular disease and diabetes associated with arsenic, but these markers are not quantitatively related to disease, and these were not actual disease endpoints.
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I have a number of recommendations for what could be done going forward. Some of these recommendations actually could be accomplished within a fairly reasonable period of time. I believe it is important to explore other nonlinear dose response models for the relationship between arsenic and health effects as was done in the first NRC report. But it is important for risk managers to understand the uncertainty in the risks associated with low levels of arsenic.
And then the Utah study of arsenic in drinking water, a study sponsored by EPA and directed by EPA, I believe offers the opportunity for further evaluation of the data from that study to determine whether some of the results from that study are inconsistent or consistent with the risk estimates presented in the NRC report. Thank you very much.
[The prepared statement of Dr. Beck follows:]
PREPARED STATEMENT OF BARBARA D. BECK
Thank you for the opportunity to discuss recent developments in the science concerning arsenic in drinking water, specifically in the areas of the toxicology of arsenic and the quantitative relationship between low level arsenic exposure in drinking water as is found in the United States and the probability of disease from those exposures. My name is Barbara Beck and I am an expert in toxicology and in health risk assessment for environmental chemicals. I have been engaged in the scientific discourse on the toxicological and epidemiologic effects of arsenic for over 10 years in various contexts, including original risk research and site-specific applications. My statement is focused in particular on the National Research Council (NRC) September 2001 report, ''Arsenic in Drinking Water: 2001 Update.''
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I am testifying at the request of the Environmental Arsenic Council, National Mining Association, Utilities Water Act Group, Edison Electric Institute, American Wood Preservers Institute, and National Rural Water Association. The opinions that I express represent my own independent conclusions based upon my review of the report and my experience in areas of toxicology of arsenic.
I would like to note that the opinions I state today are shared by others, particularly Dr. George Parris, with the American Wood Preservers Institute. Dr. Parris has prepared his own written testimony and is here in the audience today available to take questions.
Arsenic is recognized as a drinking water contaminant, however it is also a naturally and commonly occurring element, detectable in most soils and water bodies. It is for this reason that many scientists and organizations are interested in the human health risks associated with arsenic, because it is found throughout the environment.
The authors of the NRC 2001 report should be praised for performing a comprehensive and thoughtful analysis of this complicated issue over a very short period of time. I generally feel that the authors completed the task with which they were charged. However, I feel that the report and in particular the Executive Summary presents conclusions that are not necessarily supported by the available scientific literature. Rather, many of the conclusions presented in the report are based on assumptions that are based not on science but on policy, an approach that perhaps should have been left to EPA and regulatory organizations. I intend to summarize specific comments on the science and the Report.
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1. There is no epidemic of arsenic disease in the United States
Although arsenic at relatively high levels in drinking water in countries outside the U.S. has been associated with a number of diseases, it is important to recognize that such clear associations have been not been observed in U.S. populations. The arsenic diseases that are generally of interest can be categorized into two groups: cancer and noncancer effects. Cancers include the skin and internal organs, in particular cancer of the lung, bladder, and urinary tract. Noncancer effects associated with arsenic exposure include hypertension, reproductive, vascular, dermal, central nervous system effects, and diabetes. These diseases are not uniquely associated with arsenic exposure; there are many other risk factors that may strongly influence these endpoints.
There is only one large-scale study of arsenic diseases in a U.S. population. This EPA sponsored and directed study by Lewis and coworkers (1999)(see footnote 2) found no convincing evidence of cancer or noncancer effects at average exposure levels up to 191 mg/L, well above any of the proposed drinking water levels. While there are limitations to the Lewis et al. study, this study presents the possibility of no arsenic diseases at typical U.S. exposures. The public health significance of this finding is that the number of cancer cases reduced in the U.S., as the result of implementing any lower MCL for drinking water, may be unrecognizably small or nonexistent.
2. The Executive Summary of the NRC 2001 report should not be taken literally
Several statements in the Executive Summary are inconsistent with the accompanying report text. These statements either oversimplify the conclusions or are, in some cases, contradictory to the main report. For example, the Executive Summary concludes, ''any hypothetical threshold would likely occur below concentrations that are relevant to U.S. populations.'' (p.6, NRC 2001) Relevant concentrations would be in the range of 3 to 50 mg/L (see p.98, NRC 2001). This conclusion is based on comparisons between levels at which arsenic affects cells in culture and levels of arsenic in urine of exposed individuals. In contrast, Chapter 3 of NRC 2001 notes that there are limitations to determining what might happen at low doses in exposed individuals using information from mechanistic studies in isolated cells, and concludes that only qualitative comparisons may be appropriate. Importantly, the committee notes that mechanistic studies do not permit the use of cell culture data to definitively quantify risks in the whole organism. Thus, the statement in the Executive Summary indicating that thresholds of arsenic are within the levels to which people are exposed is not supported in the main report or in the scientific literature. The Executive Summary should not be taken at face value.
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3. Specific comments on the science of the NRC 2001 report
It is important to recognize that it is uncertain whether as to there are any health effects at low doses of exposure to arsenic and the magnitude of those effects. Thus, it is plausible that low doses of arsenic may be of virtually no toxicological consequence. Nonetheless, it is difficult to directly estimate arsenic disease in populations exposed to low levels of arsenic either because a study lacks sufficient resolving power to detect disease or because there is in fact no increase in disease.
In the NRC 2001 report, risks from low levels of arsenic exposures in the U.S. are extrapolated from models based on studies of internal cancers in populations outside the U.S. that were exposed to high levels of arsenic. Any extrapolation of these effects to low doses is affected by the assumptions selected. Among the techniques used in the NRC 2001 report on arsenic, there are different mathematical models, different mechanistic justifications for those models, and their application to different epidemiological studies for different diseases. Understandably, various combinations of these assumptions yield quite different risk estimates. Where the NRC 2001 report described preferences for certain data, they provide inadequate guidance as to their selections. The report should have conducted more complete analysis using the equally or more valid data and models.
3A. More plausible models are available other than those in the NRC 2001 Executive Summary
A common theme in the NRC 2001 report is the selection of the most conservative modeling approach by default, because there is no basis for doing otherwise. The NRC 1999 and 2001 reports' model selection is policy-based. By first requiring a full toxicological explanation of a model before accepting the use of that model, this approach reverses the usual process of general model fitting. NRC 2001 unfortunately employs this constraint. Virtually all of the NRC 2001 models are variants of models linearizing at low doses and forced through the origin (no effects at ''zero dose''). The analysis by Morales et al. (2000) shows that the dose-response relationship at low doses of arsenic is highly unstable and that this relationship is poorly described by a linear model (see Table 5, Morales et al., 2001). As described below, there is a scientific basis for employing other models that are non-linear and which would likely indicate lower risks than those presented in NRC 2001.
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Introduction to models
Models are the primary tools used to take data from individual scientific studies and predict the health effects from arsenic in drinking water, particularly at low and relevant levels of exposure. Ultimately, models are used to inform us of how a regulation may improve public health, for instance by estimating the number of cancer cases avoided by enforcing a particular exposure limit. Although models are mathematical representations of real, empirically measured data, there should be a biological basis to their shape. There are generally recognized techniques that can provide insights and guidance when constructing dose-response models. For arsenic, it is necessary to use the models that are most appropriate for the available data.
Statistical aspects of arsenic dose-response models
There are reasons to question the statistical validity of the NRC 2001 report's default linear model for the dose-response curve of arsenic at low levels. The NRC 2001 and Morales et al. 2000(see footnote 3) papers propose two different measures of model fitness, and apply these measures to a wide variety of models, including linear, polynomial, exponential, and multistage models. NRC 2001 notes that the dose-response curve is most likely to be sigmoidal, a shape which assumes nonlinearity. The nonlinear models perform as well or better than linear models according to the various measures of fitness presented in NRC 2001 report (for example, see Table 5–4). The NRC 2001 report selected a more conservative model, in the absence of any convincing proof of linearity. At the very least, the NRC 2001 report should have considered multiple model forms simultaneously to establish a range of valid dose-response relationships, and therefore a range of potential doses of concern. The degree to which the different models fit the data could then have been compared. In addition, the models also differ among other factors in their use of a baseline group (e.g., U.S. or Taiwanese populations). The selection of this group has a significant impact on the risk estimates. The Executive Summary presents only the highest risk values in the body of the table, noting the lower risks in a footnote. Although the Executive Summary notes that the panel was divided regarding the most appropriate baseline group, the presentation of the lower values in a footnote implies that the results based on the Taiwan baseline group are of a lesser validity.
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3B. Mechanisms support a non-linear dose-response for arsenic
An evaluation of arsenic toxicological mechanisms indicates that a non-linear dose response model is more plausible than the linear dose response model. The use of a non-linear model would result in lower risks than those presented in the NRC report. As the NRC 2001 report itself indicates, arsenic is not directly genotoxic, meaning that arsenic does not interact directly with DNA to cause point mutations. This is important in terms of understanding the relationship between arsenic exposure and toxicological effects. The assumption that a low dose of a carcinogen is linearly associated with increased risk for disease (an assumption that is not unanimously agreed upon by scientists) is based primarily on studies of chemicals that interact directly with DNA. In theory, but not necessarily in actuality, a single molecule could lead to a tumorigenic response. In contrast, the evidence is quite strong that arsenic does not interact directly with DNA. This based on studies using cancer cell lines, cultures of primary cells, and human lymphocytes exposed in vivo. Some of the common types of indirect cellular effects from arsenic exposure include chromosomal aberrations, cell signaling, cell cycle control, apoptosis, oxidative stress, and altered gene expression.
There are mechanistic differences between the effects at low and high doses of arsenic that support the use of non-linear dose-response relationship for modeling arsenic carcinogenicity. Low levels of arsenic exposure can induce protective mechanisms that limit its toxicity (see for example Slayton and Beck, 2001). Low doses of arsenic have been noted to promote many effects associated with vitality: increased cellular viability, increased cellular levels of protective molecules such as glutathione, and up-regulation of genes relating to DNA repair, control of oxidative stress, and cellular redox control. Treatment with low doses of arsenic may build resistance to higher doses. Thus, low doses of arsenic may be of virtually no toxicological consequence, and this can be reflected in a nonlinear dose-response model. In such a model, lower doses are of relatively lower toxicity than higher doses.
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Additional support for a non-linear dose response model for arsenic is provided by animal studies evaluating the possible nutritional essentiality of arsenic. While it is certainly not proven that arsenic is an essential element, scientists have called for more research on this topic rather than discarding the possibility (Institute of Medicine (IOM) 2001)(see footnote 4). Moreover, the IOM 2001 report refers to a study (presumably Mayer et al., 1993)(see footnote 5) that shows hemodialysis patients with lower serum arsenic levels than controls were at risk for central nervous system and vascular diseases. The possibility that arsenic might be an essential element supports the use of a non-linear dose-response relationship for modeling arsenic's noncancer effects.
3C. Cancer epidemiology studies overall provide no evidence of cancer at low levels
Cancer is probably the most important endpoint for quantifying risks of arsenic to public health. While serious noncancer effects are associated with arsenic, these generally occur at higher levels than cancer effects (see Section 3D). There are five recent studies discussed in NRC 2001 that associate arsenic with cancer. Four of these studies show no effects of arsenic till levels well above the present MCL. The fifth study, based on a Chilean population, alleges effects below the MCL, but the study has serious limitations that I believe preclude its use for quantification of risks. Nonetheless, the NRC 2001 report, which acknowledging the limitations of this study, used the study to present quantitative estimates of risks for the Chilean study population, and as justification for doing performing the same extrapolation for the Southwestern Taiwanese data.
The first study, Chiou et al. (2001), notes that the relative risk for urinary cancer and transitional cell carcinoma in a population of northeastern Taiwanese, using a National Taiwan comparison group, was statistically significant only at arsenic concentrations greater than 100 mg/L. In the second study by Morales et al. (2000), the relative risk for lung and bladder cancer in a population of southwestern Taiwanese, using a southwest Taiwan comparison group, showed a dose-response relationship at arsenic concentrations greater than 400 mg/L. In contrast to the NRC 2001 report, Morales considers multiple combinations of dose response formulas and comparison populations in parallel. In the third study by Lewis et al. (1999), the relative risk for lung and bladder cancer in a population of in Utah, using a general Utah comparison group, was not significantly greater than background rate at mean levels up to 191 mg/L. In the fourth study by Tucker et al. (2001)(see footnote 6) in cancer was observed only at peak concentrations of 150 mg/L or higher.
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There are strong concerns with the NRC 2001 report's use of the Ferreccio et al. 2000 study to quantify risks at low exposures to arsenic from three regions in Chile. The weaknesses of this study include inconsistency in dose estimation and selection of case controls. The selected dose ranges vary in different analyses and the numbers in the control groups differed from the numbers intended in the study design. Some of these weaknesses, which are commonly found in case-control studies, are well characterized in a recent paper by Jack Mandel (Mandell and Kelsh, 2001).(see footnote 7) The authors themselves observe that the control selections could leas to a bias with overestimation of risks at low arsenic levels and underestimation of risk at high arsenic levels. Thus, it is inappropriate to use this study in a quantitative manner.
3D. Non-cancer epidemiology studies overall provide no evidence of effect at low levels
Serious noncancer effects generally occur at higher levels of exposure than do cancer effects. I would suggest caution when using noncancer effects to quantify risks at low levels of exposure. The studies in the peer-reviewed literature generally provide no evidence of noncancer effects until exposures reach relatively high levels, well above the present MCL. There are five recent studies associating arsenic with noncancer effects. Four of these studies, which are cited by NRC 2001 when discussing human health effects (see Chapter 2, NRC 2001), show no effects of arsenic till levels well above the present MCL. A fifth study alleges effects below the MCL, but the study has limitations that I believe preclude its use for quantification of risks.
The NRC 2001 report does not use studies on noncancer effects to quantify risks. Instead, the NRC recommends a qualitative treatment of non-cancer effects. However, given the limitations of the currently available data, the EPA Science Advisory Board's (SAB) recommendation for quantitative treatment of noncancer effects in its benefits report is not well supported.(see footnote 8)
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The first and second studies, Rahman et al. 1999(see footnote 9), and Chen et al. 1995(see footnote 10), note that hypertension doesn't occur until high doses of arsenic (500 mg/L and 700 mg/L, respectively). In the third and fourth studies, by Tseng et al. 2000(see footnote 11), and Rahman et al. 1998(see footnote 12), the authors show that diabetes also doesn't occur until high doses (700 mg/L and 500 mg/L). There are strong concerns with the fifth study, an unpublished doctoral thesis by Gomez-Caminero (2001)(see footnote 13), that used biomarkers to suggest noncancer effects occurring at low doses. These biomarkers are not clearly established predictors of disease, particularly in a quantitative sense.
4. Public health consequences
The NRC 2001 report updated the NRC 1999 report on arsenic in drinking water by reviewing significant new literature. The authors have also revised the modeling by changing the shape of dose-response model used for bladder and lung cancers, incorporating control groups to establish ''zero dose'' for the relative risk model, and considering different baseline disease risk measures for both the study population and the U.S. population. However, the report only pursues one approach to the data, and constrains itself to highly conservative linear dose-response models.
There remains a great deal of uncertainty as to whether there are any health effects for arsenic at low levels in drinking water. The small number of cases (projected by NRC 2001 using a linear model, out of the total number of bladder or lung cancer cases in the U.S.) avoided as a result of implementing any lower MCL will undoubtedly be small, and could plausibly be as low as zero. It is unlikely that the number of cancer cases reduced for the U.S. population would be measurable. This might have consequences for any cost benefit analysis relying upon the NRC 2001 report.
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5. Recommendations
I have several specific recommendations for the use of the NRC 2001 report and the available literature. First, more plausible non-linear models should be used to extrapolate risks from populations with high arsenic exposures to populations with low arsenic exposures. Second, the models and risks derived from the models should use graphical methods to communicate their findings, and to illustrate concepts of uncertainty and variability in the data. Risk estimates should be quoted as ranges of the number of cancer cases reduced at different drinking water target levels. Finally, the Lewis et al. (1999) data on a U.S. study population should be pursued further to determine whether it is consistent with exposure estimates and corresponding risks from the Taiwanese epidemiological studies.
Thank you.
Chairman EHLERS. Thank you. Mr. Rubin.
STATEMENT OF SCOTT J. RUBIN, ATTORNEY AND CONSULTANT, PRESENTING RESEARCH CONDUCTED ON WATER SYSTEM AFFORDABILITY FOR THE NATIONAL RURAL WATER ASSOCIATION, SELINGSGROVE, PENNSYLVANIA
Mr. RUBIN. Mr. Chairman, and, members of the Committee, my name is Scott Rubin. It is my pleasure to appear before you this morning. The Arsenic Cost Workgroup recognized that there may be small water systems that will be unable to afford to comply with the arsenic rule. I believe that the Workgroup greatly understates the problem and fails to discuss the consequences of this problem.
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EPA assumed that people in small communities can afford to pay water bills of $800 per year. EPA then compared this figure to existing water bills, which it said were only about $200 per year. This leaves a margin of $600 that water bills can increase and still be affordable. Simply, EPA believes that it is okay for water bills to quadruple.
There are four significant problems with EPA's assumptions. First, EPA focuses on median income rather than a more accurate measure of economic need, such as poverty. Second, EPA's assumption that 2.5 percent of income is affordable is inconsistent with our experience with other utility services. Third, EPA's use of national averages and medians does not accurately measure the people who will have to pay for arsenic compliance. And, fourth, existing water bills in many parts of the country are significantly higher than EPA assumed. In nine states, the median cost of water was over $300 back in 1990.
The map, which is provided here in the room and is also appended to my written statement, shows the 461 counties that are likely to be affected by lowering the arsenic standard to 10. What do we know about these counties?
First, in these counties, there are nearly 13,000 small water systems, but only about 750 large water systems, those serving more than 10,000 people. Second, about h of these counties are very small, with fewer than 50,000 people in them. And, third, more than half of these counties have a median income below $25,000, well below the national median income. There are more than 4,000 small water systems in those low-income counties. And that is what is shown in red and the bright pink on the map.
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In addition, some of these states have the highest water rates in the country already, particularly when compared to income levels. In 1990, the three states where water bills were the highest, as a percentage of income, were Texas, New Mexico, and Arizona. These three states will be seriously impacted by a reduction in the arsenic standard.
Simply, when we look at those areas that will be affected by a lower arsenic standard, there may be hundreds, or even thousands, of small water systems that will not be able to afford the cost of arsenic removal.
Several studies show that most low-income families will pay their utility bills and cut back on something else. And often, that something else is food and medical care. Therefore, we must evaluate not only the health impacts of reducing arsenic levels, but also the offsetting health impacts of low-income families reducing their spending on food, medical care, and other necessities.
The Arsenic Workgroup recommends that Congress should authorize additional funding to help small water systems that face serious economic problems, and this is an excellent idea. But I would go further.
First, EPA must change the way it evaluates whether small water systems will be able to afford a new regulation. Compliance costs, existing water bills, income levels, and ability to pay, should be analyzed only for those areas that will face compliance costs, not for the whole country.
Second, EPA must set a reasonable and realistic threshold for affordability. It is not reasonable to assume that water bills can quadruple or that low-income families have an extra 30 or 40 or $50 per month to spend for water.
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And, finally, EPA should evaluate the public health consequences of tradeoffs that low-income households will be required to make in order to pay higher water bills. Will low-income families be better off with less arsenic in their water instead of having more food on their table? This is the kind of question that we must ask because this is the very real kind of tradeoff that tens of thousands of families will be forced to make.
Mr. Chairman, I would like to thank you again for allowing me to appear before you today.
[The prepared statement of Mr. Rubin follows:]
PREPARED STATEMENT OF SCOTT J. RUBIN
Mr. Chairman and Members of the Committee,
It is my pleasure to appear before you today to discuss whether small water systems will be able to afford to comply with a more stringent arsenic standard in drinking water.
The Arsenic Cost Workgroup recognizes that there ''may be small water systems. . .that will be unable to afford [to comply] with the arsenic rule.''(see footnote 14) I believe that the workgroup greatly understates the problem and fails to discuss the consequences of these affordability problems.
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EPA's Approach to Affordability
Let me start with a quick review of EPA's approach to evaluating whether small water systems can afford to comply with a reduced arsenic standard. EPA starts with the assumption that people in small communities can afford to pay 2.5% of the national median household income for water. EPA calculated the national median income for small water systems to range between $29,000 and $33,000 per year in 1995 for small systems of different sizes. The result is that EPA assumes that a water bill of as much as $830 per year in 1995 dollars is affordable.(see footnote 15)
EPA then subtracts from this figure an amount representing existing water bills, again in 1995. EPA says that the median cost of water in 1995 was between $195 and $228 per household per year. This leaves a margin of more than $600 per year that water bills can increase and still be ''affordable'' under EPA's criteria. Simply, EPA believes that water bills can quadruple and still be affordable.
EPA also found that nearly every arsenic-removal technology that is ''affordable'' for small water systems carries a price tag of between $100 and $500 per household per year.
The Cost Workgroup relied on EPA's approach to affordability. That reliance led to the workgroup's failure to understand the severity and magnitude of the problem.
Problems with EPA's Affordability Analysis and Assumptions
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In fact, we know that most of EPA's assumptions are wrong. And we know that most small water systems that will be impacted by a more stringent arsenic rule will not look like the national medians that EPA used.
There are four significant problems with EPA's affordability assumptions and analysis:
1. EPA focuses on median household income—that is the income at the 50th percentile—rather than a more accurate measure of economic need, such as the 10th or 20th percentile of income or the number of households in poverty. It may be true that 50% of the households can afford water bills of $800 per year, though I doubt it, but it certainly is not true that households in poverty can afford water bills of that size.
2. EPA's assumption that 2.5% of median income is affordable is not well supported. We can look to the cost of basic telephone service, which averages less than $300 per year (less than 1% of median household income), and see how low-income households respond. Even with billions of dollars of federal and state funding to help low-income customers pay their phone bills, 13% of households with incomes below $10,000 per year do not have telephone service. That number rises to 20% for households with incomes below $5,000 per year.(see footnote 16) Even these figures may understate the problem, as one study of single mothers found that ''about one-third of the welfare-reliant mothers had their telephone disconnected or went without any phone service throughout the previous year.''(see footnote 17)
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3. EPA's use of national averages and medians does not accurately measure the people who will have to pay for arsenic compliance. Arsenic in drinking water does not occur everywhere. My analysis of data from EPA's Arsenic Occurrence Database shows that there are only about 460 counties in the United States that have water systems with arsenic readings of 10 mg/L or higher. This represents less than 15% of the counties in the U.S. (I will discuss the characteristics of these, arsenic-affected counties in more detail.)
4. Existing water bills in many parts of the country are significantly higher than EPA assumed. According to the 1990 census, the national median cost of water was between $200 and $250 per household per year. But in nine states, the median cost of water was more than $300 per household—and this was ten years ago.(see footnote 18) Unfortunately, as I will discuss in a moment, several of these states with high water costs will be affected by a more stringent arsenic regulation.
Characteristics of Arsenic-Affected Counties
The attached map shows the 461 counties that have at least one water system that has recorded an arsenic reading of 10 mg/L or above. The shadings on the map show how the county's median household income in the 1990 census compares to the national median household income of $30,000 at that time. The pink and red counties have incomes below the national median, while the two shades of green show incomes above the national median. So, what do we know about these 461 counties?(see footnote 19)
177 of the counties (38%) have a population of fewer than 25,000 people
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271 of the counties (59%) have a population of fewer than 50,000 people
235 of the counties (51%) have median household income below $25,000 in 1990, compared to national median of $30,000 in 1990
There are more than 4,000 small community water systems (CWS) in the 235 counties with median incomes below $25,000
In all arsenic-affected counties, there are 9,108 CWS that each serve fewer than 500 people
The counties have 12,991 CWS that each serve fewer than 10,000 people
The counties have just 751 CWS that each serve more than 10,000 people
I We also know that some of the states that will be seriously affected by a lower arsenic standard have some of the highest water rates in the country already, particularly when compared to income levels. For example, in 1990, the three states where water bills were the highest as a percentage of median income were Texas, New Mexico, and Arizona. Each of those states had median water bills of more than $300 per year and those water bills represent between 1.2% and 1.4% of median income.(see footnote 20) As the map shows, these three states will be seriously impacted by a reduction in the arsenic regulation. In fact, more than half of the lowest-income counties (counties with median household incomes below $20,000 per year) that would be affected by this regulation are located in these three states.
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Simply, when an analysis is focused on those areas that will be affected by a lower arsenic regulation, there are strong indications that thousands of water systems will not be able to afford 100 to $500 per household annual cost of removing arsenic from drinking water.
Consequences of Unaffordable Drinking Water Regulations
What happens when a household cannot afford to pay a higher water bill? A recent study conducted for the State of Iowa reached dramatic conclusions about the tradeoffs that low-income households must make in order to pay their utility bills.(see footnote 21) That study concluded that, in order to pay their home-heating bill, low-income households made the following tradeoffs:
Over 12% went without food at some point during the month
More than 20% went without necessary medical care (failed to see a doctor when sick, failed to fill prescriptions for medicine, failing to take the full dosage of a prescription so it would last longer)
Nearly 10% were unable to pay their mortgage or rent, risking foreclosure or eviction
Almost 30% did not pay other bills or incurred debt to pay the heating bill
There is every reason to believe that low-income consumers would behave the same way if another essential, unavoidable utility bill (the water bill) increased significantly.
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A recent study from the Economic Policy Institute shows that these serious tradeoffs occur even for households with incomes that are twice the poverty level. Among the study's conclusions is that ''nearly 30% of families with incomes below twice the poverty line faced at least one critical hardship such as missing meals, being evicted from their housing, having their utilities disconnected, doubling up on housing, or not having access to needed medical care.''(see footnote 22)
These studies provide just two examples of the mounting body of evidence that requiring low-income families to increase their expenditures on a necessity will result in a reduction in other essential expenditures—such as food, shelter, utilities, and health care. Therefore, in deciding whether to require low-income families to pay dramatically higher water bills to reduce the level of arsenic, policy makers must evaluate not only the health impacts of reducing arsenic levels, but also the off-setting health impacts of reducing low-income families' spending on food, heating, cooling, and medical care.
Recommendations
The Arsenic Cost Workgroup recommends that Congress should authorize additional funding to help small water systems that face serious economic problems, and this is an excellent idea. It also recommends that the National Drinking Water Advisory Council should review the way in which EPA conducts affordability analyses, and I also strongly support that recommendation. But I would go further.
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I have three recommendations that I believe would go a long way toward correcting the problems that I have identified.
First, EPA should change the way it evaluates whether small water systems will be able to afford to comply with a new regulation. EPA's analysis should look at the affected water systems, or perhaps aggregate the information as I have done at the county level. Compliance costs, existing water bills, income levels, and ability to pay should be evaluated only for those areas that will face compliance costs, not all water systems in the country.
Second, EPA should set a reasonable and realistic threshold for affordability. It is not reasonable to assume that people, especially low-income families, can afford to have their water bills quadruple. It is not reasonable to assume that low-income families have an extra $30 or $40 or $50 per month to spend on the water bill.
Third, EPA should evaluate the public health consequences of tradeoffs that low-income households will be required to make in order to pay substantially higher water bills. Is it better to have a low-income family use $25 per month for food, heating, cooling, medicine, a trip to the dentist, or safer drinking water? It depends on the relative health benefits of each. I don't know the answer; I don't know if a low-income family would be better off with less arsenic in its water instead of having more food on the table, or if it would be better off with less arsenic in its water instead of being able to have everyone go to the dentist twice a year. But those are the kinds of questions that EPA must ask, because those are the very real tradeoffs that tens of thousands of low-income families will be forced to make.
Mr. Chairman, I would like to thank you again for allowing me to appear before the Subcommittee today.
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Chairman EHLERS. And thank you, Mr. Rubin, for being the closest to the 5-minute limit. What is especially remarkable is that you are an attorney. But we really appreciate that. Mr. Olson.
STATEMENT OF MR. ERIK OLSON, SENIOR ATTORNEY, NATURAL RESOURCES DEFENSE COUNCIL
Mr. OLSON. Yes. Thank you. Well, I appreciate the opportunity to testify. When I go home tonight, in Ms. Morella's district, and talk to my 13-year-old son, I will have to tell him when I am insisting he do his homework, that I am a member of a distinguished Panel, according to the Chairman of this Committee. Maybe that will work this time.
I wanted to talk a little bit about the incredible 59-year history of this rule making and the important contributions of the three panels that have spoken earlier, or had representatives speak earlier today.
As many of you know, the standard that we are debating was originally set during World War II in 1942. That is actually still the standard enforceable today. It obviously is not protective of public health. As long ago as 1962, the U.S. Public Health Service recommended that that standard be dropped down to 10 parts per billion, which is what was established as a standard in January of this year. EPA actually missed three separate statutory deadlines to set a new standard, and there have now been seven National Academy of Sciences reports on arsenic in drinking water, the most recent one of which you just heard about.
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We think, at some point, we have to bite the bullet and make a decision on this very important contaminant. I think the bottom line is that what the National Academy of Sciences has just told this Committee is that even if we set a standard at three parts per billion, which is the lowest level EPA is considering, and the lowest level that EPA says is feasible to achieve, the rate of cancer, the risk of cancer, would still be 1 in 1,000. What does that mean? That is ten times higher cancer risk than EPA says is acceptable.
EPA, since the Ford Administration, from the Ford Administration, the Carter Administration, the Reagan Administration, the first Bush Administration, and the Clinton Administration, all held that the highest acceptable risk for a contaminant in drinking water is 1 in 10,000. What the National Academy of Sciences just told us this morning is that even at three parts per billion, the lowest standard on the table, we are at ten times higher cancer risk than EPA says is acceptable, and has said for decades, is acceptable. That is a startling figure and it is not my figure. It is the National Academy of Sciences' figure.
The other two very important points from the Academy's most recent study that I think deserve highlighting are, first of all, they look very carefully at the issue of whether there might be a threshold for—or a nonlinear dose response for arsenic. Contrary to what you just heard from a previous witness, the Academy did go over that data and, frankly, said, as Dr. Goyer testified this morning, that there is not sufficient evidence to assume that there is a threshold, at least in the doses we are talking about, and there is not sufficient evidence to show that there is a nonlinear dose response.
I think the other important point that deserves emphasis is EPA's occurrence estimates. What has been lost here is that, according to EPA, 36 million Americans drink water every day that contains over three parts per billion of arsenic. What does that mean? Thirty-six million people today will be picking up a glass of water or cooking with water that exceeds by ten-fold, according to National Academy of Sciences, the maximum acceptable risk for cancer. It is about time we do something about it. We have been debating it long enough.
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Now, what about costs? We have heard a lot about that. The National Drinking Water Advisory Council—we have just heard a witness testify from that group. I was a little surprised that he didn't mention the first sentence in their conclusion, which is that the Working Group believes that EPA has produced a credible estimate of the cost of arsenic compliance, given the constraints of the present rule-making, data-gathering, and cost models. The bottom line is that this committee that was very much dominated by the regulated industry, their consultants, and academics, found that EPA's cost estimates were credible. What does that mean?
The National Academy has now said that EPA's risk estimates were very low and they believe that the risks are much higher than EPA estimated. The cost estimates were credible. What that means to us is that we need to be driving this standard well below 10. We believe the standard should be set at three parts per billion.
We have listed from that National Drinking Water Advisory Council report on page nine of our testimony—or page 10 of our testimony—a list of factors that could drive the cost substantially below what EPA estimated. And we believe that it is likely that EPA actually may have overestimated the cost significantly.
Finally, the third panel was the Science Advisory Board. We have already heard some of the issues that that committee raised. I will just mention that we think it is very important to focus on quantifying the skin cancer, heart disease, high blood pressure, and diabetes that that committee recommended. The bottom line is that the benefits are much higher than EPA initially thought. The costs are about the same or lower, and those costs are about three dollars per household per month for 90 percent of the people that are affected.
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Yes. The small systems are going to have a problem complying. We think the way to deal with that is by targeting the $1.7 billion in Federal money that is sent to public water systems to those systems that really need it—the small systems. Thank you very much for the opportunity to testify.
[The prepared statement of Mr. Olson follows:]
PREPARED STATEMENT OF ERIK D. OLSON
SUMMARY
After over 40 years of debate and contention, the facts on arsenic in drinking water are clear. The National Academy of Sciences (NAS), which has now produced seven reports addressing arsenic in drinking water, has concluded twice in as many years that arsenic is known to cause lung, bladder, and skin cancer in humans, and may also cause other cancers including kidney, prostate, and nasal passage cancer. NAS and EPA's Science Advisory Board (SAB) also have concluded, based on studies of people who drink elevated levels of arsenic, that it likely causes high blood pressure, cardiovascular disease, and diabetes. Even small increases in the risk of contracting these diseases, NAS concluded in 2001, ''could be of considerable public health importance.'' Other adverse health effects are also possible, according to these studies, including reproductive effects. NAS thus found in 1999 that ''the current EPA [standard] for arsenic in drinking water of 50 (mg/l [micrograms per liter, or parts per billion] does not achieve EPA's goal for public-health protection and, therefore, requires downward revision as promptly as possible.''(emphasis added)
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Since the Ford Administration and the passage of the Safe Drinking Water Act in 1974, EPA has adhered to its policy that it will limit the lifetime cancer risk presented by any contaminant in drinking water to 1 cancer in 1 million people exposed. However, in unusual cases where it is particularly difficult or costly to remove a contaminant, the agency has allowed up to a 1 in 10,000 cancer risk—a hundred times higher than its general goal. By comparison, Congress unanimously passed the Food Quality Protection Act in 1996, which sets a 1 in 1 million lifetime cancer risk as the highest risk allowed for pesticides.
Now, according to NAS' most recent report issued in September 2001, arsenic at 3 parts per billion (ppb) presents a 1 in 1,000 lifetime risk of lung and bladder cancer alone—or 10 times higher risk than EPA says is the highest it will accept, in unusual situations. At the 10 ppb level established in January 2001, according to the NAS' estimates, the lung and bladder cancer risk is about 30 times higher than EPA says is the maximum acceptable cancer risk. Importantly, NAS' estimates are ''most likely'' cancer risks of an average consumer who drinks 1 liter per day—not the ''upper bound'' risks for a consumer who drinks 2 liters per day that EPA has traditionally used in comparing to its cancer risk target. Thus, if EPA were to use its traditional risk calculations and NAS' figures, in fact a 3 ppb arsenic standard would present far greater than 10 times higher risk than EPA has held, for over two decades, is acceptable.
According to EPA, about 12 million Americans drink water containing 10 ppb or more arsenic, and 36 million Americans consume water containing over 3 ppb. Thus, according to EPA's occurrence estimates, and NAS's risk estimates, about 36 million Americans drink water every day that presents a cancer risk from arsenic ten times higher than EPA considers acceptable.
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EPA found that it is ''feasible'' and ''affordable'' for water systems to achieve a 3 ppb standard. However, after proposing a 5 ppb standard in June 2000, the agency set the final standard at 10 ppb following an outcry from the regulated industry. Industry argued that there was insufficient science to back up the standard, and that EPA had grossly underestimated the standard's costs.
Now the National Academy of Sciences tells us that the science supporting a low arsenic standard—including a standard of 3 ppb—is solid. In addition, a panel of the National Drinking Water Advisory Council (NDWAC), heavily dominated by water utilities and their consultants, found that EPA's cost estimates were ''credible.'' While NDWAC found that some improvements were possible in the cost figures, some of those changes would increase, and others would decrease, the final estimate. In addition, the SAB panel reviewing the agency's benefits estimates found that EPA should have quantified many of the non-cancer (and skin cancer) health benefits of reduced arsenic exposure, and that studies have shown that the dollar benefits of avoiding cancer are likely far greater than those estimated by EPA. The SAB committee included only economists who favor ''discounting'' the value of lives lost in the future—an approach we and many ethicists and others find unacceptable because it means that our children and grandchildren's lives are considered essentially worthless if they die of cancer many years into the future. However, even these economists concluded that EPA's ''sensitivity analysis,'' in which it assumed that latency periods may stretch decades into the future and benefits could be discounted to reflect that, may overstate the impact of latency. Instead, SAB recommended use of a ''cessation lag'' approach that would reduce the apparent deflation of benefits due to discounting of future benefits.
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EPA's studies show that for about 90% of the households affected by a 3 ppb standard, the cost would be about $3 per month—about the same as a few soft drinks. People served by the smallest water systems (under 100 people), representing a tiny percentage of those affected, could pay up to $30/month. These monthly costs do not change based on whether the standard is 3 ppb or 10 ppb, because once technology must be installed, its cost is roughly fixed. We believe that the answer to high small system costs is not to condemn rural America to drinking dangerous levels of arsenic, but rather to target some of the $1.7 billion in federal public water system assistance (or perhaps new federal assistance) to these small systems.
In sum, NRDC, and dozens of other public health, environmental, and consumer organizations conclude that the science and the economics clearly indicate that a standard of 3 ppb should be immediately established for arsenic in drinking water. This level is feasible, affordable, and can be met by small systems with some of the $1.7 billion per year the federal government spends on assisting public water systems.
INTRODUCTION
I am Erik D. Olson, a Senior Attorney at the Natural Resources Defense Council. I also head the Campaign for Safe and Affordable Drinking Water, an alliance of over 300 public health, environmental, consumer, medical, and other groups dedicated to protecting the nation's drinking water. Thank you for the opportunity to testify today.
HISTORY OF ARSENIC TAP WATER STANDARD DEBATE
Despite extensive scientific proof that the current standard for arsenic in tap water of 50 parts per billion (ppb) is unsafe, it remained unchanged from 1942 until the Clinton Administration reduced it to 10 ppb in January 2001. In 1942, the U.S. Public Health Service (USPHS) established a standard for arsenic in tap water of 50 parts per billion (ppb), see, U.S. Public Health Service, Public Health Service Report, 58:69 (January 15, 1943), which remained in effect for over half a century even though it did not consider evidence accumulated over the past fifty years that arsenic causes cancer. Id.
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In 1962, the USPHS recommended that potable water supplies not exceed 10 ppb arsenic. U.S. Public Health Service, Public Health Service Drinking Water Standards: Revised, 1962, at 26; see, 27 Fed. Reg. 2151 (March 6, 1962). Nearly 39 years later, EPA finally adopted that recommendation in January 2001.
The National Academy of Sciences (NAS) issued a report in 1999 finding that ''it is the subcommittee's consensus that the current EPA [standard] for arsenic in drinking water of 50 (mg/l [micrograms per liter, or parts per billion] does not achieve EPA's goal for public-health protection and, therefore, requires downward revision as promptly as possible.'' National Academy of Sciences, Arsenic in Drinking Water, at 8–9 (1999) (emphasis added) (hereinafter ''NAS 1999 Report'').
The NAS, EPA, International Agency for Research on Cancer, and many other scientific international bodies have declared arsenic in drinking water a known human carcinogen, based on numerous studies from around the world showing that people get bladder, kidney, lung, skin, and other cancers from arsenic in their tap water. See, e.g., NAS 1999 Report, at 83–133 (1999); EPA, Integrated Risk Information System: Arsenic, www.epa.gov/iris/subst/0278.htm.
Many developed nations, the European Union, and World Health Organization have adopted an arsenic in tap water standard at least 5 times lower than the old U.S. standard of 50 parts per billion (ppb). See, e.g., Guidelines for Drinking-Water Quality, 2nd ed. Vol. 1. Recommendations. Geneva, World Health Organization, at 41–42 (1993) (setting 10 ppb provisional arsenic guideline, based on the inability of analytical equipment at the time to detect arsenic below that level, but stating that based upon health considerations, WHO would set a lower guideline).
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Tens of millions of Americans drink arsenic in their tap water supplied by public water systems, at levels that present unacceptable cancer and non-cancer risks. See, NRDC, Arsenic and Old Laws (2000) (available at www.nrdc.org/water/drinking/arsenic/aolinx.asp). According to EPA, about 12 million Americans drink tap water containing over 10 ppb arsenic, about 22.5 million drink tap water containing over 5 ppb, and about 35.7 million drink water containing in excess of 3 ppb. EPA Technical Fact Sheet on Final Arsenic Rule, January 2001 (www.epa.gov/safewater/ars/ars–rule–techfactsheet.html); EPA Fact Sheet on Proposed Arsenic Rule, June 2000 (www.epa.gov/safewater/ars/prop–techfs.html). Thus, according to EPA's occurrence estimates and NAS' most recent cancer risk estimates, about 36 million Americans drink water every day that contains arsenic at a level presenting over 10 times EPA's maximum acceptable cancer risk.
REPEATED CONGRESSIONAL ACTION ORDERING UPDATE OF STANDARD
Congress has required EPA to update the arsenic standard using modern science at least three times, and each time EPA has failed to do so. The first Congressional mandate for an updated arsenic standard came in the original Safe Drinking Water Act of 1974. Pub. L. No. 93–523, 88 Stat. 1660, 1662–65 (Dec. 16, 1974) (requiring EPA to first issue an immediate ''interim'' standard, and shortly thereafter to issue a ''revised'' standard for each interim standard, based on the most up-to-date data). EPA adopted the 1942 USPHS standard as an ''interim'' standard in 1975, 50 Fed. Reg. 59570 (Dec. 24, 1975).
Despite assurances that a final ''revised'' standard would be issued shortly thereafter, EPA failed to update the standard for over 25 years. The 1986 SDWA Amendments again required the arsenic standard to be revised—this time by 1989—and required EPA to review it every three years thereafter to determine whether advances in treatment technology would allow a stricter standard. Pub. L. No. 99–339, Title I, §101, 100 Stat. 643, 646 (June 19, 1986); H. Con. Rep. No. 99–575, at 30, 34 (May 5, 1986) (listing arsenic as standard to be updated by June 1989, and requiring triennial reviews thereafter). EPA missed all of these deadlines.
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Finally, the 1996 SDWA Amendments required EPA to propose an amended arsenic standard by January 1, 2000, and to finalize it by January 1, 2001. SDWA §§ 1412(b)(12)(A)(iv) & (v). Despite these Congressional orders for an updated standard, EPA still failed to propose or promulgate an updated arsenic standard.
Finally, NRDC sued EPA and OMB in May 2000, when the agency failed to meet its January 1, 2000 deadline for proposing a new arsenic standard. OMB had been unlawfully sitting on the agency's proposed 5 ppb rule well after the statutory deadline had passed. Shortly after NRDC moved for an injunction, OMB released the proposed rule, and EPA published it in the Federal Register on June 22, 2000.
NAS's 1999 REPORT ON ARSENIC IN TAP WATER
The NAS 1999 report found that people drinking arsenic in their tap water at the 50 ppb EPA standard ''could easily'' have about a one in 100 risk of dying from cancer—a 100 to 10,000 times higher cancer risk than EPA generally considers acceptable. See id. at 8. NAS stated, however, that it had not conducted a formal, full blown risk assessment to develop that estimate.
The NAS 1999 report also said that arsenic's known non-cancer toxic effects include toxicity to the central and peripheral nervous systems, heart and blood vessel problems, and various precancerous lesions on the skin, such as hyperkeratosis (a pronounced scaly skin condition) as well as changes in pigmentation. The NAS report and peer-reviewed animal studies have found that arsenic may also cause birth defects and reproductive and other problems, although some of these effects are less documented than arsenic's cancerous, skin, nervous, and cardiovascular effects. NAS 1999 Report at 2–5, 101–30.
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THE 2001 NAS ARSENIC UPDATE STUDY
The September 2001 National Academy of Sciences (NAS) report on arsenic-in-tap-water responds to and rebuts every scientific argument that had been advanced by industry-funded and a few other remaining skeptics about the risks posed by arsenic in tap water. The Academy found the health risks posed by arsenic are much greater than previously assumed by the U.S. EPA. EPA has therefore admitted to reporters that they have all but abandoned efforts to weaken the standard in light of the NAS report, and now are seriously considering a standard below the new 10 parts per billion (ppb) level.
In general, NRDC agrees with the conclusions of the Academy. However, NRDC's scientists believe that EPA should use the SAB's more detailed evaluation of the data available to quantify skin cancer and non-cancer health effects of arsenic, which is an important refinement of the NAS panel's statement that while non-cancer effects of arsenic are important and should be considered, the NAS panel did not have data available to it to quantify these non-cancer effects. Our scientists believe, as did the SAB scientists, that there are now adequate data available to quantify many of these effects of arsenic, such as skin cancer, high blood pressure, and diabetes.
The Academy review shows that the cancer risks of even low levels of arsenic in our tap water are at least several times higher than EPA has ever admitted. In fact, even a standard for arsenic of 3 parts per billion presents a cancer risk of about 1 in 1000—ten times higher than EPA considers acceptable. Of course, 3 ppb is less than one-third of the new 10 ppb standard that the Bush Administration suspended.
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Of greatest importance, NAS found:
Lung and bladder cancer risks of arsenic are far higher than EPA estimated. The NAS panel's detailed analysis of several new and previous studies found the risks of lung and bladder cancer from arsenic in drinking water are several times higher than EPA had estimated in developing its 10 parts per billion (ppb) standard. For example, NAS' best estimate is that at the new standard of 10 ppb, the combined lifetime risk of lung and bladder cancer is over 30 per 10,000 (ES–10). While the agency did not publish directly comparable cancer risk estimates, EPA had estimated that the population weighted cancer risks for average consumers if a 10 ppb standard were adopted would be several times lower (66 Fed Reg. 7008, Table III. D (2), 1/22/2001). In other words, NAS found the benefits of a stronger standard to reduce the incidence of cancer is many times higher than what EPA estimated.
Cancer risks far exceed EPA's maximum acceptable cancer risk level. For more than 20 years, EPA has abided by its policy that when it sets a standard for a carcinogen in tap water, it would allow for no greater than a 1 in 10,000 cancer risk. NAS found that even at 3 ppb, arsenic poses a bladder and lung cancer risk of about 1 in 1000—or about 10 times higher than EPA policy would allow. (NAS found that even if one uses Taiwanese rather than U.S. baseline cancer rates, which most NAS panelists, as well as NRDC scientists and many other independent experts believe would understate risks), the risk would be about 4 in 10,000 at 3 ppb, and about 13 in 10,000 at 10 ppb. Thus, at the new EPA standard of 10 ppb, NAS' best estimate of the lung and bladder cancer risk is about 30 times higher than EPA policy allows.
NAS rejects industry arguments that there are problems with Taiwanese studies and that there is an alleged safe ''threshold'' for arsenic. At EPA's request, NAS reviewed and ultimately rejected numerous industry arguments, including those leveled against Taiwanese data on arsenic's cancer-causing effects (e.g., that Taiwanese allegedly are malnourished). In addition, NAS rejected arguments that EPA should assume a threshold below which arsenic does not cause cancer. NAS found that while theoretically there could be a threshold at less than 3 ppb, there is no concrete proof of this. NAS rejected industry arguments that the so-called Utah study proves there is no cancer risk from arsenic in U.S. populations. Finally, the panel found that new studies of U.S. populations would not be likely to resolve uncertainties, finding that it would be virtually impossible to achieve adequate statistical power in such studies to make them scientifically valid.
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There are possible links between arsenic and high blood pressure and diabetes. NAS found that since it issued its 1999 report, ''evidence has increased that chronic exposure to arsenic in drinking water might also be associated with high blood pressure and diabetes.''
Arsenic exposure is associated with reproductive and respiratory problems. NAS also found that data published since the 1999 study shows an association between arsenic ingestion and reproductive problems (such as miscarriages and low birth weight) and non-cancer respiratory problems. NAS recommended additional studies on these effects.
The NAS findings have enormous implications, because EPA justified its decision not to adopt a 3 ppb standard, which it found feasible, on the theory that the benefits measured primarily as cancer reduction did not justify the costs. Now that NAS has found that the benefits are likely to be many times higher than EPA had estimated, and that even a 3 ppb standard may trigger cancer risks higher than EPA considers acceptable, EPA cannot justify a failure to set a standard of 3 ppb, the level it found is economically and technically feasible to achieve.
While the Academy made no policy recommendations, the NAS panel's findings make it absolutely clear that EPA should immediately lift its suspension of the new arsenic rule and set a stricter standard, in the view of public health, medical, consumer, and environmental organizations. We believe that EPA should move forward with a new rule of 3 parts per billion. While we acknowledge that this allows a cancer risk that NAS found is 10 times higher than EPA traditionally accepts, 3 ppb is the lowest level that EPA says is feasible.
NATIONAL DRINKING WATER ADVISORY COUNCIL (NDWAC) COST GROUP
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President Bush asked two advisory groups in addition to the NAS to review the new arsenic standard. Both panels recently issued reports that also undermined arguments for weakening the rule.
The first group was a subcommittee of the Cost Working Group of the National Drinking Water Advisory Council (NDWAC), which included a strong majority of drinking water industry representatives, and their consultants and suppliers. The NDWAC panel completed its review of the costs of implementing the new arsenic rule in mid-August. While the committee was heavily weighted with water industry representatives and allies, it still found that the new EPA rule's cost estimates to be ''credible.''
The Committee found that EPA should consider whether new lower cost technologies (such as granular ferric hydroxide and newer cheaper point of use devices in homes) that have become available since EPA's original analysis was done could lower costs, and made numerous other recommendations. While some of these recommendations could lead to slightly higher compliance cost estimates (we estimate, perhaps 5–15% higher), see NDWAC Cost Working Group Report at 13, and Table 3.3, the NDWAC panel also concluded that there were nine important factors could substantially lower the cost estimates. Based upon our past experience with implementation of other EPA standards, many of the NDWAC committee-listed factors are likely to substantially reduce the costs below EPA's estimates. Specifically, the report provides:
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Because of these factors—particularly as new lower cost technologies become available, and as many small systems restructure and regionalize as many experts (including the National Academy of Sciences' 1996 report on small systems entitled ''Safe Water From Every Tap: Improving Water Service to Small Communities'') recommend and expect—we believe that the true costs any arsenic standard will be substantially below those that EPA estimated.
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THE SCIENCE ADVISORY BOARD BENEFITS ANALYSIS
The Bush administration asked a third group, a subcommittee of the EPA Science Advisory Board (SAB), to review the overall benefits of the arsenic standard. That panel issued its final report in August, which urged EPA to quantify certain health benefits of reduced arsenic exposure that the agency had downplayed or failed to quantify.
For example, the panel urged EPA to quantify heart disease, high blood pressure, skin cancer, and diabetes (as well as, if possible, prostate cancer, kidney disease, and non-malignant lung disease) that may result from arsenic in tap water. The panel also said that EPA's estimate of the benefits of avoiding non-fatal but often debilitating cancer may be far too low, and recommended that the agency consider, among other papers, a major study that found a $3.6-million benefit per cancer avoided, rather than the just over $500,000 figure EPA used in setting the January 2001 standard.
While the SAB subcommittee included at least one respected arsenic health scientist, EPA only appointed economists who supported the idea of ''discounting'' the value of human lives lost in the future. This is an extremely controversial notion that is opposed by many public health experts, children's advocates, ethicists, legal experts, economists, and others. Public health, consumer and environmental groups had urged the EPA to include on the panel academic experts with diverse viewpoints on the discounting issue, but the administration rebuffed our requests. Not surprisingly, but disappointingly, the panel recommended that the value of lives in the future be ''discounted to present value,'' theoretically rendering the lives of our children and grandchildren who could die decades from now due to arsenic contamination to be all but worthless. While NRDC and others agree that many of the benefits of the arsenic rule will not be felt for many years to come, and sometimes will only be enjoyed not by us but by our children, grandchildren, or others not yet born, these peoples' lives are just as valuable as ours are, and should not be discounted.
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The SAB panel did urge, however, that EPA use a ''cessation lag'' approach to calculating the delay in benefits, rather than a simplified multiple year latency period, as EPA had assumed in its ''sensitivity analysis.'' See, 66 Fed. Reg. at 7016. The effect of this would be to reduce the reduction in presumed benefits caused by the latency period assumption.
We strongly believe that before EPA relies upon discounting of future benefits in this or any other rule, EPA must establish a carefully balanced committee of ethicists, legal scholars, public health and children's experts, and economists with a variety of opinions on this issue to publicly hear testimony and to openly debate the approach. This is not merely an issue for economists: it is at bottom a policy issue that should be debated in public.
CONCLUSION
Taken together, the three new reports are a strong signal that any efforts to weaken the arsenic-in-drinking-water standard must be rejected, and that a new, tougher standard of 3 ppb should be adopted. The National Academy of Sciences study completely rejects complaints about the supposed lack of scientific proof of the need for a tough new standard for arsenic in our tap water, and the cost review finds EPA's cost figures ''credible.'' To stay even within 10-fold of the EPA's traditional maximum acceptable risk of 1 in 10,000, EPA must set a new arsenic standard of 3 ppb—the lowest level that is ''feasible'' and ''affordable'' for water systems to achieve.
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Discussion
Chairman EHLERS. Thank you, Mr. Olson, and thank you, all of you for your testimony. We will now turn to the question period, and I have a host of questions that I am—but I only have five minutes. Let me spend a couple of minutes of that just giving a statement, a philosophical statement.
This is so typical of the really difficult decisions we face in the modern world, in terms of evaluating not just is something safe. First of all, we have to define what safe means. And part of the problem is that the public is not educated in science and risk assessment, cost-benefit analyses—something I am hoping to correct through the new education bill, at least help them to understand the science part of it better.
But there is no such thing as being perfectly safe. And I think one of the big problems we have in many of these issues, we don't back away and say, in the overall scheme of things, what do we really have to worry about? Just to take an example, in Arizona, is the risk of cancer from the arsenic in the drinking water the greatest risk or is it the risk of skin cancer from the excess sunshine they receive there? And I would bet if you analyze that at the cost, the likelihood of skin cancer is much greater than the arsenic. So where should Arizona put their money? Where should the United States put their money?
These are very, very difficult decisions. I do appreciate the testimony you have given. I think one thing that we have established fairly clearly is that we have a reasonably good handle on the dangers of arsenic at this point. I think the summaries that you provided, Dr. Goyer, give us a good idea of what the actual dangers are. And, Dr. Cropper, you added to that in terms of the epidemiology and other factors involved. And so I think we have a good handle there.
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I think we even have a pretty good handle on the cost based on what you have told me. There is, as you know, a difference between what the EPA said what the costs would be and what the Water Works Associations and various versions said it would be. But what is interesting—that is, if you flip—if you use the same assumptions for both, the cost figures come fairly close together. I am not sure about your figures, Mr. Olson. I—when you said it is likely considerably less than what EPA estimated, I haven't seen any of it until now. But I think there is pretty well agreement, if you use the same assumptions and do the calculations, as you have done, both figures come fairly close together.
The issue is, I think, a much broader one. It is not like air pollution where we say, okay, everyone has to clean up because everyone breathes the same air. This is a more specialized problem in which a very large majority of the country that doesn't have the problem will be seeking to tell a small part of the country, you have to clean up your water and we want you to pay for it. And this raises a host of issues. One option, of course, would be to set the standard lower and say each community has to decide for themselves what their highest risks are and where their money is going to go. That would be earth-breaking and contrary to current law.
But I am just stepping back and looking at the broad picture, which I think we should do at the Congressional level and say, are there better ways of doing this? And I hope that we, in fact, can, at some point, reach conclusions on that.
The—I have a host of specific questions, but the funding one, I think, gets to the core of it in many ways, because I think we have reached not unanimous agreement, but we are close to understanding the issue pretty well. But we—this has the echoes of the unfunded mandates argument, of the unfounded mandates argument, and also the figure that has been tossed out, $1.7 billion. If we, as a Nation, would decide to do this—in other words, all the people help those who have the arsenic to correct their problem—is that the best use? Can we save the most lives for $1.7 billion by doing that than by doing other things? Obviously not. If we spent that money to get people to stop smoking, we would save far more lives. With that kind of money you could bribe people to stop smoking and save far more lives. And I think you can probably give other examples too.
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But, at the same time, people, in a sense, are a victim of their public water supply. I am personally worried—as you know, 60 percent of the water in this country comes from—or 60 percent of the population is served by water taken out of the ground. And so that is a potential risk for a lot of people.
A simple question—is there some alternative way, other than purifying all the public water supplies, individual purifiers on home faucets—can they take out arsenic or not? If not, what is the cost of providing drinking water in some alternative fashion and the public water supply, as it is presently constituted, would be used for sprinkling lawns, washing cars, industry, and so forth? And if we did that, what is the potential contamination of our larger bodies of water if they are coming from that? A quick answer just to those questions if anyone can answer. Do the faucet purifiers that are so popular now—do—are they capable of taking out arsenic? Mr. Scheltens.
Point of Entry Technology
Mr. SCHELTENS. Yeah. Mr. Chairman, the answer is yes. Is point of use, point of entry technology that goes in the home around the faucet can remove the arsenic. In some cases, that may be the most cost-effective thing to do, particularly in very, very small systems where centralized treatment may not—may be——
Chairman EHLERS. You have to recognize there are many homes that still use well water from their own well.
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Mr. SCHELTENS. There are problems inherent with that type of treatment, particularly from the standpoint of control and management. If a town does it, everybody in that town has to do it, and everybody in that town has to be willing to let the local operator of the system maintain and check those things. There are people that, for obvious reasons, don't want somebody coming into their home. So total 100 percent implementation in communities is an issue that has not been addressed.
Chairman EHLERS. Well, I trust the people to do what is wise. I mean, we have the same problem with smoke detectors and so forth. And we trust the people—we pass the laws——
Other Delivery Systems for Drinking Water
Mr. SCHELTENS. The answer is are there other delivery mechanisms for drinking water? I mean, obviously there are. When you start looking at, you know, bottles and that kind of thing. Is that the direction that the United States wants to go? For years, we have trusted our drinking water system and have delivered water to about every county in America. You would look at some other delivery mechanism, such as the—it is a whole—to me, it is almost a step backwards. We go to a lot of other countries and we are afraid, ''to drink the water.'' Do we really want to send that message to the people in our country? I don't know of another way without radically changing, like you had said, in an earthshaking type of way, of changing the delivery system.
Chairman EHLERS. Okay. My time has expired. Let me—we are pleased to recognize Mr. Matheson, who was the next one to arrive, or the first one to arrive.
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The Utah Study
Mr. MATHESON. Thank you, Mr. Chairman. I appreciate you holding this hearing today. In reading this executive summary or this study, since I am a member from Utah, I need to ask a couple of questions about the Utah study that was not used. And I understand from looking at, at least the executive summaries, there were two reasons why the Utah study was not used.
The first was described as—and I want to read this to make sure I get it right—the unconventional method used in the—in that study to characterize exposure. And the second reason it wasn't used was due to the potential influence of lifestyle differences on the incidents of cancer between the study and the comparison group. And so I would like to ask, first, what were the methods used to characterize exposure in the Utah study, and how did these compromise the results of the study?
Dr. BECK. Well, I—what they did was they used a parameter called ppb years, in which you look at how many years someone was exposed at how many ppb's arsenic in drinking water. It is actually not an unconventional way of looking at exposure. In other epidemiology studies, we see that, for example, in workplace studies looking at contaminants in air. It does make it difficult to compare that study to the other studies that are out there. And, in fact, that is what I recommend would be useful to mine those data and to compare in a more conventional manner.
The other concern is the control population. The subject population in the Utah study were Mormons, which is how they were able—because the Mormons have such good information on where people live and when and how long—they were able to track individuals' exposures over time.
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The comparison population is the—was the rest of Utah, and there was a concern that because the rest of Utah was not a hundred percent Mormon that this might compromise those results. In fact, this was an issue that there were a number of questions and answers to the editor of that article after it was published. The authors of the study, Lewis, et al., conclude that because the general population of Utah, at the time where the exposures were occurring, that would be associated with cancer, was about 70 percent Mormon, that that should not have a significant impact on the conclusions.
I think, in addition, one other factor that I believe adds to the credibility of that study is you can look within the exposed population—and they have got three dose groups within the exposed population, high, medium, and low—you don't see any trend. Now, that—the actual values in those three groups will be influenced by the control group, but the relative change would not be. And you don't see any dose response trend going from high to low—or low to high doses.
So I guess my conclusion is that study could still be a very helpful study in terms of understanding the U.S. situation.
Mr. MATHESON. Does anyone else on the Panel want to respond to that question?
Dr. GOYER. No. Not to add to Dr. Beck's comments, but we did look at that study very carefully and we concluded in the way that it was analyzed that it was not conventional, in terms of the dosimetrics. And specifically, I think, for the dosimetrics, we said that exposure to arsenic, high concentrations for a short period of time, is characterized at the—to be the same as exposure of lower concentrations for a longer period of time. And I won't go through more detail, but that was unconventional.
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Mr. MATHESON. Uh-huh.
Dr. GOYER. We do have a lot of problems with the comparison group, though. You know, as Dr. Beck said there may be as many as 70 percent Mormons who weren't smoking, but it wasn't clear that that population, that comparison population was actually suitable, that there was not a smoking effect, and we thought there probably was. That is because just a—smoking is such an overriding risk for bladder and lung cancer. You just can't disregard that some of the comparison group were smokers.
Mr. MATHESON. Do you think there is a possibility that you could use the data from the study, but look at a control group or comparison group that would be more relevant?
Dr. GOYER. Well, that is the question—and I think—I—we have to leave that to the EPA——
Mr. MATHESON. Right.
Dr. GOYER [continuing]. The people who are conducting this study. And it may—I don't have privileged information about this, but I think they may be continuing to examine it, particularly in the light of the criticisms that have been raised.
Mr. MATHESON. Okay. Thank you, Mr. Chairman.
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Chairman EHLERS. The gentleman's time has expired. Next, we turn to Mr. Forbes.
Increasing Municipal Water Cost and Well Water as an Alternative
Mr. FORBES. Thank you, Mr. Chairman. Mr. Chairman, my question is for any member of the Panel. I want to thank you for your time and effort in being here. But as the cost of our municipal water increases to meet a more stringent standard for arsenic, do you think we could see municipal water treatment systems closing and reverting to well water? And, if so, at what cost do you believe municipalities would—who have made that investment in water treatment, would likely find it too expensive to sustain?
Mr. RUBIN. Well, I guess I will take the first crack at that. In very small communities, we have already seen water systems that serve, perhaps, 30 or 40 homes close down and encourage—or basically require those residents to drill individual wells or go back to individual wells that they may have stopped using 20 or 30 years ago. Because the Safe Drinking Water Act only regulates water systems that serve more than 25 people. So if a water system can get itself down to serving fewer than 25 people, and if individual wells are an option, then that certainly happens.
I have seen it happen with larger water systems where individual customers choose to leave the system and go back to an individual well, which, again, is not regulated in any way. In most cases, it is not tested or treated in any way. So that creates some serious problems. We don't know where that dollar threshold is. I have seen it happen in Pennsylvania where, in some small communities, when the water bill hits about $400 a year, people think that it is more cost effective to drill a well for maybe $2,000 or $3,000. They then view that as being an asset to their home, rather than an annual cost that they have to lay out. I don't know if $400 is the magic number, but that seems to be the point where I have seen people really start to think about whether they should still be on a public water system.
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Mr. SCHELTENS. I will pick up on that a little bit. People are confronted with a large cost——
Chairman EHLERS. Would you—is your microphone on?
Mr. SCHELTENS. When people are confronted with a large cost, you know, what we are thinking about from the cost thing that—from the cost projections is that people are going to put in some kind of technology to clean up the water. But the reality of the matter is, is that people will look for all sorts of alternative solutions. You know, where else can I get my water from? Should I put a well in my property or should I disconnect from the system? Should I look elsewhere for quality water? I mean, and all those things are going to happen out there.
Putting in a private well has—it is a double-edged coin. And, of course, it depends. It depends on how deep the water is, what the quality of the water is. But one of the problems it causes inside of a community—because we have had this in our community—is there are people who want to be on their own well, but they also want to be connected to the public water system, sort of like a backup.
The problem is, is the danger of cross-contamination. And private wells are not regulated. They are not protected. They are not—they don't do tests on them. And the problem becomes a cross-connection contamination between private wells and public water supplies. And that is a direction that you generally do not want to go. Because even with devices, such as back-flow preventors and whatever, they are mechanical devices, that if they are not properly inspected and tested on a regular basis, you will have that problem. Will people try to do that? I am sure they will.
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Mr. FORBES. The European Union has set its standard at 10 parts per billion. How high or low is its natural occurrence of arsenic and to what extent do Europeans rely upon well water, if you know? And how have they paid for meeting the standard? Nobody knows? Good. Thank you, Mr. Chairman.
Chairman EHLERS. Any further questions?
Mr. FORBES. No, sir.
Chairman EHLERS. The gentleman's time has expired. Next, we will turn to Mr. Baird.
Arsenic Removal Technology and Its Effects on Other Contaminants
Mr. BAIRD. I thank the Chair and thank the distinguished panelists for their most interesting testimony. Let me ask a couple of questions. Does the process to remove arsenic also remove other potential contaminants that may also be carcinogens or have other adverse health effects—lead, whatever?
Mr. OLSON. I will take a crack at the beginning of that. The answer is, yes. Many of the technologies that would be used to remove arsenic will remove other contaminants. Obviously, there are about a dozen different technologies that EPA has identified that can be used. Some of them, like membranes, tend to be more expensive and remove virtually everything. Some of the cheaper technologies will only remove a handful of contaminants. But clearly there are side benefits to removing arsenic in many areas.
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Mr. BAIRD. Other comments, or is that generally accepted?
Mr. SCHELTENS. Well, again, it depends. There—in the cost analysis, there were something like 13 or so, or 14 different technologies that were looked at for arsenic removal. And, of course, we are principally looking at arsenic removal. In some cases, there are some co-benefits. In other cases, there are no co-benefits, depending on what the water supply has in it or has not in it. It is really a site-specific question and it is not something that I think you can carry across the board.
Purposeful Contamination
Mr. BAIRD. The second question would be one of the concerns that has arisen in the wake of September 11. It has to do with the security of the Nation's drinking water system from purposeful contamination by things potentially far more potent than arsenic. I know there are some pros and cons, different intervention techniques. But in line with what Mr. Ehlers, the Chair, was suggesting, it would seem a more proximal cleaning mechanism, i.e., in the house, etcetera, might be more safe or perhaps—I am interested in any thoughts. Would our efforts to reduce arsenic possibly provide us any greater or lesser security due to—from intentional contamination? We are working on some legislation now to try to explore this question, but I am interested.
Mr. OLSON. Well, if we—first of all, Congress did, in 1996, authorize the use of these point of use, point of entry devices, as a compliance technology, which might be used by some small systems. At least, in theory, many of those would give you some benefit, even if there is contamination in a central unit. With respect to other contaminants, if they are introduced before the water is treated, there may be some ability to do that. And, you know, I think it is an issue, and we would be happy to talk to you in another forum, perhaps, about that.
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Cost-Benefit Ratio
Mr. BAIRD. Finally, I was intrigued by Dr. Rubin's comment. One of—I used to teach health care policy for a while. And so I am particularly interested in the notion which then we called quality-of-life years, which have been modified a little bit. But the premise being, how much bang do you get for your buck, so to speak. And if this, indeed, costs a substantial amount of time, have there been some comparative estimates? I thought the Chair raised a good point. Does vaccination, dental care, etcetera—what is—from either the EPA or Mr. Rubin or others, what is our bang for the buck?
Now, the sad thing about Congress is you can't take money set aside for water purification and move it over to another pot. It is theoretically fungible, but it not legislatively fungible, apparently, and I have come to learn. But were we to do that in this imaginary perfect world, which I sincerely thought I would inhabit when I came here, what would be the cost-benefit ratio of other potential applications?
Dr. CROPPER. Okay. Yeah. If you look in the EPA original analysis with all the caveats, the cost per avoided cancer case comes out to be about $6.5 million. Now, I mean, one of the things you would normally do in looking at cost effectiveness would be looking, perhaps, at the cost-per-life year saved. And one of the points that we made in the report was that if you did use the sorts of dose response functions, the proportional hazard models in Morales et al., where you really can look at how cancer cases avoided vary by age, and for lung and bladder cancers, these are going to be concentrated among older people, you could provide that information. And if somebody then wanted to calculate a cost-per-life year saved they could do it.
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In terms of how—you know, is this $6.5 million figure per cancer case avoided, or per fatal cancer avoided, high? Certainly there are, in the cost effectiveness literature, other interventions that are cheaper than that. As you say, if you really could take the money and put it into, you know, annual mammogram screening programs for women between the ages of 50 and 60, you have cost-per-life year saved of perhaps, you know, $15,000 per life year.
Mr. BAIRD. Thank you. So, in other words, basically we are saving some lives potentially, but it is—these cancers tend to manifest themselves relatively late in life, when other possible factors may also contribute. And relative to the qualities of life years saved, based on reducing the cancers of this cause, there may be other applications that might be more economical and more conducive to public health.
Mr. OLSON. Well, I would like to respond to that. First of all, the figures that were just cited on the cost per cancer avoided were based on the previous EPA cancer risk estimates, which we have now heard from the National Academy were quite low and need to be increased so that those costs per life saved would go down dramatically.
The second point is that there were—the Science Advisory Board and the National Academy both identified a lot of non-cancer health effects that may not manifest themselves only late in life. There may be some that manifest themselves well earlier than that. And the Science Advisory Board did recommend that EPA quantify those.
Mr. BAIRD. Okay. Thank you, Mr. Chairman.
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Chairman EHLERS. The gentleman's time has expired. I would just mention one point. That funds do become legislatively fungible as one acquires seniority.
Mr. BAIRD. I look forward to that day.
Chairman EHLERS. It helps if you get on the Appropriations Committee as well. Next, I am pleased to recognize Mr. Grucci from New York.
Scope and Scale of Arsenic Contamination
Mr. GRUCCI. Thank you, Mr. Chairman. Mr. Rubin, I am looking at your map that is attached to your documents, the one that is up on the easel there. And I notice there are a number of states that show no detects or no hits. Is that because it is beneath the—that level that you have identified here as—and, first, you have to help me understand what 10 ug/L stands for.
Mr. RUBIN. Sure. That is the easy part. The—that is 10 micrograms per liter or parts per billion.
Mr. GRUCCI. If I wanted to draw an analogy to that, and if this room was a tank of water, how much of that would be 10—what you just said?
Mr. RUBIN. I am going to point to some of these other folks to answer that one. I think someone said earlier, it is the equivalent of about a teaspoon in, what, 1.3 million gallons of water.
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Chairman EHLERS. Yeah. That was the figure I gave at the beginning. Right.
Mr. GRUCCI. And that is awful small.
Mr. RUBIN. And in terms of what is shown on the map, these data come out of EPA's arsenic occurrence database. So some of the states or counties that show nothing may be those that never provided information to EPA. Most of them are areas where the recorded arsenic concentrations are lower than 10 parts per billion.
Cancer at Current Exposure Levels
Mr. GRUCCI. Thank you. Dr. Beck, and please correct me if I misunderstood what you said, but I thought I heard you say that there were no cancer hits or detections as a result of arsenic at current levels. Was that what you said?
Dr. BECK. What I said was in the United States, there is no observed cancer at the environmentally relevant exposure levels.
Mr. GRUCCI. And what levels were in place at the time that you came up with that conclusion or you——
Dr. BECK. It is—what——
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Mr. GRUCCI [continuing]. The information directed you to that conclusion?
Dr. BECK. It is based on a number of studies. It is based on the Lewis study, which had levels up to—the Utah study, which had levels up to 190 micrograms per liter. There are other smaller studies that had been done that had looked at skin lesions and skin cancers. And then there was a study that was done in, I think, '94, looking at bladder cancer in different counties in the United States as a function of arsenic in drinking water. And so there are no observed—there is no good evidence of any observed cancer cases in the United States at typical U.S. exposure levels.
Mr. GRUCCI. My last question, doctor, would be, is there information that we can determine what percentage of cancer victims is attributed to arsenic in their system?
Dr. BECK. What one can do, and EPA did this in their MCL risk assessment, is one can estimate how many bladder cancer cases might be associated with arsenic at drinking water—different drinking water levels, and then you can compare that to the total number of bladder cancer cases. And the percent that would be associated with arsenic, using EPA's estimates, is fairly small, which partly explains why one doesn't see anything at the present exposure levels, that there is a much larger background incidence of bladder cancer, so that any impact of arsenic is fairly modest and wouldn't be detected.
Mr. GRUCCI. Would those levels fall above or below the percentage that Mr. Olson was talking about earlier?
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Dr. BECK. I am sorry.
Mr. GRUCCI. I believe he was indicating that EPA has said that three percent is as far down as they can get—conceivably get——
Dr. BECK. Oh. I——
Mr. GRUCCI [continuing]. Arsenic to. Would your numbers be above that three percent level or below that three percent level?
Mr. OLSON. Let me at least restate what I think I said. What I said was that EPA found that three parts per billion was a—the lowest feasible level, considering economics, that you could get to. And that, according to the National Academy study that just came out, as Dr. Goyer said earlier this morning, the cancer risk of bladder—combined bladder and lung cancer risk at that level is about 1 in 1,000, which is ten times higher cancer risk than EPA has considered is acceptable for the last 20-plus years.
Mr. GRUCCI. Thank you. I have—did you want to add anything more to that?
Dr. BECK. I think Dr. Goyer had a comment.
Dr. GOYER. If I could just elaborate just a little bit.
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Mr. GRUCCI. Uh-huh.
Dr. GOYER. First of all, the question of, are the cancers caused by arsenic in the United States visible? And, as has been said, compared to the background, it would be very hard to detect them. And, for example, the—and the committee really thought about this—and there is a section in the—in Chapter Six with regard—which pertains to the implications of this kind of thing.
The conclusion there is that the background levels of lung and bladder cancer are so high in the United States that increases—regional increases in small populations due to arsenic are practically impossible to detect. But the question that you asked, is there a way of calculating it, and Dr. Beck said there was. And what the committee determined was that the lifetime risk of being diagnosed with bladder cancer in U.S. males is 342 per 10,000. And that is for a period 1996 to 1998.
Now, at 20 parts per billion, which is higher than the 10, the subcommittee estimated a theoretical lifetime excess risk of bladder cancer in males of 45 per 10,000. So this would be 13 percent of the total bladder cancers would be—at 20 parts per billion would be due to arsenic.
Now, it would take an enormous—there are a lot of technical reasons why that would be hard to detect in the United States, and that is why we went to the Taiwanese studies where there were populations exposed. But that is to give you some perspective about what the impact would be.
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Mr. GRUCCI. Thank you. Thank you, Mr. Chairman.
Chairman EHLERS. The gentleman's time has expired. Another Michiganian, Ms. Rivers.
Different Research Perspectives
Ms. RIVERS. Thank you, Mr. Chairman. In the seven years that I have served on this Committee, we have had many times people come in as skeptics, those individuals whose view really stands in opposition to the bulk of scientific findings and conclusions. And in almost every case, whether we are dealing with global climate change or chlorofluorocarbons, those individuals have been associated with or funded by industries who are negatively affected by the proposed legislation. And, Dr. Beck, you would seem to fall into that situation. So I guess the first question I would ask you is, why shouldn't I discount or be very skeptical about your testimony, given the list of organizations that you say asked you to testify here, since they all seem to have a—you know, a financial interest in whether legislation of this kind goes forward?
Dr. BECK. I guess I have a number of answers to that. I think first is to look at the underlying science and the fact that I have published in peer-reviewed literature on arsenic. And I guess a second answer comes from an experience of the Society of Toxicology meeting about three years ago.
And the Society of Toxicology is a society that has members from academia, government, industry. And there is an annual debate at the meeting. And the debate this year was—or that year, which I believe was about three years ago—was whether there were thresholds for carcinogens. And we heard debates on both sides of the argument. And then afterwards there is always a hand count as to what the general—well, the consensus of the toxicological community was. And, in that case, the consensus was that there are, in fact, thresholds for carcinogens. So that was a general conclusion of the toxicological community. So I believe that it is not a view that is really out in left field or is unsupported or is an isolated view.
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In 1997, EPA, in fact, had their own expert panel that concluded specifically that arsenic was likely to have a nonlinear dose response relationship.
Ms. RIVERS. Well, one of the things that I am interested in, though, is—I mean, you are sitting on a Panel of one, two, three, four, five, six. It doesn't appear that the other five share your views on this. We don't have other scientists who are not associated with the industry here to make that argument. How many—I mean, how broadly are your views held and where would one go to find the people and the qualifications who share your view?
Dr. BECK. I think that the belief that arsenic has a nonlinear dose response is reasonably broadly held. I would point to a number of recent publications. For example, there is work out of the University of Nebraska by Dr. Sam Cohen, who has been looking at bladder cancer models in rats, looking at a metabolite of arsenic that seems to provide good evidence for—in fact, in that case, what I would say, almost a threshold-dose response relationship for arsenic.
Ms. RIVERS. How broadly are those views held, say, as a percentage of the people who are writing in peer-reviewed publications and who are discussing this actively? How broadly are your views held? Give a percentage.
Dr. BECK. Oh, gosh. I—you know, I would hate to give a percentage that I couldn't rely on. I would say it is broadly held that there are thresholds for carcinogens. As——
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Ms. RIVERS. No. I mean, your view on arsenic.
Dr. BECK. On arsenic being nonlinear, I would say that is a reasonably broadly held view, but I would hate to give a percentage without having done a survey.
Ms. RIVERS. All right. Of the other five that are on the Panel, have you found Dr. Beck's position or views to be held by individuals or entities who are not associated with affected industries? In other words, as you go out and talk about this and interact with people who are concerned, how many of you have found this point of view to be held by people who are not associated with industries who would be affected? Dr. Goyer.
Dr. GOYER. Well, I just can comment on—in a general way. The committee really looked at this question very hard and it looked at all the possible mechanisms, and there are 11 that are put in a tabular form in the document on mechanisms that could be related to causing the cancer from arsenic. And in each of these, we were not able to find a level below which cancer didn't occur. That is all—there is a list of 11 that caused cancer in cells outside of the body experiments in the range that—of concern in their drinking water today. Now——
Ms. RIVERS. But how many—but did you encounter people in your investigations or in your studies? Did you encounter the position that this was not a great threat and we didn't need to change regulation?
Dr. GOYER. No. I think to go—I would have to think about if there was anybody from industry and they—at any of the panels that we—and when we listened to people who thought there was a threshold.
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Ms. RIVERS. Okay.
Dr. GOYER. I am not aware. No.
Ms. RIVERS. All right. Okay.
Dr. GOYER. Of all the scientists—this—I should emphasize that there is—this report was composed by, I think, a credible group——
Ms. RIVERS. Okay.
Dr. GOYER [continuing]. That did not have any conflict——
Ms. RIVERS. All right. Okay.
Dr. GOYER [continuing]. And it was reviewed by a board.
Ms. RIVERS. I want to hear from the others, if I can. I know my time is up. Dr. Cropper.
Dr. CROPPER. This is really outside of my area of expertise.
Ms. RIVERS. Okay. Mr. Scheltens.
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Mr. SCHELTENS. I am not, you know——
Ms. RIVERS. No. No. I am not asking for your scientific—I am asking you if in your interaction with people on this issue that you are encountering people who say this isn't really—we shouldn't be very concerned.
Mr. SCHELTENS. I hear from that a lot, but you have to realize we also hear from a lot of people in small rural town America whose priorities are in other things and sometimes worrying about three or five or 10 micrograms per liter of arsenic is not significant and there are other problems in life.
Ms. RIVERS. Dr. Rubin—or Mr. Rubin, and, Mr. Olson.
Mr. RUBIN. I don't have anything to contribute on that.
Mr. OLSON. I haven't run into any.
Ms. RIVERS. All right. Thank you.
Dr. BECK. May I——
Ms. RIVERS. Yes.
Dr. BECK. With all due respect, Congresswoman, I don't believe I have ever said that arsenic should not be regulated or that the standard should not be changed. What I have said is that there is a great deal of uncertainty regarding what happens at lower levels and we need a full analysis.
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Ms. RIVERS. That is usually the testimony we get, is there is too much uncertainty to move forward.
Dr. BECK. No. I don't believe I have said that either. I believe I have said that we need a fuller analysis. I believe I would agree that 50 is too high.
Ms. RIVERS. Thank you.
Chairman EHLERS. Okay. The gentlewoman's——
Ms. RIVERS. Thank you, Mr. Chairman.
10 ppb Standard
Chairman EHLERS [continuing]. Time has expired. We will have a second round of questions. And following on with the question that Congresswoman Rivers just raised, let me put the question in a different way. Ignoring all economic aspects of it, ignoring, you know, how much it is going to cost, whether the citizens can afford it, do you agree that a 10 part per billion standard, just to pick one out of the air—a 10 part per billion standard is a reasonable standard to pick based on the scientific data? Is there anyone who disagrees with that? Dr. Cropper.
Dr. CROPPER. Well, I would disagree or I would object to your saying ignoring the economics of the issue.
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Chairman EHLERS. No. No. I am——
Dr. CROPPER. I mean—I mean I really do think that is really at the heart of what the debate is about.
Chairman EHLERS. No. Just wait until I ask the second question.
Dr. CROPPER. Okay.
Chairman EHLERS. Okay. Ignoring the economics, is 10 parts per billion a reasonable assumed standard based on the data?
Mr. OLSON. Well, our view is that, no, at this point, the scientific evidence points to the need for a lower standard than 10.
Chairman EHLERS. A lower—okay. So you vote for a lower one. Any one else? All right. Now, let us look at the economics. Just looking at the economics of what this will cost, and particularly certain communities, is this standard, 10 part per billion standard, well founded?
Mr. RUBIN. Yes. I can start on that. I think we—I would suggest that we break the question into two pieces. And the first piece——
Chairman EHLERS. I already did.
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Mr. RUBIN. Well, then I am breaking the second part of your question——
Chairman EHLERS. Okay.
Mr. RUBIN [continuing]. Into two pieces, which is, does it make sense for larger water systems in larger communities—and I think Mr. Olson gave the figure of about three dollars a month for the typical household in a large water system. And that makes sense. I think if there is—if there is consensus that 10 parts per billion is the right standard, and if you can get there in larger water systems for about three dollars a month or less, that sounds fine. And the problem is that about 90 percent of the water systems that will have to do something are—have fewer than 10,000 people in them. And as you reduce the number of people, the cost per household starts to go sky high——
Chairman EHLERS. Right.
Mr. RUBIN [continuing]. And that is where there is a serious problem.
Chairman EHLERS. Dr. Cropper, you were going to say something.
Dr. CROPPER. I would second Mr. Rubin's remarks, that that—I would agree that——
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Chairman EHLERS. Okay.
Dr. CROPPER [continuing]. It is appropriated for——
Mr. RUBIN. Exactly, Mr. Chairman.
How Americans Perceive Risk
Chairman EHLERS. I—let me comment. Years ago, a friend of mine who is a physicist and, therefore, all-knowing, wrote a very interesting paper about Americans' decisions on risk analysis, even though most Americans don't know what it means. And he did that by analyzing how many dollars we spend per life saved in this country. I haven't seen any recent compilation of that. His was approximately 20 years ago. But it was fascinating. Obviously, the one that—you save money by saving lives is smoking. And the cost of losing a life there is about $127 a year or something like that.
But then, as you go up to the positive side, the biggest saving of life possible per dollar spent is immunizations. We are so used to it here we don't think of that. But worldwide, that is the lowest. And then you go up for every $5,000 spent on guardrails and highways, you save a life. For every $50,000 spent on proper signage you save a life, and so on, and all the way up to the end of the scale, where it was for every $2 billion you spend on safety on nuclear power plants, you save one life.
That is a fascinating study on what people perceive is dangerous in their lives, but we see that now with aviation. People are afraid to fly. And, yet, even after the incidents we had, that is still, by far, a safer method, of flying. And we are going to spend billions more to make it safer. But it is already far safer than automobiles, trains, and busses.
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That gets back to the question we have here—how much risk do people associate with this? I think because it is arsenic, they feel very uncomfortable having arsenic of any sort in their drinking water. But are there other forgiven investment—are there other things in the drinking water that we could actually save more lives for the same investment than arsenic? That is a long way of leading up to a question. But I am going to ask each of you—just—it doesn't have to be scientifically based, just your gut feeling based on your experience with this. Dr. Goyer.
Dr. GOYER. I don't have an answer to that question.
Chairman EHLERS. All right. Dr. Cropper.
Dr. CROPPER. I can't say with regard to drinking water because my expertise really is in the area of air pollution, but certainly there are cases in air pollution control where you could save a life for less money.
Chairman EHLERS. And could you give a couple of examples?
Dr. CROPPER. Well, if you look at studies of the benefits and costs of the 1990 Clean Air Act amendments, okay, although we are looking at benefits in the aggregate from all of the different provisions, and there are probably some that are very high cost per life saved, you are still—I can't remember the exact cost figure for—certainly for the Clean Air Act from '70 to '90, the cost per life saved was something like $125,000. And I believe it still comes out somewhere in the ball park of a million dollars in the case of the Clean Air Act amendments of 1990.
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Chairman EHLERS. Mr. Scheltens, you are the water expert.
Mr. SCHELTENS. Well, the answer is——
Chairman EHLERS. Microphone, please.
Mr. SCHELTENS. The answer is, Mr. Chairman, is that the greatest threat that people see in drinking water is what they normally experience when they get sick today when they drink a glass of water, the chronic stuff. That is the organics. That is the microbials. In fact, of all the water outbreaks in this country, that is what you hear about, whether it is Cryptosporidium or Giardia or whatever the critter is.
And there is an easy thing—relatively easy thing to ensure good public water supply, and that is disinfection. And it might sound simple and easy because it is the greatest, biggest bang for the dollar this country has ever done, starting with chlorination, and now into other techniques. But, yet, there are systems out there where that is not consistent or it is not done. And this is not an expensive thing. It is not a difficult thing. But the bigger bang for the dollar is in those lives and in those illnesses caused by either not disinfecting or improper disinfection.
Chairman EHLERS. Does anyone else wish to comment on that? Dr. Beck.
Dr. BECK. There was a study published by John Graham a number of years ago, who, as you know, is now with the Office of Management and Budget, looking at the cost per life saved of various environmental regulations from drinking water to OSHA regulations and so forth. And there really is a tremendous range in the amount that it takes to save a life as a function of different regulations, with some of the most cost-effective ones being, for example, having to do with highway safety and traffic control.
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Chairman EHLERS. Uh-huh.
Mr. OLSON. I would just like to add one thing, which is that, again, we need to remember that we have just had an Academy report saying that the risks are far higher than what EPA had previously estimated. So all those——
Chairman EHLERS. Yeah.
Mr. OLSON [continuing]. Old numbers are wrong. But, also, we can't lose sight of the fact that a lot of the benefits, as we heard from Dr. Cropper, are non-cancer benefits. And very often they—well, they haven't been quantified by EPA, and often they just get lost in these discussions and in some of these debates. So it is important to consider those non-fatal cancers and the non-cancer effects like diabetes and heart disease and so on.
Chairman EHLERS. Mr. Rubin, anything you wish to add or——
Mr. RUBIN. The only thing I would add, Mr. Chairman, is that I mean, 30 years ago or so you passed the National Environmental Policy Act that includes as part of the consideration the—what I guess we all came to call the do-nothing alternative. And in some cases, and arsenic may be one of them, doing nothing might be the best thing you can do for public health when you look at the potential impacts it could have on families that are going to have to find a way to come up with another $300 or $400 or $500 a year to pay for marginally safer drinking water.
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Chairman EHLERS. All right. I appreciate those answers. And it is a good cross-section, I think, that illustrates the problem. I remember a few years ago, when we did the Clean Drinking Water Act, and I was still in the State Legislature when it first passed, and the screams of anguish from the small communities in our state who simply could not afford to meet those requirements. And it may be that we have to look at—I think we should, in fact, look at this a holistic way and say, what can we do to maximize the impact of our money spent on clean water, whether it is pathogens, biological pathogens, or arsenic or many of the other things?
Wood Preservation
Dr. Beck, I would like to get back to you. You have—you are here representing some groups that have serious concerns about this, not so much about the drinking water standard, but other uses of arsenic that might impact drinking water in some way. And one I am particularly aware of and knowledgeable about is the wood preservative industry. And I—that, again, makes it a very difficult environmental issue because the wood preservative industry, assuming people will continue to use wood for playground equipment and a lot of other things, they have saved millions of trees, rather than the old method of just putting it in and when it rotted, you chopped down another tree and put another one in.
The other factor is, when I—most of my life, people were using creosote as a—as the substance, which I think has been proven to be far more dangerous than what we are using now. What—how do you see all this coming down from your perspective—the wood preservative industry—how does one balance that out in society, the choices between cutting down two million trees versus using the wood preservatives, whatever the figures might be? And I just pick one.
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Dr. BECK. I mean, it is a very difficult question to answer. It is clearly something that there is a lot of active discussion regarding what is even the exposure to arsenic from CCA treated wood. And, clearly, the risk assessments that factored into the drinking water are going to factor into that.
You asked a broader question of what does this mean as far as conservation of resources. Certainly use of CCA wood does conserve resources. And I guess I don't have an easy answer to that, except that I think it is useful to look at it broadly, not only in terms of risks of arsenic, but conservation of resources, as well as what are the other materials that one would wind up using instead of CCA treated wood, if that were no longer a viable alternative, and what are the risks and benefits of the alternatives.
Chairman EHLERS. Thank you. I think all of this has illustrated the extreme complexity of environmental decision-making, and one for which most people, I think, don't have a deep appreciation. But it is very clear that this Panel does. I couldn't imagine a better Panel in terms of the cross-section of views and information presented. And I deeply appreciate your interest and your willingness to come here and educate us and, in turn, through us, educate the Congress. Thank you very much for your time, your energy, your answers. I appreciate it all very much. The meeting is adjourned.
[Whereupon, at 12 p.m., the Subcommittee was adjourned.]
Next Hearing Segment(2)
(Footnote 1 return)
See ''Arsenic in Drinking Water: 2001 Update,'' in Appendix 1.
(Footnote 2 return)
Lewis, D.R., Southwick, J.W., Ouellet-Hellstrom, R., Rench, J., Calderon, R.L. (1999). Drinking water arsenic in Utah: a cohort mortality study. Environ Health Perspect 107 (5) 359–365.
(Footnote 3 return)
Morales, K., Ryan, L., Luo, T., Wu. M., Chen, C. (2001) Risk of internal cancer from arsenic in drinking water. Environ Health Perspect 108 (7) 655–661.
(Footnote 4 return)
Institute of Medicine 2001. Dietary reference intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. National Academy Press, Washington, D.C.
(Footnote 5 return)
Mayer, D.R., Kosmus, W., Pogglitsch, H., Mayer, D., Beyer, W. (1993). Essential trace elements in humans. Serum arsenic concentrations in hemodialysis patients in comparison to healthy controls. Biol Trace Elem Res Apr 37:1 27–38.
(Footnote 6 return)
Tucker, S.B., Lamm, S.H., Li, F.X., Wilson, R.W., Byrd, D.M., Lai, S., Tong, Y., Loo, L. (2001) relationship between consumption of arsenic-contaminated well water and skin disorders in Huhot, Inner Mongolia. Inner Mongolia Cooperative Arsenic Project (IMCAP) Study. Final report. July 5, 2001.
(Footnote 7 return)
Mandel, J. and Kelsh, M. (2001). A review of the epidemiology of trichloroethylene and kidney cancer. Hum Ecol Risk Assess 7(4) 727–735.
(Footnote 8 return)
''Arsenic Rule Benefit Analysis: An SAB Review,'' by EPA's Science Advisory Board.
(Footnote 9 return)
Rahman et al. 1999. Hypertension and Arsenic Exposure in Bangladesh. Hypertension 33:74–78.
(Footnote 10 return)
Chen et al. 1995. Increased Prevalence of Hypertension and Long-Term Arsenic Exposure. Hypertension 25:53–60.
(Footnote 11 return)
Tseng et al. 2000. Long-Term Exposure and Incidence of Non-Insulin-Dependent Diabetes Mellitus: A Cohort Study in Arseniasis-Hyperendemic Villages in Taiwan. Environ Health Perspect 108:847–851.
(Footnote 12 return)
Rahman et al. 1998. Diabetes Mellitus Associates with Arsenic Exposure in Bangladesh. Am J Epidemiol 148:198–203.
(Footnote 13 return)
Gomez-Caminero, A. Cardiovascular Effects of Arsenic During Pregnancy. Doctoral Dissertation, University of North Carolina, Chapel Hill, 2001.
(Footnote 14 return)
Report of the Arsenic Cost Working Group to the National Drinking Water Advisory Council (Aug. 2001), p. 34.
(Footnote 15 return)
Environmental Protection Agency, Small System Compliance Technology List for the Arsenic Rule, EPA–815–R–00–011 (Nov. 1999).
(Footnote 16 return)
Federal Communications Commission, Telephone Subscribership in the United States (March 2001).
(Footnote 17 return)
Edin, Kathryn and Laura Lein, Making Ends Meet: How Single Mothers Survive Welfare and Low-Wage Work (Russell Sage Foundation 1997).
(Footnote 18 return)
Scott J. Rubin, A Nationwide Look at the Affordability of Water Service, Proc. 1998 Ann. Conf. AWWA, Vol. C, pp. 113–129.
(Footnote 19 return)
These data come from a database that I compiled using data from the 1990 census, 2000 census, and EPA's Safe Drinking Water Information System as of July 2001.
(Footnote 20 return)
Scott J. Rubin, A Nationwide Look at the Affordability of Water Service, Proc. 1998 Ann. Conf. AWWA, Vol. C, pp. 113–129.
(Footnote 21 return)
Mercier, Joyce M., Cletus R. Mercier, and Susan Collins, Iowa's Cold Winters: LIHEAP Recipient Perspective (Iowa Dept. of Human Rights, 2000)
(Footnote 22 return)
Boushey, Heather, et al., Hardships in America: The Real Story of Working Families (Economic Policy Institute: Washington, DC 2001).