[Senate Hearing 106-956]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 106-956
 
                OVERSIGHT OF THE SAFE DRINKING WATER ACT
=======================================================================




                                HEARING

                               BEFORE THE

                            SUBCOMMITTEE ON 
                     FISHERIES, WILDLIFE, AND WATER

                                 OF THE

                              COMMITTEE ON
                      ENVIRONMENT AND PUBLIC WORKS
                          UNITED STATES SENATE

                       ONE HUNDRED SIXTH CONGRESS

                             SECOND SESSION

                               __________

                             JUNE 29, 2000

                               __________

  Printed for the use of the Committee on Environment and Public Works










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               COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS

                       ONE HUNDRED SIXTH CONGRESS
                             second session
                   BOB SMITH, New Hampshire, Chairman
JOHN W. WARNER, Virginia             MAX BAUCUS, Montana
JAMES M. INHOFE, Oklahoma            DANIEL PATRICK MOYNIHAN, New York
CRAIG THOMAS, Wyoming                FRANK R. LAUTENBERG, New Jersey
CHRISTOPHER S. BOND, Missouri        HARRY REID, Nevada
GEORGE V. VOINOVICH, Ohio            BOB GRAHAM, Florida
MICHAEL D. CRAPO, Idaho              JOSEPH I. LIEBERMAN, Connecticut
ROBERT F. BENNETT, Utah              BARBARA BOXER, California
KAY BAILEY HUTCHISON, Texas          RON WYDEN, Oregon
LINCOLN CHAFEE, Rhode Island
                      Dave Conover, Staff Director
                  Tom Sliter, Minority Staff Director
                                 ------                                

             Subcommittee on Fisheries, Wildlife, and Water

                   MICHAEL D. CRAPO, Idaho, Chairman
CRAIG THOMAS, Wyoming                HARRY REID, Nevada
CHRISTOPHER S. BOND, Missouri        FRANK R. LAUTENBERG, New Jersey
JOHN W. WARNER, Virginia             RON WYDEN, Oregon
ROBERT F. BENNETT, Utah              BOB GRAHAM, Florida
KAY BAILEY HUTCHISON, Texas          BARBARA BOXER, California

                                  (ii)












 
                            C O N T E N T S

                              ----------                              
                                                                   Page

                             JUNE 29, 2000
                           OPENING STATEMENTS

Boxer, Hon. Barbara, U.S. Senator from the State of California...    85
Crapo, Hon. Michael D., U.S. Senator from the State of Idaho.....     1
Smith, Hon. Bob, U.S. Senator from the State of New Hampshire....    71

                               WITNESSES

Fox, J. Charles, Assistant Administrator, Office of Water, 
  Environmental Protection Agency................................     2
    Prepared statement...........................................    86
    Responses to additional questions from:
        Senator Crapo............................................    92
        Senator Smith............................................   102
Grunenfelder, Gregg L., Director, Drinking Water Division, 
  Washington (State) Department of Health........................    56
    Letter, follow-up to hearing.................................   120
    Prepared statement...........................................   117
    Responses to additional questions from:
        Senator Crapo............................................   121
        Senator Smith............................................   125
Gunter, Gurnie, Director, Kansas City Water Services Department..    57
    Prepared statement...........................................   126
Hirzy, William, senior vice president, National Treasury 
  Employees Union................................................    59
    Prepared statement...........................................   140
    Responses to additional questions from Senator Crapo.........   256
Kosnett, Michael, associate clinical professor, Division of 
  Clinical Pharmacology and Toxicology, University of Colorado 
  Health Sciences................................................    61
    Letter, follow-up to hearing.................................   137
    Prepared statement...........................................   131
    Responses to additional questions from:
        Senator Crapo............................................   138
        Senator Smith............................................   139
Noonan, Norine E., Assistant Administrator, Office of Research 
  and Development................................................     5
    Prepared statement...........................................    86
    Responses to additional questions from Senator Crapo.........   113
Olson, Erik, senior attorney, Natural Resources Defense Council..    62
    Prepared statement...........................................   258
    Report, Arsenic and Old Laws, NRDC..........................267-285
    Responses to additional questions from:
        Senator Crapo............................................   262
        Senator Smith............................................   265
Paris, David, Water Supply Administrator, Manchester Water 
  Treatment Plant, Manchester, New Hampshire.....................    63
    Prepared statement...........................................   285
    Report, Cost-Benefit of Proposed Arsenic MCL, American Water 
      Works Association.........................................300-317
    Responses to additional questions from Senator Crapo.........   296
Tompkins, J. Richard, president, National Association of Water 
  Companies and president, Middlesex Water Company...............    65
    Prepared statement...........................................   317
    Responses to additional questions from Senator Crapo.........   321
Van Dyke, Randall, general manager, Clay Regional Water and 
  president, National Rural Water Association....................    67
    Prepared statement...........................................   322

                          ADDITIONAL MATERIAL

Article, Litigation in the 20th Century on Artificial 
  Flouridation of Water.........................................202-256
Letters:
    Alliance for Discoveries in Health...........................   381
    American Dental Association..................................   327
    American League of Anglers and Boaters.......................   371
    Fairleigh Dickinson University...............................   181
    Fitzwilliam Village, NH, Water District......................   254
    House Committee on Science..................................186-201
    Manchester, NH, Health Department............................   385
    Pennsylvania State Supreme Court.............................   180
    Several foreign water/environmental ministers...............147-167
    University of Toronto School of Dentistry....................   183
Memoranda, water flouridation, EPA..............................168-179
Reports
    Arsenic and Old Laws, Natural Resources Defense Council.....267-285
    Arsenic in Ground Water Resources of the United States, U.S. 
      Geological Service......................................... 46-48
    Cost-Benefit of Proposed Arsenic MCL, American Water Works 
      Association...............................................300-317
    Variance Technology Findings for Contaminants Regulated 
      Before 1996, EPA........................................... 12-40
Statements:
    American Dental Association.................................330-371
    Association of State Drinking Water Administrators...........   387
    California Water Association.................................   372
    Castro, Richard A., El Paso, TX..............................   386
    City of Albuquerque, NM......................................   326
    Masters, Roger D., and Myron J. Coplan.......................   377
















                OVERSIGHT OF THE SAFE DRINKING WATER ACT

                              ----------                              


                        THURSDAY, JUNE 29, 2000

                                     U.S. Senate,  
               Committee on Environment and Public Works,  
             Subcommittee on Fisheries, Wildlife and Water,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 9:30 a.m. in 
room 406, Senate Dirksen Building, Hon. Michael Crapo (chairman 
of the subcommittee) presiding.
    Present: Senators Crapo and Smith [ex officio].

          OPENING STATEMENT OF HON. MICHAEL D. CRAPO, 
              U.S. SENATOR FROM THE STATE OF IDAHO

    Senator Crapo. This hearing will come to order.
    This is the Subcommittee on Fisheries, Wildlife and Water 
hearing on pending issues relating to the implementation of the 
Safe Drinking Water Act.
    As a schedule driven statute, the Safe Drinking Water Act 
deserves periodic and regular oversight. In 1999, this 
subcommittee held a hearing to receive testimony on matters 
that were of the highest concern to our stakeholders at that 
time. And it's our intention to provide a forum today for those 
matters that come to the forefront, both those matters that 
came to the forefront last year as well as any other issues 
that people are concerned about that feel we need to focus on 
during the next 12 months.
    Although there is no shortage of issues to discuss in our 
limited time today, it's my expectation that our witnesses will 
focus on many of their pressing concerns and raise as many of 
those issues as possible. While the magnitude of certain 
matters will draw considerable attention today, I hope not to 
foreclose debate on any and all issues.
    In 1996, Congress comprehensively reformed the Safe 
Drinking Water Act to accomplish several goals. Primary among 
these goals were the need to make regulatory implementation of 
health standards better reflect the availability of resources, 
science and actual risks. At the same time, a very rigorous 
schedule of rulemaking and other procedural steps was 
established to ensure that the Environmental Protection Agency, 
State environmental and health agencies, municipalities and the 
private sector would best serve the public.
    These developments have served to highlight the complexity 
of implementing a regulatory regime that aims to serve every 
American but can exacerbate resource and funding shortfalls at 
the Federal and State levels and in the private sector. As new 
rules are increasingly applied to smaller systems, the reach 
and impact of the Act touches even more people.
    I expect today for several witnesses to address the 
difficulties of establishing drinking water rules based on 
science that is constantly changing and open to different 
interpretations. Within this framework, the EPA is expected to 
produce standards that recognize the limitations of scientific 
understanding and the funding available to implement them. 
Rules will be instituted that ignore the realities of 
scientific uncertainty, with the knowledge the standards may 
have to be revised in the future to respond to information 
showing greater or lesser risks, and the finite resources 
available to respond to them are unrealistic and inappropriate.
    The spectrum of views represented by our witnesses today 
should provide a perspective on many issues raised by the 
implementation of the Safe Drinking Water Act. I am looking 
forward to a full and stimulating discussion of these matters 
and then exploring possible solutions to them.
    At this time, I ought to state to those present that we are 
going to have a bit of a problem with the voting schedule on 
the Senate floor. We are scheduled to have two votes back to 
back at 9:40, which means the votes probably won't start right 
at 9:40, and we will probably be able to go for about 10 
minutes into the first vote before recessing to go over to 
vote.
    Hopefully, the Senators this morning will all be on time 
and we will be able to make both of those votes in a short 
period of time and only have about a 15-minute delay. But 
because of that schedule, you probably won't see many of the 
other Senators making it here until after that break. That 
means, Mr. Fox, that they won't probably hear your testimony, 
but they will get to ask you questions.
    [Laughter.]
    Senator Crapo. So I'm sorry about that.
    We will proceed, Mr. Fox, to your testimony, and then see 
how far we can get through the questions I have before the 
votes are called. To the rest of you, I apologize. This is 
hopefully only going to mean about a 15-minute extension of the 
timeframe that we would have held you here today. But I 
apologize for the potential problem that we will have from 
interruptions from the Senate floor.
    And with that, Mr. Fox, you may proceed.

STATEMENT OF J. CHARLES FOX, ASSISTANT ADMINISTRATOR, OFFICE OF 
             WATER, ENVIRONMENTAL PROTECTION AGENCY

    Mr. Fox. Thank you, Mr. Chairman. I will soon be joined by 
my colleague, Dr. Noonan, who is the Assistant Administrator 
for Research and Development. There's a lot of unusual traffic 
patterns out there today and I apologize for my lateness.
    I am prepared to offer our detailed comments on how we are 
doing on the Safe Drinking Water Act, but if you'll indulge me, 
I need to start out with a comment on our favorite acronym. My 
understanding is that late last night, the Senate approved a 
rider to the supplemental appropriations bill that would have 
the effect of rolling back the total maximum daily load 
program, which provides, I think, important protections for the 
people of this country.
    I know the Senate prides itself on being a deliberative 
body, perhaps the world's greatest deliberative body. But I 
think you would agree that this is contrary to the well-
established processes of fairness that the Senate considers 
various legislation. And it's obviously contrary to the 
jurisdiction of this committee.
    This legislation, to my knowledge, was never voted out of 
this committee, never voted out of any committee in Congress. 
And unfortunately, we find ourselves now in a position of 
trying to deal with Clean Water Act legislation in the context 
of a military construction supplemental appropriations bill 
that will be considered under rapid consideration as the Senate 
tries to get out for the July 4th recess.
    I will just say that I remain committed to working with 
members of this committee to address any outstanding issues 
that remain. That is how I have approached this process from 
the beginning. I would urge members of this committee to 
contact members of the appropriations committee and respect the 
processes and the forums that exist to have these important 
deliberations about the future of water in this country.
    Senator Crapo. Well, I appreciate your statement, Mr. Fox. 
I should clarify, I understand as well and I'm aware of the 
provision that was put into the military construction 
appropriations bill, and in fact strongly support the inclusion 
of that provision. It was not the legislation that is, the 
legislation that Senator Smith and I have introduced that is 
before this committee, and is not a rider in that sense. It is 
simply an appropriations provision prohibiting the EPA from 
expending funds to proceed with the implementation of the rule.
    And as you know, you and I have a very big difference of 
opinion on whether the rule is an appropriate rule or a good 
rule for the water quality of the United States. And I respect 
that difference, and I do respect and acknowledge that you've 
been working with us very closely to address those issues.
    However, what you have been, you, the EPA, has been 
unwilling to do at this point is to give us time to work out 
those differences. And the EPA has been consisting in stating 
that it is going to proceed with the adoption and finalization 
of the rule. That being the case, Congress is left with 
virtually no option but to say to the EPA that it cannot expend 
funds on the implementation of the rule until we have worked it 
out.
    And last year, of course, we had Congressional action as 
well, as you know, to address slowing down the process. And 
given the fact that we were facing deadlines within literally a 
few weeks, we felt we had no other option other than to stop 
the EPA from proceeding.
    Now, assuming that that is what happens and this 
legislation passes, I still intend to work closely and to 
address these issues and to pursue the other objectives in our 
legislation, which are to address the very water quality issues 
that you are seeking to address in the rule. So I would hope 
that we can continue our discussions and our collaboration on 
this issue. But I hear your point and I'm certain that your 
comments will be quickly reflected from this hearing today to 
the other members of this committee and to the members of the 
Senate.
    Mr. Fox. Thank you very much.
    We are pleased today to be able to discuss EPA's 
implementation of the Safe Drinking Water Act Amendments of 
1996. Nearly 4 years into implementation, EPA has completed all 
of the actions that are required of us to date. I think this is 
a remarkable record, not just for the Agency, but frankly for 
this committee in the work that they did in outlining not just 
an ambitious but ultimately a workable schedule for providing 
drinking water that is safe for all Americans.
    As a result of the work of EPA, the States, water systems 
and the public, the United States has one of the safest 
drinking water supplies in the world. Over 90 percent of 
Americans served by community water systems receive water with 
no reported health standard violations.
    The 1996 amendments moved us toward more comprehensive 
drinking water protection and gave us the framework to reduce 
emerging risks. The Safe Drinking Water Act revolving loan fund 
has been extremely successful in less than 4 years of 
operation. EPA has given out nearly $2.5 billion in grants to 
all 50 States, Puerto Rico, the District of Columbia and the 
territories. States have made over 1,000 loans totaling over $2 
billion to water systems to address the most significant public 
health needs. States are also taking advantage of the set 
asides in the revolving fund to conduct source water 
assessments and buildup State programs.
    Drinking water systems have also made outstanding progress 
in implementing the right to know provisions of the Safe 
Drinking Water Act. Consumer confidence reports give customers 
of drinking water systems the information they need to make 
their own health decisions. Today, approximately 253 million 
Americans have access to their first annual consumer confidence 
report and over 100 million Americans are able to read their 
reports on line.
    Many residents in the District of Columbia's metropolitan 
area, in fact, are receiving their next report at this time, 
because there is a July 1st deadline for the second annual 
consumer confidence report.
    Effective drinking water protection has to start with an 
understanding of the threats to the water sources, and States 
are making significant steps forward on their source water 
assessments. Forty-nine States and territories have approved 
source water assessment and prevention programs and are 
conducting assessments for their water supplies.
    EPA is also working with the States to develop their 
capacity and operator certification programs to ensure that all 
water systems will be able to meet the demands of providing 
safe water.
    In the past 2 years we have proposed or finalized a series 
of new rules that would extend coverage to microbial and other 
high risk contaminants. We have done this with extensive 
research, which my colleague, Norine Noonan, will describe, and 
stakeholder involvement. We have included special emphasis on 
the needs of small water systems and their consumers.
    This spring, EPA proposed a groundwater rule and what's 
called the long term one enhanced surface water treatment rule 
to address the needs of consumers of groundwater systems and 
small surface water systems respectively. When finalized, these 
rules will complete a cycle of microbial protection by covering 
all consumers of public water systems.
    The risk-risk tradeoff between disinfectants and their 
byproducts is difficult. However, the extensive stakeholder 
process that EPA used to develop these complex rules gives us 
better supported and understood rules that strengthen human 
health protection. We are now concluding a new round of 
discussions of the second phase of these rules which will 
incorporate the results of the microbial and disinfection 
byproducts research that is currently ongoing.
    In November 1999, EPA proposed the radon rule, which will 
have an important impact on reducing the human health risk from 
radon in drinking water as well as indoor air from soil. 
Recently also EPA proposed to lower the maximum contaminant 
level for arsenic, another high priority drinking water 
contaminant. The National Academy of Sciences found that the 
current arsenic standard of 50 parts per billion does not meet 
EPA's goal of human health protection and recommended that EPA 
lower this MCL as quickly as possible.
    While the Agency is proud of its successes and 
accomplishments, we are also aware of many daunting challenges, 
both in the short and long term. We are certainly aware that 
the significant number of new requirements of the Safe Drinking 
Water Act represents a significant demand on the States and 
systems' ability to implement the wide variety of activities. I 
believe that they are manageable through the framework provided 
by the Safe Drinking Water Act but will require concerted 
effort by all participants in the drinking water community.
    As EPA has implemented the Safe Drinking Water Act, we have 
attempted to ease some of the strain. We have had extensive 
stakeholder involvement in our actions, including a particular 
focus on small water systems.
    The cost of providing Safe Drinking Water Act will continue 
to be a challenge. The increased complexity of future public 
health threats requires a new level of sophistication in the 
water industry. The drinking water industry has released its 
assessment of the annual drinking water infrastructure funding 
gap which you will hear about shortly. EPA's own drinking water 
needs survey identified over $138 billion in industry needs.
    At this point, I will turn to my colleague, Norine Noonan, 
to talk about some of our important research priorities.
    Senator Crapo. Thank you. Dr. Noonan.

STATEMENT OF NORINE E. NOONAN, ASSISTANT ADMINISTRATOR, OFFICE 
  OF RESEARCH AND DEVELOPMENT, U.S. ENVIRONMENTAL PROTECTION 
                             AGENCY

    Dr. Noonan. Mr. Chairman, EPA recognizes the critical 
importance of drinking water research to ensure scientifically 
sound decisions on regulations to protect human health and the 
environment. We're committed to the highest quality research in 
our drinking water program.
    We've established drinking water research as one of our 
highest priority programs. We have more than doubled our annual 
investment from $20.8 million in fiscal year 1996 to almost $49 
million in the fiscal year 2001 President's request. The fiscal 
year 2001 request is an increase of $5 million over fiscal year 
2000 enacted, because we recognize the need for these 
additional resources to address key drinking water research 
issues.
    These increases have come, I want to let you know, over a 
period of flat or declining budgets for ORD as a whole. We have 
delivered literally hundreds of peer-reviewed products that 
directly support both near term regulatory priorities such as 
microbial and disinfection byproducts, arsenic and the surface 
and groundwater rules. We've increased funding to enable us to 
expand our health research activities, including epidemiology 
studies on disinfection byproducts and arsenic, microbial 
pathogens and waterborne disease occurrence studies.
    The peer-reviewed research strategies and plans guide our 
research. We have completed much of the research in our MDBP 
and arsenic research plans. In the contaminant candidate list 
research strategy, this strategy is scheduled for review by our 
own Science Advisory Board in August.
    Wwe expect to complete the comprehensive drinking water 
research strategy in fiscal year 2001. We've also strengthened 
partnerships with outside research organizations. These 
partnerships leverage millions of dollars of additional funding 
for important areas of research such as sensitive 
subpopulations and waterborne pathogens. Examples include the 
National Institutes of Environmental Health Sciences, with whom 
we leverage over $5 million a year. Also the Centers for 
Disease Control Prevention and the American Water Works 
Association Research Foundation.
    Our STAR, or Science to Achieve Results grants program, has 
successfully expanded the involvement of universities and other 
not for profit organizations in performing high quality 
research in support of drinking water research priorities.
    In the area of microbial pathogens, EPA has provided new 
information and new methods to characterize and control the 
risks to safe drinking water posed by these organisms. We have 
also focused on the needs of small communities through 
engineering research on simple, effective and less costly 
treatment alternatives. In the area of arsenic, our research 
plan has been used both internally and externally as a guide 
for planning and carrying out short-term and long-term 
research.
    EPA has completed the high priority short-term projects in 
the research plan, and we have also made significant progress 
in addressing the longer term research needs. In developing the 
proposed rule, the Agency considered the results of these 
studies as well as other research.
    We have doubled our resource commitment to research on 
contaminants listed in the Contaminant Candidate List. The 
draft CCL research plan is complete and will be reviewed, as I 
said, by the SAB in August of this year. This draft plan has 
incorporated extensive input from a wide variety of 
stakeholders.
    We have also placed considerable emphasis on research on 
sensitive subpopulations and life stages, from studies in 
laboratory animals on mechanisms and dose response to 
population based epidemiology studies. We will summarize all of 
this work in a report to be transmitted to Congress later this 
summer, and that report is on schedule.
    We have a comprehensive, coordinated approach to assess 
needs and make budgetary decisions for research to support all 
of the Agency's programs. For drinking water, the research 
planning process is collaborative, in partnership with the 
Office of Water and mindful of the views of external 
stakeholders. Based on our analysis, we believe that the 
funding level and the resources requested for fiscal year 2001 
are sufficient to meet both the near term regulatory 
requirements as well as future needs.
    Let me say, though, that we are committed to an annual 
review of resources for this as well as other priority 
activities, and to making appropriate adjustments where 
necessary.
    We place a high priority on sharing information with 
stakeholders to ensure that they are informed and can provide 
appropriate input to research needs and priorities. We meet 
with the drinking water community on a regular basis, and we 
are in the process of establishing a new research working group 
under the National Drinking Water Advisory Council to further 
strengthen the long-term liaison with stakeholders.
    We have strong internal systems in place to assure 
accountability for resources and for research. Over the past 
year and in response to the needs of the Office of Water, we 
have been working intensively to develop a tracking system that 
will improve the availability of information on all of our 
drinking water research. We intend for this system to be widely 
available both within and outside EPA.
    Last, Mr. Chairman, we are meeting the challenges, the 
research challenges, posed by the SDWA Amendments of 1996. 
We've planned our research to address the highest priorities 
and we've adhered to a rigorous process of peer review to 
ensure science of the highest quality. The increased funding 
devoted to this research within a flat overall budget is clear 
evidence of the priority we assign to this work, and we remain 
committed to assuring adequate funding for fiscal year 2001 and 
beyond.
    I thank the Chairman.
    Senator Crapo. Thank you very much, Dr. Noonan and Mr. Fox.
    We are about 8 or 9 minutes into the first vote--10 minutes 
into the first vote. And I need about 5 minutes to get over to 
the Senate floor to vote. So I think what I will do is recess 
the hearing at this point before beginning questions. I will 
let all of the other committee members who are probably over on 
the Senate floor doing the same thing know that they still have 
a chance to ask questions of the first panel and encourage them 
to get back over here.
    And again, I apologize for this interruption. It's one of 
those hassles that we deal with in our life up here. But at 
this point, I will recess the committee, and we will reconvene 
very shortly after the second vote is called. This committee is 
recessed.
    [Recess.]
    Senator Crapo. The hearing will come to order.
    Once again, I appreciate everyone's accommodation of our 
voting schedule. And it's a very busy morning, we expect other 
Senators to soon join us. But until they do, I'll get to ask 
all the questions I can.
    And let me start out, Mr. Fox, and Dr. Noonan and Ms. 
Dougherty, we welcome you to answer among yourselves, whomever 
has the most appropriate information.
    The first question I have is, what are the current EPA 
guidelines in determining whether a public water system is a 
large or small water system?
    Mr. Fox. My understanding, Mr. Chairman, and if I get this 
wrong, the Director of our Ground Water and Drinking Water 
Office, Ms. Dougherty, whom I didn't introduce earlier, will 
correct me. A large public water system is considered anything 
that supplies drinking water to over 10,000 residents. A small 
system is considered under 10,000. The definition as to whether 
it is public or not depends on how many people are actually 
connected to the system, and that number is 25 people or 15 
connections.
    [Additional information supplied for the record follows:]


               Public Water Systems: Five Size Categories
------------------------------------------------------------------------
            System size                       Population served
------------------------------------------------------------------------
Very small.........................  25-500
Small..............................  501-3,300
Medium.............................  3,301-10,000
Large..............................  10,001-100,000
Very large.........................  > 100,000
------------------------------------------------------------------------


    Senator Crapo. OK. On what basis does EPA determine whether 
a regulation is affordable for a small system?
    Mr. Fox. The 1996 Amendments included a number of 
provisions related to affordability to assure that the 
regulations we develop are affordable to small systems. For 
example, they gave us an opportunity to come up with 
alternative technology that might be something slightly less 
than the best available technology if it was still affordable.
    The Act actually asked us to define what we meant by 
affordable. We went through a process involving development of 
criteria and public comment and came up with a conclusion that 
affordable generally represented 2.5 percent of the median 
household income, which is roughly, on a national average, 
about $750 a year. And then we evaluate this affordability 
based upon the existing suite of rules and regulations and 
costs that might apply to a drinking water system in assessing 
whether or not an individual rule is in fact ``affordable.''
    Senator Crapo. So 2.5 percent of the median family's income 
is what the EPA's understanding is of what would be affordable 
for a family to be expending for their share of water quality 
systems?
    Mr. Fox. That's correct.
    Senator Crapo. And that is just the water quality, that's 
not any other cost impact from other EPA regulations?
    Mr. Fox. That's correct.
    [Additional information supplied for the record follows:]

    The per household cost used by EPA in comparing the 2.5 
percent of median household income is the per household 
reflection of the total cost of a rule. That cost includes all 
elements of a rule's impact: monitoring, State costs, system 
treatment costs, and other administrative costs. All of these 
costs are ultimately designed to result in a particular water 
quality.

    Senator Crapo. Can you give me a little perspective on 
that? To me that seems like a pretty high percentage. I'm just 
reacting to it. Can you give me a perspective on that?
    Mr. Fox. Yes. Again, speaking in gross generalities, and it 
always gets awkward, because there are such differences 
throughout this country, but on average, people spend today, I 
think the figure is about $250 a year for drinking water 
services. The Congress asked us to evaluate what is affordable 
in the context of the suite of new requirements that Congress 
included in the 1996 SDWA amendments.
    We went through an exercise of figuring out, what is the 
appropriate level. Then as you would imagine, if we set that 
level too high, it would end up being not affordable. And I 
must admit that I had some of the initial reflections that you 
had when I saw this.
    If we set it too low, of course, then we are in effect 
saying that our public health protection standards are going to 
be also low. Because of the way the Act is structured, we 
always have to make an affordability determination. And based 
on these kinds of criteria, we went through the process and 
came up with the number that we did.
    Senator Crapo. And if I understood you correctly, you used 
the figure of $750. Is that what the 2.5 percent translates 
into per family?
    Mr. Fox. Right, on a national average.
    Senator Crapo. On a national average?
    Mr. Fox. That's right.
    Senator Crapo. And that prior to promulgation of these or 
implementation of the requirements of the Safe Drinking Water 
Act, it was at a $250 level?
    Mr. Fox. That is the estimate of the current average annual 
water bills. But I also want to make a point here that based on 
the suite of regulations that we have developed so far pursuant 
to the amendments, we are not approaching the affordability 
criteria. Because when you look at the suite of regulations 
that we've done, radon, for example, and arsenic, most recently 
proposed, they don't affect all systems throughout the country. 
These requirements would affect only those systems that have to 
do additional treatment. And so we evaluate each rule on its 
affordability based on our expectation as to which systems 
would be impacted by it.
    Senator Crapo. So different systems would be impacted by 
different rules, each of which would have a cost to them. And 
you're trying to keep the cost of the rules applicable to a 
particular system under 2.5 percent of the median family 
average in the community.
    [Additional information supplied for the record follows:]

    By applying its affordability criteria to prospective rules 
to determine whether or not rules will be affordable, we are 
trying to determine, on average, how the rule will impact 
systems. Since these are national rulemakings, we cannot ensure 
that any particular system will or will not find the rule 
affordable. Other programs are designed to address 
disadvantaged communities.

    Mr. Fox. Right. And that's what the statute provided for 
us. And I would say, too, just for clarification, the statute 
also specifically said that we were not to include the 
microbial rules in our consideration of affordability.
    Senator Crapo. Now, I would assume that if the average is 
$750 for the Nation that a community that was below that 
average would have a lower dollar figure, using the same 
percentage. Let's just take a hypothetical. Let's say there was 
a community where the 2.5 percent for that community was $500 
instead of $750. Does that mean that the EPA's decisionmaking 
on how to implement the standards of the Safe Drinking Water 
Act for that community would impose no greater than a $500 
burden, or would the EPA be using the national average of $750?
    Mr. Fox. We do it based on the national average, not by 
community.
    Senator Crapo. So the poorer communities could see even 
more percentage of their median family income taken by these 
rules?
    Mr. Fox. That is possible.
    Senator Crapo. In fact, if I know my math right, it would 
be a large, something approaching half. Would that be right? 
Would those falling below the median, this shows that I don't 
remember my mathematics, what percentage of families in the 
country would fall below the median and average income?
    Mr. Fox. You're asking me, too, to remember my difference 
between medians and means. If I could get that for the record.
    Senator Crapo. Is there a mathematician in the audience?
    [Laughter.]
    Mr. Fox. Dr. Noonan has a Ph.D.
    Dr. Noonan. For the median, 50 percent for the median. 
Fifty percent of the households are above and 50 percent are 
below.
    Senator Crapo. OK, that's what I thought. But I didn't want 
to step out and make a mistake.
    But that would mean, then, that 50 percent of the families 
would be paying more than 2.5 of their median family income 
under this approach.
    Mr. Fox. That's correct.
    Senator Crapo. Obviously I have several concerns that just 
come to mind. If we're paying on average now $250, and what is 
determined to be affordable is $750, that's a 300 percent 
increase, 200 percent increase.
    Mr. Fox. Right. And I don't disagree with the math, and I 
don't disagree with the fundamental premise of your line of 
questioning here, Mr. Chairman. But I think the other context 
important to keep in mind is that when this committee passed 
the Safe Drinking Water Act Amendments, we also included for 
the first time significant new Federal funds that would be 
available to communities to help them comply with the new 
amendments.
    Senator Crapo. And do those funds count against the 
affordability figures?
    Mr. Fox. The way the affordability is calculated involves 
the total cost of implementing the regulations, so that when we 
can provide loans and other assistance to these communities, we 
are helping them meet their affordability criteria. And then 
basically my point was simply that we now have truly a multi-
billion dollar program. The initial statistics are that 75 
percent of these loans are going to small communities. So we 
really are succeeding in, I think, helping supplement some of 
the needs of the smaller communities throughout the country.
    Senator Crapo. Well, that is helpful, and I appreciate 
that. But also, I hope that you can appreciate that what you're 
telling me is that the EPA is determined that under this 
legislation, the average family in American can expect to see 
their family income that is attributed to water quality to 
triple, or to go up to triple what it is now.
    Mr. Fox. I would say that slightly differently. Under this 
legislation and under the rulemaking the national median never 
exceed tripling. We've developed this in a way that we will 
keep an ongoing budget, a running budget, if you will, on this 
index through all the regulations that we are going to be 
developing under the Safe Drinking Water Act.
    Senator Crapo. I'm curious, how did the EPA determine what 
is ``affordable''? And how was it that it went from what is now 
being paid by families that I think are all strapped to three 
times that, and that's still considered to be affordable? Is 
there some kind of a formula that is being used in the country 
these days for those kinds of determinations?
    Mr. Fox. I will turn to Cynthia Dougherty to give you more 
detail. But developing affordability guidelines was a specific 
requirement of the statute and we went through a public notice-
and-comment period to get additional ideas as to what people 
thought was affordable. I know we had had some general index in 
the past on the wastewater side as to what was affordable that 
the Government had been using for the better part of a decade 
or two. But maybe Cynthia has some additional information.
    Ms. Dougherty. We can get you some more specific 
information for the record, including the actual document that 
we used for the criteria.
    Senator Crapo. I'd appreciate that.
    Ms. Dougherty. We basically did cost comparisons of other 
household expenses, and other risk reduction activities that 
people undertake, such as using bottled water and home 
treatment, point of use, point of entry devices that they do. 
So we did those comparisons and looked at the costs as we knew 
them and came up with the based on our findings.
    Senator Crapo. All right. You know, I recognize that you 
have a statutory responsibility to make this determination, and 
I think that that is a proper determination to be making. It's 
just an interesting issue, and I'd be interested to see just 
how an Agency does determine what a family, what is affordable 
for a family in this context or in any other. So I would 
appreciate the details of that being provided to the committee.
    Mr. Fox. We will do that.
    [The information referred to follows:]



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    Senator Crapo. And this might be a good opportunity for me 
to divert from the specifics of the Safe Drinking Water Act to 
a general question that I have that relates to this issue, and 
to virtually all of the other regulatory issues we face in the 
country. And that is, the cost of regulations. Regardless of 
whatever regulation we're dealing with, particularly when they 
deal with the public health, the argument is that if we don't 
do whatever it is that the regulation proposes, that we're 
going to see a reduction in the quality of life or a reduction 
in the quality of health in the country.
    A dimension of that argument has been brought forward in 
the last few years that each of these activities has a cost to 
it. We've been discussing the cost here. And that each time you 
take from a family resources, in this case, say we're taking 
$250 or $500 from a family, you are impacting that family's 
ability to provide for its own health care, provide for its own 
quality of life and so forth. And that there is a reduction in 
the public health by taking resources from the family and from 
the community at large.
    The argument in response, I would think, seems to have to 
be that the benefit that is being gained by taking those 
resources from the community is greater than the benefit of 
leaving those resources in the community. And you've probably 
seen the same studies I have. Some studies say that that's 
rarely the case and some studies say that that's always the 
case, or they justify it in each individual case.
    I just want to, on a sort of a policy or principle level, 
ask your opinion, Mr. Fox, and Dr. Noonan and Ms. Dougherty, 
you're welcome to jump in on this. Do you agree that each time 
we pass regulatory requirements into law that cause a financial 
impact on society that that does by taking from society those 
resources, it does have an impact on the quality of life?
    Mr. Fox. There's no question that there are economic 
impacts on all sides of the ledger as a result of the actions 
we take. I can tell you from the drinking water standpoint, and 
certainly all the Water Office regulations that I'm familiar 
with, we do fairly extensive cost benefit analysis of these 
various proposals. And some of them are easier to do than 
others.
    When there is a drinking water rule with documented, 
significant public health benefits, we can attribute some 
dollars associated with those benefits. Sometimes it's easier 
than others. Cancer, for example, is sometimes a very difficult 
risk to cost, because it's often very subtle, it's often very 
long-term. We're often talking about a very small number of the 
population that are particularly affected by it.
    But some of our microbial rules, for example, have much 
more immediate and frankly acute effects, such as some of the 
effects of Cryptosporidium or E. coli and the like. We try to 
do our best to evaluate this. I will be the first to say that 
I've spent a good deal of time with economists, and not unlike 
lawyers, you can get them to hold a wide variety of opinions as 
to ultimately what the predictable impact of something is. But 
we really do our best to evaluate costs and benefits to give 
that information to the public, take comment on it, and 
ultimately come up with a sound rule as a result of it.
    Senator Crapo. I'm assuming that you identify risks 
associated with whatever situation you're dealing with, and 
somehow quantify those risks.
    Mr. Fox. That's correct.
    Senator Crapo. And I am also assuming, in fact, I've seen 
analyses that try to quantify the risk of taking resources from 
the community. If we can trust our quantification of these 
respective risks, I assume you didn't compare those two risks. 
Is that what's being done?
    Mr. Fox. We so not compare those risks specifically, but it 
gets a lot more complicated, because there are so many risks 
that you can't quantify and they become much more qualitative. 
And you then have to make certain judgments about the risks. I 
suspect we will spend this morning some time this morning on 
the subject of arsenic, for example. There is a good deal of 
information about some cancer endpoints associated with arsenic 
that we can quantify. There's a lot of information about some 
cancer endpoints that we can't quantify very well, and there's 
certainly a lot of information about completely non-cancer end 
points that we have a very difficult time quantifying.
    So these judgments do become fairly qualitative at some 
fundamental level. This is all the information that we try to 
put together. One of the other judgments that's fascinating--I 
spend a good deal of time with economists trying to do this on 
the Clean Water Act--is determining the value of clean water. 
There is an interesting set of statistics about what people 
perceive concerning the value of clean water. In other words, 
``What is it worth for me to know that I have a stream nearby 
that is clean.'' There is a value to that, and economists even 
try and quantify that.
    So it is very difficult and certainly an important and 
emerging science.
    Senator Crapo. I've seen some of those formulas. Dr. 
Noonan?
    Dr. Noonan. Actually, Mr. Chairman, I'd like to address 
your question about the premise that if we don't implement 
rules, somehow the public health will be reduced from a 
baseline. That assumes that we can measure a baseline for 
public health.
    But I think the other way of looking at it is, in many 
cases when we implement rules, we actually improve public 
health from the baseline. In which case you're actually putting 
resources back into the community that might have been spent on 
mitigation of bacterial disease, might have been spent on 
hospitals stays, might have been spent on doctor visits, that 
won't be because we have implemented rules that will mitigate 
microbial contaminants.
    Senator Crapo. Sort of the prevention side of the issue.
    Dr. Noonan. Exactly. And I think that one of the things 
that is increasingly obvious is that the country as a whole 
needs to consider much more in terms of preventive medicine 
rather than curing disease once we have it.
    Senator Crapo. I would agree with that.
    Dr. Noonan. And I will also say one other thing, and that 
is we are sponsoring, in ORD, a lot of work in environmental 
economics and social sciences that may help us to elucidate 
some better mechanisms for evaluation of these kinds of 
currently unquantifiable benefits. In fact, if I may say, we 
are currently the largest funder of environmental economics 
research now in the Federal Government, and nearly all of that 
work is done in universities.
    Senator Crapo. Well, thank you. And I'm very interested in 
that. So if there are any primers or papers that you have on 
that that don't take a scientist to read, I've love you to send 
them in to me and let me review them. Because that's a very 
interesting topic to me.
    Another aspect of this topic, though, gets back to what 
I've always called and heard referred to as the old 80-20 rule, 
or the idea that you get a major part of your benefit, like 80 
percent of your benefit from the first 20 percent of the 
dollars you spend. And as you get closer and closer and closer 
to those ultimate refinements, you spend much, much more money 
to get each added incremental increase in whatever it is that 
we are working on. And that does relate directly back to 
questions like arsenic and some of those rules.
    And here's the question I raise, in a broader context or 
you can answer this in the context of arsenic, if you want to 
use it as an example. But it seems to me that we very often 
approach these kinds of issues with an assumption that seems to 
say that each increased reduction of a pollutant or a 
contaminant in whatever water supply or whatever it is that 
we're dealing with increases the public health in sort of a 
straight line basis, whatever that increase has been for the 
earlier reductions, we assume that it is that way for even the 
later reductions.
    And as we are able to technologically able to calculate and 
to identify smaller and smaller percentages of pollutant in a 
water source, to take an example, I raise the question of 
whether the cost benefit analysis remains the same as the cost 
for removing that extra one part per billion triples and the 
benefit of the removing that last little one part per billion 
plummets. And it seems to me that that question has to come 
into play as we look at whether to go from 50 parts to billion 
to 5 parts per billion, or maybe 1 part per trillion or 
whatever it is that the next scientific advance will let us 
measure.
    Would you respond, Mr. Fox?
    Mr. Fox. Yes. In fact, you hit on precisely the 
deliberations that I faced on arsenic and making a decision 
about what number to propose. The conventional wisdom is 
exactly as you suggest, and the experience in the wastewater 
area was precisely that. The cost per pound removal for the 
first 90 percent is X, and then for the next 10 percent becomes 
2X, 3X as you get further and further.
    I think it was that paradigm, if you will, that led this 
committee to draft an amendment to the Safe Drinking Water Act 
that allowed us to consider cost in establishing a drinking 
water standard. It was the principle that public health 
protection can be maximized at minimal cost. When I was first 
briefed on arsenic, I asked staff to let me see this beautiful 
asymptotic curve that's going to show me precisely where to 
pick the arsenic number, but it didn't come out that way.
    The unfortunate reality with arsenic, it that it is very 
linear. What we ended up seeing because of the nature of the 
treatment technologies is that any given arsenic level I picked 
ended up providing a certain amount of protection to a certain 
amount of people at a certain amount of cost. And this graph 
ended up being pretty much linear.
    So I was faced with having to decide how many million 
Americans do I want to protect, and what is the appropriate 
cost. It wasn't the wonderful curve that I had hoped to see in 
environmental protection.
    Senator Crapo. Well, let me ask you a question. I'm 
assuming that there is some point at which the level of arsenic 
in the water is so low that it's probably below background for 
what is normal in water in naturally occurring circumstances. 
Are you telling me that if we can identify one part per 
trillion that that one part has to be removed?
    Mr. Fox. No. Let me make it specific using arsenic as an 
example. The way we normally do drinking water regulations and 
the way the statute directs us is to start from what we call 
feasible: that is, what is the feasible level. Feasibility is a 
cost and monitoring test, and it is generally the number that 
we try to pick.
    In arsenic, the feasible number would have been three parts 
per billion. We moved off from the feasible level based on an 
evaluation that, in fact, there were some economic 
considerations that we had to consider.
    Senator Crapo. Let me ask you a question. When you say 
feasible, you mean, leaving cost aside, it's what we 
technologically can achieve?
    Mr. Fox. No. Feasible is: what can you technologically 
achieve, taking costs into consideration, and what do our 
monitoring capabilities allow us to measure down to.
    Senator Crapo. That was three parts per billion?
    Mr. Fox. That's correct. For large systems.
    Senator Crapo. For large systems, OK. How about for small 
systems?
    Mr. Fox. The feasibility history only applies to large 
systems.
    Senator Crapo. Then proceed. Then you add a cost analysis, 
a cost benefit analysis?
    Mr. Fox. Right. Staying with arsenic for just a second, the 
National Academy of Sciences issued a report on arsenic. 
Depending on how you evaluate the study, and I would truly 
believe that we followed it to the best that we could, they 
said 50 parts per billion was clearly unsafe. In fact, they 
said 50 parts per billion was a risk range of about 10 to the 
minus 3. If you do extrapolate the National Academy of Sciences 
study down, you're probably in the range of 4 to 6 parts per 
billion, and I'm sure other witnesses are going to have 
different opinions on this. But that's certainly where we ended 
up coming down on this one.
    If you end up considering the normal Agency risk range, how 
we've done these things in the past, which is typically 10 to 
the minus 4 to 10 to the minus 6 for a cancer range, your 
arsenic number would actually be well below three.
    Dr. Noonan. About 2 parts per billion.
    Mr. Fox. About 2 parts per billion to 10-4. So 
tradition, if you will, for drinking water was leading us to an 
arsenic number that was very low. The National Academy was 
pulling this way down, our traditional agency risk range would 
have even been below three, and the feasibility analysis would 
have taken us to three.
    Given this pressure on arsenic, we then took the new 
language of the Safe Drinking Water Act that allows us to 
consider costs, and it gave us the ability to move off of what 
was feasible based on a consideration of cost, and that's 
basically how we ended up at five.
    As I discussed earlier, when you look at these various cost 
estimates, it truly became very linear. And as the cost doubled 
the number of populations served doubled, and that was related 
to a halving of, in effect, a halving of the arsenic standard. 
And it ended up staying at that relationship through much of 
the line.
    Senator Crapo. Is arsenic naturally occurring in water?
    Mr. Fox. Yes. Arsenic is a naturally occurring substance. 
But it is also a byproduct of other, if you will, industrial 
activities. Mining is one of the most common.
    Senator Crapo. And do we have an understanding of what the 
natural occurrence--I realize that varies I'm sure from 
regions.
    Dr. Noonan. It varies. It's quite geographically variable.
    Senator Crapo. But what is the range of naturally occurring 
arsenic?
    Mr. Fox. We have good country maps that we can get to you. 
Generally speaking, in the southwestern and western regions of 
the country, arsenic levels in ground water are fairly high. 
There actually are pockets in New Hampshire, for example, and 
other States around the country.
    [The information referred to follows:]

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    Senator Crapo. Now, you said that the tradition or the 10 
-4----
    Dr. Noonan. Let me try to explain, Mr. chairman.
    Senator Crapo. How do we get to that?
    Dr. Noonan. Typically what we look at what level of a 
particular pollutant or substance causes obvious adverse health 
effects. In other words, where do you begin to see real frank 
adverse effects in people. In this case, for arsenic, what we 
looked at, and what we had the best evidence on, was cancer 
risk--bladder cancer and skin cancer.
    Senator Crapo. Now, it's going to be different for 
different substances, right?
    Dr. Noonan. Oh, yes. Absolutely. Absolutely.
    In the case of arsenic, you begin to see obvious adverse 
effects that are lethal, that is, bladder cancer and skin 
cancer, at a level of somewhere between 200 and 500 parts per 
billion. Typically what the Agency does in a risk assessment, 
it says, OK, we need a margin of safety below that adverse 
effect level. And our typical margins of safety bring us down 
to somewhere between 10-4 and 10-6 risk 
range. So we often have to go down 4 to 6 orders of magnitude 
below the level at which you see these frank adverse effects, 
or lethal effects in this case.
    Senator Crapo. Can you tell me why we resulted, or how we 
came to that determination that we had to go 4 to 6 levels 
lower?
    Dr. Noonan. Well, typically, that has to do with 
variability in the population, the susceptibility of 
individuals and the realization that, and I think I could defer 
to some of my risk assessors, this is a tried and true 
methodology for dealing with cancer risk, particularly, that 
you want to go down about several orders of magnitude below the 
adverse effects level.
    Senator Crapo. I'm sorry to keep interrupting you, but has 
that general determination been subjected to a rigorous cost 
benefit analysis? In other words, if you go down two levels, 
it's going to cause so much, four levels, so much, six levels, 
so much?
    Dr. Noonan. It depends on the pollutant and on the rule 
that you're writing, whether or not that health standard is 
subjected to a cost benefit analysis. My understanding is for 
drinking water it typically is, when you----
    Mr. Fox. And I would just say that this is a history of the 
Agency that I know for 20 years anyway, on the cancer end point 
public health protection we generally try and protect the 
population in the 10 to the minus 4 to the 10 to the minus 6 
risk range. This has been something, as I think Norine said, 
that has been well established, that has been extensively used 
for a long time.
    Dr. Noonan. Peer reviewed, I mean, this is not methodology 
that hasn't been tested.
    Mr. Fox. We don't always get there. Arsenic tends to be at 
the low end of that risk range because of cost. Some other 
contaminants, because of the cost effectiveness, we can end up 
with 10 to the minus.
    Senator Crapo. Well, the reason I ask is because in recent 
years there have been a lot of questions raised at the 
Congressional level as to whether we build conservative default 
after conservative default after conservative default into our 
rules to the point where they become beyond the level of common 
sense and beyond the level of science and extremely expensive. 
And that's the question I'm getting at.
    Dr. Noonan. And we understand that, Mr. Chairman, and I 
think we try to reevaluate the methodologies and the guidelines 
that we use to set those risk ranges on a periodic basis, so 
that we are confident that the methodologies that we are using 
to assess risk reflect the most up to date and the most 
excellent thinking in the scientific community, not just in 
EPA, but around the country. Our folks are actually in very 
much a leadership role, particularly in risk assessment, among 
their peers in the country. I have a person who works for me 
who is currently the President of the Society for Risk 
Analysis, elected president. And that's a professional society 
of people who do this for a living and who work on risk issues.
    So I think, though, if we get back to arsenic for a minute, 
let's just finish the calculation.
    Senator Crapo. Yes.
    Dr. Noonan. If the frank adverse effect that we see for 
cancer is between 200, somewhere between 200 and 500 ppb, 
that's where they begin, for the average person, and people are 
not generally average except in Lake Wobegon, where they're all 
above average----
    Senator Crapo. I'm glad you added that last part!
    Dr. Noonan. But if we do the calculation, if we go down 
ten-fold, that would be about 20 parts per billion. Let's pick 
the mid-range, 300, that would be 30 parts per billion. If we 
go down a hundred-fold, that's only 10-2, we're now 
at 3 ppb. You can see where we're going. I mean, we're 
currently essentially less than 100fold below the obvious 
adverse effect level.
    That quite frankly from a health perspective gives us not 
an insignificant bit of concern, but we also have bearing down 
on us the cost element of this. And so what we've tried to do 
is pick the number that is both affordable, from my colleague's 
standpoint, and a number that is the most protections of human 
health that we can get to.
    Senator Crapo. If you were to go to 10 to the minus--here 
comes my math, distance from my math classes again--if you were 
to go to 10 to the minus 6, let's say 10 to the minus 5, 
because that's in between the 4 and the 6, that would be what, 
100,000?
    Dr. Noonan. Well, let's keep going. At 10-2, 
it's 3 ppb. We're going to pick the mid-range. At 
10-3, it's 0.3 ppb. At 10-4, 0.03 ppb. At 
10-5, it's .003 ppb, or about 3 parts per trillion.
    Senator Crapo. Can we measure that, 3 parts per trillion?
    Mr. Fox. No, as I said, our feasible level that we 
determined was basically 3 parts per billion. And this gets 
into reliability of laboratories across the country.
    Senator Crapo. And I've got to believe, and again, I'm not 
a scientist, and I will listen to the scientists, but I've got 
to believe there is some point at which a human being can 
consume water that has some tiny little fraction of these 
materials in it that is not going to be lethal or even a 
significant risk. Is that not a valid assumption? Is there some 
point?
    Mr. Fox. Many people smoke cigarettes all their lives and 
never get lung cancer.
    Senator Crapo. Well, I'm not talking about that. That's a 
risk. I'm talking about, does water have to be absolutely 
devoid of any foreign substance for us to drink it?
    Dr. Noonan. No. Absolutely not. Of course not.
    Mr. Fox. It won't be.
    Senator Crapo. I know you're not saying that. But my 
question is, isn't there some point for arsenic at which is it 
naturally occurring in most water and which has historically 
not been a health risk?
    Mr. Fox. Well, there is some tension and difficulty in this 
line of questioning, if you will. I know you're just really 
asking for information here, but Cryptosporidium is a naturally 
occurring organism, Giardia is naturally occurring, E. coli at 
some level is naturally occurring. I really look at our job as 
trying to provide multiple pathways of public health 
protection, so that people can turn on their tap with 
confidence that they're not going to get sick to their stomach 
or they're not going to contract skin cancer or lung cancer.
    Dr. Noonan. Over a lifetime of exposure.
    Senator Crapo. Well, I am, too, but I want them to have 
enough money to own a television, so they can turn it on and 
find out about their health needs.
    Dr. Noonan. I understand that, Mr. Chairman. I think, 
though, that we have struck a balance here, particularly in the 
arsenic rule, that is as protective of public health as we can 
get, taking into consideration the kinds of affordability 
criteria for American families. I know that you share the goal 
of protecting public health. And I think it's our conviction 
that we've got it right here from that standpoint.
    Mr. Fox. Let me make this clear, too. This is not a slam 
dunk, if you will. We proposed a number of five parts per 
billion. You will hear, I'm sure, from a number of other 
witnesses, that there's a lot of uncertainty in the science 
behind these numbers. I fully acknowledge that, and we really 
want to go through a rigorous public debate to figure out what 
the right numbers should be.
    We actually proposed five, but we are also taking comment 
on a number of other values, so that in the end, if the Agency 
wanted to make a different decision, it would be able to do so.
    Senator Crapo. Well, you just led to my next question. 
Because you're right, there will be others who will testify, I 
assume, that the science is uncertain and that the cost is too 
low, the cost is too high, the cost benefit analysis does not 
justify this standard. The question I have in that context is 
that if the EPA does adopt a five part per billion standard at 
this point, it's my understanding that under the law, that 
would not be reviewable for 6 years. And so we would be living 
with that for 6 years while we would then see the science 
presumably come in to tell us whether it was the right 
decision.
    First of all, am I right in terms of my assumption about 
how the law works? And second, is it not quite risky to do 
that, given the fact that we do have uncertainty in the 
science?
    Mr. Fox. My understanding of the law is that the Agency is 
required to review these every 6 years, but we would have the 
option of reviewing them at a sooner period.
    Senator Crapo. So if science came up that said, oh, we made 
a mistake here, it could easily have been at 10 or 20 parts per 
billion, and we could save the public tremendous amounts of 
money and resources to put into other health improvement 
efforts, you could take that action?
    Mr. Fox. That's right. I would say that. I appreciate very 
much the line of questioning and that's among the facts we have 
to consider. History generally shows it goes the other way.
    Senator Crapo. I do understand that. Although again, some 
of us are concerned that the history we had is one of an 
approach to this which accumulates conservative default 
standards, or whatever the terminology is that I want to use, 
that have an effect of driving costs up with very low benefits, 
at the point when we get to that outer end of the range when 
the benefit of each incremental increase is much more 
expensive.
    Mr. Fox. Right.
    Senator Crapo. Well, I appreciate this discussion we've 
had. Because I believe that the discussion, whether it is a 
specific discussion of arsenic or the general discussion of how 
we are approaching cost benefit analysis and these difficult 
questions of where we best put our resources, and the level of 
confidence that we want to achieve is one of the more critical 
regulatory issues that we face in America today.
    And I do believe that our quality drinking water is one of 
the most important objectives that we can achieve, and one of 
the most important responsibilities that you have. And we share 
that commitment. And I certainly do not believe that we should 
do anything that would diminish our ability to assure that 
Americans have safe, clean water to drink. It is a very high 
value. And I can understand why you would be placing a high 
value on it in your cost benefit analysis.
    By the same token, we want to be sure that with all of the 
other areas in which we need to apply resources at the Federal 
level, let me say at the governmental level, through the use of 
tax dollars, as well as the demands that we will be placing on 
people and their own pocketbooks as they achieve these 
objectives, we want to be sure we do it in the most effective 
way possible, and that we aren't violating some very common 
sense considerations, and some good science that hopefully we 
can get to help us make these determinations.
    And I would again invite you on this issue to think of me 
when you come across papers or analyses or whatever that help 
elucidate a better understanding of it. Because I truly want to 
be able to achieve this objective. You mentioned the NIEHS in 
your initial remarks, one of you did.
    Dr. Noonan. I did.
    Senator Crapo. Dr. Noonan, you did. I toured their 
facilities in North Carolina. They're at the Research Triangle 
down there, I believe.
    Dr. Noonan. Yes. Our new building is being built directly 
across the lake.
    Senator Crapo. And I have actually toured the EPA 
facilities, which, I don't know if that was in the new 
building, this was several years ago.
    Dr. Noonan. Those were the old facilities.
    Senator Crapo. I've toured the EPA research facilities 
there, too, and I've met with some of your scientists and their 
scientists and others. And I have a very strong interest in 
this. And the way I approach it is that, I think that good 
science has to drive our decisionmaking. It will never give us 
all the answers, because we have to give the cost benefit 
analysis too and make the public policy decisions in the arena 
that we have here before us today.
    But good science has to give us the key to what is 
achievable and then what the benefits of that are going to be. 
And I'm very confident that we have the ability in this country 
to generate that kind of science. I just want us to be sure 
that we use it effectively.
    And I appreciate your commitments to this. I think that we 
as a Nation have shown the world that we have a commitment to 
protecting our environment and protecting our public health. 
And in that context, as I've said, safe, clean drinking water 
is one of the highest and most significant priorities in that 
system. And so I look forward to working with you on that.
    I have no further questions, and I know there were other 
Senators who must have been delayed who would like to raise 
some, but I guess they'll have to submit them in writing.
    Did you want to say something, Mr. Fox?
    Mr. Fox. I was just going to make an observation that in my 
job, there are a lot of tough decisions. But I can tell you 
unequivocally, the hardest one is picking an MCL. Because you 
have to weigh so many different factors, there's so much 
uncertainty. But it is also, as you point out, one of the most 
important decisions we can make for public health.
    Senator Crapo. Well, I appreciate that and understand what 
you're saying. And I also appreciate the fact that you are 
stating here today that you are ready to listen to the concerns 
from the stakeholders and others who are involved in our 
national and local drinking water systems and hopefully we'll 
be able to find some consensus in terms of what is the best 
step to take here.
    Mr. Fox. Cynthia will be staying. As you can imagine, I 
have other pressing business to attend to this afternoon.
    Senator Crapo. Maybe we ought to tie you up here all day.
    [Laughter.]
    Dr. Noonan. Mr. Chairman, if I might, I just want to 
reiterate and thank you very much for your comments. I think 
the whole reason for the existence of my organization is to 
provide or to fund the kind of excellent and high quality 
science that underpins the actions that the Agency takes. I 
think we call upon our colleagues in the scientific community 
and the industrial community and anywhere in the country where 
we can find such expertise, and in our own laboratories. I 
think we have a number, many, very high quality people who are 
in leadership positions in their disciplines.
    We share your commitment to the highest quality science to 
be used in the soundest way possible. I will say with regard to 
arsenic, I thank very much, one of the witnesses you will hear 
from later from the National Academy of Sciences, because they 
have essentially compiled in this book, in this report, 
probably the most extensive compilation of analysis and work on 
arsenic that exists today. I think what it showed us is that 
indeed we were on the right track. It gave us greater 
confidence in the studies that we used to underpin the 
decisions that we made on arsenic.
    And so I think it did show that we can work very 
effectively in delivering high quality science to the Agency, 
and I thank you for your words to that effect.
    Senator Crapo. Well, I appreciate your commitment to that. 
One of the comments that was made to me by one of the 
scientists down in North Carolina when I was down there a few 
years ago was, we were talking about these issues as well. And 
at the time, I don't remember what the issue was, but there was 
something where there was a big concern as to whether we were 
going overboard in our effort. And this particular scientist, 
on this particular issue, said, you know, I think that the 
science on this is going to show that we are going too far and 
that we could achieve our objective in a better way.
    But he said, the key here is, we need the science to tel us 
that answer. And I said to him, I think you would find that 
those who are fighting that situation or this situation, if 
they could be sure they had good science and they trusted what 
the science was telling them, that there would be much higher 
level of consensus, that either we do or we don't take this 
next step or we take a different step. Because we would have 
confidence in where we were headed and that it was needed, and 
that the risk was a real risk as opposed to a risk that may 
have been more generated by political activity than scientific 
analysis.
    And so that's why it's so critical that your efforts 
proceed. And I should say also, I have a lot of other questions 
I want to ask, I'm going to submit them. As usual, we don't 
have enough time for the full discussion that we'd like to 
have. So I would encourage you to respond to these questions 
promptly in writing.
    But they relate, some of them, to how the Agency is 
prioritizing its research and things like that. Because I'll 
tell you what, I'm a very strong ally of getting the necessary 
funding to the research, so that we can get some of those 
answers. When those scientific answers come in, then when they 
come down on my side of an issue, I'm going to be happy. When 
they come down against my side of an issue, I'm going to have 
to change my point of view.
    Mr. Fox. Well, we might have some new funds to apply 
research.
    [Laughter.]
    Senator Crapo. We're going to try to make you some funds 
available.
    Dr. Noonan. Thanks, sir. We look forward to welcoming you 
to our new facilities when we move in next year. We hope you 
will come and visit them.
    Senator Crapo. All right, thank you very much. And again, 
Mr. Fox, with regard to the TMDL issue, I do commit to you, as 
you have committed to me, that we will, regardless of how this 
all comes out in the short term, we'll continue to work on 
this.
    Mr. Fox. Actually, that will be a problem. Because I just 
was advised of the language, and apparently the language is 
written such that I'm not allowed to do any work on it. So we 
actually will not be having any conversations.
    Senator Crapo. Well, we'll work on that. Thank you.
    Thank you very much for your patience, ladies and 
gentlemen. We will now call up our second panel. And I 
apologize, this panel has eight people on it. We made the 
decision to do one panel of eight instead of two panels of 
four, because we've found that the give and take we get, at 
least I've found, the give and take we get with everybody 
sitting at the table is more productive than if we have to have 
one panel come next and say, well, I would have liked to have 
talked with Mr. or Mrs. so and so, and didn't get a chance to.
    So we will now have the panel as follows, and we'll ask you 
to testify in this order. Mr. Gregg Grunenfelder, and please 
excuse me if I foul up on any of your names. Mr. Grunenfelder 
is the Director of the Drinking Water Division of the 
Washington Department of Health. Mr. Gurnie Gunter, the 
Director of the Kansas City Water Services Department. Mr. 
William Hirzy, the Senior Vice President of the National 
Treasury Employees Union, Chapter 280. Dr. Michael Kosnett, the 
Associate Clinical Professor at the Division of Clinical 
Pharmacology and Toxicology at the University of Colorado 
Health Services. Mr. Erik Olson, Senior Attorney with the 
Natural Resources Defense Council. Mr. David Paris, the Water 
Supply Administrator, Manchester Water Treatment Plant, 
Manchester, New Hampshire. And I should say that some of these 
folks are testifying on behalf of national associations. I'll 
go back and pick that up in a second.
    Mr. Richard Tompkins, the President of the National 
Association of Water Companies. And Mr. Randall Van Dyke, the 
General Manager of the Clay Regional Water.
    Now, let me go back and indicate that Mr. Grunenfelder is 
speaking on behalf of the Association of State Drinking Water 
Administrators. Mr. Gunter is speaking on behalf of the 
Association of Metropolitan Water Agencies. Mr. Hirzy, on 
behalf of the Union and the interests that are of concern 
there. Mr. Kosnett on behalf of the National Research Council 
Subcommittee on Arsenic in Drinking Water. Mr. Olson on behalf 
of the Natural Resources Defense Council. Mr. Paris on behalf 
of the American Water Works Association. Mr. Tompkins on behalf 
of the National Association of Water Companies. And Mr. Van 
Dyke on behalf of National Rural Waters Association.
    Now, gentlemen, let me remind all of you of the rules. With 
such a large panel, we have to watch our time very closely. We 
have the clock here, the lights here which will give you 5 
minutes for each of you to conclude your testimony. And the 
green light will be on for the first 4 minutes. When 1 minute 
remains, you will have the yellow light come on. And when the 
red light comes on, it's time for you to wrap up.
    We ask you to please pay attention to the lights, and if 
you do go over very far, I will lightly rap the gavel to remind 
you. The reason is because we like to have a lot of give and 
take with you. We do have your written testimony, we have 
reviewed it. And you will also get an opportunity in the 
question and answer period to cover some of the things you may 
not have been able to cover in your 5 minutes.
    We are very aware that your 5 minutes is going to run out 
before you've run out of things to say. But we ask you to 
please follow the lights and we will try to help you be 
reminded of that.
    Now, before we start with the panel, we've been joined by 
the Chairman of our full committee, Senator Smith. If you'd 
like to make a statement, Senator Smith, I'd be glad to give 
you the time at this point.
    Senator Smith. Well, I'll defer on the statement, Mr. 
Chairman, but just to thank you for your leadership on this 
issue and for holding the hearing. I'll just listen to the 
witnesses and then participate in the questioning. Thanks.
    Senator Crapo. Thank you very much.
    Then we will proceed in that order. Mr. Grunenfelder, 
you're first.

 STATEMENT OF GREGG L. GRUNENFELDER, DIRECTOR, DRINKING WATER 
           DIVISION, WASHINGTON DEPARTMENT OF HEALTH

    Mr. Grunenfelder. Thank you very much. Mr. Chairman, good 
morning, and thank you for the opportunity to provide a State's 
perspective to the Safe Drinking Water Act discussion today. I 
am the Director of the Division of Drinking Water for the 
Washington State Department of Health. And I'm here speaking on 
behalf of the Association of State Drinking Water 
Administrators.
    The Association represents the State drinking water 
administrators in the 50 States and 6 territories who have the 
responsibility for implementing the many provisions of the Safe 
Drinking Water Act and ensuring the delivery of safe water. 
State public health agencies have been implementing drinking 
water protection programs for many years. In 1974, these 
efforts came under the purview of the Safe Drinking Water Act.
    The 1996 amendments added significant new requirements to 
this core public health protection program, and with those, 
significant new challenges, challenges in the form of things 
like the radon rule, the arsenic rule, disinfection, 
disinfection byproduct rule, enhanced surface water treatment 
rule and consumer information programs like the consumer 
confidence report and public notification rule.
    To be successful in this implementation and meeting these 
new challenges, I want to highlight two things that I think we 
need. We need significant new resources and staff to do the 
job. Laws on paper do nothing to protect public health. The 
laws need to be implemented.
    Second, we need reasonable regulatory schedules and 
integrated thinking into how we'll move forward to meet these 
new complex requirements. In other words, the laws need to be 
implementable.
    Things are not going smoothly. And in fact, the trends we 
are seeing are diluting an already stressed public health 
system. A few of the areas I want to highlight for you today, 
one again addresses the issue around inadequate funding and 
apparent unwillingness to address cumulative costs and program 
integration.
    States are clearly under-resourced to do the job Congress 
envisioned in 1996. The way I visualize it is that in 1996, 
many new things got added to the safe drinking water table. And 
that table grew to about 12 feet long. But States were left 
with a table cloth that was about 6 feet long. So significant 
parts of the Safe Drinking Water Act table are not being 
covered. On our own, States are being forced into making tough 
prioritization decisions on what parts of the table will be 
covered and what parts won't with the resources we have 
available.
    Another issue to highlight is early implementation. In 
spite of this clear lack of resources, we see a continued 
insistence on early implementation of rule requirements prior 
to States adopting their own rules within the statutory 
framework of 2 years from the data of rule promulgation. States 
need time to establish basic regulatory and enforcement 
authorities, enhance data systems and inform water systems and 
train water system owners and operators of the new 
requirements.
    The EPA regions are in no position to assume implementation 
activities. We need thoughtful implementation plans that are 
worked out in conjunction with States.
    Third, we see a trend for changing roles and expectations. 
We're seeing a shift in the basic public health model of 
oversight and assurance to one of being more of a consulter and 
an implementer. Daily operation and maintenance have always 
been the primary responsibility of water systems, certified 
operators, licensed professional engineers, with technical 
assistance from States and other providers when needed. We're 
seeing a trend to get State programs more directly involved in 
consulting roles with utilities on the operation and 
maintenance side of their business, rather than providing basic 
regulatory oversight. We simply don't have the resources to 
take on these new responsibilities.
    And finally, increasing record keeping and reporting 
burdens. With the new rules coming down, each of them contains 
numerous data and reporting requirements which are overwhelming 
data systems, many of which are not fully functional now. 
Required reporting requirements should be carefully considered 
in the context of all of the Safe Drinking Water Act 
requirements, not rule by rule, and each must provide 
meaningful, useful information which are linked to real public 
health issues.
    In conclusion, as you said, Mr. chairman, safe and reliable 
drinking water is vital to the health of every community, and 
assuring safe drinking water should be a top priority for all 
of us. Given the current path we're on, full implementation of 
the Safe Drinking Water Act is not doable.
    State drinking water administrators want to succeed in 
assuring safe and reliable drinking water supplies in our 
country. But it will take a fundamental shift in direction to 
make this happen. It will take, No. 1, significantly more 
resources directed toward implementation. No. 2, a more 
thoughtful, coordinated and manageable approach to achieve your 
vision that is contained in the Act.
    And No. 3, it will take EPA working with States as 
partners, or Congress working with States as partners, to 
achieve meaningful success in assuring safe drinking water.
    Thank you for the opportunity to comment, Mr. Chairman.
    Senator Crapo. Thank you very much, Mr. Grunenfelder.
    Mr. Gunter?

    STATEMENT OF GURNIE GUNTER, DIRECTOR, KANSAS CITY WATER 
                      SERVICES DEPARTMENT

    Mr. Gunter. Good morning, Chairman Crapo and Chairman 
Smith. I'm Gurnie Gunter, the Director of the Kansas City, 
Missouri Water Services Department. And on behalf of the 
Nation's largest municipal drinking water agencies, thank you 
for holding this hearing.
    I'm a board member of the Association of AMWA and my 
testimony today is on that Association's behalf. We represent 
the largest municipal drinking water agencies in the United 
States. Together AMWA member agencies serve clean, safe 
drinking water to over 110 million people.
    First, I would like to commend EPA's Office of Groundwater 
and Drinking Water for its remarkable efforts to implement the 
1996 amendments. The Act sets out to a demanding regulatory 
schedule and EPA has made it their business to meet that 
schedule. State regulators deserve a commendation also. The 
list of Federal regulations that the States must implement 
becomes larger and more demanding each year. Yet, the Federal 
contribution to this effort covers only 35 percent of the bill.
    Today I will highlight only a few points contained in our 
written testimony, so I ask that the full written testimony be 
included as part of the record of the hearing.
    Senator Crapo. Without objection, it will be. That will be 
the case for all of your written testimony.
    Mr. Gunter. Our main priority is the implementation of 
drinking water standards based on sound science. Congress and 
the Administration share this goal and enacted it in a 
bipartisan fashion in 1996.
    Congress took a major step when it gave EPA the flexibility 
to let science determine drinking water standards. We believe 
that this is the cornerstone of the amendments and it 
recognizes that the most serious threat to public health should 
be addressed first, and that resources are limited at all 
levels of Government. It also recognizes that the public ought 
to receive true value for what they are being asked to spend.
    Nevertheless, the Association has concerns with how EPA is 
incorporating science into its standard setting program. For 
instance, EPA recently finalized the maximum contaminant level 
goal of zero for chloroform, despite noting in the final rule 
that the best available peer-reviewed science indicated a non-
zero value is more appropriate. And there are other examples.
    It would be unreasonable to expect perfection, given an 
ever changing base of scientific knowledge. But the importance 
of meeting the science provisions is paramount. And if 
satisfying these provisions means altering statutory deadlines 
for rule development, we hope that the subcommittee and the 
full committee will be amendable.
    The filtered backwash rule is a case in point. AMWA 
recommends that the subcommittee and Congress consider an 
extension of the August 2000 deadline so that EPA may repropose 
the rule to consider basic knowledge of risks, costs and 
benefits. Similarly, when the comment period closes on the 
arsenic proposal, EPA will be left with only a few months to 
finalize the rule prior to the January 2001 deadline. We ask 
the subcommittee and Congress to consider a 6-month extension 
to give the Agency adequate time to consider stakeholder 
comments.
    Today, AMWA also recommends that the subcommittee request 
an independent review by the National Academy of Sciences or 
General Accounting Office of how well EPA is incorporating 
science into regulatory decisions. We believe it would benefit 
the Agency, as it seeks to implement the 1996 amendments.
    Also in the amendments, Congress calls on EPA to develop 
health risk reduction and cost analysis documents to be 
published for public comment at the same time a rule is 
proposed. So far, EPA's cost and risk analyses are not 
published for comment in the Federal Register, along with the 
proposed rule. Additionally, the analyses stray from normal 
cost benefit practices. For example, EPA chooses to discount 
costs but not benefits. Thus, the Agency compares apples to 
oranges.
    Moving from the specific mandates, I would also like to 
mention three related issues. Since I am running out of time, I 
will just indicate what they are. One is the issue of MTBE, 
another is the issue of funding infrastructure, and the other 
is the issue that involves liability reform against suits 
against water suppliers, which is creating a situation that 
will make the statute really not-relatable. The courts will 
decide what we do.
    Thank you again for giving me the opportunity to testify.
    Senator Crapo. Thank you very much, Mr. Gunter. And we will 
carefully review those three points in your written testimony.
    Dr. Hirzy?

  STATEMENT OF WILLIAM HIRZY, SENIOR VICE PRESIDENT, NATIONAL 
             TREASURY EMPLOYEES UNION, CHAPTER 280

    Mr. Hirzy. Good morning, Chairman Smith, Chairman Crapo and 
fellow staff workers. Thank you for the opportunity to appear 
today to present the views of the Union on the issue of 
fluoridation of public water supplies.
    Our union represents the staff scientists, lawyers and 
others who analyze hazard exposure and economic data and advise 
management how to use them in public health protection. We're 
not here today to speak for EPA, but rather the union, founded 
17 years ago to protect EPA workers from unethical pressure by 
EPA managers. It was on that basis in 1985 that we first got 
involved in this issue.
    In 1997, we voted to oppose fluoridation and our opposition 
has grown stronger as more adverse data on the practice have 
come in. In the interest of time, let me state our 
recommendations first. We ask that you order an independent 
review of the cancer bioassay of sodium fluoride mandated in 
1977 by Congress. Evidence for carcinogenicity in that assay 
was systematically downgraded by a special executive branch 
commission appointed and run by the very agencies that Congress 
did not trust to run the bioassay in the first place. That 
action saved fluoridation temporarily.
    We ask that you order chronic toxicity studies on the two 
waste products that are now used in 90 percent of fluoridation 
programs. EPA says there are at present no chronic toxicity 
data on them, and we ask that you order EPA to set an MCL for 
fluoride that's truly protective of all American citizens, 
infants and adults alike. Because the current one does not, in 
violation of the Safe Drinking Water Act.
    We ask that you order epidemiology studies using dental 
fluorosis as an index of exposure to determine the extent of 
other toxic effects, especially effects on the brain and bone 
in the population that are attributable to fluoride. We ask 
that you convene a joint Congressional committee to give this 
issue the full airing that it deserves. It's been 23 years 
since the last one and it's high time for a new one.
    I offer the following in support of these recommendations. 
The American people and especially our children are getting way 
too much fluoride. Two-thirds of children living in fluoridated 
communities have dental fluorosis in at least one tooth. Dental 
fluorosis is the visible manifestation of toxic over-exposure 
to fluoride during their developmental years.
    The initial findings of the cancer bioassay were for clear 
evidence of carcinogenicity and that is consistent with several 
epidemiology and many mutagenesis studies. The protected 
pollutant status that fluoride enjoys within EPA and other 
Federal establishments is remarkable, as the charts over here 
show.
    EPA stated regarding the chemical used in 90 percent of 
fluoridated communities that, ``By recovering fluosilicic acid 
from fertilizer manufacturing, water and air pollution are 
minimized, and water authorities have a low-cost source of 
fluoride.'' In other words, EPA's solution to pollution by this 
waste product is dilution. As long as it's not dumped into 
rivers and lakes but rather into drinking water systems.
    Congressman Calvert of the House Science Committee has 
letters of inquiry out to EPA and other Federal entities on 
this subject.
    The 1983 report of the Surgeon General's panel on fluoride 
to EPA was altered without consultation or notification of the 
panel members so as to help EPA justify an outrageous set of 
drinking water standards promulgated in 1986. The results of 
the 50-year experiment conducted in Kingston and Newburg, New 
York, show that there's no overall difference in dental caries 
rates between the two communities. But there is a significantly 
higher incidence of dental fluorosis in the fluoridated 
community.
    Since 1994, there have been six studies that show adverse 
effects of fluoride on the brain, even at the so-called optimal 
level of one part per million. The epidemiology studies that we 
recommend above should make a prime effort to look at brain 
effects, given the national concern over attention deficit and 
hyperactivity disorder and autism in our children.
    Three trial judges since 1978 made findings of fact that 
water fluoridation poses an unreasonable risk to the American 
people. Fluoridation proponents like to say that there's no 
real controversy about fluoridation, and they're right. When 
these three disinterested trial judges heard weeks of 
testimony, they came to the same conclusion that our union did 
about the unreasonable risks involved. The findings of fact 
remain untouched in those trials today.
    Recent publications indicate a link between the use of 
silicofluorides for fluoridation and elevated blood levels in 
children and anti-social behavior. And leading dental 
researchers are changing their views on the safety and efficacy 
of fluoridation. Drs. John Culquhon and Hardy Limeback, both 
former spokespersons for fluoridation, have published 
recantations of their former position.
    On behalf of EPA's professional community, I urge the 
subcommittee to convene a select committee for a national 
review of water fluoridation. It's high time we do that. I'd be 
happy to take questions. Thank you.
    Senator Crapo. Thank you very much, Dr. Hirzy.
    Dr. Kosnett?

  STATEMENT OF MICHAEL KOSNETT, ASSOCIATE CLINICAL PROFESSOR, 
DIVISION OF CLINICAL PHARMACOLOGY AND TOXICOLOGY, UNIVERSITY OF 
                    COLORADO HEALTH SCIENCES

    Mr. Kosnett. Thank you, Senator Crapo, Senator Smith, staff 
members and other guests.
    I'm Michael Kosnett. I'm a member of the committee on 
Toxicology of the National Research Council. I'm also a former 
member of the Subcommittee on Arsenic in Drinking Water. I 
serve as an associate clinical professor at the University of 
Colorado Health Sciences Center in the Division of Clinical 
Pharmacology and Toxicology. I'm happy to be here today to 
discuss some aspects of the National Research Council's 
Subcommittee on Arsenic in Drinking Water's findings regarding 
the health risks of arsenic in drinking water.
    As you know, the National Research Council is an 
independent organization. It's a branch of the National 
Academies of Sciences. It's non-governmental, yet it often is 
called upon to convene panels and to perform scientific studies 
to address health issues and other issues at the request of the 
Federal Government or other parties.
    In 1997, in the spring, the NRC convened a panel at the 
request of the U.S. Environmental Protection Agency. The charge 
to this subcommittee included a request that the committee 
review EPA's characterization of the human health risks posed 
by arsenic in drinking water. We were asked to determine the 
adequacy of EPA's current maximum contaminant level for 
protecting public health and also to identify priorities for 
research to fill data gaps.
    The subcommittee was comprised of a group of experts 
selected by the Chair of the NRC on the basis of their 
knowledge and expertise in a variety of topics that were 
covered by the charge to the committee. It's important to note 
that the committee consisted of an international grouping of 
experts from multiple disciplines, including toxicology, 
epidemiology, biostatistics, chemistry and nutrition.
    As with all National Research Council committees, the 
selection process was attentive to achieving balance and 
scientific perspective and to avoiding conflicts of interest. 
It should be noted that the members were drawn from academic 
institutions, national health agencies, private corporations, 
industry sponsored research organizations and private 
consultants. The subcommittee adhered to a collective writing 
process and the report reflects the scientific consensus of its 
members.
    Moreover, the subcommittee report was subjected to internal 
National Research Council institutional oversight and to 
external peer review by public and private sector experts drawn 
from a broad range of backgrounds and perspectives. Every 
comment and question submitted to the subcommittee by these 
peer reviewers was addressed before the final report was 
issued.
    The 310-page report of the National Research Council 
Subcommittee on Arsenic in Drinking Water was released in the 
spring of 1999. I have included as part of my written testimony 
two key sections of the report, the executive summary and a 
short but important chapter entitled Risk Characterization. And 
these sections highlight the key findings and recommendations 
of the subcommittee.
    Thank you.
    Senator Crapo. Thank you very much, Dr. Kosnett.
    Mr. Olson?

  STATEMENT OF ERIK OLSON, SENIOR ATTORNEY, NATURAL RESOURCES 
                        DEFENSE COUNCIL

    Mr. Olson. Good morning and thank you, Senator Crapo and 
Senator Smith.
    I wanted to try to put some of the issues that we're 
discussing today into a little bit of historical perspective. 
We believe that some of the difficulties that the committee is 
going to hear about today and already has heard about in the 
drinking water industry are a result of what is a revolution 
going on right now in the industry. We call it, and many others 
do, the ``Third Revolution'' in water delivery in the world.
    The first revolution occurred in Biblical times, and 
through the Roman Empire, when piped water began to be 
provided. The second revolution occurred around the turn of the 
last century, before World War I, when water systems began to 
switch to sedimentation, coagulation, filtration and chlorine. 
There were enormous public health benefits. In fact, the 
Centers for Disease Control and Prevention recently found that 
this second revolution, occurring about the time of World War 
I, was one of the largest public health benefits and 
accomplishments of the entire century.
    The third revolution is what is going on now. It is going 
to cost a lot of money, but clearly it is necessary. That 
revolution will result in basically three barriers to 
contamination of public water supplies. First, there will be 
prevention and source water protection. I assume Mr. Paris may 
talk about that, because his utility has been one leader in 
achieving that kind of prevention.
    A second is broad spectrum treatment, advanced treatment 
using advanced technologies that now we believe will start 
being used by utilities across the United States over the next 
20 years. And third, that the pipes that deliver the water to 
our houses will be overhauled. Many of them are 100 years old 
or older. In fact, the drinking water that came out of the tap 
here that many of us are drinking flowed through pipes many of 
which were built during the Lincoln Administration. And we are 
still dealing with that in many cities across the United 
States.
    We have massive microbial risks across the country 
continuing, unfortunately. We think many of them have been 
addressed. But the Milwaukee waterborne disease outbreak that 
occurred several years ago that sickened 400,000 people and 
killed about 100 people is a reminder that we need to deal with 
those risks. Similarly, an outbreak that just happened in 
Ontario with E. coli in drinking water that killed between 4 
and 15 people of E. coli from their tap water is another 
reminder that we cannot let our guard down.
    There have been many major challenges, and I just wanted to 
briefly mention three that are of most importance and maybe 
concentrate mostly on the arsenic issue. Because we believe 
that this is a major public health risk.
    The National Academy's arsenic study, and you just heard 
from one of the panelists, found that the current EPA drinking 
water standard is inadequate. Let me quote from the panel's 
conclusions: ``It's the subcommittee's consensus, the current 
EPA's MCL for arsenic in drinking water does not achieve EPA's 
goal for public health protection, and therefore requires 
downward revision as promptly as possible.''
    The committee also found that the bladder cancer risk at 
the current EPA standard is about a 1 in 1,000 cancer risk. In 
addition, the Academy said that if one considers the total 
cancer risk, that cancers could easily result in a combined 
cancer risk of on the order of 1 in 100, at the current EPA 
standard.
    What I think is quite significant is that that cancer risk 
is approximately 10,000 times higher than EPA's usual targeted 
cancer risk. For example, the entire United Sates Senate just 
three and a half years ago voted for legislation called the 
Food Quality Protection Act that set a standard of one in a 
million for food, one in a million cancer risk is the maximum 
acceptable cancer risk for pesticides in our foods.
    What I think is significant is that the cancer risk posed 
by arsenic in tap water at the current standard is 
approximately 10,000 times higher than that. It is a very 
significant risk that we cannot pretend does not exist. Why is 
the arsenic issue so important? Well, we've been dealing with 
this standard that was set in 1942. Congress has repeatedly 
told EPA to update that 1942 standard now three times, the 
first in 1974, the second in 1986 and now in 1996. The standard 
remains the same. We feel it's a very important public health 
issue. And EPA's proposed rule, although we would like to see a 
somewhat lower standard, something that is feasible, three 
parts per billion, we certainly believe EPA has taken a major 
step forward.
    Thank you and I've got many more points in my testimony, 
but I'll leave it at that.
    Senator Crapo. Thank you, and we will review it carefully.
    Mr. Paris. I understand you're from our Chairman's home 
State.

     STATEMENT OF DAVID PARIS, WATER SUPPLY ADMINISTRATOR, 
  MANCHESTER WATER TREATMENT PLANT, MANCHESTER, NEW HAMPSHIRE

    Mr. Paris. I am. I'm proud to be from New Hampshire, a 
lifelong resident of that State. And this is really a privilege 
and an honor for me this morning to be able to address the 
subcommittee.
    I am from Manchester Water Works, the water supply 
administrator, meaning that my job with them is to run a water 
supply for about 125,000 people. Today I'm appearing on behalf 
of American Water Works Association, which is really the 
world's largest single group of water suppliers, scientists, 
regulators, manufacturers and suppliers of water treatment and 
water supply equipment.
    We represent, I believe, most of the water companies that 
would be in your constituent districts. And we consider these 
people the people that we act on behalf of, in particular.
    I'd like to address today American Water Works' position on 
a number of the issues that you see before you in our written 
testimony that is on the record, and try to draw some analogies 
and some real world comparisons to how these rules will impact 
on my home State up in New Hampshire.
    The 1996 amendments created a huge challenge for EPA, as 
Erik I think correctly paraphrases. We are in a State currently 
where our rulemaking and our science has changed dramatically 
and continues to change very rapidly. The Office of Ground 
Water and Drinking Water I think has done an admirable job to 
meet those demands and those challenges.
    I'm going to speak today with some degree of criticism 
about certain aspects of what they have felt that they need to 
do. Our major concern will be that they in our estimation, have 
compromised sound science, in some cases, for statutory 
deadlines. We are all certainly committed to seeing these rules 
take place and be implemented if in fact they are to our 
constituents' benefits and to our constituents' best welfare.
    However, when deadlines take precedence over science that 
is in progress, we take exception. You will hear that from me 
this morning.
    AWWA fully supports the President's current budget 
allocation of $49 million for drinking water research, research 
that supports science, the science necessary to build a strong 
drinking water program, one that we can all buy into. That's a 
short-term goal, though, because as you're hearing, there are 
not only the rules that you see in front of you to consider. 
The 1996 amendments created a candidate contaminant list which 
will every 5 years put a mandate before the Agency to either 
regulate or not regulate five additional candidate 
contaminants. That is a very strong and extraordinarily 
challenging demand, I think, for EPA to meet without the proper 
resources available to support the science to get it done.
    Arsenic is a good example of a rule that has arrived ahead 
of its science. Neither AWWA, nor I, nor anybody else at this 
table disputes that the 50 part per billion standard that was 
established in 1942, as Erik said, was in need of some review 
and alteration. Our concern is that the consideration of sound 
science and cost-benefit analysis driving that rule to lowered 
MCLs becomes extraordinarily important when those MCLs start 
impacting, as you mentioned before, Senator, the 80th 
percentile and then to get from the 80th percentile to the 10th 
percentile.
    In New Hampshire, it will impact about 20 percent of our 
600 groundwater supplies, putting the same people in these 
small communities on notice that they'll need to add treatment 
for arsenic as well as for radon. Radon is another high impact 
rule that is out there and we want to compliment the 1996 
amendments for recognizing the background of contribution of 
radon to the air as well as to water.
    But at this point in time, we're looking for a way to 
actually get that done. Gregg Grunenfelder, initially talked 
about how these rules tend to cluster and accumulate on the 
plates of the State drinking water people. They're having a 
really hard time discerning how to implement the air mitigation 
program as part of the drinking water rule. We'd like to 
suggest that the Indoor Air Radon Abatement Act might be a 
better place to put some of that responsibility.
    In other rules here concerning disinfection byproducts, the 
stage two regulations, I have been active with AWWA in its 
negotiation process for the Federal advisory panel to establish 
new drinking water standards. It's an extraordinary success, 
and it is one of the parts of the 1996 amendments we fully 
support and would like to continue to see the public 
participation process work.
    On infrastructure, and unfortunately I will not be able to 
really speak to this, we feel that there is a funding gap that 
will inevitably develop here in the next 20 years and Congress 
could do much to help support the State drinking water 
revolving loan fund to help utilities and water suppliers meet 
some of those deficits that they will inevitably see.
    MTBE, is another New Hampshire concern and one close to my 
heart. MTBE has become one of those contaminants that we truly 
compliment this committee, Chairman Smith, Chairman Crapo, 
Chairman Inhofe, Senators Boxer and Feinstein, for their very 
quick actions in helping to deal with this emerging 
contaminant, which is of huge importance to the drinking water 
industry. In New Hampshire alone, as you'll see in our 
comments, Manchester has had to deal with this in a supply that 
is fully protected and that only allows power boating. It's 
just one of those unfortunate side products of what we thought 
was going to be a good program for controlling air pollution.
    In conclusion, despite these comments, I compliment EPA for 
their efforts. They would need, I think a little more time, 
something that this committee and Congress could give them to 
help them with their statutory deadlines, to be sure that they 
don't compromise good science.
    Thank you very much.
    Senator Crapo. Thank you very much, Mr. Paris.
    Mr. Tompkins?

     STATEMENT OF J. RICHARD TOMPKINS, PRESIDENT, NATIONAL 
  ASSOCIATION OF WATER COMPANIES; PRESIDENT, MIDDLESEX WATER 
                            COMPANY

    Mr. Tompkins. Good morning, Chairman Smith and Chairman 
Crapo. I am President of Middlesex Water Company, which is an 
investor owned water company located in central New Jersey. 
Like David Paris, I am responsible for the provision of safe 
and adequate water service to over 200,000 people.
    At present time, I am the President of the National 
Association of Water Companies, which is the non-profit trade 
organization that exclusively represents the Nation's private 
and investor owned drinking water industry. I am offering this 
testimony today on behalf of the NAWC, which has over 300 
members in 43 States, and serves reliable drinking water to 
over 23 million Americans every day.
    We represent the capital investment segment of the water 
utilities. Our member companies pay State, local and Federal 
taxes.
    The National Association of Water Companies commends you 
and your subcommittee for conducting these oversight hearings. 
We feel these add a very important perspective to our 
continuing efforts to provide safe, adequate and proper service 
to our customers.
    My testimony presents comments on six areas of concern. And 
I'd like to note that these are constructive comments. They're 
not meant to criticize anyone, but to build better regulation 
for the future. These areas of concern, which are included in 
my written statement, are the proposed radon rule, the proposed 
arsenic rule, MTBE contamination of drinking water, the 
implementation of the drinking water State revolving fund, the 
threat to national drinking water standards posed by tort 
litigation, and drinking water infrastructure needs.
    With respect to the radon rule, NAWC does not believe that 
the proposed MCL of 300 picocuries per liter or any level below 
1,000 picocuries per liter can be justified by cost benefit 
analysis. I have a study from NAWC's California chapter, the 
California Water Association, which documents in detail the 
deficiencies of EPA's cost estimates, and I would like to 
submit this statement for the record.
    Senator Crapo. Without objection.
    Mr. Tompkins. In summary, NAWC believes that the nationwide 
implementation of effective State multi-media mitigation 
programs is essential for the radon rule to achieve its 
intended goals. We urge Congress to consider legislation that 
would place the requirements of the multi-media mitigation 
program in EPA's air program where it belongs, and to provide 
States with sufficient resources to implement it.
    The effective MMM programs implemented in every State plus 
a drinking water MCL of 4,000 picocuries per liter will provide 
far greater health benefits at a more reasonable cost than the 
drinking water standard of 300 picocuries per liter alone.
    With respect to the arsenic rule, I think you've heard 
enough discussion on that. The NAWC also urges EPA to 
reconsider the available body of scientific evidence and to 
consider a final standard of no less than the 10 parts per 
billion that is currently used by the World Health 
Organization.
    The MTBE contamination of drinking water, use of MTBE as an 
oxygen additive in reformulated gasoline has created a 
significant and unacceptable risk to drinking water, both 
surface and groundwater, in many areas of the country. 
Recently, EPA recommended that Congress amend the Clean Air Act 
to significantly reduce or eliminate the use of MTBE as a fuel 
additive. In New Jersey, the Clean Water Council, of which I am 
a member, has recommended that MTBE be banned immediately.
    Water contamination tort litigation was mentioned by other 
witnesses. NAWC is working with its sister organizations who 
represent the water industry to propose legislation that will 
make compliance with the Federal standards a defense against 
potential tort litigation such as the lawsuits that are ongoing 
in California at this time. There are other areas where we all 
face potential litigation. I think all of the associations will 
endorse this legislation. We will be asking Congress to pass 
this legislation in the future.
    The last item is the drinking water infrastructure needs. 
We've identified about $385 billion that is needed over the 
next 20 years to improve the infrastructure. We look to the 
Government to make low interest funding available, and we urge 
you not to consider a grant program, but to promote self-
supporting operations in all aspects of the water utility 
industry.
    Thank you very much.
    Senator Crapo. Thank you very much, Mr. Tompkins.
    Mr. Van Dyke?

 STATEMENT OF RANDALL VAN DYKE, GENERAL MANAGER, CLAY REGIONAL 
       WATER; PRESIDENT, NATIONAL RURAL WATER ASSOCIATION

    Mr. Van Dyke. Good morning, Senator Crapo and Senator 
Smith.
    My name is Randy Van Dyke, and I'm the General Manger of 
Clay Regional Water, a rural water system in northwest Iowa. 
I'm also president of the National Rural Water Association, 
which represents about 17,000 small utilities in communities 
and rural water systems. And on behalf of those small 
communities, I would like to thank you for this opportunity to 
be here this morning.
    I would like to focus my comments on the review of three 
key principles in the Safe Drinking Water Act of 1996. One, the 
use of sound science and cost benefits in rulemaking. No. 2, 
input from stakeholders in that process. And three, the 
emphasis on flexibility in the law. In my written testimony 
I've got many examples, and I'll just mention a few.
    First, sound science and cost benefit. We see that EPA has 
not taken the initiative to obtain adequate data and sound 
science, including the use of the most recent occurrence 
information, reasonable health effect study and reasonable 
compliance cost information when they're promulgating their new 
rules. Frequently, that good science and good research are 
started too late. And that research selection and data 
collection, lag far behind the timing when EPA is to write and 
finalize these new regulations.
    Consequently, old information and inadequate science is 
utilized as best available science, creating weak or wholly 
inadequate conclusions, which place devastating financial 
impacts on small systems across the Nation.
    Without anybody holding EPA accountable, only a strong 
emphasis on statutory deadlines is accomplished. Selective 
science is used instead of good science, and appropriate cost-
benefit analysis that was envisioned in the 1996 Safe Drinking 
Water Amendments. For instance, arsenic. There is a very 
uncertain scientific evidence of the health effects of arsenic 
at the levels proposed by EPA. Recently, EPA's own Science 
Advisory Board expressed concern that EPA's proposal for a 
maximum contaminant level of 5 ppb may be precipitous action 
and that a less extreme proposal be made until new studies are 
complete. Any decisions by EPA to go below the current 50 parts 
per billion standard would place an enormous cost on small 
systems without the public health benefits to justify that 
action.
    The unintended consequence of regulating small communities 
in the absence of public health and cost information can be 
devastating, causing more harm than benefit to the customers.
    In the stakeholder input, we have been disappointed with 
the consistency in which the Agency dismisses or sets aside 
input from stakeholders, the scientific community and the 
public. Numerous local officials have participated at great 
length on panels and stakeholders groups, only to see EPA 
unilaterally make all policy decisions. Ultimately, 
stakeholders are having little impact on the final rule. Work 
groups to provide background information, are pressed to 
provide incomplete or not-peer-reviewed data and submitted at 
the last possible moment.
    Finally, flexibility as a remedy for this bureaucracy. The 
question has been asked, is it possible for EPA to ever choose 
a flexible approach. We have concluded that based upon our 
observations, that it is not possible for EPA to utilize that 
flexibility. But they cannot be faulted for this, because EPA 
is first and foremost a regulatory agency. They are only liable 
politically and legally when they don't fully enforce any of 
the regulatory measures to its fullest extent.
    However, due to its mission incentives and culture, EPA at 
every opportunity has chosen to use its discretion in the Safe 
Drinking Water Act to increase the bureaucracy of its 
regulations. Here are some examples of our concern. Capacity 
development, that act provides for States to develop a program 
for assuring that it is sufficient for technical, managerial 
and financial capacity for all water systems and water systems 
applying for State revolving fund assistance.
    National Rural Water Association recommended that States, 
not EPA, develop the capacity development strategies for 
meeting these specific areas written into the statute. This 
would provide States full flexibility to address small systems 
capacity development. Contrary to this input, EPA has written 
formal guidelines for these capacity development strategies, 
despite the fact that there is no statutory authority for EPA 
to write such a guidance. Our contention is that States should 
have ultimate flexibility in this process and that every State 
is presently operating a form of capacity development strategy 
simply in its regulatory compliance and technical assistance 
programs
    EPA says that writing these guidelines was supported by the 
majority of stakeholders in a stakeholder process. However, 
this was not a stakeholder idea. It was a proposal initiated by 
EPA and pushed rigorously thorough that process.
    Radon. EPA has proposed a radon maximum contaminant level 
of 300 picocuries per liter. Under the Act, a community can 
comply with the outdoor air equivalent, if its State initiates 
a multi-media mitigation program. However, EPA appears to be 
requiring an overly prescriptive mitigation program, rather 
than an education technical assistance approach. If the States 
do not adopt workable multi-media programs then small 
communities will be required to comply with the 300 picocuries 
per liter, which is an unreasonably stringent standard. Small 
systems should not be penalized for States' inaction or EPA's 
overly complex MMM program demands.
    In closing, improving drinking water for small communities 
is more of a resource problem than a regulatory problem. Every 
community wants to provide safe water and meet all drinking 
water standards. After all, all local water systems are 
operated by people whose families drink the water every day, 
who are locally elected by their community, and who know first-
hand how much their communities can afford.
    I want to again thank the committee for this hearing and 
ask for your assistance in clarity of the intent and the 
meaning of the provisions of the 1996 SDWA amendments and your 
resistance to call from special interest groups represent more 
and more ever stringent Federal unfunded mandates upon 
communities.
    Thank you.
    Senator Crapo. Thank you very much, Mr. Van Dyke.
    And to the whole panel, your testimony, both written and 
oral, has been very helpful to the committee. And we encourage 
you to continue to advise the committee of concerns.
    I want to start out by approaching the issue of what 
possible solutions or support we can provide at the 
Congressional level at this point in time. And in that context, 
a number of you have made recommendations of legislative action 
that could be very helpful.
    And I'd like to go over several of those recommendations 
that I think might be able to be worked into hopefully a 
noncontroversial bill. And just ask the panel if any of you 
have disagreements with any of these legislative proposals, and 
if so, to state the basis of your disagreement.
    The first one, which has been mentioned by several of you, 
is to extend the current statutory deadlines for the EPA's 
action by, say, 6 months, so that a little more time can be put 
into place for the EPA to work with the stakeholders on some of 
the disputes about what the applicable science tells us. Is 
there any objection by members of the panel to legislation 
giving a 6-month extension of the deadlines? Mr. Olson?
    Mr. Olson. Yes. I assume that what you're talking about, 
are you talking about the arsenic standard?
    Senator Crapo. I would be assuming the arsenic standard and 
I think the radon, there were a couple of them that were 
mentioned by folks here. I can go back through my list. I know 
arsenic was one of them. Why don't you talk about arsenic, and 
I'll look at my list here.
    Mr. Olson. Senator, I guess I would urge that we take an 
historical perspective, for example, on the arsenic standard. 
EPA was originally required to review the 1942 standard for 
arsenic in 1974. EPA never completed and update the standard 
back in 1974, saying more research and time was necessary. 
Congress again ordered EPA to do it in 1986. EPA was put under 
court order. EPA missed the original deadlines, asked for 
extensions and said more time was necessary under the 1986 Act.
    Now, in 1996, EPA again was ordered to do this by Congress, 
and given an extended period of time. It was given the research 
of the National Academy of Sciences, which told EPA and the 
Nation that the standard should be reduced as promptly as 
possible.
    We believe that at this point, EPA has had ample 
opportunity and time to review its standard. We have agreed on 
numerous occasions to extensions of time for this process. We 
believe that the time has come for the Agency to make this 
difficult decision and to bite the bullet. I think we would 
oppose the 6-month extension, simply because we think that the 
Agency has had plenty of time to do it. It has the science and 
we don't believe that an extension of time is necessary. In 
fact, we're concerned that it would lead to additional 
extensions in perpetuity to review this 58-year-old standard.
    Senator Crapo. Mr. Kosnett, and I'd ask each of you to be 
very brief, because we're running out of time. I just want to 
know your reactions. Mr. Kosnett?
    Mr. Kosnett. Senator, our committee stated specifically in 
its conclusions that the standard should be lowered as promptly 
as possible. We felt that the state of the science today was 
such that, based on sound scientific principles and scientific 
consensus, we could conclude that the current level was not 
protective of public health.
    Senator Crapo. Before we go to the others, I want to divert 
to that point very quickly. Did the study that you were a part 
of support the 5 part per billion level versus the 10 part per 
billion level, or whatever, or just recommend reduction?
    Mr. Kosnett. We were not asked to recommend a specific 
level. And we did not recommend a specific level. We were 
cognizant of the fact that the setting of a specific level 
involves not just health issues, but other concerns as well.
    Senator Crapo. Understood.
    Mr. Kosnett. And so we did not provide a number to EPA. But 
we did feel that the current consensus was that it should be 
lowered as quickly as possible.
    Senator Crapo. Mr. Grunenfelder and then Mr. Paris.
    Mr. Grunenfelder. And my perspective is broader. And it 
depends on what you want to achieve. If it's to get rules 
adopted that's one thing. If you want to see rules implemented, 
that's another. To implement them, I don't think 6 months 
across the board will adequately address the need to prioritize 
that we're trying to achieve with public health protection and 
make sure that we can actually roll these things out and get 
them implemented.
    So I think some of the higher public health rules, we 
should be working on them. We should move those forward. Some 
of the lower ones I think 6 months is not nearly enough. And 
I'll just quickly make an example of radon, where EPA's 
assessment of risk, the risk from drinking water to the radon 
problem, is 3 percent of the risk for radon. So is that a high 
drinking water priority which we should divert resources to 
when there are other, I think more important public health 
priorities.
    Senator Crapo. Thank you. Mr. Paris, and then I'll have to 
turn to the Chairman.
    Mr. Paris. Senator, thank you. We would support the 6-month 
extension in particular for arsenic. The rationale behind that 
right now is that that rule is just released. It is to be 
finalized in January of 2001, as by statute. Our fear is that 
even though we will have a comment period, it will be shortened 
insofar as EPA's ability to respond to the comments in this 
particular rule. We feel they need more time than they will be 
allocated. So we certainly would support that for those 
reasons.
    The filter backwash rule is another example of a rule that 
we are extraordinarily concerned with. It was put out by 
statutory deadline. We find tremendous problems with that rule. 
We think that a statutory extension on that is also reasonable.
    And I'll make one other point, and that's the coordination 
of the rules that impact the same utilities. We have a couple 
of rules that deal with arsenic and radon that have every 
potential to impact exactly the same utilities, the utilities 
that are smallest and least able to handle those rules. I'm not 
asking here that those be delayed, but I am asking that they be 
coordinated so that the same utility that has to deal with both 
rules can have the opportunity to do it once and do it finally 
and not have to incrementally take steps that may damage 
previous steps.
    Thank you.
    Senator Crapo. All right, thank you. I'll pursue this line 
in a little bit. But the Chairman has his turn to ask questions 
now.
    Senator Smith. Thank you very much, Chairman Crapo. And 
thank you for holding these hearings.
    I have a statement for the record. I would ask unanimous 
consent that that be entered into the record.
    Senator Crapo. Without objection.
    [The prepared statement of Senator Smith follows:]
          Statement of Hon. Bob Smith, U.S. Senator from the 
                         State of New Hampshire
    Good morning. I would like to first thank Senator Crapo for his 
leadership on the Fisheries, Wildlife and Water Subcommittee and for 
holding this oversight hearing on the Safe Drinking Water Act and 
recently proposed national primary drinking water standards.
    It has been over 3 years since Congress overwhelmingly passed the 
Safe Drinking Water Act Amendments of 1996. This Act is an excellent 
example of what can be achieved when we work together on a bipartisan 
basis.
    When we were drafting the 1996 Amendments to the Safe Drinking 
Water Act, the committee worked closely with the Administration, state 
and local governments, and stakeholders to ensure that all Americans 
receive clean and safe drinking water. Today's hearing is an important 
step in carrying out the goals of these Amendments.
    With several new regulations proposed in the past year, including 
the radon and arsenic rules, cooperation between Congress, the 
Environmental Protection Agency (EPA), and the drinking water community 
is necessary to protect public health while continuing to address the 
costs to our economy and small systems as a result of new drinking 
water standards.
    I have been working on the issue of improving our drinking water 
supply for many years. I have worked on the radon issue since 1991 when 
EPA proposed a rule to limit radon in drinking water. I took an 
interest in this issue because of its importance to New Hampshire. At 
that time, it was estimated that cities and towns in New Hampshire 
would have to sepnd as much as $12 billion to comply with the EPA's 
proposed limit. Even more importantly, the proposed rule would have 
achieved very little environmental or health benefit since it would 
have reduced indoor air levels by only 2-5 percent--the real source of 
risk. I was convinced that the very limited risk reduction did not 
justify the costs of the new rule.
    However, the cost factor was not what caused me the greatest 
concern. I believed that EPA's proposed rule was not based on sound 
science. Even EPA's own Science Advisory Board criticized the proposed 
standard as very costly with minimum health benefits. I agreed with the 
Board's assessment that controlling radon from all sources was 
necessary. I also believe resources should be directed toward the 
greatest health risk, which is from airborne emissions, not drinking 
water.
    In the 1996 Safe Drinking Water Act Amendments, we greatly improved 
the process by requiring that sound, peer-reviewed science and cost-
benefit analyses be used when the Environmental Protection Agency 
conducts risk assessments for all drinking water standards. I supported 
a provision that required the National Academy of Sciences (NAS) to 
conduct a full risk assessment of radon in an effort to produce a more 
scientifically based standard for radon in drinking water.
    The NAS report on radon, released in 1998, concluded that, ``the 
increased level of indoor radon that is caused by using water in the 
home is generally small compared with the level of indoor radon that 
originated in the soil beneath the home.'' Radon is an air problem, not 
a water problem. The report also found that the risk from radon is 
higher among smokers because the combination of radon and smoking 
increases cancer risks.
    Today, EPA is in the process of finalizing the proposed rule on 
radon. The radon rule sets a Maximum Contaminant Level (MCL) for radon 
in drinking water at 300 picoCuries per Liter (pCi/L) and an 
Alternative Maximum Contaminant Level (AMCL) for radon at 4,000 pCi/L. 
While the NAS report supports the approach taken in the new proposed 
AMCL for radon, I continue to have serious concerns about the science 
underlying the specific radon standards, the costs associated with 
compliance with the new standards, and the burdens placed on small 
systems to find affordable treatment technologies. Small drinking water 
systems should not be responsible for addressing an air problem, when 
they deal with water.
    I look forward to hearing from EPA today how it plans to address 
these issues, and any others that may be raised by stakeholders.
    Another major proposed regulation that could have a substantial 
impact on small systems is the arsenic rule. At EPA's request, the 
National Research Council, a subset of NAS, reviewed data on the health 
effects of arsenic in drinking water and recommended revising the MCL 
for arsenic to a level below 50 parts per billion (ppb). I support 
lowering the standard. It is clearly warranted to protect public 
health. But I am concerned that EPA has gone too far.
    EPA has recommended 5 ppb as the new MCL for arsenic, a level that 
the science on arsenic just does not justify. Other levels, such as 10 
and 20 ppb, have been proposed by EPA for comment and can be supported 
by the available science. The 1996 Amendments to the SDWA require the 
best available, peer-reviewed data when selecting an MCL. I don't 
believe the data to support an MCL of 5 ppb is available right now.
    Proponents of the 5 ppb standard argue that EPA should adopt a 
lower standard even if the science is not there. I believe the better, 
and legal, solution is to adopt a scientifically justifiable standard 
now and then review it in a few years. The SDWA provides for a 6-year 
review of all drinking water standards. Arsenic would be an ideal 
candidate for this review. When stronger science is available that can 
substantiate the 5 ppb level, reduce the level then. As with the radon 
standard, I also have concerns that economically viable treatment 
technologies do not exist for small systems to meet such a low 
standard.
    I have a number of questions for the Administration and the water 
companies and associations represented here today about the Safe 
Drinking Water Act and the proposed radon and arsenic rules. These 
issues are very important to me because of the high levels of radon and 
arsenic in drinking water in New Hampshire.
    Another issue of concern to the citizens of my State is the issue 
of fluoride, and in some cases the addition of fluoride to the water 
supply. I am pleased that Dr. Hirzy was able to testify on this 
significant issue on behalf of the National Treasury Employees Union 
Chapter 280 to express his concerns about fluoride and the fluoridation 
of public drinking water supplies. I have been contacted by a number of 
constituents in New Hampshire and across the country who have voiced 
concerns about negative health effects associated with fluoride in 
drinking water.
    In 1986, EPA set the revised Maximum Contaminant Level and Maximum 
Contaminant Level Goal for fluoride in drinking water at 4 parts per 
million (ppm), taking into account the need for an adequate margin of 
safety. Many public water systems add fluoride--usually at a level of 1 
ppm--to prevent the incidence of tooth decay. As I mentioned, I've 
heard from a number of people across the country who are concerned 
about this practice. I recognize that the Safe Drinking Water Act 
prohibits the EPA from requiring the addition of any substance, 
including fluoride, to drinking water for preventative health care 
purposes. However, since this subcommittee has jurisdiction over the 
Safe Drinking Water Act, I believe we have an opportunity to ensure 
that EPA is on target with assessing the risks of fluoride in drinking 
water. I hope we can address the fluoride controversy and what the 
Federal Government's role may be in the debate during today's hearing.
    I look forward to hearing from the witnesses this morning. Thank 
you.
    Senator Smith. And we appreciate your being here, all of 
you. I echo the comments of Chairman Crapo in the sense that 3 
years ago, we passed this bill. We tried to help and I guess 
the question is, how did we do. It seems as if there still are 
some problems. And that's why we're glad to have you here.
    But in passing that law in 1996, which I think was probably 
unanimous through the Senate, I don't remember if there were 
any objections or not, but we tried to work with the 
stakeholders, folks like yourselves, before drafting and 
passing that bill. But with all these new proposed regulations 
that are coming especially in radon and arsenic and other 
areas, we want to continue to protect public health and at the 
same time, not be unreasonable in terms of what you have to 
face.
    Mr. Paris, thank you for coming, welcome from New 
Hampshire. It's good to have you here.
    Can you give us a sense, and perhaps others may wish to 
comment on it as well, but just in your area of Manchester, the 
cost ramifications, if we were to go with these proposed rules, 
no forbearance, if you will? How would this affect your 
ratepayers? If you can break it down to the individual level.
    Mr. Paris. I'll give it a shot. The system that I 
represent, first of all I think it's important to understand 
it's a large system. It reflects probably the greatest ability 
to pay. And the rules that we're dealing with today to a very 
large degree are significantly directed toward smaller systems. 
I think the number and intensity of the rulemaking for small 
systems is perhaps the key element.
    In Manchester, for instance, even though it's not a rule, 
one of the more significant issues we're going to have to deal 
with very shortly is MTBE. That falls outside the rulemaking 
parameters, but it is still one of those issues as public 
health people and as being responsive to drinking water quality 
we must be responsive to. I think it's a grand example of the 
industry taking steps as well as Congress to mitigate a problem 
that is recognized by the general profession and public health 
experts as one that needs to have action taken. And that that 
action is being taken outside the purview of a regulatory 
mandate. And I applaud that. And I think that that says more 
about the way these rules can function than anything else.
    For Manchester, the microbial disinfection byproducts 
cluster, if you will, will be the primary focus and impact. We 
will need to perhaps change the way that we disinfect our water 
as a result of that. And I would use Manchester as a poor 
example in that we have made such investment in our system, and 
I'm very proud of that, that we probably will be able to comply 
with the actual letter of the law even after these stage two 
rules are implemented.
    But for many utilities, it will mean that they will be 
adding ozone or ultraviolet irradiation to their systems at 
significant cost for their customers. It will be done in, I 
think, a collaborative and a cooperative method to try to get 
to some of the microbial issues and the microbial risks that 
are out there.
    It's difficult for me to put numbers on it for Manchester, 
but I would say for the smaller utilities in New Hampshire, 
these will be considerable hits. And their bills will go along 
the lines of what the ability to pay constraints are that we 
discussed earlier.
    Senator Smith. Let me focus on MTBE for a moment, and I'll 
come back to you, Mr. Paris. We've got representatives across 
the country here. Can you just, yes or no, is MTBE a problem in 
your various regions? Mr. Gunter, you're Kansas City, right?
    Mr. Gunter. Currently it's not a problem, not a serious 
problem.
    Mr. Grunenfelder. In the Sate of Washington, we don't have 
widespread contamination, either, that we have found.
    Senator Smith. Who else?
    Mr. Tompkins. In New Jersey, there is a slight problem in 
the northwestern part, in Sussex County, from leaking 
underground tanks. But it's very small and it's contained to 
that area.
    Senator Smith. The Congress has focused on this, obviously 
it's a huge issue. I know it's big in New Hampshire, Mr. Paris. 
Do we have any estimates at this point how many systems are 
affected in that State?
    Mr. Paris. Yes, I was involved with a recent rulemaking 
with the State of New Hampshire legislature where the State 
passed guidance at 13 parts per billion for MTBE in drinking 
water. During that proceeding, the estimates were that there 
would be, I think, Dover and perhaps one other community that 
could be in violation of that standard, but that there were, 
the number is almost 20 percent, something like that, of the 
community supplies that either detected MTBE or were in 
jeopardy of it, due to plume emanation. There was considerable 
concern.
    It's also a concern, not only from leaking underground 
storage tanks, but as I mentioned before, from power boating 
and recreational use. As you know, in the beautiful town of 
Wolfboro, we have tremendous pressure on our resources for 
recreation.
    Senator Smith. Well, this really gets to the heart of the 
problem we all face here as Senators, everybody says, well, 
just ban it. That's easier said than done for a number of 
reasons that are associated with the Clean Air Act. Of course, 
the root of the problem is that the underground storage tanks 
leak. But that's for gasoline. It does not deal with the issue 
of somebody putting gasoline in a boat and putting the nozzle 
back and dripping some of that into the water, which then 
diffuses rapidly through the lake. In the case of Lake 
Winipesaukee in New Hampshire, which is a huge lake that has a 
lot of boats, and most States have lakes with boating, so it 
could become a severe problem in that area as well.
    So it is a safe drinking water issue. It's a clean air 
issue. It's a leaking underground storage tank issue. And it's 
a very complex one, but one that I would just say to all of 
you, if you don't have it yet, you're lucky. But it could very 
well become a problem.
    But here again, this goes back, Mr. Chairman, to if we had 
done good risk assessment and looked at the science, we would 
have known or should have known that this was going to be a 
problem if it did get into our groundwater. So we're trying to 
fix the air problem and in doing that, we created another 
problem, because we didn't really investigate the science.
    Just one more round for Mr. Hirzy before I yield, Mr. 
chairman. Mr. Hirzy, I know you're an employee of the EPA. And 
I'm assuming that your views conflict with the Agency on the 
issue of fluoridation. Is that correct?
    Mr. Hirzy. Given the fact that EPA has set the maximum 
contaminant level, as indicated on the chart, at 4,000 parts 
per billion, and the so-called optimum level is 1,000 parts per 
billion, one could assume that. A citizen inquired of 
Congressman Bob Young to ask EPA about the American Dental 
Association listing EPA as an endorser of fluoridation. The 
then Assistant Administrator for Water, Bob Perciasepe, wrote 
back to Congressman Young and said that EPA has asked ADA to 
take EPA's name off the list of endorsers of fluoridation.
    So it's a wash. EPA I think is playing the good Federal 
solider and supporting this program that's been a Federal 
mandate more or less for 50 years. But officially, it's not on 
the list of endorsers.
    Senator Smith. Has EPA given you any indication, given you 
or your union any indication that the drinking water standards 
for fluoride will be reviewed in the near future?
    Mr. Hirzy. They haven't talked to me about this issue. We 
did have a meeting with Cynthia Dougherty and some of her staff 
members about a year or so ago and laid out our case for such a 
revision. But we have not had any indication that that was 
going to happen.
    Senator Smith. You cited several studies which were very 
interesting. I saw them in your statement. What kind of, are 
these basically independent studies with no peer review, or has 
there been sufficient peer review to give these studies 
credibility or not?
    Mr. Hirzy. The ones that are of most concern to us are the 
peer-reviewed studies that have appeared on Neurotoxicology and 
Teratology and Brain Research in 1995 through 1998. The work of 
Phyllis Mullinex, for instance, indicated that when rats were 
dosed, pregnant dams were dosed with fluoride that would result 
in serum levels in the brain of the pregnant dams that mimics 
serum levels in human beings drinking water at that maximum 
contaminant level, the dams gave birth to pups that were 
hyperactive, born hyperactive and remained hyperactive 
throughout their life. That was the reference in my testimony 
to asking for an epidemiology study that looked after that 
particular end point.
    Also in that same journal in 1998, a group of Chinese 
workers published the results of some research in which they 
gave basically the same doses that the Mullinex group did, and 
indicated that there was a depletion of certain critical 
chemicals in the brain, basically the lipids that constitute 
the neuronal membrane, that that could explain on a mechanistic 
basis the outcome of the Mullinex study.
    Then in Brain Research, in 1998, a group of researchers, 
which included an EPA scientist, found that one part per 
million of sodium fluoride resulted in changes in the cerebral 
vasculature in the test animals and also kidney damage.
    Senator Smith. Well, the current MCL and MCLG or maximum 
contaminant level and maximum contaminant level goal for 
fluoride, as you know, from both natural and added, or 
deliberate addition, sources is four parts per million. If EPA 
were to revise those standards, which is I think what you're 
suggesting should be done, what would be your recommendation 
based on the science of what that standard should be?
    Mr. Hirzy. I ran some calculations based on the brain 
research article. And if one applied EPA's reference dose 
methodology, as opposed to the methodology that's been used to 
set MCLGs in the past, the reference dose methodology would 
indicate a level well below a thousandth of a part per billion 
of fluoride in the water. The Surgeon General's panel to which 
I referred in my testimony, folks who were working on that 
panel made a comment to the effect that we'd have to have rocks 
in our head if we recommended what at that time was called an 
RMCL of anything more than about one and a half PPM.
    Senator Smith. Mr. Olson, do you share the concerns 
expressed by Dr. Hirzy on fluoride?
    Mr. Olson. I don't consider myself an expert on fluoride. 
But we certainly think that, first of all, you should know that 
we sued over the original fluoride standard over 10 years ago, 
urging that the standard be dropped. We thought that a standard 
more in the neighborhood of one or below was more appropriate, 
because EPA admits that there are dental fluorosis spots that 
occur on children's teeth when you get up to the four part per 
million level.
    There is a lot of science, as Dr. Hirzy suggests, that's 
come out since then. So I guess our view is that certainly 
there is a need for a careful peer review of all these new 
data, and there are significant concerns that have been raised 
over the last 5 years from some of the studies. We don't have a 
position right now on what the standard should be. But we think 
that a careful peer review and an open process to look at that 
new science is definitely called for.
    Senator Smith. And just a final statement, and I'll yield 
back to the Chairman.
    The problem we face here at the Federal level is that each 
community makes the determinations, it's my understanding, 
whether they put fluoride in their water. This is not a mandate 
from EPA. So have other regions of the country experienced, I 
don't know if you all have fluoride, but have other regions in 
the country experienced the same thing? I'm getting a lot of 
complaints about the issue of fluoride from New Hampshire, the 
citizens. Does anybody else have similar experience?
    Mr. Hirzy. If I may, it's my understanding that the State 
of California has set a health protection goal for less than a 
part per million, based on a review of the data there. I could 
stand corrected on that, but that's my understanding, that the 
actions that have taken place in California.
    Senator Smith. So you're asking that the standard be what? 
What are you asking? What do you think it should be?
    Mr. Hirzy. Half a part per million at most. That would 
allow for the feasibility to not impose, I think, unreasonable 
burdens on many water companies. I think, however, I'm going to 
reiterate my statement that based on the science, and 
especially this brain research article, the so-called reference 
dose methodology that EPA uses would require, the dose being 
something like .000007 milligrams per kg per day, which would 
bring the MCLG down approaching zero.
    Senator Smith. Thank you.
    Senator Crapo. All right, thank you. Let me get back to the 
questions I had started out with, with regard to possible 
legislation. Mr. Gunter had recommended as another approach 
that we require that the cost benefit analysis or the cost risk 
analysis be published with the rules, so that we can see what 
that analysis was. Is there any objection to that approach, to 
requiring the EPA to do that, here on the panel?
    Mr. Olson. I just want to add one thing. EPA does publish 
them, and they release them publicly. I guess the concern is 
that they're not in the Federal Register.
    Senator Crapo. Right, at the time of the publication of the 
rules, is that the issue, Mr. Gunter?
    Mr. Gunter. That was the issue.
    Senator Crapo. So apparently they do publish them, but not 
at the same time. So we can't evaluate them in the context of 
the rule itself. Any objection to a requirement in a statute 
that would clarify that at the same time we analyze the rule, 
we have the cost benefit analysis data available? Mr. Van Dyke?
    Mr. Van Dyke. Mr. chairman, I'm not sure how many 
scientific studies on arsenic were looked at the by the Science 
Advisory Board. But they did suggest that that was an extreme 
proposal that EPA was coming up with 5 micrograms per liter. I 
just want to point out that there are five significant new 
studies that are now underway. You might want to take a look at 
when those studies would be available in light of the timeframe 
extension. That could be significant in terms of what Mr. Fox 
was talking about before, regarding affordability and 
compounding effects of some of these regulations.
    A community was mentioned with radon and with arsenic. And 
during an extended timeframe, we could look at compounding 
effects of some of these regulations. There was a suggestion by 
Mr. Fox that EPA does not consider an exceedance of three times 
the affordability of median household income. I'm not aware of 
a rule or any variance to that effect, and I would appreciate 
if the committee could look into that. If there is such a 
variance that as reference, or any variance above $750 per 
household income. Because any one of these single rules could 
far exceed that in terms of individual and compounding effects, 
which reiterates what I've heard commonly referred to in a lot 
of literature as a train wreck for small systems. There are 
significant impacts.
    Senator Crapo. So if I understand you right, you're saying 
you're aware of proposed rules that individually exceed the 
$750 amount of affordability that Mr. Fox was talking about?
    Mr. Van Dyke. Yes. On a compounding effects basis. There is 
significant costs. Whether you look at it on the $750 or the 
three times median household income average, there will be 
extreme costs.
    Senator Crapo. Let me go to the third suggestion by Mr. 
Gunter, or maybe it was his second, which was an independent 
National Academy of Sciences review of how well the EPA is 
incorporating science into its regulatory decisions. We have 
seen not only in this context but in a number of other contexts 
some serious questioning of whether the EPA's science is being 
done well, and whether they're incorporating good science into 
their decisionmaking. Any objection to a National Academy of 
Sciences study of this issue?
    Mr. Olson. Senator, could I respond both to the previous 
question and this one? I don't think we would have any 
objection to legislation that would say that in the future, EPA 
should publish a cost benefit analysis with its, or the HRRCA, 
as it's called, with the rule. I'm not sure there's a big 
problem with that. I would be concerned if it would cause 
delays in upcoming rulemakings.
    Senator Crapo. Understood.
    Mr. Olson. You should know that there always is a cost 
benefit analysis included in every EPA proposed rule and final 
EPA rule. It's just this HRRCA, which is generally a massive 
document that's much more detailed that comes out, in some 
cases a little later.
    With respect to the National Academy of Sciences review, I 
don't think we would have any objection to a National Academy 
of Sciences review. It's always good to have sound science.
    Senator Crapo. All right, thank you. I know there were a 
number of other legislative proposals brought up by members of 
the panel. But because of, in the interest of time, I want to 
move on to another aspect of this. And it is the question of 
the affordability of the regulations, which was raised with the 
first panel.
    As you heard in the testimony given by the EPA, they're 
using a 2 and a half percent of median family income nationwide 
standard, which as they testified was $750. As came out in that 
testimony, that would be higher than 2 and a half percent for 
half the families in the country and lower than 2 and a half 
percent for half the families in the country.
    But it was about three times what the current cost per 
family is. And I would just like your input on that general 
standard at this point. It seems to me that affordability is a 
very big issue. And particularly that is the case for smaller 
facilities and communities that have less resources to apply to 
the remediation.
    The question I have is, although Mr. Fox testified that 
they hadn't yet reached that $750 level, Mr. Van Dyke 
indicates, depending on how you look at it, in a cumulative 
effect, it has been reached or will be with a number of these 
new proposed new rules. And it seems to me that what we are 
looking at is tripling the average family's cost of this across 
the country. Am I understanding that correctly, and do any of 
you have any comments on this issue in general? Mr. Van Dyke.
    Mr. Van Dyke. The rural water system that I manage, our 
current average cost without any of these proposed rules in 
effect is in excess, for the average household usage, of over 
$500 now, before any of these rules take effect.
    Senator Crapo. So you're at about $500 now, for your 
system, above it?
    Mr. Van Dyke. Yes, sir. The other issue is, the feasibility 
analyses that are based on the rulemaking that was described by 
Mr. Fox, was for large systems, rather than on small systems.
    Senator Crapo. That's right.
    Mr. Van Dyke. Our concerns and a problem for us, is in 
terms of the way EPA uses that information.
    Senator Crapo. But that information is used for small 
system?
    Mr. Van Dyke. Yes, sir. And microbial rules that are being 
promulgated are exempt from the affordability issues. They are 
not considered in the feasibility analysis.
    Senator Crapo. Oh, so not all of the rule's impacts are 
included in the calculation of affordability?
    Mr. Van Dyke. That's my understanding.
    Senator Crapo. Mr. Grunenfelder.
    Mr. Grunenfelder. I just wanted to echo the concerns around 
a small water system. In the State of Washington, we only have 
97 water systems that have over 1,000 connections. So that's 
about 3,000 population. Whereas we have almost 2,000 water 
systems with less than 100 connections. So about 300 
population.
    And the cost impacts of implementing these rules on these 
very, very small communities is dramatically different than, 
again, the larger communities. It takes a lot more effort and 
time to work through these issues, as a result. So the State of 
Washington, I think, ranks either second or third in the 
country in terms of getting State revolving fund loans out to 
small communities. But again, this is making a very, very small 
dent in the overall impact. And the timing it takes to roll 
these rules out and actually get them going.
    Senator Crapo. Mr. Grunenfelder, just in terms of the 
system which you are familiar with, if the EPA rules are 
adopted as proposed in these various areas, will that have an 
effect of reaching the $750 level per family in terms of the 
cost that will be imposed? Can you tell whether that's going to 
hit this target?
    Mr. Grunenfelder. I have no doubt in my mind that it will. 
But for example, just looking at how the arsenic rule would 
affect small systems, it will affect hundreds of small 
groundwater systems in the State that have naturally occurring 
arsenic. So again, it's the small water systems that will have 
to build the same treatment facility that the larger systems 
will, with again a rate base of maybe 30 customers to spread 
that cost over, or 40 customers to spread that cost over. And 
the rates accumulate very, very rapidly.
    Senator Crapo. And what kind of accommodation, if any, does 
the EPA provide or propose to provide for a community that has 
to achieve the same objective with 30 users that 3,000 or 
30,000 user community would be required to meet?
    Mr. Grunenfelder. And again, right now it's only the 
emphasis of trying to target the State revolving loan fund 
money to these small communities, which we are clearly doing. 
But for example, the secretary in the State department of 
health and I got to visit two small communities last Friday. 
And when you go and sit down with a water board that has a 50 
connection water system, so 50 homeowners in their community 
trying to meet enhanced surface water treatment rule 
disinfection byproducts that will be coming up, a number of 
other rules, they are at a total loss of how they will do that. 
Let alone repay loans which they might be able to get. They 
have no credit capacity to get loans.
    So it just creates a real dilemma. And again, it's taking 
us a long time to work through that community to look at how 
State grant programs or other types of funding can be brought 
to bear on meeting the requirements. Because we do want them to 
meet the requirements.
    Senator Crapo. By the way, before I let any others who want 
to answer this get in, I would like to just quickly ask, one of 
the other legislative proposals that has been made by a number 
of you is more resources for infrastructure needs. I assume 
there's no objection on the panel is we would try to provide 
more resources for the infrastructure needs.
    Anybody else want to comment on any of these issues? Mr. 
Olson.
    Mr. Olson. Yes, I'd like to speak just for a moment about 
the affordability issue. I think it's important first of all to 
recognize that water is an incredible bargain in the United 
States. Most people spend less on their tap water than they do 
on cable TV, on gas, on bottled water, on electricity, on phone 
systems.
    And everyone, I brought with me this report that was done 
by the water utilities themselves that suggests that over the 
next 20 years we're going to have in the neighborhood of $5 
billion that has to be spent to upgrade these systems. So the 
cost of water is going to go up. And they say most of it is not 
from EPA regulations, it's from other issues that are going on.
    The other important issue is that 90 percent of the U.S. 
population gets its water from these larger systems. Nine out 
of ten Americans gets their water from these large systems. So 
for example, the arsenic rule is going to cost about $5 a month 
for those systems affected for the large systems, $5 to $10 a 
month. The cost is very reasonable, generally, for any of these 
regulations, for nine out of ten people.
    The issue becomes these small systems. And we have a 
proliferation of them. And I think all this revolution we've 
heard about is going to force many small systems either to 
package technology that basically comes in on a skid and they 
have to install it or at a point of use which is basically a 
filter you put on your tap or point of entry where you put it 
in your house, or to consolidation and regionalization of many 
of these small systems.
    The last thing I think is important is that in 1996, I 
don't know if you're aware of this, but Congress did put a 
special provision about small systems in the Act that deals 
with this very high cost for some small systems. Basically it's 
a three-pronged approach.
    First, they can get out of some of the requirements through 
variance and exemption provisions that the States administer. 
Second, there's targeted money through the State revolving fund 
for small systems, and third, there's a special requirement for 
special technology for small systems that would be available 
when they issue a new standard.
    So I think a lot of these issues will be dealt with. It's 
going to be a wrenching, difficult time for many small systems 
over the next 5 to 10 years.
    Senator Crapo. Thank you. Mr. Tompkins.
    Mr. Tompkins. Senator, I'd just like to comment on the 
affordability issue, that from the National Association of 
Water Companies standpoint, if there are consumers who have an 
affordability problem, the social agency would make available 
some form of supplement to their utility bill. And this could 
be done from Congress right on down, so that you're not making 
the water utility the social agency.
    Senator Crapo. Thank you. Quickly, before I go on, Mr. 
Grunenfelder, how often do you get variances from the EPA, as 
you try to help these small systems?
    Mr. Grunenfelder. On things like monitoring waivers, we've 
done some pretty comprehensive assessment throughout the State 
to see where certain areas of the State simply don't have 
certain types of VOC or volatile organic chemical, synthetic 
organic chemical contaminants. And we have granted waivers in 
those areas.
    Things like mailing consumer confidence reports to 
customers. We have not pursued a waiver in that area, thinking 
that consumers should know about their water. So it varies with 
the requirement and how we see it fitting with our objective in 
the State, which is to get information to the public and 
protect their health.
    Senator Crapo. All right, thank you. I apologize to the 
panel, I've got pages of questions here that I'd like to go 
through and we are already out of time. But I would like to, 
and I probably will submit some written questions to you and 
ask you to respond to them.
    But I would like to spend just a few minutes here, I'll go 
late to my next meeting, and just have a brief discussion of 
the general issue that I was discussing with the first panel, 
which is this question of whether we have the right level of 
default protection in our system and whether we are hitting 
that right point in terms of the amount of resource that we are 
directing toward certain recovery when the cost gets higher and 
higher as we get to the incremental increases.
    And the first part of that is, as I understood what we 
talked about with the first panel, we tend to have a tradition 
or a standard that we follow in the industry or in the 
regulatory community of identifying where the risk level is and 
trying to get somewhere between 10 to 4, 10 to 6 levels, 10 to 
the minus 4, 10 to the minus 6 levels below that in terms of 
the risk that will be acceptable. Now, if I've stated that 
right--have I stated it right? Mr. Olson, do you want to say it 
the right way?
    Mr. Olson. Well, I think there are two different issues and 
they tend to be confused very often. One is the level at which 
you regulate a carcinogen, where EPA traditionally has tried to 
target a goal of no more than 1 in 10,000 people drinking the 
water for a lifetime would get cancer from that carcinogen. 
That's for carcinogens, and actually, they try to make it 
stricter than that if possible or feasible.
    The other issue is for something to cause a certain acute 
effect, you know, a chemical that will cause you to get sick 
almost instantly. In that case, they will establish safety 
factors, so they'll do animal tests or they'll base it on human 
epidemiological evidence. And then they'll try in some cases to 
put a safety factor on it.
    For nitrate, for example, there is virtually no safety 
factor. There are human studies that show children, babies get 
sick when they drink water containing nitrate at above around 
10 parts per million, and the standard is 10 parts per million. 
They just figured there was no feasible way to get below it.
    Senator Crapo. Anybody else want to clarify this issue for 
me? Mr. Paris.
    Mr. Paris. If I may, I fully concur with Mr. Olson's 
interpretation. One of the comments you'll see in our written 
testimony has to do with how, when you take that interpretation 
for risk and you apply it to a small system, it literally takes 
hundreds of years before any incidence of illness or cancer, in 
this particular case, would occur in that particular community, 
taking 1 in 10,000 for 70 years and saying your community has 
300 people in it, it takes many, many years, hundreds of years, 
before it impacts to that type of regulation and that type of 
risk evaluation has an impact on that community.
    It's one of those pragmatic issue, if you will, it reflects 
in our thinking on why some of these rules, as applied to 
larger populations, fall down in the practical line of thinking 
when you apply them to smaller systems. So I would reflect that 
in our written testimony as part of our argument.
    Senator Crapo. Any other comments on just what that 
standard is and how it's used? Mr. Van Dyke.
    Mr. Van Dyke. Mr. Paris has a strong point here. Radon is 
an example of that. If there's a potential chance of a risk of 
cancer from radon attributable by water, if you try to mitigate 
that, a community might be mitigating an unknown or less than 
zero possible health risk benefit. Feasibility assessments that 
were described by Mr. Fox, again, use large system analysis. 
But 94 percent of all public water supplies are below 10,000 
population, about 65,000 public water supplies are small.
    So the criteria that we're using to judge this risk benefit 
analysis doesn't work really well in that model when you get 
down to the smaller systems. It just breaks down.
    A more appropriate way, would be to look at cumulative 
risks of a given population in their area, including water, 
medical needs, and other things, rather than solely water.
    Senator Crapo. Mr. Kosnett.
    Mr. Kosnett. I just wanted to address an issue regarding 
that. The risk to any one given person is no different in a 
small town than in a large town. The statistical power for you 
to detect it in a small town is limited by virtue of the fact 
that it's a small town.
    But the risk is the same to people, regardless of whether 
they live in a small town or a big town.
    Senator Crapo. Let me ask you a question to clarify the 
concern that I have in that context. I am assuming, and let's 
assume for the purpose of this question that this is true, that 
the median income of the small town is going to be lower than 
the median income in the large town. Well, first of all, let me 
ask, would that be a safe assumption generally? Anybody 
disagree with that assumption?
    Mr. Tompkins. Well, in the case of some of these resort 
communities, I don't think so.
    Senator Crapo. You're right. In a community, say a resort 
community, it would not be correct.
    Well, let me just say it this way. I'm assuming that in 
rural America, that the income levels on a median basis are 
lower than they are in urban America. Is that a fair 
assumption? I see members of the panel shaking their head yes. 
Let's assume that for the time being, and assume that in a 
general case, you're looking at people with lower levels of 
income, and lower numbers of people to provide for the funding 
of the technology that is needed to solve the problem.
    Recognizing that the risk to them is the same in the small 
community versus the large community, on an individual basis, 
if the cost to that community on an individual basis is 
extremely higher than it is in an urban area, isn't that 
generating another element of risk to that individual because 
of the loss of income? Dr. Kosnett, do you have an opinion on 
that?
    Mr. Kosnett. I don't want to opine on the risk associated 
with economic changes in a person's status, because that's not 
my area of expertise. So I would defer to other people on that.
    Senator Crapo. Do you know, Doctor, are there experts in 
that area?
    Mr. Kosnett. About the risk of having a lower income?
    Senator Crapo. Yes. The health risks of having a lower 
income.
    Mr. Kosnett. I'm certain that there are some associations 
between health status and income. However, that is an area of 
specialization in public health, and I think the committee 
could get input from those individuals.
    Senator Crapo. OK, thank you. Mr. Van Dyke?
    Mr. Van Dyke. Mr. Chairman, in my written testimony, I 
quote an expert in this area, Scott Rubin:

        ``Public health protection isn't free, whether it's 
        medical care, sewage treatment, clean drinking water, 
        AIDS prevention, prescription medicine, food, heat, or 
        shelter. Costs are real. We don't have enough money to 
        go around.''
        ``So yes, if we're setting public health policy, and 
        that's what drinking water regulation is, we'd better 
        make sure that we're getting our money's worth. Because 
        if we're not buying meaningful public health 
        protection, all we've done is take money away from 
        people who need to put food on the table, pay the 
        doctor or keep a house warm.
        ``The point is simple. Whenever you do anything to 
        increase the price of water, we are forcing millions of 
        families to make another tradeoff which will directly 
        affect their health. At the same time, we take a family 
        that is barely squeaking by and we push them over the 
        edge.''

    Senator Crapo. I guess that's the question that I want to 
get at. Maybe we'll have to have a hearing on just that issue 
and get some experts in here on that issue.
    But the point has been made to me a number of times over 
the years that when you get to families who are already maxed 
out on their disposable income in terms of food, health, 
shelter, the costs of clean drinking water and safe drinking 
water and the many other things, medicine, prescription drugs, 
whatever it is that they need, and you decide to reallocate 
that spending for them through a Federal or a State action, 
there is a cost. Or there is an impact, I guess is the point.
    And somehow I think we've got to bring that impact into the 
mix of the discussion. Because it may be that the points that 
have been raised earlier about needing more Federal resources 
and State resources for these communities that don't have the 
numbers of population to be able to bring in the technology is 
a big part of the answer.
    But we've got to, in my opinion, identify the full impact 
here. Because that's what resonates in the political climate. 
And it's not just that people want to use these dollars for 
non-discretionary items, for luxury items or a new Corvette or 
whatever that may be. The question is whether people need it 
for their prescription drugs or for other non-discretionary 
items of their budgets.
    To me, that aspect of the cost benefit analysis needs to be 
brought to the forefront and identified. I think that may be 
what Mr. Gunter was talking about in terms of getting that 
analysis in terms of the cost benefit brought forward and made 
a part of the rule proposal itself.
    I'm pretty much capped out on time. But if any of you would 
like to make one last quick comment, I would certainly welcome 
it.
    Mr. Olson. I think this issue has been debated by this 
committee since the Safe Drinking Water Act passed, the small 
community versus large community issue. I just think it's 
important to focus on the fact that the committee has always 
tried to avoid creating one standard for people in cities where 
they get safe drinking water and a different standard for 
people in small communities that get water that is not safe.
    So that tension has always existed. We don't want to create 
second class citizens across the United States in rural 
communities where they get less safe water.
    The way that we think you deal with that, and I think the 
1996 amendments included important provisions that tend to 
allow more flexibility for small systems and there is quite a 
bit of additional resources and flexibility in the 1996 
amendments that I think largely deal with a lot of those 
issues.
    Senator Crapo. Thank you, and I certainly agree. Yes, Mr. 
Hirzy.
    Mr. Hirzy. May I please, Senator. There is one and only one 
substance that the Federal Government has been mandating and 
promoting that every American citizen consume via their 
drinking water systems, and that's fluoride. It's been 23 years 
since there's been a national hearing in the Congress on the 
science and the social impacts of that particular substance 
that the Federal Government is pushing. I would like to 
reiterate my call for a national Congressional hearing on 
fluoridation, so that the latest science can be brought to bear 
on that issue.
    Senator Crapo. Dr. Hirzy, your call has been heard, and I 
will check with and coordinate with the chairman of the full 
committee, Senator Smith. The comments and suggestions of all 
of you that may not have even been able to be talked about here 
today are certainly welcome. I was just reminded, I'm going to 
leave the record open for 2 weeks so if you'd like to 
supplement the record with any further thoughts or comments, 
you're welcome to do so.
    I agree with the points that have been made, the risk is 
the same at an individual level across the country. And we 
don't want to have citizens who get a different benefit from 
the law depending on where they live. I just think it's very 
complex. Because if we do that analysis in the context of only 
one thing, like arsenic, or fluoride or whatever, and don't 
realize that we're dealing with populations that may have very 
high costs associated with what we are providing to them in 
terms of this standard that they get to pay for, that we could 
be making them second class citizens in terms of the heating 
that they have in their home or the health benefits they get 
through their health care that they can provide to the family 
or the quality of the food that they eat and so forth.
    So it's just a very complex analysis. And I do think that 
one area of strong consensus that I'm sensing here in the panel 
and that I'm agreeing with is that it's very possible that the 
solution is that when we look at the communities that are small 
enough that they don't have a resource or a population base to 
solve these problems in an affordable way that doesn't have 
these large impacts on other aspects of their health, and their 
quality of life, then that's an area where, if we want to have 
a Federal standard, then we'd better have some Federal support 
for achieving that standard.
    So I'll let you have the last word, Mr. Van Dyke, and then 
I'm going to have to wrap it up.
    Mr. Van Dyke. Mr. Chairman, Mr. Olson talked about the 
issues that were discussed in the Safe Drinking Water Act on 
small versus large and some of the tools that were put in the 
1996 Act. I won't take up the time of the committee, but ask 
that you turn to my testimony. For a number of different 
reasons notwithstanding, what Mr. Grunenfelder said that State 
primacy agencies are allowing some variances on monitoring, EPA 
has not granted other variances, or used any of the tools that 
Mr. Olson described. I refer again to my testimony for 
examples. There are several reasons why that hasn't occurred, 
but in the shortness of time, I just ask that you address this 
issue in the future.
    And maybe the committee might look into why this is 
occurring--those tools are not being put into place.
    Senator Crapo. That's a very good point, in terms of using 
tools, providing resources is one. But the variances and the 
other tools, if they're not being utilized, need to be 
utilized, and I appreciate that comment.
    Again, I wish we could go on more. This is a very important 
issue and I believe we've had a good discussion of it today. 
However, we are always caught by time issues here. And I 
appreciate your time that you've given us today. We will be 
paying very close attention to this, and if we can, find some 
consensus and some common ground on which we can move forward 
with legislation to help improve this, we will.
    We will continue to use our oversight function here to 
assure that we achieve some of these objectives that can be 
achieved without legislation. And I ask you to continue your 
valiant efforts in keeping us informed of what we need to be 
focused on.
    And with that, this hearing is adjourned.
    [Whereupon, at 12:47 p.m., the subcommittee was adjourned, 
to reconvene at the call of the Chair.]
    [Additional statements submitted for the record follow:]
        Statement of Hon. Barbara Boxer, U.S. Senator from the 
                          State of California
    Thank you, Mr. Chairman.
    When the Safe Drinking Water Act was passed in 1974 many Americans 
took the purity of their drinking water for granted. Today, reports of 
radon, arsenic, MTBE and other contaminants fouling our water undermine 
the public trust in that water.
    In California, where water is scarce, the loss of a drinking water 
supply to contamination can be devastating to local communities. The 
City of Santa Monica now pays to import water from the Colorado River 
after losing its main drinking water wells to MTBE contamination. Lake 
Tahoe, known for its one-a-kind lake, has lost about half of its 
drinking water wells to the same fate.
    I am pleased that EPA is moving forward to control some of these 
drinking water threats. Earlier in the year, EPA finally announced that 
it would begin the regulatory process of banning MTBE. I hope that we 
move forward in the full committee to ban MTBE faster than EPA's 
timetable, but I am pleased to see EPA finally moving on this issue.
    In response to a 1999 National Academy of Science report, EPA also 
recently took action to control arsenic in drinking water. Arsenic has 
turned up in drinking water supplies around the nation. It can cause 
cancer, cardiovascular problems, skin lesions, reproductive problems 
and harm to the nervous system. In its report, the NAS found that the 
existing drinking water standard--which was set in 1942--does not 
protect public health.
    It found that this outdated standard ``could easily'' result in a 
total cancer risk of 1 in 100. This is about 100 time greater risk than 
EPA allows under other drinking water rules.
    I applaud EPA for moving forward to regulate arsenic in drinking 
water, and I look forward to learning more about this issue today.
    Finally, the NAS also recently concluded that radon in drinking 
water should be controlled. The NAS found that radon can be present in 
drinking water at levels high enough to cause substantial cancer risks. 
It also found that the presence of radon in indoor air--where it seeps 
in from soil--is an even more significant threat.
    I understand that EPA does not have the authority to regulate 
indoor air, and so can't control radon in this way. EPA's proposed rule 
creatively tries to lessen the impact of regulating radon in drinking 
water by encouraging states to regulate radon in the air. If a State 
does, it can meet a less stringent drinking water standard for radon. I 
am interested in learning more about this approach today. Thank you, 
Mr. Chairman.
                               __________
 Joint Testimony of J. Charles Fox, Assistant Administrator, Office of 
 Water, and Norine E. Noonan, Ph.D. Assistant Administrator, Office of 
     Research and Development, U.S. Environmental Protection Agency
    Thank you, Mr. Chairman, for the opportunity to address the 
Subommittee today. We are pleased to be able to discuss the 
Environmental Protection Agency's implementation of the Safe Drinking 
Water Act Amendments of 1996.
    We are proud of the many successes achieved to date. Nearly 4 years 
into implementation, EPA has completed all actions required of us to 
date by the 1996 Amendments. As a result of the work of EPA, States, 
water systems, and the public, the United States has one of the safest 
drinking water supplies in the world. Over 90 percent of Americans 
served by community water systems receive water with no reported health 
standard violations.
    The 1996 Amendments moved us toward more comprehensive drinking 
water protection by: improving the way EPA sets drinking water safety 
standards based on good science and data; providing funding for 
infrastructure investments for communities; emphasizing prevention 
through source water assessments, capacity development, and operator 
certification; addressing some of the most pressing problems of small 
water systems; expanding public information and involvement; addressing 
some of the highest public health risks; and, giving us a framework to 
alleviate emerging risks.
    The 1996 Amendments also acknowledge that drinking water protection 
must be a shared effort across the entire drinking water community. EPA 
has used this concept to guide its implementation activities. Through 
an extensive stakeholder process, the drinking water community has come 
together to work through a number of issues. We have greatly expanded 
consultation with the National Drinking Water Advisory Council, 
established in the statute, through a series of working groups on 
concerns ranging from small system needs to a new approach to benefits 
assessment, and currently for our 6-year review of existing contaminant 
standards. We and our stakeholders convened a day-long forum on 
December 16, 1999, which was the 25th anniversary of the enactment of 
the Safe Drinking Water Act, to plan for future protection needs as 
well as ways to begin to meet those needs. Nineteen organizations 
within the drinking water community agreed to several goals for 
drinking water protection, including: decisions based on sound science 
and risk to health; integrated, comprehensive water supply management; 
effective source water protection; well-managed and -operated water 
systems; and, strong public information and outreach. All participants 
should be commended for their efforts.
    successes in meeting the statutory mandates and in implementing 
                                programs
Funding
    The Drinking Water State Revolving Fund (DWSRF) has been extremely 
successful in less than 4 years of operation. EPA has given out nearly 
$2.5 billion in grants to all 50 States, Puerto Rico, the District of 
Columbia, and the territories. States have made over 1,000 loans 
totaling over $2 billion to water systems to address the most 
significant public health needs. States are also taking advantage of 
the set-asides in the DWSRF to conduct the source water assessments and 
buildup State programs. Small water systems have been a focus of the 
DWSRF. Nearly 3/4ths of all DWSRF loans awarded have gone to systems 
serving fewer than 10,000 persons.
Right-to-Know/Consumer Awareness
    Drinking water systems have also made outstanding progress in 
implementing the right-to-know provisions in SDWA. Activities such as 
the consumer confidence reports give customers of drinking water 
systems the information they need to make their own health decisions. 
Today, approximately 253 million Americans have access to their first 
annual consumer confidence report. Over 100 million Americans are able 
to read their water quality report online. These reports provide 
information the public is demanding. In 1999 EPA's Safe Drinking Water 
Hotline received over 10,000 calls from consumers about their water 
quality, most coming near the October deadline for the first consumer 
confidence report. EPA's Local Drinking Water Information website is 
accessed over 5,000 times per month. I expect this interest to continue 
as the second reports come out by July 1, 2000.
    The public needs immediate information about health threats so they 
can protect themselves and their children. EPA recently completed 
revisions to the Public Notification Rule, which now requires faster 
notice in emergencies, specifically within 24 hours. While providing 
for faster and clearer communication to consumers, the rule will also 
reduce burden to water systems by requiring fewer notices overall and 
enabling water systems to better target notices to the seriousness of 
the risk.
    Preventing Contamination of Drinking Water (Source Water 
Protection, Capacity Development & Operator Certification)
    The 1996 Amendments recognized that a prevention program is 
necessary to stay ahead of future problems. Effective drinking water 
protection has to start with an understanding of the threats to the 
water source, and States are making significant steps forward on their 
source water assessments. Forty-nine States/Territories have approved 
Source Water Assessment and Prevention Program, and are conducting 
assessments for the water supplies within their State.
    Providing safe drinking water will continue to increase in 
complexity. Water systems must have the financial, technical, and 
managerial ability to meet new challenges and continue to provide safe 
drinking water to their consumers. EPA has developed guidance to States 
on both capacity development programs and programs to ensure that all 
water systems have access to a fully qualified operator. All States are 
developing their capacity development and operator certification 
programs.
Regulating High-Risk Contaminants
    Additionally, I would like to talk about the success we've had 
addressing contaminants of highest risk to human health. In the past 2 
years, we have proposed, or finalized, a series of new rules that would 
extend coverage against microbial and other high risk contaminants. We 
have done this with extensive research, which will be described later 
in this testimony, and stakeholder involvement, including special 
emphasis on the needs of small water systems and their consumers.
    The Administration and Congress agreed that the most significant 
threat to public health was microbial contamination, such as E.coli and 
Cryptosporidium. Adverse health effects from exposure to microbial 
pathogens in drinking water are well documented. As we have seen in 
Milwaukee and New York--and most recently in our neighbor, Ontario, 
Canada--these health effects can include severe infections that can 
last several weeks and may result in death.
    This spring EPA proposed the Ground Water Rule and the Long Term/
Enhanced Surface Water Treatment Rule to address the needs of consumers 
of ground water systems and small water systems, respectively. When 
promulgated, these rules will complete a cycle of microbial protection 
with the Interim Enhanced Surface Water Treatment Rule, issued in 1998. 
Together these rules will cover all consumers of public water systems 
and reduce threats to human health from microbial disease.
    Disinfection of drinking water to protect from microbial 
contamination is one of the major public health advances in the 20th 
century. However, the disinfectants themselves can react with naturally 
occurring materials in the water to form unintended byproducts that may 
pose health risks. EPA's Disinfectants/Disinfection Byproducts Rule, 
released with the Interim Enhanced Surface Water Treatment Rule in 
1998, addresses the potential health threats that may be related to the 
disinfection process itself. It strengthens standards for 
trihalomethanes, establishes new drinking water standards for seven 
disinfectant byproducts and three disinfectants, and requires treatment 
techniques to further reduce exposure to disinfection byproducts.
    The risk-risk tradeoff between disinfectants and their byproducts 
is difficult. However, the extensive stakeholder process that EPA used 
to develop these complex rules gives us better supported and understood 
rules that strengthen human health protection. We are now concluding a 
new round of discussions on the second phase of these rules, which will 
incorporate the results of the microbial and disinfection byproducts 
research that is currently ongoing.
    In November 1999, EPA proposed the Radon Rule, which will have an 
important impact on reducing the human health risk from radon in 
drinking water as well as in indoor air from soil. Because of the 
multimedia nature of radon risk, the SDWA Amendments created a unique 
multimedia mitigation program to address both risks. Radon in indoor 
air is the second leading cause of lung cancer in the United States. 
Although the risk posed by radon from drinking water is much smaller 
than that from indoor air, the 1999 report from the National Academy of 
Sciences confirmed that radon in drinking water causes cancer. I 
believe that our approach of an alternative maximum contaminant level 
and multimedia mitigation program accurately and fully reflects the 
1996 SDWA Amendments' provisions to protect public health and will 
result in a reduction of cancer cases from both indoor air and drinking 
water.
    Recently EPA proposed to lower the maximum contaminant level for 
arsenic, another high-priority drinking water contaminant. Arsenic is a 
known carcinogen that is also linked to many non-cancer health effects. 
In a March 1999 report, the National Academy of Sciences' National 
Research Council found that the current arsenic standard of 50 parts 
per billion (ppb) does not meet EPA's goal of human health protection, 
and recommended that EPA lower the MCL as quickly as possible.
    Finally, EPA's implementation efforts have given us a sensible and 
workable regulatory framework for the future. The 1996 SDWA Amendments 
require EPA to make a regulatory determination on whether to regulate 
at least five contaminants by 2001. Using recommendations from the 
public, the scientific community, and a National Drinking Water 
Advisory Council working group, EPA released its Contaminant Candidate 
List in 1998 to aid in this determination and to help set priorities 
for the Agency's drinking water program. In establishing the list, EPA 
has divided the contaminants among those which are priorities for 
additional research, those requiring additional occurrence data, and 
those which are priorities for consideration for rulemaking. To provide 
sound occurrence data, EPA promulgated the Unregulated Contaminant 
Monitoring Rule in September 1999, which will provide information on 
the occurrences in drinking water of specific contaminants. The 
National Contaminant Occurrence Data base, developed at the same time, 
holds these and other data to assist regulatory decisions. Finally, EPA 
is developing its process for reviewing the current drinking water 
standards as part of the mandated 6-year review.
                        drinking water research
    A vigorous and responsive research program is vital to the 
establishment of scientifically sound, cost-effective drinking water 
regulations that protect the health of both the general public and 
subgroups that may be at greater risk than the general population. To 
meet this challenge, EPA has demonstrated a commitment to strengthen 
its drinking water research program, which is one of the highest 
priority areas of research in the Agency. Funding for drinking water 
research in the EPA Office of Research and Development (ORD) has more 
than doubled from $20.8 million in fiscal year 1995 to $48.9 million in 
the fiscal year 2001 President's Budget request. The fiscal year 2001 
request represents a $5 million increase over fiscal year 2000. These 
increases in funding have enabled EPA to address critical research 
needs for priority contaminants on the current regulatory agenda (e.g., 
arsenic, disinfection by-products, Cryptosporidium), as well as to 
expand into new areas of research for unregulated chemicals and 
microbial pathogens that may be the subject of future regulatory 
determination (i.e., those on the Contaminant Candidate List). Health 
effects research in particular has been increased over this period, 
with the additional funds being used to support: epidemiology studies 
on disinfection by-products and arsenic, investigations of the toxic 
effects and mechanisms of action of chemical contaminants in drinking 
water, research on the health effects of important microbial pathogens, 
and waterborne disease occurrence studies. Research has also been 
increased to address methods for detection and control of microbial 
pathogens.
    EPA is meeting the near-term research needs and requirements of the 
1996 SDWA amendments through a targeted program that emphasizes 
research in the areas of health effects, exposure, risk assessment, and 
risk management research. EPA drinking water researchers are recognized 
worldwide for their expertise and scientific contributions in each of 
these areas. We have also expanded the drinking water research effort 
nationally by leveraging resources and capabilities with universities, 
various Federal and State agencies, the water industry, and other 
public and private research entities across the country. The Agency's 
extramural research grants program (STAR) has been able to 
substantially increase the involvement of the academic community in 
helping to solve important drinking water risk assessment and risk 
management problems. EPA researchers are working with scientists from 
the Centers for Disease Control and Prevention (CDC) and the National 
Institute of Environmental Health Sciences (NIEHS) on such topics as 
sensitive subpopulations, disinfection by-products and waterborne 
pathogens. We are partnering with the American Water Works Association 
Research Foundation (AWWARF) and other organizations to select and fund 
many high priority drinking water research projects.
    In the testimony that follows, I would like to update you on the 
status of our research to support the implementation of the 1996 SDWA 
Amendments. I am also pleased to share with you the progress that we 
have made over the past year with respect to assessing future drinking 
water research needs and resource requirements, further strengthening 
our interactions with drinking water stakeholders, and improving 
research tracking mechanisms.
Research on Microbial Pathogens/Disinfection By-Products
    Research by EPA scientists, collaborators and grantees over the 
past decade has played a crucial role in establishing the scientific 
basis for the rules to protect the public against contamination of 
drinking water with microbial pathogens and disinfection by-products. 
The Agency has been highly successful in addressing the priority 
research needs identified in the Research Plan for Microbial Pathogens 
and Disinfection By-Products in Drinking Water, and we are continuing 
to conduct research in areas where the greatest uncertainties remain. 
EPA has provided new information and methods to characterize and 
control the risks posed by microbial pathogens of public health 
concern, one of the most important of which is Cryptosporidium. Agency 
researchers have also been leaders in the development of data and 
methods to determine the health effects and occurrence of disinfection 
by-products. In recognition of the special needs of small communities, 
EPA engineers have evaluated a variety of alternatives to conventional 
water treatment systems that are effective, simpler, and less expensive 
to operate and maintain.
Research on Arsenic
    The EPA's Research Plan for Arsenic in Drinking Water has been used 
by EPA and outside research entities as a guide to the planning and 
implementation of both short- and long-term research on this important 
drinking water contaminant. EPA has completed each of the high 
priority, short-term research projects in the research plan. We have 
also made progress in addressing longer term research needs. Examples 
of completed research include an initial epidemiology study on health 
effects in a U.S. population (in Utah), refinement of techniques for 
the analysis of the different forms of arsenic in water and in 
biological samples, and laboratory and field tests on arsenic control 
technologies (including those for small systems). In developing the new 
proposed arsenic rule, the Agency has considered the results of studies 
conducted by EPA investigators and scientists worldwide. Research that 
is currently being conducted to address the more complex, long-term 
issues (e.g., health effects at low doses) will support the required 
review and revision, as appropriate, of the arsenic standard subsequent 
to the establishment of a new rule in 2001.
Research on the Contaminant Candidate List (CCL)
    The list of microbial pathogens and chemicals on the CCL includes 
contaminants that either have sufficient data to support regulatory 
determinations or that need additional research in the areas of health 
effects, analytical methods, occurrence and/or treatment. Pursuit of 
this research has become an increasingly important part of the drinking 
water research program. The fiscal year 2001 budget request includes 
$13.3 M for research on CCL contaminants, which represents more than 
double the CCL budget in fiscal year 2000 when the Congressional 
earmarks in the fiscal year 2000 enacted budget are excluded. This is 
enabling EPA to address the highest priority research needs identified 
in the draft CCL Research Plan, which will be reviewed by the Agency's 
Science Advisory Board this summer and finalized shortly thereafter. 
The draft CCL Research Plan has incorporated extensive input from 
outside scientists, the water industry, and other stakeholders.
    Examples of current CCL research include efforts to develop and 
evaluate analytical detection methods for several CCL pathogens (e.g., 
microsporidia, Norwalk virus, echovirus and coxsackievirus). Studies 
are underway to determine the occurrence of various emerging pathogens 
in source and potable waters. A survey is being conducted to collect 
information on CCL pathogens from public health laboratories across the 
country. Research to evaluate the effectiveness of conventional and 
alternative treatment technologies in removing or inactivating these 
contaminants is being conducted. For the CCL chemicals, a number of 
research activities have been initiated in the areas of health effects, 
analytical methods development, risk assessment and treatment. The 
results of these studies and those conducted by outside organizations 
will provide the data needed to support the second round of CCL 
regulatory determinations in 2006.
Research on Sensitive Subpopulations
    EPA has placed considerable emphasis on research to characterize 
the extent to which individuals in different life stages (fetuses, 
infants, children, the elderly), those with pre-existing diseases, or 
other groups of individuals may be more sensitive than the general 
population to the effects of waterborne pathogens and chemicals. 
Population-based epidemiology studies are being conducted to identify 
potentially harmful contaminants, risk factors, and sensitive 
subpopulations. Studies in laboratory animals are providing hazard 
identification and dose-response data, and are helping to elucidate how 
contaminants cause their effects. Standardized toxicity tests, better 
exposure data, and improved risk assessment methods are being developed 
to provide an improved scientific basis for characterizing risks to 
sensitive subpopulations. The status and results of these studies are 
summarized in a Report to Congress that is in the final stages of 
preparation and will be submitted later this summer.
Research Planning and Budget
    EPA uses a comprehensive, coordinated approach to assess needs and 
make budgetary decisions for research to support all of the Agency's 
programs. Research needs for drinking water are evaluated and 
prioritized by ORD in close partnership with the Office of Water, using 
peer-reviewed research plans and strategies (including those for 
microbial pathogens/disinfection by-products and arsenic). Input is 
also obtained during periodic consultations with scientific advisory 
groups and stakeholders. Our annual research planning and budget cycle 
reflects these efforts. In addition, a new multi-year planning effort 
is underway to link near- and long-term research priorities with annual 
planning and budgeting. Research priorities to support future 
regulatory determinations are being guided by the draft CCL Research 
Plan and by a new Comprehensive Drinking Water Research Strategy that 
is scheduled for completion in fiscal year 2001.
    The Office of Research and Development has been working closely 
with the Office of Water over the past 6 months to examine research 
needs, resource requirements, and timeframes for when results must be 
available to support future regulatory activities. Based on these 
analyses, we believe that the current level of funding and the 
resources requested for fiscal year 2001 are sufficient to meet both 
the near-term regulatory requirements as well as the needs of future 
regulatory activities.
Stakeholder Involvement and Research Tracking
    EPA places a high priority on sharing information with stakeholders 
to ensure that all groups are fully informed about research activities 
and can provide input concerning research needs and priorities. An 
example of a highly successful effort to involve stakeholders early in 
the research planning process is the Drinking Water Research Needs 
Workshop, co-sponsored by EPA and AWWARF in September 1999. 
Participants from the water industry, universities, various government 
agencies and the private sector worked together to identify and 
prioritize research needs for unregulated drinking water contaminants 
and to estimate the resources that would be required to address these 
needs. The EPA's draft CCL Research Plan was a key focus of discussions 
at the workshop, and a Research Needs Report that summarized the 
workshop proceedings has already been used by EPA to develop the next 
draft of the CCL Research Plan. Another example of stakeholder 
involvement is a series of meetings that were held throughout the 
country in 1999 as part of the SDWA 25th Anniversary Futures Forum 
activities. These meetings, which were co-sponsored by EPA and several 
partner organizations, focused on drinking water research needs and a 
variety of other topics such as drinking water treatment technologies, 
source water quality and quantity, vulnerable subpopulations and small 
water systems.
    To further involve the stakeholders in shaping the future drinking 
water research agenda, EPA is establishing a new research working group 
under the National Drinking Water Advisory Council (NDWAC). This 
working group will assist the Agency in developing the Comprehensive 
Drinking Water Research Strategy. In addition, research information-
sharing meetings are being held with the drinking water community on a 
regular basis.
    With regard to research tracking, over the past year we have been 
examining ways to improve the availability of information associated 
with projects listed in the Agency's drinking water research plans. A 
new prototype tracking system is being tested as a basis for evaluating 
the feasibility and utility of an expanded version that includes all 
drinking water research. This internet-based system will allow 
individuals from inside and outside the Agency to easily access 
information on drinking water research projects. The planned 
improvements to the research tracking system, combined with the 
opportunities provided by EPA for stakeholders to provide input into 
the Agency's research agenda, will collectively allow the drinking 
water community to become more informed about the status, timing, and 
funding of ORD research activities.
Sound Science to Support SDWA
    The need for sound and objective science to improve the efficiency 
and effectiveness of drinking water regulations is a central issue in 
the 1996 Amendments to the Safe Drinking Water Act. EPA is meeting this 
challenge through the efforts of a dedicated work force of scientists 
and engineers, along with the collaboration of investigators from 
various agencies, universities, and other research entities throughout 
the country. An increased level of funding is enabling the Agency to 
develop scientifically sound approaches and data to characterize risks 
to human health, and to provide practical, cost-effective approaches 
for preventing and managing risks associated with exposure to the 
drinking water contaminants of greatest public health concern.
                               challenges
    While the Agency is proud of its successes and accomplishments, we 
are also aware of the many daunting challenges both in the short- and 
long-term--facing the entire drinking water community. We are certainly 
aware that the significant number of new requirements in SDWA 
represents a significant demand on the States' and systems' ability to 
implement a wide variety of activities. I believe that they are 
manageable through the framework provided by the Safe Drinking Water 
Act, but will require concerted effort by all participants in the 
drinking water community. As EPA has implemented SDWA, we have 
attempted to ease some of this strain. We have had extensive 
stakeholder involvement in our actions, including a particular focus on 
small water systems. This has improved the quality of our rules and 
provided flexibility to States and water systems. The SDWA Amendments 
provide the authority to accommodate the needs and concerns of small 
systems and to emphasize technologies as a cost-effective approach to 
achieve compliance with our rules. We are working with States and the 
organizations representing them to address specific issues, like 
resource needs. We have also given the regulated community advance 
notice of new requirements, so that they may better prepare. I believe 
that the Contaminant Candidate List process, when fully implemented, 
will give us a fair and workable way to address the highest risks to 
public health. We will also attempt to consolidate rules by type to 
move away from a contaminant-by-contaminant approach to regulation.
    As we develop our rules we have taken into consideration the 
impacts that other rulemakings will have on the regulated community. We 
have tailored rules to consider local or regional considerations. We 
have phased implementation components where possible. We have worked to 
improve the capacity of water systems to meet these new requirements 
through early and improved technical assistance, training, outreach, 
and funding through the DWSRF. And we are working to lessen the 
pressure on water systems as the last line of defense by promoting all 
of the tools for watershed and source water protection through such 
mechanisms as the Clean Water Act and the Food Quality and Protection 
Act.
    The cost of providing safe drinking water--finding a water supply, 
treating the water, delivering the water, and maintaining the system--
will continue to be a challenge. The additional complexity of future 
public health threats will require an increased level of sophistication 
in the water industry. EPA's 1997 Drinking Water Needs Survey Report to 
Congress identified over $138 billion in industry needs with the vast 
majority of these needs targeted for delivery of water not for meeting 
regulatory requirements. The drinking water industry has released their 
own assessment of drinking water infrastructure needs, which you will 
hear about in their testimony. EPA is committed to working with 
Congress, the drinking water industry, and consumers to ensure that 
Americans continue to receive safe, affordable drinking water into the 
future.
    To continue and improve on our current standard of public health 
protection will require constant vigilance and the ability to look 
ahead to address emerging issues. Challenges to our drinking water 
still exist. These include unknown or newly emerging threats to public 
health, a pace of development that may threaten source water quality if 
not properly managed, an expanding and aging population that 
increasingly includes those with special health concerns, a need for 
additional high-quality research on health effects and treatment 
technologies, and a need for accurate information on compliance with 
drinking water standards. Collection of data that is reliable and 
accurate and information systems that can serve not only as 
repositories of data but also as a user-friendly reference for the 
drinking water community and the general public is a challenge that EPA 
is addressing at this time.
    For the longer term, the Office of Water and the Office of Research 
and Development will continue to work closely and ensure that the 
research needed to determine which contaminants from the Contaminant 
Candidate List are to be regulated is conducted and completed so that 
we have firm scientific underpinnings for these future rules. The 
identification of, and decisions on, the contaminants to be regulated 
and the research to be done on these contaminants are two of the 
biggest challenges facing EPA over the next several years. The new 
regulatory framework set forth in the 1996 SDWA Amendments, which 
allows the drinking water community to assist in the decisionmaking 
process on the contaminants to be regulated, has not yet been fully 
realized. We are working toward that approach and believe that EPA and 
its stakeholders can attain the objectives that Congress intended. I am 
confident that the Agency will be able to report its successes and 
accomplishments in implementing the total regulatory framework 
contained in the 1996 Amendments.
    This concludes our presentation. Thank you again for the 
opportunity to discuss these important issues. We would be happy to 
address any questions you may have at this time.
                                 ______
                                 
           Responses by Charles Fox to Additional Questions 
                           from Senator Crapo

    Question 1. What is the current EPA policy for determining whether 
a public water system is small or large?
    Response. Consistent with section 1412(b)(4)(E)(ii) of the Safe 
Drinking Water Act (SDWA), EPA's policy for determining whether a 
public water system is small or large is based on the population served 
by the system. There are three categories of small systems that serve 
10,000 or fewer people. Large metropolitan water systems are defined as 
serving more than 10,000 people.

    Question 2. On what basis does the EPA determine whether a proposed 
drinking water standard and regulation is feasible (i.e., affordable) 
for public water systems? What size water system do you currently 
consider ``large'' when determining whether a standard is feasible?
    Response. Section 1412(b)(4)(D) of SDWA, as amended, defines the 
term feasible to mean ``. . . feasible with the use of the best 
technology, treatment techniques, and other means which the 
Administrator finds, after examination for efficacy under field 
conditions and not solely under laboratory conditions, are available 
(taking cost into consideration).'' Cost assessments for the treatment 
technology feasibility determinations have been based upon impacts to 
regional and large metropolitan water systems. This protocol was 
established and published in the Congressional Record when SDWA was 
originally enacted in 1974 and was carried over when the Act was 
amended in 1986 and 1996. The population size categories that EPA have 
historically used to make feasibility determinations for regional and 
large metropolitan water systems has ranged from 50,000--75,000 people 
to 100,000--500,000 people.

    Question 3. On what basis does the EPA determine whether a proposed 
regulation is affordable for a small system?
    Response. Based on section 1412(b)(4)(E)(ii) of SDWA, EPA makes 
affordable technology determinations for the following small system 
size categories: a population of 10,000 or fewer but more than 3,300; a 
population of 3,300 or fewer but more than 500; and a population of 500 
or fewer but more than 25. EPA uses its affordability criteria to 
evaluate the cost of available technologies for these categories in 
determining whether or not these technologies represent affordable 
compliance technologies. If no affordable compliance technologies can 
be identified, EPA would identify variance technologies that could meet 
a less stringent regulatory level. (More detailed information on 
affordability is contained in the answer to question 7.)

    Question 4. In your 1998 report, Variance Technology Findings for 
Contaminants Regulated Before 1996, the EPA writes that ``[t]he most 
common population size categories used [to make cost assessments for 
treatment technology feasibility determinations] were 50,000-75,000 and 
100,000-500,000 people.'' What is the estimated percent and number of 
public water systems and community water systems these size categories 
represent? What is the median size of public water systems?
    Response. Large systems are currently grouped into the following 
population-served categories: 10,001--50,000 people, 50,001--100,000 
people, 100,001--1,000,000 people and > 1,000,000 people. For community 
water systems, there are an estimated 779 systems (1.4 percent) that 
serve more than 50,000 people of which an estimated 431 systems (0.8 
percent of total systems) serve between 50,001 and 100,000 people. 
These largest of the large systems provide water to over 55 percent 
percent of the population served by community water systems. The median 
size for community water systems is in the 101--500 people-served 
category, which falls into the small system category. All systems in 
this size category serve about 4 percent of the population.

    Question 5. Does the EPA feel legally required to set standards 
based on what is feasible for systems serving populations greater than 
50,000 or 100,000? What does this mean for the affordability of 
drinking water standards nationwide and the vast majority of systems?
    Response. EPA is legally required under SDWA to set standards based 
on what is feasible for large systems. SDWA also requires EPA to make 
affordable technology determinations for small systems and to identify 
technologies that meet these requirements. In EPA's publication, 
``Variance Technology Findings for Contaminants Regulated Before 
1996,'' feasible technologies such as reverse osmosis, granular 
activated carbon, and lime softening were not affordable in the 25--500 
people-served category. However, centrally managed point-of-use devices 
were affordable options in this size category, but would not be 
implementable in large systems. Thus, the structure of SDWA allows EPA 
to find different solutions for different size systems in order to 
achieve compliance with drinking water standards.

    Question 6. In testimony, you explained that the EPA considers 
public water systems serving more than 10,000 individuals to be 
``large'' systems. Your statistics indicate that nearly 80 percent of 
people served by public water systems are served by these large 
systems. This is consistent with the understanding of this committee as 
expressed in the Report of the Committee on Environment and Public 
Works on S. 1316, the Safe Drinking Water Act Amendments of 1995 (S. 
Rept. 104-169). Specifically the report explains that (P. 31). However, 
in recent documents the EPA has stated that the ``EPA will continue to 
use feasibility for large systems in setting NPDWRs [serving 
populations greater than 50,000].'' (63 FR 669432, December 16, 1998). 
What size category of systems has the EPA used to determine feasibility 
of MCLs for the M/DBP cluster of rules, the proposed arsenic rule, and 
the proposed radon rule? What percent of the population is served by 
the system size category(ies) used for these rules?
    Response. About 50 percent of the population served by the water 
systems affected by the M/DBP rule receive water from the system sizes 
used for the feasibility determinations, i.e., those serving more than 
50,000 people. Both non-community and community water systems are 
covered by the M/DBP rule. About 55 percent of the population served by 
the water systems affected by the proposed arsenic rule receives water 
from the system sizes used for the feasibility determinations. Only 
community water systems are covered under the proposed arsenic rule. 
About 31 percent of the population served by the water systems affected 
by the proposed radon rule receive water from the system sizes used for 
the feasibility determinations. Only community ground water systems are 
covered by the proposed radon rule.

    Question 7. The feasibility of a proposal has great implication on 
whether the regulation will serve the purpose of promoting public 
health because if it is too costly and burdensome, it may not be able 
to be implemented by small systems. The EPA has identified drinking 
water costs exceeding 1 percent-2 percent of a community's median 
household income (MHI) to be potentially burdensome (in line with other 
Federal agencies' guidelines for affordability) (U.S. EPA, Information 
for States on Developing Affordability Criteria for Drinking Water, EPA 
816-R-98-002). In your testimony, you explained that the Agency uses a 
national level affordability threshold set at 2.5 percent of MHI for 
determining affordability. If so, it seems that the EPA has set the 
affordability threshold for small system variance at an usually high 
level as a policy decision to make variance technologies unavailable to 
all but ``a small subset of small systems'' because of the threshold's 
correlation to economic burden. (U.S. EPA, Variance Technology Findings 
for Contaminants Regulated Before 1996, p.48). This affordability 
threshold would seem to impose a greater burden on more small 
communities than the government typically requires. The EPA's writing 
on this approach makes it seem that Congress did not intend for small 
systems variances to be available in a meaningful way. On what do you 
base this policy? How is this consistent with the strong emphasis 
Congress placed in 1996 on making regulatory compliance workable for 
small communities and systems? Using this approach, how many variance 
technologies has the EPA identified for those existing and pending 
regulation for which variance technologies are permitted? Does this 
approach render Sec.  1415(e) on small systems variances meaningless?
    Response. EPA believes there are some important distinctions among 
the affordability criteria that have been used for various purposes. We 
also believe that our approach to developing affordability criteria to 
determine whether small system variances may be granted appropriately 
balances a number of important considerations. Moreover, we think it is 
important to recognize a number of other key elements of the 1996 SDWA 
amendments that relate to affordability for small systems and that can 
be used to address their unique circumstances.
    EPA's guidance document, ``Information for States on Developing 
Affordability Criteria for Drinking Water,'' (1998) recommends an 
affordability threshold of 2.5 percent of median income. We are aware 
this criterion is higher than that used by various States, and by some 
other agencies and organizations (including the Department of Housing 
and Urban Development, National Consumer Law Center, and earlier 
guidance from EPA itself), to assess household affordability of 
drinking water costs for various purposes. EPA notes that the State 
affordability criteria listed in Appendix F are intended for use in 
prioritizing systems for assistance from the Drinking Water State 
Revolving Fund and are not necessarily the same criteria that the State 
would use to make small system variance determinations. The threshold 
used for determining whether additional assistance is needed to meet a 
National Primary Drinking Water Regulation should, in EPA's view, be 
lower than the threshold used to determine when a system may be allowed 
to operate at a lesser level of protection than the MCL.
    EPA would be concerned about an approach involving the use of what 
it considered to be an inappropriately low national level affordability 
criteria since it would not, in our view, be supported by its analysis 
of comparable household expenditures for other goods and services. We 
considered the percentage of median household income spent by an 
average household on such items as housing (28 percent), transportation 
(16 percent), food (12 percent), energy and fuels (3.3 percent), 
telephone (1.9 percent), water and other public services (0.7 percent), 
entertainment (4.4 percent), and alcohol and tobacco (1.5 percent) in 
identifying an initial range of options for the affordability 
threshold. (This analysis did not consider comparable expenditures by 
low-income households.) One of the key factors that EPA used to select 
an affordability threshold of 2.5 percent of median household income 
was cost comparisons with other risk reduction activities for drinking 
water. Section 1412(b)(4)(E)(ii) of the SDWA identifies both Point-of-
Entry and Point-of-Use devices as options for compliance technologies. 
EPA examined the projected costs of these options. We also investigated 
the costs associated with supplying bottled water for drinking and 
cooking purposes. The median income percentages associated with these 
risk reduction activities were: Point-Of-Entry (> 2.5 percent), Point-
of-Use (2 percent), and bottled water (> 2.5 percent).
    The complete rationale for EPA's selection of 2.5 percent as the 
affordability threshold is described in ``Variance Technology Findings 
for Contaminants Regulated Before 1996.'' EPA is concerned that a less 
restrictive set of criteria could have the net result of a national 
level finding that this and many future drinking water rulemakings were 
unaffordable for small systems--thus creating, in effect, a two-tiered 
approach to national rulemakings and public health protection. A two-
tiered approach could be created because large systems would be 
complying with the MCL while some small systems might be operating at a 
level above the MCL, though it would still need to be protective of 
public health. These systems could only receive a small system variance 
if the State determined that there was no affordable technology and 
that alternate sources or restructuring were unaffordable.
    EPA did not identify any variance technologies for the existing 
regulations for which variance technologies are permitted (U.S. EPA, 
``Variance Technology Findings for Contaminants Regulated Before 
1996,'' EPA 815-R-98-003). This document did note that in one instance, 
the centrally managed, point-of-use device option was the only 
affordable compliance technology. EPA has not identified variance 
technologies in any of the proposed rules for which variance 
technologies are permitted. EPA does not believe that the approach used 
to make affordable technology determinations renders small system 
variances meaningless and notes that variance technologies may be 
available for future regulations.
    One important option that Congress authorized in the 1996 SDWA 
amendments was point-of-use devices as a mechanism for small systems to 
comply with drinking water regulations (section 1412(b)(4)(E)(ii)). EPA 
believes that the centrally managed point-of-use device option in SDWA 
is a lower cost alternative for very small systems to comply with the 
MCL that reduces the need for variance technologies. Under this option, 
small systems maintain at-the-tap units inside each customer's home and 
treat only the water used for consumption and food preparation. This 
results in treating about 1 percent of the total water used in a 
household and can significantly reduce treatment costs in very small 
systems (those serving less than 100 people). Thus, SDWA currently 
provides a compliance approach that could significantly reduce costs in 
small systems compared to traditional approaches.
    The 1996 SDWA amendments also authorized the Drinking Water State 
Revolving Fund (DWSRF). As of April 1, 2000, $2.4 billion of the $3.6 
billion appropriated for the DWSRF program had been awarded to States. 
State DWSRF programs have made more than 1,000 loans at a total level 
of some $2 billion to construct needed infrastructure projects. Of the 
loans that have been made, 74 percent have gone to small systems 
serving fewer than 10,000 people. These loans represent 41 percent of 
the funds available for loans. The affordable technology determinations 
assume that all treatment costs are borne by the systems and are passed 
along to customers (a conservative assumption that would tend to 
project higher small system costs than would actually result). Loans or 
grants from the DWSRF or the Rural Utility Service of the U.S. 
Department of Agriculture would lower household impacts in systems 
receiving these loans. Other mitigating measures that can reduce the 
impact on households include: rate design, consolidation strategies, 
and regionalization approaches that are discussed in Appendix F of 
``National-Level Affordability Under the 1996 Amendments.''

    Question 8. SDWA is silent with respect to the cumulative costs of 
rules. If the EPA seeks to implement dozens of rules all individually 
``affordable,'' would that cumulative impact be too much for many 
public water systems and households to bear? How does the EPA take into 
consideration cumulative costs of rules?
    Response. EPA develops the cost impact of each rule separately. 
(This estimate excludes costs to treat co-occurring contaminants that 
have already been costed out by other rules.) We also consider the 
cumulative costs of the rules because this is an extremely important 
consideration for determining whether a rule individually or in 
combination with other rules will breach the affordability threshold. 
We do not believe that any of the soon-to-be promulgated rules, either 
individually or in combination, will cause the affordability threshold 
to be exceeded. However, this could be a factor in the future and will 
be an important consideration as we examine the impact of current rules 
on the affordability ``baseline.'' The baseline of existing water bills 
will be adjusted upward to account for treatment costs resulting from 
rules promulgated after 1996 in two ways. First, an estimate will be 
made of each rule's impact on the baseline costs. The national median 
annual household water bill for each size category will be adjusted by 
averaging the total national costs for the size category over all the 
systems in the size category. This revised baseline will be subtracted 
from the affordability threshold (based on 2.5 percent median household 
income for each population size category) to determine the new 
available expenditure margin. The affordable technology determinations 
will be made by comparing the projected costs of treatment against the 
lower available expenditure margin. Second, actual changes in the 
baseline will be measured approximately every 5 years by the Community 
Water System Survey and the national Census. These changes will reflect 
not only the increased costs resulting from our rules but also any 
changes resulting from other factors that could affect capital or 
operating and maintenance costs.

    Question 9. What portions of systems are expected to require 
financial assistance under this approach? Do you feel it would be 
better public policy for SDWA regulations to be affordable to a greater 
portion of households? Do you have any recommendations for the Congress 
on this matter?
    Response. Determining if there are affordable compliance 
technologies under section 1412(b)(4)(E)(ii) is only one of several 
ways that SDWA provides for the consideration of affordability. 
(Variance technologies are identified when there are no affordable 
compliance technologies for a given system size/source water quality 
combination.) The other three SDWA provisions refer to the 
affordability criteria established by the State or primacy agent for 
system-level determinations. The most significant of these system-level 
affordability criteria is found in section 1452(b) of SDWA, i.e., 
affordability on a per household basis is one of the three factors used 
to prioritize systems for assistance from the Drinking Water State 
Revolving Fund. EPA published information to assist States in the 
development of their affordability criteria as required by section 
1415(e)(7)(B). While EPA has provided information to the States to help 
them in these efforts, States are responsible for making site-specific 
decisions about financial assistance. Thus, EPA cannot estimate the 
number of systems expected to require financial assistance.
    When determining if there are affordable compliance technologies 
under section 1412(b)(4)(E)(ii), Congress specifically instructed EPA 
to consider the three smallest size categories of water systems. 
Section 1412(b)(15)(A) requires EPA to identify variance technologies 
if, given the quality of the source water to be treated, there are no 
affordable compliance technologies for that system size category. The 
critical factor is source water quality conditions that can affect 
treatment costs rather than system-level financial considerations. As 
each category contains thousands of systems, EPA has chosen to define 
affordability based on the median system within each size category. As 
noted in the response to question #7, basing affordability 
determinations on the most financially troubled systems would undercut 
compliance technologies and set a double standard for health 
protection: one for economically disadvantaged systems and one for 
everyone else. Conversely, basing affordability decisions on what the 
better-off systems can afford would place variance technologies beyond 
all practical application. Thus, we have designed our affordability 
criterion (for purposes of a national affordability determination) to 
apply to the median case and have established this criterion after 
considering a number of important factors, as described in the response 
to question #7.
    Finally, although some individual systems are in financially poor 
condition, EPA also considers affordability to be a problem that has a 
user level dimension. Even within larger, better-off water systems, 
there are users with very low incomes for whom even current water 
charges might be burdensome. If EPA were to define affordability for 
new treatment technologies such that even these groups could afford the 
cost, there would be no new technologies found to be affordable and, 
consequently, there would be no additional level of public health 
protection. Fortunately, there are ``lifeline rates,'' i.e., declining 
block rates and other tools available to the individual systems that 
allow them to tailor financial relief to the needs of the individual 
user.
    We believe it would be premature at this point to offer 
recommendations to Congress, as we are just now beginning to see, in 
real terms, how the affordability aspects of the 1996 amendments will 
impact the process. We should have a better sense of how this will work 
after the tools have been in place for some time.

    Question 10. Does the EPA plan to go back and compare estimated 
compliance costs with actual compliance costs of rules for purposes of 
reassessing affordability? How will the EPA use the information gained 
from such a review to apply for future rulemakings?
    Response. Yes. EPA plans to compare estimated compliance costs with 
actual costs of rules for purposes of reassessing affordability. In 
fact, one such analysis was presented in the preamble to the proposed 
radon rule, where treatment costs from the cost models were compared 
with costs at sites with aeration treatment. It was found that EPA's 
cost estimates tended to overestimate costs for small systems. EPA's 
approach to reassessing affordability is to use the Community Water 
System Survey and national Census data to measure changes in annual 
household water bills in small systems. This approach captures not only 
the increased costs resulting from implementation of drinking water 
regulations, but also any changes resulting from other factors that 
could affect annual water bills. It is important to recognize that any 
cost projections associated with a particular rule are estimates. 
Actual costs will depend upon thousands of individual decisions made by 
utilities as they seek to find the lowest cost compliance solutions. 
This more accurate information is important in understanding the 
affordability of our rules and the impact of this information on the 
``baseline'' (discussed in question/answer #8) and on future 
rulemakings.

    Question 11. In separate provisions of the 1996 SDWA amendments, 
Congress directed the EPA to promulgate regulations on enhanced surface 
water treatment and control of the recycling of filter backwash in the 
treatment process. In April, the EPA jointly proposed an enhanced 
surface water treatment rule for small systems and the filter backwash 
rule (LT1/FBR) and co-mingled the cost-benefit analyses for these two 
provisions. Why did the EPA merge the two and jointly assess the Health 
Risk Reduction and Cost Analyses (HRRCA) for these quite different 
rules?
    Response. The Long Term/Enhanced Surface Water Treatment Rule (LT/
ESWTR) and Filter Backwash Recycling Rule (FBRR) were published as 
separate components in a single Notice of Proposed Rulemaking published 
in the Federal Register on April 10, 2000 for several reasons. First, 
the 1996 SDWA amendments acknowledge the interrelationship of the FBRR 
and the Enhanced Surface Water Treatment rule. Section 1412(b)(14) of 
the amendments states:
    [T]he Administrator shall promulgate a regulation to govern the 
recycling of filter backwash water within the treatment process of a 
public water system. The Administrator shall promulgate such regulation 
not later than 4 years after the date of the enactment of the Safe 
Drinking Water Act Amendments of 1996 unless such recycling has been 
addressed by the Administrator's Enhanced Surface Water Treatment Rule 
prior to such date (emphasis added).
    Second, the primary goal of both rules is the same, i.e, to ensure 
that drinking water systems are providing at least 2-log removal of the 
infectious pathogen Cryptosporidium. Third, the entities most affected 
by both rules are small drinking water systems serving fewer than 
10,000 people. The LT1ESWTR affects only small drinking water systems; 
almost 75 percent of the systems affected by the FBRR are small 
systems. Publishing the proposed rules in the same Federal Register 
notice provided small systems the ability to understand, review, 
evaluate, and comment on both rules simultaneously, thereby reducing 
the amount of burden necessary to review. EPA believes that publishing 
the two rules in the same Federal Register notice increased the 
audience who might otherwise have only commented on one of the rules. 
Finally, both rules address the performance of filtration and treatment 
at drinking water systems. Because the rules are interrelated, systems 
could be expected to make changes to address one rule that would, in 
turn, affect compliance with the other. Combining the rules at proposal 
allowed stakeholders and small systems to simultaneously evaluate how 
best to address both rules, which are intended to become effective at 
nearly the same time.
    With respect to the co-mingling issue, the Health Risk Reduction 
and Cost Analyses (HRRCA) supporting the LT1/FBR proposal was discussed 
in a single Regulatory Impact Analysis (RIA) document. However, the RIA 
clearly indicated the results of the risk, benefit, and cost analyses 
for the LT1 component separately, the FBR component separately, as well 
as analyzing the combined impact of the two rules. In response to 
comments received and concerns expressed in other forums, EPA will 
promulgate the rules separately with separate and distinct RIAs.

    Question 12. Is it the EPA's view that you have the authority to 
mix diverse rules together and jointly evaluate their costs and 
benefits when public water systems must take very different steps to 
meet each of the requirements?
    Response. The Agency has indicated that these rules are 
interrelated, i.e., 1) they have the same goal of providing at least 2-
log removal of the infectious pathogen Cryptosporidium, 2) they affect 
primarily the same universe of small drinking water systems, and 3) 
they deal with the same issues of drinking water treatment plant 
performance. The costs and benefits described in the Notice of Proposed 
Rulemaking were evaluated separately for the LT1ESWTR and FBRR as well 
as in combination. EPA is publishing the final rules separately and 
will evaluate only the costs and benefits of each specific rule. 
Although systems may, in fact, take different steps to address the 
LT1ESTR and FBRR, a significant number of small systems will make 
decisions and take action that address both rules simultaneously, 
thereby achieving cost-effective solutions that save a system's 
valuable resources. The Agency continues to believe that States and 
systems should be given every opportunity to maintain flexibility in 
addressing regulations, while at the same time reducing costs. 
Proposing both rules in a single Federal Register notice allowed 
stakeholders to focus attention on both rules and prioritize sound 
strategies and solutions for dealing with the requirements.

    Question 13. Has the Agency prepared an assessment of the costs and 
benefits of the proposed LT1/FBR rules individually?
    Response. Yes. The proposed rule contained separate cost and 
benefit analyses for the LT1ESWTR and the FBRR, as well as a combined 
analysis. This was carried out so stakeholders could evaluate the costs 
and benefits of each rule independently as well as the combined effect 
of the two similar rules.

    Question 14. What level of uncertainty do these proposed rules 
involve in terms of estimated occurrence of microbial contaminants and 
benefits of the proposed regulatory approach without the ICR data? 
Given the potential impact of the rule on small systems, would it be 
better policy to delay promulgation to allow the data to be 
incorporated into the rule?
    Response. Examination of the ICR occurrence data analysis and new 
Cryptosporidium infectivity data indicates that benefits will remain 
similar to the benefits calculated under the current analysis for the 
LT1ESWTR. However, the final LT1ESWTR rule and supporting documentation 
will include a sensitivity analysis that describes the new data and the 
effects the data will have on benefits. Using either the ICR or non-ICR 
data, the quantified and non-quantified benefits justify the costs of 
the LT1ESWTR. EPA was not able to quantify the benefits of the proposed 
FBRR because of data limitations; nevertheless, the Agency believes 
there are considerable unquantified benefits, in terms of minimizing 
the adverse impacts of microbial contamination, that provide an 
adequate justification for this rulemaking. Specifically, the ICR data 
do not address filter backwash impacts therefore, the new data would 
not remedy the data limitation problems. As allowed under the 1996 SDWA 
Amendments, the Agency has determined that the non-quantified benefits 
justify the costs of the FBRR. The Agency does not believe that it is 
in the interest of public health protection to delay these rules until 
final analysis, including scientific peer review, of the new occurrence 
data is completed. As indicated, both benefit analyses (non-ICR and 
ICR) firmly justify the promulgation of the LT1ESWTR rule. (As 
discussed above, the FBRR is not directly affected by the ICR data.) 
Delaying the LT1ESWTR rule would result in vastly unequal levels of 
health protection from the highly infectious pathogen, Cryptosporidium, 
for people drinking water in small communities as compared to those in 
larger communities. Delay would also result in small systems not 
addressing risks associated with microbes under the LT1ESWTR at the 
same time they are addressing risks from disinfection byproducts under 
the Stage 1 Disinfection Byproduct Rule promulgated in 1998. The 
importance of addressing both risks simultaneously was a foundation of 
the 1997 Federal Advisory Committee's Agreement in Principle as well as 
the 1996 SDWA amendments. Delaying the LT1ESWTR could result in 
microbial disease outbreaks in small communities throughout the country 
in 2004 as systems change disinfection to reduce disinfection 
byproducts and unknowingly increase risks associated with microbial 
pathogens such as Giardia and Cryptosporidium.

    Question 15. How much more time would the EPA require to 
incorporate the available ICR data into the proposed regulations? Will 
the regulations be sufficiently sound if you proceed without the use of 
the data?
    Response. The Agency is in the process of completing its analysis 
of the ICR data, including scientific peer review. However, EPA will be 
including a sensitivity analysis in the final rule and rule 
documentation, which includes the new ICR and Cryptosporidium 
infectivity data. The sensitivity analysis will be incorporated into 
the HRRCA analysis supporting the final LT1ESWTR. The HRRCA analyses 
supporting both the LTIESWTR and FBRR are sound. New analysis using the 
ICR and new Cryptosporidium infectivity data indicates that risks and 
benefits associated with the LT1ESWTR are similar to risks and benefits 
associated with the data used to support the Interim Enhanced Surface 
Water Treatment Rule (IESWTR) less than 2 years ago. Both analyses 
yield the same conclusion, i.e., the benefits justify the costs of the 
rule.

    Question 16. What is the status of, and schedule for completing, 
research supporting the arsenic rule? Please comment specifically on 
the status of research Congress has called for and supported in recent 
years.
    Response. Research conducted by EPA to support the arsenic rule has 
been guided by the Agency's peer-reviewed Research Plan for Arsenic in 
Drinking Water. This plan emphasizes research to reduce uncertainties 
in assessing and controlling health risks associated with exposure to 
low levels of arsenic in drinking water, as required by the 1996 SDWA 
Amendments. EPA has completed all of the high-priority, short-term 
research projects described in the plan. Many of these studies directly 
support the current arsenic rule, while others represent significant 
progress in addressing longer term research needs.
    Specific projects that have been completed include: 1) an initial 
epidemiology study on important health endpoints in an arsenic-exposed 
population in Utah; 2) collaborations with investigators conducting 
epidemiology studies in other countries; 3) studies on the metabolism 
and mode of action of arsenic; 4) an evaluation of analytical 
techniques for speciation of the different forms of arsenic in water 
and in biological samples; 5) the development of a national data base 
on arsenic concentrations in water; 6) the synthesis of existing and 
new data to support the risk assessment for arsenic; 7) laboratory and 
field tests on arsenic control technologies; and 8) studies on the 
management of arsenic residuals generated by water treatment processes.

    Question 17. Could you review the science supporting an arsenic 
standard of 5 parts per billion (ppb) compared to 10 ppb and explain 
how the Agency considered cost, benefits, and uncertainties in 
developing the new standard?
    Response. The key elements of the Agency's review of health 
effects, uncertainties, costs, and benefits as well as its evaluation 
of other possible MCL choices are thoroughly discussed in the preamble 
to the proposed rule (relevant section attached). In brief, EPA 
examined the various health effects attributable to arsenic in drinking 
water at various levels with a particular focus on the National Academy 
of Sciences' report. In so doing, we identified a number of 
quantifiable adverse health effects, mainly due to bladder cancer as 
well as a number of currently unquantified or partially quantified 
health effects, e.g., lung cancer, cardiovascular effects, skin cancer, 
etc. We then sought to monetize these benefits, where possible. We also 
developed the costs associated with various possible arsenic levels 
based on the projected costs, including those for treatment, 
monitoring, and administration. For developing both costs and benefits, 
we identified a number of uncertainties and summarized these in the 
preamble to the proposed rule. In weighing the various regulatory 
options, we considered the costs and benefits, both monetizable and 
non-monetizable and the associated uncertainties. As described in the 
preamble, the Agency proposed to exercise the discretionary authorities 
of section 1412(b)(6) of the Safe Drinking Water Act (SDWA) to move 
away from the ``feasible'' level of 3 parts per billion or ppb, a level 
based on consideration of costs to large systems and the capability of 
analytical methods. We further proposed that 5 ppb best reconciled the 
various factors under consideration, but we also solicited comment on 
regulatory options of 3 ppb, 10 ppb, and 20 ppb, in recognition of the 
uncertainties associated with this decision and the possibility of 
weighing these decision criteria differently. As noted in the 
discussion, MCL options of 10 or 20 ppb provide less certainty that the 
MCL would be protective of human health. Of particular concern was the 
(then) unquantified effects of lung cancer. NAS suggested that excess 
lung cancer deaths from arsenic could be two to fivefold greater than 
the excess bladder cancer deaths. Since the publication of the 
proposal, more specific information about arsenic's ability to cause 
lung cancer has become available and we apprized the public of this 
information in a Notice of Data Availability (NODA).

    Question 18. The EPA is required to review and, if necessary, 
revise each drinking water standard every 6 years. The law requires the 
revised standard to maintain or provide greater protection for public 
health. When testifying before the subcommittee and asked whether the 
EPA could relax a 5 pbb arsenic standard to reflect research results 
that showed a less stringent standard would provide the intended level 
of protection, you replied, ``Yes.'' Is this the EPA's interpretation 
of its authorities under Sec. 1412(b)(9)?
    Response. Yes. We believe it is possible that a standard of 5 ppb, 
if promulgated, could be relaxed in subsequent years using the 
authority of Sec. 1412(b)(9) if review of available information at the 
time supported such a decision. In particular, the Agency would conduct 
an extensive examination of the data and information about the Maximum 
Contaminant Level Goal (MCLG) for arsenic as well as information about 
an associated possible revised Maximum Contaminant Level (MCL). In 
evaluating the MCLG/MCL, EPA must continue to meet the requirements of 
Sec. 1412(b)(4). Of particular interest, in the case of arsenic, would 
be a determination of whether or not the dose-response curve for 
arsenic was non-linear (i.e., whether a certain threshold of exposure 
existed before adverse effects attributable to arsenic were observed). 
Such a finding would operate to raise the MCLG from the level of zero 
that has been proposed and hence, make it more likely that the MCL 
could also be raised without violating the statutory requirements of 
Sec. 1412(b)(9).

    Question 19. Given the delay in proposing the arsenic rule, will 
the EPA be able to respond meaningfully to the public comments and 
still finalize the rule by January?
    Response. EPA will finalize the arsenic rule after we carefully 
review, consider, and respond adequately to public comments. We will 
strive to complete the rulemaking process as close as possible to 
the1996 SDWA amendments' statutory deadline for this rule.

    Question 20. What percent of MCL exceedances for radon and arsenic 
are projected to occur among the system category used to determine 
feasibility for these proposed contaminant standards?
    Response. For community water systems, there are an estimated 779 
systems (1.4 percent) in the three size categories that serve more than 
50,000 people. These systems provide water to over 55 percent percent 
of the population served by community water systems. For arsenic, just 
over 1.1 percent of the proposed MCL of 5 ug/L exceedances occur in 
systems serving more than 50,000 people. For radon, 0.5 percent of the 
proposed MCL of 300 pCi/L exceedances occur in systems serving more 
than 50,000 people. For the radon rule, the percentage is lower because 
the rule only applies to ground water systems. Many larger systems rely 
solely on surface water.

    Question 21. In estimating household costs for complying with the 
proposed arsenic rule, has the EPA made any assumptions about systems 
receiving variances and exemptions?
    Response. As required by section 1412(b)(4)E of SDWA, as amended, 
we examined available treatment technologies for small systems (those 
serving less than 10,000 people) and were able to identify affordable 
technologies for all small system size categories. Thus, we would not 
expect to issue a national finding that any particular size category 
was unaffordable and warranted variance technologies and identification 
of an associated regulatory level less stringent than the MCL. States 
have authority to provide exemptions to particular facilities to allow 
more time to comply with an MCL. For small systems, States may provide 
up to 9 additional years (beyond the 3 to 5 years for compliance). We 
also did not attempt to forecast the extent to which States may issue 
exemptions to any particular facility to allow additional time to 
comply with the MCL.

    Question 22. In 1996, Congress gave the EPA authority to set a 
standard less stringent than the feasible level when benefits do not 
justify the costs; the EPA may set the standard at a level that 
maximizes health risk reduction benefits. Given the reported lack of 
scientific evidence regarding the existence of adverse health effects 
of arsenic at very low levels, the preponderance of expected occurrence 
among small systems, and the expected costs and technical challenges 
posed by a very low standard, why did the Agency choose not to use this 
authority in developing the proposed MCL?
    Response. In the June 22, 2000 proposed rule, EPA indicated its 
intention to exercise these authorities to set a standard less 
stringent than the feasible level, which EPA has proposed to be 3 ppb. 
The proposed MCL of 5 ppb represents a level other than the feasible 
level. We also solicited comment on whether or not, based on 
consideration of the factors noted in your question, we should exercise 
those authorities to move to a level higher than 5 ppb (i.e., 10 or 20 
ppb).

    Question 23. Similarly, given the relatively high costs to small 
communities and low benefits associated with reducing radon exposures 
from water compared to air, why did the Agency choose not to use this 
authority under the rule?
    Response. EPA did consider the benefits and cost authority provided 
to the Administrator through the1996 SDWA amendments and made a 
determination that the benefits justify the costs for the proposed MCL. 
The 1998 Health Risk Reduction and Cost Analysis shows that the 
benefit-cost ratios were very similar across the wide range of 
regulatory levels considered. The legislative history of this cost-
benefit provision indicates that the Administrator is not required to 
demonstrate that the dollar value of the benefits are equal or greater 
than the costs (Senate Report 104-169 at S. 1316, p. 33)

    Question 24. The EPA's radon Health Risk Reduction and Cost 
Analysis states that 85 percent of cancer cases from water exposures to 
radon will occur among smokers. How was this risk incorporated into the 
cost benefit analysis? What is the cost-benefit ratio of the proposed 
standard excluding smoking-related illnesses?
    Response. Regarding risks to smokers, the National Academy of 
Sciences (NAS) Radon in Drinking Water Committee, as part of their 
assessment of the risks of radon in drinking water, considered whether 
groups within the general population, including smokers, may be at 
increased risk. The NAS found that current and former smokers (those 
who have smoked at least 100 cigarettes over a lifetime) were at 
increased risk from exposure to radon, but did not identify smokers or 
any other group as a sensitive subpopulation (i.e., a subpopulation 
that warrants protection at levels more stringent than those applicable 
to the general population). The proposed maximum contaminant level 
(MCL) of 300 pCi/L was not selected to target protection to smokers. 
Rather, EPA's proposed MCL is based on risks to the general population, 
including current and former smokers. The risk assessment for radon in 
air is based on an average member of the population, which includes 
smokers, former smokers, and people who have never smoked. The 
projected cancer deaths in smokers and former smokers would not have 
occurred but for the added exposure to smokers caused by drinking water 
with radon levels above the proposed maximum contaminant level (MCL). 
EPA determined that 85 percent of the risk accrues to current and 
former smokers by combining the risks to current, former, and never 
smokers, using a national estimate of current and former smokers of 58 
percent for males and 42 percent for females. The benefit-cost ratio 
for the general population is 0.89 at the proposed MCL. For current and 
former smokers the ratio is 0.71. For people who have never smoked the 
ratio is 0.17.

    Question 25. A number of communities have expressed concern that 
the feasibility of complying with the radon Alternative MCL instead of 
the MCL will depend on the details of the EPA's guidelines for State 
MMM programs. However, the guidelines were not available for comment 
with the proposed rule. What is the status of the MMM program 
guidelines and has the Agency received comment on them?
    Response. As part of the proposed regulation, EPA published four 
criteria that the Agency proposes to use to approve States' MMM program 
plans. It is these four criteria that a State's MMM plan must meet. In 
addition, EPA explicitly requested public comment on various aspects of 
the criteria. The proposed criteria for MMM program plans provide and 
ensure extensive flexibility for States in the design, development, and 
implementation of MMM. The proposed MMM criteria identify certain 
information that is required to be developed and then described in an 
MMM program plan in order to be approved by EPA. EPA expects States' 
MMM plans to vary in the specifics of their responses to each of the 
criteria. The Agency will also be providing a handbook of ideas, 
suggestions, recommendations, options, resources, and other information 
to help States and others to develop and design their MMM plans. 
However, the information in the handbook is for consideration only and 
is not required to be included in a MMM plan to receive approval. The 
handbook will be available with the final rule.

    Question 26. In the other chamber, a bipartisan effort is underway 
to provide better public health protection than the proposed radon in 
drinking water rule. The legislation, for which the EPA has provided 
technical advice, would focus on indoor air radon reduction efforts and 
have water suppliers comply strictly with EPA's proposed alternative 
radon standard of 4,000pCi/l. Does the EPA believe this type of 
legislation would provide better public health protection than the 
proposed radon regulation?
    Response. There are health risks for radon in both water and indoor 
air. EPA agrees that the risks from radon in indoor air are greater. In 
the proposed radon regulation, States are provided the flexibility to 
select either the MCL or the MMM/Alternative MCL option in order to 
target their efforts on the risks most important to each State. 
However, EPA encourages States to seriously consider adopting the MMM 
option as the most cost-effective approach to reducing public health 
risks from radon.
    EPA has not yet formally received proposed legislation from either 
the House or the Senate. However, the Agency is aware of interest in 
proposing legislation on indoor radon that would facilitate State's 
implementation of MMM programs that would provide the accompanying 
flexibility for community water system compliance with the Alternative 
MCL. EPA also understands that such legislation would not affect the 
timeline for promulgation of the final radon regulation. EPA intends to 
fulfill its obligation under the bipartisan SDWA amendments of 1996 to 
develop protective standards for radon in drinking water, which the NAS 
has confirmed poses a cancer risk. EPA is committed to protecting 
public health, while providing States with statutorily authorized 
flexibility to use a multimedia approach in limiting the public's 
exposure to radon.

    Question 27. The EPA has stated that it will adopt the radon 
regulation by the statutory deadline of August 2000. Does the EPA still 
plan to keep to this timeline? Given the lateness of the initial 
activities by the EPA and the wide public interest in the rule, does 
the EPA need more time to fully accommodate public comments and 
concerns?
    Response. The Agency has received extensive and detailed public 
comment on the proposed rule and plans to take adequate time in order 
to be fully responsive to the issues and concerns raised by our 
stakeholders and the general public.

    Question 28. You are no doubt familiar with the Water 
Infrastructure Network report on unmet infrastructure needs, which 
suggests an approximately $20 billion per year shortage of 
infrastructure funding? What does the EPA expect its upcoming 
infrastructure ``gap analysis'' to detail? If the report outlines unmet 
needs, what recommendations does the EPA have for addressing that gap?
    Response. In 1995, EPA conducted the first Drinking Water 
Infrastructure Needs Survey to estimate the capital investment needs of 
community water systems. The survey, which was published as the 
``Drinking Water Infrastructure Needs Survey: First Report to Congress, 
February 1997,'' showed that the national drinking water need is 
large--$138.4 billion (in 1995 dollars) for the next 20 years. Of this 
total, approximately $76.8 billion is for current infrastructure 
improvements to protect public health. (These ``current needs'' are 
projects to treat for contaminants with acute and chronic health 
effects and to prevent contamination of water supplies. A portion of 
these needs are for SDWA compliance.) The installation and 
refurbishment of transmission and distribution lines accounted for over 
50 percent of the total need, followed by treatment, storage, and 
source needs. EPA has been conducting the second Infrastructure Needs 
Survey and will release the results in February 2001.
    Both the WIN report and the EPA study agree that there is a 
critical need for continued capital investment in our Nation's aging 
water infrastructure to ensure that Americans continue to receive 
clean, safe water.
    During 1999 and 2000, EPA had preliminary discussions to inquire 
whether a funding gap exists between the national need for 
infrastructure investment and the national spending on drinking water 
infrastructure. The drinking water and wastewater programs will be 
entering into a closer analysis of this issue during the coming year. 
EPA has taken steps to investigate how to help systems operate more 
efficiently to reduce their overall costs. For example, EPA offers 
training sessions to assist smaller systems with operating and managing 
their assets with the aim of prolonging the life of their 
infrastructure while minimizing the costs of maintenance or 
replacement.
    Over the past several decades, the Nation has invested over a 
trillion dollars to build and upgrade sewage treatment plants, minimize 
industrial discharges, and protect our drinking water. As a result, 
millions of pounds of pollution have been removed from our waterways, 
the number of waterbodies safe for fishing and swimming has more than 
doubled, and 90 percent of Americans drink tap water that meets Federal 
health standards. However, the continued provision of clean and safe 
water will require EPA and state and community partners to work 
together to make the needed investments.
                                 ______
                                 
           Responses by Charles Fox to Additional Questions 
                           from Senator Smith

    Question 1. The EPA asked the National Academy of Science/National 
Research Council (NAS/NRC) to review EPA's characterization of 
potential human health risks from ingestion of inorganic arsenic in 
drinking water, review available data on metabolism and health effects 
and identify further research if needed. Except for hazard 
identification at higher doses, NRC identified more research in order 
to improve our understanding of risks from low-dose exposure to arsenic 
and the best course of action. Nevertheless, the NRC concluded that 
``upon assessing the available evidence,. . . the current EPA MCL for 
arsenic in drinking water of 50 ug/l does not achieve EPA's goal for 
public health protection and therefore requires downward revision as 
promptly as possible.''
    a) Is the NRC referring to the 10-4-10-6 risk range as the EPA's 
goal for public health protection for arsenic in drinking water?
    Response. In its executive summary excerpt of the document, 
``Arsenic in Drinking Water'' (March 1999), NRC does not explicitly 
refer to the 10-4-10-6 risk range that has been used by EPA in 
establishing drinking water MCLs for carcinogens. However, we believe 
the NRC was well aware of this range and note that its recommendation 
that the current level of 50 ppb is not sufficiently protective was 
made after the report observes that 50 ppb is associated with a risk of 
approximately 10-3--outside of EPA's target risk range.

    Question 1(b). For risk management purposes, can a final MCL fall 
outside that range because of feasibility and cost-benefit analyses and 
still achieve the EPA's goal for public health protection?
    Response. EPA ordinarily seeks to establish MCLs whose risk are 
within the target risk range of 10-4 to 10-6. However, an MCL can be 
promulgated consistent with SDWA requirements and still be outside the 
traditional risk range. This could happen, for example, if feasibility 
were a problem and the resulting MCL had to be set quite high relative 
to the Maximum Contaminant Level Goal (MCLG), or if the Agency 
determined that the benefits of an MCL within the target risk range did 
not justify the costs.

    Question 2. The NRC stated that ``. . . no human studies of 
sufficient statistical power or scope have examined whether consumption 
of arsenic in drinking water at the current MCL ([50 ppb or] 
approximately 0.001 mg/kg per day) results in an increased incidence of 
cancer or non-cancer effects.'' It further stated that ``. . . It is 
not uncommon for several hypothesized models to fit observed data about 
equally well but to produce substantially different risk estimates at 
low-dose exposure.''
    Since the scientific community has known for years that there are 
important gaps in our understanding of the modes of action of arsenic, 
why were there no studies designed to shed more light on the low-dose 
response in the 3-50 ppb range, as stipulated in the 1996 statutory 
requirement?
    Response. Studies to address the issue of low-dose effects of 
arsenic have been and continue to be a key component of EPA's drinking 
water research program. These long-term studies, as described in the 
Research Plan for Arsenic in Drinking Water, have been designed to 
address the highly complex scientific issue of the shape of the dose-
response curve in the low dose region. Difficulties encountered in 
conducting these studies have included: 1) the limited power of 
epidemiology studies to detect effects in this low dose range for the 
types of illnesses reported to be associated with exposure to arsenic; 
and 2) the lack of a suitable animal model for observing arsenic-
induced effects.
    Research conducted or supported by EPA is making important 
contributions to our understanding of the low dose effects of arsenic. 
EPA investigators completed a pilot epidemiology study on a population 
in Utah that was exposed to a range of arsenic concentrations in 
drinking water. In addition to studying various health effects for 
their possible association with exposure to arsenic, the researchers 
were able to examine and compare the patterns of metabolism of arsenic 
in the study participants. Other opportunities for studying human 
populations, with a particular focus on issues relating to the 
metabolism of arsenic, are being considered for funding in 2001. 
Studies in animals on the metabolism and mode of action of arsenic are 
also providing important insights that will guide future research on 
the effects of arsenic at low doses. EPA has also worked in partnership 
with the American Water Works Association Research Foundation and the 
Association of California Water Agencies to support research to address 
this issue, and jointly sponsored a grant solicitation in 1996. Through 
that activity EPA is supporting research in the academic community on 
the interactions between arsenic and glutathione and the resulting 
impacts on arsenic toxicity and arsenic-induced health effects; and a 
dose-response study evaluating the susceptibility of skin keratoses 
from ingestion of low levels of arsenic in drinking water.

    Question 3. For dose-response assessment, the studies are not 
conclusive in the low-dose range. NRC stated that ``additional 
epidemiological evaluations are needed to characterize the dose-
response relationship for arsenic-associated cancer and non-cancer end 
points, especially at low doses. Such studies are of critical 
importance for improving the scientific validity of risk assessment.'' 
The NRC also stated that ``the most accepted explanation for the mode 
of action for arsenic carcinogenicity is that it induces chromosomal 
abnormalities without interacting directly with DNA. These markers of 
tumor response would lead to a dose-response curve that exhibits 
sublinear characteristics at some undetermined region in the low-dose 
range, although linearity cannot be ruled out.'' [emphasis added].
    (a) Congress recognized the importance of health effects research 
in regulating arsenic, as demonstrated by the 1996 statutory 
requirement to develop a research plan to reduce the uncertainties in 
assessing health risk associated with exposure to low levels of 
arsenic. EPA's research has not adequately reduced those uncertainties 
so far. What research is planned to improve our understanding of the 
low dose-response?
    Response. As described in the previous response, EPA is conducting 
or supporting long-term research in human populations and in laboratory 
animals to improve our understanding of the shape of the dose-response 
curve in the low dose region. EPA has been working with the States to 
identify new opportunities for conducting epidemiology studies in areas 
of the country, such as the pilot study conducted by EPA in Utah, that 
could provide information on potential cancer and noncancer effects at 
low doses. Studies are being conducted in laboratory animals and human 
populations to identify possible biological indicators of exposure and 
effect, which may be helpful in describing the dose-response curve in 
future studies in human populations. This includes work to characterize 
the relationship between metabolism and toxicity, to determine the 
variability of metabolites as a function of sex, age, volume of water 
ingested, and to examine the role of diet as a source of exposure to 
arsenic. Efforts are being made to improve risk assessments in the low-
dose range by developing a physiologically based model of the kinetic 
and dynamic behavior of arsenic. Research using animals is evaluating 
events that occur at the molecular and cellular level to evaluate the 
mechanism(s) by which arsenic causes its effects. In addition, research 
is being conducted on the various factors that may modify human 
susceptibility to arsenic at low exposure levels.

    Question 3(b). Is such research underway and will the results be 
available in time for finalization of the proposed rule?
    Response. With the exception of the Utah pilot study, all of the 
efforts described above are long-term research activities that are 
underway. The results of these studies will not be available in time 
for finalization of the proposed rule. The risk assessment for the 
proposed rule is based on the large body of peer-reviewed scientific 
literature that has already been published, and will consider any new 
results from the Utah pilot study that are available in time.

    Question 4. For exposure assessment, the EPA analysis has several 
limitations that need to be pursued further. For example, EPA's 
assessment is primarily based on the Taiwanese study which used 
``ecological data'' instead of individual exposure. The NRC cautioned 
interpretation of any risk assessment based on ecological data alone 
because of the inherent uncertainties in them. That study also grouped 
exposure concentrations into broad exposure categories. The NRC also 
found that practice to add considerable uncertainty about exposure 
concentrations in the Taiwanese data because of the considerable 
variability in the arsenic concentrations in multiple wells within some 
of the villages. Another factor that affects exposure in the Taiwanese 
study was arsenic intake from food which apparently was not adequately 
accounted for, thereby introducing even more uncertainty.
    Please discuss and characterize, in some detail, each of these and 
other sources of uncertainty of the Taiwanese study including how they 
affect risk assessment in the low dose-response range (i.e., 
overestimation or underestimation of risk).
    Response. As stated in the preface to your question, there are 
several sources of uncertainty in the Taiwan studies (Tseng and Chen). 
These include not only ecological design but also the fact that arsenic 
from food intake was not examined. In addition, there were other 
chemicals in the well water including humic acids, and the methodology 
for analyzing arsenic was a colorimetric one.
    While it is preferable to have individual exposure data, there are 
none for arsenic, so EPA used the available ecological, grouped data. 
The Executive Summary of the NRC report noted that the ecological 
Taiwan studies provide ``the best available empirical human data for 
assessing the risks of arsenic-induced cancer.'' The NRC report 
referred to the older Tseng study data as grouped into ``three broad 
exposure groups.'' However, NRC's risk analyses used Taiwanese data 
published by Chen, which grouped people's exposure by village into 42 
categories. NRC mentioned that Poisson model results were less affected 
by grouping Chen's data than the model EPA used in its 1988 risk 
assessment. Results in other populations (e.g., Mexico, Chile) are 
consistent with the results from Taiwan.
    Because arsenic is naturally occurring, people can be exposed to 
low levels of arsenic primarily from food and water. Various foods 
contain organic and inorganic arsenic. In general, the inorganic forms 
of arsenic are the ones of most toxicological concern. The most common 
forms found in most fish and shellfish are arsenobetaine and 
arsenocholine. Available evidence indicates that these two organic 
arsenicals are not toxic to humans, so levels of arsenic from fish 
consumption are of little toxicological significance. The levels of 
inorganic arsenic in foods could be of concern, but we do not have 
sufficient information to understand at what level the inorganic 
arsenic in food is of concern. For EPA's risk assessment, however, the 
important question is whether the food from Taiwan had more inorganic 
arsenic than food from the United States or other countries, such as 
Chile and Argentina. There are a few suggestions in the scientific 
literature that the food in Taiwan may have had more inorganic arsenic 
than the comparable food in the U.S., but the data base for both 
countries is limited. In the proposed arsenic rule, the Agency noted on 
page 38949 that not accounting for sources of arsenic intake in Taiwan 
other than drinking water (i.e., from food) would overestimate risk in 
the U.S.
    It is possible that other substances in the water, such as humic 
acids, could have affected the cancer incidence in Taiwan. If this were 
so, one would have expected to see lower risks from arsenic exposures 
in Chile and Argentina (rather than comparable risks) because the water 
in these countries did not have humic acids. It has also been suggested 
that selenium deficiency in the diet of the study population may have 
increased its susceptibility to arsenic relative to the general U.S. 
population. It is plausible but not proved that poor diet substantially 
exacerbates the toxicity of arsenic. Much more work is needed to draw 
any definitive conclusions about the role of specific dietary 
components in the manifestations of arsenic toxicity.
    NRC notes that the colorimetric assays used to make arsenic 
measurements in Taiwan can accurately measure to 40 g/L. Only five of 
the 42 Taiwanese villages had less than 40 g/L, so risks were not 
significantly affected by the analytical limitations.

    Question 5. Risk characterization: To characterize the arsenic risk 
in drinking water in the US, EPA relied principally on the 
extrapolation of the Taiwanese study to the United States. There are 
some concerns about that extrapolation. The NRC identified several 
factors in this regard that it stated it could not assess 
quantitatively. These are poor nutrition and low selenium 
concentrations in Taiwan, genetic and cultural characteristics, and 
arsenic intake from food. For example, NRC found that arsenic intake 
from food in Taiwan is higher than in the US, resulting in an 
overestimation of risk from drinking water. The NRC noted that selenium 
should be considered as a moderator of arsenic toxicity and should be 
taken into account. According to NRC, not accounting for the fact that 
the Taiwanese have less selenium intake than US population could result 
in overestimation of the benefits of arsenic reduction in the US. 
Another factor that tend to overestimate risk is the measure of total 
arsenic in drinking water, while the risk calculations are based on 
inorganic arsenic, the hazardous form of arsenic. The justification 
given in the proposed rule for the use of total arsenic appears to be 
based on very limited data of arsenic occurrence in drinking water in 
US. In some cases, the proposed rule acknowledges these limitations but 
stops short of performing at least a qualitative assessment.
    Please discuss how EPA treated these overestimations of arsenic 
risk in applying the Taiwanese study to conditions in the US, 
particularly in the proposed MCL range.
    Response. In the arsenic risk assessment, there are several risk 
factors that cannot be quantitatively assessed, which add to the 
uncertainty surrounding the risk of arsenic exposure. Each must be 
considered to see if it could make a major impact on the calculated 
risk. If selenium and/or poor nutrition were major factors, it could be 
expected that the risks of bladder and lung cancers in Chile and 
Argentina two countries with apparently adequate nutrition would be 
quantitatively lower than those found in Taiwan. However, the NRC Panel 
found that the risks of bladder and lung cancer after arsenic exposure 
were similar in the three countries. Likewise, the genetic and cultural 
differences in the three populations were not reflected in the 
magnitude of risks.
    We discussed the effect of arsenic content in the diet on risks in 
the previous question. The proposed arsenic rule provides the worldwide 
bladder cancer mortality ranges known to EPA on page 38942 and EPA 
requests comment (page 38950) on whether we have properly weighed the 
uncertainties that overestimate and underestimate risks.
    The reasons for proposing a total arsenic MCL are discussed in the 
proposed arsenic rule under the heading, ``Why is EPA proposing a total 
arsenic MCL?'', on page 38952. As a general rule, the vast majority of 
arsenic found in U.S. drinking water sources is inorganic, and this 
also appeared to be the case in Taiwan. Accordingly, it does not appear 
that using total arsenic is an overestimation of exposure and proposing 
the rule as total arsenic does not appear to be a problem.
    Section 1412(b)(4)(B) of the Safe Drinking Water Act requires EPA 
to set an MCL as close to the MCLG as is feasible, unless it would 
increase the risk from other contaminants (Sec. 1412(B)(5)) or if EPA 
proposes that the benefits would not justify the costs 
(Sec. 1412(B)(6)). Within this framework, EPA proposed an MCL of 5 g/L 
and asked for comment on a level of 3 g/L, as well as on levels of 10 
g/L, and 20 g/L (pages 38950-38952 of the preamble). Prior to that, EPA 
discussed the sources of uncertainty: mode of action, population 
differences, diet, selenium, model choice for analyzing data, grouped 
data, and ethnic differences on pages 38949-38950.

    Question 6. The EPA's estimate of arsenic in drinking water in the 
US is based on limited data, extensive generalizations, and other 
assumptions. It appears that those estimates are therefore subject to 
large uncertainties. Do the large uncertainties associated with risk 
assessment in the low dose-response range make the EPA's estimate of 
the occurrence of arsenic in drinking water more or less important with 
respect to risk management? Please explain. Please include how 
uncertainties in the estimate of arsenic occurrence affects the cost-
benefit analysis.
    Response. The estimate of occurrence is central to our analysis of 
both costs and benefits, since occurrence establishes ``the baseline'' 
(i.e., determines how many public water systems would have to comply 
with a particular regulatory level and, correspondingly, how many 
people would receive the health benefits associated with a particular 
regulatory level). We believe that an accurate occurrence estimate is 
an extremely important component of our overall risk management 
analysis for this rulemaking (as it is for any major contaminant 
rulemaking). While we acknowledge that there are uncertainties 
associated with the data and information on occurrence used for the 
development of the proposed arsenic in drinking water regulation, we 
respectfully disagree with the characterization that it is based on 
``limited data, extensive generalizations, and other assumptions.'' We 
believe the 25,000+ data points examined have led to a reliable and 
reasonable estimate of the level of occurrence of arsenic in public 
water systems. Our occurrence estimate compares closely with those of 
the American Water Works Association and the U.S. Geological Survey.

    Question 7. Do the large uncertainties associated with risk 
assessment in the low-dose range and the large uncertainties in the 
estimation of arsenic occurrence in US drinking water make an accurate 
estimate of cost of available technology more or less important with 
respect to risk management? Please explain.
    Response. An accurate estimate of the cost of available technology 
(and other costs associated with compliance with the proposed rule) is 
central to our analysis of the costs and benefits of the rule as is an 
accurate understanding of the occurrence. EPA attempts to reduce 
uncertainties and gain the best possible understanding of every 
component of our risk assessment, characterization, and management 
processes.

    Question 8. The cost-benefit analysis used in the EPA's 
decisionmaking does not appear to be conducted with the same level of 
rigor as the risk assessment.
    a) Please explain why such a difference if both components carry 
significant weight in the decisionmaking.
    Response. The benefits analysis is derived substantially from the 
risk assessment. For example, the risk of excess cancer deaths at any 
particular arsenic level derived from the risk assessment is used, in 
part, to monetize the benefits by multiplying the number of projected 
deaths by the value of a statistical life (VSL). Thus, we do not agree 
with the premise of the question that a different level of rigor was 
employed in the various analyses. We believe that the cost-benefit 
analysis was performed as rigorously as possible, given the available 
data and information.

    Question 8(b). Since the Administrator used the cost-benefit 
analysis to depart from the feasible MCL, could her decision have been 
subjected to an unknown degree of uncertainty introduced by the cost-
benefit analysis?
    Response. As with any scientific undertaking, there is a measure of 
uncertainty associated with the calculation of the costs and benefits 
of the proposed rule. However, these uncertainties were clearly 
identified and are discussed in the preamble to the proposed rule. 
Greater or lesser weight given to the various uncertainties could 
influence the selection of the MCL option and is one of the principal 
reasons the Agency is soliciting comment on a range of MCL options.

    Question 8(c). Has the cost-benefit analysis used in the proposed 
rule been peer reviewed? If so, by whom and what were some of the 
recommendations for improvement? Are there peer-reviewed guidelines 
that EPA uses for its cost-benefit analysis?
    Response. The component elements of the cost-benefit analysis were 
peer reviewed or reviewed by independent third parties. However, the 
overall risk management decisions based upon that analysis involved the 
exercise of the Agency's discretionary authorities. There are a set of 
peer-reviewed (by the Science Advisory Board) guidelines that provide 
an overall framework for the Agency's cost-benefits analyses. In 
addition, the elements of EPA's approach to cost-benefit analysis for 
this proposed rule that were reviewed, either by peers or independent 
parties, and some of the principal recommendations in each case are as 
follows. 
    Risk Assessment: NAS' National Research Council provided 
recommendations on the strength and limitations of various national and 
international health effects research that serve as a basis for risk 
assessment.
    Occurrence Estimates: Informal discussions with water industry 
experts, internal peer review by the Agency's statisticians, 
consultation with the U.S. Geological Survey provided: 1) an approach 
for dealing with ``censored data,'' i.e., results of analyses below 
detection levels but known to be greater than zero; 2) a geographic 
approach to developing state-wide estimates for states with only 
limited arsenic data available; and 3) recommendations relative to how 
much historic data to accept and still be considered representative of 
current conditions.
    Benefits Analysis (overall): National Drinking Water Advisory 
Council provided specific recommendations on how to treat both 
qualitative and quantitative data in the cost-benefit analysis.
    Benefits Analysis (latency and value of a statistical life): EPA's 
Science Advisory Board recommended that the Value of a Statistical Life 
is the best available metric to value lives saved as a result of cancer 
cases avoided; and, recommended that the Agency consider, as a part of 
its final regulatory impact analysis, discounting benefits based upon a 
latency period prior to the onset of cancer and increasing benefits to 
account for rising income over the course of a life time.
    Cost Analysis (general): Blue Ribbon Panel of industry experts 
provided specific recommendations concerning baseline assumptions to be 
used in costing of equipment projected to comply with drinking water 
rules and other related issues.
    Cost Analysis (arsenic): EPA's Science Advisory Board provided 
critical evaluation of the Agency's treatment technology costing 
decision tree and other analyses performed to develop national cost 
projections for proposed arsenic rule; recommended that the Agency 
further investigate issues related to disposal of water treatment 
utility waste residues generated as a result of treating for arsenic.

    Question 8(d). Did the EPA analysis of Community Water Systems 
(CWS) and the best available technology (BAT) consider the cost of such 
technology when optimized for arsenic removal?
    Response. Yes, our analysis specifically examined the optimal use 
of various technologies and the associated costs.

    Question 8(e). What biases are introduced as a result of data 
averaging on the estimated cost of smaller CWS?
    Response. EPA's approach to estimating unit treatment costs is very 
conservative. In our view, it more than compensates for any biases 
introduced as a result of relying on some data averaging. For example, 
the performance of ion exchange for arsenic removal is affected by 
sulfate. EPA has developed two sets of equations based on sulfate 
concentrations of less than 25 mg/L and in the range of 25--90 mg/L. 
The unit costs are based on the highest sulfate concentration in the 
range. For a system with 30 mg/L sulfate, the operating and maintenance 
costs are overestimated by a factor of 3 because the costs are based on 
90 mg/L sulfate. Thus, EPA believes that the use of conservative 
assumptions in the unit costs would account for any bias introduced by 
data averaging on the estimated cost of compliance in smaller CWS. EPA 
has compared estimated compliance costs with actual costs of rules for 
purposes of validating its cost models. One such analysis was presented 
in the preamble to the proposed radon rule, where treatment costs from 
the cost models were compared with costs at sites with aeration 
treatment. It was found that EPA's cost estimates tended to 
overestimate costs for small systems.

    Question 9. Why hasn't the proposed rule been reviewed by the 
Science Advisory Board (SAB) before its publication for general 
comment, particularly those portions that address the use of data to 
determine occurrence of Arsenic in drinking water, the effectiveness of 
BAT, and the economics? (b) Will there be enough time for EPA to 
consider and revise those portions of the proposed rule, especially in 
light of the weight given to the cost justification of the proposed MCL 
by the Administrator's invocation of her new authority?
    Response. The Agency began working with representatives of the SAB 
in early Fall of 1999 to arrange a time to accomplish the SAB's review 
of the proposed rule. Unfortunately, the earliest time that such a 
review could be scheduled was March 2000. Nevertheless, we believe 
there will be sufficient time to consider the comments of the SAB on 
the proposed rule, particularly those comments dealing with costs of 
the proposed rule and EPA's proposed decisions regarding BAT. (The SAB 
was not specifically asked to review the Agency's occurrence estimates 
nor did it ask to do so.)

    Question 10. EPA stated in the proposed rule that this is the first 
time that the Administrator has invoked her authority to set a MCL less 
stringent than the feasible level because of cost benefit 
considerations. In that context, please describe the rationale for not 
proposing a MCL of 10 or 20?
    Response. The key elements of the Agency's review of health 
effects, uncertainties, costs, and benefits as well as its evaluation 
of other possible MCL choices are thoroughly discussed in the preamble 
to the proposed rule (relevant section attached). In brief, EPA 
examined the various health effects attributable to arsenic in drinking 
water at various levels with a particular focus on the National Academy 
of Sciences' report. In so doing, we identified a number of 
quantifiable adverse health effects, mainly due to bladder cancer, in 
addition to a number of currently unquantified or partially quantified 
health effects (e.g., lung cancer, cardiovascular effects, skin cancer, 
etc.). We then sought to monetize these benefits, where possible. We 
also developed the costs associated with various possible arsenic 
levels, based on the projected costs including those for treatment, 
monitoring, and administration. In developing both costs and benefits, 
we identified a number of uncertainties and summarized these in the 
preamble to the proposed rule. In weighing the various regulatory 
options, we considered the costs and benefits (both monetizable and 
non-monetizable) and the associated uncertainties. As described in the 
preamble, the Agency elected to exercise the discretionary authorities 
of section 1412(b)(6) of the Safe Drinking Water Act (SDWA), to move 
away from the proposed ``feasible'' level of 3 parts per billion or 
ppb, a level based on consideration of costs to large systems and the 
capability of analytical methods. We next determined that 5 ppb best 
reconciled the various factors under consideration, but we also 
solicited comment on regulatory options of 3 ppb, 10 ppb, and 20 ppb, 
in recognition of the uncertainties associated with this decision and 
the possibility of weighing these decision criteria differently. As 
noted in the discussion, MCL options of 10 or 20 ppb provide less 
certainty that the MCL would be protective of human health. Of 
particular concern, in this regard, was the unquantified effects of 
lung cancer. NAS suggested that excess lung cancer deaths from arsenic 
could be two to fivefold greater than the excess bladder cancer deaths. 
Since the publication of the proposal, more specific information about 
arsenic's ability to cause lung cancer has become available and we have 
apprized the public of this information in a Notice of Data 
Availability (NODA).

    Question 11. In view of where we are in terms of uncertainties in 
our knowledge of risk assessment of arsenic in drinking water (more 
than 12 years since the issuance of the Special Report by EPA's Risk 
Assessment Forum), and uncertainties in knowledge of arsenic occurrence 
in the nation's CWSs and best available technologies, what lessons has 
the Agency learned that would improve risk management?
    Response. Prior attempts to develop a revised arsenic in drinking 
water regulation were hampered by a lack of information concerning the 
effects of arsenic in low doses. While uncertainties still remain, we 
believe that the research and analysis completed to date has raised 
significant concerns relative to arsenic in drinking water and supports 
a new arsenic in drinking water regulation. This finding is strongly 
echoed by the NAS' National Research Council and is generally accepted 
by virtually all stakeholders in the drinking water arena, including 
environmental and public health advocates, state regulators, and 
industry representatives. In addition, our overall ability to perform 
more robust risk management analyses has been strengthened by the 
Agency's efforts to improve the scope and accuracy of the individual 
component analyses that comprise risk management (see response to 
earlier question concerning peer review of the elements of the cost-
benefit analysis).

    Question 12. Mr. Fox stated in his testimony that ``. . . [NAS] 
said 50 parts per billion was a risk range of about 10-3 . If you do 
extrapolate the National Academy of Sciences study down, you're 
probably in the range of 4 to 6 parts per billion,. . . If you end up 
considering the normal agency risk range, how we've done these things 
in the past, which is typically 10-4 to 10-6 for a cancer range, your 
arsenic number would actually be well below three. . about 0.02. The 
National Academy was pulling this way down, our traditional agency risk 
range would have even been below three, and the feasibility analysis 
would have taken us to three. So given this pressure on arsenic, we 
then took the new language of the of the Safe Drinking Water Act that 
allows us to consider costs, and it gave us the ability to move off of 
what was feasible based on a consideration of cost, and that's 
basically how we ended up at five.''
    a) Based on that testimony, if 50 ppb represents 10-3 annual risk, 
then wouldn't 5 ppb represent 10-4 risk, which falls within the EPA's 
``normal risk range'' of 10-4--10-6?
    Response. Yes, we agree that 5 ppb, under the terms of the 
question, would fall within the 10-4--10-6 risk range.

    Question 12(b). If 5 ppb is within the EPA's normal risk range, 
shouldn't the ``feasible'' MCL be somewhat higher based on the above 
and the following testimony?
    Mr. Fox further stated in his testimony that ``Feasible is what can 
you technologically achieve, what is affordable, and what do our 
monitoring capabilities allow us to measure down to.''
    Response. No, the feasible level is based on consideration of cost 
effectiveness for large systems and the capabilities of analytical 
methods. For arsenic, removal of arsenic to relatively low levels (down 
to 3 ppb) is technologically achievable, cost-effective for large 
systems, and measurable by existing analytical methods.

    Question 12(c). Does EPA use the feasibility test to arrive at a 
risk value that is always constrained to the 10-4-10-6 range or can a 
``feasible'' MCL fall outside this range, i.e., 2x10-4?
    Response. The feasible level is determined irrespective of the 
target risk range and independent of any risk assessment. Thus, it 
could theoretically fall outside of the target risk range. However, as 
noted above, the feasible level for arsenic is below (i.e, more 
stringent than) the proposed MCL.

    Question 13. Mr Fox stated in his testimony: ``So given this 
pressure on arsenic, we then took the new language of the Safe Drinking 
Water Act that allows us to consider costs, and it gave us the ability 
to move off of what was feasible based on a consideration of cost, and 
that's basically how we ended up at five.''
    We assume Mr. Fox is referring to the EPA's authority of moving 
away from the ``feasible'' MCL using cost as a basis as given in 
section 1412 (b)(6).
    a) Is EPA finding that while the ``feasible'' MCL is affordable, 
the costs of its implementation do not justify the benefits? Please 
explain.
    Response. Yes, EPA is proposing to use the authorities of section 
14112(b)(6) to find that the benefits of the feasible level do not 
justify the costs and is proposing to exercise these authorities to 
establish the MCL at a higher (i.e., less stringent) level.

    Question 13(b). Is EPA departing from the ``feasible'' MCL solely 
on the basis of its cost-benefit analysis as testified?
    Response. Yes.

    Question 14. The EPA, in its proposed rule, lists in addition to 
cost, the degree of scientific uncertainty regarding the dose-response 
curve (affected by differences in nutrition and arsenic in food) as 
basis for departure from the ``feasible'' MCL.
    a) Please explain this apparent conflict with Mr. Fox's testimony 
referred to above.
    Response. In Mr. Fox's testimony, he refers to consideration of 
costs as a basis for choosing a proposed regulatory level higher than 
the feasible level. Mr. Fox was implying, but did not explicitly state, 
that costs were deemed to be too high in comparison with benefits. The 
apparent conflict to which you refer is the proposed rule's reference 
to the uncertainties surrounding the scientific basis for the health 
effects as a basis for moving from the feasible level. These positions 
are not in conflict because the benefits portion of the cost-benefit 
analysis relies largely on the health risk assessment. Thus, 
uncertainties associated with our understanding of the health effects 
of arsenic at low levels carry over into the benefits analysis and the 
resultant cost-benefit comparison. Thus, the preamble and Mr. Fox's 
testimony are not in conflict.

    Question 14(b). Instead of this back-end adjustment that confounds 
the analysis, why isn't the Agency accounting for the scientific 
shortcomings in the front-end and arriving at a more acceptable dose-
response curve?
    Response. The NAS' National Research Council stated that 
``information on the mode of action of arsenic and other available data 
that can help to determine the shape of the dose-response curve in the 
range of extrapolation are inconclusive and do not meet EPA's 1996 
stated criteria for departure from the default assumption of linearity. 
Of the several modes of action that are considered most plausible, a 
sublinear dose-response curve in the low-dose range is predicted, 
although linearity cannot be ruled out.'' In other words, the NAS was 
not able to identify a ``more acceptable'' dose-response. The Agency is 
relying on the NAS' recommendation in this regard.
Arsenic

    Question 15. I understand that in the draft proposed rule EPA sent 
to the Office of Management and Budget (OMB), the Agency suggested a 
limit of 5 ppb for arsenic and asked for comments on 3 ppb and 10 ppb. 
At the request of OMB, EPA is now accepting comment on 20 ppb. It would 
seen that OMB has concerns with the cost-benefit analysis used for the 
proposed arsenic rule. What are OMB's concerns?
    Response. The OMB reviewed all aspects of the proposal and 
supporting documentation. A summary of changes made to the rule and the 
preamble as a result of OMB is available in the docket for this rule 
and is attached for your reference.

    Question 16. A group of water associations have found that an MCL 
of 5 ppb for arsenic would place a significant burden on water 
utilities. The group estimates public water systems nationwide would 
have to invest $1.25 billion annually for an MCL of 5 parts per billion 
(ppb) and $0.5 billion for an MCL of 10 ppb. EPA estimates are $374 
million for an MCL of 5ppb and $160 million for an MCL of 10 ppb.
    A. Can you explain the discrepancies between EPA's and the water 
associations' estimates?
    Response. The American Water Works Association Research 
Foundation's (AWWARF) cost estimates are based on 6 case studies of 
medium and large utilities in the West and Southwest--scaled up to the 
country as a whole. EPA's estimates are based upon a detailed analysis 
of a wide array of water utilities of various system sizes and source 
water characteristics. In addition, the AWWARF study includes an 
assumption that arsenic waste residuals from water treatment plants 
will be extremely costly to dispose of. We agree that this will 
occasionally be the case but do not share AWWARF's view of the 
magnitude of this problem. We will be meeting with AWWARF 
representatives in coming weeks to compare assumptions and calculations 
in an effort to refine our cost estimates, as appropriate.
    B. Were increased disposal costs of handling arsenic-contaminated 
waste and infrastructure needs accounted for in EPA's calculation of 
the costs of the proposed rule?
    Response. Yes, but as noted above, we do not share AWWARF's 
estimates of the magnitude of these costs.

    Question 17. EPA was almost 5 months late in proposing the arsenic 
rule. Is EPA still expecting to be on target for the January 2001 Safe 
Drinking Water Act statutory deadline to propose a revised standard? 
What additional research is necessary before finalization of the 
arsenic rule can occur?
    Response. EPA will finalize the arsenic rule after we carefully 
review, consider, and respond adequately to public comments. We will 
strive to complete the rulemaking process as close as possible to 
the1996 SDWA amendment's statutory deadline for this rule. We will look 
with interest to the comments received on the proposed rule. However, 
we also believe we have identified a number of the principal concerns 
and issues of stakeholders through our attendance of public meetings 
and conferences and correspondence. Thus, we are currently considering 
and evaluating an array of opinion and input while we await additional 
comments in response to the proposed rule. We are not awaiting any 
additional research to be completed before completion of the arsenic 
rule. However, we have issued a Notice of Data Availability, which 
notifies the public of the availability of quantified data on lung 
cancer as a result of arsenic in drinking water.

    Question 18. EPA estimates that 12 percent of community water 
systems would need to take corrective action to lower arsenic levels to 
5 ppb. 94 percent of these systems serve less than 10,000 people per 
system. EPA has not proposed variance technologies to assist these 
systems with coming into compliance with the proposed standards.
    a) For what reasons has EPA not proposed variance technologies for 
small systems?
    Response. As required by section 1412(b)(4)(E) of SDWA, we examined 
available treatment technologies for small systems (those serving less 
than 10,000 people) and were able to identify affordable technologies 
for all small system size categories. Thus, we would not expect to 
issue a national finding that any particular size category was 
unaffordable and warranted variance technologies and identification of 
an associated regulatory level less stringent than the MCL. We also did 
not attempt to forecast the extent to which States may issue exemptions 
to any particular facility to allow additional time to comply with the 
MCL.

    Question 18(b) and (c). How is EPA addressing the needs of small 
community water systems?
    What guidance will you provide these systems to enable their 
compliance with the standards?
    Response. EPA has taken a number of steps to address the particular 
concerns of small systems. Chief among these was the convening of a 
group of small entity representatives (SERs) under the auspices of a 
small business panel convened pursuant to the Small Business Regulatory 
Enforcement and Fairness Act. The SERs provided valuable information to 
the Agency on the particular concerns of small systems. Their concerns 
are reflected in the panel report, which is available in the docket for 
this rulemaking. The Agency carefully considered the issues and 
concerns of small entities in the development of this rule and will be 
providing specific guidance to small entities to aid in their 
compliance with this rule shortly after the rule is promulgated. Among 
the principal concerns of small entities was the importance of 
identifying affordable, easy-to-operate treatment technologies to 
comply with a revised arsenic MCL.
Radon

    Question 19. The proposed maximum contaminant Level (MCL) for radon 
is significantly below the average outdoor level for radon in air. How 
do you justify the MCL of 300 pC/L (picoCuries per Liter) if radon 
transferred from water to air at 300 pCi/L is substantially less than 
the natural radon variability outdoors?
    Response. In developing the proposed MCL, EPA has followed the 
framework provided by the Safe Drinking Water Act (SDWA) for setting 
limits for radon in drinking water, and solicited comments on the MCL 
proposed. EPA believes the proposed MCL of 300 pCi/L, in combination 
with the proposed Alternative MCL and MMM approach, accurately and 
fully reflects the SDWA's provisions. SDWA requires EPA to set the MCL 
as close as feasible to the maximum contaminant level goal (MCLG), 
which the Agency proposed as zero, based on extensive documentation 
that radon is a known carcinogen with no known health effects' 
threshold. In the case of radon, EPA has proposed a feasible level (as 
defined by the availability of cost-effective treatment technologies 
and analytical methods) of 100 picocuries per liter (pCi/L). The Agency 
used the flexibility under SDWA to take into account the costs of 
controlling radon from other sources to propose an MCL at 300 pCi/L, 
which is within the upper end of the Agency's traditional target risk 
range of one excess cancer death per 10,000 people.

    Question 20. Do you agree that the greatest risk to human health 
posed by radon is from radon found in air? If this is the case, 
wouldn't it be more beneficial to set a realistic MCL for radon in 
water that protects human health and direct more resources toward the 
State Indoor Radon Programs?
    Response. EPA believes Congress recognized the multimedia nature of 
radon risk when it amended the Safe Drinking Water Act (SDWA) in 1996. 
Radon in indoor air is the second leading cause of lung cancer in the 
United States, after smoking. However, though the risk posed by radon 
from drinking water is much smaller, the 1999 report from the National 
Academy of Sciences (NAS) confirmed that radon in drinking water causes 
cancer deaths, primarily lung cancer from inhaling radon transferred 
into indoor air from drinking water.
    Under the proposed rule, States have the flexibility to select 
either the Maximum Contaminant Level (MCL) or the Multimedia 
Mitigation(MMM)/Alternative MCL option. In the event that a State opted 
not to develop an MMM program, individual community water systems 
(CWSs) would have the option of developing local MMM programs. EPA 
believes, however, that an MMM program at the State level would 
minimize the burden on community water systems. EPA believes the MMM 
approach in the radon proposal offers an important and effective 
opportunity under the SDWA framework to reduce the highest levels of 
radon in drinking water, while spending resources most cost effectively 
to address the more significant public health risk--radon in indoor 
air. Most states, including New Hampshire, currently have a program to 
address radon in indoor air under the State Indoor Radon Grant Program 
that is partially funded by EPA. The MMM program is intended to enhance 
these existing state radon programs. Although the 1996 SDWA amendments 
contain no new authorizations for funds to implement the regulation for 
radon in drinking water, EPA has proposed to make available existing 
funding sources to implement this regulation. The State Indoor Radon 
Grant program would be available for a State MMM program.

    Question 21. I have concerns with the inclusion of smokers in the 
risk assessment that was used to set the radon standard? Based on a 
recent industry assessment, the MCL wold rise to 800 pCi/L if smokers 
were removed from the assessment. How does EPA justify the inclusion of 
smokers in the risk assessment?
    Response. Regarding risks to smokers, the National Academy of 
Sciences' (NAS) Radon in Drinking Water Committee, as part of its 
assessment of the risks of radon in drinking water, considered whether 
groups within the general population, including smokers, may be at 
increased risk. The NAS found that current and former smokers (those 
who have smoked at least 100 cigarettes over a lifetime) were at 
increased risk from exposure to radon, but did not identify smokers or 
any other group as a sensitive subpopulation (i.e., a subpopulation 
that warrants protection at levels more stringent than those applicable 
to the general population). The proposed maximum contaminant level 
(MCL) of 300 pCi/L was not selected to target protection to smokers. 
Rather, EPA's proposed MCL is based on risks to the general population, 
including current and former smokers. The risk assessment for radon in 
air is based on an average member of the population, which includes 
smokers, former smokers, and people who have never smoked. Based upon 
available information and models, the projected cancer deaths in 
smokers and former smokers, modeled as an excess risk, would not have 
occurred but for the added exposure to smokers caused by drinking water 
with radon levels above the proposed maximum contaminant level (MCL).

    Question 22. How will EPA determine what constitutes an acceptable 
Multi-Media Mitigation Program?
    Response. EPA published the proposed criteria for determining what 
constitutes an acceptable MMM Program in the proposed rule. We would 
use those four criteria. The proposed MMM criteria require certain 
information to be developed and then described in an MMM program plan 
in order to be approved by EPA. We will approve the plan if that 
information is included. As required by SDWA, EPA will evaluate MMM 
programs every 5 years, and is proposing to work with States to improve 
MMM program plans as needed as a result of that evaluation.

    Question 23. A number of water utilities have expressed liability 
concerns if they decide to implement a Multi-Media Mitigation Program 
to meet the Alternative MCL level, but their respective state selects 
to establish the MCL level. What is EPA doing to address these 
liability concerns?
    Response. It is EPA's understanding that, in California, private 
and some publicly owned utilities are concerned about tort liability 
for residual risk when meeting the Alternative MCL, because of the 
perception of a dual standard and the availability of a more protective 
MCL. Private utilities have been sued on the basis of residual risk, 
even when meeting existing standards for drinking water. The California 
Supreme Court has agreed to hear these cases, likely this Fall. If 
California and other States adopt the Alternative MCL and MMM program 
as expected, then there will be only one standard in the State (the 
Alternative MCL), not a dual standard. The Agency intends to provide 
States and CWSs with information that will be useful in communicating 
the relative risks of radon in drinking water and radon in indoor air. 
A single standard at the State level may help to address tort liability 
concerns to some extent.
MTBE

    Question 22. What regulatory decisions has EPA made that are 
relative to MTBE contamination of drinking water?
    Response. EPA has decided to proceed with proposal of a secondary 
standard for MTBE. The secondary standard would provide EPA's 
recommendation to States of an appropriate level for MTBE in finished 
water supplies from the standpoint of taste and odor. Also, at the same 
time, we are moving forward to gather additional information about the 
health effects and extent of occurrence of MTBE (at levels associated 
with health effects) in order to determine whether or not to proceed 
with a health-based primary standard for MTBE.

    Question 23. What are EPA's current plans for determining the 
potential health effects of MTBE contamination of drinking water?
    Response. Current plans for determining the health effects of MTBE 
contamination of drinking water will be based on two sources of 
information. First, using current toxicological data and recently 
developed information that characterizes the pharmacokinetic behavior 
of the chemical, EPA will develop:1) an estimate of the level of 
exposure likely to be without an appreciable risk of adverse non-cancer 
effects during a lifetime (oral reference dose [RfD]) and, 2) an 
estimate of excess lifetime cancer risk that may result from continuous 
exposure to the agent (cancer unit risk). These estimates will be used 
to aid in the characterization of the hazard and risk of MTBE and for 
comparison with other fuel additives. EPA intends that this assessment 
information will be placed on its publicly accessible Integrated Risk 
Information System (IRIS). The Agency anticipates that these draft IRIS 
assessment documents for MTBE will be submitted for external peer 
review and will be publicly available in Spring 2001. EPA's second 
source of information will include an analysis of health effects 
testing of baseline gasoline and gasoline with MTBE, TAME, ETBE, or 
ethanol, as this data becomes available. It is likely that this 
analysis will take place after the development of the MTBE RfD and 
cancer unit risk, which may necessitate a future review of the MTBE RfD 
and cancer unit risk assessments.
Fluoride

    Question 24. As you know, Dr. William Hirzy testified at the 
hearing against fluoride and the fluoridation of public water supplies. 
What is EPA's official policy on the fluoridation of drinking water?
    Response. On July, 25, 1997, Robert Perciasepe, then Assistant 
Administrator of the Office of Water (OW), wrote to the American Dental 
Association and addressed the Agency's position on fluoridation. He 
stated:
    As you no doubt are aware, the Safe Drinking Water Act prohibits 
EPA from requiring or supporting the addition of any substance 
(including fluoride) to drinking water for preventive health care 
purposes. Those decisions are made on a State or local basis and do not 
directly involve EPA. . . . .State or local fluoridation practices 
typically result in a total fluoride concentration of 1.2 mg/L or less, 
well below the EPA Maximum Contaminant Level Goal (MCLG) for fluoride 
of 4 mg/L.
    Thus, the law does not prevent fluoridation and EPA does not expect 
any adverse health effects will occur from the practice. A copy of Mr. 
Perciasepe's letter is attached.

    Question 25. When was the last time EPA reviewed the health effects 
data and current MCL and MCLG for fluoride in drinking water? How is 
EPA addressing the concerns of the anti-fluoride community with respect 
to the MCL for fluoride in drinking water?
    Response. The last EPA-sponsored review of fluoride was done by the 
National Research Council (NRC) of the National Academy of Sciences 
(NAS). Their assessment was published by National Academy Press in the 
book, Health Effects of Ingested Fluoride, in August 1993. The NRC 
concluded that the current 4 mg/L standard is appropriate as an interim 
standard to protect the public health.
    The Institute of Medicine at NAS completed a review of fluoride as 
a dietary constituent in 1997. NAS established Adequate Intake (AI) 
Values for prevention of dental cavities by life-stage group and 
Tolerable Upper Intake Levels (UL) by life-stage group. The UL values 
for infants and children through age 8 ( 0.7 to 2.2 mg/day) protect 
against dental fluorosis and the values for older children and adults 
(10 mg/day) protect against skeletal fluorosis. This review did not 
involve EPA.
    EPA responds to letters, E-mails, and telephone calls it receives 
from the anti-fluoride community. The EPA responses provide information 
on the Maximum Contaminant Level (MCL)/MCLG that protects against 
skeletal fluorosis and the Secondary MCL which protects against dental 
fluorosis. A Regulatory Background summary is included with the EPA 
letters. The Regulatory Background summary provides information on 
fluoridation and fluoridation additives as well as on the EPA MCL/MCLG 
and SMCL. (The Regulatory Background summary is attached.)

    Question 26. Does EPA plan to review fluoride during the 6-year 
review of national primary drinking water standards to begin this 
August?
    Response. Yes, EPA will re-examine the health effects of fluoride 
in the context of our reevaluation of all drinking water regulations as 
required under Section 1412(b)(9) of the Safe Drinking Water Act 
amendments of 1996.

    Question 27. What health effects data exist on the safety of 
fluosilicate additives in drinking water? What are the Agency's future 
plans for conducting research on the safety of these additives?
    Response. The fluosilicate additives dissociate at the 
concentrations used in fluoridation releasing fluoride ions. 
Accordingly, the extensive toxicological data available for sodium 
fluoride are believed to apply to the fluosilicate products, and the 
risk assessment for fluoride ion in drinking water applies to the 
fluosilicates used for fluoridation.
    EPA has found one report on the toxicology of fluosilicate 
additives. Data on hydrofluosilicic acid are included in a report 
submitted to EPA under TSCA Section 8(e) by Rhone-Poulenc in 1992. The 
report includes data on skin irritation, eye irritation and an acute 
oral LD-50 in rodents The results of these studies provide minimal 
information on the toxicological properties of hydrofluosilicic acid 
and are suitable only for identification of hazard and not for risk 
assessment. A copy of the report is attached.
    The EPA has no present plans for conducting research on the safety 
of fluosilicate additives. Fluosilicate additives are certified for use 
in the treatment of potable water under ANSI/NSF Standard 60: Drinking 
Water Treatment Chemicals--Health Effects. Standard 60 allows the 
agencies that certify additives against the Standard to request 
specific toxicological data to support certification. The need for 
toxicological studies should be appraised by the agencies that certify 
products against the Standard, and, if there are data needs, they 
should be requested from the manufacturers as part of the certification 
process. The enclosed Regulatory Background summary provides 
information on the additives certification program and provides contact 
information for two programs that have certified fluosilicate products: 
NSF International and Underwriter's Laboratories.
                                 ______
                                 
          Responses by Norine Noonan to Additional Questions 
                           from Senator Crapo

    Question 1. What steps has the EPA taken in response to the 
recommendations of the September GAO report criticizing Agency 
prioritization of SDWA research funding and planning?
    Response. The Agency has made considerable progress in responding 
to the recommendations of the September GAO report regarding 
prioritization of research funding and planning. Working closely with 
the Office of Water, the Office of Research and Development has 
conducted an evaluation of research needs, resource requirements and 
timeframes for when the results of research must be available to 
support near- and long-term regulatory requirements. EPA has also 
engaged outside stakeholders, including the American Water Works 
Association (AWWA), the AWWA Research Foundation (AWWARF), other 
governmental agencies, universities and other public and private sector 
groups to address important scientific issues associated with drinking 
water.
    EPA's yearly request for resources for drinking water research is a 
multi-faceted approach. The first step involves ORD's Water Research 
Coordination Team's (WRCT) evaluation of that fiscal year's drinking 
water research needs and the resources needed to achieve them. The 
WRCT's recommendation for funding drinking water research is based on 
risk-based prioritizations of research needs, is consistent with the 
peer-reviewed and published drinking water research plans, considers 
evolving drinking water research needs in developing research plans/
strategies, and uses information collected from Stakeholder and FACA 
drinking water meetings. The planned yearly research is intended not 
only to meet the immediate regulatory needs of EPA, but also to meet 
future drinking water needs and other Sound Science research needs of 
the Agency. The WRCT's recommendations are reviewed by ORD senior 
management and subsequently by the EPA Research Coordination Council, 
which is comprised of senior representatives from ORD and each of the 
EPA's Program Offices. The Agency's budget planning process seeks to 
ensure balance across the Agency's research resource needs.
    The fiscal year 2001 President's Budget request for drinking water 
research has grown from $20.8 million in fiscal year 1995 to $48.9 
million in fiscal year 2001. These research activities address high 
priority research areas associated with disinfection by-products, 
arsenic and microbial contaminants. Since 1996, the external research 
community has received over $19 million to support drinking water 
research activities in grants awarded through EPA's Science to Achieve 
Results (STAR) program.
    EPA places a high priority on sharing information with stakeholders 
regarding the status and plans for research on drinking water 
contaminants. The drinking water community will continue to have many 
opportunities to provide input into drinking water research planning 
and funding through stakeholder meetings and a new National Drinking 
Water Advisory Committee (NDWAC) research working group that is being 
established. Below are examples of ongoing efforts in specific research 
areas:
    Microbial Pathogens/Disinfection By-products (M/DBP) Research--
EPA's research activities on microbial pathogens and disinfection by-
products (DBPs) in drinking water are consistent with the highest 
priorities identified in the Research Plan for Microbial Pathogens and 
Disinfection By-Products in Drinking Water. This research has supported 
informed risk management decisions for the Stage 1 and Stage 2 DBP 
rules and the new microbial rules that apply to surface water and 
ground water.
    Arsenic Research--As required by SDWA, a comprehensive research 
plan for arsenic (the Research Plan for Arsenic in Drinking Water) has 
been developed. The Plan focuses on reducing the uncertainty in 
assessing health risks associated with exposure to low levels of 
arsenic. Other areas of research included in the plan are the 
evaluation of cost-effective treatment technologies for small water 
systems and improved analytical methods.
    Contaminant Candidate List (CCL)--The draft CCL Research Plan, 
developed with considerable stakeholder input, was peer reviewed by the 
EPA Science Advisory Board on August 8-9, 2000. An internal CCL 
research implementation workgroup will ensure that the actual 
timeframes and sequencing of research are appropriately established and 
periodically reviewed.
    Comprehensive Drinking Water Research Strategy--Finally, a 
comprehensive evaluation of research needed to support the full range 
of drinking water decisions facing the Agency over the next 5 years is 
currently being undertaken. The Comprehensive Drinking Water Research 
Strategy will describe near- and long-term research needs for M/DBPs, 
arsenic, CCL contaminants, the additional data needs to aid in the 
required review of existing standards, and other emerging issues such 
as preserving water quality in distribution systems. The Strategy, 
which will be completed in FY2001, will be used to guide discussions 
within the EPA and with stakeholders concerning research needs and 
resource requirements for the entire drinking water research program.

    Question 2. Has the EPA developed a long-term plan for research?
    Response. As mentioned in the response to Question #1, EPA has 
developed a draft Contaminant Candidate List (CCL) Research Plan that 
was reviewed by the EPA's Science Advisory Board in August, 2000. This 
plan describes a process for determining the future research agenda for 
unregulated drinking water contaminants, and establishes priorities for 
research on specific waterborne pathogens and chemicals on the first 
CCL. EPA is also developing a Comprehensive Drinking Water Research 
Strategy that frames the important scientific questions and identifies 
research needs and priorities associated with SDWA rulemaking 
activities over the next 5 to 10 years. The strategy describes critical 
research issues for chemical and microbiological contaminants in the 
areas of health effects, exposure, risk assessment and risk management 
(i.e., prevention or control of risks). Specific topic areas include, 
for example, disinfection by-products, arsenic, and CCL contaminants, 
as well as cross-cutting issues such as sensitive subpopulations and 
water reuse. EPA will work closely with the water community to ensure 
stakeholder input during the development of the strategy, and to 
promote coordination of research with outside organizations.

    Question 3. How would you characterize the scientific soundness of 
the Taiwan study on arsenic? Do you believe this represents a firm 
foundation for the proposed EPA standard with regard to dose-response 
modeling? How heavily did the EPA rely on the Taiwan study in 
developing its proposed standard?
    Response. An important consideration in assessing the health 
effects of arsenic is that humans are much more sensitive to arsenic 
than are animals. We do not currently have a reliable animal model to 
study the health effects of arsenic. Therefore, we rely, to a 
considerable extent, on human studies from locations where sizable 
populations have been exposed to relatively high levels of arsenic 
(e.g., hundreds of parts per billion) and where adverse health effects 
attributable to arsenic are clearly demonstrable. In establishing a 
regulatory level in the U.S., we then seek to extrapolate to a ``safe'' 
level one with a significantly smaller risk of adverse health effects.
    The Taiwan study (Tseng and Chen) was based on populations of 
40,000 individuals who were exposed to high levels of arsenic over many 
years. There are several sources of uncertainty in the Taiwan study. 
These include the overall design of the studies as well as the fact 
that arsenic from food intake was not specifically examined. In 
addition, the methodology for analyzing arsenic in water was not as 
precise as some of the methodologies available today. There was also 
uncertainty associated with tying the concentrations of arsenic in 
wells to individuals in the villages consuming water from those wells. 
Finally, there may be differences between the study population and the 
general U.S. population that could affect susceptibility to arsenic in 
drinking water (e.g. selenium or other nutritional deficiencies).
    EPA asked the National Academy of Sciences (NAS) to assess all 
appropriate studies and information in order to provide us with their 
advice on the health effects of arsenic. The NAS considered the Taiwan 
study as well as other available studies, particularly those in Chile 
and Argentina. The NAS provided examples of quantitative estimates of 
the dose-response in humans associated with arsenic in drinking water 
to the Agency, and stated that the current MCL is not sufficiently 
protective and needs to be revised to be made more stringent as soon as 
possible. The Executive Summary of the NRC report noted that the Taiwan 
studies provide ``the best available empirical human data for assessing 
the risks of arsenic-induced cancer.'' The Agency relied heavily on 
this recommendation in developing a proposed MCL. However, it should be 
recognized that we proposed setting a level higher than the feasible 
level after consideration of benefits and costs. We also clearly 
pointed out the uncertainties associated with the underlying studies 
and request comment on higher, alternative MCL options.

    Question 4. What plans has your office made to prepare for the 
upcoming review of existing standards required every 6 years?
    Response. EPA has undertaken a comprehensive initiative to prepare 
for the once every 6 year review of existing standards. We have been 
examining occurrence and health effects information on these existing 
contaminants to determine whether or not this information warranted a 
revision of the maximum contaminant levels. In addition, we have been 
examining the various implementation histories (e.g., monitoring 
provisions) to determine whether or not the rules warranted revisions 
from this standpoint. In particular, we have asked for the advice of 
the National Drinking Water Advisory Council to guide how we conduct 
the review and expect the Council's recommendations by this Fall. In 
addition, we have held one nationally advertised stakeholder meeting 
and plan to hold others.

    Question 5. What are the five new contaminants that the EPA intends 
to review in 2001 in accordance with the requirement of SDWA? What 
resources has the EPA devoted to the purpose?
    Response. EPA published a Contaminant Candidate List (CCL) in March 
1998 that included 60 contaminants which may be candidates for future 
regulation. Of these 60, we believe 48 contaminants require additional 
research related to health effects, occurrence, treatment technologies, 
analytical methods, or health effects in order to make a determination 
of whether or not they should be regulated by August 6, 2001 (as 
required by the SDWA). For the remaining 12, we believe we currently 
have sufficient information to make this determination. Outcomes of 
this determination could be to regulate no contaminants, all 12 
contaminants, or some lesser number of contaminants. However, we need 
to have considered at least five contaminants as a part of this 
process. The 12 contaminants under consideration are Acanthamoeba, 
sulfate, sodium, manganese, boron, 1,3-dichloropropene, naphthalene, 
metolachor, metribuzin, aldrin, dieldrin, and hexachlorobutadiene. It 
is also possible that decisions could be made on additional 
contaminants, such as perchlorate and MTBE, if sufficient and timely 
information becomes available. Moreover, in response to our request, 
the National Drinking Water Advisory Council recommended in June 2000 a 
protocol for making regulatory determinations. In addition, we held one 
nationally announced stakeholder meeting and expect to hold others as 
we work toward decisions by August 2001.
    To date, the total resources devoted to this determination process 
are approximately $1.2 million and include about four (4) EPA full time 
equivalents (staff), who have examined voluminous available data and 
information, and $800,000 to support the work of contractors in 
assisting EPA staff in this evaluation. We asked for advice from the 
National Drinking Water Advisory Council to help us establish a 
protocol for making regulatory determinations. We received the 
Council's recommendations this past June.

    Question 6. Given the heightened interest in fluoride in drinking 
water in several communities around the country, has the EPA moved the 
review of this potential contaminant forward in the review process?
    Response. The 1996 amendments to the Safe Drinking Water Act 
request that EPA review the maximum contaminant level (MCL) values for 
regulated chemicals every 6 years and revise them as appropriate. EPA 
has initiated this process for the chemicals (including fluoride) 
regulated before 1996. The Agency is presently working with the 
National Drinking Water Advisory Committee to develop the protocol for 
the review process. The review will consider new health effects data 
along with improvements in analytical methods and treatment 
technologies. An Advanced Notice of Proposed Rule Making (ANPRM) is 
planned for the Summer of 2001. The ANPRM will seek public comment on 
EPA's preliminary decision whether to revise, or not revise, the 
standard for each of these chemicals. EPA plans to publish in the 
Federal Register its final revise/not revise decisions in the Summer of 
2002. If the Agency decides to revise the fluoride standard, the 
rulemaking schedule for that revision will also be published in the 
2002 notice.

    Question 7. Given the interest in MTBE among the states, what 
research is the EPA undertaking to move the evaluation of this 
potential contaminant forward in the regulatory determination process?
    Response. EPA is conducting a number of research activities to 
address key uncertainties in the assessment and control of risks 
associated with exposure to MTBE. Many of the projects being carried 
out by researchers at EPA, as well as by scientists at other government 
organizations, industry, and academic institutions, can be found in 
Appendix 2 of the EPA's ``Oxygenates in Water: Critical Information and 
Research Needs'' (1998). A description of EPA research on MTBE can also 
be found at the following website address: http://www.epa.gov/mtbe/
research.htm
    A brief description of EPA research on MTBE is provided below:
    1. Health effects of MTBE. EPA scientists are conducting an 
experimental evaluation of the pharmacokinetics (i.e., uptake, 
metabolism and elimination) of MTBE by inhalation, oral, and dermal 
routes of exposure. One of the primary goals of this study is to 
provide data for the development of route-to-route extrapolation 
models, which will enable risk assessors to make better use of all of 
the available health effects data on MTBE.
    2. MTBE toxicological reviews. Agency scientists are compiling and 
reviewing toxicological information as part of the process of 
developing an MTBE oral reference dose (RfD) and cancer risk estimate 
for use in MTBE risk assessments.
    3. Monitored natural attenuation of MTBE under varying geological 
conditions. This project addresses the question of the extent and rate 
of the natural biodegradation of MTBE under several different 
geochemical conditions. The results will be of use in characterizing 
the potential for exposure to MTBE, and will assist in developing 
guidance on the extent to which monitored natural attenuation can be 
incorporated into the remedial actions taken at leaking underground 
storage tanks where MTBE is present.
    4. Cost-effectiveness of MTBE treatment methods. Research is being 
conducted to evaluate the cost-effectiveness of different treatment 
options for ground water or drinking water that is contaminated with 
MTBE. One project involves an analysis of the use of granular activated 
carbon (GAC) that has been treated with iron to adsorb MTBE from 
contaminated ground water, after which hydrogen peroxide is added to 
regenerate the GAC and oxidize the adsorbed MTBE. Another project is 
exploring the conditions necessary to air strip MTBE from drinking 
water supplies and the advanced oxidation technologies necessary to 
destroy released MTBE. Different techniques for biodegrading MTBE using 
membrane reactors are being evaluated, and a field study of various 
technologies for removing MTBE from drinking water is being conducted 
in California.

    Question 8. The National Research Council recommended that the EPA 
establish a deputy administrator position for science and technology to 
coordinate and oversee research. What is the Agency's view of this 
recommendation? How has the EPA responded to this recommendation?
    Response. In a letter sent to several Members of Congress, W. 
Michael McCabe, Acting Deputy Administrator, stated:
    The National Research Council's report contains a variety of 
recommendations for strengthening scientific practices within EPA and 
EPA's Office of Research and Development (ORD). While the Agency is 
continuing to examine the report's individual recommendations, in 
general we believe the Agency's mission to protect human health and the 
natural environment would be well-served if the report's 
recommendations were adopted. Perhaps most significantly, we agree with 
the recommendation that a new position be created for a deputy 
administrator for science and technology and that there be a statutory 
term appointment for the Assistant Administrator (AA) for ORD. A top 
science official with the authority to coordinate and oversee 
scientific activities throughout the Agency would help coordinate among 
EPA's diverse programs and help strengthen EPA's overall scientific 
performance. We also agree that a longer fixed term for the AA/ORD 
would help strengthen the scientific and managerial leadership of that 
organization and enhance the continuity of that leadership.

    Question 9. How much is the EPA relying on outside research to 
develop pending rules?
    Response. A considerable amount of outside research was considered, 
along with the contributions of EPA scientists and collaborators, in 
the development of the arsenic rule and the Microbial/Disinfection By-
Products (M/DBP) Stage 2 rules. The radon rule was based primarily on 
research conducted by outside organizations. The health effects 
portions of the preambles of the radon (11/2/1999) and arsenic (6/22/
00) proposed rules provide more detailed information about the outside 
research utilized. The preamble to the Spring 2001 M/DBP Stage 2 rule 
will provide similar information.
                               __________
      Statement of Gregg L. Grunenfelder, Safe Drinking Water Act 
 Implementation The State Perspective, on Behalf of the Association of 
                  State Drinking Water Administrators
    The Association of State Drinking Water Administrators (ASDWA) is 
pleased to provide written testimony on implementation of the Safe 
Drinking Water Act (SDWA) of 1996 to the Senate Committee on 
Environment and Public Works Subcommittee on Fisheries, Wildlife, and 
Drinking Water. ASDWA represents the state drinking water 
administrators in the 50 states and six territories who have 
responsibility for implementing the many provisions of the SDWA and 
ensuring the provision of safe drinking water. State drinking water 
programs are committed to providing safe drinking water and improved 
public health protection to the citizens of this nation. ASDWA's 
testimony will focus on the many successes that the states have 
achieved over the last 4 years as well as many of the disturbing trends 
that are emerging, and the challenges that remain.
    States have been protecting drinking water for more than 25 years, 
in some cases going back decades to the early U.S. Public Health 
Service standards. Since 1974, states have adopted and been 
implementing standards for 20 inorganic chemicals including lead and 
nitrate; 56 organic chemicals including pesticides, herbicides, and 
volatile chemicals; total trihalomethanes; total and fecal coliform; as 
well as implementing treatment requirements for surface water systems 
for turbidity, Giardia, and viruses. In addition, states have developed 
technical assistance programs, conducted sanitary surveys, and 
addressed operator certification, training, enforcement, emergency 
response, and review of water utilities plans and specifications.
    The 1996 reauthorization of the Safe Drinking Water Act contained 
numerous new requirements to continue to ensure safe drinking water in 
this country. These new requirements include: consumer confidence 
reports; revisions to the lead/copper rule; Stage 1 D/DBP rule; interim 
enhanced surface water treatment rule; source water assessments and 
delineations for all public water systems; unregulated contaminant 
monitoring requirements; a revised public notification rule; a long-
term enhanced surface water treatment rule; a filter backwash rule; a 
radon rule; a rule to protect ground water; an arsenic rule; a 
radionuclides rule; Stage 2 disinfection by-products rule; long-term 2 
enhanced surface water treatment rule; water system capacity 
development programs; and operator certification program revisions. In 
addition, the U.S. Environmental Protection Agency (EPA) is required to 
obtain data to make determinations on whether to regulate an additional 
five more contaminants every 6 years.
    The states were willing players and partners in the discussions 
leading up to reauthorization in 1996 with the specific understanding 
that a significant new mandate such as this law, which encompasses 
sweeping new reforms and activities outside of the traditional drinking 
water program, must be accompanied by significant new resources and 
staff. While critical, resources alone are simply not enough. In 
addition, states need a reasonable regulatory schedule and the 
flexibility to allow states to shift staff and resources to new 
programs in a calculated and manageable fashion. Unfortunately, almost 
4 years into implementation, the states are seeing disturbing trends 
emerge from EPA that are preventing the states from achieving full 
implementation of the law. In fact, these trends are resulting in a 
dilution of public health protection efforts and the forced 
prioritization of state program activities. These trends include:
      Inadequate Funding and Unwillingness to Address 
Cumulative Costs and Program Integration
      Early Implementation
      Changing State Roles and Expectations
      Increasing Record Keeping and Reporting Burden
    Each of these topics is discussed in more detail below.
Inadequate Funding and Unwillingness to Address Cumulative Costs and 
        Program Integration
    On average, states have historically provided 65 percent of the 
total funding for the drinking water program while EPA has provided 
only 35 percent, even though the SDWA authorizes EPA to fund up to 75 
percent of the full costs of the program. Currently, about $271 million 
in state and Federal dollars is available to the state drinking water 
program. A Resource Needs Model, recently developed by the states and 
EPA, projects that state drinking water programs face a $100 million 
resource shortfall and a shortfall of almost 2,000 FTEs for FY-01. 
These shortfalls almost double through 2005 based on anticipated state 
workloads for the plethora of new regulations and programs being 
promulgated (see page 7).
    To further compound the problem, EPA has not requested any increase 
in state PWSS program grants (current funding level is $90 million), 
that provides the reliable, sustainable base for state operations, 
since FY-96. In fact, the Agency has not even requested the full amount 
of $100 million as authorized in the SDWA. Although the Agency often 
looks to the drinking water SRF as a new source of funding for states, 
they do not fully recognize that states cannot hire permanent staff 
using a funding source that changes annually and the authority for 
which expires in 2003; that requires a 100 percent match of new state 
dollars; and that puts states in direct competition for the same pool 
of funding with water systems that have overwhelming infrastructure 
needs to improve public health protection.
    The practical outcome of failing to provide any new PWSS funds is 
that state funding bases have been eroded over the years due to 
inflation and indirect and direct cost increases. In addition, the 
growing economy has made hiring and retaining staff more difficult as 
state salary levels become less competitive in the marketplace. The 
state drinking water programs have never been fully and adequately 
funded and are now challenged to meet enormous new mandates without the 
significant new money and staff needed to ensure full and effective 
implementation of the new programs as well as maintenance of the 
existing core programs.
    The situation is further exacerbated by EPA's unwillingness or 
inability to fully address the cumulative costs to states for each of 
the very complex and comprehensive new programs and regulations being 
developed. There appears to be no acknowledgement that state program 
funding is finite and, in fact, already inadequate, nor a willingness 
to simplify and streamline regulations and provide adequate flexibility 
to reduce state implementation burdens. This attitude forces states to 
prioritize their activities based on available staff and resources and 
ensures that full implementation will likely not be realized. The 
states were committed in 1996 to take on the new mandates of the SDWA 
with the understanding that resources, staff, and needed tools would be 
available to ensure full and effective implementation of the new 
program as well as maintenance of the existing program. States are 
still committed to the improved public health protection opportunities 
envisioned in the law but are growing increasingly frustrated and angry 
that barriers are being erected to preclude their achievement of these 
goals.
    Recommendations: 1) EPA should work with the states to confirm the 
current staff and resources needed to fully implement the program; 2) 
EPA should work with the states and Congress to close the documented 
resource gap and ensure that adequate funding will be available in 
future years based on the individual and cumulative costs of new 
regulations and programs; 3) EPA must also work with states to 
streamline and simplify new regulations and programs to reduce 
increased burden to the greatest extent possible; and 4) in the event 
that the gaps cannot be closed, EPA must be willing to engage the 
states in discussions on how to prioritize and manage the new mandates 
with existing or inadequate resources.
Early Implementation
    The situation referenced above is further exacerbated by the 
Agency's continued insistence on early implementation of rule 
requirements prior to states adopting their own rules within the 
statutory framework of 2 years from the date of rule promulgation. This 
is especially troublesome with respect to the overwhelming number of 
rules EPA currently has out for review and the difficulty states and 
water systems will have complying with all of these new rules 
simultaneously. States need their rules in place in order to establish 
basic regulatory and enforcement authorities; to train operators and 
water system owners on Federal as well as state requirements; reprogram 
data management systems to accept new data reporting requirements, 
track compliance, and report to EPA; and ensure adequate laboratory 
capacity. Forty-nine of the 50 states have primacy and have the 
mechanisms in place to work with utilities within their state to 
achieve and maintain compliance. Inserting EPA Regions into the 
process, who are not onsite and do not have the resources, experience, 
and mechanisms in place to do much more than send letters and issue 
orders, greatly complicates the process and leaves the program in great 
disarray at the point when states must assume responsibility. This is a 
disservice to the states, the utilities, and the public across this 
country and brings into question the concept of primacy and state 
authority.
    Recommendations: 1) The Agency's use of Memoranda of Understanding 
(MOU) prior to state rule adoption is not acceptable and the Agency 
must immediately cease all activities directed at forcing states to 
implement requirements before state rules are adopted; 2) EPA should 
forego all attempts to require EPA Regions to assume interim 
implementation activities.
Changing State Roles and Expectations
    Of significant concern to ASDWA and the states is the expanding 
expectation of scale and scope being promoted by EPA that dramatically 
changes the state role from regulatory oversight to implementer of SDWA 
regulations. States have historically assured safe drinking water by 
conducting basic oversight and surveillance of water utilities and 
measuring utility compliance through performance measures such as 
compliance with public health standards of finished water. While some 
states have the capacity to be more involved in operations issues, for 
the most part, the daily operations and maintenance of utilities have 
primarily been left to the utility--using certified operators, licensed 
consulting engineers, and technical assistance from the states and 
other providers when needed. This has historically been the case 
because of resource and technical capacity limitations at the state 
level and liability issues associated with making process control 
decisions for the utilities that are regulated by the states.
    This direction represents a significant change from the majority of 
current state practices and must involve a meaningful dialog with state 
drinking water administrators, environmental commissioners, public 
health agency directors, Governors, Congress, and legislative bodies. 
The majority of state drinking water programs currently do not have the 
resources or sufficient staff with the technical expertise to work with 
individual utilities on a one-to-one basis to help make decisions on 
operating practices. If the Agency wants to make this change, then the 
states, including appropriate legislative bodies, must have buy-in to 
this process and there must be assurance that adequate numbers of 
trained state staff and resources will be made available to meet these 
new expectations.
    At a time when most citizens want government out of daily 
decisionmaking, EPA is establishing a structure to position government 
regulators to assume operational responsibility of our drinking water 
infrastructure. The Agency is not being honest with itself, Congress, 
and the public if it believes that state drinking water programs are 
currently in any position to fully implement these new provisions, even 
with a minimal oversight role, much less be able to assume a 
significant new role in water plant treatment, operations, and 
management decisionmaking.
    Recommendations: 1) Congress needs to consider the fundamental role 
for government regulators to play; and 2) EPA needs to recognize that 
they are promoting a significant change in scale and scope of the 
program with expectations that states need to increase their day-to-day 
management role of water utilities. This shift needs to be more fully 
explored by the states and EPA, and additional funding made available 
to support this expansion of state responsibility and staff technical 
capacity if this change is accepted.
Increasing Record Keeping and Reporting Burden
    Although ASDWA recognizes EPA's need to ensure, on the Federal 
level, that a rule is being implemented properly, EPA must recognize 
the increasing burden that is being placed on state data management 
programs with consideration for the number of upcoming rules. States, 
which should be EPA's partners in ensuring safe drinking water, are 
willing to submit necessary data elements to EPA to meet this need, but 
do not have the staff or resources to report extraneous data elements 
that are not necessary, and based on past experience, are typically not 
even used by the Agency. Therefore, prior to proposing a final rule, 
EPA must enter into a dialog with state drinking water program staff to 
evaluate what data must be collected by the water systems, what data 
must be reported to states, and the minimum data elements that must be 
reported to the Agency, and determine the impact these requirements 
will have on states and water systems. The cumulative costs and impacts 
of these continual data requests must also be evaluated to ascertain if 
collectively they are providing states and EPA with meaningful data 
linking rules to real public health improvements.
Successes
    In spite of the many roadblocks, hurdles, and challenges that state 
drinking water programs have faced over the last 4 years, and indeed 25 
years, states have attained a significant amount of success in 
implementing the provisions of the SDWA. For example, States have made 
significant progress in working with utilities using surface water 
supplies to install new treatment facilities to assure a much higher 
level of public health protection. Sources of lead from drinking water 
have been significantly reduced; the data and information about water 
system quality and compliance is now more readily available to the 
public through Consumer Confidence Reports, state compliance reports, 
the Envirofacts data base, and state web sites; the quality of water 
plant operators and water system capacity is being significantly 
improved; and an important source of funding for infrastructure 
improvements has been established in all states and loans are now being 
made to water systems to improve both their infrastructure and their 
ability to provide safe water to their consumers. States are also now 
beginning a very comprehensive and resource intensive effort to 
delineate and assess the quality of all source water being used for 
drinking water to ensure that local communities have the tools and 
information they need to protect their drinking water sources.
    States intend to do all they can to meet their existing and new 
commitments, however, the road blocks and barriers being placed before 
and upon states are beginning to take their toll. More and more states 
are vocalizing their frustrations with the excessive, and in many cases 
unrealistic, expectations that are appearing in new regulations; the 
unrealistic expectations that EPA has for early implementation of the 
rules; and most critically, the lack of sufficient funding and staff to 
fully and effectively meet their own expectations as well as those of 
EPA, Congress, and the public.
    The states are not interested in continuing to be the victims of 
GAO reports and IG investigations that find deficiencies in state 
programs when the staff, resources, and tools have not been made 
available for states to succeed. While quietly prioritizing and 
addressing implementation activities at the state and local level may 
meet the states' short-term needs, it is doubtful that ultimately it 
will meet the expectations of the public and Congress. States do not 
want to see the gains that have been made over the last 25 years eroded 
as focus and attention shifts from base, core public health activities 
to complex, new, and in many cases unimplementable regulations. The 
fundamental principles of the SDWA Amendments of 1996 are sound and, if 
correctly administered, have the potential to provide meaningful new 
public health protections. The states want the chance to succeed and 
they want the opportunity to help craft, as EPA's partners, the future 
direction of programs that will ensure the provision of safe drinking 
water in this country.
Upcoming Rulemaking Schedule
      11/99 Proposed Radon Rule
      4/00 Proposed Long Term/Enhanced Surface Water Treatment 
Rule
      4/00 Proposed Filter Backwash Rule
      4/00 Radionuclides NODA
      4/00 Proposed Minor Changes to Stage 1 M/DBP Rule
      5/00 Proposed Ground Water Rule
      5/00 Proposed Secondary Standard for MTBE
      5/00 Final Public Notification Rule
      6/00 Proposed Arsenic Rule
      8/00 Final Radon Rule
      8/00 Final Filter Backwash Rule
      11/00 Final LT
      11/00 Final Ground Water Rule
      11/00 Final Radionuclides Rule
      12/00 Final Secondary Standard for MTBE
      1/01 Final Arsenic Rule
                                 ______
                                 
                                                     July 29, 2000.

The Honorable Mike Crapo and Barbara Boxer,
U.S. Senate,
Committee on Environment and Public Works,
Subcommittee on Fisheries, Wildlife, and Water,
Washington, DC 20510-6175

Dear Senators Crapo and Boxer: Enclosed please find my response on 
behalf of the Association of State Drinking Water Administrators 
(ASDWA) with regard to questions provided by Senators Crapo and Smith 
as followup to the June 29 Senate hearing on implementation of the Safe 
Drinking Water Act (SDWA). I am pleased to provide this response and 
look forward to working with you and the members of the subcommittee to 
address these issues.
    I would like to re-iterate the States' commitment to ensuring 
public health protection and reaching the challenging goals set under 
the new SDWA. To accomplish this large undertaking, States need to know 
that there will be a reasonable, rationale implementation schedule that 
will allow them to be effective players in the process; that the 
necessary tools such as staff, resources, data systems, laboratory 
capacity, etc. will be available in a timely manner; and that 
regulations will be developed in a manner that is implementable for 
States as well as water systems.
    On behalf of ASDWA, we appreciate the opportunity to share some of 
the state concerns with you and look forward to working with you in the 
future.
            Sincerely,
                                     Gregg L. Grunenfelder,
   Director, Washington Drinking Water Divisionand ASDWA President-
                                                             Elect.
                                 ______
                                 
        Responses of Gregg Grunenfelder to Additional Questions 
                           from Senator Crapo

    Question 1. Under the radon rule, much is predicated on States 
adopting a multi-media mitigation program to provide water systems with 
an alternative MCL. What do you expect state costs to administer such a 
system to be? How many States do you anticipate will adopt a multi-
media program?
    Response. The current approach to the proposed radon rule allows 
water systems to comply with an alternative standard of 4000 pCi/L but 
only after the state has developed a multi-media mitigation (MMM) 
approach to address radon in air (or the water system has developed its 
own program). EPA's own documentation shows that the primary health 
concern associated with radon is inhalation of radon from soil gases 
(98 percent) and a minor, secondary impact is through drinking water (2 
percent). The primary concern that States have with the radon rule and 
the multi-media approach is that it holds the state drinking water 
programs responsible for ensuring the implementation of an air program. 
In some States, the air program does not even reside in the Agency 
responsible for implementing the SDWA. Even those States that have both 
programs in one Agency most commonly have the program in a different 
part of the Agency--not the drinking water program.
    Management within EPA's OGWDW has indicated on several occasions 
that they do not intend to request additional funding through the water 
program to implement the MMM approach. They contend that any increased 
funding should come through requests from the air program within EPA. 
To date, we have no indication that the air program is seeking any 
additional funding to ensure implementation. This puts the drinking 
water programs in a position of having to redirect limited, and in 
fact, inadequate resources from high priority drinking water needs to 
fund the development and implementation of an air program.
    States are in agreement that radon in air is a health issue but 
feel strongly that the implementation of that program should reside 
with the air program. State drinking water programs believe that from a 
public health and cost benefit perspective is that the drinking water 
standard should be set at 4000 pCi/L and that the drinking water 
programs assume responsibility for ensuring that all water systems meet 
this standard. In addition, EPA's air program should work with States 
to enhance indoor air programs to address the real health risks 
associated with radon. This approach will have a meaningful impact in 
bringing down the levels in those water systems that have high radon 
levels, and provide greater health protection by ensuring that 
strengthened air radon programs reach those consumers exposed to high 
levels in air.
    The current approach sends a mixed message to the public that two 
standards for radon in drinking water--4000 pCi/L and 300 pCi/L are 
both protective of public health. The further irony is that there is no 
clear linkage between water and air actions. A water system could 
comply with 4000 pCi/L or 300 pCi/L but none of their customers benefit 
from a reduction of radon in air. The best case scenario is that all 
water systems comply with the 4000pCi/L standard and all consumers 
benefit from a strengthened air program.
    At this point in time, 10 state drinking water programs have 
indicated that they currently do not plan to implement a MMM program. 
The primary reason is that they do not currently have a radon in 
drinking water problem. In their view, it is counter to the needs of 
the drinking water program to redirect inadequate resources to an air 
issue when there is not a problem in drinking water. Ten States have 
not yet made a decision and will likely not do so until they see the 
final rule and understand the cost and transactional issues for the 
state. Ten States have indicated a qualified yes to a MMM program but 
again the final decision will rest on the complexity and 
implementability of the final rule and the support of their upper 
management and Governors to commit the resources needed to implement 
the program. Twelve States have indicated that they will likely 
implement an MMM program but the majority are doing so primarily 
because they believe it is irresponsible to hold their water systems 
``hostage'' to a 300 pCi/L standard in drinking water. The remaining 
eight States have not indicated a response.
    At this time, it is not possible to fully evaluate state costs for 
implementing an MMM approach. Until the final rule is promulgated and 
States understand how the program will be implemented which includes 
the monitoring, reporting and documentation involving MMM aspects of 
the rule and evaluation can not be made. It is, however, a major 
concern that neither the drinking water or air program at EPA has 
indicated any interest in providing additional resources for this 
effort.

    Question 2. How should EPA address the cumulative cost of drinking 
water regulations?
    Response. EPA needs to more clearly and fully evaluate the 
cumulative costs of current as well as future regulations on both water 
systems and state drinking water programs. The new SDWA law did not 
negate or lessen the responsibility that States have to ensure that the 
pre-1996 regulations are fully implemented. This requires continued 
monitoring, reporting, and enforcement activities on the part of the 
States and water industry. As EPA develops new regulations, they do 
attempt to quantify water system and state costs, but at least on the 
part of the States do not evaluate whether current state resources are 
adequate or where new resources will be obtained to implement the new 
requirements.
    For water systems, EPA does attempt to put together cost impacts, 
broken out by system size and classification, but does not take the 
next step in evaluating the cumulative impacts of all the rules and the 
impacts that this cost has on overall water system affordability. EPA 
should be directed to aggregate the costs, per household, for various 
system sizes and evaluate if the costs still meet the affordability 
criteria they have established such as the percent of median household 
income. The clear need is for EPA to take a comprehensive, integrated 
look at the cumulative costs of all rules, not just whether one rule or 
another by itself meets their affordability criteria. This will be 
especially critical for many of the upcoming regulations, which will 
have a disproportionate impact on small ground water systems.

    Question 3. What is ASDWA's view of the EPA's current approach to 
assessing the feasibility of drinking water standards?
    Response. The constant dilemma is how to ensure that regulations 
and standards that are designed to be feasible for large systems under 
the law are also in fact feasible for small systems. The law provides a 
number of approaches that the Agency can take such as evaluating the 
availability of cost effective technology for various systems sizes, 
including a large number of small system categories. This is an 
important step in every rulemaking and one that is designed to evaluate 
whether affordable technologies are available that would allow small 
systems to obtain compliance. EPA appears to be taking this 
responsibility seriously and has provided this information under new 
rulemakings. EPA has also attempted to stagger small system compliance 
deadlines and simplify monitoring requirements to make rules more 
implementable for small water systems while still ensuring compliance. 
These approaches should continue to be used in the future.
    Occasionally, however, this analysis is not productive such as 
under the radon rule where the Agency's own analysis shows that a 
standard of 300 pCi/L is not affordable for small systems. This also 
only takes into account this one rule, not the cumulative cost of past 
and future rules. A number of stakeholders have stated that we should 
not be creating ``second class citizens'' meaning that the same level 
of protection should be afforded to everyone. The dilemma is how to 
avoid this situation recognizing that 96 percent of the water systems 
that are regulated are small and may not have the economies of scale to 
meet new regulations in a cost effective manner.

    Question 4. What do you anticipate will be the principle 
conclusions of the next needs assessment from States? Do you anticipate 
there to be changing trends not evident in the current needs 
assessment?
    Response. With regard to the infrastructure funding needs for water 
systems, members of the State Revolving Fund (SRF)work group have 
already been informed that the assessment identified at least three 
times as many eligible/documented projects as the 1995 assessment, 
although this will not necessarily translate into triple the national 
need. Several large cost filtration projects were included in the 1995 
needs report but not in the 1999 report since they were already under 
construction. The identified costs for SDWA compliance will likely 
shift as compliance with old rules is achieved and new rules are 
promulgated affecting more systems. The needs report will also likely 
underestimate the actual need because it did not allow for 
identification of costs for rules that have not yet been promulgated by 
EPA such as the radon and arsenic rules for which there are potentially 
large capital costs.
    Certain capital costs are almost certainly understated because they 
are difficult to identify. These include consolidation of water systems 
and creation of new systems as two examples. Other capital costs have 
simply been excluded by EPA because they are not eligible for SRF 
funding, but which could be major capital needs. Examples include the 
cost of acquiring water rights or building surface reservoirs for 
unfinished water storage. The costs of complying with the Endangered 
Species Act may require a major capital investment, particularly for 
cities in the West.

    Question 5. Your testimony criticizes the EPA for underfunding the 
state PWSS program grants. What level is necessary to meet state needs 
to hire staff and provide for state operations?
    Response. Historically, States have provided 65 percent of the 
funding and EPA only 35 percent of the funding made available to 
implement the SDWA. This is in sharp contrast to the language in the 
statute that authorizes EPA to fund up to 75 percent of the full cost 
of implementing the law.
    In 1999, ASDWA, in partnership with EPA, revised and updated a 
resource needs model that evaluated state program implementation needs 
at the national level for small, medium, and large systems through FY-
05. This national model determined that state program resource needs 
will rise from $353 million in FY-99 to $459 million in FY-05. State 
staffing needs will rise from 5,025 full time equivalents (FTEs) in FY-
99 to 5,838 FTEs in FY-05.
    Based on ASDWA's interpretation of the data, acknowledging what 
States are currently taking from the SRF set-asides, we estimate a 
resource shortfall of $83 million in FY-99 rising to $207 million in 
FY-05 with an FTE shortfall of 1627 FTEs in FY-99 rising to 2,670 FTEs 
in FY-05.
    States recognize that there are two primary sources of Federal 
funding now available to the States under the new SDWA. These include 
the PWSS grants and set-asides from the SRF. The PWSS program grants, 
however, have historically provided the basic foundation from which 
States could hire full-time, permanent staff. The level of funding for 
PWSS grants to States (not tribes) has not increased since FY-96. It is 
also funded at only $90 million, not the full $100 million as 
authorized in the statute. The SRF provides new set-aside authority 
that theoretically can provide up to 10 percent of the funds for 
program implementation. Unfortunately, the theoretical availability of 
the funds through the SRF has not translated into actual state use of 
the full amount.
    The reasons that more of the set-aside is not being used are many. 
They include: the perceived transient nature of the SRF--both in the 
availability of consistent level of funding from year-to-year and the 
fact that the funding is set to expire in FY-03; the lack of state 
overmatch funds; the set-asides that EPA is taking off the top at the 
National level which may vary from year-to-year and which ultimately 
reduces the available funding to the States; and the various threats of 
funding withholding for failure to meet EPA expectations on capacity 
development and operator certification programs. All of these 
``unknowns'' translate into a valid question on the part of the States 
as to the reliability of this funding in the short and long term, 
particularly since the use of these funds are set on an annual basis 
based on Intended Use Plans that are subject to public involvement and 
stakeholder comment. In addition, in many States the SRF funds are 
viewed primarily as a resource for capital projects to address 
significant infrastructure improvement needs. In these States there is 
a policy direction to focus use of these funds on infrastructure 
improvement projects, and not enhancement of state program 
implementation efforts. In this regard, state drinking water programs 
find themselves competing for money to further ``grow'' state 
government with the dollars designated by Congress through the statute 
to be used for much needed drinking water infrastructure improvements 
to protect public health. This is a difficult battle to fight and in 
some States is politically infeasible.
    The States would like to work with Congress and EPA to further 
evaluate the barriers associated with the use of the SRF set-asides and 
determine how adequate funding can be made available to the States in a 
manner that offers a permanent source of funding and with a funding 
vehicle that is readily available and useable to the States.

    Question 6. Where will States turn to meet their funding shortfalls 
in staffing and operational needs?
    Response. State drinking water programs have historically been 
underfunded even though many have increased their use of state general 
fund revenue and instituted various types of fee-based programs over 
the years. In fact, many States are providing significantly higher 
levels of funding than the Federal Government to implement this Federal 
mandate. And although a number of States are in very good economic 
condition due to the growing economy, Governors are remaining fiscally 
conservative and reluctant to increase the size of ongoing programs. 
Therefore, as in the past, and likely for the future, States to 
prioritize their activities at the state and local level based on the 
most important public health issues in each state. Frankly, this means 
that not all aspects of all the rules are likely to be fully 
implemented, at least not within the timeframe expected by EPA.
    The States believe there needs to be a dual approach to closing the 
resource gap. First, increased levels of Federal funding must be 
provided to the States in a manner that allows them to fully and 
efficiently use the new funding. States must also evaluate their own 
contributions and determine whether additional resources can also be 
made available at the state level. Second, EPA and Congress need to 
more fully understand the resource and staffing issues at the state 
level that provide barriers to full and effective implementation and 
steps must be taken to streamline and simplify current as well as 
future regulations. Transactional costs need to be minimized to the 
maximum extent, States need to have the full 2 years authorized under 
the statute to adopt their regulations, and States, as well as water 
systems need a reasonable, rationale approach to implementation with a 
schedule and timeframe that allows States to develop the internal 
infrastructure they need to track, report, and ensure compliance.
    Until such time as the States are fully funded and staffed to meet 
the new requirements of the SDWA, many will continue to try to patch 
together their program using contractors and leveraging the services of 
technical assistance providers and others to assist in implementation. 
A number will set implementation priorities and the timeframe for 
implementation may be extended. Finally, some States may have to resort 
to requesting the additional 2-year extension for rule adoption to try 
and better schedule their workload.

    Question 7. Early implementation by the EPA of rule requirements 
under the SDWA presents state regulatory agencies with compounded 
resource demands and other complications. How can the EPA better work 
with the States to address their concerns?
    Response. States are very concerned with, and fundamentally 
disagree with, EPA's interpretation of the statute that all water 
systems must be in compliance with new regulations within 3 years of 
rule promulgation. This reading of the law does not allow the States 
the statutorily mandated 2 years to adopt their own regulations and 
obtain legislative authority if needed. States are concerned that EPA's 
approach is not honoring the state primacy process and appears to be 
making the state role superfluous to the drinking water implementation 
process. This has the potential to provide a significant barrier to 
state flexibility if States are not given the opportunity to craft 
flexible regulations that meet state-specific needs because EPA has 
already started implementing regulations at the national level on the 
date of rule promulgation.
    States need time to address their own administrative process and 
involve their citizens in the rule development process. The 2-year 
period for adoption and the third year before the rule becomes 
effective is critical for States to train their staff and utility 
operators, certify laboratories and ensure laboratory capacity, revise 
data management systems, notify systems of their monitoring and 
compliance responsibilities based on state-adopted regulations, and 
ensuring enforcement authority. It is crucial that States be able to 
develop the infrastructure they need to manage implementation.
    EPA needs to fully understand the barriers and constraints that the 
States are under in the rule development process; better appreciate the 
infrastructure that must be developed at the state level to ensure 
compliance with regulations; honor the 2-year state adoption process; 
and allow States the opportunity to use the flexibility Congress gave 
them to craft state regulations. EPA also has to understand the 
potential impacts on state fee programs when EPA assumes responsibility 
for early implementation.
    EPA also needs to acknowledge States as full partners in developing 
new programs and regulations under the SDWA, not just another 
stakeholder. EPA could be directed to go to a state association such as 
ASDWA for review of their proposed rules and initiatives for 
administrative/implementation issues much like they now go to the 
Science Advisory Board to address scientific aspects of their proposed 
rules. EPA should also be charged with assessing state implementation 
costs during the 6-year review process and use that information to 
modify its current methodologies for estimating these costs. EPA also 
needs to improve its process for developing implementation plans/
guidance for the States, allowing States full involvement in the 
process and ensuring that all new activities and data management flow 
charts are available at the time of rule promulgation.
    At the hearing on June 29, Senator Crapo asked if there were any 
legislative fixes that should be addressed to improve the law. ASDWA 
would ask the Senator and this subcommittee to review the law in the 
area of effective and compliance dates and evaluate whether a 
modification is needed to allow States as well as water systems the 
opportunity to adopt and implement regulations and achieve compliance.

    Question 8. What recommendations do state administrators have for 
the EPA in providing technical assistance and developing a data 
collection and management system that reflects the increasing 
complexity of implementing new regulations?
    Response. State data management programs are currently struggling 
to keep up with the volume of data they must manage. One of the biggest 
problems they face is rule complexity and a disconnect between what EPA 
wants to know and what it needs to know for rule implementation. EPA 
needs to consider data management and data needs as an integral part of 
rule/program development. They need to put together data implementation 
plans for each new rule/program, ensuring that the changes and flow 
charts are made available to the States at time of rule promulgation so 
that States can make the necessary changes to their data bases in a 
timely manner. Rule managers also need to be cognizant of how state 
data systems operate, the types of data and timeframe that data is 
currently gathered, and work to ensure that new data elements fit 
within that data construct. EPA should also be strongly encouraged to 
maintain and continue supporting the development of SDWIS/State--a data 
management system designed to assist States in managing their data 
needs and reporting to EPA.
    States and EPA also need to work together to develop data reporting 
elements that track outcomes rather than process. In its rule 
proposals, the Agency should be required to articulate exactly what 
question(s) it is trying to answer by requesting a particular piece of 
data and how that data will be used by the Agency. The cumulative cost 
of reporting burdens across rules should also be evaluated.
    In the area of technical assistance, the States urge EPA to 
continue to conduct training sessions on new rules at time of rule 
promulgation and also at time of rule implementation. To make these 
training sessions most effective, implementation manuals and guidance 
documents should be provided to States with several weeks lead time to 
allow them to review the materials and seek additional input and 
comments from others on their staff. A schedule of training 
opportunities also needs to be made available at least a year ahead of 
time to afford States the opportunity to plan their travel budgets. 
Detailed information about locations and agendas for specific training 
should be made available at least 2 months in advance to allow States 
to process their out-of-state travel orders.
                                 ______
                                 
        Responses by Gregg Grunenfelder to Additional Questions 
                           from Senator Smith

    Question 1. In your statement, you address significant funding gaps 
in the public water system supervision grants and other grant programs. 
What are your recommendations for addressing these shortfalls?
    Response. The States and EPA need to open a dialog on state funding 
issues and evaluate how the documented resource gap can be closed. 
States and EPA need to develop an understanding of the barriers that 
currently exist to States fully using the SRF set-aside funds and 
understand the technical and staff barriers that may prevent States 
from significantly increasing their funding and staffing levels. Once 
understood, we should work toward a resolution to make SRF funds more 
accessible; recognize the cumulative cost of the regulatory burden on 
States; and acknowledge this through the development of more easily 
implemented regulations. At a minimum, the EPA should request the full 
authorization for both the PWSS grant program and the SRF and Congress 
could consider allocating some of the existing budget surplus to 
increase PWSS grant funds.
    EPA needs to better understand the cumulative cost impacts on the 
States and may need to work with States to develop implementation 
priorities based on the highest priority public health issues should 
full staffing and funding not be made available. EPA should also 
evaluate the DWSRF with an eye to potentially reducing or eliminating 
some of the numerous cross cutter issues that make providing funds to 
small systems more difficult.

    Question 2. What additional flexibility is necessary for States to 
implement the arsenic, radon, and other proposed rules to be finalized 
over the next year?
    Response. A very important flexibility is for EPA to allow States 
the 2 years authorized in the statute to develop their state 
regulations. A number of the new rules tend to be treatment technique 
rules that require States to take a larger role in decisionmaking and 
evaluating compliance and treatment options using a toolbox of options. 
This flexibility can not be realized if EPA starts implementing the 
Federal rule before States have evaluated their various options and 
adopted their rules.
    Under the radon rule, States do not believe that EPA is allowing 
them the opportunity to use their full flexibility in deciding whether 
or not to develop a multi-media mitigation (MMM) program and whether it 
makes more sense to require the lower drinking water standard. A recent 
letter from EPA to the Nation's Governors urging them to adopt the 
multi-media approach had to undergo several major iterations before the 
Agency agreed to even mention that the rule allowed another 
implementation option.
    Another concern of the States is the perceived tendency on the part 
of the Agency to micro-manage rule implementation. It seems like the 
Agency tries to manage every possible scenario which makes the rules 
very complex and cumbersome. The States would argue that the best 
approach would be to establish the outcome measures for each rule and 
let the States decide how the outcome should be achieved.
    With the barrage of new rules hitting States and water systems 
simultaneously, the high degree of complexity of the rules, and the 
lack of consistency among rules, States will need to be able to 
prioritize their workload, make judgments on the occurrence of 
contaminants within their States and be able to issue state-wide or 
area wide waivers, and may need the flexibility to extend 
implementation schedules for lower priority activities.
                               __________
   Statement of Gurnie Gunter, Director, Kansas City Water Services 
Department, Kansas City, Missouri, on Behalf of the Metropolitan Water 
                                Agencies
Introduction
    Good morning, Chairman Crapo, Chairman Smith, and members of the 
subcommittee. I'm Gurnie Gunter, Director of the Kansas City, Missouri, 
Water Services Department. On behalf of the nation's largest municipal 
drinking water agencies, thank you for holding this hearing. We 
appreciate the priority status you have given oversight of the 
implementation of the Safe Drinking Water Act.
    The Kansas City Water Services Department is responsible for water, 
wastewater, industrial waste and stormwater. We produce and deliver 
high-quality drinking water that surpasses Federal and state standards; 
we collect and treat discharged wastewater and by-products from 
residents as well as businesses; and we operate and maintain a 
stormwater system to collect, transport and dispose of precipitation 
that falls in the area. The Kansas City Water Services Department 
delivers drinking water to about 650,000 people every day.
    In addition, I am a board member of the Association of Metropolitan 
Water Agencies (AMWA), and my testimony today is on the Association's 
behalf. AMWA represents the largest municipal drinking water agencies 
in the United States. Together, AMWA member agencies serve clean, safe 
drinking water to over 110 million people.
History
    Since late 1996, when the Amendments to the Safe Drinking Water Act 
were enacted, the Environmental Protection Agency has developed a 
number of new rules and programs. These include a source water 
assessment program, a rule requiring annual water quality reports for 
consumers, an updated program for water systems to inform consumers of 
violations of drinking water regulations, and a loan program for 
drinking water systems.
    One of the most important fundamental changes brought about by 
these Amendments is Congress' directive to the Agency to rely on ``the 
best available, peer-reviewed science and supporting studies conducted 
in accordance with sound and objective scientific practices.''
    To meet the requirements of the 1996 Amendments, EPA is at work on 
a number of new rules. These include rules governing filter backwash, 
ground water disinfection, radon, other radionuclides and, most 
recently, arsenic. Also, EPA, water suppliers and environmental 
organizations are engaged in negotiations over the second phase of a 
rule to control microbes and the chemical byproducts of disinfection. 
And finally, EPA with the help of the National Drinking Water Advisory 
Council is establishing a process to determine other contaminants to 
regulate from the Contaminant Candidate List.
Support for EPA and the States
    The last time AMWA testified on implementation of the Safe Drinking 
Water Act was before any major, new regulations had been issued under 
the 1996 revisions. The Act set out a demanding regulatory schedule, 
and AMWA commends EPA's Office of Ground Water and Drinking Water for 
its hard work. Also in previous testimony, AMWA strongly supported 
adequate funding for EPA's drinking water program as key to attaining 
the promise of the new Act. Today, we reiterate that support and call 
your attention to several areas of funding need.
    AMWA's major concern, given the requirements of the Act for the use 
of sound science, is adequate drinking water research funding. Research 
is critical to ensuring that drinking water regulations address 
contaminants that actually occur in drinking water and that occur at 
levels of public health concern. This is important so that the limited 
resources at all levels of government--Federal, state, and local--are 
directed at high-priority risks. It is also critical for the public, 
who must ultimately bear the increased costs of drinking water driven 
by new regulations, to receive true value for what they are being asked 
to spend. This year, EPA has requested nearly $49 million in drinking 
water research funding. AMWA believes that this is the minimum needed, 
and we urge you and your colleagues in the Senate to support this 
request.
    AMWA also would like to express its support for our state 
regulators. The Safe Drinking Water Act authorizes Federal funding for 
up to 75 percent of state implementation costs. At present, state 
program funding hovers at just over 35 percent, while the list of 
regulations that states must implement becomes larger and more 
demanding each year. Recognizing this deficiency and seeking to ensure 
the Safe Drinking Water Act is implemented as per Congress' intent, 
AWMA recommends that state primacy programs be funded at more 
appropriate levels.
    Lastly, we encourage Congress to support the authorized level of $1 
billion per year for the Drinking Water State Revolving Fund. This 
program assists water systems throughout the country in building 
facilities to meet the new requirements of the Act.
Areas Where Implementation Can Be Improved
    We have already noted the remarkable amount of effort EPA has put 
into implementing the 1996 Amendments, but we would also like to 
express a number of concerns and to offer recommended actions. The 
Agency is already aware of these recommendations, as they appeared in 
AMWA's official comments on various proposed rules.
    Source Water Protection. First and foremost, AMWA looks to EPA to 
better coordinate its various programs to prevent pollution of the 
nation's drinking water sources. It is more effective and more 
equitable to prevent pollution in the first place rather than rely on 
drinking water suppliers to install ever more complex and costly 
treatment to remove that pollution from the public's water. It is more 
effective for two reasons. First, no treatment technology removes all 
contaminants 100 percent of the time. Second, prevention at the source 
for many contaminants reduces threats to recreational use of water 
sources as well as the aquatic environment. It is more equitable, since 
preventing pollution at its source ensures that those responsible for 
it bear the costs of removal, rather than transferring those costs to 
drinking water system customers.
    The case of MTBE, the gasoline additive approved by EPA under the 
Clean Air Act, provides an example of why coordination is needed. At 
the time MTBE was approved for use, EPA's scientists warned that, 
because of its characteristics, pollution of drinking water supplies 
was likely. The additive was nevertheless approved, and now we have 
extensive MTBE contamination of drinking water supplies. Consideration 
of drinking water concerns in the initial decision would have led to 
better results.
    Indeed, the Clean Water Act and Safe Drinking Water Act offer many 
opportunities for coordination to protect drinking water sources.
    The Use of Sound Science. The revised Safe Drinking Water Act 
stresses the use of sound science in developing and making regulatory 
decisions. As previously noted, AMWA has strongly supported increased 
research funding for drinking water to meet this purpose. 
Unfortunately, recent events have given all of us reason for concern. 
As you may know, EPA recently finalized a maximum contaminant level 
goal (MCLG) for chloroform at zero, despite noting in the final rule 
that the best available, peer-reviewed science indicated a non-zero 
value was more appropriate. EPA has now vacated the chloroform standard 
after a court ruling that the Agency failed to use the best-available 
science.
    More recently, EPA proposed a Filter Backwash Rule while 
acknowledging that they lack sufficient scientific information to know 
what risks might be involved, the effectiveness of current treatment, 
or the benefits that the public might receive from implementation of 
the rule. EPA's own Science Advisory Board has pointed out major 
deficiencies in the proposal.
    There are a number of other similar examples. AMWA believes that 
such things are bound to happen with EPA struggling to meet mandated 
deadlines for issuing regulations. It would be unreasonable to expect 
perfection given an ever-changing base of scientific knowledge. While 
AMWA appreciates that the demanding schedule laid out in the Safe 
Drinking Water Act may lead to some oversights, we urge you to stress 
to EPA the importance of meeting the sound science provisions of the 
Act. We also recommend that Congress be open to changing statutory 
deadlines when there is reasonable expectation that additional, near-
term information will better provide for the public's interests. 
Focusing on the mandated timelines in the Act to the point of ignoring 
its other provisions will not ultimately lead to the sensible, cost 
effective regulations the public deserves. The Filter Backwash Rule is 
a case in point. AMWA recommends that Congress consider an extension of 
the August 2000 deadline so that basic knowledge of risks, costs and 
benefits can be developed.
    AMWA also recommends that the subcommittee consider requesting an 
independent review of how well EPA is incorporating science into 
regulatory decisions. An independent review by the National Academy of 
Sciences or the General Accounting Office could both serve as a 
template for EPA and assist the Agency in targeting its resources. It 
also would help ensure that future regulations have a solid footing 
based on science.
    Health Risk Reduction and Cost Analyses. One of the most 
significant provisions of the Safe Drinking Water Act is the 
requirement for preparation of a Health Risk Reduction and Cost 
Analysis (HRRCA) document to be published for public comment at the 
same time a rule is proposed. AMWA believes that this document is a key 
public right-to-know provision of the Act. With a straightforward 
analysis of risks and costs, the public will know the answer to a very 
basic question, ``What am I getting for my money?''
    So far, the cost and risk analyses, with the exception of that for 
radon, have tended to be buried within a very long and complex 
Regulatory Impact Analysis. Moreover, the analyses are not published 
for comment in the Federal Register along with the proposed rule. 
Rather, HRRCAs must be obtained either from the rule docket or accessed 
via the Internet, and it is not clear that public comments are desired 
or whether they will even be reviewed and considered by the Agency.
    A key component of HRRCAs required by the Act is an analysis of the 
``quantifiable and nonquantifiable health risk reduction benefits for 
which there is a factual basis in the rulemaking record to conclude 
that such benefits are likely to occur as the result of treatment to 
comply with each (maximum contaminant) level'' (emphasis added). AMWA 
is concerned that several of the analyses to date have tended to rely, 
at least in part, on speculative (``what if'') analyses.
    Additionally, the analyses stray from normal cost-benefit 
practices. For example, EPA chooses to discount costs, but not 
benefits. Thus the Agency compares apples to oranges, which obfuscates 
whether the benefits of a rule justify the costs.
    These are but a few of the problems that concern AMWA about how 
Health Risk Reduction and Cost Analyses are being conducted under the 
Safe Drinking Water Act. If these analyses are truly intended to inform 
decisionmakers, then they must be very clear in addressing actual 
rather than speculative risk reduction benefits. And, if these analyses 
are truly intended to inform the public about the benefits they may 
receive for what they will pay, then the HRRCAs must be clear, 
straightforward, and easy to read.
    AMWA recommends that the subcommittee consider requesting an 
independent review of how well EPA's cost-benefit analyses conform to 
standard practices and to the requirements of the Act. An independent 
review by the National Academy of Sciences or the General Accounting 
Office could both serve as a template for EPA and assist the Agency in 
targeting its resources. It would also help ensure that future cost-
benefit analyses present information that is most useful to 
decisionmakers and the general public.
Comments on Specific Proposed Regulations
    Arsenic Rule. Just last week, EPA proposed regulating arsenic at 5 
parts per billion (ppb), but will also be taking comment on 3, 10 and 
20 ppb. EPA is required under SDWA to promulgate a final rule by 
January 2001. The 1996 Amendments also required that the National 
Academy of Sciences (NAS) conduct a review of EPA's arsenic risk 
assessment. The NAS report recommended that EPA revise the existing 50 
ppb standard for arsenic downward as quickly as possible but did not 
recommend a specific level. The report also recommended that EPA 
conduct more studies of its arsenic toxicity analysis and risk 
characterization, conduct additional human studies, and identify 
markers of arsenic-induced cancers. The arsenic standard is a very 
complex issue, and the proposal rule will draw many valuable comments 
from stakeholders. Unfortunately, once the comment period closes EPA 
must finalize the standard only a few months later. We ask the 
subcommittee to consider extending this deadline by 6 months to give 
EPA more time to evaluate comments.
    In addition, the Science Advisory Board's Drinking Water Committee 
was charged with reviewing the proposed rule for EPA. In a preliminary 
draft report prepared earlier this month, the committee suggested that 
EPA consider setting the arsenic standard higher than the proposed 
level of 5 ppb. The committee noted that the available science might 
support a standard in the range of 10 to 20 ppb.
    Filter Backwash Rule. The Act also requires EPA to issue a rule 
governing filter backwash recycle practices by August 2000. The rule is 
intended to address the concentration of contaminants in the drinking 
water treatment process resulting from cleaning of water filter beds. 
AMWA is concerned about the lack of scientific data that is available 
to support this rule. In the preamble of the rule, EPA acknowledges 
that there is a paucity of data available regarding the recycle 
practices of filter backwash.
    As noted earlier, AMWA requested that EPA repropose the rule to 
address several issues including the lack of available data. AMWA 
suggests that Congress extend the deadline for this rule to provide EPA 
with an additional year to evaluate the issue.
    Radon Rule. EPA is required to finalize the Radon Rule by August 
2000. Under the 1996 Amendments, Congress established the need for a 
mitigation program to reduce radon levels in indoor air. It is 
generally accepted that indoor air radon mitigation provides greater 
risk reduction than other methods of removal. Therefore, EPA developed 
a dual compliance regulatory approach: water systems may comply with an 
``alternative'' maximum contaminant level (MCL) of 4000 picoCuries per 
liter (pCi/L) where the state, or the water system itself, operates an 
indoor air radon mitigation program. And where no mitigation program 
exists, water systems must either initiate one or comply with a 
``primary'' MCL of 300 pCi/L. This approach is intended to attract 
water systems to participate in indoor air radon mitigation programs 
and thus achieve a higher risk reduction.
    AMWA endorses the concept of addressing radon through multimedia 
programs that reduce indoor air risk. AMWA agrees that that indoor air 
radon mitigation provides greater risk reduction than does the 
treatment of drinking water. AMWA would like to see the Radon Rule 
refocused on encouraging states to adopt the multimedia program option 
and reducing the burden on water systems to develop their own indoor 
air program or be forced to comply with the maximum contaminant level.
Liability Reform for Suits Against Water Suppliers
    AMWA also urges the subcommittee to focus its attention on the 
emerging threat to water suppliers of suits alleging the delivery of 
unsafe water even where the water surpasses the requirements of EPA 
rules.
    Over the past 2 years, nearly a dozen tort suits some of them 
class-actions--have been filed against California water suppliers. 
Other suits could appear in other states at any time. The California 
suits allege damage from regulated and unregulated contaminants, and 
they threaten to undermine the ability of water systems to supply 
affordable water to consumers. The cost of litigation and the financial 
repercussions of cash awards could push the price of water beyond the 
reach of millions of families and affect other city services. Judgments 
could include cash awards or massively expensive treatment facilities 
to supplement existing ones.
    The suits also threaten to render the Safe Drinking Water Act, 
particularly its mandate for science-based health standards, 
inconsequential when courts are handed the responsibility of setting 
drinking water standards. Further, liability against water suppliers 
makes these agencies the stewards of rivers, streams, lakes and 
aquifers that supply raw water to the treatment facilities. Meanwhile, 
neither the Clean Water Act nor the Superfund program provide any 
assurance to water suppliers that drinking water sources will be 
priorities for prevention and cleanup.
Infrastructure Challenges
    A recent report by the Water Infrastructure Network (WIN), which is 
comprised of water suppliers, city officials, environmental 
organizations, and state agencies, shows that drinking water agencies 
spend roughly $13 billion per year on infrastructure to protect public 
health. But according to the report, that amount is only about half of 
what may be needed. The WIN report indicates that approximately $11 
billion more per year is needed through 2019. EPA's recent ``gap'' 
analysis and a report by the American Water Works Association confirm 
this overwhelming shortfall.
    Mr. Chairman, and members of the subcommittee, AMWA member agencies 
are exploring every avenue available to fund this anticipated future 
need. The vast majority of large municipal water systems currently fund 
100 percent of their infrastructure as well as 100 percent of all 
federally mandated treatment requirements. We have embraced public-
private partnerships and private investment where it makes sense from a 
local perspective. We have adopted new efficiencies and streamlined our 
process. In short, we attempt to run our agencies not only as public 
services, but as businesses, too.
    AMWA is currently working with local governments, other water 
supply associations, state groups as well as the environmental 
community to assess the need and to develop appropriate funding 
solutions. AMWA is committed to evaluating all possibilities for future 
financing, and as we proceed, will keep the subcommittee apprised of 
any financing options that impact the long-standing partnerships we 
have had with the Federal Government.
Methyl Tertiary Butyl Ether (MTBE)
    Finally, the issue of MTBE deserves consideration. AMWA wishes to 
thank Chairman Crapo, full committee Chairman Smith, Chairman Inhofe of 
the clean air subcommittee, and Senators Boxer and Feinstein for their 
responses to MTBE contamination.
    AMWA urges swift action on the part of the committee and Congress 
to pass legislation that significantly reduces or eliminates the use of 
MTBE to prevent further water contamination, to assist water systems 
where supplies are contaminated, and to support development of 
treatment technologies to remove existing contamination.
    Water systems in at least 31 states have detected MTBE in their 
wells or surface sources. As you know, the primary sources of 
contamination are leaking underground gasoline storage tanks, although 
there is concern that air deposition is another source. Since MTBE is 
very soluble in water and does not cling to soil well, it has a 
tendency to migrate much more quickly in water than other components of 
gasoline. MTBE renders drinking water unfit for human consumption due 
to strong taste and odor levels, even at levels as low as 2 parts per 
billion. Most consumers perceive drinking water with an unpleasant 
taste or odor as being unhealthy, and in some cases the water may very 
well be unsafe to drink. The bottom line is that consumers will not 
tolerate MTBE in their water.
Conclusion
    Let me conclude by calling your attention to the main points 
included in this testimony:
      AMWA expresses its support for EPA's Office of Ground 
Water and Drinking and the state drinking water primacy agencies that 
implement the Safe Drinking Water Act. Recognition of their hard work 
is well-deserved, and we encourage Congress to support their efforts.
      Research is critical to ensure that drinking water 
regulations address contaminants that actually occur in drinking water 
and that occur at levels of public health concern.
      AMWA looks to EPA to better coordinate their various 
programs to prevent pollution in sources of drinking water.
      AMWA recommends that the subcommittee consider requesting 
an independent review of how well EPA is incorporating science into 
regulatory decisions.
      If Health Risk Reduction and Cost Analysis (HRRCA) are 
truly intended to inform decisionmakers, then they must be very clear 
in addressing actual rather than speculative risk reduction benefits. 
And, if these analyses are truly intended to inform the public about 
the benefits they may receive for what they will pay, then the HRRCAs 
must be clear, straightforward, and easy to read.
      AMWA recommends that the subcommittee consider an 
independent review of how well EPA's cost-benefit analyses conform to 
standard practices.
      AMWA urges the subcommittee to focus its attention on the 
emerging threat to water suppliers of suits alleging the delivery of 
unsafe water even where the water surpasses the requirements of EPA 
rules.
      AMWA makes note of the $11 billion-per-year shortfall in 
funding for municipal drinking water agencies anticipated over the next 
20 years.
      AMWA urges swift action on the part of the committee and 
Congress to pass legislation that significantly reduces or eliminates 
the use of MTBE to prevent further water contamination, to assist water 
systems where supplies are contaminated, and to support development of 
treatment technologies to remove existing contamination.
    Thank you for the opportunity to provide this testimony today. AMWA 
is committed to working with the Environment and Public Works 
Committee, Subcommittee on Wildlife, Fisheries, and Water, and EPA to 
ensure safe and affordable drinking water for the nation.
                               __________
   Statement of Michael J. Kosnett, M.D., M.P.H., Associate Clinical 
Professor of Medicine Division of Clinical Pharmacology and Toxicology 
  University of Colorado Health Sciences Center Denver, Colorado, on 
 Behalf of the National Research Council's Subcommittee on Arsenic in 
                             Drinking Water
    Good morning Mr. Chairman and members of the committee. I am 
Michael J. Kosnett, MD, MPH, a member of the Committee on Toxicology of 
the National Research Council (NRC), and a former member of the NRC's 
Subcommittee on Arsenic in Drinking Water. I am also an Associate 
Clinical Professor of Medicine in the Division of Clinical Pharmacology 
and Toxicology at the University of Colorado Health Sciences Center. I 
am pleased to appear before the committee today to discuss the findings 
of the NRC Subcommittee with respect to the health risks posed by 
arsenic in drinking water.
    The National Research Council is an operating arm of the National 
Academy of Sciences, an independent, nongovernmental organization whose 
work often involves convening expert panels and study groups to address 
scientific and public health issues of interest to the Federal 
Government and other parties. The NRC's Subcommittee on Arsenic in 
Drinking Water was convened in the Spring of 1997 at the request of the 
U.S. Environmental Protection Agency. The charge to the subcommittee 
included a request to review EPA's characterization of the human health 
risk posed by arsenic in drinking water, to determine the adequacy of 
the EPA's current Maximum Contaminant Level (MCL) for protecting public 
health, and to identify priorities for research to fill data gaps.
    The subcommittee was comprised of a group of experts selected by 
the chair of the National Research Council on the basis of their 
knowledge and experience in various aspects of the topics covered in 
the charge to the committee. It is important to note that the committee 
membership comprised an international grouping of experts from multiple 
scientific disciplines, including toxicology, epidemiology, 
biostatistics, chemistry, and nutrition. As with all NRC committees, 
the selection process was attentive to achieving balance in scientific 
perspective, and to avoiding any conflicts of interest. It should be 
noted that the members were drawn from academic institutions, national 
health agencies, private corporations, industry supported research 
organizations, and private consultants. The subcommittee adhered to a 
collective writing process, and its report reflects the scientific 
consensus of its members. Moreover, the subcommittee report was 
subjected to internal NRC institutional oversight, and to external peer 
review by public and private sector experts drawn from a broad range of 
backgrounds and perspectives. Every comment and question submitted by 
these peer reviewers was addressed by subcommittee members before the 
report was finalized.
    The final 310 page report of the NRC Subcommittee on Arsenic in 
Drinking Water was released in the Spring of 1999. I have attached two 
key sections of the report as part of this statement: the Executive 
Summary, and a short but important chapter entitled ``Risk 
Characterization.'' These sections highlight the key findings and 
recommendations of the subcommittee.
    Arsenic in Drinking Water Subcommittee on Arsenic in Drinking Water 
Committee on Toxicology Board on Environmental Studies and Toxicology 
Commission on Life Sciences National Research Council March 1999
  national research council subcommittee on arsenic in drinking water
Robert A. Goyer (Chair), University of Western Ontario (emeritus), 
London, Ontario, Canada
H. Vasken Aposhian, University of Arizona, Tucson, Arizona
Kenneth G. Brown, Kenneth G. Brown, Inc., Chapel Hill, North Carolina
Kenneth P. Cantor, National Cancer Institute, Bethesda, Maryland
Gary P. Carlson, Purdue University, West Lafayette, Indiana
William R. Cullen, University of British Columbia, Vancouver, Canada
George P. Daston, The Procter & Gamble Company, Cincinnati, Ohio
Bruce A. Fowler, University of Maryland Medical School, Baltimore, 
Maryland
Curtis D. Klaassen, University of Kansas Medical Center, Kansas City, 
Kansas
Michael J. Kosnett, University of Colorado Health Sciences Center, 
Denver, Colorado
Walter Mertz, Retired Director of Beltsville Human Nutrition Research 
Center, Rockville, Maryland
R. Julian Preston, Chemical Industry Institute of Toxicology, Research 
Triangle Park, North Carolina
Louise M. Ryan, Harvard School of Public Health and Dana Farber Cancer 
Institute, Boston, Massachusetts
Allan H. Smith, University of California, Berkeley
Marie E. Vahter, Karolinska Institute, Stockholm, Sweden
John K. Wiencke, University of California, San Francisco
Carol A. Maczka, Director, Toxicology and Risk Assessment Program
Kulbir S. Bakshi, Program Director for the Committee on Toxicology
Margaret E. McVey, Project Director (prior to January 1998)
Ruth E. Crossgrove, Editor
Mirsada Karalic-Loncarevic, Information Specialist
Catherine M. Kubik, Senior Program Assistant
Lucy V. Fusco, Project Assistant
Executive Summary
    The Safe Drinking Water Act (SDWA) directs the U.S. Environmental 
Protection Agency (EPA) to establish national standards for 
contaminants in public drinking-water supplies. Enforceable standards 
are to be set at concentrations at which no adverse health effects in 
humans are expected to occur and for which there are adequate margins 
of safety. Enforceable standards are standards that can be achieved 
with the use of the best technology available.
    Arsenic is a naturally occurring element present in the environment 
in both inorganic and organic forms. Inorganic arsenic is considered to 
be the most toxic form of the element and is found in groundwater and 
surface water, as well as in many foods. A wide variety of adverse 
health effects, including skin and internal cancers and cardiovascular 
and neurological effects, have been attributed to chronic arsenic 
exposure, primarily from drinking water. EPA's interim maximum 
contaminant level (MCL) for arsenic in drinking water is 50 micrograms 
per liter (ug/L). Under the 1996 SDWA amendments, EPA is required to 
propose a standard (an MCL) for arsenic in drinking water by January 
2000 and finalize it by January 2001.
                     the charge to the subcommittee
    In 1996, EPA's Office of Water requested that the National Research 
Council (NRC) independently review the arsenic toxicity data base and 
evaluate the scientific validity of EPA's 1988 risk assessment for 
arsenic in drinking water. The NRC assigned this project to the 
Committee on Toxicology (COT), which convened the Subcommittee on 
Arsenic in Drinking Water, whose membership includes experts in 
toxicology, pharmacology, pathology, chemistry, nutrition, medicine, 
epidemiology, risk assessment, and biostatistics. The subcommittee was 
charged with the following tasks: (1) review EPA's characterization of 
human health risks from ingestion of arsenic compounds found in food 
and drinking water and the uncertainties associated that 
characterization; (2) review available data on cancer and noncancer 
health effects from exposure to arsenic compounds in drinking water and 
the implications of these effects on the Assessment of the human health 
risks from arsenic exposure; (3) review data on the toxicokinetics, 
metabolism, and mechanism or mode of action of arsenic and ascertain 
how these data could assist in assessing human health risks from 
drinking-water exposures, and (4) identify research priorities to fill 
data gaps. EPA did not request, nor did the subcommittee endeavor to 
provide, a formal risk assessment for arsenic in drinking water.
               the subcommittee's approach to its charge
    The subcommittee evaluated data relating to key elements of the 
risk-assessment process--hazard identification, dose response, and risk 
characterization--that addresses the protective nature of the current 
MCL. Specifically, the subcommittee reviewed information on the health 
effects of arsenic exposure and data on the disposition and the 
mechanism or mode of action of arsenic. The subcommittee also evaluated 
other information that could affect the risk assessment, such as 
variations in human susceptibility, and current capabilities to measure 
arsenic in various media, including biological tissues. The major 
conclusions and recommendations of the subcommittee in each of those 
areas are discussed in the remainder of this summary. The implications 
of these findings on the assessment of human health risk is provided 
below in the section on risk characterization.
                     the subcommittee's evaluation
Health Effects
    The subcommittee concludes that there is sufficient evidence from 
human epidemiological studies in Taiwan, Chile, and Argentina that 
chronic ingestion of inorganic arsenic causes bladder and lung cancer, 
as well as skin cancer. With minor exceptions, epidemiological studies 
for cancer are based on populations exposed to arsenic concentrations 
in drinking water of at least several hundred micrograms per liter. Few 
data address the degree of cancer risk at lower concentrations of 
ingested arsenic. Noncancer effects resulting from chronic ingestion of 
inorganic arsenic have been detected at doses of 0.01 milligram per 
kilogram (mg/kg) and higher per day. Of the noncancer effects, 
cutaneous manifestations of exposure have been studied most widely. 
Developmental and reproductive effects resulting from chronic ingestion 
of inorganic arsenic have not been demonstrated in humans, although 
arsenic is known to pass through the placenta. Parenteral 
administration of inorganic and organic forms of arsenic are known to 
be teratogenic in a number of mammalian species, and oral 
administration affects fetal growth and prenatal viability. Arsenic has 
not been tested for essentiality in humans, nor has it been found to be 
required for any essential biochemical processes. Arsenic 
supplementation at very high concentrations (e.g., 350-4,500 nanograms 
per gram (ng/g)) in the diet has been shown to affect growth and 
reproduction in minipigs, chicks, goats, and rats.
Recommendations
    Additional epidemiological evaluations are needed to characterize 
the dose-response relationship for arsenic-associated cancer and 
noncancer end points, especially at low doses. Such studies are of 
critical importance for improving the scientific validity of risk 
assessment. With respect to cancer, studies are recommended to refine 
the dose-response relationship between arsenic ingestion and cancer of 
the skin, bladder, and lung, and to investigate the effect of arsenic 
on cancer at other sites. With respect to noncancer effects, particular 
emphasis should be placed on epidemiological study of arsenic-
associated cutaneous effects, cardiovascular and cerebrovascular 
disease, diabetes mellitus, and adverse reproductive outcomes.
    Future studies on the beneficial effects of arsenic in experimental 
animals should carefully monitor the amount and speciation of arsenic 
in diets and water, use biomarkers to assess arsenic exposure and 
bioavailability, and use techniques that assess the toxicity and 
benefits of arsenic in a more specific manner than is possible through 
measurement of growth and reproductive success. In humans, the 
concentration of arsenic in total parenteral nutrition (TPN) should be 
determined by validated analytical methods and related to the health 
status of patients on long-term TPN.
    Disposition (Absorption, Distribution, Metabolism, and Excretion)
    In humans, inorganic arsenic is readily absorbed from the 
gastrointestinal tract and is primarily transported in the blood bound 
to sulfhydryl groups in proteins and low-molecular-weight compounds, 
such as amino acids and peptides. The half-life of arsenic in the body 
is about 4 days, and it is primarily excreted in the urine. Humans and 
some animals methylate inorganic arsenic to forms that are less acutely 
toxic and more readily excreted. However, the methylation process 
varies among animal species, making most animal models less suitable 
for studying the disposition of arsenic in humans. The methylation of 
ingested arsenic is not inhibited or overloaded, unless acute toxic 
doses are ingested. Substantial variations in the fractions of 
methylated forms of arsenic in urine are also known to occur among 
different populations and individuals within the same exposed 
population. Such variations might be indicative of genetic differences 
in the enzymes responsible for the methylation of arsenic. Methylation 
of arsenic might also be influenced by such factors as the arsenic 
species absorbed, high acute doses, nutrition, and disease. The extent 
to which variation in arsenic methylation affects its toxicity, 
including carcinogenicity, is not known.
Recommendations
    Because of interspecies differences in the disposition of arsenic, 
more human studies are needed, including research using human tissues. 
Factors influencing the methylation, tissue retention' and excretion of 
arsenic in humans also need to be investigated.
Mechanism or Mode of Action
    The mechanism or mode of action by which inorganic arsenic causes 
toxicity, including cancer, is not well established. In vivo studies in 
rats and mice to determine the ability of organic arsenic to act as a 
cocarcinogen or as a promoter have produced conflicting results. on the 
arsenic metabolite, dimethylarsinate (DMA), suggest that it is not an 
initiator but might act as a promoter. However, those studies used 
verse high doses, making interpretation of the results difficult, 
especially if DMA is formed in situ following the administration of 
inorganic arsenic.
    The most accepted explanation for the mode of action for arsenic 
carcinogenicity is that it induces chromosomal abnormalities without 
interacting directly with DNA. These markers of tumor response would 
lead to a dose-response curve that exhibits sublinear characteristics 
at some undetermined region in the low-dose range, although linearity 
cannot be ruled out.
    The mechanism of action by which arsenic induces noncancer effects 
is centered on its inhibitory effects on cellular respiration at the 
level of the mitochondrion. Hepatotoxicity is a major health effect 
related to decreased cellular respiration. Oxidative stress might also 
have an important role in both cancer and noncancer effects.
Recommendations
    Identification of proximate markers of arsenic-induced cancers and 
their application in carefully designed epidemiological studies might 
better define the cancer dose-response curves at low concentrations. 
Molecular and cellular characterization of neoplasms from arsenic 
exposed populations and appropriate controls might aid in identifying 
the mechanism by which arsenic induces tumors. Chronic low-dose studies 
in a suitable animal model (mouse, hamster, or rabbit) might increase 
our understanding of the mode of action of arsenic carcinogenicity, 
particularly the potential role of chromosomal alterations.
    A greater understanding is needed of the inter-relationships 
between arsenic's effects on cellular respiration and its effects on 
biochemical processes, including methylation, formation of reactive 
oxygen species, oxidative stress, and protein stress response.
Variation in Human Sensitivity
    Human sensitivity to the toxic effects of inorganic arsenic 
exposure is likely to vary based on genetics, metabolism, diet, health 
status, sex, and other possible factors. These factors can have 
important implications in the assessment of risk from exposure to 
arsenic. A wider margin of safety might be needed when conducting risk 
assessments of arsenic because of variations in metabolism and 
sensitivity among individuals or groups. For example, people with 
reduced ability to methylate arsenic retain more arsenic in their 
bodies and be more at risk for toxic effects. One study suggests that 
children have a lower arsenic-methylation efficiency than adults. 
Similarly, poor nutritional status might decrease the ability of an 
individual to methylate arsenic, resulting in increased arsenic 
concentrations in tissues and the development of toxic effects. There 
is some evidence from animal studies that low concentrations of S-
adenosylmethionine, choline, or protein decrease arsenic methylation.
Recommendations
    Factors that influence sensitivity to or expression of arsenic-
associated cancer and noncancer effects need to be better 
characterized. Particular attention should be given to the extent of 
human variability and the reasons for it with respect to arsenic 
metabolism, tissue accumulation, and excretion (including total and 
relative amounts of urinary arsenic metabolites) under various 
conditions of exposure. Gene products responsible for metabolism, diet, 
and other environmental factors that might influence the susceptibility 
to or expression of arsenic-associated toxicity also need to be 
characterized in human studies and in suitable animal models. Potential 
differences between young children and adults in arsenic-methylation 
efficiency need to be validated and considered in any risk assessment 
of arsenic. Finally, quality-control data are needed to ensure that 
reported variations are not due to the analytical methods or procedures 
used. Standard reference materials are needed to analyze arsenic 
species in urine.
Other Considerations
    Assessment of arsenic exposure via drinking water is often based on 
the measurements of arsenic concentrations in drinking water and 
assumptions regarding the amount of water consumed. Such data are 
estimates, the uncertainty of which will depend on the method used. The 
subcommittee evaluated various biomarkers (e.g., arsenic in urine, 
blood, hair, and nails) to measure the absorbed dose of inorganic 
arsenic and concluded that blood, hair, and nails are much less 
sensitive than urine as biomarkers of exposure. Specifically, the 
subcommittee concluded that the total concentration of inorganic 
arsenic and its metabolites in urine is a useful biomarker for both 
recent (previous day) and ongoing exposure. The concentration of 
urinary inorganic arsenic and its metabolites is less influenced by the 
consumption of seafood than is the total concentration of urinary 
arsenic. The concentration of arsenic in blood is a less-useful 
biomarker of continuous exposure because the half-life of arsenic in 
blood is short (approximately 1 fur), the concentration might be 
markedly affected by recent consumption of seafood, and it is difficult 
to speciate arsenic in blood. Measurements of arsenic in hair and nails 
have little use as biomarkers of absorbed dose, largely because of the 
difficulty in distinguishing between arsenic absorbed from ingestion 
and arsenic uptake in hair and nails from washing with contaminated 
water.
    At present, the practical quantitation limit (PQL) for arsenic in 
water in most commercial and water utility laboratories is 4 ug/L. 
Measurement of total concentration of arsenic in drinking water is 
adequate for regulatory purposes.
Recommendations
    More data are needed that tie biomarkers of absorbed arsenic dose 
(especially urinary Concentrations of arsenic metabolites) to arsenic 
exposure concentrations, tissue concentrations, and the clinical 
evidence of arsenic toxicity. Data are particularly lacking for people 
living in different parts of the United States. Possible relationships 
between arsenic concentrations in urine, blood, hair, and nails need to 
be evaluated. In particular, the degree of external binding of arsenic 
to hair and nails should be examined.
    There is a need for further development of analytical techniques to 
determine the chemical species of arsenic in various media--water, 
food, urine, and biological tissues. Quality-control data and certified 
standards for arsenic speciation are also needed.
                         risk characterization
    In the context of its task, the subcommittee was asked to consider 
whether cancer or noncancer effects are likely to occur at the current 
MCL. No human studies of sufficient statistical power or scope have 
examined whether consumption of arsenic in drinking water at the 
current MCL results in an increased incidence of cancer or noncancer 
effects. Therefore, the subcommittee's characterization of risks at the 
current MCL is based on observed epidemiological findings, experimental 
data on the mode of action of arsenic, and available information on the 
variations in human susceptibility.
    In the absence of a well-designed and well-conducted 
epidemiological study that includes individual exposure assessments, 
the subcommittee concluded that ecological studies from the arsenic 
endemic area of Taiwan provide the best available empirical human data 
for assessing the risks of arsenic-induced cancer. The cultural 
homogeneity of this region reduces concern about unmeasured 
confounders, although the potential for bias still exists due to 
considerable uncertainty about the exposure concentrations assigned to 
each village. Ecological studies in Chile and Argentina have observed 
risks of lung and bladder cancer of the same magnitude as those 
reported in the studies in Taiwan at comparable levels of exposure.
    Information on the mode of action of arsenic and other available 
data that can help to determine the shape of the dose-response curve in 
the range of extrapolation are inconclusive and do not meet EPA's 1996 
stated criteria for departure from the default assumption of linearity. 
Of the several modes of action that are considered most plausible, a 
sublinear dose-response curve in the low-dose range is predicted, 
although linearity cannot be ruled out. In vitro studies of the 
genotoxic effects of arsenic indicate that changes in cellular function 
related to plausible modes of carcinogenesis can occur at arsenic 
concentrations similar to the current MCL. However, the subcommittee 
believes that those data and the confidence with which they can be 
linked to arsenic-induced neoplasia are insufficient to determine the 
shape of the dose-response curve in the low-dose range (point of 
departure). The subcommittee also finds that existing scientific 
knowledge regarding the pattern of arsenic metabolism and disposition 
across this dose range does not establish the mechanisms that mitigate 
neoplastic effects.
    Human susceptibility to adverse effects resulting from chronic 
exposure to inorganic arsenic is likely to vary based on genetics, 
nutrition, sex, and other possible factors. Some factors, such as poor 
nutrition and arsenic intake from food might affect assessment of risk 
in Taiwan or extrapolation of results in the United States.
    The subcommittee also concludes that the choice of model for 
statistical analysis can have a major impact on estimated cancer risks 
at low-dose exposures, especially when the model accounts for age as 
well as concentration. Applying different statistical models to the 
Taiwanese male bladder-cancer data revealed that a more stable and 
reliable fit is provided by Poisson regression models that 
characterized the log relative risk as a linear function of exposure. 
The estimation of risk at low doses using those models is substantially 
higher than that using the multistage Weibull model. As an alternative 
to model-based estimates of risk, the subcommittee finds that the 
point-of-departure methods discussed in the 1996 draft EPA guidelines 
for cancer risk assessment give much more consistent low-dose estimates 
across a wide range of dose-response models. For male bladder cancer, a 
straight-line extrapolation from the 1 percent point of departure 
yielded a risk at the MCL of 1 to 1.5 per 1,000. Because some studies 
have shown that excess lung cancer deaths attributed to arsenic are 2-S 
fold greater than the excess bladder cancer deaths, a similar approach 
for all cancers could easily result in a combined cancer risk on the 
order of 1 in 100.' It is also instructive to note that daily arsenic 
ingestion at the MCL provides a margin of exposure less than 10 from 
the point of departure for bladder cancer alone. The public health 
significance of daily ingestion of a given amount of arsenic in 
drinking water will be influenced by the background levels of arsenic 
consumed in food.
Recommendations
    On the basis of its review of epidemiological findings, 
experimental data on the mode of action of arsenic, and available 
information on the variations in human susceptibility, it is the 
subcommittee's consensus that the current EPA MCL for arsenic in 
drinking water of 50 ug/L does not achieve EPA's goal for public-health 
protection and, therefore, requires downward revision as promptly as 
possible.
    Sensitivity analyses should be conducted to determine whether the 
results, including the way exposure concentrations are grouped 
together, are sensitive to the choice of model. The potential effect of 
measurement error and confounding on the dose-response curve and 
associated confidence limits should be further addressed.
    To assist in the application of cancer data observed in different 
populations to cancer risks predicted for the United States, 
information on nutritional factors in study populations that pertains 
to susceptibility to arsenic-induced cancer should be investigated.
    Modeling of epidemiological data should not be limited to the 
multistage Weibull model. Over models, including those which 
incorporate information from an appropriate control population, should 
be considered. The final risk value should be supported by a range of 
analyses over a broad range of feasible assumptions.
Risk Characterization
    In its Statement of Task to the subcommittee, EPA requested 
guidance regarding ``the adequacy of the current EPA maximum 
contaminant levels (MCLs) and ambient-water-quality-criteria (AWQC) 
values for protecting human health in the context of stated EPA policy. 
. . .'' EPA's stated policy in setting MCLsfor known human carcinogens 
has the ``goal of ensuring that the maximum risk at the MCL falls 
within the 104 to 106 range that the Agency 
considers protective of the public health, therefore achieving the 
overall purpose of the SDWA (Safe Drinking Water Act)'' (EPA 1992). EPA 
has not requested, nor has the subcommittee endeavored to provide, a 
formal risk assessment for arsenic in drinking water. However, the 
subcommittee believes it can provide EPA with an up-to-date summary 
appraisal of two key elements of the risk-assessment process--hazard 
identification and dose response--that qualitatively, if not 
quantitatively, address the protective nature of the current MCL.
    As the subcommittee discussed in detail elsewhere in this report, 
there is sufficient evidence from human epidemiological studies in 
Taiwan, Chile, and Argentina to conclude that ingestion of arsenic in 
drinking water poses a hazard of cancer of the lung and bladder, in 
addition to cancer of the skin. Overt noncancer effects of chronic 
arsenic ingestion have been detected at arsenic doses on the order of 
0.01 mg/kg per day and higher. Ofthe noncancer effects, cutaneous 
manifestations of exposure have been studied most widely. No human 
studies of sufficient statistical power or scope have examined whether 
consumption of arsenic in drinking water at the current MCL 
(approximately 0.001 mg/kg per day) results in an increased incidence 
of cancer or noncancer effects. Therefore, a characterization of the 
risk that exists at the current MCL must rely on extrapolation by using 
observed epidemiological findings, experimental data on mode-of-action-
related end points, and available information regarding the anticipated 
variability in human susceptibility.
    At present, studies from the arsenic endemic area of Taiwan 
continue to provide the best available empirical human data for use in 
assessing the dose-response relationship for arsenic-induced cancer. 
The current state of knowledge is insufficient to reliably apply a 
biologically based model to those data. In accordance with EPA's 
``Proposed Guidelines for Carcinogen Risk Assessment'' (EPA 1996), the 
subcommittee reviewed modes of action based on markers of tumor 
response and on available data that can determine the shape of the 
dose-response curve in the range of extrapolation. As discussed in 
Chapter 7, the several modes of action that are considered most 
plausible would lead to a dose-response curve that exhibits sublinear 
characteristics at some undetermined region in the low-dose range. 
Nonetheless, in the context of its task, the subcommittee considered 
the magnitude of the likely cancer risks within the range of human 
exposure at approximately the current MCL.
    In vitro studies of the genotoxic effect of submicromolar 
concentrations of arsenite on human and animal cells and one study of 
bladder-cell micronuclei in humans with arsenic concentrations of 57 to 
137 ug/L in urine indicate that perturbations in cellular function 
related to plausible modes of carcinogenesis might be operating at 
arsenic exposure concentrations associated with the current MCL. The 
subcommittee believes that those data and the confidence with which 
they can be linked to arsenic-induced neoplasia are insufficient to 
determine the shape of the dose response curve between the point of 
departure and the current MCL. The subcommittee also finds that 
existing scientific knowledge regarding the pattern of arsenic 
metabolism and disposition across this dose range does not establish 
mechanisms that mitigate neoplastic effects. In light of all the 
uncertainties on mode of action, the current evidence does not meet 
EPA's stated criteria (EPA 1996) for departure from the default 
assumption of linearity in this range of extrapolation.
    In Chapters 2 and 10, the subcommittee reviewed the strengths and 
limitations of the Taiwanese data. Chapter 10 also discussed the 
implications of applying different statistical models to the Taiwanese 
internal-cancer data for the purpose of characterizing cancer risk at 
the current MCL in the United States. With respect to EPA's 1988 risk 
assessment for arsenic-induced skin cancer in which the multistage 
Weibull model was used, a sensitivity analysis, within the limits of 
the available data, suggests that misclassification arising from the 
ecological study design and the grouping of exposures would likely have 
only a modest impact on EPA's risk estimates. Sensitivity analyses 
applied to male bladder-cancer risk estimated by the multistage Weibull 
model had a greater impact on results. However, a more stable and 
reliable fit was provided by Poisson regression models that 
characterized the log relative risk as a linear function of exposure. 
For male bladder cancer, a straight-line extrapolation from the 1 
percent point of departure (LED,) yielded a risk at the MCL of 1 to 1.5 
per 1,000. Considering the data on bladder and lung cancer in both 
sexes noted in the studies in Chapter 4, a similar approach for all 
cancers could easily result in a combined cancer risk on the order of 1 
in 100. It is also instructive to note that daily arsenic ingestion at 
the MCL, approximately 100 ug in adults, provides a margin of exposure 
less than 10.
    As discussed in Chapter 8, the subcommittee recognizes that human 
susceptibility to the adverse effects of chronic arsenic exposure is 
likely to vary based on genetics, sex, and over possible factors. Some 
factors, such as poor nutrition and arsenic intake from food, Night 
affect assessment of risk in Taiwan or extrapolation of results in the 
United States.
    Upon assessing the available evidence, it is the subcommittee's 
consensus that the current EPA MCL for arsenic in drinking water of 50 
ug/L does not achieve EPA's goal for public health protection and 
therefore requires downward revision as promptly as possible.
                               references
    EPA (U.S. Environmental Protection Agency). 1992. Drinking water; 
national primary drinking water regulations--synthetic organic 
chemicals and inorganic chemicals; national primary drinking water 
regulations implementation. Fed. Regist. 57(138):31797.
                                 ______
                                 
                                                   August 28, 2000.
Senator Barbara Boxer,
Senator Mike Crapo,
U.S. Senate,
Committee on Environment and Public Works,
Subcommittee on Fisheries, Wildlife, and Water,
Washington, DC 20510-6175
    Re: Arsenic in Drinking Water and EPA's Implementation of the Safe 
Drinking Water Act
Dear Senators Boxer and Crapo: I am pleased to respond to your letter 
of July 13, 2000 in which you requested that I address supplemental 
questions on arsenic in drinking water posed by Senators Crapo and 
Smith. As you are aware, I testified before the Subcommittee on 
Fisheries, Wildlife, and Water as a representative of the National 
Research Council's Subcommittee on Arsenic in Drinking Water. The peer-
reviewed product of this expert panel was a report to the United States 
Environmental Protection Agency released in March, 1999. Entitled 
``Arsenic in Drinking Water'' (NRC, National Academy Press: Wash, DC, 
1999) this report alone represents the consensus opinion of the 
National Research Council. In responding to the inquiries by Senators 
Crapo and Smith, I will endeavor to quote or clearly paraphrase 
sections of this report that address their particular questions. For 
questions that were not specifically addressed by the NRC report, I am 
providing my personal opinion, based on my experience and expertise in 
the area of the human health effects of arsenic exposure.
                                        Michael J. Kosnett.
                                 ______
                                 
        Responses by Michael J. Kosnett to Additional Questions 
                           from Senator Crapo

    Question 1. How would you characterize the scientific soundness of 
the Taiwan study on arsenic? Do you believe this represents a firm 
foundation for the proposed EPA standard with regard to dose-response 
modeling?
    Response. In its report, the NRC subcommittee stated, ``At present, 
studies from the arsenic endemic area of Taiwan continue to provide the 
best available human data for use in assessing the dose-response 
relationship for arsenic-induced cancer.'' (NRC, p. 300). In chapters 2 
and 10, the NRC subcommittee reviewed the strengths and limitations of 
the Taiwanese data. The NRC subcommittee made particular note of the 
fact that epidemiological studies in Chile and Argentina have observed 
arsenic-related risks of lung and bladder cancer of the same magnitude 
as those reported in the studies in Taiwan at comparable levels of 
exposure (NRC, p 292). This finding lends support to the scientific 
validity and generalizability of the Taiwanese data. By virtue of its 
considerable discussion on dose-response modeling using the Taiwanese 
data-set, the NRC subcommittee, in my opinion, clearly envisioned that 
EPA could further utilize this dataset in its assessment of health risk 
at lower levels of arsenic exposure. However, it should be emphasized 
that the NRC subcommittee did not base its concerns on the health risks 
of arsenic exposure at the current MCL of 50 ppb solely on dose-
response modeling using the Taiwanese data. The NRC subcommittee noted 
that the margin of exposure between the current MCL of 50 ppb and 
levels of exposure associated with an observed risk of death from 
arsenic induced cancer in the Taiwanese, Chilean, and Argentine studies 
was less than 10 fold. The NRC subcommittee also noted that ``In vitro 
studies of the genotoxic effect of submicromolar concentrations of 
arsenite on human and animal cells, and one study of bladder cell 
micronuclei in humans with arsenic concentrations of 57 to 137 ug/L in 
urine indicate that perturbations in cellular function related to 
plausible modes of carcinogenesis might be operating at arsenic 
exposure concentrations associated with the current MCL.'' (NRC, p 
300).

    Question 2. What arsenic level do you believe the existing science 
supports?
    Response. The NRC subcommittee was not asked to recommend a 
specific new MCL for arsenic, nor did it do so in its report. However, 
in its concluding chapter on Risk Characterization, the NRC 
subcommittee addressed implications of the available human 
epidemiological data regarding the potential human cancer risk 
associated with the current MCL of 50 ppb. The report stated, 
``Considering the data on bladder and lung cancer in both sexes noted 
in the studies in Chapter 4, a similar approach for all cancers could 
easily result in a combined cancer risk [at the current MCL of 50 ppb] 
on the order of 1 in 100.'' (NRC, p 301).
    The NRC subcommittee assessed the available scientific evidence, 
and did not find a scientific basis for EPA to depart from the default 
assumption of linearity in extrapolating cancer risk from arsenic 
exposure. Based on EPA'S 1996 document, ``Proposed Guidelines for 
Carcinogen Risk Assessment,'' EPA's criteria for abandoning the default 
assumption of linearity have not been met. As such, given that the 
lifetime cancer risk at the current MCL of 50 ppb could be on the order 
of 1 in 100, (and that the observed lifetime cancer risk in a Chilean 
population consuming drinking water of 500 ppb was 1 in 10, per Smith 
et al, 1998), the cancer risk at EPA's new proposed MCL of 5 ppb could 
be on the order of 1 in 1000. This exceeds by at least one order of 
magnitude the lifetime cancer risks of 1 in 10,000 to 1 in 1,000,000 
that EPA has traditionally accepted as protective of the public health. 
Therefore, in my opinion, the existing science supports lowering the 
MCL to the lowest feasible level, namely 3 ppb, if the only 
considerations are a desire to be protective of the public health in a 
manner consistent with EPA'S overall science policy.

    Question 3. How does a 5 ppb level of exposure compare to dietary 
or organic [sic] exposures?
    Response. The NRC subcommittee referred to a study by Tao and 
Bolger (1998) that estimated daily dietary exposure to arsenic for the 
US population. (NRC p 47). The NRC subcommittee report stated, ``. . . 
if water contains 5 ug/L of arsenic and 2 L per day is consumed, the 
contribution of inorganic arsenic from diet and water are comparable.'' 
(emphasis added).
    On the premise that the submitted question is also inquiring about 
dietary exposure to organic arsenic, it should be noted that the study 
cited above assumes that the arsenic in seafood consists 10 percent of 
inorganic forms and 90 percent of organic forms. Because the average 
American diet is estimated to include some seafood, total arsenic 
consumption (sum of inorganic and organic), is expected to exceed 
intake of inorganic arsenic intake alone.

    Question 4. Do you believe that a linear application of the 
existing data on arsenic exposure levels is appropriate or do you 
believe it is likely that a threshold exists below which no adverse 
effects occur?
    Response. The NRC subcommittee report stated, ``In light of all the 
uncertainties on mode of action, the current evidence does not meet 
EPA'S stated criteria (EPA 1996) for departure from the default 
assumption of linearity in this range of extrapolation.'' (NRC, p 300). 
The range of extrapolation referred to was between the level of arsenic 
in drinking water associated with observed increases in cancer and the 
current MCL of 50 ppb.
    The NRC subcommittee stated, ``For arsenic carcinogenicity, the 
mode of action has not been established, but the several modes of 
action that are considered plausible (namely, indirect mechanisms of 
mutagenicity) would lead to a sublinear dose-response curve at some 
point below the point at which a significant increase in tumors is 
observed.'' (NRC p. 206; emphasis added). However, the committee found 
no evidence that the ``point'' where the dose-response might become 
nonlinear occurs between the current MCL of 50 ppb and the proposed MCL 
of 5 ppb. Moreover, the subcommittee noted, ``Because a specific mode 
(or modes) of action has not yet been identified, it is prudent not to 
rule out the possibility of a linear response.'' The NRC subcommittee 
could not identify a threshold for arsenic exposure below which no 
cancer risk exists. I therefore consider it appropriate that EPA 
adhered to the default assumption of linearity in developing a revised 
MCL.
                                 ______
                                 
        Responses by Michael J. Kosnett to Additional Questions 
                           from Senator Smith

    Question 1. How comfortable are you with the science that was used 
for EPA'S proposed rule compared to other proposed standards, such as 
the radon rule?
    Response. The NRC subcommittee did not compare the state of the 
science available to rulemakers for arsenic to that available to 
rulemakers for other toxic substances, such as radon.
    It is my understanding that the radon rule, like the arsenic rule, 
has been based in part on estimating the human cancer risk at low 
environmental levels by extrapolating observed human cancer risks at 
higher exposure levels. However, in the case of arsenic, the range of 
extrapolation is smaller than has been the case for radon.
    The body of scientific knowledge available to EPA in reaching a 
decision to lower the arsenic MCL is extensive. In addition to the 
material summarized in the NRC report, EPA now has available several 
very recent human epidemiological studies (from Chile, Finland, and 
Utah), that have provided additional health risk data. In particular, 
EPA now has available the new case-control study by Ferreccio C et al, 
Lung cancer and arsenic concentrations in drinking water in Chile, 
Epidemiology, 2000, in press, that supports an arsenic-related lung 
cancer risk as high or higher than estimated from the studies in 
Taiwan. Unlike regulations that are based largely on findings of animal 
studies, the health risks from arsenic have been demonstrated in human 
populations. The data base includes several epidemiological studies in 
different countries demonstrating an observed human cancer risk from 
arsenic ingestion at levels of exposure that are only one order of 
magnitude above the current MCL. In addition, in vitro (laboratory) 
studies have demonstrated a cellular effect arsenic on functions 
related to plausible carcinogenic modes of action at concentrations 
that are relevant to the current MCL. Although human arsenic metabolism 
has been the subject of many studies, none have established the 
presence of detoxification mechanisms or other in vivo factors that 
would mitigate or prevent a neoplastic effect at the current MCL of 50 
ppb, or for that matter at 5 ppb.
    In my opinion, the quality and quantity of the available scientific 
data provides a sufficient scientific basis for EPA'S recommended 
revision in the arsenic MCL.

    Question 2. Did NRC find a clear link between low levels of arsenic 
and adverse health effects?
    Response. The NRC subcommittee reported that, ``No human studies of 
sufficient statistical power or scope have examined whether consumption 
of arsenic in drinking water at the current MCL (approximately 0.001 
mg/kg per day) results in an increased incidence of cancer or noncancer 
effects.'' (NRC, p 299). The NRC subcommittee took note of several 
studies that observed very high human risks of fatal bladder and lung 
cancer at levels of arsenic exposure that were less than or equal to 1 
order of magnitude above the current MCL of 50 ppb, and less than or 
equal to 2 orders of magnitude above the proposed MCL of 5 ppb. The NRC 
subcommittee documented a number of noncancer effects of arsenic that 
have been associated with levels of human exposure less than or equal 
to one order of magnitude above the current MCL. As has been noted 
previously, the NRC subcommittee also reported that ``In vitro studies 
of the genotoxic effect of submicromolar concentrations of arsenite on 
human and animal cells, and one study of bladder cell micronuclei in 
humans with arsenic concentrations of 57 to 137 ug/L in urine indicate 
that perturbations in cellular function related to plausible modes of 
carcinogenesis might be operating at arsenic exposure concentrations 
associated with the current MCL.'' (NRC, p 300).
                               __________
 Statement of Dr. J. William Hirzy, National Treasury Employees Union 
                              Chapter 280
     Good morning Mr. Chairman and Members of the subcommittee. I 
appreciate the opportunity to appear before this subcommittee to 
present the views of the union, of which I am a Vice-President, on the 
subject of fluoridation of public water supplies.
    Our union is comprised of and represents the professional employees 
at the headquarters location of the U.S. Environmental Protection 
Agency in Washington D.C. Our members include toxicologists, 
biologists, chemists, engineers, lawyers and others defined by law as 
``professionals.'' The work we do includes evaluation of toxicity, 
exposure and economic information for management's use in formulating 
public health and environmental protection policy.
    I am not here as a representative of EPA, but rather as a 
representative of EPA headquarters professional employees, through 
their duly elected labor union. The union first got involved in this 
issue in 1985 as a matter of professional ethics. In 1997 we most 
recently voted to oppose fluoridation. Our opposition has strengthened 
since then.
Summary of Recommendations
    1) We ask that you order an independent review of a cancer bioassay 
previously mandated by Congressional committee and subsequently 
performed by Battelle Memorial Institute with appropriate blinding and 
instructions that all reviewer's independent determinations be reported 
to this committee.
    2) We ask that you order that the two waste products of the 
fertilizer industry that are now used in 90 percent of fluoridation 
programs, for which EPA states they are not able to identify any 
chronic studies, be used in any future toxicity studies, rather than a 
substitute chemical. Further, since Federal agencies are actively 
advocating that each man woman and child drink, eat and bathe in these 
chemicals, silicofluorides should be placed at the head of the list for 
establishing a MCL that complies with the Safe Drinking Water Act. This 
means that the MCL be protective of the most sensitive of our 
population, including infants, with an appropriate margin of safety for 
ingestion over an entire lifetime.
    3) We ask that you order an epidemiology study comparing children 
with dental fluorosis to those not displaying overdose during growth 
and development years for behavioral and other disorders.
    4) We ask that you convene a joint Congressional Committee to give 
the only substance that is being mandated for ingestion throughout this 
country the full hearing that it deserves.
National Review of Fluoridation
    The subcommittee's hearing today can only begin to get at the 
issues surrounding the policy of water fluoridation in the United 
States, a massive experiment that has been run on the American public, 
without informed consent, for over 50 years. The last Congressional 
hearings on this subject were held in 1977. Much knowledge has been 
gained in the intervening years. It is high time for a national review 
of this policy by a Joint Select Committee of Congress. New hearings 
should explore, at minimum, these points:
      1) excessive and un-controlled fluoride exposures;
      2) altered findings of a cancer bioassay;
      3) the results and implications of recent brain effects 
research;
      4) the ``protected pollutant'' status of fluoride within 
EPA;
      5) the altered recommendations to EPA of a 1983 Surgeon 
General's Panel on fluoride;
      6) the results of a fifty-year experiment on fluoridation 
in two New York communities;
      7) the findings of fact in three landmark lawsuits since 
1978;
      8) the findings and implications of recent research 
linking the predominant fluoridation chemical with elevated blood-lead 
levels in children and anti-social behavior; and
      9) changing views among dental researchers on the 
efficacy of water fluoridation
Fluoride Exposures Are Excessive and Un-controlled
    According to a study by the National Institute of Dental Research, 
66 percent of America's children in fluoridated communities show the 
visible sign of over-exposure and fluoride toxicity, dental fluorosis. 
\1\ That result is from a survey done in the mid-1980's and the figure 
today is undoubtedly much higher.
---------------------------------------------------------------------------
     \1\Dental caries and dental fluorosis at varying water fluoride 
concentrations. Heller, K.E, Eklund, S.A. and Burt, B.A. J. Pub. Health 
Dent. 57 136-43 (1997).
---------------------------------------------------------------------------
    Centers for Disease Control and EPA claim that dental fluorosis is 
only a ``cosmetic'' effect. God did not create humans with fluorosed 
teeth. That effect occurs when children ingest more fluoride than their 
bodies can handle with the metabolic processes we were born with, and 
their teeth are damaged as a result. And not only their teeth. 
Children's bones and other tissues, as well as their developing teeth 
are accumulating too much fluoride. We can see the effect on teeth. Few 
researchers, if any, are looking for the effects of excessive fluoride 
exposure on bone and other tissues in American children. What has been 
reported so far in this connection is disturbing. One example is 
epidemiological evidence \2\ showing elevated bone cancer in young men 
related to consumption of fluoridated drinking water.
---------------------------------------------------------------------------
    \2\ A brief report on the association of drinking water 
fluoridation and the incidence of osteosarcoma among young males. Cohn, 
P.D. New Jersey Department of Health (1992).
    Time trends for bone and joint cancers and osteosarcomas in the 
Surveillance, Epidemiology and End Results (SEER) Program. National 
Cancer Institute. In: Review of fluoride: benefits and risks. 
Department of Health and Human Services. 1991: F1-F7.
---------------------------------------------------------------------------
    Without trying to ascribe a cause and effect relationship 
beforehand, we do know that American children in large numbers are 
afflicted with hyperactivity-attention deficit disorder, that autism 
seems to be on the rise, that bone fractures in young athletes and 
military personnel are on the rise, that earlier onset of puberty in 
young women is occurring. There are biologically plausible mechanisms 
described in peer-reviewed research on fluoride that can link some of 
these effects to fluoride exposures. \3\ \4\ \5\ \6\ Considering the 
economic and human costs of these conditions, we believe that Congress 
should order epidemiology studies that use dental fluorosis as an index 
of exposure to determine if there are links between such effects and 
fluoride over-exposure.
---------------------------------------------------------------------------
    \3\ Neurotoxicity of sodium fluoride in rats. Mullenix, P.J., 
Denbesten, P.K., Schunior, A. and Kernan, W.J. Neurotoxicol. Teratol. 
17 169-177 (1995)
    \4\ Fluoride and bone--quantity versus quality [editorial] N. Engl. 
J. Med. 322 845-6 (1990)
    Summary of workshop on drinking water fluoride influence on hip 
fracture and bone health. Gordon, S.L. and Corbin, S.B. Natl. Inst. 
Health. April 10, 1991.
    \5\ Effect of fluoride on the physiology of the pineal gland. Luke, 
J.A. Caries Research 28 204 (1994).
    \6\ Newburgh-Kingston caries-fluorine study XIII. Pediatric 
findings after 10 years. Schlesinger, E.R., Overton, D.E., Chase, H.C., 
and Cantwell, K.T. JADA 52 296-306 (1956).
---------------------------------------------------------------------------
    In the interim, while this epidemiology is conducted, we believe 
that a national moratorium on water fluoridation should be instituted. 
There will be a hue and cry from some quarters, predicting increased 
dental caries, but Europe has about the same rate of dental caries as 
the U.S. \7\ and most European countries do not fluoridate. \8\ I am 
submitting letters from European and Asian authorities on this point. 
There are studies in the U.S. of localities that have interrupted 
fluoridation with no discernable increase in dental caries rates. \9\ 
And people who want the freedom of choice to continue to ingest 
fluoride can do so by other means.
---------------------------------------------------------------------------
    \7\ WHO oral health country/area profile programme. Department of 
Non-Communicable Diseases Surveillance/Oral Health. WHO Collaborating 
Centre, Malmo University, Sweden. URL: www.whocollab.odont.lu.se/
countriesalphab.html
    \8\ Letters from government authorities in response to inquiries on 
fluoridation status by E. Albright. Eugene Albright: contact through J. 
W. Hirzy, P.O. Box 76082, Washington, D.C. 20013.
    \9\ The effects of a break in water fluoridation on the development 
of dental caries and fluorosis. Burt B.A., Keels ., Heller KE. J. Dent. 
Res. 2000 Feb;79(2):761-9.
---------------------------------------------------------------------------
Cancer Bioassay Findings
    In 1990, the results of the National Toxicology Program cancer 
bioassay on sodium fluoride were published,\10\ the initial findings of 
which would have ended fluoridation. But a special commission was 
hastily convened to review the findings, resulting in the salvation of 
fluoridation through systematic down-grading of the evidence of 
carcinogenicity. The final, published version of the NTP report says 
that there is, ``equivocal evidence of carcinogenicity in male rats,'' 
changed from ``clear evidence of carcinogenicity in male rats.''
---------------------------------------------------------------------------
    \10\ Toxicology and carcinogenesis studies of sodium fluoride in 
F344/N rats and B6C3F1 mice. NTP Report No. 393 (1991).
---------------------------------------------------------------------------
    The change prompted Dr. William Marcus, who was then Senior Science 
Adviser and Toxicologist in the Office of Drinking Water, to blow the 
whistle about the issue, which led to his firing by EPA. Dr. Marcus 
sued EPA, won his case and was reinstated with back pay, benefits and 
compensatory damages. I am submitting material from Dr. Marcus to the 
subcommittee dealing with the cancer and neurotoxicity risks posed by 
fluoridation.
    We believe the subcommittee should call for an independent review 
of the tumor slides from the bioassay, as was called for by Dr. Marcus, 
with the results to be presented in a hearing before a Select Committee 
of the Congress. The scientists who conducted the original study, the 
original reviewers of the study, and the ``review commission'' members 
should be called, and an explanation given for the changed findings.
Brain Effects Research
    Since 1994 there have been six publications that link fluoride 
exposure to direct adverse effects on the brain. Two epidemiology 
studies from China indicate depression of I.Q. in children. \11\ \12\ 
Another paper (see footnote 3 above) shows a link between prenatal 
exposure of animals to fluoride and subsequent birth of off-spring 
which are hyperactive throughout life. A 1998 paper shows brain and 
kidney damage in animals given the ``optimal'' dosage of fluoride, viz. 
one part per million. \13\ And another \14\ shows decreased levels of a 
key substance in the brain that may explain the results in the other 
paper from that journal. Another publication (see footnote 5 above) 
links fluoride dosing to adverse effects on the brain's pineal gland 
and pre-mature onset of sexual maturity in animals. Earlier onset of 
menstruation of girls in fluoridated Newburg, New York has also been 
reported (see footnote 6 above).
---------------------------------------------------------------------------
    \11\ Effect of high fluoride water supply on children's 
intelligence. Zhao, L.B., Liang, G.H., Zhang, D.N., and Wu, X.R. 
Fluoride 29 190-192 (1996).
    12. Effect of fluoride exposure on intelligence in children. Li, 
X.S., Zhi, J.L., and Gao, R.O. Fluoride 28 (1995).
    \13\ Chronic administration of aluminum-fluoride or sodium-fluoride 
to rats in drinking water: alterations in neuronal and cerebrovascular 
integrity. Varner, J.A., Jensen, K.F., Horvath, W. And Isaacson, R.L. 
Brain Research 784 284-298 (1998).
    \14\ Influence of chronic fluorosis on membrane lipids in rat 
brain. Z.Z. Guan, Y.N. Wang, K.Q. Xiao, D.Y. Dai, Y.H. Chen, J.L. Liu, 
P. Sindelar and G. Dallner, Neurotoxicology and Teratology 20 537-542 
(1998).
---------------------------------------------------------------------------
    Given the national concern over incidence of attention deficit-
hyperactivity disorder and autism in our children, we believe that the 
authors of these studies should be called before a Select Committee, 
along with those who have critiqued their studies, so the American 
public and the Congress can understand the implications of this work.
Fluoride as a Protected Pollutant
    The classic example of EPA's protective treatment of this 
substance, recognized the world over and in the U.S. before the 
linguistic de-toxification campaign of the 1940's and 1950's as a major 
environmental pollutant, is the 1983 statement by EPA's then Deputy 
Assistant Administrator for Water, Rebecca Hanmer, \15\ that EPA views 
the use of hydrofluosilicic acid recovered from the waste stream of 
phosphate fertilizer manufacture as,
---------------------------------------------------------------------------
    \15\ Letter from Rebecca Hanmer, Deputy Assistant Administrator for 
Water, to Leslie Russell re: EPA view on use of by-product fluosilicic 
(sic) acid as low cost source of fluoride to water authorities. March 
30, 1983.
---------------------------------------------------------------------------
    ``. . . an ideal solution to a long standing problem. By recovering 
by-product fluosilicic acid (sic) from fertilizer manufacturing, water 
and air pollution are minimized, and water authorities have a low-cost 
source of fluoride. . . ''
    In other words, the solution to pollution is dilution, as long as 
the pollutant is dumped straight into drinking water systems and not 
into rivers or the atmosphere. I am submitting a copy of her letter.
    Other Federal entities are also protective of fluoride. Congressman 
Calvert of the House Science Committee has sent letters of inquiry to 
EPA and other Federal entities on the matter of fluoride, answers to 
which have not yet been received.
    We believe that EPA and other Federal officials should be called to 
testify on the manner in which fluoride has been protected. The union 
will be happy to assist the Congress in identifying targets for an 
inquiry. For instance, hydrofluosilicic acid does not appear on the 
Toxic Release Inventory list of chemicals, and there is a remarkable 
discrepancy among the Maximum Contaminant Levels for fluoride, arsenic 
and lead, given the relative toxicities of these substances. Surgeon 
General's Panel on Fluoride We believe that EPA staff and managers 
should be called to testify, along with members of the 1983 Surgeon 
General's panel and officials of the Department of Human Services, to 
explain how the original recommendations of the Surgeon General's panel 
\16\ were altered to allow EPA to set otherwise unjustifiable drinking 
water standards for fluoride.
---------------------------------------------------------------------------
    \16\ Transcript of proceedings--Surgeon General's (Koop) ad hoc 
committee on non-dental effects of fluoride. April 18-19, 1983. 
National Institutes of Health. Bethesda, MD.
---------------------------------------------------------------------------
Kingston and Newburg, New York Results
    In 1998, the results of a fifty-year fluoridation experiment 
involving Kingston, New York (un-fluoridated) and Newburg, New York 
(fluoridated) were published. \17\ In summary, there is no overall 
significant difference in rates of dental decay in children in the two 
cities, but children in the fluoridated city show significantly higher 
rates of dental fluorosis than children in the un-fluoridated city.
---------------------------------------------------------------------------
    \17\ Recommendations for fluoride use in children. Kumar, J.V. and 
Green, E.L. New York State Dent. J. (1998) 40-47.
---------------------------------------------------------------------------
    We believe that the authors of this study and representatives of 
the Centers For Disease Control and EPA should be called before a 
Select Committee to explain the increase in dental fluorosis among 
American children and the implications of that increase for skeletal 
and other effects as the children mature, including bone cancer, stress 
fractures and arthritis.
Findings of Fact by Judges
    In three landmark cases adjudicated since 1978 in Pennsylvania, 
Illinois and Texas, \18\ judges with no interest except finding fact 
and administering justice heard prolonged testimony from proponents and 
opponents of fluoridation and made dispassionate findings of fact. I 
cite one such instance here.
---------------------------------------------------------------------------
    \18\ Highlights in North American litigation during the twentieth 
century on artificial fluoridation of public water supplies. Graham, 
J.R. and Morin, P. Journal of Land Use and Environmental Law 14 195-248 
(Spring 1999) Florida State University College of Law.
---------------------------------------------------------------------------
    In November, 1978, Judge John Flaherty, now Chief Justice of the 
Supreme Court of Pennsylvania, issued findings in the case, Aitkenhead 
v. Borough of West View, tried before him in the Allegheny Court of 
Common Pleas. Testimony in the case filled 2800 transcript pages and 
fully elucidated the benefits and risks of water fluoridation as 
understood in 1978. Judge Flaherty issued an injunction against 
fluoridation in the case, but the injunction was overturned on 
jurisdictional grounds. His findings of fact were not disturbed by 
appellate action. Judge Flaherty, in a July, 1979 letter to the Mayor 
of Aukland New Zealand wrote the following about the case:
    ``In my view, the evidence is quite convincing that the addition of 
sodium fluoride to the public water supply at one part per million is 
extremely deleterious to the human body, and, a review of the evidence 
will disclose that there was no convincing evidence to the contrary. . 
 
    ``Prior to hearing this case, I gave the matter of fluoridation 
little, if any, thought, but I received quite an education, and noted 
that the proponents of fluoridation do nothing more than try to impune 
(sic) the objectivity of those who oppose fluoridation.''
    In the Illinois decision, Judge Ronald Niemann concludes: ``This 
record is barren of any credible and reputable scientific 
epidemiological studies and or analysis of statistical data which would 
support the Illinois Legislature's determination that fluoridation of 
the water supplies is both a safe and effective means of promoting 
public health.''
    Judge Anthony Farris in Texas found: ``[That] the artificial 
fluoridation of public water supplies, such as contemplated by 
(Houston) City ordinance No. 80-2530 may cause or contribute to the 
cause of cancer, genetic damage, intolerant reactions, and chronic 
toxicity, including dental mottling, in man; that the said artificial 
fluoridation may aggravate malnutrition and existing illness in man; 
and that the value of said artificial fluoridation is in some doubt as 
to reduction of tooth decay in man.''
    The significance of Judge Flaherty's statement and his and the 
other two judges' findings of fact is this: proponents of fluoridation 
are fond of reciting endorsement statements by authorities, such as 
those by CDC and the American Dental Association, both of which have 
long-standing commitments that are hard if not impossible to recant, on 
the safety and efficacy of fluoridation. Now come three truly 
independent servants of justice, the judges in these three cases, and 
they find that fluoridation of water supplies is not justified.
    Proponents of fluoridation are absolutely right about one thing: 
there is no real controversy about fluoridation when the facts are 
heard by an open mind.
    I am submitting a copy of the excerpted letter from Judge Flaherty 
and another letter referenced in it that was sent to Judge Flaherty by 
Dr. Peter Sammartino, then Chancellor of Fairleigh Dickenson 
University. I am also submitting a reprint copy of an article in the 
Spring 1999 issue of the Florida State University Journal of Land Use 
and Environmental Law by Jack Graham and Dr. Pierre Morin, titled 
``Highlights in North American Litigation During the Twentieth Century 
on Artificial Fluoridation of Public Water. Mr. Graham was chief 
litigator in the case before Judge Flaherty and in the other two cases 
(in Illinois and Texas).
    We believe that Mr. Graham should be called before a Select 
Committee along with, if appropriate, the judges in these three cases 
who could relate their experience as trial judges in these cases.
Hydrofluosilicic Acid
    There are no chronic toxicity data on the predominant chemical, 
hydrofluosilicic acid and its sodium salt, used to fluoridate American 
communities. Newly published studies \19\ indicate a link between use 
of these chemicals and elevated level of lead in children's blood and 
anti-social behavior. Material from the authors of these studies has 
been submitted by them independently.
---------------------------------------------------------------------------
    \19\ Water treatment with silicofluorides and lead toxicity. 
Masters, R.D. and Coplan, M.J. Intern. J. Environ. Studies 56 435-49 
(1999).
---------------------------------------------------------------------------
    We believe the authors of these papers and their critics should be 
called before a Select Committee to explain to you and the American 
people what these papers mean for continuation of the policy of 
fluoridation.
Changing Views on Efficacy and Risk
    In recent years, two prominent dental researchers who were leaders 
of the pro-fluoridation movement announced reversals of their former 
positions because they concluded that water fluoridation is not an 
effective means of reducing dental caries and that it poses serious 
risks to human health. The late Dr. John Colquhoun was Principal Dental 
Officer of Aukland, New Zealand, and he published his reasons for 
changing sides in 1997. \20\ In 1999, Dr. Hardy Limeback, Head of 
Preventive Dentistry, University of Toronto, announced his change of 
views, then published a statement \21\ dated April 2000. I am 
submitting a copy of Dr. Limeback's publications.
---------------------------------------------------------------------------
    \20\ Why I changed my mind about water fluoridation. Colquhoun, J. 
Perspectives in Biol. And Medicine 41 1-16 (1997).
    \21\ Letter. Limeback, H. April 2000. Faculty of Dentistry, 
University of Toronto.
---------------------------------------------------------------------------
    We believe that Dr. Limeback, along with fluoridation proponents 
who have not changed their minds, such as Drs. Ernest Newbrun and 
Herschel Horowitz, should be called before a Select Committee to 
testify on the reasons for their respective positions.
    Thank you for you consideration, and I will be happy to take 
questions.



[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


                                 ______
                                 
         Responses by J. William Hirzy to Additional Questions 
                           from Senator Crapo
    Question 1. If Federal and State regulatory agencies do not 
prohibit it, is it appropriate for communities to make the 
determination about whether to fluoridate water?
    Response. Since fluoride delivered in drinking water is intended to 
alter bodily function by changing the structure and composition of a 
body part, the teeth, it clearly is a drug. (It also unintentionally 
changes the structure and composition of bone.) For a community to 
require each and every citizen to take a drug, with no control over 
dose, with no acknowledgment or accommodation for citizens who may have 
adverse effects from the drug, and for the purpose of allegedly 
minimizing (and not preventing), a non-communicable, non-life 
threatening condition, is fundamentally wrong.
    Vaccination against communicable, serious and/or life threatening 
conditions, even in the face of objections from some of the vaccinated, 
is often cited by proponents of fluoridation as a public health analogy 
that addresses the question of acquiescence of the drug-treated 
citizen. The analogy is flawed for many reasons, not the least of which 
are: 1) the types of conditions prevented by vaccination; and 2) the 
virtual absence of controversy over effectiveness.
    Of the advanced nations that do not fluoridate, Belgium, Germany, 
Japan, Luxembourg, the Netherlands and Norway have stated clearly that 
one reason for not doing so is the violation of individual rights 
inherent in forcing medication on the entire population through their 
public water supplies.
    In many communities, the issue of fluoridation is, indeed, put to 
the community through referendum. What invariably occurs in these cases 
is that the Federal Government applies enormous and disproportionate 
influence on the referendum. Money appropriated by Congress to the 
Department of Health and Human Services is offered through the Public 
Health Service and Centers For Disease Control as fluoridation grants. 
These agencies send in speakers, and flood the local media--which often 
refuse to even acknowledge existence of opposition, let alone grant 
``equal time''--with pro-fluoride messages. The American Dental 
Association sends in its hired guns to protect that organization's 
institutional reputation (and tort liability) through speaking 
engagements where opponents are pilloried and ridiculed. Such referenda 
become battles between citizens, who want nothing more than to drink 
pure water from their taps, and institutions whose interest is in 
perpetuating and expanding fluoridation and whose resources are 
virtually limitless and--ironically--drawn in large measure from taxes 
on those in opposition.
    If communities are to be saddled with the ethically inappropriate 
task of deciding whether to medicate all its citizens, then provision 
for informed decisionmaking must be made, including decisions on the 
ethical issues. This is not a partisan political debate in which 
campaign finance limits and the First Amendment collide. Rather, this 
is a matter of public health policy in which a full, open and thorough 
exposition of the issues is clearly required in the public interest.
    There is hardly a more appropriate role for Congress to play in 
such case than to provide a record on the pros and cons of fluoridation 
through a full airing of this subject. I call again, as I did in my 
testimony on June 29, 2000, for Congress to provide a forum for 
developing that record.

    Question 2. It has been widely asserted that declining dental decay 
rates in North America are attributable largely to fluoridation and 
also generally improved dental health practices by the public. To what 
do you primarily attribute the improved dental health status in the 
United States?
    Response. There is virtually no dispute, even among those who are 
concerned by the uncontrolled and increasing exposure of the public to 
fluoride, that fluoridated tooth pastes are effective in decreasing 
dental decay by interfering with the metabolic processes of 
Streptococcus mutans, the organism chiefly responsible for dental 
decay. This effect occurs because of the high concentration of fluoride 
(generally about 0.15 percent w/w) in those tooth pastes. In addition, 
better diet and better dental hygiene in general are factors in 
deceased dental decay rates in the U.S. Some of the more convincing 
data come from the 50-year experiment at Kingston and Newburgh, New 
York. These show that the un-fluoridated city of Kingston has, in fact, 
a small advantage in dental decay rates among children over the 
fluoridated city of Newburgh. Furthermore, the data collected during 
the 1986-7 national survey of 39,000 U.S. school children show that a 
community's fluoridation status plays no role in determining the 
percentage of caries-free children or the ranking of the community 
using the Decayed, Missing and Filled permanent teeth index.
    As health and public utility officials in many of the countries of 
the world that do not fluoridate have gone on record saying, there are 
more effective, less ethically troubling and safer ways of taking 
advantage of the fluoride ion's cariostatic propensity than putting it 
in the public water supply.

    Question 3. Is the appearance of dental fluorosis always 
symptomatic of too much exposure to fluoride? If so, can this be traced 
to additives in water, fluoride pills, or fluoride in dental products?
    Response. By definition, the appearance of dental fluorosis is 
symptomatic of over-exposure to fluoride. All sources of fluoride taken 
into the body (including, e.g. inhalation) contribute to the body 
burden of fluoride. In addition to the sources about which you inquire, 
foods and beverages containing fluoride from fluoridated process water 
and pesticide residues contribute to the body burden of fluoride.
    There is a wealth of literature on the relative contributions by 
these various sources to the body burden of fluoride. But, once again, 
the striking simplicity of the summary data from the Kingston-Newburgh 
experiment are revealing. In non-fluoridated Kingston, in 1995, the 
prevalence of dental fluorosis in children aged 7-14 years was 11.5 
percent, and in fluoridated Newburgh the prevalence was 18. . 5 
percent. In 1955, 10 years after the start of the experiment, the data 
were 0.0 percent fluorosis in Kingston and 7.3 percent in Newburgh.
    Proponents like to argue that fluorosis arises from abuse of tooth 
paste and/or fluoride supplement tablets. But it is not defensible to 
argue that such abuse is greater across the population of children in 
Newburgh than it is in Kingston, and that the difference in fluoride 
exposures due to drinking/cooking water is only a minor factor--across 
a time span of forty-five years.

    Question 4. It is the subcommittee's understanding that national 
data on the costs of correcting fluorosis are not available; national 
data on the costs of bonding (a corrective treatment for fluorosis and 
other conditions) do not include information on the purpose for the 
bonding. Do you have any information regarding the amount of bonding 
that is done to correct for dental fluorosis?
    Response. I do not have information on the amount of bonding that 
is done to correct for dental fluorosis. Representative Calvert, 
Chairman of the Subcommittee on Energy and Environment, posed a closely 
related question to Jeffrey Koplan, Director of the Centers For Disease 
Control, and perhaps when Mr. Koplan responds information on that 
subject may be forthcoming. I am aware that Dr. Hardy Limeback, Head of 
the Preventive Dentistry Department, University of Toronto, is 
interested in this subject and has carried out research this field. He 
may be a source of information. He may be reached via e-mail at 

    Once again, thank you for considering this important public health 
question and for starting a process that many health professionals hope 
will culminate in a full Congressional hearing on fluoridation as soon 
as possible.
    Those of us who are very worried about the growing, uncontrolled 
exposures to fluoride also hope that the Federal Government will soon 
take corrective action, such as a Congressional ban on the distribution 
of fluoride through the Nation's public water supplies.
                               __________
Statement of Erik D. Olson, Senior Attorney, Natural Resources Defense 
                                Council
    Good morning, I am Erik D. Olson, a Senior Attorney at the Natural 
Resources Defense Council (NRDC), a national non-profit public interest 
organization dedicated to protecting public health and the environment. 
We have over 400,000 members nationwide. We appreciate the opportunity 
to testify today on the implementation of the Safe Drinking Water Act.
    Drinking water treatment improvements at the turn of the 20th 
Century advanced public health protection enormously. Much of the 
nation's drinking water infrastructure, however, has aged, is outdated, 
and is simply inadequate. We must modernize our water systems to 
safeguard the nation's water supplies from new and emerging 
contaminants and the pressure of increased population.
    While EPA has estimated that the costs of modernization will exceed 
$138 billion dollars, many in state and local governments, in the water 
industry, and the public health and environmental communities believe 
the true costs of this needed massive upgrade will be many times 
higher. For example, a report published in March 2000 by a coalition of 
state and local governments, the water industry, and a water 
professional trade association called the Water Infrastructure Network 
(WIN) estimated that the cost of updating our water systems would 
significantly exceed previous estimates. Specifically, the WIN report 
found that building new and replacing old drinking water facilities 
will cost $480 billion dollars (including finance costs) over the next 
20 years, and that about $1 trillion dollars is needed for capital, 
financing, operation and maintenance of the facilities over that 
period. Consequently, the WIN investigators concluded that there is a 
funding gap of about $15 billion per year for drinking water 
infrastructure, operation, and maintenance. Most of these expenses, 
however, are expected to be necessary irrespective of Safe Drinking 
Water Act regulatory requirements. Aging pipes in distribution systems, 
antiquated water treatment plants, water professionals' recognition of 
the need for infrastructure improvements, public demands for improved 
water quality, taste, odor, and reliability, growth, and other factors 
will all drive this investment. While most of these costs will be 
incurred with or without new EPA regulations, clearly many improvements 
will be necessary in water treatment and distribution systems in order 
to meet modern demands for safer tap water. Major new public 
investments will be needed to fund this important national priority and 
significant research initiatives are necessary to support and guide 
this modernization.
    The United States and drinking water suppliers in other developed 
nations' have begun a ``Third Revolution'' in drinking water provision. 
The WIN report recognized this revolution as requiring greater 
financing. The ``First Revolution'' occurred when water was initially 
captured, stored, and channeled or piped for household drinking and 
other uses. This important advance began in pre-biblical times in 
Sumaria and other parts of the Middle East, and was expanded and 
refined by the Roman Empire. The ``Second Revolution'' was triggered by 
the steady march forward of medical science, the acceptance of the 
``germ theory'' of disease, and the leadership of public health 
proponents such as John Snow who, in 1849, linked the London cholera 
outbreaks to water supplies. This knowledge led to the development of 
treatment and disinfection techniques such as coagulation, 
sedimentation, filtration, and ultimately, chlorination. These 
processes were installed by many major water suppliers beginning in the 
19th Century and leading to widespread adoption by the first World War. 
These technologies have resulted in enormous public health benefits, 
and have been hailed by the Centers for Disease Control and Prevention 
(CDC) as one of the greatest triumphs of public health protection in 
the 20th Century.
    The ``Third Revolution'' in drinking water provision has now been 
launched by utilities in the U.S. and Europe. This revolution is marked 
by the culmination and synthesis of the ``multiple barriers'' approach 
to preventing disease from drinking water that had long been advocated 
by Abel Wolman and other 20th Century water industry leaders. In 
essence, the Third Revolution consists of a three-pronged approach to 
modern drinking water protection: (1) vigorous measures to prevent 
contamination of drinking water, through source water protection 
actions; (2) adoption of modern, highly effective, and broad-spectrum 
water treatment technologies that can remove a wide array of emerging 
contaminants simultaneously, such as membranes, ultraviolet radiation 
disinfection, and granular activated carbon with ozone disinfection; 
and, (3) the modernization of aging water distribution systems, 
sometimes over a century old, that often contain lead, frequently cause 
main breaks, harbor microbial growth, and, according to the CDC, are a 
significant cause of waterborne disease outbreaks.
    Among the challenges now facing the water industry are:
1. Arsenic
    The National Academy of Sciences, in a report issued in 1999, 
recognized that arsenic in tap water poses a significant public health 
risk in the United States, and that EPA's outdated tap water standard 
for arsenic, which was set in 1942, ``does not achieve EPA's goal for 
public health protection and, therefore, requires downward revision as 
promptly as possible.'' The Academy concluded that drinking water 
containing arsenic at the 50 parts per billion (ppb) level allowed by 
the outdated current standard ``could easily'' pose a total cancer risk 
of 1 in 100 about 100 times higher than EPA would ever allow for tap 
water under other rules. For the sake of comparison, the cancer risk 
allowed by this arsenic standard is about 10,000 times higher than the 
risk EPA may permit in food under the Food Quality Protection Act of 
1996, which Congress passed unanimously. The Academy also found that 
there was an insufficient basis to find a threshold for arsenic 
carcinogenesis, and that there was no credible evidence that arsenic 
was a necessary nutrient in humans. Moreover, the Academy discussed a 
litany of other adverse non-cancer health effects from arsenic in tap 
water, including cardiovascular effects, nervous system problems, skin 
lesions, possible reproductive harms and other effects. Several peer-
reviewed, published studies completed in the year since the Academy's 
report have reinforced the conclusion that a much lower standard for 
arsenic in tap water is needed to protect public health. For example, a 
recently published study showed increased cancer rates in Finland among 
persons who consumed low levels of arsenic (below 5 ppb). Most 
recently, three studies published in the July 2000 issue of the 
National Institutes of Health's journal, Environmental Health 
Perspectives, found that arsenic in drinking water is linked to skin 
problems and other adverse health effects even in well-nourished 
populations. Additionally, the studies link the presence of arsenic in 
tap water to certain reproductive problems in exposed women, and 
increased cancer risks.
    Last week EPA published a proposal to reduce allowable arsenic 
levels from 50 ppb down to 5 ppb a level that still presents a cancer 
risk higher than the 1 in 10,000 cancer risk that EPA traditionally 
allows in tap water. NRDC, along with many public health professionals 
and organizations, believe that EPA should set the standard at 3 ppb, 
the level that EPA says is closest to the health goal (Maximum 
Contaminant Level Goal) and is practical, economically feasible and 
affordable.
2. Radon
    Currently, radon in tap water poses significant cancer risks to 
over 40 million Americans. Another National Academy of Sciences report, 
issued last year, found that radon is known to cause cancer, and 
concluded that a multimedia mitigation strategy should be pursued to 
deal with the radon problem. The Academy found that while radon can be 
present in tap water at levels posing substantial risks, generally the 
vast majority of risks from radon comes from radon seepage into homes 
from soils.
    Congress enacted a provision in the 1996 Safe Drinking Water Act 
Amendments that allows states or water systems to adopt Multimedia 
Mitigation (MMM) programs for radon that focus on the highest indoor 
radon risks. States and public water systems with approved MMM programs 
do not need to assure compliance with the Maximum Contaminant Level for 
radon in tap water. Instead, they can meet a less stringent 
``Alternative Maximum Contaminant Level'' (AMCL), because they will be 
providing greater public health benefits by reducing the overall indoor 
radon levels through the MMM program than through achieving the MCL for 
tap water. EPA's proposed rule for implementing this provision could 
prove to be an important step toward protecting public health from 
radon, if it can assure that the MMM programs actually will achieve the 
public health benefits billed.
3. Cryptosporidium, Other Microbial Risks, and Disinfection Byproducts
    EPA has engaged in a lengthy, multi-stage process of negotiations 
over the past 8 years with the water industry, states, local 
government, water treatment trade associations, public health groups, 
and environmental organizations in an effort to tackle the complex 
issue of microbial contaminants and disinfection byproducts. These 
negotiations have wrestled with how to control the parasite 
Cryptosporidium (which made over 400,000 people ill and killed over 100 
in Milwaukee in 1993, and has led to many smaller outbreaks since 
1993).
    The negotiations also have sought to improve protection from the 
class of contaminants known as disinfection byproducts, which are 
created when chemicals such as chlorine are used to disinfect water. 
The chemical reactions between the disinfectant and organic matter in 
the water create unwanted byproducts, which are a potentially toxic 
soup of chemicals that have been linked in both animal studies and 
human epidemiological studies to certain forms of cancer and 
reproductive problems such as miscarriages and birth defects. We are 
now in the midst of serious negotiations over the ``Stage 2'' 
disinfection byproduct rules, and the ``Long Term 2'' rule for surface 
water treatment. A proposed rule is anticipated in early or mid-2001.
4. Groundwater Rule
    In the 1996 amendments, Congress charged the EPA with issuing a 
rule requiring that groundwater supplied public water systems disinfect 
their drinking water, unless such disinfection were to be found 
unnecessary. EPA recently has proposed a groundwater rule, which is now 
open for public comment. NRDC has begun to review the proposal and 
while we believe that the proposal includes several important measures 
that may improve public health protection, it also has several 
fundamental flaws that will need to be fixed to prevent the rule from 
becoming bogged down at the state level and not being implemented.
    The 1996 SDWA Amendments encourage better health protection, and 
the EPA should be commended for the using a generally open public 
process to implement the majority of this law. Several other important 
challenges remain:
       Appropriations Acts and a Court Decision Have 
Effectively Eliminated the Drinking Water State Revolving Fund (DWSRF) 
Set-Aside for Health Effects Research, Undercutting Funding Assurances.
    This committee and the 1996 SDWA Amendments adopted a provision in 
the DWSRF ensuring $10 million set-aside for health effects research, 
SDWA .1453(n). The appropriations committees, however, have included 
provisions purporting to negate this set-aside in the last several 
appropriations acts. Unfortunately, a court decision reached with the 
support of the EPA effectively found that the appropriations language 
overrode the set-aside in the Act. Thus, this committee's effort to 
assure long-term funding of this research has been nullified by 
subsequent Congressional action. This committee should fight for the 
full set-aside for this research.
       A Forum for Open Public Research Planning and Priority 
Setting is Necessary.
    EPA should formalize an open public process for developing its 
drinking water research plans, similar to the highly successful 
Microbial and Disinfection Byproducts Council, but with additional 
assurances of public comment and openness. This is a far more effective 
approach than the largely closed-door process EPA used in planning its 
arsenic research, for example.
       A Modest, Dedicated Water Fee, Allocated to a Trust Fund 
Without Further Appropriation, is Needed to Support Long-Term Drinking 
Water Research and to Address High Priority Health Risks for Small 
Systems.
    As part of a series of discussions with the water industry and 
others, NRDC and many in the public interest community (and frankly, 
even some in the industry), have come to the conclusion that Congress 
should enact a modest water fee to support a long-term guarantee of 
adequate research funding for drinking water. The funds raised should 
be set aside in a trust fund that is available without needing further 
appropriations. This would prevent the research agenda from being 
buffeted by the ever-changing winds of the annual appropriations 
process. In addition, we believe that those funds should be made 
available for direct funding of the most substantial public health 
threats posed by drinking water systems, such as grants for emergency 
repairs, treatment, or consolidation of small systems with serious 
health standard violations.
       The Need for a National Dialogue on How to Fund the 
Massive Funding Gap for Drinking Water Infrastructure Improvement and 
Modernization.
    The massive shortfall in resources available for water systems to 
upgrade, replace, and expand their infrastructure is a problem that 
must be addressed. NRDC believes there is a serious need for a national 
dialog on how this funding gap will be addressed. While certainly 
Federal funding will not itself plug this massive hole, the time has 
come for a serious discussion of what the respective Federal, state, 
and local governmental roles are, and what role private industry might 
play in this overhaul. We believe that there is a need for Federal 
leadership on this issue, and for significantly increased Federal 
resources to be dedicated to this crucially important national need.
       Other Research Needs: Assuring More Effective Public 
Right-to-Know, Better Source Protection, More Affordable Advanced 
Treatment Technologies, Better Analytical Methods, and Improved Small 
System Management, Restructuring, and Treatment.
    EPA needs to conduct further research about how to build public 
understanding of tap water challenges. The EPA right-to-know report 
rules issued in 1998 that required the first reports to be issued to 
consumers by October 1999, and subsequent annual reports every July, 
starting July 2000 (next month), are a major step forward. It is 
critical, however, that methods be developed to improve public 
understanding of these complex issues. Other important areas of 
research include: investigations into ways in which source water 
protection can be made a more effective tool for drinking water 
protection; research on how modern treatment methods can be improved 
and costs decreased; development of better, cheaper, and easier 
analytical methods; and improved approaches to assuring small system 
compliance through restructuring or treatment upgrades.
       Research to Support Treatment, Occurrence, and Related 
Issues for Microbes, Disinfection Byproducts, Groundwater, and 
Distribution System Risks.
    New standards will be issued over the next several years for many 
contaminants, yet EPA resources for research on the availability of 
treatment and occurrences are inadequate. These rules will be 
determinative as to whether the ``Third Revolution'' in drinking water 
protection involving true multiple barriers to contamination in the 
form of source water protection, advanced ``leap frog'' treatment 
technologies, and modern distribution system management will occur in 
the early 21st Century, or whether the nation's aging and often 
outdated water supplies will continue to inadequately address these 
emerging problems and to deteriorate. A stronger research commitment is 
needed.
       Compliance Problems that Continue to Plague the Drinking 
Water Program. Widespread violations of the SDWA, and inadequate state 
and EPA enforcement against even the most recalcitrant violators 
continue to be a major problem.
    Improved data collection and management and a stronger commitment 
to enforcement are crucial to assist EPA, states, and the public to 
address these issues. Compliance problems and data collection and 
management failures have been catalogued in a USA Today series 
published in October 1998, in a recent EPA audit discussed in a front 
page USA Today article in late 1999, and in EPA's own 1998 and 1999 
Annual Compliance Reports. The EPA drinking water program and the 
states need to upgrade their management systems and programs. Routine 
audits of federally funded state programs are a crucial part of this 
effort. The new SDWA small system viability provisions could begin to 
reduce these problems, but substantial additional resources and 
research are needed to assure that these programs bear fruit. 
Additionally, small system technical assistance should be granted on a 
competitive basis, based upon the best available research, so that 
these assistance providers demonstrate that they can deliver accurate 
technical assistance to small systems in a cost-efficient manner. We 
oppose ``earmarked'' assistance funding that is non-competitive because 
it often fails to allocate resources to maximize health benefits.
       Better Leveraging of Other Federal Agency Resources.
    The Federal Government has a wealth of expertise and resources 
directly relevant to EPA's drinking water program that should be better 
integrated into EPA's efforts. For example, the Centers for Disease 
Control, Agency for Toxic Substances Disease Registry, and several 
institutes at the National Institutes of Health, including the National 
Cancer Institute, the National Institute of Environmental Health 
Sciences, the National Institute of Allergy and Infectious Disease, 
National Institute of Child Health and Human Development, National 
Heart, Lung, and Blood Institute, National Institute of Neurological 
Disorders and Stroke, and many other institutes and agencies conduct 
research of which the EPA often is unaware. A better program is 
urgently needed to assure more information sharing and collaboration 
among the Federal agencies. Some successful examples of collaboration 
can be noted such as the waterborne disease estimation research being 
jointly spearheaded by EPA and CDC, and the joint work on disinfection 
byproducts by EPA, ATSDR, and NTP. Perhaps more often, however, there 
is little or no collaboration among many of the agencies while setting 
priorities and conducting research. This lack of coordination can 
result in serious lost opportunities and resources through potential 
duplication of efforts.
    In conclusion, NRDC strongly believes that EPA's implementation of 
the 1996 Amendments to the Safe Drinking Water Act is beginning to show 
signs of achieving substantial public health gains. Some of the most 
knotty, difficult issues that have faced EPA and the nation's drinking 
water supplies for the past quarter century since the original 1974 
SDWA was passed, and in many cases for even longer than that, are now 
being squarely addressed. This process will not be simple, nor will it 
be cheap. However, this effort is necessary to protect public health 
and to achieve public demands for a reliable supply of safe, good-
tasting tap water for all Americans. A vigorous and well-funded EPA 
research and regulatory effort is crucial to the long-term success of 
the drinking water program and the nation's tap water safety. Only a 
long-term stable source of adequate funding will assure that this is 
achieved.
                                 ______
                                 
          Responses of the Eric Olson to Additional Questions 
                           from Senator Crapo

    Question 1. Your testimony suggests an arsenic MCL of 3 ppb is 
appropriate. Do you believe the underlying science supports such a 
level?
    Response. The underlying science does support this level; in fact 
the underlying science supports a level lower than 3 ppb. According to 
decades-old EPA policy long supported by Congress, a health-protective 
tap water standard should allow a maximum lifetime cancer risk no 
greater than a level presenting a lifetime cancer risk from 1 in 
1,000,000 (10-6) to at most 1 in 10,000 (10?) for people who drink 
about 2 liters of water per day--a level consumed daily by tens of 
millions of Americans. This would require EPA to set a drinking water 
standard well below the current 50 ppb standard--in the range of 0.5 to 
1 ppb, according to the figures and risk estimation methods used for 
total cancer risk by the National Academy of Sciences' 1999 report, 
Arsenic in Drinking Water. Limitations in the analytical techniques 
widely used for measuring arsenic in water, however, would likely 
necessitate a standard of 3 ppb, rather than a standard of 1 ppb, 
because reliably quantifying arsenic at levels below this would be 
difficult using current standard lab equipment and practices. Based on 
an extrapolation of NAS's risk estimates, even a relatively skict 
arsenic standard of 3 ppb would pose a fatal cancer risk several times 
higher risk than EPA has traditionally accepted in drinking water. This 
issue is discussed in greater detail in the attached recent NRDC 
report, Arsenic and Old Laws (2000), which was written as a pro bono 
professional courtesy by Dr. Paul Mushak, an expert on arsenic and 
metal toxicity who has sat on several National Academy of Sciences 
committees. The cost of arsenic removal is quite affordable (at most a 
few dollars a month per household) for the vast majority of households 
(>90 percent) affected by arsenic. The relatively small percentage of 
people served by very small systems where the costs would be greater 
have several options available under the SDWA, including restructuring 
or consolidation, availability of Federal funds, point of use or point 
of entry devices, and other affordable small system technologies, and 
even state variances or exemptions where none of those other options 
works.

    Question 2. Is it your understanding that the primary exposure to 
radon is through the air? If so, do you believe that limited community 
water system resources should be directed to other contaminants that 
are more readily found in drinking water systems?
    Response. Yes, it is our understanding that on average for the 
nation, the primary exposure to radon is through the air. However, it 
also is known that in some homes and in some communities, radon in 
drinking water is a significant radon source, and can even be the 
predominant source of radon exposure. Moreover, EPA's 1994 report to 
Congress on radon in drinking water found, using cancer risk figures 
later confirmed by the National Academy of Sciences' 1999 report on 
radon in drinking water, that radon presents one of the highest cancer 
risks of any carcinogen in tap water. People who live in apartment 
buildings above the first floor or in mobile homes or other homes that 
are raised above the ground and lack basements, and who use drinking 
water containing elevated levels of radon, can get more radon from 
drinking and showering than they would through soil seepage. 
Furthermore, contrary to the implication of the question above, 
elevated levels of radon posing cancer risks calculated by the National 
Academy of Sciences to be in excess of those traditionally accented bv 
EPA occur in the tan water of tens of millions of Americans. We believe 
community water system resources should be required to treat for 
elevated levels of radon, a known human carcinogen, where the levels 
pose unacceptable cancer risks, because radon in drinking water poses 
significant threats to human health. In fact, the main reason radon in 
drinking water threatens public health is due to inhalation during and 
after water use, though ingestion also contributes to cancer risk. For 
example, people who take showers soon after someone else in the 
household are likely to be exposed to very high radon and radon-related 
cancer risks, because of the buildup of cancer-causing radon decay 
products in the bathroom. In some cases, the levels found in the shower 
would exceed Nuclear Regulatory Commission standards for nuclear power 
plant discharges. Therefore, due to exposure occurring through the air, 
the risks from radon in water are very high and can have serious health 
consequences, including lung cancer.
    In addition, the treatment for radon in tap water is simple and 
inexpensive. The only process needed to remove radon from water is 
aeration--that is, air must be bubbled through the water through 
treatment equipment to dissipate the radon. Therefore, for a relatively 
small cost (a few dollars per household per year for the vast majority 
of affected households), through the centralized application of 
treatment, a community water system can protect its population against 
a significant cancer risk. Such centralized, low-cost per household 
treatment is not possible for radon soil seepage into home basements.

    Question 3. Do you believe stakeholders and the public have a 
meaningful opportunity to influence the ultimate outcome of EPA 
proposals?
    Response. In recent years, EPA has made great strides in improving 
the public's opportunity to influence EPA tap water regulations. For 
example, EPA used to rely almost exclusively upon the Administrative 
Procedure Act's notice and comment rulemaking procedures of publishing 
a proposal, taking comment for 30 or more days, and then publishing a 
final rule. However, EPA has in recent years substantially expanded the 
public's ability to discuss regulatory matters with the Agency, often 
at the earliest stages of regulatory development. EPA now routinely 
holds formal and informal ``stakeholder'' meetings open to all parties. 
The Agency also holds special meetings with small water systems under 
the auspices of with the Small Business Regulatory Enforcement and 
Fairness Act (SBREFA), and with state and local governments pursuant to 
the Executive Order on federalism and the Unfunded Mandates Executive 
Order and law. In fact, due to our lack of resources, the public 
interest community often is unable to take advantage of many of the 
opportunities for input provided by EPA, resulting in often unbalanced 
views being presented to the Agency on important regulatory and other 
matters. This is particularly the case when EPA schedules (as it often 
does) ``public'' meetings to discuss regulatory matters to coincide 
with major industry or state or local government trade association 
meetings, which may be convenient for those parties, but virtually 
assures a one-sided meeting.
    In some important cases EPA has used a full-blown regulatory 
negotiation (reg-neg), in which all interested parties are afforded an 
opportunity to participate in formulating the rule in a consensus 
process. For example, EPA has used the reg-neg process for the Stage 1 
disinfection byproduct rule, the Enhanced Surface Water Treatment Rule, 
the Interim Enhanced Surface Water Treatment Rule, the Stage 2 
disinfection byproduct rule, and the Long Term 2 Enhanced Surface Water 
Treatment Rule.
    Unfortunately, despite recent improvements in some cases, we have 
found that in other cases, the best and sometimes the only way to 
assure EPA action is to use the judicial process. For example, we have 
known for decades that EPA's ``interim'' arsenic standard, first set in 
1942, was completely out-of-date. Notably, as early as 1962, the U.S. 
Public Health Service cited evidence of arsenic's carcinogenicity and 
low-level toxicity and recommended that arsenic levels in tap water be 
lowered f?ve-fold, yet EPA has stuck with the standard originally set 
in 1942. Congress also recognized this problem and required the EPA to 
revise the arsenic standard on three different occasions. Neither the 
enormous mountain of scientific evidence of unacceptable risks nor 
congressional mandates forced the EPA to propose the arsenic standard. 
The rule was not proposed until we filed a complaint against the EPA to 
compel its publication. This is just one example where we have had to 
use the judicial process to either force the EPA to follow a 
congressional mandate or scientific evidence.

    Question 4. Other than funding, what assistance can the EPA provide 
community water systems and the public to offset shortfalls in 
infrastructure needs?
    Response. EPA can provide technical assistance to community water 
systems, and can work with states to encourage restructuring and 
consolidation of smaller or less efficient water systems experiencing 
financial difficulties. Regionalization, consolidation, or other 
restructuring opportunities can allow smaller systems to enjoy the 
economies of scale enjoyed by larger systems, bringing costs down and 
efficiencies and water quality up. However, the only real option to 
combat the infrastructure needs in many communities is to either fund 
some now, or fund much more later. As I explained in my testimony, the 
Water Institute Network (WIN)' has estimated that there is currently an 
estimated funding gap of $23 billion a year between the current 
investments in infrastructure and the investments that will be needed 
annually over the next 20 years to update the infrastructure to protect 
the public's health. Most of these costs will be incurred irrespective 
of any new EPA regulations. Water and wastewater utilities will have 
difficulty meeting this enormous cost alone. Local solutions, like 
increasing water rates or operating and treatment efficiencies, can 
only address a portion of the problem. Financing the full $23 billion a 
year gap with utility rate increases could significantly increase the 
rates that some people pay for water and sewage treatment across the 
nation. This could result in a significant impact for some families, 
because some people--particularly in small, rural, and low-income 
communities--may not have disposable income to pay for the expected 
increases in water and wastewater rates.
    Therefore, there is a real need for Federal investment. 
Accordingly, there is ample precedent for, and clear economic principle 
supporting, a Federal role in funding water and wastewater 
infrastructure. The importance of wastewater infrastructure was well 
understood in the 1960's as the Nation watched the quality of its 
waters decline precipitously and chose in the 1972 Clean Water 
Infrastructure Network, Clean and Safe Water for the 21st Century: A 
Renewed National Commitment to Water and Wastewater Infrastructure 
(2000).
    Water Act, to spend Federal tax collars to reverse this trend. 
Despite increasing public demand for cleaner surface waters and safer 
drinking water, despite shifts in population that can strand water and 
wastewater assets in urban core cities with few ways to pay for needed 
improvements, and despite the nearly universal need to replace billions 
of dollars of aging and failing water distribution and wastewater 
collection systems, the total Federal contribution to water and 
wastewater continues to decline.
    These infrastructure systems, like highways, airports, and transit 
systems, underpin the U.S. economy broadly and their benefits accrue 
widely to users without geographic limitations imposed by local 
political boundaries. Moreover, the water system has network benefits 
that are felt only after all, or substantial portions, of the network 
is complete and functional, affording Americans anywhere in the country 
access to minimum levels of services. Consequently, a Federal solution 
is necessary. The Water Infrastructure Network appropriately suggests: 
Federal solutions like direct grants from the General Fund, a dedicated 
Clean and Safe Water Trust Fund, or other forms of targeted assistance 
make good economic sense. Each approach has certain advantages and 
limitations in terms of its ability to provide (1) sufficient funding 
to meet the water and wastewater investment gap; (2) an equitable 
distribution of funds; (3) funding stability and long-run 
predictability of capital; and, (4) financial and administrative 
innovation. Yet, any of these options would renew the Federal 
commitment structure investments play in health of all Americans, the 
welfare of our communities, the integrity of our natural environment, 
and the strength of our economy.
                                 ______
                                 
            Responses by Eric Olson to Additional Questions 
                           from Senator Smith

    Question 1. In your statement, you refer to a study in Finland that 
supports the need to reduce the MCL for arsenic in drinking water below 
5 ppb. What studies have been conducted in the U.S. that support 
decreasing the MCL for arsenic below 10 ppb? How similar is the Finland 
population to the U.S. population?
    Response. There have been several studies done by U.S. 
investigators that support decreasing the MCL for arsenic below 10 ppb. 
The best available, peer-reviewed science supports an arsenic standard 
below 10 ppb. Most significantly, the National Academy of Sciences' 
landmark 1999 report, Arsenic in Drinking Water, found that the current 
arsenic standard of 50 ppb could pose a total cancer risk of 1 in 100, 
and found that there is not sufficient evidence to depart from the 
traditional scientific linear, no-threshhold cancer risk assessment 
method. The NAS committee was not asked to recommend a standard and did 
not do so. However, using NAS's figures and risk assessment method, in 
order to achieve a cancer risk for a person consuming 2 liters of water 
per day of no more than one in 10,000--the highest cancer risk EPA ever 
allows--the tap water standard should be set at about 0.5 to 1 ppb. 
(See, Mushak, Arsenic and Old Laws (2000), attached). EPA's arsenic 
criteria for surface water is in the parts per trillion, and 
California's draft recommended public health level is 2 parts per 
trillion--2,500 times stricter than EPA's proposed standard of 5 ppb. 
California's recommendation was based on studies from University of 
California experts who found that a person who daily drinks 1.6 liters 
of water containing arsenic at the current EPA standard is put at about 
a 1 in 50 risk of fatal cancer of fatal cancer. See Smith et al., 
``Cancer Risks from Arsenic in Drinking Water,'' Environmental Health 
Perspectives, vol. 97, pp. 259--67 (1992); Bates, M.N., Smith, A. H., 
and Hopenhayn-Rich, C: ``Arsenic Ingestion and Internal Cancers: a 
Review,'' American Journal of Epidemiology, 135(5): 462--76 (March, 
1992). Even more recently, three studies in the July 2000 issue of that 
National Institutes of Health's journal Environmental Health 
Perspectives that found that arsenic is linked to skin and other health 
effects even in populations that are well nourished, that arsenic is 
linked to certain reproductive problems in exposed women, and that 
cancer risks are increased among many people consuming tap water 
containing arsenic.
    The data from the Finland study are relevant to the risk the U.S. 
population faces from arsenic; these results are for a well-nourished 
population socio-economically similar to the U.S., and simply serve to 
confirm and reinforce evidence of arsenic's carcinogenicity and 
toxicity collected around the world. Notably, Dr. Paul Mushak, an 
expert on arsenic and metal toxicology who has sat on several National 
Academy of Sciences and other peer review panels, recently directly 
confronted this question. Dr. Mushak stated in a recent affidavit: ``Of 
particular note is that the increased cancers from As in drinking water 
are from both Asian (Taiwanese) and a South American, Eurocentric 
(Chilean) population--populations differing racially, nutritionally, 
and in life-style behaviors, a fact that effectively demolishes the 
arguments advanced by certain regulated stakeholders that these studies 
may have limited regulatory meaning for Americans. Similarly, 
environmental factors that have been held by some to confound the 
relevance of an As connection to cancers in foreign populations are 
spurious and cannot disconnect arsenic as the causative agent in 
increasing the cancer risks.'' The studies that Dr. Mushak refers to 
are particularly noteworthy because they study very large populations; 
the Taiwanese study population was 40,000 subjects with a control group 
of more than 7000 individuals and a recent Chilean study population 
included over 400,000 exposed Chileans. See Smith, et. al, ``Marked 
increase in bladder and lung cancer mortality in a region of Northern 
Chile due to arsenic in drinking water.'' Am. J. Epidemiol. 147: 660--
669 (1998). Tseng WP. ``Effects and dose-response relationships of skin 
cancer and Blackfoot Disease with arsenic.'' Environ. Health Perspect. 
19:109-119(1977).

    Question 2. You mentioned in your statement that NRDC has concerns 
with the proposed Groundwater rule? What fundamental flaws have you 
identified and how would you propose to correct these?
    Response. NRDC, along with Clean Water Action (CWA) and many other 
organizations, in the Campaign for Safe and Affordable Drinking Water, 
have identified our top issues with the Ground Water Rule. The issues/
flaws identified in a recent CWA review, which NRDC believes identifies 
many of the key problems with the rule (listed in no particular order), 
include:
    1. One flaw of the current rule is that disinfection has become the 
last alternative, even though Centers for Disease Control and 
Prevention (CDC) data show that most waterborne disease outbreaks occur 
in groundwater-supplied systems. EPA has chosen to move from a position 
of requiring disinfection of ground water systems, with exceptions 
(where it can be shown that it is not necessary), to a position of not 
requiring disinfection of a ground water system until all other options 
have been exhausted. The proposed rule casts a set of complicated and 
unenforceable measures which are bound to vary widely in quality and 
oversight from state to state across the nation. We believe the EPA 
should change this position and have a presumption that the water 
requires disinfection unless the water system can show otherwise based 
on sound scientific data.
    2. Another problem with the rule is that states do not have to set 
time limits for ground water systems to fix problems. EPA sets no outer 
time bounds by which States have to require a drinking water provider 
with a significant deficiency to take corrective action. This could 
leave many communities in the situation they now face, according to a 
General Accounting Office report on the subject--going from sanitary 
survey to sanitary survey over time, knowing there is a problem, but 
not seeing any fix ever implemented. This extreme form of ``regulatory 
flexibility'' makes any enforcement scheme almost impossible and leaves 
many people vulnerable to illness or death. Consequently, we believe 
the EPA needs to set time limits for ground water systems to insure 
public health is protected.
    3. Problematically, ground water systems, under this rule, will not 
have to test for both pathogens and viruses. EPA is not proposing to 
require water providers to test for both pathogens and viruses, but 
allows them to test for either one despite a strong opinion to the 
contrary from the drinking water committee of the Science Advisory 
Board (SAB) and EPA's own National Drinking Water Advisory Committee 
(NDWAC). We think this is a false economy that will leave the public in 
the dark about real and potential water quality issues, and will pose a 
significant public health threat.
    4. The Sanitary Surveys are too infrequent. EPA will not require 
sanitary surveys to be done frequently enough to find problems in time 
to correct them. EPA is proposing that community water systems (COOS) 
do a survey every 3 years and that non-community water systems do a 
survey every 5 years. States have been reducing the frequency of 
surveys over time. For states where the frequency required is more 
frequent than the proposed rule, we may see significant slippage in 
frequency of sanitary surveys. Further, EPA is proposing that if a CWS 
treats their water ``to achieve 4-log inactivation or virus removal'' 
or shows an ``outstanding performance record,'' then the survey cycle 
will be extended from 3 to 5 years. The question of what constitutes an 
``outstanding performance record'' is left up to the States with little 
or no assurance of national consistency or oversight. We oppose 
allowing the survey cycle to move to a 5-year periodicity--too much can 
change over that length of time. Also, we think that the question of 
what constitutes ``outstanding performance record'' is too undefined 
and will have too much variability from State to State. Finally, we 
believe that a sanitary survey should be done prior to a new ground 
water system coming on line.
    5. States may design Sanitary Surveys that vary widely in quality 
and oversight. The EPA/State Joint Guidance on Sanitary Surveys and the 
new EPA ``Guidance Manual for Conducting Sanitary Survey of Public 
Water System'' published as technical assistance are non-binding and 
will not close the gap in the wide inconsistencies in how sanitary 
survey are performed and how identified problems are corrected. Also, 
the two guidances do not give the necessary direction to the States on 
which of the eight elements of the sanitary survey might be more of a 
priority, treating them all equally. Some of the survey elements 
require more in depth work or the benefits of the survey element are 
lessened or lost. Further, States should have to evaluate all eight 
elements laid out in the Joint guidance and not be allowed to 
grandfather in surveys conducted under the Total Coliform Rule (TCR) 
that don't touch on all eight elements. Finally, onsite verification 
should take place. It's not good enough to have a written certification 
to verify correction.
    6. States are not required to have a cross connection control 
Program. States should be required to have a cross connection control 
program. Significant problems in the distribution system may be caused 
by cross connections. Instituting a cross connection control program 
would go a long way to ferreting out problems and point to solutions. 
Waiting for the Long Term 2 ESWTR to begin the process puts off 
implementation of a critical element for the prevention of a real 
problem.
    7. EPA should establish a baseline list of significant deficiencies 
which states may exceed. EPA should mandate a minimum cross the board 
list of significant deficiencies to be evaluated by the States. EPA may 
want to provide an additional list of significant deficiencies from 
which the States may pick and choose. We feel that this option will 
provide both consistency in the program across the Nation and give 
States the necessary flexibility to tailor its program to local 
conditions and to innovate or expand its initiatives.
    8. EPA should require public participation and Right To Know 
throughout the Ground Water Rule. EPA should carry over the ethic of 
public participation and right to know that is ensconced in the 1996 
Amendments to the Safe Drinking Water Act. Public Water Systems should 
be required to hold a public meeting to explain the results of a 
sanitary survey, including a description of any significant deficiency, 
potential associated health problems and resultant plans, timetables 
and capitol budgets for needed corrective actions. A summary of the 
results of a sanitary survey should be incorporated into the next 
Consumer Confidence Report and the sanitary survey should be made 
available in public places like the library, over the net, and through 
the mail in the next billing cycle. States or their designated sanitary 
survey technician should work with the water provider to solicit public 
involvement in doing the sanitary survey just as they would with the 
source water assessment (SWA). Information provided by the public 
should be factored into implementation of corrective actions.
    9. All Ground Water Systems Should Monitor for Bacterial Indicators 
and Coliphage Regardless of their Sensitivity. If a ground water 
systems does not disinfect, EPA proposes that it be required to do a 
hydrogeologic sensitivity assessment (HSA) to determine if it's source 
water is vulnerable to contamination. A determination of sensitivity 
can be nullified by the state if it can be shown that there is a 
hydrogeolgic barrier (HB) that will stop contaminants from getting into 
the source water. EPA has determined by definition that ground water 
system in karst, fractured bedrock or gravel areas are sensitive. EPA 
has left out sandy soil aquifers from this categorical determination of 
sensitivity. We agree with the drinking water committee of the Science 
Advisory Board (SAB) which said that all ground water systems should 
``be required to monitor for bacterial indicators and coliphage for at 
least 1 year regardless of sensitivity determinations.'' Also, we think 
that sandy aquifers should be included because it is common knowledge 
that viruses move from septics (and other sources) through sandy 
coastal plains into ground water. In addition we think that a HB 
determination and a sensitivity nullification should not lead to a 
source water monitoring exemption.
    10. The SWAP Should Be More Tied Into the Ground Water Rule. Though 
EPA advises States to take the SWAP process into account, we feel that 
EPA could do much more to formally tie source water assessments and the 
sanitary surveys/HSAs together. Where State source water assessment 
plans (SWAPs) incorporate ground water system assessments that take in 
all eight elements of the GWR's proscribed sanitary survey scheme and 
provide the basis for doing a HSA, they may aide the States in 
rationalizing the two processes, both saving dollars and speeding up 
the implementation of any necessary corrective actions. If the State's 
SWAP however does not meet the minimum needs of the GWR then the State 
must do the SWAP and the sanitary survey/HSA. A mediocre approved SWAP 
should not be used as an excuse to backslide on all the necessary 
elements proscribed by the GWR.
                                 ______
                                 
              [From the Natural Resources Defense Council]
   Arsenic and Old Laws: A Scientific and Public Health Analysis of 
  Arsenic Occurrence in Drinking Water, Its Health Effects, and EPA's 
                  Outdated Arsenic Tap Water Standard
                 executive summary and recommendations
Findings
    Arsenic in drinking water poses a significant public health risk in 
the United States. According to our most conservative analysis of new 
EPA data covering only 25 states, at least 34 million Americans in over 
6,900 communities drank tap water supplied by systems containing 
arsenic, a known toxin and carcinogen, at average levels that pose 
unacceptable cancer risks. \1\ Our ``best'' estimate, based on what we 
believe to be the most reasonable (but less conservative) analytical 
techniques, indicates that 56 million Americans in over 8,000 
communities in those 25 states drank water with arsenic at these risky 
levels. \2\
---------------------------------------------------------------------------
    \1\ The phrase ``unacceptable cancer risk'' is used here to mean 
water containing arsenic at a level posing a lifetime risk of dying 
from cancers in all internal organs--bladder, kidney, liver, and lung--
of over 1 in 10,000, based on the methodologies, estimates, and cancer 
risk characterizations described in the National Academy of Sciences' 
recent report, Arsenic in Drinking Water, at 8, 301 (1999), and based 
on the standard assumption that a person consumes two liters of water 
per day. A 1-in 10,000 cancer risk traditionally is the highest cancer 
risk EPA ever allows in tap water when setting standards, although the 
Agency usually seeks to set standards at a stricter level, posing a 
lower cancer risk. See Chapters 1 and 2 for details.
    \2\ As discussed in Chapter 1, the 56 million population exposed 
figure is our best estimate of the average arsenic exposure levels of 
consumers in the 25 states included in the new EPA data base analyzed 
in this report. While this analysis is conservative (it may 
underestimate the extent of exposure), an even more conservative 
analysis would suggest that a minimum of 34 million people in these 25 
states drank water posing a significant cancer risk. The latter highly 
conservative low average estimate assumes, when calculating average 
arsenic levels, that no arsenic was in the water at times when early 
crude tests with a high reporting limit of, for example, 10 ppb, found 
none, even though subsequent more sensitive tests found arsenic. On the 
other hand, the mid-average approach assumes that arsenic was present 
at half the reporting limit if, in some tests, arsenic was not detected 
using a high reporting limit, and other more sensitive tests found 
arsenic. See Chapter 1 for details.
---------------------------------------------------------------------------
    These newly public figures are based on more than 100,000 arsenic 
samples collected from 1980 to 1998 by more than 24,000 public water 
systems in 25 states, which were then compiled by the U.S. 
Environmental Protection Agency (EPA). The Natural Resources Defense 
Council (NRDC) obtained the data under the Freedom of Information Act 
and analyzed them. While arsenic levels can vary with time, when 
considering cancer risk, the average levels generally are of primary 
concern. For this reason, NRDC calculated average arsenic levels in the 
systems evaluated. Because data were available for only half of the 
states in the nation, these are likely to be significant underestimates 
of the total U.S. population exposed to arsenic in tap water.
    NRDC also has generated maps for this report showing the geographic 
distribution of arsenic problems for all 25 reporting states. This 
marks the first time that EPA's drinking water data base has been 
publicly analyzed using a Geographic Information System (GIS) to 
generate maps of drinking water problems.
    This report includes a summary of the adverse health effects of 
arsenic in drinking water by an eminent expert on the subject, based 
upon a 1999 National Academy of Sciences (NAS) report and a review of 
peer-reviewed literature. The NAS report and other scientific 
literature discussed here have concluded that arsenic in drinking water 
is a known cause of bladder, lung, and skin cancer. In addition, the 
NAS report and many previous studies have found that arsenic in 
drinking water may also cause kidney and liver cancer.
    Arsenic's known noncancer 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.
    The NAS concluded in 1999 that EPA's 57 year-old arsenic standard 
for drinking water of 50 parts per billion (ppb), set in 1942 before 
arsenic was known to cause cancer, ``does not achieve EPA's goal for 
public health protection and, therefore, requires downward revision as 
promptly as possible'' (NAS, 1999, p. 9). In fact, the academy said 
that drinking water at the current EPA standard ``could easily'' result 
in a total fatal cancer risk of 1 in 100--about a 10,000 times higher 
cancer risk than EPA would allow for carcinogens in food, for example.
                            recommendations
    EPA must immediately adopt a strict, health-protective standard for 
arsenic in tap water. The Safe Drinking Water Act (SDWA) Amendments of 
1996 required EPA to propose a revised arsenic standard (to replace the 
old standard set in 1942) by January 1, 2000, a deadline the Agency has 
missed. This is the third time EPA has violated a statutory mandate to 
update the arsenic standard. EPA is required to finalize a new standard 
by January 1, 2001. We conclude--as did NAS--that EPA should 
expeditiously issue a stricter Maximum Contaminant Level standard for 
arsenic. EPA must consider that many Americans also have unavoidable 
exposure to arsenic in their food, so relatively low levels of arsenic 
in tap water can cause safety levels to be exceeded. A health-
protective tap water arsenic standard should allow a maximum lifetime 
cancer risk no greater than that EPA has traditionally accepted (a 
level presenting a lifetime cancer risk from 1 in 1,000,000 to at most 
1 in 10,000 for vulnerable or highly exposed individuals).
    This would require EPA to set a drinking water standard well below 
the current 50 ppb standard--in the range of 1 ppb. Limitations in the 
analytical techniques widely used for measuring arsenic in water, 
however, would likely necessitate a standard of 3 ppb, rather than a 
standard of 1 ppb, because reliably quantifying arsenic at levels below 
this would be difficult using current standard lab equipment and 
practices. Based on an extrapolation of NAS's risk estimates, even a 
relatively strict arsenic standard of 3 ppb could pose a fatal cancer 
risk several times higher risk than EPA has traditionally accepted in 
drinking water. EPA data, which the Agency recently said probably 
overestimate costs, indicate that the cost per household of a 2 ppb 
standard would be from $5 to $14 per month for the vast majority (87 
percent) of affected consumers; users of small systems may have to pay 
significantly more. EPA's (admittedly high) estimates also project that 
nationally an arsenic standard of 2 ppb would cost $2.1 billion per 
year, and a 5 ppb standard would cost $686 million per year.
    EPA should reduce its cross-media guidance level for arsenic and 
should fund improved analytical methods to lower detection limits for 
arsenic. Health data indicate that EPA's current guidance level 
establishing the maximum recommended daily arsenic exposure, called a 
reference dose (which is unenforceable itself, but is used by EPA in 
developing enforceable standards in all environmental media, including 
water), is too high and may not protect vulnerable populations, such as 
children. To protect children, EPA should reduce this reference dose 
from 0.3 micrograms per kilogram per day (g-kg per day) to at 
most 0.1 g-kg per day, and should immediately reevaluate the 
reference dose in light of the 1999 NAS risk estimates, suggesting that 
the cancer risk at this level would still be unacceptable. In addition, 
EPA should fund efforts to reduce the level at which arsenic can be 
reliably detected in drinking water, so that it can be found down to 
levels at which it may pose a health risk (below 1 ppb).
    Water systems should be honest with their customers about arsenic 
contamination and potential health risks. Only if water systems tell 
their customers the truth about arsenic contamination in their tap 
water, and about the health threat it poses, will the public support 
efforts (including possible rate increases) to remedy the problem.
    Systems with arsenic problems should work with government officials 
to clean up their source water. Some systems may be able to reduce 
arsenic levels by cleaning up or changing the source of their water. 
For example, some arsenic contamination results from leaching of 
arsenic from old waste dumps, mines, or tailings, or from past use of 
arsenic-containing pesticides. Government officials and water systems 
should team up with citizens to remedy contamination at these sites so 
water supplies are not arsenic-contaminated. In addition, recent 
studies have shown that high groundwater pumping rates have increased 
arsenic levels in some wells. It should be investigated whether 
reducing pumping rates or reworking wells can reduce some systems' 
arsenic levels.
    Water systems unable to get cleaner source water should treat to 
remove arsenic; state and Federal funds should be increased to assist 
smaller Systems in paying for upgrades. As noted above, there is 
readily available treatment technology that can remove arsenic from tap 
water, at a cost of about $5 to $14 per month per household for the 
vast majority of people (87 percent) served by systems with arsenic 
problems. Very small systems serving a small fraction of the population 
drinking arsenic-contaminated water, however, will often be more 
expensive to clean up per household (due to the lack of economies of 
scale). For these systems, Federal and state assistance to improve 
treatment is available, and arsenic contamination should be a high 
priority for these drinking water funds. Additional Federal and state 
funding through State Revolving Fund (SRF), USDA's Rural Utility 
Service, and other programs may also be needed. The SRF established by 
the SDWA Amendments of 1996 should be funded at least to the full 
authorized amount ($1 billion per year) to help smaller systems with 
arsenic problems.
    EPA should improve its arsenic and other drinking water data bases. 
EPA should upgrade its drinking water data base, known as the Safe 
Drinking Water Information System (SDWIS) so that it includes all of 
these arsenic data, as well as unregulated contaminant data, as 
required by the Safe Drinking Water Act--and makes them accessible to 
the public. The SDWIS data base must also be upgraded to include more 
accurate latitude and longitude (``lat-long'') data. The ready 
availability and low cost of new GPS (global positioning system) units 
for recording lat-long coordinates--available for a few hundred 
dollars--should drive EPA to require accurate lat-long data for the 
distribution systems, treatment plants, and intakes of each public 
water system. Such data will have a wealth of uses for water systems, 
state and local officials, EPA, and the public in using GIS systems for 
protecting source water, for developing targeted and well-documented 
rules, and for other purposes.
                                 ______
                                 
                               Chapter 1
arsenic has been found at levels of health concern in the tap water of 
               tens of millions of americans in 25 states
    NRDC has obtained new data showing that tens of millions of 
Americans are consuming tap water every day that poses unacceptable 
cancer risks. This chapter summarizes these new arsenic occurrence 
data, while subsequent chapters discuss in detail the health 
implications of arsenic contamination of drinking water and the need 
for a stricter standard for arsenic in tap water.
    The source of these new data is an EPA data base not previously 
made public, obtained by NRDC under the Freedom of Information Act. In 
preparing to develop an updated standard for arsenic in drinking water, 
EPA asked all states for data on the occurrence of arsenic in the tap 
water served by public water systems. Twenty-five states responded (see 
Figure 1, National Arsenic Occurrence Map), providing over 100,000 
arsenic test results taken from 1980 to 1998 from over 23,000 public 
water systems. These water systems serve a total of about 99.5 million 
Americans, or 40 percent of the 1990 U.S. population. Because the data 
base does not cover states in which approximately 60 percent of the 
U.S. population resides, the estimates of population affected by 
arsenic in their tap water likely are substantial underestimates. NRDC 
has deleted from consideration, as potentially unreliable, samples that 
exceeded 1,000 parts per billion.
    These new data reveal startling new details about the extent of 
arsenic contamination in the tap water. Table 1 shows our best estimate 
is that over 56 million Americans in these 25 states consumed water 
from systems containing arsenic at levels presenting a potentially 
fatal cancer risk above the level that is EPA's highest acceptable 
cancer risk (1 in 10,000). Even our extremely conservative ``low 
average'' analysis approach indicates that at a minimum, over 34 
million people in these 25 states drank water posing these elevated 
cancer risks. Our estimates are based on detailed evaluations of the 
EPA-collected occurrence data and the National Academy of Sciences 
(NAS) total cancer risk estimates. \3\ Table 2 notes the total 
potentially fatal cancer risk that would be associated with drinking 
two liters of water containing arsenic at a given level for a lifetime, 
based upon the NAS estimates. Chapter 2 includes a further discussion 
of these data on risks and health effects, and how these estimates were 
derived.
---------------------------------------------------------------------------
    \3\ As is discussed in Chapter 3, NAS estimated that, considering 
lung and bladder cancers death studies, the total cancer risk at the 
current tap water standard of 50 ppb ``could easily'' be 1 in 100. NAS, 
in Arsenic in Drinking Water, at 8, 301 (1999). The NAS also noted that 
while there may be some indication that arsenic may not have a linear 
dose-response relationship at low doses, these data are ``inconclusive 
and do not meet EPA's 1996 stated criteria for departure from the 
default assumption of linearity.'' Ibid. at 7. Thus, as discussed in 
Chapter 2, we assume, as did NAS, that dose-response is linear with no 
threshold, and that the total lifetime potentially fatal cancer risk of 
consuming 2 liters a day of arsenic-contaminated water poses the risks 
noted in Table 2. While NAS did not explicitly calculate risks posed by 
water with arsenic at levels below 50 ppb, its analysis is used to 
develop Table 2.
---------------------------------------------------------------------------
    As is clear from Tables 1 and 2, tens of millions of Americans are 
consuming tap water every day at levels that may pose a serious 
potentially fatal cancer risk and other health risks. Appendix A lists 
each public water system in which arsenic was found in the 25 states 
reporting data. The national map is intended to show the general areas 
that are hardest hit by the highest levels of arsenic. However, to 
determine whether arsenic has been found in a particular public water 
system, according to EPA's data base, readers should refer to the table 
of water systems reported in Appendix A. The map cannot be used by 
itself to identify whether a particular water system has an arsenic 
problem, because often there are several water systems located 
immediately adjacent to each other, and the map was generated at a 
scale that cannot be used to identify precisely which water system 
contains a given level of arsenic.

                            Table 1: Arsenic Levels in Tap Water Systems in 25 States
                                             Low and Best Estimates
----------------------------------------------------------------------------------------------------------------
                                                                                       Best            Best
                                                   Low Estimate*   Low Estimate*   Estimate** of   Estimate** of
         Average Arsenic Level (in ppb)            of Number of      of Total        Number of         Total
                                                   Water Systems    Population     Water Systems    Population
                                                     Affected         Served         Affected         Served
----------------------------------------------------------------------------------------------------------------
None detected...................................          15,624      40,619,400          15,624      40,619,400
Detected, <1*...................................           2,068      28,017,372             884       5,925,297
;1 and <3.......................................           2,935      19,994,024           3,146      25,711,312
;3 and <5.......................................           1,321       7,440,564           1,947      17,494,651
;5 and <10......................................           1,348       5,033,538           1,652      10,611,259
;10 and <15.....................................             535       1,451,616             566       2,075,157
;15 and <20.....................................             251         243,526             258         340,284
;20 and <25.....................................             171         269,393             173         270,332
;25 and <50.....................................             280         354,802             283         376,542
;50.............................................              66          99,736              66          99,736
    Total.......................................          24,599     103,523,971          24,599     103,523,970
    Total at or above 1 ppb (0.5 ppb presents              6,907      34,887,199           8,091      56,979,263
     the highest cancer risk EPA traditionally
     allows in tap water).......................
----------------------------------------------------------------------------------------------------------------
*The low estimate is based on the assumption that any nondetect, no matter what the reporting limit, contained
  no arsenic, even if other samples showed arsenic was present. This highly conservative analysis results in a
  large number of systems having average concentrations below 1 ppb, because all reported nondetects, no matter
  what the reporting limit, are averaged as zero. See the discussion in the text for more details on how these
  averages were calculated.
** The best estimate is the estimated mid-average level of each system, which is the average of the detected
  levels of arsenic and, for those systems for which there was at least one detect of arsenic, one-half the
  level of detection for all nondetects. See the discussion in the text for more details on how these averages
  were calculated.


  Table 2: Lifetime Risks of Dying of Cancer from Arsenic in Tap Water
    Based upon the National Academy of Sciences' 1999 Risk Estimates*
------------------------------------------------------------------------
   Arsenic Level in Tap Water (in       Approximate Total Cancer Risk
     parts per billion, or ppb)        (assuming 2 liters consumed/day)
------------------------------------------------------------------------
0.5 ppb............................  1 in 10,000 (highest cancer risk
                                      EPA usually allows in tap water)
1 ppb..............................  1 in 5,000
3 ppb..............................  1 in 1,667
4 ppb..............................  1 in 1,250
5 ppb..............................  1 in 1,000
10 ppb.............................  1 in 500
20 ppb.............................  1 in 250
25 ppb.............................  1 in 200
50 ppb.............................  1 in 100
------------------------------------------------------------------------
*See note 3 and Chapter 3 for details on how we calculated total cancer
  risk based on an extrapolation of NAS's risk estimates, which assumed
  a linear dose-response and no threshold.

 water systems with elevated levels of arsenic and state maps showing 
                    distribution of arsenic problems
    Arsenic contamination of tap water is not a problem limited to a 
few pockets of the nation, nor is it limited in scope to small water 
systems. Tables 3 through 5 present summary data showing some water 
systems in which the EPA and state data indicate serious arsenic 
contamination problems may be found.
    In addition, using ArcView Geographic Information System (GIS) 
software, and the latitude and longitude coordinates for public water 
systems reported in EPA's Safe Drinking Water Information System 
(SDWIS), NRDC has developed 25 state maps showing the regional 
variations in arsenic levels in tap water. The larger the dot, the 
larger the population served water system. In addition, we used 
graduated red coloration to show the concentration of arsenic found in 
the water, from light pink (representing low concentrations of arsenic) 
to bright red (representing mid-level arsenic levels) to dark red 
(representing severe arsenic contamination). In addition, NRDC wanted 
to give readers a picture of where arsenic was being searched for but 
not found. We used separate maps with graduated blue-green coloration 
to represent nondetects, with light blue-green representing nondetects 
using low levels of quantification (for example 1 ppb), and darker 
blue-green representing nondetects using high limits of quantification 
(for example 10 ppb).
    As is clear from these tables and the 25 state maps, although 
arsenic contamination of tap water has substantial regional variation, 
no state is immune to the problem. Moreover, many of the nation's 
larger cities have levels of arsenic that are substantially above the 
level presenting what EPA would consider an acceptable cancer risk 
(that is, 1 in 10,000 risk of fatal cancer).
How Average Arsenic Levels are Calculated in This Report and in 
        Appendix A
    Arsenic levels can vary with time, and old samples often used 
cruder analytical techniques that could not detect low arsenic levels 
(below 10 parts per billion). We found that the so-called reporting 
limits for arsenic (that is, the lowest level of arsenic in the water 
that states require to bereported) in many states was 5 to 10 ppb in 
the 1980's and even in the early 1990's. Figure 3 shows that in some 
states, such as California, many water systems testing their water for 
arsenic were allowed to report as nondetected any level of arsenic 
below the state's relatively high reporting limits.
    In many cases, those reporting limits later were lowered, due to 
improved analytical methods, and arsenic started to be reported in the 
water of many more communities, as would be expected. This presented a 
problem for our analysis: when a water system had for years not 
reported arsenic, and then reported it when the reporting limit 
dropped, how should we calculate the arsenic level for that system? 
Additionally, a relatively small number of water systems had very 
inconsistent reported levels of arsenic over time, and we had to decide 
how to report their average levels as well. We decided that when a 
water system conducted multiple tests of its water, we would use two 
different averaging techniques to estimate the arsenic exposure for 
consumers of that water:
    First, we calculated a very conservative low average, which assumes 
that when arsenic was not reported as detected, there was absolutely no 
arsenic in the water at that time, even if the limit of detection was 
high (for example, 10 ppb), and even if other tests showed that arsenic 
was present in the water at levels somewhat below the previous 
reporting limit. For example, if a water system did five tests when the 
reporting limit was 10 ppb from 1985 to 1990 and found no arsenic, and 
then tested twice in 1993 to 1995 when the reporting limit was 3 ppb, 
and it found 8 ppb both of those later times, the low average 
calculated for that system would be 2.3 ppb (that is, [0 ppb + 0 ppb + 
0 ppb + 0 ppb + 0 ppb + 8 ppb + 8ppb] / 7 measurements = 2.3 ppb).
    Second, we based our best estimate on a calculated mid-average, 
which assumes that if at least some arsenic was detected in a water 
system at some time, then whenever arsenic was not reported as 
detected, it was present at a level of one half of the reporting limit. 
Using the same example, if a water system had five tests when the 
reporting limit was 10 ppb from 1985 to 1990 and found no arsenic, and 
then tested twice in 1993 to 1995 when the reporting limit was 3 ppb, 
and found 8 ppb both of those later times, the mid-average calculated 
for that system would be 5.8 ppb (that is, [5 ppb + 5 ppb + 5 ppb + 5 
ppb + 5 ppb + 8 ppb + 8 ppb]  7 measurements = 5.8 ppb).
                                 ______
                                 
                               Chapter 2
   an overview of the scientific and health issues raised by arsenic 
  regulation: what are the key science and health issues for arsenic 
                        regulation in tap water?
    There are several important public health issues raised by the 
presence of arsenic in America's tap water, including:
    1.Why should the public care about arsenic in drinking water?
    2.What are some of the environmental and biological characteristics 
of arsenic that are important to human health?
    3.What are the adverse health effects of the various chemical forms 
of arsenic found in U.S drinking water?
    4.Who in America is at special risk for adverse health effects from 
arsenic?
    5.What can we conclude about the adequacy of the U.S. EPA's current 
drinking water standard for arsenic?
    6.What can we conclude about the adequacy of other regulatory 
guidelines or standards for arsenic, for example the EPA reference dose 
(RfD) for ingested arsenic?
    7.What can we conclude about what a health-protective level of 
arsenic in American drinking water supplies should be to prevent cancer 
and noncancer effects in American populations?
    8.How can we prevent arsenic from getting into drinking water, or 
remove it from drinking water once it's there?
                        analysis and discussion
Why should the public care about arsenic in its drinking water?
    Arsenic is an element of the earth's crust that has many economic 
and industrial uses. However, it also is highly toxic in many of its 
chemical forms, even at the low concentrations often found in drinking 
water. Arsenic itself, as the core element in various arsenic 
compounds, remains unaltered even though it may bind or unbind with 
other elements or undergo changes in valence, or charge state. This 
scientific reality has many implications for how the element moves 
through the human environment and how we can effectively regulate it.
    Some drinking water arsenic comes from contamination by human 
activities. For example, arsenic can be released by industrial or 
mining waste sites, or can seep from a pesticide dump site into 
groundwater serving as a community water source. Other drinking water 
arsenic occurs naturally. Thus, water supplies from wells drilled into 
groundwater aquifers that can be laced with geochemical arsenic.
    In fashioning remedies to the problem of arsenic contamination in 
drinking water, it may be important to consider the origin of the 
arsenic. But no matter the source of arsenic, public health concerns 
dictate that the problem be solved promptly. Where the arsenic 
contamination is from human activity, waste cleanups (such as Superfund 
cleanups) may solve the problem, while in other cases the only remedy 
available may be arsenic removal at the drinking water treatment plant. 
The bottom line is that as a matter of community and preventive 
medicine, we must seek to minimize or prevent adverse health effects 
and risks from arsenic in tap water.
What are some of the environmental and biological characteristics of 
        arsenic that are important with respect to its effects on human 
        health?
    Tap water is one important way that people are exposed to arsenic, 
but they may also encounter arsenic in other environmental media, such 
as food, dust, soil, and ambient air. Toxic forms of arsenic are 
harmful to people no matter how they get into our bodies. Water can be 
the predominant source of the toxic forms of arsenic for many 
Americans, but in order for arsenic to be a health concern, it is not 
necessary that drinking water be the sole or dominant source of human 
arsenic intake. In other words, arsenic levels in our blood increase no 
matter what the source, so more arsenic in toxic forms from tap water 
or any other source increases our health risk.
    This environmental and biological reality prevents our viewing tap 
water arsenic in isolation. If we chose to quantify health risks only 
for drinking water arsenic and did not consider suspected or known 
contributions from other human arsenic intake sources, we might well be 
underestimating overall or aggregate health risks. That is, our risk 
numbers would be at the low end of the likely range of risk numbers 
with all sources accounted for. This view, however, does not invite the 
industries responsible for arsenic in one medium to point the finger at 
other sources as deserving either sole or more regulatory control. For 
one thing, some media lend themselves more readily to effective control 
of environmental contaminants and associated human exposures than 
others. This multimedia, integrated risk concept is particularly 
critical in the case of drinking water arsenic. Tap water arsenic is 
more easily controlled through centralized regulation, for example, 
controls on community water supplies, than arsenic in various dispersed 
sources and pathways, such as arsenic in soils, arsenic in home 
remedies popular in certain cultures, contaminated garden crops, or 
localized air arsenic emissions from smelters. Consequently, the 
regulatory attention given to arsenic in water is especially critical.
    One characteristic of drinking water arsenic of special concern to 
regulators and scientists is the element's typical occurrence in an 
especially toxic form, inorganic oxyarsenic. Oxyarsenic occurs in two 
different charge states (or valences) of importance here: pentavalent, 
which has five valence electrons (essentially points at which other 
chemical groups can attach to it), and trivalent, which has three such 
valence electrons, or attachment points. These forms are associated 
with a variety of cancer and noncancer toxic effects in humans. A 
wealth of recent health and scientific data identify trivalent and 
pentavalent oxyarsenic as equally toxic under the typical long-term, 
lower-level exposures to these arsenicals sustained by human 
populations. Earlier, crude studies in which test animals were fed 
large quantities of either valency form under acute, that is, very 
short-term, conditions seemed to show some difference in the way the 
animals' metabolisms reacted, but we now know that result mainly 
related to the high-dose, short-time conditions of the studies. These 
conditions do not apply to long-term exposures of human populations to 
lower, but still toxic, exposure levels.
    Most Americans are adept at recognizing visible or ``macroscale'' 
acute and chronic (continuing) hazards to their health and readily 
accept the usual characterizations of those hazards by experts. 
Examples include acute injuries from fire and various chronic diseases 
linked to smoking. But many people are less aware of environmental 
contaminants and their toxic potentials. Many toxic contaminants such 
as arsenic occur in the environment at extremely low concentrations, 
yet these levels still can be high enough to be of health concern 
because they can be toxic at trace (part-per-million, ppm) or ultra-
trace (part-per-billion, ppb and part-per-trillion, ppt) levels. In 
some cases, the injuries to human health from exposure to contaminants 
may only be seen after persistent contact with the contaminant for 
years or even decades; in other cases, complex medical and laboratory 
tests must be done to establish their presence.
What are the adverse health effects of arsenic in those chemical forms 
        likely to occur in America's drinking water?
    The public's perception of arsenic is still largely literary and 
forensic (stemming from such classics as the Joseph Kesselring play 
Arsenic and Old Lace and the film it inspired), and is most often 
recognized as the poison of choice for homicide, suicide, and other 
nefarious activities. This perception of arsenic toxicity represents 
only its most severe form. Such poisonings are acute, triggered by 
ingestion of very high amounts of inorganic arsenic (such as 
oxyarsenic) over a short time. When arsenic is ingested in large 
amounts deliberately or inadvertently, it produces a constellation of 
severe and often fatal injuries to the cardiovascular, gastrointestinal 
and nervous systems. This report examines the less-dramatic (but 
perhaps more important overall) dose-response and public health 
implications of widespread lower-level arsenic exposure of populations 
or their subsets.
    We are concerned with arsenic exposures and toxic responses that 
are long term, occur at relatively much lower doses than those 
producing acute, fatal poisoning, and affect entire populations or 
population segments rather than a toxic outcome reported for a specific 
individual. In fact, we now know that the levels of arsenic and other 
elements in the environment that are toxic are so low that scientists 
could not previously have anticipated adverse effects without the 
growing scientific data base of human epidemiological, experimental 
animal, and toxicological mechanistic studies. This large and evolving 
data base defines significant toxic risks across a wide spectrum of 
doses or exposures.
    The available information on the adverse health effects of arsenic 
in drinking water and in other media are to be found in various 
authoritative expert consensus documents listed in this paper's 
illustrative bibliography. These include documents of Federal agencies 
such as the EPA, and independent scientific bodies such as the National 
Academy of Sciences (NAS). These treatises and individual critical 
reviews and research papers form the foundation of the analyses and 
conclusions presented in this paper. This analysis and its conclusions 
about the impact of tap water arsenic on public health are focused on 
adverse effects associated with the element's toxicological character. 
Some experimental animal studies of arsenic's biological activity in 
recent years have suggested a potential role for the element as a 
nutrient in those animal species tested. Nutrient roles at very low 
intakes and toxic effects at higher intakes are not uncommon with 
environmental elements and do not, in any way, ease the need for 
control of excessive exposures. A nutrient role in humans, within the 
framework of the battery of widely accepted criteria to establish such 
roles, has not been determined for arsenic.
    Indeed, the NAS's recent report on arsenic in drinking water notes 
that ``studies to date do not provide evidence that arsenic is an 
essential element in humans or that it is required for any essential 
biochemical process.'' (NAS, 1999, p. 259) Any nutrient role would have 
to be at very low levels, in common with other elements with dual 
bioactivity. It is highly unlikely that arsenic could ever be regulated 
to levels so low that any yet-to-be-established human deficiency for 
the element would occur. This topic was discussed in detail by the 
author elsewhere (Mushak, 1994).
Arsenic-Induced Skin and Internal Cancers
    Long-term exposure of nonoccupational human populations to 
environmental arsenic is associated with skin cancer and with various 
internal cancers, such as bladder, kidney, liver, and lung cancer. The 
NAS's 1999 report on arsenic in drinking water concluded that arsenic 
is ``known'' to cause skin, bladder and lung cancer, and noted that 
there is substantial evidence that arsenic in drinking water is 
associated with other cancers, including cancers of the liver and 
kidney.
    Workers encountering airborne arsenic in the workplace are known to 
be at high risk for lung cancer and possibly other cancers as well. 
Nonworker populations who have been intensely studied for increased 
prevalence and incidence of skin and internal cancers, and whose cancer 
histories underlie the calculations of cancer risks for Americans 
exposed to drinking water arsenic, received their cancer-causing 
arsenic exposures from arsenic in drinking water. Consult the 
bibliography for further details. Among the key references are the 1984 
EPA health assessment document for arsenic, the 1988 EPA assessment of 
some specific issues for arsenic and human health, the EPA 1996 
document for arsenic health assessment, and the 1999 NAS detailed 
report on cancer and other adverse effects, Arsenic in Drinking Water.
    Some of the most compelling evidence for arsenic as a carcinogenic 
(cancer-causing) substance is to be found in various studies of a large 
Taiwanese population exposed to arsenic in their drinking water. Also 
compelling are data showing elevated cancer rates in people who drank 
arsenic-contaminated water in Argentina and Chile. The Taiwanese study 
population was huge, numbering more than 40,000 subjects, and included 
a large control population with more than 7,000 individuals. Study 
groups of these sizes in the environmental epidemiology of toxic 
elements are not very common. The earliest cancers appearing in these 
Taiwanese and in other groups were skin cancers--consisting of various 
histopathological types--followed later in their lives by cancers of 
internal organs--bladder, kidney, liver, lung. Arsenic-associated skin 
cancers occur in specific body areas not exposed to sunlight: the 
trunk, soles, and palms. Therefore, arsenic cancer lesions can be 
distinguished from cancers caused by sun exposure.
    Additional strong evidence that arsenic in drinking water causes 
cancer is from Chile, where a larger population was studied than that 
in Taiwan--more than 400,000 people. Researchers evaluating this 
Chilean population found marked increases in mortality for bladder and 
lung cancer in particular. Approximately 7 percent of all deaths over 
age 30 could be attributed to arsenic (Smith AH et al. 1998).
    Some regulators and others have argued that the threat to life 
caused by arsenic-associated cancers differs between skin cancers and 
cancers of the bladder, kidney, liver, or lung. They argue that the 
latter cancers collectively offer a higher mortality risk and are 
therefore more life-threatening. This distinction is hardly reassuring, 
nor does it counsel neglect of skin cancer as a public health concern. 
Only some of the arsenic-associated cancers arising in skin and 
associated with arsenic are benign (the basal cell lesions) while the 
squamous cell carcinomas may metastasize to other organs. In any event, 
the findings of internal organ cancers in reports that are more recent 
than those for skin cancers have significantly reinforced public health 
and safety concerns associated with arsenic.
    While some regulators have suggested that skin cancer should be 
downgraded as a health concern because it sometimes is not fatal, is 
inappropriate to consider only fatal cancers in assessing arsenic's 
risks to public health. Nonfatal cancers inflict enormous emotional and 
economic costs to the victims of these cancers, their families, and 
society as a whole.
    Not surprisingly, new findings on arsenic carcinogenesis have 
generated a number of recent studies, such as ones looking at how 
representative the Taiwanese population data are for risk analyses in 
U.S. communities exposed to arsenic in drinking water and other 
environmental media. Some in industry and their representatives have 
challenged the Taiwanese data, despite the fact that the Taiwanese data 
are the most extensive to date, and that rates of cancers associated 
with drinking water arsenic are proportional, considering varying 
exposure levels, to those found in other geographically distinct areas, 
such as Argentina and Chile.
    To date, however, no one has successfully challenged the view by 
U.S. regulators and the NAS that the Taiwanese and Chilean studies 
provide strong evidence of arsenic's carcinogenicity in humans. Several 
appraisals of these challenges merit comment and the author noted these 
in a 1995 paper (Mushak and Crocetti, 1995).
    Some attacks on the Taiwanese data have argued that the nutritional 
status and metabolic aspects of the study population put it at greater 
risk for toxicity from arsenic exposures than U.S. communities. 
However, the results of these studies have not produced any convincing 
challenges to the scientific validity of the data on nutritional 
grounds (Mushak and Crocetti, 1995). Impaired nutrition as a factor 
producing increased arsenic toxicity in Taiwanese, even if it were 
valid, is hardly an exclusionary criterion for comparisons with 
Americans. The argument of differential nutrition requires that we 
assume Americans exposed to drinking water arsenic, unlike the 
Taiwanese, are all well-nourished and at lower risk for arsenic 
toxicity. This is simply untrue. Undernutrition is a chronic public 
health and societal problem in America, including for those in the 
high-risk arsenic groups, the elderly and young children (see below).
    Industry and some others have cited additional factors to argue 
that one cannot compare the Taiwanese exposures to arsenic to American 
arsenic exposures. They have claimed that other contaminants, such as 
alkaloids, in the Taiwanese well water are the culprits or at least co-
culprits. Again, this argument is unconvincing. For example, arsenic 
produces cancers and other arsenic-associated effects in a number of 
other exposure settings comparable to the Taiwanese situation, but 
where alkaloidal contaminants are absent.
    Others have held that the Taiwanese have genetic determinants that 
alter arsenic metabolism in the body, resulting in a different 
likelihood of cancers, but genetic predisposition to arsenic-associated 
cancers also remains an open issue. Some recent studies suggest that 
there may be genetic polymorphism (that is, many different human 
genetic types) in the enzyme pathway which is thought to detoxify 
arsenic in our body (``detoxifying biomethylation''), but such 
polymorphism has yet to be linked to risk differences for various 
cancers. Furthermore, we do not know the range of genetic diversity in 
Americans with respect to these arsenic methylation enzymes. Nor do we 
have a good handle on the mechanisms of arsenic carcinogenesis, or the 
metabolic transformations of the element. Research has also suggested 
that increased arsenic methylation may be linked to a higher cancer 
risk. This author first hypothesized in 1983 that the body's metabolic 
diversion of methyl groups away from needed bodily processes to 
detoxifying arsenic could be a factor in causing arsenic toxicity 
(Mushak, 1983). Thus, as NAS's 1999 report concluded, there is no basis 
on which to rest any argument that the solid body of Taiwanese data 
associating arsenic in tap water with several cancers, or the 
confirmatory data from Argentina and Chile, should be rejected.
    These studies, taken together, paint a compelling picture. They 
have lead the NAS and many other august bodies to conclude that arsenic 
in drinking water is known to cause cancer in humans.
Noncancer Adverse Effects of Arsenic
    Low-level arsenic exposure has other toxic effects besides cancer. 
Inorganic arsenic in drinking water has been associated with toxicity 
to the central and peripheral nervous systems, the heart and blood 
vessels, and various precancerous lesions in the skin, including 
hyperkeratosis, a pronounced scaly skin condition, and changes in 
pigmentation. These skin changes are so characteristic that the medical 
literature notes that laypeople could easily identify workers who used 
arsenic as a sheep-dip pesticide, simply because of their obvious skin 
lesions.
    Ingested inorganic arsenic produces both central and peripheral 
nervous system effects in exposed humans. Peripheral nervous system 
effects on both sensory and motor nerve function mainly harm adults, 
while very young children are more susceptible to central nervous 
system effects on the brain. The effects of arsenic exposure in 
children may persist over the long term, based on data described in 
EPA's 1984 health assessment document (EPA, 1984). Irreversible 
toxicity must obviously be viewed much more seriously than reversible 
effects. Once injury has occurred, simply reducing the exposure does 
not undo the harm.
    Exposures to arsenic in drinking water and other media also cause 
toxic effects on peripheral blood vessels. In its extreme form, vessel 
toxicity takes the form of a dry gangrene, called Blackfoot Disease, 
particularly noted in the more heavily exposed Taiwanese. Lower 
exposures were linked to a very painful peripheral blood vessel 
disorder in Chilean children exposed to drinking water arsenic, 
resembling Raynaud's Disease. The latter arises from arterial and 
arteriolar spasm and contractions leading to impaired blood flow and 
cyanosis (inadequate oxygen reaching the tissues). Studies also have 
linked arsenic exposure from drinking water to higher rates of 
diabetes.
    Data from the Taiwanese studies and from studies of other 
populations reveal that there is a dose-response relationship for 
ingested water arsenic and several non-cancer toxic effects (NAS, 1999; 
EPA, 1984, 1996). By dose-response relationship, we simply mean that as 
the arsenic intake increases, both the frequency and the severity of 
toxic effects increase in the exposed people. This type of dose-
response relationship is one of the most important pieces of evidence 
that health scientists use to determine that a toxic chemical actually 
causes a particular toxic effect. For example, scientists have 
documented a dose-response relationship in human populations showing 
that increased exposure to arsenic in drinking water causes more 
frequent and more severe skin lesions and serious vascular effects.
    Arsenic also has been linked to injury to the cardiovascular 
system, a particular concern in the United States where cardiovascular 
diseases already are a major public health concern. Elevated arsenic 
exposures should be considered a potential added risk factor in 
addition to other widely recognized risk factors for cardiovascular 
diseases.
Who in America is at special risk for adverse health effects from 
        environmental arsenic?
    Different people respond to exposure to arsenic or other toxins in 
different ways. The toxic responses can vary greatly, even when people 
are exposed to the same amount of a contaminant such as arsenic.
    There are many reasons for this variability in toxic response, 
arising from either intrinsic factors or extrinsic causes. Intrinsic 
factors are those peculiar to the individual, and over which the 
individual has little control, for example, gender, age, race, stage of 
development, or group behavioral traits. Extrinsic factors are those 
outside the individual's characteristics and include length of exposure 
to a toxic substance. A general discussion of characteristics that can 
heavily influence the differential toxicity of toxins to different 
individuals, in the context of lead, is included in the NAS's 1993 
report on populations sensitive to lead exposure (NAS, 1993a), of which 
the chief author of this report was a co-author. A second NAS report 
appearing in 1993 (NAS, 1993b) detailed the increased sensitivity of 
very young children to pesticides compared to adults. As discussed 
below, many of the basic principles that may lead to higher risks in 
children from lead or pesticides (for example, children's immature 
detoxification systems and higher exposure to drinking water per unit 
of body weight) apply to arsenic.
    Variability in the human population's sensitivity to environmental 
contaminant toxicities is now an accepted principle in scientific, 
regulatory, and legislative quarters. This acceptance by science is 
found in numerous documents and individual research papers dealing with 
environmental contaminants, illustrated in the cited treatises and 
papers. Agencies such as the EPA regulate environmental metals and 
other contaminants with an eye to those populations at special risk, 
not ``average'' populations. That is, population segments with 
particular biological sensitivities or enhanced exposures are 
identified in relevant rulemaking for adequate protection from exposure 
and associated toxic harm.
    In 1996 Congress enacted the Food Quality Protection Act (FQPA), 
Pub. L. No. 104-170, 110 Stat. 1489 (1996), partly in response to the 
1993 NAS report on children and pesticides (NAS, 1993b), Pesticides in 
the Diets of Infants and Children. The FQPA mandates special protection 
for young children from pesticides, including a general requirement 
that an added tenfold margin be included to ensure safety for children, 
unless reliable data show that such an additional safety factor is 
unnecessary to protect children. Similarly, Congress adopted the 
``Boxer Amendment'' in the 1996 Safe Drinking Water Act Amendments, 
which requires EPA to consider children, infants, pregnant women, and 
other especially vulnerable subpopulations in setting drinking water 
standards. SDWA Sec. Sec.  1412(b)(1)(C), (b)(3)(C)(5), 1457(a).
    We can readily identify two segments of the U.S. population that 
are at risk. First, older adults who have sustained elevated arsenic 
exposures over the long term are at special risk. Both cancer and 
noncancer toxic effects can occur in these individuals as a result of 
their prolonged exposure.
    Second, very young children can be at elevated risk. The very 
young, especially infants and toddlers, are more likely to come into 
direct contact with arsenic. For instance, they often put arsenic-
contaminated items in their mouths. In addition, pound for pound they 
consume more arsenic and other contaminants than adults. A higher 
arsenic intake rate for children per unit of body weight has been 
shown, as seen for example in the 1999 study of Calderon et al. 
evaluating American subjects. Additionally, the very young, being less 
able to defend against toxicants than are older children or adults. In 
the case of arsenic, we have to take into account that the very young 
do not detoxify arsenic as efficiently as adults, as shown in recent 
studies. Data from a study by Concha (1998a) indicate the fraction of 
toxic inorganic arsenic found in exposed children's urine is about 50 
percent higher than it is in adult women exposed to similar levels. 
These investigators found that about 50 percent of the arsenic in 
children's urine was in the toxic inorganic form, while the adults had 
just 32 percent inorganic form, suggesting that children may be less 
able to detoxify arsenic and therefore may be more susceptible to its 
toxic effects. Data from a study by Kurttio et al., (1998) indicate 
that this differential in biomethylation-detoxification may persist 
over many years. We also must consider that children are more sensitive 
to the central nervous system effects of arsenic than adults are, and 
that children who sustain central nervous system injuries from arsenic 
may have irreversible injury, as noted above (EPA, 1984).
    A third high-risk population, not fully characterized, is fetuses, 
which can be exposed to arsenic by way of maternal exposure. Arsenic, 
like a number of other environmental contaminants, crosses the 
placental barrier in pregnant mammals (for example, NAS, 1999). The 
fetus is even more biologically sensitive than the infant and toddler. 
Arsenic intoxication of the conceptus (human embryo relatively shortly 
after conception) can potentially target both organogenesis (the 
generation of the developing vital organs) in the embryo stage and 
further development in the later, fetal stage. While no in-utero 
arsenic effects have been documented for human exposures, we do know 
that oral intake of arsenic in experimental animal studies produced 
birth defects, impaired fetal growth, and reduced the survival of fetal 
and newborn animals (see, for example, NAS 1999). Of particular concern 
here is the recent finding that arsenic enters the fetal circulation in 
pregnant women by at least the third trimester, and that the level of 
arsenic in umbilical cord blood approaches the maternal arsenic level 
(Concha et al., 1998b).
    Because of variations in human sensitivity to arsenic, including 
indications that children may be more vulnerable to this toxin, the NAS 
(1999) suggested that ``a wider margin of safety might be needed when 
conducting risk assessments of arsenic because of variations in 
metabolism and sensitivity among individuals or groups''(p. 5). The 
next chapter, dealing with conclusions about the regulatory status of 
drinking water arsenic in America, focuses on these risk groups.
                                 ______
                                 
                               Chapter 3
           conclusions for safe regulation of drinking water
What can we conclude about the adequacy of the U.S. EPA's current 
        drinking water standard for arsenic?
    The present EPA drinking water standard, as an enforceable Maximum 
Contaminant Level (MCL), is 50 micrograms of arsenic per liter water 
(50 g/L, equivalent to 50 parts per billion, or ppb). This 
value has not changed since 1942, and was promulgated with few 
scientific underpinnings. There is therefore little scientific support 
for its regulatory adequacy. This MCL was issued before the 
accumulation of the large body of scientific and human health data 
produced over the last 30 to 40 years, a period that included the 
Taiwanese studies and numerous authoritative treatises on arsenic, 
including some from the NAS and EPA. As long ago as 1962, the U.S. 
Public Health Service recommended that water containing more than 10 
g/L (or ppb) of arsenic (one-fifth of the still-current 
standard) should not be used for domestic supplies.
    Congress has directed EPA to update the 1942 arsenic standard three 
times--in 1974, 1986, and 1996. A court ordered EPA to complete this 
task in the early 1990's, but several extensions were granted. EPA 
still has not updated the standard. In a legislative mandate in the 
Safe Drinking Water Act Amendments of 1996, Congress again directed EPA 
to publicly propose an updated arsenic standard based on current 
evidence by January 1, 2000, a deadline that EPA has now, again, 
missed. EPA is then required to promulgate the final arsenic standard 
by January 1, 2001.
    The current scientific and health risk assessment status of arsenic 
within that mandate makes it clear that EPA's current MCL of 50 
g/L is grossly inadequate for protecting public health. The 
extent of that inadequacy is effectively captured in the NAS report, 
Arsenic in Drinking Water (NAS, 1999). The report focused heavily on 
risk assessment estimates for human cancer frequencies as a function of 
drinking water and food arsenic and derived cancer risks for arsenic in 
environmental media, particularly drinking water. Our analysis concurs 
strongly with the academy's findings and recommendations as well as the 
following conclusion:
    On the basis of its review of epidemiological findings, 
experimental data on the mode of action of arsenic, and available 
information on the variations in human susceptibility, it is the 
subcommittee's consensus that the current EPA MCL for arsenic in 
drinking water of 50 g/L does not achieve EPA's goal for 
public-health protection and, therefore, requires downward revision as 
promptly as possible (NAS, 1999, pp. 8-9).
    The NAS report did not recommend a specific MCL below 50 that would 
be fully health protective. It did, however, provide a series of cancer 
risk assessments for cancers of the skin and internal organs. This 
approach for bladder and lung cancers employed the traditional 
straight-line extrapolation from rates at elevated arsenic exposures. 
Put differently, the NAS assumed--as is usually assumed by scientists 
based on traditional principles of toxicology, unless there is strong 
evidence to the contrary--that there is a direct, linear relationship 
between cancer risk and arsenic exposure. The academy committee 
members, correctly and conservatively (with respect to the best health 
protection), noted that low-dose extrapolation models based on 
available data may or may not be ``sublinear'' compared to linear 
extrapolation. That is, arsenic at extremely low doses may, or may not, 
cause relatively less cancer risk per microgram than it does at high 
doses. However, the NAS experts concluded, the evidence for such ``non-
linear'' models of arsenic-associated cancer risk is not compelling 
enough to rule out the traditional linear approach, so the health-
protective linear approach should be used. The NAS scientists then used 
studies of people who had been exposed to arsenic in their tap water at 
elevated levels (for example in Taiwan) to model, or estimate, the 
risks of people exposed to lower levels.
    The 1999 NAS report calculated that arsenic consumption in drinking 
water at the current EPA MCL would produce a male fatal bladder cancer 
lifetime risk of 1 per 1,000 to 1.5 per 1,000, using a linear 
extrapolation approach. Factoring in lung cancer risk and its relative 
robustness compared to bladder cancer (lung cancer risk is about 2.5 
times greater than bladder cancer risk), an overall internal cancer 
risk rate ``could easily result in a combined lung cancer risk'' of 1 
percent, or 1 in 100, according to the NAS's 1999 report (p. 8). The 
high level of cancer risk from arsenic ingestion in water at the 
present MCL does not account for concurrent intakes of carcinogenic 
arsenic from food or idiosyncratic sources (for example, certain 
prepared ethnic remedies that contain arsenic). In the past, EPA 
estimated a lower cancer risk from arsenic in tap water than did NAS in 
1999. For example, EPA's Integrated Risk Information System (EPA, 1998) 
estimated about a 10fold lower cancer risk for arsenic than the more 
recent NAS study (NAS, 1999), apparently in part because EPA evaluated 
only bladder cancer risks, whereas NAS considered the higher risk of 
lung cancer as well, based on recent studies. We believe the NAS risk 
estimates are more reliable and should be adopted by EPA.
    The lifetime risks of dying from internal cancers due to drinking 
water arsenic estimated in this paper based on linear extrapolations in 
this paper from the NAS 1999 arsenic report are generally supported by 
studies of people drinking relatively low levels of arsenic in their 
tap water. For example, a recent study from Finland (Kurttio et al., 
1999), found that Finns who drank water containing low levels of 
arsenic (less than 0.1 ppb) had about a 50 percent lower risk of 
getting bladder cancer than their countrymen who drank water containing 
somewhat more arsenic (0.1 ppb to 0.5 ppb). Significantly, people who 
drank more than 0.5 ppb arsenic had more than a 140 percent increase in 
bladder cancer rates compared to those who consumed levels less than 
0.1 ppb.
    The pros and cons of models that characterize cancer risk bring up 
the role and judgment of risk assessors. The NAS's 1983 seminal 
document on risk assessment in regulatory agencies and elsewhere in the 
Federal Government (NAS, 1983) suggested a four-part paradigm for 
quantifying health risk that is now widely used in various incarnations 
by governmental agencies and others. The 1983 report also repeatedly 
made note of the role of judgment in the risk assessment process, a 
fact too often ignored by interested parties viewing regulatory risk 
assessment models. Without a totally clear scientific consensus on the 
guaranteed best scientific approach, or in the face of equally 
acceptable approaches, we must opt for the scientific approach that 
provides the maximum protection for human populations. The linear 
extrapolation approach adopted by the NAS subcommittee is in full 
accord with this principle, which should apply to assessment of cancer 
risks for environmental contaminants.
What can we conclude about the adequacy of other regulatory guidelines 
        or standards for arsenic, for example the EPA reference dose 
        (RfD) for ingested arsenic?
    EPA issues guidelines for the intake levels of environmental 
contaminants that the Agency generally considers to be free of toxic 
risk during long-term, that is, lifetime, exposures. In the case of 
oral intakes these values are called reference doses, RfDs. They are 
expressed in milligrams (mg) of contaminant daily intake per unit body 
weight in kilograms (kg-day). RfDs, being derived for oral intakes, do 
not usually take account of other routes of intake. Inhalation of 
contaminants might be a significant exposure route, in which case a 
reference concentration, RfC, expressed as milligrams per cubic meter 
of ambient air, may also be used. It is important to note that if more 
than one exposure route is significant, we must recognize that the RfD 
is less protective than we would otherwise conclude if we thought that 
arsenic in drinking water was the sole route of exposure. EPA, in its 
general description of the RfD approach, notes the need to take account 
of other intake routes (EPA, 1993).
    EPA has set the RfD for ingested inorganic arsenic, the amount 
viewed as not being linked to any health risk, at 0.0003 mg/kg-day (0.3 
g/kg-day). This value is derived for skin hyperpigmentation 
and keratosis and potential vascular effects. Analyses in the 
preparation of this paper, including a review of health effects data 
for the United States, found no currently valid and convincing reasons 
to say this value is too low. Thus, no higher RfD is warranted.
    EPA's failure to fully consider risks to children in the RfD 
derivation is of concern. It is true that early childhood is only a 
fraction of the total lifetime interval considered when deriving an RfD 
for lifetime effects of arsenic. However, the relatively inefficient 
detoxification of a potent carcinogen and toxin by children, and the 
increased sensitivity (and higher exposure per unit of body mass) of 
children to arsenic-associated central nervous system effects, are 
serious issues. EPA should revise the current RfD downwards to account 
for the apparent elevated vulnerability of children; the data certainly 
do not support any upward revision of the current value.
    In addition, EPA has not reconciled the health risks represented by 
the current RfD value based on noncancer toxic effects with the 
internal cancer risk estimates calculated for drinking water arsenic in 
the 1999 NAS report. The current RfD permits a ``safe'' daily intake by 
a 70 kg adult male of 21 g arsenic per day. Risk-
characterization estimates in the NAS report for the MCL value permit 
calculation of a cancer risk for this ``safe'' 21 g daily 
intake that markedly exceeds any acceptable regulatory risk management 
guideline for cancer. Put differently, the amounts of arsenic intake 
that may be safe for noncancer risks are unsafe for cancer risks.
    To protect children and infants, an RfD at least threefold lower, 
0.1 g/kg-day, is certainly more defensible and more protective 
of identifiable at-risk populations in the United States. This 
adjustment is based upon standard EPA use of ``uncertainty'' factors 
for the RfD. The current uncertainty factor of three should be 
increased 10, the next generally permitted level for such a factor, 
based on concerns about the special susceptibility of children. Even 
such a lower RfD, it should be noted, would still present a cancer risk 
higher than EPA would generally consider acceptable. We recommend that 
the RfD be reduced to at most this level.
What can we conclude about what a health-protective level of arsenic in 
        U.S. drinking water supplies should be to prevent cancer and 
        noncancer effects in the U.S. population?
    According to the data, we need a much lower and more protective EPA 
standard for drinking water arsenic and a much lower and more 
protective reference dose guidance level for arsenic.
    Given the risk estimates for all internal cancers provided in the 
NAS's 1999 report, the current EPA MCL for arsenic must be revised 
downward to no higher than a value at the Practical Quantitation Level 
(PQL) of 3 ppb. EPA completed a thorough review of laboratory 
capabilities in 1999, and concluded that the PQL is 3 ppb (Miller, 
1999). Thus, a new MCL of 3 ppb is reasonable, based on the newest 
analytical methodology assessment from EPA (which is more current than 
the 4 ppb figure cited by NAS, 1999, a level based on earlier studies, 
see, Eaton et al., 1994; Mushak and Crocetti, 1995).
    Our conclusion that the MCL should be 3 ppb is driven by 
practicality, that is, one cannot regulate below what one can measure 
for compliance. This does not say that values lower than the PQL of 
about 3 ppb pose no cancer risk; it only recognizes that quantification 
of these lower levels in drinking water is problematic at this time. 
While many laboratories can reliably detect arsenic at levels below one 
ppb, reviews of a variety of laboratories to date have found that many 
others are unable to reliably detect and quantify the concentration of 
arsenic at these levels. As the NAS recommended in its 1999 report on 
arsenic in drinking water, EPA should immediately seek to reduce the 
PQL for arsenic by developing and standardizing improved analytical 
techniques for arsenic. The only alternative to setting an MCL at the 
PQL would be for EPA to establish a ``treatment technique'' for 
arsenic, an approach that seems difficult to justify here since arsenic 
is reliably detectable down to the low ppb range.
    There is no scientifically sound reason for increasing the 
noncancer RfD value from 0.3 g/kg-day to a higher value. To 
the contrary, as noted above, there is good reason to adjust the value 
lower. Adults ingesting the ``safe'' arsenic dose for noncancer effects 
will simultaneously be at too high a risk for internal organ cancers. 
While EPA's risk management guideline for permissible skin cancer risk 
was changed to 1 in 10,000 in 1988, the guideline for the more 
dangerous, more often fatal internal cancers should remain at 1 in 
1,000,000. One cannot get to anything near this cancer rate guideline 
with the present RfD value if one assumes significant contribution of 
carcinogenic inorganic arsenic from food.
    For these reasons, an RfD at least threefold lower, 0.1 g/
kg-day, is certainly more defensible and more protective of 
identifiable at-risk populations in the United States.
How can we prevent arsenic from getting into drinking water, or remove 
        it from drinking water once it's there?
    1. Preventing Arsenic From Getting Into Water Supplies.
    Arsenic gets into drinking water from a variety of sources. Sources 
from human activities include:
    Leaking of arsenic from old industrial waste dumps. Arsenic is one 
of the most common contaminants found at Superfund sites, for example.
    Leaching of arsenic from mines and mine tailings. Some hard-rock 
and other mines expose arsenic-bearing rock to the elements, 
``liberating'' the arsenic into the environment, and in some cases 
causing serious arsenic contamination of ground and surface water.
    Runoff or leaching of old arsenic-containing pesticides from sites 
where they were heavily used. In some cases, the old arsenic-based 
pesticides remain in the areas where they were applied, manufactured, 
or disposed of years ago, and can get into water supplies.
    Heavy groundwater pumping. Recent studies in Wisconsin and 
elsewhere have shown that heavy pumping of groundwater has increased 
arsenic levels in some wells. In some cases heavy pumping appears to 
have pulled water out of heavily arsenic-contaminated layers of rock 
that were not the primary aquifer being tapped but had not been sealed 
off from the well. In other cases, possibly because overpumping appears 
to have caused groundwater levels to drop, increasing arsenic-bearing 
rock contact with air and thereby increasing arsenic leaching).
    Cleaning up old dumpsites under Superfund and related programs may 
reduce arsenic contamination in some systems affected by arsenic from 
industrial sites. Additionally, arsenical pesticide hot spots, and 
certain mine waste sites, are sometimes covered by Superfund or other 
cleanup laws and should be addressed in order to reduce water 
contamination.
    Efforts to reduce leaching and drainage from mines and mine 
tailings by improving reclamation and mining practices should also be 
undertaken to reduce arsenic loading into many water sources. 
Furthermore, it is worth investigating whether reworking contaminated 
wells (for example, using a casing and cement to seal off arsenic-
bearing rock layers that may be leaking water into the well) and/or 
reducing pumping rates may in some cases reduce arsenic levels in 
systems. Government officials and water systems should work with 
citizens to remedy these problems so water supplies are not 
contaminated by arsenic and do not need to be treated for arsenic 
removal.

    2. Readily Available Treatment Technologies Can Remove Arsenic from 
Drinking Water.
    The best way to avoid arsenic contamination from reaching our taps 
is to prevent it from getting into the environment in the first place. 
Where prevention is not possible, as when the arsenic occurs naturally, 
and when no alternative water source is available and the system cannot 
consolidate with another, cleaner water system, water treatment is 
readily available. Treatment already in use by some progressive water 
utilities has been demonstrated to reduce or essentially eliminate 
arsenic contamination of tap water. Among the effective arsenic 
treatment options EPA has identified (EPA, 1999; EPA 1994) are:
    Modifying Existing Coagulation and Filtration. Large water systems 
that already have coagulation and filtration technology (as most 
surface water systems do) can take simple steps to modify these 
processes to substantially reduce arsenic levels. Changing their use of 
iron or manganese oxidation, use of ferric chloride or ferric sulfate, 
and alum coagulation and filtration can reduce arsenic by 80 to 95 
percent. These steps are relatively inexpensive.
    Water Softening with Lime. Many water systems already use lime to 
``soften'' their water (that is, to reduce water ``hardness'' by 
removing the minerals calcium and magnesium). We now know that 
softening, if optimized, can reduce arsenic levels by 60 to 90 percent. 
It is about as inexpensive as coagulation and filtration modifications.
    Activated Alumina. Activated alumina can be packed into beds 
through which water is run in a treatment plant to remove arsenic. 
While this method works well for most waters, if the source water has 
high levels of selenium, fluoride, or sulfate, it is not as effective 
at arsenic removal.
    Ion Exchange. This technology, already used by many water systems, 
can remove arsenic effectively in most water. Again, however, if levels 
of certain other chemicals (such as sulfate, selenium, fluoride, or 
other dissolved solids) are too high, pretreatment using other 
technologies is needed to assure that adequate levels of arsenic are 
removed.
    Electrodialysis Reversal. Essentially the same process as used to 
clean blood at dialysis centers, electrodialysis takes advantage of the 
charge of particles (like arsenic) and a special membrane under the 
influence of an electric current, and can remove about 80 percent of 
arsenic from water.
    Reverse Osmosis and Nanofiltration Membranes. RO and NF membranes 
can remove 90 percent to more than 95 percent of arsenic. These 
membranes can reject substantial amounts of water, and therefore waste-
stream recovery or other actions may be necessary in the arid West. 
Also, particularly if arsenic levels in the raw water are high, 
treatment or disposal of the concentrated brine created by removing the 
arsenic from the water can increase costs.
    Point of Use and Point of Entry Treatment. Under the 1996 Safe 
Drinking Water Act Amendments, water suppliers are authorized, under 
strict conditions, to use point-of-use filters (for example, RO units 
installed under kitchen sinks) or point of entry filters (for example, 
treatment devices in the basement at the point water goes into the 
home) to comply with drinking water standards. EPA studies have shown 
that these devices can be affordable and effective to treat for 
arsenic, and may be cheaper for small systems than installing 
centralized treatment. For this to work in a national rule, EPA would 
have to clarify utilities' utility responsibility in assuring the 
continued operation and maintenance of such devices.

    3. Treatment Costs to Remove Arsenic are Modest for Most Consumers.
    For several years, EPA has been evaluating the cost of installing 
treatment to meet various Maximum Contaminant Levels (MCL) for arsenic. 
EPA's most recent public analysis (Taft, 1998) found that if the 
standard were lowered from the current 50 ppb down to 5 ppb, it would 
cost most households (those served by city systems serving 100,000 
people or more) about $2 a month, and would cost up to $14 a month for 
people living in smaller towns (with 10,000 to 100,000 people). Even a 
standard as low as 2 ppb would cost city dwellers with arsenic problems 
about $5 a month, and those living in affected towns as small as 10,000 
people would pay about $14 a month.
    Systems serving over 10,000 people serve the vast majority of 
people affected by arsenic contamination. Our analysis of EPA's 25-
state arsenic data base shows that about 9 out of 10 people (87 
percent) who consume arsenic at a significant level in their tap water 
(over 1 ppb) are served by these systems serving more than 10,000 
customers.
    For the 13 percent of consumers who get their water from smaller 
systems, however, treatment costs can be significantly higher than they 
are for consumers in cities, because of the lack of economies of scale. 
Thus, EPA estimates that people drinking water from a system serving 
3,300 to 10,000 people may have to pay as much as $20 a month, and the 
smallest systems (assuming the worst case and that no point-of-use or 
other devices were allowed) could reach $100 a month (Taft, 1998).
    Using these figures, EPA has estimated that a 5 ppb arsenic rule 
would cost about $686 million per year, and a 2 ppb standard would cost 
$2.1 billion. However, EPA recently admitted (Taft 1998) that both 
these national cost estimates and the individual household cost 
estimates are probably overstatements of the true costs of treatment 
for several reasons:
    Most important, EPA assumed that all systems that exceeded the MCL 
would install full treatment of all of their water to get it well below 
the MCL. More recent analysis shows, however, that most water systems 
would actually treat only some of their water and then would blend it 
with untreated water, in order to produce water just under the MCL, to 
keep the costs down.
    EPA assumed that if a water system with multiple wells has just one 
or a few wells exceeding the arsenic MCL, the system will treat all of 
its wells, including those below the MCL; EPA now understands that this 
is extremely unlikely.
    EPA's estimates did not account for recent advances in treatment 
technologies, such as the newly understood ability of the relatively 
inexpensive ion-exchange treatment to effectively treat all but the 
highest sulfate waters.
    EPA's estimates failed to account for improvements in water quality 
that are expected to be required by other EPA rules, such as the 
groundwater rule, the Stage 2 Microbial and Disinfection Byproducts 
rule, and the uranium rule, all of which are expected to drive many 
water systems to use treatment that will also reduce arsenic.
    The older EPA estimates do not consider the availability of point-
of-use and point-of-entry devices now authorized by the 1996 SDWA 
Amendments, technologies that are substantially less expensive than 
centralized treatment for many small systems.
    EPA's cost estimates do not account for expected reductions in 
treatment costs as more treatment technology is installed.
    4. The States and Federal Government Should Assist Small Systems 
That Cannot Afford Arsenic Treatment.
    Even with these reasons to believe EPA is overestimating costs, it 
is clear that at least some small systems will have to pay relatively 
high costs per household to have arsenic-safe water. For these smaller 
systems, Federal and state assistance to improve treatment is 
available, and arsenic contamination should be a high priority for 
these drinking water funds. Additional Federal and state funding 
through State Revolving Funds (SRF), USDA's Rural Utility Service, and 
other programs may also be needed. The SRF established by the Safe 
Drinking Water Act Amendments of 1996, which has not been fully funded 
since the act's passage, should be funded at least to the full 
authorized amount ($1 billion per year) to help smaller systems with 
arsenic problems.
    Therefore, even using EPA's high cost estimates, \4\ a strict 
arsenic standard for tap water would be both sound public health policy 
and affordable for consumers. It is EPA's obligation to protect the 
American public from arsenic contaminated tap water, by issuing a 
strict MCL of 3 ppb arsenic.
---------------------------------------------------------------------------
    \4\ The Association of California Water Agencies and the American 
Water Works Association have charged the EPA has underestimated 
national arsenic treatment costs. However, EPA has responded in detail 
to these allegations and thoroughly rebutted these arguments.
---------------------------------------------------------------------------
                              conclusions
    Americans should be able to turn on their taps and be sure that 
their drinking water is safe. Arsenic is perhaps the worst example of 
EPA's failure to address a serious health risk from a chemical 
contaminant in drinking water. The Agency has had over a quarter 
century, since the Safe Drinking Water Act passed in 1974, to adopt a 
modern tap water standard for arsenic, but has failed to do so. The 
time has come for the Agency to act. Specifically, we recommend that:
    EPA Must Immediately Propose and Finalize by January 1, 2001 a 
Health-Protective Standard for Arsenic in Tap Water. The National 
Academy of Sciences (NAS) has made it clear, and we agree, that EPA 
should expeditiously issue a stricter Maximum Contaminant Level 
standard for arsenic. Based on available scientific literature and NAS 
risk estimates, this standard should be set no higher than 3 ppb--the 
lowest level reliably quantifiable, according to EPA. Even an arsenic 
standard of 3 ppb could pose a fatal cancer risk several times higher 
than EPA has traditionally accepted in drinking water.
    EPA Must Revise Downward its Reference Dose for Arsenic. EPA's 
current reference dose likely does not protect such vulnerable 
populations as infants and children. Furthermore, ``safe'' arsenic 
intakes in the RfD present unacceptably high cancer risks. To protect 
children, EPA should reduce this reference dose from 0.3 micrograms per 
kilogram per day (g-kg/day) to at most 0.1 g-kg/day. 
For concordance with cancer risk numbers, EPA should reevaluate the RfD 
in more depth as expeditiously as feasible.
    EPA Should Assure that Improved Analytical Methods Are Widely 
Available to Lower Detection Limits for Arsenic. EPA must act to reduce 
the level at which arsenic can be reliably detected in drinking water, 
so that it can be reliably quantified by most labs at below 1 ppb, the 
level at which it may pose a health risk.
    Water Systems Should be Honest With Consumers about Arsenic Levels 
and Risks. It is in public water systems' best long-term interest to 
tell their customers about arsenic levels in their tap water and the 
health implications of this contamination. Only when it is armed with 
such knowledge can the public be expected to support funding and 
efforts to remedy the problem.
    Water Systems Should Seek Government and Citizen Help to Protect 
Source Water. Water systems should work with government officials and 
citizens to prevent their source water from being contaminated with 
arsenic.
    Water Systems Should Treat to Remove Arsenic, and Government Funds 
Should be Increased to Help Smaller Systems Pay for Improvements. 
Readily available treatment technology can remove arsenic from tap 
water, at a cost that is reasonable ($5 to $14 per month per household) 
for the vast majority of people (87 percent) served by systems with 
arsenic problems. Very small systems serving a small fraction of the 
population drinking arsenic-contaminated water, however, will often be 
more expensive to clean up per household. Assistance to such systems 
should be a high priority for drinking water funds such as the SRF and 
USDA's Rural Utility Service programs. The SRF should be funded at at 
least $1 billion per year to help systems with arsenic problems.
    EPA Should Improve its Arsenic, Geographic Information, and 
Drinking Water Data bases. EPA should upgrade its Safe Drinking Water 
Information System to include and make publicly accessible all of the 
arsenic and unregulated contaminant data, as required by the Safe 
Drinking Water Act. EPA also should require water systems to provide 
accurate lat-long data using GPS systems, which will have widespread 
use in GIS systems by Federal, state, and local officials, and the 
public, for source water protection, developing targeted and well-
documented rules, and for other purposes.
                              bibliography
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Other Reports and Papers
    Calderon RL, Hudgens E, Le XC, Schreinmachers, Thomas DJ. Excretion 
of arsenic in urine as a function of exposure to arsenic in drinking 
water. Environ. Health Perspect. 107: 663-667 (1999).
    Chen CJ, Chen CW, Wu MM, Kuo TL. Cancer potential in liver, lung, 
bladder and kidney due to ingested inorganic arsenic in drinking water. 
Br. J. Cancer 66: 888-892 (1992).
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children with chronic high arsenic exposure in northern Argentina. 
Environ. Health Perspect. 106: 355-359 (1998a).
    Concha G, Vogler G, Lezeano D, Nermell B, Vahter M. Exposure to 
inorganic arsenic metabolites during early human development. Toxicol. 
Sci. 44: 185-190 (1998b).
    Hopenhayn-Rich C, Biggs ML, Smith AH, Kalman DA, Moore LE. 
Methylation study of a population environmentally exposed to arsenic in 
drinking water. Environ. Health Perspect. 104:620-628 (1996a).
    Hopenhayn-Rich C, Biggs ML, Fuchs, A, Bergoglio, R, Tello, EE, 
Nicoli, H, Smith, AH, Bladder Cancer Mortality Associated with Arsenic 
in Drinking Water in Argentina. Epidemiology 7:117-124 (1996b).
    Kurttio P, Komulainen H, Hakala E, Kahelin H, Pekkanen J. Urinary 
excretion of arsenic species after exposure to arsenic present in 
drinking water. Arch. Environ. Contam. Toxicol. 34: 297-305 (1998).
    Lewis, D., Southwick, J., Oullet-Hellstrom, R., Rench, J., 
Calderon, R., Drinking Water Arsenic in Utah: A Cohort Mortality Study. 
Environ. Health Perspect. 107: 359-365 (1999)
    Miller, W., U.S Environmental Protection Agency. Presentation on 
Practical Quantitation Limit for Arsenic Before June 1999 Arsenic 
Stakeholders Meeting. (1999)
    Mushak P. Mammalian biotransformation processes involving various 
toxic metalloids and metals. In: Chemical Toxicology and Clinical 
Chemistry of Metals, (S.S. Brown and J. Savory, Eds.), Academic Press, 
London, 1983, pp. 227-245.
    Mushak P. Persisting scientific issues: Arsenic and human health. 
In: Arsenic Exposure and Health, (W.R. Chappell, C.O. Abernathy, C.R. 
Cothern, eds.), Science and Technology Letters, Proceedings of the 
International Conference on Arsenic Exposure and Health Effects: New 
Orleans, LA, July 28-30, 1993, (publ. 1994) 305-318.
    Mushak P, Crocetti AF. Risk and revisionism in arsenic cancer risk 
assessment. Environ. Health Perspect. 103: 684-689, 1995.
    Smith AH, Hopenhayn-Rich C, Bates MN, Gaeden HM, Hertz-Picciotto I, 
Duggan HM, Wood R, Kosnett NJ, Smith MT. Cancer risks from arsenic in 
drinking water. Environ. Health Perspect. 97:259-267 (1992).
    Kuttrio P, Pukkala E., Kahelin, H., Auvinen, A., Pekkanen., J. 
Arsenic Concentrations in Well Water and Risk of Bladder and Kidney 
Cancer in Finland. Environ. Health Perspect. 107:705-710 (1999)
    Smith AH et al. Marked increase in bladder and lung cancer 
mortality in a region of Northern Chile due to arsenic in drinking 
water. Am. J. Epidemiol., 147:660-669 (1998).
    Taft, J., U.S. Environmental Protection Agency. ``Analysis of 
Arsenic Control Levels Using Existing Information.'' (1998)
    Tondel M, Rahman M, Magnuson A, Chowdhury IA, Faruquee, Ahmad SA. 
The relationship of arsenic levels in drinking water and the prevalence 
rate of skin lesions in Bangladesh. Environ. Health Perspect. 107: 727-
729 (1999).
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skin cancer in an endemic area of chronic arsenism in Taiwan. J. Natl 
Cancer Inst. 40:453-463 (1968).
    Tseng WP. Effects and dose-response relationships of skin cancer 
and Blackfoot Disease with arsenic. Environ. Health Perspect. 19:109-
119 (1977).
    Uthus EO. 1992. Evidence for arsenic essentiality. Environ. 
Geochem. Health 14: 55-58.
    Vahter M. Environmental and occupational exposure to inorganic 
arsenic. Acta Pharmacol. Toxicol. 59:31-34 (1986).
    Warner ML, Moore LE, Smith MT, Kalman DA, Fanning E, Smith AH. 
Increased micronuclei in exfoliated bladder cells of individuals who 
chronically ingest arsenic-contaminated water in Nevada. Cancer 
Epidemiol. Biomarkers Prev. 3:583-590 (1994).
    Yamauchi H, Takahashi, K, Mashiko M, Yamamura Y. Biological 
monitoring of arsenic exposure of gallium arsenide and inorganic 
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(1989).
                               __________
Statement of David Paris, Water Supply Administrator, Manchester Water 
Treatment Plant, Manchester, NH, on Behalf of the American Water Works 
                              Association
Introduction
    Good morning Mr. Chairman. I am David Paris, Water Supply 
Administrator of the Manchester Water Treatment Plant, Manchester, New 
Hampshire. The Manchester Water Treatment Plant provides drinking water 
to 128,000 people in Manchester and the surrounding communities of 
Derry, Londonderry, Grassmere, Goffstown, Bedford and Auburn NH. I 
serve on the American Water Works Association (AWWA) Water Utility 
Council and am here today on behalf of AWWA. AWWA appreciates the 
opportunity to present its view on the implementation of the Safe 
Drinking Water Act Amendments of 1996.
    Founded in 1881, AWWA is the world's largest and oldest scientific 
and educational association representing drinking water supply 
professionals. The association's 56,000-plus members are comprised of 
administrators, utility operators, professional engineers, contractors, 
manufacturers, scientists, professors and health professionals. The 
association's membership includes over 4,2000 utilities that provide 
over 80 percent of the nation's drinking water. AWWA and its members 
are dedicated to providing safe, reliable drinking water to the 
American people.
    AWWA utility members are regulated under the Safe Drinking Water 
Act (SDWA) and other statutes. AWWA believes few environmental 
activities are more important to the health of this country than 
assuring the protection of water supply sources, and the treatment, 
distribution and consumption of a safe and healthful adequate supply of 
drinking water. AWWA strongly believes that the successful 
implementation of the reforms of the SDWA Amendments of 1996 is 
essential to effective regulations that protect public health.
EPA Drinking Water Program
    The Environmental Protection Agency (EPA) drinking water program 
took on greatly increased responsibilities in the 1996 SDWA amendments. 
These responsibilities included developing a new regulatory process 
requiring additional science and risk analysis for regulations, 
creating a contaminant occurrence data base and methodology to select 
contaminants for regulation, promulgating regulations for arsenic, 
radon and microbial and disinfectant/disinfection by-products (M/DBP), 
identifying new treatment technologies for small systems, administering 
the newly created drinking water state revolving fund, and developing 
regulations and guidelines for consumer confidence reports, operator 
certification programs, source water assessment and monitoring relief.
    In satisfying these requirements, EPA has involved the public in 
the regulatory process to an extent not equaled by any other Federal 
agency and stands as a model for Federal rulemaking. EPA has involved 
private citizens, scientists, drinking water professionals, medical 
professionals, public health officials, economists, and environmental 
and consumer advocacy representatives, as well as other experts, to 
provide recommendations on how to carry out these new regulatory 
responsibilities. The EPA Office of Groundwater and Drinking Water is 
to be commended for taking this exemplary approach for public 
involvement that should result in better regulations that protect 
public health.
    However, AWWA does have a major concern that EPA is not conducting 
essential research and developing new data to support drinking water 
regulations as expected in the 1996 SDWA Amendments. There is also a 
long-term concern that the authorizations for the new drinking water 
state revolving fund will not be adequate to address the needs 
identified to comply with SDWA regulations and upgrade drinking water 
infrastructure to ensure that high quality safe drinking water is 
provided to the American people. In this statement, AWWA will focus on 
the research and infrastructure funding needs as well as highlight 
AWWA's concerns with the arsenic, radon, radionuclides and M/DBP 
rulemaking. Although it is not an SDWA implementation issue, this 
statement also will address AWWA's concern about MTBE contamination of 
drinking water an issue that cuts across several statutes and EPA 
programs.
Drinking Water Research
    The use of best-available, peer-reviewed good science as the 
foundation of the new drinking water standard-setting process under the 
SDWA amendments of 1996 will require extensive drinking water 
research--particularly health effects research. Unfortunately, there 
has been a cycle in which critical drinking water research lags behind 
the regulatory process. We must break that cycle. This can be done 
through improved funding and planning.
    The nation needs an integrated, comprehensive drinking water 
research program. EPA must develop research schedules that meet 
regulatory needs along with a research tracking system so that the 
researchers and their EPA project officers can be held accountable and 
Congress must appropriate the funds required to carry out timely 
research. Only with timely appropriations and Congressional oversight 
can EPA, the drinking water community and consumers work together to 
ensure that sound science yields the most appropriate regulations and 
practices possible for the provision of safe drinking water for all the 
people in America.
Drinking Water Research Funding
    Funding for drinking water research is a critical issue. The 1996 
SDWA Amendments require EPA to develop comprehensive research plans for 
Microbial/Disinfection By-Products (M/DBP) and arsenic as well as other 
contaminants. An estimated total of over $100 million is needed for the 
combined arsenic and M/DBP regulatory research plans alone and this 
figure does not include other needed drinking water research on radon, 
a whole array of other radionuclides, groundwater contamination, 
children's health issues, endocrine disruptors, and other new 
contaminants on EPA's Contaminant Candidates List (CCL) that will 
require additional occurrence, treatment, and health effects research.
    In the past year, AWWA and other stakeholders worked closely with 
EPA to resolve any future research resource gaps beginning with the 
fiscal year 2001 budget process. As a result of this cooperative 
approach to determining drinking water research needs, AWWA believes 
that the $48,872,500 requested in the President's Budget for fiscal 
year 2001 is the absolute minimum necessary for fiscal year 2001, (and 
may not be enough) to assure that the essential research will be 
conducted on which to base drinking water regulations as required by 
the Safe Drinking Water Act (SDWA).
    Over the past several years, public water suppliers have worked 
together with EPA and the Congress to secure increased research funding 
for the nation's drinking water program. We believe that, through this 
cooperative effort, essential increases in research dollars have been 
obtained for drinking water over the past few years after several years 
of steady decline.
    In August 2001, EPA will select at least five contaminants from the 
Contaminant Candidate List (CCL) and determine whether or not to 
regulate them. This process will be repeated every 5 years. To 
determine whether to regulate a contaminant and establish a maximum 
contaminate level (MCL) or another regulatory approach, EPA will need 
good health effects research. Recognizing the serious burden this 
regulatory mandate presents, the drinking water community has offered 
its time, resources and expertise to work with EPA to develop a 
research plan for the contaminants on the CCL.
Drinking Water Research Planning
    Developing a comprehensive drinking water research plan is 
necessary. EPA finalized the first Contaminant Candidate List (CCL) in 
February, 1998, which contained 61 contaminants that could be 
considered for future regulations. Of these 61 contaminants, only 12 
currently have adequate information to move forward in the standard-
setting process. The balance of the contaminants (including such 
important contaminants as MTBE, triazines, and acetochlor) need 
additional health effects, treatment, analytical methods, and 
occurrence research. A comprehensive research plan for this large 
number of contaminants needs to be completed, peer-reviewed, adequately 
resourced, and then implemented. EPA has been working over the past 
couple of years to develop such a comprehensive plan. The total funding 
need for a comprehensive research plan is unknown at this time, but the 
amount is expected to be substantial.
    The vast majority of EPA's ongoing drinking water research is 
related to the M/DBP Cluster and arsenic. EPA has established 
innovative research partnerships with the AWWA Research Foundation 
(AWWARF) and the Association of California Water Agencies (ACWA) that 
has partially filled the research gap on these two issues. However, 
very little research is ongoing on other priority regulations such as 
radon, other radionuclides, the filter backwash rule, etc. While the 
research on the M/DBP Cluster and arsenic is important, these other 
priority contaminants and future contaminants for regulatory action 
cannot be neglected.
    Long-range planning is needed to break the cycle of drinking water 
research lagging behind the regulatory needs. Assume that EPA will 
finish their overall contaminant research plan and have it peer 
reviewed by mid-2001. Then, EPA issues a research request, receives 
proposals, selects specific proposals, and contracts for the research. 
This process will take at least 6 months, so the research would not 
start until early 2002. Most research takes a minimum of 2 to 3 years 
to complete, with an added year for complete peer review, so the 
results would be available in 2006. The timing of this future research 
(which is based on a lot of optimistic assumptions)) bumps up against 
the statutory deadline for the second round of regulatory 
determinations in 2001. Since EPA has put a strong emphasis on meeting 
statutory deadlines, the result may be the promulgation of regulations 
without the good science that was envisioned in the 1996 SDWA 
Amendments. Long-range research planning efforts must be accelerated by 
EPA to breaking cycle of research availability only after regulatory 
decisions have been made.
            additional drinking water research improvements
    Recently the National Research Council (NRC), an arm of the 
National Academy Sciences (NAS) recommended that the position of deputy 
administrator for science and technology be created within EPA to 
oversee research throughout the Agency. AWWA has long contended that 
coordination of research in EPA needed to be improved. While EPA 
recently has begun to improve the quantity and quality of its science, 
a higher level of coordination is needed to ensure its effectiveness. 
The current position of Assistant Administrator for Research and 
Development does not have Agency wide responsibility or authority to 
oversee all of the science needed for policymaking. AWWA recommends 
that the Congress give serious consideration to the NRC proposal.
    AWWA also suggests that EPA work closely with other Federal 
agencies such as the Centers for Disease Control and Prevention (CDC), 
the National Institutes of Health, the US Department of Agriculture, 
the US Army Corps of Engineers, etc., to leverage resources so that the 
research efforts can be maximized. The Congress and EPA need to 
continue to look for innovative research partnerships to get the job 
done, similar to what was developed for the M/DBP cluster and arsenic. 
Congress should also consider funding these partnerships for drinking 
water research independent of other environmental research to give the 
drinking water program, a public health program that affects every 
person in the United States, the priority it deserves.
                       drinking water regulations
    While timely, best available, peer-reviewed good science is 
essential to intelligent regulatory decisionmaking, how that science 
and other data are actually used in decisionmaking is critical. AWWA is 
concerned about the scientific basis for some regulatory decisions. 
Incomplete or old science, although it is the ``best-available'' may 
still be inadequate science. Making regulatory decisions on inadequate 
science is not in accordance with the intent of the 1996 SDWA 
Amendments. The use of cost data and benefit assumptions appears to be 
arbitrary and capricious in some cases. Most disturbing of all is a 
perception that researchers may have been pressured into conclusions. 
The following drinking water regulations, either proposed or under 
development, illustrate AWWA's concerns.
Arsenic
    The 1996 SDWA Amendments required EPA to propose a revised arsenic 
regulation by January, 2000, and promulgate a final regulation by 
January, 2001. The National Academy of Sciences' (NAS) conducted a 
comprehensive review of the arsenic risk assessment that was released 
last year. The 1996 SDWA Amendments also required EPA to develop a 
comprehensive research plan on low-levels or naturally occurring 
arsenic. The objective of the plan was to develop an extensive arsenic 
research program. The plan has been completed but has not yet been 
fully executed and the vast majority of the research results will not 
be ready in time to impact the regulation. The key issue for the 
arsenic regulation is that the health effects data and the results of 
the health effects research needed to be available by mid-1999 to meet 
the deadlines in the SDWA. Only five major arsenic health effects 
research projects were started by that time. Since EPA had not made a 
significant start on the bulk of the necessary health effects (which 
will take several years to complete), it is likely that very little of 
the necessary research will be completed in time to be used in 
developing a revised arsenic regulation.
    The lack of realistic prioritization of the arsenic research, from 
the AWWA viewpoint, has minimized the potential for the ongoing 
research to substantially reduce the uncertainty in the arsenic risk 
assessment. The ongoing research projects may (or may not) be the 
specific projects that could have the most impact in reducing that 
uncertainty, but nobody knows for sure at this point. AWWA is concerned 
that some of the ongoing research may simply lead to the need for more 
research rather than give answers that are meaningful for the 
regulatory process.
    AWWA agrees with the NAS that the current arsenic regulation needs 
to be revised in accordance with the provisions of the 1996 SDWA 
Amendments. One of the conclusions of the NAS study is that 
``Additional epidemiological evaluations are needed to characterize the 
dose-response relationship for arsenic-associated cancer and non-cancer 
end points, especially at low doses. Such studies are of critical 
importance for improving the scientific validity of risk assessment.'' 
Some of the ongoing research being conducted by EPA (in accordance with 
the Arsenic Research Plan) and work being conducted by the arsenic 
research partnership between the AWWA Research Foundation (AWWARF), the 
Association of California Water Agencies (ACWA), and EPA includes 
epidemiological studies that will address some of the NAS questions. 
The research will provide some of the answers for the risk assessment; 
however, none of these epidemiological studies will be completed until 
AFTER the arsenic regulation is finalized.
    AWWA has grave concerns regarding the scientific basis upon which 
the forthcoming arsenic regulation will be promulgated. Recently, 
Inside EPA published a memo from Mr. Andrew Hanson, Office of 
Congressional Intergovernmental Affairs (OCIR) to Irene Suzukida-
Dooley, Office of Ground Water and Drinking Water (OGWDW). In this 
memo, OCIR indicates that it will not support a proposal of 5 parts per 
billion (ppb) of arsenic in drinking water. The memo goes on to say 
that National Research Council (NRC) panelists who participated in the 
``Arsenic in Drinking Water Study'' released this spring ``cited 
numerous specific concerns about methodologies employed in the risk 
analysis''. Through the Freedom of Information Act process, AWWA has 
obtained notes regarding the discussions with the NRC panelists.
    Frankly, the comments of the panelists are quite disturbing. Of the 
four panelists interviewed, there are three messages that resound. 
First, these comments indicate that the panel was pressured into 
creating conclusions that were not ``weak'', ``wimpy'', or ``less than 
conclusive''. While AWWA highly respects and supports the work of the 
NRC, this indication of collusion could draw into question (or at least 
the perception of a question) the very scientific basis upon which EPA 
is basing this regulation. Although the Executive Summary of NRC report 
states that ``data that can help to determine the shape of the dose-
response curve in the range of extrapolation are inconclusive and do 
not meet EPA's 1996 stated criteria for departure form the default 
assumption of linearity'', the second connotation drawn from the 
panelist's quotes is that there appeared to be agreement among the 
panel that the dose-response curve is clearly non-linear. The report 
goes on to state ``Of the several modes of action that are considered 
most plausible, a sublinear dose-response curve in the low-dose range 
is predicted, although linearity can not be ruled out.'' Here the panel 
considers a sublinear dose-response curve ``most plausible''. It is 
AWWA's opinion that this whole issue of dose-response extrapolation 
adds enormous uncertainty to the standard setting process and makes 
high cost standards for arsenic in the single digits very unrealistic. 
What specific research does EPA have planned to address the issue of 
non-linearity in the dose-response curve? Will this data be available 
for the 6-year review cycle? The quotes from the panelists further 
indicate a third most disturbing point; a proposal below 10 ppb of 
arsenic in drinking water is ``not supportable'' and ``not realistic''. 
This final revelation from some of the panelists begs the question ``If 
the NRC panelists do not feel that an MCL below 10 ppb is supportable, 
on what basis will EPA base a proposed MCL of 5ppb?''
    Earlier this month, in a preliminary draft report, the Drinking 
Water Committee of EPA's Science Advisory Board (SAB) said that the 
available scientific evidence on arsenic's health effects could justify 
a standard of 10 ppb or even 20 ppb under the 1996 SDWA Amendments. 
This again calls into question the basis for EPA's proposed MCL of 5 
ppb. The SAB Drinking Water Committee noted that there are 
uncertainties associated with the use of old Taiwanese data to estimate 
the risks from arsenic and concluded that EPA may have misinterpreted 
the data and overestimated lung cancer risks. According to the draft 
SAB report, results from the Taiwanese and other studies should not be 
rigidly extrapolated to the U.S. population. Poor nutritional status in 
Taiwan, Chile, and India may have influenced the health effects. A 1999 
study conducted in Utah found no evidence of either bladder or lung 
cancer at arsenic levels of 200 ppb, the report said. In addition, the 
report noted that studies conducted in animals have shown that 
deficiencies in selenium substantially increases the toxicity of 
arsenic. Urinary concentrations of selenium in the area of Taiwan were 
found to be between three and four micrograms per liter, as opposed to 
60 micrograms per liter in the United States. The report also noted 
that other nutritional factors were not taken into account by EPA, nor 
were rates of infectious hepatitis, which have been associated with 
cancer.
    Clearly the scientific basis upon which to base such a number is 
questionable at best. In light of the SAB draft report and the quotes 
from the NRC panelists, the scientific data is not necessarily as 
strong as previously thought. EPA recognized in the recent abstract of 
the Utah cohort mortality study that the relationship between health 
effects and exposure to drinking water arsenic is not well established 
in the U.S. populations. EPA concluded that further evaluation of 
potential health effects in low-exposure U.S. populations is warranted. 
By its own admission, the Agency does not clearly understand the health 
effects issues as they relate to U.S. populations. Since the science on 
which to base an MCL of 5 ppb is questionable, how can EPA justify the 
high cost of the MCL?
    EPA invoked the cost benefit provisions of the SDWA to support the 
choice of an MCL of 5 ppb for arsenic. However, EPA did not employ a 
marginal analysis to justify this decision. EPA has not therefore 
performed a proper cost benefit analysis and has not complied with the 
SDWA. SDWA compliance inherently exhibits diminishing returns. As lower 
and lower treatment targets are considered, costs increase at an 
increasing rate while the increment of exposure reduction achieved 
diminishes with each additional increment of stringency. This 
relationship implies that there is a balance point where the marginal 
benefit obtained equals the marginal cost and net benefits are 
maximized. This is the right way to use cost benefit analysis to 
justify a decision. However, this is not what EPA did to justify the 
proposed arsenic MCL.
    EPA discussed an aggregate comparison of total costs and benefits 
to justify its choice of an MCL. In this procedure, the more favorable 
relationship between benefits and costs from the first increments of 
additional stringency (i.e., moving from 50 ppb to 20 ppb) are averaged 
in with the less favorable data relating to the last increments (i.e., 
moving from 10 ppb to 5 ppb). EPA based its decision on a comparison of 
these aggregates (and other risk criteria of its own making). The SDWA 
specifically states that the incremental costs and benefits associated 
with each alternative MCL must be considered. EPA presents such values 
but provides no discussion of them and does not incorporate them into 
its justification, relying instead on aggregate cost benefit comparison 
and analysis of uncertainties on the benefits side. The aggregate 
comparison performed by EPA embodies a decision rule that is structured 
such that it will always over-shoot the economically optimal level of 
stringency that would be prescribed by marginal analysis. EPA's 
decision rule is arbitrary and has no standing in economic analysis. It 
is not a cost benefit analysis and does not meet the clear or implied 
intent of the SDWA.
    AWWA also has concerns about the national cost estimate used by 
EPA. The AWWA Research Foundation did an independent analysis of the 
costs of implementing the arsenic drinking water regulation at varying 
MCLs. The differences in estimates were significant, using the same 
methodology. The differences are:

 
----------------------------------------------------------------------------------------------------------------
                                                5 ppb                    10 ppb                   20 ppb
----------------------------------------------------------------------------------------------------------------
EPA Estimate.........................  $378 million/year......  $164 million/year......  $62 million/year
AWWA Estimate........................  $1.46 billion/year.....  $605 million/year......  $55 million/year
----------------------------------------------------------------------------------------------------------------

    These widely differing cost estimates need to be reconciled before 
the final rule is promulgated.
    The arsenic drinking water regulation was proposed last week on 
June 22nd, and comments are due to EPA on September 20th. However, 
because the rule has been delayed and EPA has a statutory deadline to 
promulgate the final regulation in January 2001, AWWA is deeply 
concerned that EPA will not have sufficient time to evaluate comments 
and that an MCL based on inadequate science and cost and benefit data 
may be promulgated. AWWA strongly urges EPA to carefully reconsider the 
body of scientific evidence available and recommends that the proposed 
arsenic standard be no less than 10 ppb which is the World Health 
Organization (WHO) standard.
       microbial, disinfectant & disinfection by-products cluster
    This ``cluster'' of regulations is the most significant and 
potentially the most costly of all drinking water regulations required 
in the 1996 SDWA amendments. It includes Disinfectant/Disinfection By-
Product Rules, Enhanced Surface Water Treatment Rules, a Filter 
Backwash Rule and the Groundwater Rule. The regulations in this 
``cluster'' require substantial research, most of which will not be 
completed by the time indicated in the SDWA.
    Research on microbial contaminants and disinfectants and 
disinfection by-products is a critical need. Each day there are roughly 
50,000 deaths in the world attributed to microbial contamination of 
drinking water. Much of this threat has essentially been eliminated in 
the United States through disinfection of drinking water. However, it 
is now known that disinfection of drinking water can produce chemical 
by-products, some of which are suspected human carcinogens or may cause 
other toxic effects. Controlling risks from these by-products must be 
carefully balanced against microbial risks to ensure that when reducing 
disinfection levels or changing treatment to lower by-product risk, 
significant microbial risks are not created.
    Research on disinfectants and disinfection by-products, as endorsed 
by the National Academy of Sciences and EPA's Science Advisory Board, 
is essential. The cost to the Nation of microbial and disinfection by-
products regulations under the SDWA will certainly be in the billions 
and could be as high as $60 billion or more depending on the final 
rule. An appropriate investment in health effects research will ensure 
that costs of regulation will be commensurate with the health benefit 
and not driven to extremes because of the lack of data.
    Cryptosporidium is a microbial pathogen of major concern to 
drinking water supplies. The Centers for Disease Control, in 
correspondence with EPA, has pointed out that extensive research on the 
health implications of this pathogen and dramatic improvements in 
analytical methods for its detection are necessary before it is 
possible to evaluate the public health implications of its occurrence 
at low levels and determine the appropriate regulatory response. 
Adequate funding for research on Cryptosporidium, as well as other 
emerging pathogens, is essential to protect the health of millions of 
Americans.
    The final Filter Backwash Rule, which will prevent unsafe 
concentrations of contaminants in the drinking water treatment process 
resulting from cleaning water filter beds, is scheduled to be 
promulgated by August 2000. However, this rule has become a major 
concern since there is not much data on which to base a regulation and 
the potential for significant compliance costs.
    For the Filter Backwash Rule, EPA assembled a collection of studies 
that appears to reflect 1,907 individual surface water samples. As 
presented, this assemblage cannot be directly related to drinking water 
sources. Few of these individual studies obtained positive samples and 
large data sets appear to be prone to lower observed occurrence than 
smaller data sets. Twenty-six of the studies either reported ranges of 
observation including zero or neglected to provide a range of 
observations.
    Most disturbing is that the assembled studies did not include the 
most recent and comprehensive survey of drinking water treatment plant 
influent water concentrations available from the Information Collection 
Rule (ICR) data collected over 18 months in 1997 and 1998. During that 
data collection process, public water systems serving greater than 
100,000 persons collected monthly protozoan samples using an existing 
EPA approved method. The resulting data has been available to EPA since 
December 1999. The raw ICR data suggests that less than 7 percent of 
large public water systems use source waters that contain 
Cryptosporidium oocysts. Preliminary estimates from statistical models 
of this data indicate that the median oocyst concentration to be 
approximately 0.03 oocysts per liter rather than the values of 4.70 and 
10.64 oocysts per liter cited by EPA in their proposal for the Filter 
Backwash Rule. After all the cost and time involved to collect this 
information under the requirements of the ICR, why is EPA discounting 
this most recent information?
    EPA correctly points out the difficulties in performing 
Cryptosporidium analysis for filter backwash samples. Where recovery 
data are provided in the literature, the rates have been typically low. 
It is important to point out that the volumes analyzed have been very 
small due to high turbidity in the samples. It is not uncommon for 
spent filter backwash samples to have equivalent volumes analyzed of 
much less than one liter. Therefore, the focus by EPA on high outlier 
levels of oocysts reported is unjustified. EPA is aware of the 
uncertainties of individual protozoan measurements and citing these 
outlier values violates the sound statistics that have been developed 
by EPA and others over the past several years to better understand 
protozoan data. The 1996 SDWA Amendments call for the use of ``best 
available'' science. EPA does not appear to be following this provision 
of the law in the Filter Backwash Rule.
                                 radon
    EPA is under a statutory deadline to finalize the radon drinking 
water regulation by August 6, 2000. AWWA has significant concerns about 
whether regulating radon in drinking water is cost effective 
particularly the primary Maximum Contaminant Level (MCL) of 300 
picacuries per liter. For the radon drinking water regulation to 
provide effective public health benefits, it is essential that states 
adopt a multi-media mitigation (MMM) program to abate radon in indoor 
air which is the primary threat to public health.
    However, AWWA believes that there are some flaws in establishing 
the primary MCL. AWWA has repeatedly indicated to EPA our numerous 
concerns regarding the Health Risk Reduction and Cost Analysis (HRRCA) 
for radon. These concerns cover a wide range of issues such as life 
years saved estimates, latency times, discounting rates, cumulative 
costs of regulation, affordability, entry points to the distribution 
system, and treatment costs. Many of these factors can have a dramatic 
impact on the benefit-cost ratio. Depending on the assumptions, the 
cost-benefit ratio can vary from a high of 0.95, indicating a 
reasonable comparison of benefits to costs, to a low of 0.04, where the 
costs are clearly extreme compared to the benefits received.
    The first and foremost issue is a policy concern in determination 
of when ``benefits justify costs.'' Some Federal Agencies use a cost 
benefit ratio to justify an expenditure. The US Army Corps of 
Engineers, for example, uses a ratio of 1:2. Studies on the lead 
service line replacement portion of the Lead and Copper Rule show a 
dismal cost benefit ratio of 100:1. Prudent public policy dictates that 
federally mandated expenditures at the state and local level should 
have a ratio where benefits exceed costs.
    Costs from the radon HRRCA show that it will have a devastating 
impact on small water systems, which are the majority of systems 
expected to take action as a result of the regulation. Simply looking 
at national costs, in aggregate, allows economies of scale for larger 
systems to mask the regulations affect on smaller systems. When one 
looks at the very very small systems category cost benefit ratios range 
from a disappointing 20:1 to 50:1. To make matters worse, benefits 
accrue locally in tiny increments. Again in the very very small system 
size, costs are estimated at $10,000 per year, with a corresponding 
10,000-14,000 years between statistical cancer cases avoided. Clearly 
the primary MCL should take into account the regulatory impacts on 
small systems, which it does not.
    The accounting of benefits in the HRRCA is inconsistent with common 
risk assessment and risk management principles. For example, risk 
assessment and management in the EPA's drinking water program typically 
assumes a 70-year exposure period. This implies that 1/70 of the 
benefits will appear in the first year after implementation, 2/70 in 
the second year and so on. The HRRCA grossly over estimates benefits by 
assuming that the full benefit of the regulation is realized in the 
first year, and succeeding years. The HRRCA should be revised to 
reflect a phase in, or latency period, for benefits.
    Also of concern is the failure of the HRRCA to account properly for 
time in the benefits estimate. The HRRCA discounts costs of a 7 percent 
annual rate, but does not discount benefits at all. This inflates the 
benefits estimate. Costs and benefits should be discounted at the same 
rate and the HRRCA should reflect this. AWWA estimates that the failure 
to phase in benefits and the failure to consider the timing of benefits 
shifts the cost benefit ratio from approximately 1:1 an to unfavorable 
5:1, or even 9:1.
    With the cost benefit ratios for the primary MCL shifting 
negatively, the multi-media mitigation program that Congress wrote into 
the 1996 SDWA Amendments becomes critical to providing a public health 
benefit. The EPA's 1994 Report to Congress placed the dollar cost of 
saving a life through a radon indoor air program at $700,000. This is 
almost ten times lower than the cost to save a statistical life through 
drinking water efforts on radon. AWWA supports the concept of the MMM 
program; however, AWWA has a significant concern that the MMM program 
in the statute and in the proposed radon regulation will not work as 
intended. There is little incentive in the SDWA for a State to adopt a 
MMM program simply to enforce the alternative MCL for radon rather than 
the primary MCL. In States that do not adopt a MMM program for radon, 
the costs to drinking water consumers will be exorbitant with very 
little public health benefit.
    AWWA urges Congress to provide incentives in the Indoor Air Radon 
Abatement Act for States to adopt a MMM program that would meet the 
requirements for a State to enforce the alternate MCL for radon. This 
would put the MMM program and requirement in the air program where it 
more rightfully belongs and provide resources for the States to 
successfully implement the MMM program. If all States have a MMM 
program, the alternate MCL will provide more public health benefit and 
at a more reasonable cost than the primary MCL. AWWA also believes that 
there should be a single standard for radon in drinking water based on 
the MMM since the major health threat is from air. AWWA recommends that 
the Congress address this flaw in the SDWA as soon as possible before 
the American people are faced with the exorbitant cost that would 
result from enforcing the primary MCL in the proposed regulation.
                             radionuclides
    AWWA, through its volunteers and contractors, has invested 
significant time and resources on the benefit-cost analysis (BCA) in 
the Notice of Data Availability (NODA) that was published on April 21st 
for the Radionulclides Rule. The BCA components, and the process to fit 
them together, used in the NODA are critical, as this is one of the 
first BCA conducted under the new provisions of the 1996 Safe Drinking 
Water Act Amendments.
    At this time, AWWA does not believe that the BCA presented in the 
radionuclides NODA meets the requirements of Section 1412(b)(4)(C) of 
the SDWA. EPA simply put the costs in one column, and the benefits in 
another column to meet this requirement. AWWA believes that a much more 
robust BCA must be included in the final regulation, and the lack of a 
more robust BCA in the final regulation would be considered arbitrary 
and capricious and contrary to the clear SDWA language.
    Considerable mention is made in the NODA of the EPA ``policy'' that 
MCLs must be established such that individual lifetime cancer risks do 
not exceed a threshold of 10-4. This notion that a maximum ``allowable 
risk'' (of 10-4) is the ultimate binding constraint on EPA rulemaking 
regardless of what the costs of the rule are, or how the benefits 
compare to those costs is quite troubling.
    Clearly, there is no statutory mandate or authority to have a self-
defined and self-imposed Agency policy on an ``acceptable risk'' floor. 
The 1996 SDWA Amendments do not impose or envision such a constraint. 
Consider a case in which the cost of a potential MCL was not justified 
by its benefits, but where the estimated cancer risk at a less 
stringent alternative exceeded the 10-4 level. The NODA language 
appears to clearly state that the Administrator would be obliged to set 
the MCL at the unjustified level (to maintain a 10-4 risk ceiling) 
rather than follow the letter and intent of the statute and set a less 
stringent MCL that was indeed justified on a reasonable benefit-cost 
basis. EPA should explicitly clarify whether this indeed is its intent 
and interpretation of the statute. If this is the case, then the 
``acceptable risk'' floor of 10-4 is more of a rule than a policy, and 
EPA should publish an ``acceptable risk'' proposal that allows for 
public comment on such a critical issue.
                     drinking water infrastructure
    According to the EPA Drinking Water Infrastructure Needs Survey 
released on January 31, 1997, $12.1 billion is needed in the immediate 
future to protect drinking water supplies. Of this amount, $10.2 
billion, or 84 percent, is needed to protect water from microbial 
contaminants which can produce immediate illness or death. According to 
the needs survey, between 1995 and 2015, a total of $138.4 billion will 
be needed to upgrade the infrastructure of the nation's water utilities 
to meet requirements of the SDWA. It is also important to note that 
this figure does not include other drinking water infrastructure needs, 
such as replacing aging transmission and distribution facilities, which 
are not eligible for funding from the Drinking Water State Revolving 
Fund (DWSRF).
    In an independent analysis, AWWA estimates that the total drinking 
water needs, taking full account of infrastructure replacement needs, 
is on the order of $385 billion over a 20 year period. The Water 
Infrastructure Network (WIN), of which AWWA is a member, recently 
released a report that estimates that the total drinking water and 
waste water infrastructure needs over a 20 year period approaches one 
trillion dollars. AWWA will soon release a report that will outline the 
size and shape of the investment need for drinking water in the United 
States. The findings illustrate that the size of the need will vary 
from place to place, reflecting the age, character and history of the 
community. The AWWA report raises the questions that need to be 
addressed to determine how best to meet the Nation's drinking water 
infrastructure needs.
    The report concludes that, in the aggregate, after accounting for 
the potential of best practices in asset management, research and new 
technologies, efforts to increase ratepayer awareness and support, and 
possible alternative compliance scenarios, in some utilities there 
still remains a ``gap'' between what is needed for infrastructure re-
investment and what is practical to fund through water rates. This gap 
can be expected to grow over the next few decades as a reflection an 
infrastructure building boom years ago that will begin to reach the end 
of its useful life.
    AWWA remains committed to the principle of full cost recovery 
through water rates as the essential under-pinning of local 
sustainability of water infrastructure. Longer term, the objective 
should be to flatten the replacement function and restore utilities to 
full cost recovery and financial sustainability.
    AWWA does not expect that Federal funds will be available for 100 
percent of the infrastructure needs of the nation's water utilities. 
The DWSRF is a loan program with a state match. Ultimately, the rate-
paying public will have to pay for the nation's drinking water 
infrastructure, regardless of whether financing comes from the DWSRF or 
other sources. However, AWWA does believe that DWSRF funding is a major 
issue for congressional oversight to ensure that Federal funding is 
adequately available to meet the intended purposes of the SDWA. Over 
the next 20 years, it is clear that SDWA compliance requirements and 
infrastructure needs will compete for limited capital resources. 
Infrastructure needs and SDWA compliance can no longer be approached as 
separate issues. Oversight should take place in the context of the 
total compliance and infrastructure need and how the needs should be 
apportioned among the various financing mechanisms and sources.
    There are a number of enhancements to the DWSRF that should be 
considered to increase its effectiveness, such as:
      increasing the authorized DWSRF funding levels to fund 
SDWA compliance projects and other needs.
      expanding the DWSRF to encompass system rehabilitation 
and replacement in addition to SDWA compliance as eleigible 
expenditures, allowing communities to take a more comprhensive approach 
to providing safe drinking water. As drinking water regulations become 
more stringent, upgrading the distribution system, like protecting 
drinking water sources, becomes a larger factor in maintaining the 
regulated safety level until the water reaches the consumer.
      Examining strategies for streamlining current operations 
of DWSRFs and strategies to encourage more innovative use of DWSRFs at 
the state level.
    AWWA will provide a copy of the forthcoming report to members of 
the committee. We look forward to working with you to help resolve the 
Nation's growing drinking water infrastructure needs.
                  drinking water standards litigation
    Within the last several years, lawsuits have been initiated against 
public water systems for allegedly delivering contaminated drinking 
water despite the fact that the public water systems were in compliance 
with Federal and state drinking water regulations. At this time, these 
cases are concentrated in California and have been subject to a unique 
California law. However, these type of cases could be initiated 
nationwide and undermine the SDWA drinking water regulatory program.
    Public water systems are regulated under the SDWA. The regulations 
have been developed over many years based on the health effects of 
contaminants, measurement capabilities and technical feasibility. The 
1996 SDWA Amendments require the use of cost and benefits in setting 
drinking water standards. The regulatory requirements were the product 
of extensive congressional debate concerning how best to develop 
drinking water standards to protect public health. Processes have been 
developed both at the national and state level to develop regulations 
based on best available science, costs and benefits.
    This type of litigation could result in judges and juries setting 
drinking water standards that would vary across the nation. Standards 
could be far different from those set by Federal and state agencies 
under the SDWA regulatory process. National uniformity of standards and 
uniformity within a state will be eroded. Public water systems facing 
uncertainty about which standards to meet will be pressured to follow 
the most stringent standard set by any judge or jury in the country to 
avoid liability. This will significantly increase the cost of water to 
consumers with very little, if any, benefit.
    To protect the integrity of the SDWA regulatory program and prevent 
exorbitant drinking water costs to consumers, the SDWA should be 
amended to make compliance with Federal and state drinking water 
standards a defense in lawsuits involving contaminants covered by such 
standards. AWWA urges this committee to pass such legislation and will 
work with the committee and others on this issue.
                   methyl tertiary butyl ether (mtbe)
    Although it is not the subject of this hearing, we believe that we 
would be remiss to not mention methyl tertiary butyl ether (MTBE) 
contamination of drinking water. MTBE contamination is an issue that 
cuts across the Clean Air Act, the Resource Conservation and Recovery 
Act (RCRA) and the Safe Drinking Water Act. MTBE contamination clearly 
illustrates the pitfalls of regulating within a statutory ``stove 
pipe'' and why coordination across programs is necessary within EPA.
    The Clean Air Act of 1990 required that areas of the country with 
certain air quality problems use reformulated gasoline (RFG) with an 
increased oxygen content. MTBE is the oxygen additive most commonly 
used by the petroleum industry to satisfy the RFG mandate. Since MTBE 
is very soluble in water and does not ``cling'' to soil well, it has a 
tendency to migrate much more quickly into water than other components 
of gasoline. The use of MTBE has created a significant and unacceptable 
risk to drinking water and groundwater resources. At levels as low as 
20 parts per billion, MTBE makes drinking water unfit for human 
consumption because of taste and odor. It should also be noted that 
MTBE has been detected in the taste and odor of drinking water at 
levels as low as 2 parts per billion.
    In Santa Monica, California, seven wells supplying 50 percent of 
the water for the city were shut down because of MTBE concentrations as 
high as 600 parts per billion. It is estimated that it will cost the 
city $150,000,000 to develop new water sources. This does not include 
the cost of remediation and treatment of the contaminated wells. Cases 
of persistent MTBE plumes extending for kilometer-scale distances in 
the subsurface have been documented in Port Hueneme, California; Spring 
Creek, Wisconsin; and East Patchoque, New York. Recent testing 
conducted by the US Geological Survey (USGS) shows MTBE has been found 
in approximately 20 percent of the groundwater in RFG areas. As many as 
9,000 community water wells in 31 states may be affected by 
contamination from MTBE. The data was from one-third of the wells in 
those states and is generally representative of the entire nation. 
Source water is being impacted from a variety of sources including 
pipeline leaks, spills, leaking underground storage tanks, and 
recreational boating on source waters.
    For example, at my own utility in Manchester, we are finding low 
levels of MTBE in Lake Massabesic. While the levels are relatively low 
as shown below, the increases in the summer due to boating are clear. 
Additionally, Lake Massabesic is a well-protected watershed, with 
Manchester owning about 95 percent of the shoreline. Recreational use 
is limited, as there is not overnight docking allowed, and there are 
only 3 boat ramps with about 100 parking spaces total. Although these 
levels are relatively low, as previously mentioned in this statement, 
consumers with acute taste and odor sense may detect an objectionable 
taste and odor at the single digit level.
    According to the report of the EPA Blue Ribbon Panel on Oxygenates 
in Gasoline, a major source of groundwater MTBE contamination appears 
to be releases from underground gasoline storage tanks. The EPA Blue 
Ribbon Panel on Oxygenates in Gasoline recommended enhanced funding 
from the Leaking Underground Storage Tank (LUST) Trust Fund to ensure 
that treatment of MTBE contaminated drinking water supplies can be 
funded. The LUST funds could only be used for contamination resulting 
from leaking underground storage tanks. Since leaking underground 
storage tanks appear to be the major source of MTBE contamination in 
ground water, the LUST Trust fund is an existing option to consider as 
a source of potential funding assistance for some cases of MTBE 
contamination of drinking water supplies in circumstances that meet the 
criteria of the law. As part of MTBE legislation, AWWA recommends that 
Congress amend RCRA to clarify the use of the LUST Trust Fund to 
provide alternative drinking water supplies or treatment for drinking 
water sources contaminated by MTBE from leaking underground storage 
tanks. AWWA is very pleased that Senator Smith has addressed this issue 
in draft legislation circulated on June 13, 2000. We thank Senator 
Smith and other Senators and staff for their assistance on this issue.
    In testimony before the House VA, HUD, and Independent Agencies 
Appropriations Subcommittee and in a similar statement submitted to the 
Senate VA. HUD, and Independent Agencies Appropriations Subcommittee, 
AWWA recommended that Congress appropriate at least $100,000,000 for 
LUST to accelerate the clean up of LUST sites with priority for MTBE 
contaminated sites to prevent contamination of water supplies. There is 
a backlog of about 169,000 LUST site clean ups. EPA and the States have 
put increased emphasis on monitoring for MTBE as part of the 
Underground Storage Tank (UST) program so the number of MTBE 
contaminated sites may increase. Eliminating leaking tanks is an 
immediate remedy to protect drinking water supplies from further 
contamination until MTBE is phased out or eliminated.
    Congress appropriated $70,000,000 for the LUST program in fiscal 
year 2000. The fiscal year 2001 President's budget requests $72,100,000 
for the LUST program. AWWA strongly believes that the requested 
increase is not sufficient to accelerate cleanups of LUST sites that 
are difficult to remediate because they are contaminated by MTBE. EPA's 
goal for fiscal year 2001 to complete 21,000 LUST cleanups is 
commendable but not adequate to address the immediate needs of millions 
of Americans who no longer can drink the water from their wells. An 
aggressive, high priority effort is necessary to cleanup sources of 
MTBE from leaking underground storage tanks as quickly as possible. 
AWWA is pleased that the House Appropriations Committee increased the 
LUST appropriation to $79,000,000 for fiscal year 2001; however, we 
hope that $100,000,000 can be appropriated in the Senate.
    Numerous bills have been introduced in Congress and draft 
legislation circulated that would amend the Clean Air Act to ban or 
phaseout MTBE as a fuel additive. EPA has recently called for Congress 
to amend the oxygenate requirement in the Clean Air Act to ban or 
phaseout the use of MTBE as a fuel additive. The EPA Blue Ribbon Panel 
on Oxygenates in Gasoline recommended action to amend the Clean Air Act 
to remove the oxygenates requirement and to clarify Federal and state 
authority to regulate and/or eliminate the use of gasoline additives 
that threaten drinking water.
    AWWA has developed the following legislative principles that will 
address the contamination of drinking water sources by MTBE:
    1. Amend the Clean Air Act to significantly reduce or eliminate the 
use of MTBE as a fuel additive.
    2. Ensure that air quality gains are not diminished as MTBE use is 
reduced or eliminated.
    3. Require adequate research to be conducted on any replacement 
fuel additive for MTBE to ensure that a replacement will not 
contaminant drinking water sources.
    4. Provide Federal funding assistance to public water systems that 
have MTBE contaminated water sources for treatment or alternative water 
supplies.
    AWWA recommends that Congress take swift action on legislation 
necessary to prevent further contamination of water supplies by MTBE or 
other fuel additives and provide assistance to public water systems 
that have MTBE contaminated water supplies. We look forward to working 
with Senator Smith and others to advance legislation addressing this 
critical issue.
                               conclusion
    We have covered a lot of issues in our statement today. Although 
much of the statement appears critical of EPA, we want to emphasize 
that EPA has made a good faith effort in other areas to implement the 
1996 SDWA amendments. The Agency's outreach and involvement of 
stakeholders in the regulatory process is to be commended. However, our 
concerns raised in how EPA uses science and cost benefit analysis in 
regulations are valid and are issues that bear watching by the 
Congress.
    We look forward to working with the committee on MTBE and drinking 
water infrastructure issues. We thank you for your consideration of our 
views.
    This concludes the AWWA statement on the implementation of the 1996 
Safe Drinking Water Act Amendments. I would be pleased to answer any 
questions or provide additional material for the committee.
                                 ______
                                 
           Responses of David Paris to Additional Questions 
                           from Senator Crapo

    Question 1. What does AWWA estimate to be the shortfall in research 
funding for the regulatory activities of the EPA under the SDWA?
    Response. It is difficult to estimate the total drinking water 
research needs as EPA has failed to develop an overall drinking water 
research plan for all contaminants that could potentially be regulated 
under the SDWA. While individual research plans have been developed for 
M/DBPs and arsenic, EPA has consistently failed to develop an overall 
drinking water research plan that clearly lists each research project 
with a budget and a timeframe (start date and completion date). While 
EPA has developed a process for conducting the Contaminant Candidate 
List (CCL) research, this process plan doesn't even estimate when this 
research might start or be completed. For example, twentytwo 
contaminants need a suitable analytical method to be developed and 
validated before the health effects and treatment research can begin. 
Six of these contaminants are microbials (primarily specific virus 
strains), and reliable microbial analytical methods are particularly 
difficult to develop. The analytical method for Cryptosporidium has 
been researched extensively for over a decade, and continues to be 
elusive. A determination cannot be made if a specific treatment 
technology is removing a specific contaminant if a suitable analytical 
method is not available to measure removal. The proper dosing for 
health effects research cannot be completed without a suitable 
analytical method. Therefore, it is impossible to estimate the total 
cost for the health effects, treatment, and analytical method research 
for the research priority contaminants on the Contaminant Candidate 
List (CCL).

    Question 2. What level of research funding for each of the 
following proposed rules or priority contaminants does AWWA believe is 
the absolute minimum: 1) arsenic, 2) radon, 3) M/DBP cluster of rules, 
4) other priority contaminants such as MTBE?
    Response. As stated in the answer to the previous question, it is 
difficult to estimate the needs of individual drinking water 
contaminant research, as EPA has failed to develop an overall drinking 
water research plan for all contaminants that could potentially be 
regulated under the SDWA.

    Question 3. Your testimony is fairly critical of the research being 
used to support the proposed arsenic rule. Do you believe that EPA 
should delay promulgation of the rule until additional 
epidemiologicaland other studies are complete?
    Response. AWWA believes that the schedule for the promulgation of 
the arsenic regulation should allow for 1 year between the proposal and 
the final regulation so that EPA can assimilate the many public 
comments that they will receive on the proposal, and incorporate these 
comments into the final regulation. AWWA supports the conclusion of the 
National Research Council (NRC) report that the current arsenic 
regulation needs to be revised in a timely manner. Additional research, 
such as epidemiological studies, is always ongoing, and at some point, 
EPA needs to use the best available research and make its regulatory 
decision. However, AWWA believes that EPA needs to take another look at 
the Utah epidemiological study conducted by its own researchers. This 
study does not show the same bladder and lung cancers as the studies 
from Taiwan, Chile, and Argentina that are being used as the basis for 
the proposal. The Utah study is the only epidemiological study that has 
been conducted in the U.S., and, therefore, should be accorded more 
weight in EPA's risk assessment.

    Question 4. If the scientific research does not support an arsenic 
MCL below 10 ppb and if the EPA is precluded from revising standards 
upward (even if future science supports such a decision) should the 
Agency establish a standard at 5 ppb?
    Response. AWWA believes that EPA should establish an arsenic 
standard at no lower than 10 ppb at this time due to the uncertainties 
as to the arsenic health effects at very low levels. While the NRC 
report gave one example of an arsenic risk assessment, the NRC 
recommended that ``the final calculated risk should be supported by a 
range of analyses over a fairly broad feasible range of assumption''. 
In the proposal, EPA has not conducted this range of analyses and has 
simply relied on the one NRC example.

    Question 5. Do you have any concerns with the EPA's estimate of 
costs and benefits for the proposed arsenic rule?
    Response. AWWA has extensive concerns with both EPA's costs and 
benefits in the arsenic proposal. On the cost side, the feasibility of 
operating large scale arsenic removal facilities (ion exchange, 
activated alumina, or coagulation/microfiltration) has not been 
adequately addressed in the proposal. Although small scale arsenic 
removal facilities exist at this time, large scale arsenic removal 
facilities have not been tested in the field. AWWA also believes that 
EPA has overestimated the number of treatment facilities that will be 
able to dump their waste streams into a sanitary sewer system that 
feeds into a Publicly Owned Treatment Works (POTW).
    Additionally, AWWA believes that EPA has painted a much more 
positive picture of the costs at a local level than is the reality. For 
example, Albuquerque, New Mexico, is one of the larger cities with 
potentially significant financial impacts from the arsenic proposal. 
Even with their larger rate base, Albuquerque has estimated that their 
rates will increase by 40 percent to comply with the proposed arsenic 
standard of 5 ppb.
    EPA touts the Drinking Water State Revolving Loan Fund (DWSRF) as a 
funding solution, while the reality is that the DWSRF is dwarfed by the 
capital costs for compliance with the arsenic proposal. For example, 
the State of Utah has estimated the capital costs for all of systems to 
comply with the proposed arsenic standard of 5 ppb to be approximately 
$170 million. The past 4 years (FY97--FY00) of Utah's DWSRF allotment 
totals $34 million. The water utilities in Utah also need the DWSRF to 
comply with other drinking water regulations in addition to arsenic.
    On the benefits side, AWWA believes that the arsenic proposal does 
not contain a true incremental Benefit-Cost Analysis (BCA) as required 
by Section 1412(b)(3)(C) of the 1996 SDWA Amendments. EPA has not 
published and sought comment on the incremental costs and benefits with 
each alternative MCL considered. In this proposal, EPA simply puts the 
costs in one column, and the benefits in another column to meet this 
requirement.
    Other flaws are apparent in the benefits analysis. EPA incorrectly 
assumes that the benefits from the arsenic regulation begin to accrue 
immediately, as EPA does not take into account the cancer latency 
period. Regulations don't save lives, per se; rather, life expectancy 
is extended due to cancer avoided and these benefits start in the 
future. Therefore, EPA needs to take into account the cancer latency 
period and discount these future benefits back to present value to 
match up with the present value of the costs for the treatment 
technology. The Environmental Economic Advisory Committee (EEAC) of the 
EPA Science Advisory Board (SAB) supports the adjustments to benefits 
based on the timing of the risk. (An SAB Report on EPA's White Paper 
Valuing the Benefits of Fatal Cancer Risk Reductions, July 2000)
    Additionally, unintended consequences will likely play a 
significant role in the implementation of the arsenic proposal. These 
items will likely lead to negative benefits, and will likely result 
from the implementation of the arsenic proposal. These items have not 
yet been identified by EPA and need to be incorporated into the final 
regulation as potentially negative benefits. The following list is not 
intended to be comprehensive, but rather a list of examples:

      Risk of acute exposure to arsenic and/or nitrate due to 
chromatographic peaking of anion exchange technology;
      Environmental risks associated with the generation, 
storage, and handling of arsenic treatment waste streams;
      Environmental risks associated with discharge to Publicly 
Owned Treatment Works (POTW) of liquid waste streams;
      Public health risks associated with the transport, 
storage, and use of chemicals and waste products at groundwater 
treatment facilities located in community neighborhoods;
      Solid waste disposal in non-hazardous landfills (arsenic 
and salt contamination plumes, availability of space, etc.);
      Viability of small communities to continue to provide 
public sources of drinking water;
      Opportunity cost, i.e., removing capital from the pool 
available to U.S. communities and misguided use of public health funds;
      Loss of water availability;
      Groundwater storage and recharge operation impacts;
      Indirect/Direct Additive Approvals; and
      Water quality degradation issues due to arsenic control.

    Question 6. At what public water system size does AWWA believe 
costs outweigh the benefits of the proposed radon rule?
    Response. AWWA believes that the benefit-cost analysis for the 
radon rule should not be based on system size, as even large 
groundwater systems are made up of several wells. It is the number of 
wells per system that have to be treated that increases costs.

    Question 7. What level of involvement have AWWA and other 
stakeholders had in the final EPA proposals for radon, arsenic, and 
other contaminant standards?
    Response. AWWA, along with many other stakeholders, have been 
extensively involved in the development of the proposals for radon, 
arsenic, and the filter backwash rule. EPA has done a respectable job 
in conducting stakeholder meetings for these proposals. However, we are 
concerned that EPA only conducted a single stakeholder meeting for the 
arsenic proposal in Reno, Nevada on August 8th, The location of this 
single stakeholder meeting precluded many impacted systems in the upper 
Midwest and the Northeast from participating in this stakeholder 
meeting.

    Question 8. Given the conclusion of the WIN report on 
infrastructure needs, from where does AWWA expect the shortfall of 
resources needed to meet costs of current and upcoming regulations to 
come?
    Response. The cost of replacing aging infrastructure and the cost 
of compliance are two issues that are raising affordability questions 
for some communities and can no longer be approached as separate 
issues.
    The WIN report identifies the size of the infrastructure 
replacement need. The size of the gap between the cost of that need and 
what local communities can afford to pay to meet the need is an issue 
that is currently being examined by AWWA and other stakeholders. We 
know that the gap, if there is one, will vary from community to 
community. Some communities may be able to fund the need through 
existing and projected rate revenues, best practices for asset 
management, new technologies and other improved operations/management 
practices. Other communities may not be so fortunate for a variety of 
economic and social reasons.
    The cost of compliance with future regulations compounds the 
affordability question. While many individual regulations may be 
affordable, the cumulative affect of several vary expensive regulations 
such as radon, arsenic, groundwater and the Microbial/Disinfectant 
Byproducts (M/DBP) cluster of regulations may raise significant 
affordability problems in smaller communities and in a few large urban 
water systems.
    AWWA does not expect the Federal Government to fund 100 percent of 
the need or the gap. A large portion will come from local rate 
increases, best practice asset management, improved technology and 
improved operations. More efficient regulations may also contribute to 
reducing the gap.
    AWWA is engaged in a process with other stakeholders to determine 
the size of the gap, the appropriate role of the various levels of 
government in funding the gap for communities that have reached the 
affordability ceiling and how best to fund the gap. Later in the year 
or early next year, AWWA and the other stakeholders may be in a better 
position to provide this information to the committee.

    Question 9. Beyond financial assistance, what support can the EPA 
provide public water systems in addressing infrastructure resource 
gaps?
    Response. EPA can help educate the American people concerning the 
need to invest in drinking water infrastructure to assure the highest 
quality safe drinking water. EPA should also examine ways to streamline 
the current operations of the drinking water state revolving fund 
(DWSRF) to make the program more efficient for states to administer and 
utilities to obtain loans. The cost of compliance, which is competing 
for infrastructure dollars at the local level, can be reduced by doing 
thorough research on regulations to ensure that the consumer is getting 
a benefit commensurate with the cost of the regulation as required in 
the Safe Drinking Water Act. The contaminant-by-contaminant regulatory 
approach needs to be revamped to get a more cost-effective means of 
providing safe drinking water. EPA needs to make broader use of risk 
analysis and regulate by classes of contaminants that can use the same 
treatment techniques and not have competing regulatory requirements.

    Question 10. What is AWWA's view on the EPA's current approach to 
assessing the feasibility of drinking water standards and regulations?
    Response. AWWA is concerned with EPA's continued use of a format 
for Benefit-Cost Analysis (BCA) that doesn't meet the requirements of 
Section 1412(b)(4)(C) of the 1996 SDWA Amendments. EPA's BCA in past 
proposals would be considered marginal, at best. AWWA believes that a 
much more robust BCA must be included in final regulations.
    Additionally, AWWA believes that EPA needs to look at the combined 
affordability from the combined effects of all of the new drinking 
water regulations. EPA looks at the affordability of each regulation 
one at a time, and that is not the reality for a drinking water 
utility. Many small systems will be impacted by arsenic, radon, the 
Groundwater Rule, and the Stage 1 and Stage 2 Disinfectants/
Disinfection By-Products Rule (D/DBPR). Complying with these 
regulations will likely require the installation of more than one 
treatment technology where none may have existed before. EPA cannot 
continue to look at each regulation one at a time, and must analyze the 
combined impacts of all of its regulations.

    Question 11. What are AWWA's views on the EPA's proposed method of 
accounting for new regulations in its affordability criteria for 
identifying small system variance technologies as proposed in the 
arsenic rule? (65 FR 38926, June 22, 2000)
    Response. AWWA believes that EPA's proposed method for accounting 
for new regulations in its affordability criteria is oversimplified for 
such a complex issues for several reasons. First, EPA's method doesn't 
take into account the impacts to lower-income households. On an system-
wide basis, the installation of arsenic removal treatment technology 
may be affordable while creating severe economic hardships for 
households at the poverty level or facing a large rate increase. 
Second, an increase of $500 per year (the difference between the 
``affordable'' threshold of $750 per year and the average of $250 per 
year) is significant for any household. A tripling of water rates is 
going to create rate shock anywhere. Third, EPA again touts the 
Drinking Water State Revolving Loan Fund (DWSRF) as a solution to 
disadvantaged communities. As discussed previously, there is not enough 
money in the entire DWSRF to comply with the proposed arsenic standard 
of 5 ppb.
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Statement of J. Richard Tompkins, Middlesex Water Company, on behalf of 
              the National Association of Water Companies
    Good morning, Mr. Chairman. My name is J. Richard Tompkins. I am 
the President of Middlesex Water Company, an investor-owned community 
water system serving a population of more than 200,000 in northern New 
Jersey. I am also the President of the National Association of Water 
Companies (NAWC), a non-profit trade association that exclusively 
represents the nation's private and investor-owned drinking water 
industry. I am offering this testimony on behalf of NAWC's membership 
over 300 companies in 43 states that provides safe, reliable drinking 
water to over 23 million Americans every day.
    Mr. Chairman, NAWC commends you and your subcommittee for 
conducting these oversight hearings on the implementation of the 1996 
Amendments to the Safe Drinking Water Act (SDWA), the second such 
hearings by your subcommittee in as many years. With its emphasis on 
public participation and right to know, and the requirements for sound 
science and cost-benefit analysis in the regulatory process, the 1996 
Act represents a new paradigm for environmental legislation of which 
this committee and Congress can be justly proud.
    Although our statement expresses some concerns over current and 
future issues regarding the Act and the drinking water industry, NAWC 
believes that overall EPA has made a good faith effort to comply with 
the letter and spirit of the Act. In particular we wish to commend EPA 
for its timely implementation of the Consumer Confidence Reports (CCR) 
rule; its efforts to seek increased funding for scientific research 
through the fiscal year 2001 appropriations process; its positive 
response to complaints about its SDWIS compliance data base (although 
much still needs to be done); and its efforts to implement the new 
Drinking Water State Revolving Loan Fund (DW-SRF) in an equitable 
manner.
    Areas of concern that we wish to address today include the proposed 
radon rule, the proposed arsenic rule, MTBE contamination of drinking 
water sources, inequitable implementation of the DW-SRF by some states, 
the threat to national drinking water standards posed by tort 
litigation, and drinking water infrastructure needs.
EPA's Proposed Radon Rule
    NAWC does not believe that EPA's proposed MCL of 300 pCi/L, or any 
level below 1000 pCi/L, can be justified by cost-benefit analysis, 
especially for small companies. NAWC's California chapter, the 
California Water Association, has prepared a statement that documents 
in detail the deficiencies of EPA's cost estimates, and we would like 
to submit CWA's statement for the record of this hearing.
    The cost differences between compliance with the proposed 
alternative MCL (AMCL) of 4000 pCi/L and 300 pCi/L can be huge. NAWC's 
largest company, American Water Works Company, estimates capital costs 
of $1.3 million for a treatment level of 4000 pCi/L compared with $134 
million for a treatment level of 300 pCi/L, a 100-fold difference.
    NAWC supports state-sponsored Multimedia Mitigation (MMM) programs 
as the most cost-effective way to achieve substantial health benefits 
through reduction in exposure to radon in indoor air. Furthermore, we 
believe that the prospect of water systems implementing local MMM 
programs in the absence of state programs is unrealistic. It is highly 
doubtful that the nation's public water systems, especially small 
systems, will have sufficient resources to achieve the goals of 
multimedia mitigation by themselves without state assistance. Tracking 
new home construction and remedial venting of existing homes is far 
removed from the chartered objectives of community water systems, not 
to mention the added burdens that would be placed on water ratepayers.
    In summary, NAWC believes that nationwide implementation of 
effective state MMM programs is essential for the Radon Rule to achieve 
its intended goals. Otherwise systems will be faced with the very 
unattractive alternatives of implementing local MMM programs or meeting 
a very costly MCL which cannot be justified by cost-benefit analysis. 
We urge Congress to consider legislation that would place the 
requirements of the MMM program in EPA's air program where it belongs 
and to provide states with sufficient resources to implement it. 
Effective MMM programs implemented in every state plus a drinking water 
AMCL of 4000 pCi/L will provide far greater public health benefits at a 
more reasonable cost than a drinking water MCL of 300 pCi/L standing 
alone.
EPA's Proposed Arsenic Rule
    NAWC agrees with the National Academy of Science that the current 
arsenic standard of 50 ppb needs to be revised in accordance with the 
provisions of the 1996 SDWA Amendments. However we are not convinced 
that EPA's proposed standard of 5 ppb, announced June 22, 2000, can be 
justified.
      Earlier this month, in a preliminary draft report, the 
Drinking Water Committee of EPA's Science Advisory Board (SAB) 
concluded that the available scientific evidence on health effects 
could justify a standard of 10 ppb or even 20 ppb.
      The World Health Organization has an arsenic standard for 
drinking water of 10 ppb.
      According to the AWWA Research Foundation, the cost of 
compliance with a standard of 5 ppb is 2 1/2 times that of compliance 
with a standard of 10 ppb.
    NAWC urges EPA to reconsider the available body of scientific 
evidence and to consider a final standard of no less than 10 ppb.
MTBE Contamination of Drinking Water Sources
    The use of Methyl tertiary butyl ether (MTBE) as an oxygen additive 
in reformulated gasoline has created a significant and unacceptable 
risk to drinking water surface and groundwater sources in many areas 
throughout the United States. Recently EPA recommended that Congress 
amend the Clean Air Act to significantly reduce or eliminate the use of 
MTBE as a fuel additive.
    On May 4, 2000, NAWC joined three other drinking water Associations 
in urging Congress promptly to consider legislation that would:
      Amend the Clean Air Act to significantly reduce or 
eliminate the use of MTBE in gasoline.
      Ensure that air quality gains are not diminished as MTBE 
use is reduced.
      Require adequate research to be conducted on any 
replacement fuel additive to ensure that such a replacement will not 
contaminate drinking water sources.
      Provide assistance to public water systems that have MTBE 
contaminated sources for treatment or for alternative water supplies.
    We urge Congress to take swift action to resolve this threat to our 
nation's drinking water supplies in accordance with these principles.
State Revolving Loan Funds
    When NAWC testified before this subcommittee in March, 1999, we 
observed that 19 states had declared privately owned drinking water 
systems to be ineligible for DW-SRF assistance through their 
constitutions, statutes or official policies. This unfortunate 
consequence is a clear, and in many cases deliberate, violation of 
Congressional intent that SRF loans should benefit customers of all 
public water systems, regardless of ownership. In fact, this intent was 
made explicit in this committee's report accompanying the 1996 
Amendments. Unfortunately, the most recent data from EPA reveals that, 
15 months later, the numbers of states ignoring Congressional intent 
has been reduced by only two.
    Mr. Chairman, EPA's state-by-state allocation of SRF funding is 
based on infrastructure needs surveys that include the needs of all 
utilities regardless of ownership. Those 17 non-complying states are 
accepting Federal funds based in part on the needs of privately owned 
utilities in their states while refusing to allow those same utilities 
to apply for SRF assistance. Plainly put, this is discriminatory not 
just against the companies but also against their customers, both of 
whom pay the taxes that make these funds available in the first place.
    Some argue that privately owned companies, even those serving the 
public, should not receive Federal assistance not even loans. Congress 
considered that argument in 1996, and concluded that regulation by 
state public utility commissions would assure that the interest savings 
from SRF loans would benefit customers not company shareholders. In 
fact the National Association of Regulatory Utility Commissioners 
(NARUC) has joined us in criticizing the failure of these states to 
comply with Congressional intent.
    We have urged EPA to base its SRF allocations on the needs of those 
customers that the states are actually willing to help. The funds 
forfeited by those states that refuse to comply would be reallocated to 
those who do. If EPA cannot, or will not, take this step, we believe 
that Congress should intervene to end this discrimination.
Water Contamination Tort Litigation
    NAWC continues to be concerned about a new kind of lawsuit which we 
believe seriously threatens America's drinking water industry and the 
regulatory system under which it has successfully operated for many 
years. In California, the plaintiff's bar has organized and commenced 
more than a dozen mass tort lawsuits against several community water 
systems (both public agencies and private companies) for allegedly 
delivering contaminated water, even though those systems claim to be in 
full compliance with state and Federal standards. As you know, these 
standards have been developed by regulatory agencies over many years 
based on the health effects of contaminants, measurement capabilities, 
and technical feasibility. They are the product of extensive 
Congressional debate over both the need to protect the public health 
and the cost of treatment.
    If 12 jurors conclude that these national standards are inadequate 
to protect the public health, water systems across the country will 
need to consider whether to comply with uniform national standards or 
the relatively arbitrary and unpredictable standards set by random 
juries. Furthermore, the costs of defending these lawsuits as well as 
increased insurance coverage will place upward pressure on water rates 
and charges. Ultimately, the substantial judgments that could result 
from these lawsuits could threaten the financial stability of water 
systems across the country.
    In September 1999, a California appellate court that had 
consolidated 11 of these cases ruled that the complaints against 
regulated systems should be dismissed because they were preempted by 
the authority of the California Public Utilities Commission. However, 
the complaints against the public agencies were ordered to proceed. In 
December 1999, The California Supreme Court accepted petitions for 
review of the intermediate court's decision.
    Regardless of the ultimate outcome in California, water systems all 
over the country remain vulnerable to the threat of this kind of 
litigation. Given the widely acknowledged success of the SDWA since its 
enactment more than 25 years ago, we believe that it would be most 
unfortunate, if not potentially disastrous, if the heart of the Act 
uniformly enforced national drinking water standards were to be eroded 
or destroyed by litigation.
    Accordingly we have been working with other drinking water groups 
to draft legislation that would:
      Make compliance with drinking water standards a defense 
in civil lawsuits against water utilities.
      Cover unregulated contaminants as well by requiring proof 
of negligence (as opposed to strict liability).
      Give deference to compliance determinations by state 
primacy agencies (without requiring those agencies to go beyond current 
requirements).
      Protect all utilities (public and private, large and 
small) from frivolous lawsuits which are expensive to defend.
      Preserve, through a standard ``savings clause,'' defenses 
already available under Federal or state law.
    Mr. Chairman, we look forward to working with the Members of this 
committee as we proceed with this endeavor.
Drinking Water Infrastructure Needs
    A 1997 EPA report estimated that the drinking water industry must 
invest $138 billion over the next 20 years to replace failing 
infrastructure. At that time, this amount actually exceeded EPA's total 
estimate of existing water industry assets. A recent analysis by the 
American Water Works Association estimated total infrastructure needs 
to be $385 billion. When wastewater needs are added, that number more 
than doubles.
    The private sector stands willing and able to help with these 
infrastructure financing challenges. Creative partnerships should be 
encouraged and pursued so that municipalities can tap and pursue the 
private capital markets. If such partnerships were fully pursued, many 
cities and towns all across the country could successfully address many 
of their infrastructure financing shortfalls.
    However, some have responded to this challenge by calling upon 
Congress to consider massive Federal grant or trust fund programs. NAWC 
believes such a call to be, at best, premature. In addition, if the 
water industry cannot meet the infrastructure challenge substantially 
on our own over the long run, we will have admitted that our utility 
models are not self-sustaining. In other words, NAWC believes that the 
supply and delivery of potable water should be cost effective and 
should pay for itself as is the case with the electric, gas and 
telecommunication utilities. Consequently, we need to find solutions 
that will assure that water utilities are economically viable in the 
future, without subsidy.
    In summary, if it is demonstrated that Federal assistance is 
warranted, NAWC will be prepared to support narrowly targeted solutions 
that:
      Are economically efficient and equitable.
      Include all water utilities regardless of size or 
ownership.
      Support innovation.
      Assure that utilities are self-supporting over the long 
term.
      Provide special assistance to economically depressed 
areas based on consumer needs.
    These are long-term challenges, and we look forward to working with 
this committee to achieve long-term solutions that will allow the 
industry to stand on its own two feet.
    In conclusion, Mr. Chairman, NAWC very much appreciates this 
opportunity to present our views, and I would be happy to respond to 
any questions.
                                 ______
                                 
         Responses by Richard Tompkins to Additional Questions 
                           from Senator Crapo
    Question 1. What does the NAWC believe to be the per household cost 
implications of a radon rule of 300 pCi/L, either generally or for your 
membership?
    Response. It is always difficult to talk about costs per household 
with drinking water regulations because usually the costs are not 
spread out evenly over all households. In the case of radon talking 
about average cost per household is so misleading as to be virtually 
useless. Radon is only found in very specific parts of the country. 
Furthermore, radon only shows up in the source water of groundwater 
facilities, which tend to be small, thus concentrating the costs even 
more. To illustrate the wildly differing costs different utilities 
face, one of NAWC's members surveyed its utilities and found that the 
cost per household of a 300 pCi/L rule ranged from $7 per household to 
$200 per household.
    We agree with the comments to EPA from American Water Works 
Association, which stated ``the proposed MCL would not give rise to an 
affordability concern for most water systems serving 500 people or 
more. However, there are indications that low-income households served 
by smaller water systems. . . might be faced with serious tradeoffs 
that could adversely affect the occupants' health''.
    Also, costs per household for radon should not be viewed in 
isolation, but considered together with costs of other pending 
regulations such as arsenic, M/DBPs and groundwater.

    Question 2. The EPA's cost estimates per household for the 
treatment for arsenic do not vary considerably for systems below 1 
million customers irrespective of the proposed MCL. Does this 
conclusion match findings of NAWC's analyses?
    Response. On June 22n? EPA proposed a new arsenic standard of 5 
ppb, and has asked for comments on standards of 3, 10, and 20 ppb. In 
the proposed regulation EPA endeavored to answer this very question:
    ``Costs per household do not vary dramatically across MCL option. 
This is because of the fact that once a system installs a treatment 
technology to meet an MCL target, costs do not vary significantly based 
upon the removal efficiency it will be operated under. ``
    However, the AWWA Research Foundation has found that the cost of 
compliance with a standard of 5 ppb is 2 I/: times that of compliance 
with a standard of 10 ppb. AWWARF also sharply disagreed with EPA's 
national cost estimates. They estimated that compliance with a standard 
of either 5 or 10 ppb would about 4 times more expensive than EPA 
estimated. NAWC is on record urging EPA to reconsider the available 
body of scientific evidence and to consider a final standard of no less 
than 10 ppb.

    Question 3. State SRF allocations are based on infrastructure needs 
for both private and public systems. However, several states, by their 
own determination, preclude private systems from accessing the SRF. 
Should the EPA prepare future allotment formulas based on the needs of 
systems eligible to receive funds from that state?
    Response. Yes. Fairness and consistency require that EPA take into 
account State eligibility determinations when preparing the State 
allotment formulas.
    Thus far, EPA officials have been even-handed and persistent in 
their efforts to implement the DW-SRF equitably. However, they have 
been resisted by about 17 States which do not allow access to the DW-
SRF by privately owned systems, despite the clear intent of Congress.
    Presently, EPA is considering implementing a policy that would base 
a state's SRF allocation only on those infrastructure needs that the 
state has determined to be eligible. (The funds subtracted from States 
that do not comply with Congressional intent would be redistributed to 
those States that are in compliance.) This makes perfect sense. Why 
award a state an allocation for infrastructure needs which the state 
has no intention of assisting? NAWC believes that such a revised policy 
would be fair and proper for all community water systems and their 
customers, as well as the states.
    Also, If EPA concludes that it lacks legal authority to make such a 
policy, we urge Congress to make such authority explicit and to require 
its implementation.

    Question 4. Is it your expectation that additional states will 
extend DW-SRF eligibility to private systems in the future?
    Response. Not without specific direction from EPA or Congress.
    Since the establishment of the DW-SRF many states have changed 
their laws or practices to extend SRF eligibility to private systems, 
thus fulfilling Congressional intent. However, in the 15 months since 
NAWC last testified before this committee the number of states denying 
private system access to the SRF has only been further reduced by 2, to 
17. (Illinois, Indiana and North Dakota have included private 
utilities. West Virginia has gone the other way, excluding privates. 
Note: of the states represented on the subcommittee, only Wyoming 
excludes privates. On the full committee only Montana and Oklahoma 
exclude privates.)
    When Congress established the DW-SRF in 1996, it recognized that 
all benefits from low interest loans are passed on to the utilities' 
customers (in fact, the State Public Utilities Commissions require it). 
To deny such loans to private and investor-owned utilities penalizes 
the customers of such utilities. Therefore, NAWC believes that EPA and 
Congress should continue encouraging all States to implement the SRF as 
intended.

    Question 5. Tort litigation in California has raised the issue of 
liability of water systems to unregulated contaminants. Is this an 
isolated problem?
    Response. No, the California litigation is not an isolated problem. 
There have been toxic tort actions filed in other states, but have thus 
far been settled, including the Milwaukee cryptosporidium lawsuit. The 
California suits, on the other hand, are the first in which trial 
lawyers have apparently mounted an organized effort to target the water 
industry. Over the last several years a dozen different suits, with 
hundreds of plaintiffs, were filed in California. If the plaintiffs are 
successful we believe a wave of lawsuits could be set loose all across 
the country. Should this happen the following problems will be 
presented for the water industry, Congress, and Federal and State 
regulators:
    1. Undermining Water Quality Regulations. This litigation could 
result in 12 jurors in a state courtroom setting national drinking 
water standards--standards far different from those set by the Federal 
and state agencies under the regulatory process. Those jurors will have 
heard ``scientific'' testimony that those standards do not protect 
public health. Water suppliers, facing uncertainty about which 
standards to meet, will be pressured to follow the most stringent 
standards set by any jury in the country to avoid liability. National 
uniformity (and uniformity within the states) will be eroded.
    2. Water Cost Increases. Such litigation will place upward pressure 
on water prices due to the costs of defense (which could be substantial 
given the expert testimony and multiple plaintiffs) and the unexpected 
expenses of new water treatment technologies -technology beyond that 
required by Federal and state regulations to avoid potential liability. 
This economic burden will fall most heavily on working class families 
where water--a necessity of life--will take a bigger share of their 
paychecks.
    3. Threat to Financial Stability of Water Agencies. Mass tort 
litigation can result in catastrophic judgments against utilities and 
public agencies and--if Superfund has taught us anything--insurance may 
not be available to cover these new liabilities. Most water suppliers 
do not have reserves for damages of this magnitude and have limited 
access to outside sources of funds. Sudden and substantial rate 
increases are likely.
                               __________
Statement of Randy Van Dyke, President, Clay Regional Water, on Behalf 
   of the National Rural Water Association and the Iowa Rural Water 
                              Association
    Good morning Chairman Crapo and Members of the committee. My name 
is Randy Van Dyke. I am the general manager of the Clay Regional Water, 
a rural water system in Iowa and President of the National Rural Water 
Association which represents over 17,000 small and rural communities. 
On behalf of all these small communities I would like to thank the 
committee for this opportunity.
    I will focus my comments today on a review of three of the key 
principles of the Safe Drinking Water Act of 1996--one, the use of 
sound science and cost/benefit in rulemaking; two, input from 
stakeholders in the process; and three, an emphasis on flexibility in 
the law to reduce bureaucracy.
    Small communities embraced these principles, hoping they would 
limit Federal drinking water rules from wasting local public health 
resources. Unfortunately, this has proven not to be the case across the 
board and I will briefly explain.
    First, sound science and cost/benefit. The EPA has not taken the 
initiative to obtain adequate data, and sound science, including the 
use of the most recent accurance information, reasonable health affects 
studies, and compliance cost information when promulgating new rules. 
Frequently, good scientific studies are started too late and research 
data collection lag behind the timing for EPA to write and finalize new 
regulations. Consequently, old information and inadequate science is 
utilized as ``best available science'' creating weak or wholly 
inaccurate conclusions, placing a devastating financial impact on small 
water systems across this nation. Without anyone holding EPA 
accountable, only a strong emphasis on statutory deadlines is 
accomplished. Selective science and data is used instead of the good 
science and that cost/benefit analyst that was envisioned in the 1996 
SDWA amendments. Here are some examples:
    EPA's proposed ground water rule is incredibly broad in scope, and 
it based on one private utility funded occurrence study that the 
science community considered inadequate. Compliance cost have not been 
accurately calculated, and EPA disregarded rural water's request to 
study the possibility of designing a simple monitoring method that 
would have greatly simplified the rule.
    EPA failed to use the best available science to set requirements 
under the LTlESWTR. Independent analysis of the Cryptosporidium 
occurrence data from the Information Collection Rule (ICR) survey 
indicated actual mean occurrence levels (considering recovery and 
viability) are likely to be an order of magnitude different (or less) 
than the figures used by EPA . Opposite the conclusion reached by EPA 
the ICR figures indicated that the cost far exceeded any benefit, ``If 
the facts don't fit the theory, change the facts.'' Albert Einstein 
(1879-1955)
    Disinfectant/Disinfection byproducts--The small systems have 
withdrawn from two prior Federal Advisory Committee Act (FACA) on D/DBP 
because there was not adequate science to justify a standard to a level 
that was affordable by small systems. We are now participating in a 
third FACA where the science is still inadequate and data is lacking 
for small systems.
    Arsenic--There is very uncertain scientific evidence of the health 
effects of arsenic at levels proposed by EPA. Recently, EPA's own 
Science Advisory Board expressed concern that EPA proposal for a MCL of 
5 parts per billion may be a precipitous action and that a less extreme 
proposal made until new studies are completed. Any decision by EPA to 
go below the current 50 parts per million standard will place an 
enormous cost on small systems without the public health benefits to 
justify such an action. The unintended consequences of regulating small 
communities in the absence of public health and cost information can be 
deleterious, causing much more harm than benefit to the customers. The 
problem with the current approach is best articulated by consumer 
expert Scott Rubin, who said: ``Public health protection is notiree. 
Whether it's medical care, sewage treatment, clean drinking water, AIDS 
prevention, prescription medicine, food, heat, or shelter--it costs 
real money. And we don't have enough to go around. So, yes if we're 
setting public health policy, and that's what drinking water regulation 
is, we better make sure that we're getting our money's worth. Because 
if we're not buying meaningful public health protection, all we've done 
is take away money that people need to put food on the table, pay for a 
doctor, and keep the house warm. . . . My point is simple: Whenever we 
do anything to increase the price of water, we areforcing millions 
offamilies to makeyet another tradeoff which will directly affect their 
health. And, at the same time, we take a family that was barely 
squeaking by and we push them over the edge. ``
    Five major arsenic scientific studies are started at this time. The 
bulk of the health effects information necessary to appropriately set a 
rule will not be completed during the time of the regulatory rulemaking 
process.
    To paraphrase Mark Twain, there is nothing as pesky as a good 
anecdote. What should be done in the City of Lidgerwood North Dakota, a 
very small city with just over 400 homes, an agriculture based economy 
with a high concentration of retired person, 70 miles south of Fargo. 
The city spent the better part of 1 million dollars to comply with the 
current arsenic standard which brought their levels from 56 parts per 
billion to 17. To comply with a 5ppb standard they would have to 
completely rebuild the treatment system for a cost over 1.5 million 
dollars.
    Variances and Determining URTH (unreasonable risk to health): The 
SDWA contemplated that standards would be become affordable for small 
systems through the use of variances as described by Senator Baucus 
[Senate--November 29, 1995]
    The bill provides special help to small systems that cannot afford 
to comply with the drinking water regulations and can benefit from 
technologies geared specifically to the needs of small systems. Here is 
how it would work. Any system serving 10,000 people orfewer may request 
a variance to install special small system technology identif ed by 
EPA. What this means is that if a small system cannot afford to comply 
with current regulations through conventional treatment, the system can 
comply with the act by installing affordable small system technology. 
Small systems that seek a variance will be protectedirom f nancial 
penalties while their application is being reviewed, and they would 
have 3 years to install the affordable technology. States approve the 
variance, but only if the technology provides adequate water quality 
and public health protection. So small systems are not forced to use 
big city treatment. But they must fully protect public health.
    For a variety of reasons, EPA has not granted any variances. 
However, more concerning, is that EPA has not determined a criteria for 
who will be granted vanances. This failure to determine a simple (or 
any) policy on what cost/benefit principal will be used to grant 
variances or what URTH levels of contaminants will force small systems 
to comply with the same standards as large systems. This was the 
problem the SDWA of 1996 was attempting to remedy. We urge the 
committee to require EPA to publish any numerical levels (ranges) for 
all regulations that will not result in an unreasonable risk to health 
as contemplated in the SDWA and the methodology for determining URTH 
levels so small communities can plan for the future. Also, we would 
request that the committee ensure that when any standards that are set 
using the criteria that is affordable for a large city, there is a 
corresponding level identified under the variance provisions based on 
either (1) public health or URTH or (2) the affordability of venous 
systems sizes identified in the small system technology provisions.
    This information would be very beneficial for small communities to 
use in explaining--to their constituents--the need and public health 
benefits from compliance.
    Occasionally, EPA is being held accountable tor moving forward 
without sound science--as in the case of the recent Chloroform lawsuit. 
However, this avenue of accountability is prohibitively costly for 
small communities who generally rely on the Congress to monitor EPA 
actions.
    Second,-stakeholder input, we have been disappointed by the 
consistency in which the Agency dismisses or sets aside input from 
stakeholders, the scientific community and the public. Numerous local 
officials have participated, at great length, on panels and 
stakeholders groups, only to see EPA unilaterally make all policy 
decisions. Ultimately, stakeholders are having very little impact on 
the final rule. Work groups to provide background information to 
stakeholder committees and panels frequently are pressured to put on 
the table information that is incomplete, not peer reviewed and 
submitted at the last possible moment. Concerns about the compounding 
effect of the new rules on small communities and state primacy agencies 
ability to implement is largely ignored. Individually, here are some 
examples:
    Arsenic and D/DBP Stakeholders and small communities petitioned the 
Agency without success to delay rulemaking for 2 to 5 years until the 
new research gives meaningful answers to the question of health 
effects. In both cases, new epidemiology studies once evaluated will 
clearly characterize the dose-response relationship for non cancer end 
points. Currently, work groups and scientific panelists are pressured 
into creating conclusions that are weak and not supported by the data 
or health effects at the lower levels suggested by EPA.
    Third, flexibility as a remedy to bureaucracy. The question has to 
be asked, is it possible for EPA to ever choose to be flexible in its 
approach. We can conclude based on empirical and theoretical 
observation that it is not possible for EPA to utilize flexibility. 
They can not be faulted for this however, because EPA is first and 
foremost a regulatory Agency. They are only liable, politically and 
legally, when they don't fully enforce any and every regulatory measure 
to its fullest extent. Success for a regulatory Agency is not measured 
in the vagaries of public health progress, but in application of finite 
regulations. Due to its mission, incentives, and culture EPA at every 
opportunity has chosen to use any discretion in the SDWA to increase 
the bureaucracy of its regulations.
    The following are a few examples of our concerns:
    Capacity Development: the Act provides for states to develop a 
program for assuring that there is sufficient technical, managerial and 
financial capacity for all new water systems and for water systems 
applying for State Revolving Fund assistance. This is the scope of the 
law with a very limited Federal role. Rural water recommended that 
states (not EPA) to develop a state capacity development strategy for 
meeting four specific areas written into the statute. This would 
provide states the full flexibility to address small system capacity 
development. Contrary to this input, EPA has written formal guidelines 
for these capacity development strategies despite the fact that there 
is no statutory authority for EPA to write such a guidance. Our 
contention is that states have ultimate flexibility in this process and 
that every state is presently operating a form of capacity development 
strategy simply in its regulatory compliance and technical assistance 
programs. EPA says that the guidelines were supported by a majority of 
the stakeholders in the stakeholder meeting. However, this was not a 
stakeholder idea--it was a proposal initiated by EPA and pushed 
vigorously in the meeting.
    Ground Water Rule: We felt that the rule should clearly demonstrate 
ground water contamination (physical, chemical, biological, or 
radiological substance or matter in the water) before requiring systems 
to disinfect or take any other steps. This common sense, ``innocent 
until proven guilty'' idea is the direction that the small communities 
feel EPA should adopt. However, EPA chose to develop a rule that 
regulates what a community must do to prevent contamination--a major 
change in the Federal regulatory model. All EPA instruction on how to 
run a community (water system) to prevent contamination should be NON-
regulatory (i.e., information, grants, training, education etc. to 
encourage towns to adopt the latest practices). EPA's ambiguous and 
opened ended rule functions more like a permit and leaves small 
communities without any discernable idea of when compliance is 
achieved. It can be interpreted differently from state to state and 
case to case.
    Consumer Confidence Reports: We encouraged EPA to support a 
grassroots outreach program to assist communities with the first 
generation of CCRs because the enormous complexity of publishing the 
reports we thought, at least for the first report, EPA should use 
educational programs and flexibility to get systems to comply. 
Unfortunately this was not what Agency chose. After making the rule as 
complex and detailed as possible EPA has initiated an enforcement 
policy that resulted in EPA letters saying: ``you are in violation of 
the CCR rule . . . your system could be subject to Federal formal 
enforcement actions . . . [which] carry potential penalties of up to 
$257,000 per day.'' Keep in mind, that many of these towns don't have 
computers. have never heard of the Consumer Confidence Report.
    Operator Certification Money: under section 123, EPA was to provide 
for the ``reimbursement for the costs of training, including an 
appropriate per diem for unsalaried operators, and certification for 
persons operating systems serving 3,300 persons or fewer that are 
required to undergo training pursuant to this section. . . through 
grants to States.'' EPA was authorized to use up to $30,000,000 from 
the SRF to accomplish this objective. To date, these funds have not 
been allocated to state even through EPA is evaluating state 
certification programs.
    Radon: EPA has proposed a radon maximum contaminant level 300 psi/
l. Under the Act, a community can comply with the outdoor air 
equivalent if its state initiates a multimedia mitigation program. 
However, EPA appears to be requiring overly prescriptive mitigation 
program rather than an education/technical assistance approach. If 
states do not adopt workable multi-media programs than small 
communities will be required to do so, or comply with the 300 psi/l 
standard--an unreasonably stringent standard. Small systems should not 
be penalized by state inaction or EPA's overly complex MMP demands.
    In closing Mr. Chairman, we must acknowledge and thank EPA for 
willingness to invite small systems in the stakeholder process, and the 
efforts on the part of the staff to include small communities in their 
rulemaking process. However, let me close by highlighting what is 
working in rural areas to help communities provide safe drinking water 
and comply with EPA's implementation of the rules.
    Ask yourself, which communities in my state can't be trusted to 
take every et fort to provide safe drinking water. We continually ask 
for the list of the small communities that need to improve their 
drinking water and are not willing to take the steps to do it. No such 
list exists. Under the SDWA EPA was required to make such a list for 
recalcitrant systems. This has never been accomplished to our 
knowledge.
    What is axiomatic in rural Amencan and overlooked in Washington is 
that small towns will take the necessary measures to protect their 
water. However they need common-sense assistance in a form they can 
understand (reasonable, practical and affordable). It takes someone 
siting down with them evening after evening, and working with them 
through the ENTIRE process. Giving them a copy of the Federal register 
and phone number to call is no help at all.
    This is why much of the SDWA is misdirected--improving drinking 
water in small communities is more of a RESOURCE problem than a 
REGULATORY problem. Every community wants to provide safe water and 
meet all drinking water standards. After all, local water systems are 
operated by people whose families drink the water every day, who are 
locally elected by their community, and who know, ilrst-hand, how much 
their community can afford.
    An anecdote from rural New York captures what is happening across 
the country: the Village of Cato is a typical rural community, 
consisting of 230 homes, a part-time Mayor, a village budget of three 
hundred thousand dollars and two full-time employees.
    Last year, the EPA mandated that Cato publish a Consumer Confidence 
Report. This lengthy, confusing report is detailed in 26 pages of the 
Federal Register prose.
    Over 50 thousand small communities across the country, just like 
Cato, had to comply with the rule. On behalf of those communities, we 
feel that there are two ways to implement this rule and one is better 
than the other.
    First, is the rural water, grassroots way. Using funds provided by 
Congress, New York Rural Water Association helped over 500 communities 
publish their Consumer Confidence Report. For about half of the 500, 
they held regional 1-day training sessions. The towns could bring their 
required data to our sessions and using our staff, our computers, a 
simplified template of EPA's requirements. and a little magic--the 
towns could leave at the end of the day with their Report and the 
knowledge to do it on their own next year. The second half of the 500 
communities needed more individual attention because their staff was 
not able to leave their j obs for a day, or they were too small to have 
staff. Keep in mind, that many of these towns don't have computers, 
have never heard of the Consumer Confidence Report, and have priorities 
of their own. This was the case in Cato, a circuit rider technician 
traveled to Cato and using his expertise and laptop, walked the village 
clerk and the water operator through the process, so that they could 
publish the report and comply with the rule. Across the country, rural 
water circuit riders assisted tens of thousands of small communities in 
a similar fashion. The result was a compliance rate for the rule higher 
than anyone had anticipated.
    The second way to implement this rule is simply to send a letter to 
all the systems informing them of the rule and giving them an arbitrary 
compliance date. And following up that letter with another one from EPA 
saying: ``you are in violation of the CCR rule . . . your system could 
be subject to Federal formal enforcement actions . . . [which] carry 
potential penalties of up to $25,000 per day.''
    This so-called Consumer Confidence Rule, is just one of many that 
EPA has promulgated--some are over 100 Federal register pages. Small 
towns depend on rural water assistance for help with EPA's complicated 
rules. What is working in small towns is providing common-sense 
assistance in a form they can understand and afford.
    Last year, rural water technicians and Circuit Riders made over 
50,000 ON-SITE contacts with small and rural water/wastewater systems. 
This is the only useful assistance many of these communities ever 
receive. Often the contacts result in important public health 
protection, substantial money savings to the community, avoidance of 
EPA fines, and enhanced long-term viability of the system.
    I would like to again thank the committee for this hearing, ask for 
your continued support for additional technical resources to the 
grassroots level, your assistance to clarify the intent and meaning of 
key provision in the 96 Amendments, and your resistance to calls from 
special interest groups for more and more, ever stringent Federal 
unfunded mandates on communities. Unfortunately things aren't that 
simple. The key to long-term improvement is local support, local 
education and available resources.
                               __________
                Statement of the City of Albuquerque, NM
    The City is committed to protecting the health and welfare of our 
citizens and appreciates the opportunity to testify regarding the 
proposed revision to the drinking water standard for arsenic. Our water 
system serves more than 450,000 residents through a distributed network 
of 92 wells and 45 reservoirs. The majority of these facilities are 
located in existing neighborhoods adjacent to residences, businesses 
and schools. Although the City has successfully implemented water 
conservation measures and is working toward direct use of our San Juan-
Chama water, we pumped more than 3 8 billion gallons of water from the 
underlying aquifer in 1999.
    Arsenic is a naturally occurring element in our ground water with 
concentrations ranging from 2 to 50 parts per billion (ppb). The EPA 
proposal to lower the maximum contaminant level (MCL) from 50 ppb to 5 
ppb will impact about 70 percent of the wells at an estimated cost of 
compliance between $190 and $380 million ($20/month/customer). At a 
standard of 20 ppb, the City's cost is estimated to ranges from $40 to 
$70 million ($5/month/customer). Our cost of compliance estimates, 
which are based on 3 years of research in Albuquerque by the University 
of Houston, thousands of water quality samples, and cost estimates 
developed by local and national experts, attempted to address some of 
the issues that EPA has refused to estimate. For example, EPA has 
refused to develop and include the cost for acquisition of new land for 
construction of the facilities, increase in arsenic concentrations with 
depth in the aquifer and acquisition of new water supplies to offset 
water lost during treatment. One serious question that is still 
unresolved is the disposal of the residuals. Is the residual arsenic in 
the waste stream going to be considered a hazardous waste? If the 
answer is yes, the City's cost of compliance figures do not reflect the 
need to transport hazardous waste out of New Mexico because there are 
currently no permitted hazardous waste facilities that can safely 
dispose of the residuals in New Mexico.
    According to EPA, the high national costs for water treatment are 
justified because they prevent arsenic-related bladder and lung cancer 
cases and deaths. EPA estimated arsenic-related risks by extrapolating 
bladder cancer study results from populations in southern Taiwan 
consuming high water borne arsenic levels as compared to U.S. 
populations consuming low waterborne arsenic. A linear statistical 
model was used to extrapolate from high to low dose arsenic exposures. 
Although there is considerable evidence suggesting that the arsenic 
dose-response relationship for cancer is sub-linear, EPA acknowledges 
this problem and states ``because current data on potential modes of 
action are supportive of sub-linear extrapolation, the linear approach 
could overestimate risk at low doses''. They also note that the 
overestimate ``makes an increasing difference as dose decreases''. 
Given the uncertainty in the model, EPA concludes that ``decisions 
about safe levels are public health policy judgments''.
    While EPA has concluded that they have overestimated the risks by 
using the linear approach, there are other uncertainties with the 
health science. The Taiwan study was a ecological epidemiological study 
where the actual waterborne arsenic levels for each person were not 
known, but were estimated. Based on the findings from a study completed 
in Millard County, Utah, one could argue that the results from a study 
of arsenic health effects in Taiwan cannot be extrapolated to the U.S. 
More specifically, no evidence of increased cancer risk has been seen 
in studies of U.S. populations exposed to low levels of drinking water 
arsenic.
    When the Nation invests in public health programs, such as the 
revised arsenic MCL, it is critical that the projected benefits be 
certain. The best science should be applied before a standard is 
adopted. In fact, the costs of achieving a 5 ppb MCL for arsenic range 
from 93 to 374 times the $50,000 per year cost criteria used to 
evaluate other public health and medical intervention programs. Only 
for an MCL of 20 ppb can we estimate that the most optimistic 
assumptions of benefits, with no discounting for the delay in observing 
the benefits, meets EPA's own cost-effectiveness criteria.
    Given the fact that EPA acknowledges that they have overestimated 
the risks in the U.S., the City feels strongly that Congress should 
investigate how EPA is meeting the science requirements as directed by 
the Amendments to the 1996 Safe Drinking Water Act. In addition, we 
recommend that the MCL be set at 20 ppb in the interim until the 
necessary research is completed for reevaluation of the standard in 6 
years.
                               __________
                               American Dental Association,
                                                     July 13, 2000.

The Honorable Michael Crapo, Chairman,
Subcommittee on Fisheries, Wildlife, and Drinking Water,
Environment and Public Works Committee,
U.S. Senate,
Washington, DC 20510

RE: ``Safe Drinking Water Act'', June 29, 2000
Dear Mr. Chairman: The American Dental Association (ADA) has endorsed 
fluoridation oaf community water systems for 50 years as a safe and 
effective way to prevent tooth decay. Fluoride is nature's cavity 
fighter, occurring naturally in the earth's crust, in combination with 
other minerals in rocks and soil. Small amounts of fluoride occur 
naturally in all foods and beverages. Water fluoridation is the process 
of adjusting the natural level of fluoride to a concentration 
sufficient to protect against tooth decay, a range of from 0.7 parts 
per million (ppm) to 12 ppm.
    Thanks in large part to community water fluoridation, half of all 
children ages 5 to 17 have never had a cavity in their permanent teeth. 
According to the April 2000 Journal of Dental Research, She use of 
fluorides in the past 40 years has been the primary factor in saving 
some $40 billion in oral health case costs in the 1 United States.
    Just last month, Surgeon General David Satcher wrote in his report, 
Oral Health Care in America, ``Community water fluoridation is safe and 
effective in preventing dental caries in both children and adults. 
Water fluoridation benefits all residents served by community water 
supplies regardless of their social or economic status.''
    Revised national health objectives in Healthy People 2010 again 
include objectives to improve the nation's oral health. Oral Health 
Objective 9 states that at least 75 percent of the population should be 
receiving the benefits of optimally fluoridated water by the year 2010. 
According to the most recent Centers for Disease Control and Prevention 
(CDC) Fluoridation Census, only 62 percent of the population served by 
public water systems has access to fluoridated water.
    After 50 years of research and practical experience, the 
preponderance of scientific evidence indicates that fluoridation of 
community water supplies is both safe and effective. Methods and 
populations differ, but studies show that water fluoridation can reduce 
decay in baby teeth by as much as 60 percent and can reduce tooth decay 
in permanent teeth by nearly 35 percent.
    Even before the first community fluoridation program began in 1945, 
epidemiological data from the 1930's and 1940's revealed lower decay 
rates in children consuming naturally occurring fluoridated water 
compared to children consuming fluoride-deficient water.
    Since that time, innumerable studies have been conducted to 
demonstrate the safety and/or effectiveness of water fluoridation. 
Three outstanding reviews of community water fluoridation are:

      Newbrun E. Effectiveness of water fluoridation. J Public 
Health Dent 1989; 49(5):279-89. (Results of 113 studies in 23 countries 
were analyzed.)
      Ripa LW. A half-century of community water fluoridation 
in the United States: review and commentary. J Public Health Dent 1993; 
53(1): 17-44. (Analysis of 50-year history of community water 
fluoridation.)
      Murray JJ. Efficacy of preventive agents for dental 
caries. Caries Res 1993; 27(Suppl 1):2-8. (Review of studies conducted 
from 1976 through 1987.)

    Numerous large-scale epidemiological studies of water fluoridation 
have been conducted, making fluoridation one of the most widely studied 
public health measures. Because these large investigations have been 
consistently validated, water fluoridation is not as frequently studied 
as in past decades. Water fluoridation is a perfect example of how well 
designed studies stand the test of time and scientific scrutiny. 
Studies included in the review articles listed continue to be 
referenced today and have become ``classics'' in the public health 
field.
    Many well-documented studies have compared the decay rates of 
children before and after fluoridation in the same community, as well 
as with children in naturally fluoridated and/or nonfluoridated 
communities. Because of the high geographic mobility of our populations 
and the widespread use of fluoride toothpastes, supplements and other 
topical agents, such comparisons are becoming more difficult to 
conduct.
    Although other forms of fluoride are available, persons in 
nonfluoridated communities continue to demonstrate higher dental decay 
rates than their counterparts in communities with water fluoridation as 
determined in the following studies:

      Brunelle JA, Carlos JP. Recent trends in dental caries in 
U.S. children and the effect of water fluoridation. J Dent Res 1990; 
69(Spec Iss):723-7. (Review of 1987 survey of 40,000 school children 
compared to survey in 1979-80.)
      Horowitz HS. The effectiveness of community water 
fluoridation in the United States. J Public Health Dent 1996 Spec Iss; 
56(5):253-8. (Review of 50 years of water fluoridation.)
      Selwitz RH, Nowjack-Raymer RE, Kingman A, Driscoll WS. 
Dental caries and dental fluorosis among schoolchildren who were 
lifelong residents of communities having either low or optimal levels 
of fluoride in drinking water. J Public Health Dent 1998; 58(1):28-35. 
(Review of tooth decay experience between children who were lifelong 
residents of optimally fluoridated communities versus those who were 
lifelong residents of communities having low fluoride levels in 
drinking water.)

    The safety and/or effectiveness of community water fluoridation 
have been examined not only in communities within the US, but also in 
other communities worldwide. Below are several international studies of 
community water fluoridation:

      Fluoride, teeth and health. Royal College of Physicians. 
Pitman Medical, London; 1976. (There is no evidence of a relationship 
between water fluoridation and congenital malformations, thyroid 
disorders, cancers or allergies.)
      Knox KG. Fluoridation of water and cancer: a review of 
the epidemiological evidence. Report of the Working Party. London: Her 
Majesty's Stationary Office; 1985. (Neither fluoride occurring 
naturally in water, nor fluoride added to water supplies, is capable of 
inducing cancer, or of increasing the mortality from cancer.)
      Spencer AJ, Slade GD, Davies M. Water fluoridation in 
Australia. Comm Dent Health 1996; 13(Suppl 2):27-37. (Water 
fluoridation is the most effective and socially equitable means of 
achieving community wide reductions in dental decay.)
      World Health Organization. Fluorides and oral health. 
Report of a WHO Expert Committee on Oral Health Status and Fluoride 
Use. WHO Technical Report Series 846. Geneva; 1994. (Water fluoridation 
is the most effective method of reaching an entire population so that 
all social classes benefit without the need for active participation on 
the part of individuals. It is essential that water fluoridation have 
the support of the leading health authorities and of the government.)

    Mr. Chairman, community water fluoridation plays an important role 
in the health of infants and toddlers. Early childhood caries (ECC) is 
a serious socio-behavioral and dental problem that afflicts infants and 
toddlers in many communities and populations in the United States and 
other countries. The condition reaches epidemic proportions in low-
income and Native American communities in the United States. Known also 
as baby bottle tooth decay or nursing bottle mouth, the condition is 
characterized by severe decay, especially in the upper front teeth, 
which can result in tooth loss in infants and toddlers. Water 
fluoridation has been identified as the most highly recommended 
preventive strategy for early childhood caries.

      Ismail AI. Prevention of early childhood caries. 
Community Dent Oral Epidemiol 1998; 26(Suppl 1):49-61. (Water 
fluoridation provides the only means of ECC prevention that does not 
require a dental visit or parental motivation.)

    From time to time, the safety and effectiveness of water 
fluoridation has been questioned. None of these charges has ever been 
substantiated by generally accepted science. It is important to review 
information about fluoridation with a critical eye.
    Recently, extensive investigative reports found no scientific 
evidence that exposure to fluoride at the levels found in optimally 
fluoridated water presents any risk for the development of any disease 
process.
    There have been claims that exposure to fluoride presents a 
neurotoxic (harmful or damaging to nerve tissue) risk or lowered 
intelligence. Such claims are based on a 1995 study (Mullenix PJ, 
Denbesten PK, Schunior A, Kernan WJ. Neurotoxicity of sodium fluoride 
in rats. Neurotoxicol Teratol 1995; 17(2): 169-77) in which rats were 
fed fluoride at levels up to 125 times greater than that found in 
optimally fluoridated water. The study attempted to demonstrate that 
rats fed extremely high levels of fluoride (75 ppm to 125 ppm in 
drinking water) showed behavior-specific changes related to cognitive 
deficits. These amounts are far in excess of the U.S. Public Health 
Service recommended fluoride levels of 0.7 to 1.2 ppm in water systems.
    In addition, the experiment also studied the offspring of rats who 
were injected two to three times a day with fluoride during their 
pregnancies in an effort to show that prenatal exposure resulted in 
hyperactivity in male offspring. Independent scientific review of this 
finding did not support the conclusions made by the authors and 
discounts the potential of sodium fluoride as a potential 
neurotoxicant. (Ross JF, Daston GP. Neurotoxicology and Teratology 
1995; 17(6): 685-6.) (Whitford GM. The metabolism and toxicity of 
fluoride, 2nd rev. ed. Monographs in oral science, Vol. 16. Basel, 
Switzerland: Karger; 1996.)
    Other studies attempted to link fluoride exposure to direct effects 
of the brain. One such 1998 study raised concerns about potential 
relationships between aluminum-fluoride and sodium-fluoride and 
Alzheimer's disease. (Warner JA, Jensen KF, Horvath W. Isaacson RL. 
Chronic administration of aluminum-fluoride or sodium-fluoride to rats 
in drinking water: alterations in neuronal and cerebrovascular 
integrity. Brain Res 1998; 784: 284-98.) Upon further review by other 
scientists, the study was found to contain major flaws in the 
experimental design, making it impossible for any definitive 
conclusions to be drawn. (American Dental Association, Health Media 
Watch: Study linking fluoride and Alzheimer's under scrutiny. J Am Dent 
Assoc 1998; 129: 1216-8). The study also conflicts with the position of 
the Alzheimer's Disease Foundation, which states that there is little 
evidence to suggest that aluminum has a causative role in the disease.
    Another study related to the comparison of fluoridated versus non-
fluoridated communities in upstate New York (Schlesinger ER, Overton 
DE, Chase HC, Cantwell KT. Newburgh-Kingston caries-fluorine study 
XIII: pediatric findings after 10 years. J Am Dent Assoc 1956; 52:296-
306). The original study noted a 5-month difference in the average age 
of menarche between girls from the two cities, which the authors 
indicated as ``not statistically significant.''
    One risk that has been attributed to water fluoridation is the 
possible formation of very mild dental fluorosis on permanent teeth in 
about 13 percent of children. Dental fluorosis is not a health effect; 
it is a cosmetic effect usually unnoticeable by untrained examiners. 
Mild dental fluorosis is characterized by nearly imperceptible white 
flecks in the enamel of permanent teeth. The risk of dental fluorosis 
can be greatly reduced by simple steps and without denying children the 
benefits of water fluoridation.
    In 1997, the Food and Nutrition Board of the Institute of Medicine 
developed a comprehensive set of reference values for dietary nutrient 
intakes. These new reference values, the Dietary Reference Intakes 
(DRI), replace the Recommended Dietary Allowances (RDA) that had been 
set by the National Academy of Sciences since 1941. The new values 
present nutrient requirements to optimize health and, for the first 
time, set maximum-level guidelines to reduce the risk of adverse 
effects from excessive consumption of a nutrient. Along with calcium, 
phosphorous, magnesium and vitamin D, DRIs for fluoride were 
established because of its proven effect on tooth decay.
    Mr. Chairman, the ADA's policies regarding community water 
fluoridation are based on generally accepted scientific knowledge. This 
body of knowledge is based on the efforts of nationally recognized 
scientists who have conducted research using the scientific method, 
have drawn appropriate balanced conclusions based on their research 
findings and have published their results in peer-reviewed professional 
journals that are widely held or circulated. Confirmation of scientific 
findings also reinforces the validity of existing studies.
    With the advent of the Information Age, a new type of ``pseudo-
scientific literature'' has developed. The public often sees scientific 
and technical information quoted in the press, printed in a letter to 
the editor or distributed via an Internet Web page. Often the public 
accepts such information as true simply because it is in print. Yet the 
information is not always based on research conducted according to the 
scientific method, and the conclusions drawn from research are not 
always scientifically justifiable. In the case of water fluoridation, 
an abundance of misinformation has been circulated. Therefore, 
scientific information from all print and electronic sources must be 
critically reviewed before conclusions can be drawn.
    We have attached a copy of the ADA's recent publication 
Fluoridation Facts to provide additional information concerning the 
safety and effectiveness of community water fluoridation. Nearly 100 
national and international organizations recognize the public health 
benefits of fluoridation for preventing dental decay. We would 
appreciate your including this along with our letter in the hearing 
record.
            Sincerely,
                      Richard F. Mascola, D.D.S. President.

                   John S. Zapp, D.D.S. Executive Director.
                                 ______
                                 
 [From the American Dental Association, Council on Access, Prevention 
                    and Interprofessional Relations]
                           Fluoridation Facts
                              introduction
Background
    Since 1956, the American Dental Association (ADA) has published 
Fluoridation Facts. Revised periodically, Fluoridation Facts answers 
frequently asked questions about community water fluoridation. In this 
1999 edition, the ADA Council on Access, Prevention and 
Interprofessional Relations provides updated information for 
individuals and groups interested in the facts about fluoridation. The 
United States now has over 50 years of practical experience with 
community water fluoridation. Its remarkable longevity is testimony to 
fluoridation's significance as a public health measure.
    Important points to remember about fluoride and community water 
fluoridation are:
      Fluoridation is considered beneficial by the over-
whelming majority of the health and scientific communities as well as 
the general public.
      Fluoride helps prevent tooth decay. All ground and 
surface water in the U.S. contains some naturally occurring fluoride. 
If a community's water supply is fluoride-deficient (less than 0.7 
parts fluoride per million parts water) fluoridation simply adjusts the 
fluoride's natural level, bringing it to the level recommended for 
decay prevention (0.7-1.2 parts per million).
      Fluoridation is a community health measure that benefits 
children and adults. Simply by drinking optimally fluoridated water, 
members of a community benefit, regardless of income, education or 
ethnicity--not just those with access to dental care.
      Fluoridation protects over 360 million people in 
approximately 60 countries worldwide, with over 10,000 communities and 
145 million people in the United States alone.\1\
      As with other nutrients, fluoride is safe and effective 
when used and consumed properly. From time to time, opponents of 
fluoridation have questioned its safety and effectiveness. None of 
these charges has ever been substantiated by generally accepted 
science. After 50 years of research and practical experience, the 
overwhelming weight of scientific evidence indicates that fluoridation 
of community water supplies is both safe and effective.
      Just 50 cents per person per year covers the cost of 
fluoridation in an average community. Over a lifetime, that is the 
approximate price of one dental filling, making fluoridation very cost 
effective.
      Time and time again, public opinion polls show an 
overwhelming majority of Americans support water fluoridation.\2\
Support for Water Fluoridation
    Since 1950, the American Dental Association (ADA), along with the 
United States Public Health Service (USPHS), has continuously and 
unreservedly endorsed the optimal fluoridation of community water 
supplies as a safe and effective public health measure for the 
prevention of dental decay. The ADA's policy on fluoridation is based 
on its continuing evaluation of the scientific research on the safety 
and effectiveness of fluoride. Over the years, and as recently as 1997, 
the ADA has continued to reaffirm its position of support for water 
fluoridation and has strongly urged that its benefits be extended to 
communities served by public water systems.\3\ Today, fluoridation is 
the single most effective public health measure to prevent tooth decay 
and to improve oral health over a lifetime.
    The American Dental Association, the U.S. Public Health Service, 
the American Medical Association and the World Health Organization all 
support community water fluoridation. Other national and international 
health, service and professional organizations that recognize the 
public health benefits of community water fluoridation for preventing 
dental decay are listed on the inside back cover of this publication.
Scientific Information on Fluoridation
    The ADA's policies regarding community water fluoridation are based 
on generally accepted scientific knowledge. This body of knowledge is 
based on the efforts of nationally recognized scientists who have 
conducted research using the scientific method, have drawn appropriate 
balanced conclusions based on their research findings and have 
published their results in refereed (peer-reviewed) professional 
journals that are widely held or circulated. Confirmation of scientific 
findings also reinforces the validity of existing studies.
    From time to time, opponents of fluoridation have questioned its 
safety and effectiveness. None of these charges has ever been 
substantiated by generally accepted science. It is important to review 
information about fluoridation with a critical eye. Listed below are 
several key elements to consider when reviewing information about 
fluoride research.
    1. The author's background and credentials should reflect expertise 
in the area of research undertaken.
    2. The year of the publication should be apparent. The information 
should be relatively current, although well-designed studies can stand 
the test of time and scientific scrutiny (e.g. overwhelming evidence 
already exists to prove the effectiveness of water fluoridation). A 
review of existing literature can provide insight into whether the 
results of older studies have been superceded by subsequent studies.
    3. If the information is a review of other studies, it should be 
representative of the original research. Information quoted directly 
from other sources should be quoted in its entirety.
    4. The research should be applicable to community water 
fluoridation and use an appropriate type and amount of fluoride. Many 
research projects investigate the use of fluoride at much higher levels 
than recommended for community water fluoridation. For example, the 
results of a study using a concentration of 125 parts per million (ppm) 
doses of fluoride are not comparable to water fluoridated at 0.7 to 1.2 
ppm.
    5. How the research is conducted is relevant. Research conducted in 
vitro (outside the living body and in a laboratory environment) may not 
lead to the same results as research conducted in viva (in a living 
human or other animal).
    6. Animal studies should be carefully reviewed. In animal studies 
(e.g., rodent), excessively high doses of fluoride are sometimes used. 
In addition, the fluoride used in these experiments is often 
administered by means other than in drinking water (e.g. by injection). 
Information obtained in animal studies may be highly questionable as a 
predictor of the effects of human exposure to low concentrations of 
fluoride, such as those used to fluoridate water.
    7. Publications presenting scientific information should have an 
editorial review board to help ensure that scientifically sound 
articles are published.
    8. The publication should be easily obtainable through a medical/
dental library.
    With the advent of the Information Age, a new type of ``pseudo-
scientific literature'' has developed. The public often sees scientific 
and technical information quoted in the press, printed in a letter to 
the editor or distributed via an Internet Web page. Often the public 
accepts such information as true simply because it is in print. Yet the 
information is not always based on research conducted according to the 
scientific method, and the conclusions drawn from research are not 
always scientifically justifiable. In the case of water fluoridation, 
an abundance of misinformation has been circulated. Therefore, 
scientific information from all print and electronic sources must be 
critically reviewed before conclusions can be drawn. Pseudo-scientific 
literature may peak a reader's interest but when read as science, it 
can be misleading. The scientific validity and relevance of claims made 
by opponents of fluoridation might be best viewed when measured against 
criteria set forth by the U.S. Supreme Court. (Additional discussion on 
this topic may be found in Question 36.)
    Fluoridation Facts is designed to answer frequently asked questions 
about fluoridation by summarizing relevant published articles as 
indicated by numbered references within the document. A corresponding 
list of references appears in the back of the booklet.
    Fluoridation Facts is not intended to include and review the 
extensive literature on community water fluoridation and fluorides.
History of Water Fluoridation
    Research into the beneficial effects of fluoride began in the early 
1900's. Frederick McKay, a young dentist, opened a dental practice in 
Colorado Springs, Colorado, and was surprised to discover that many 
local residents exhibited strange brown stains on their permanent 
teeth. McKay could find no documentation of the condition in the dental 
literature and eventually convinced Dr. G.V. Black, an expert on dental 
enamel, to study the condition. Through their research, Black and McKay 
determined that mottled enamel, as Black termed the condition, resulted 
from developmental imperfections in teeth. (Mottled enamel is a 
historical term. Today, this condition is called severe dental 
fluorosis.) Black and McKay also noted that these stained teeth were 
surprisingly resistant to decay.
    Following years of observation and study, McKay determined that it 
was high levels of naturally occurring fluoride in the drinking water 
that was causing the mottled enamel. McKay's deductions were researched 
by Dr. H. Trendley Dean, a dental officer of the U.S. Public Health 
Service. Dean designed the first fluoride studies in the United States. 
These early studies were aimed at evaluating how high the fluoride 
levels in water could be before visible, severe dental fluorosis 
occurred. By 1936, Dean and his staff had made the critical discovery 
that fluoride levels of up to 1.0 part per million (ppm) in the 
drinking water did not cause mottling, or severe dental fluorosis. Dean 
additionally noted a correlation between fluoride levels in the water 
and reduced incidence of dental decay.\4\ \5\ Following Dean's initial 
findings, community-wide studies were carried out to evaluate the 
addition of sodium fluoride to fluoride-deficient water supplies. The 
first community water fluoridation program began in Grand Rapids, 
Michigan, in 1945.\6\ \7\
Water Fluoridation as a Public Health Measure
    Throughout decades of research and more than 50 years of practical 
experience, fluoridation of public water supplies has been responsible 
for dramatically improving the public's oral health status. In 1998, 
recognizing the ongoing need to improve health and well being, the U.S. 
Public Health Service revised national health objectives to be achieved 
by the year 2010. Included under oral health was an objective to 
significantly expand the fluoridation of public water supplied In 1994, 
the U.S. Department of Health and Human Services issued a report which 
reviewed public health achievements. Along with other successful public 
health measures such as the virtual eradication of polio and reductions 
in childhood blood lead levels, fluoridation was lauded as one of the 
most economical preventive values in the nations Finally, a policy 
statement on water fluoridation reaffirmed in 1995 by the USPHS stated 
that water fluoridation is the most cost-effective, practical and safe 
means for reducing the occurrence of tooth decay in a community.\10\
    Simply by drinking optimally fluoridated water, the entire 
community benefits regardless of age, socioeconomic status, educational 
attainment or other social variables.\11\ Community water fluoridation 
does not discriminate against anyone based on income, education or 
ethnicity. Fluoridation's benefits are realized without behavior change 
on the part of an individual. The benefits of water fluoridation are 
not limited to those with access to dental care.
Water Fluoridation's Role in Reducing Dental Decay
    Water fluoridation and the use of topical fluoride have played a 
significant role in improving oral health. Studies show that water 
fluoridation can reduce the amount of cavities children get in their 
baby teeth by as much as 60 percent; and can reduce tooth decay in 
permanent adult teeth by nearly 35 percent. Increasing numbers of 
adults are retaining their teeth throughout their lifetimes due in part 
to the benefits they receive from water fluoridation. Dental 
expenditures for these individuals are likely to have been reduced and 
innumerable hours of needless pain and suffering due to untreated 
dental decay have been avoided.
    It is important to note that dental decay is caused by dental 
plaque, a thin, sticky, colorless deposit of bacteria that constantly 
forms on teeth. When sugar and carbohydrates are eaten, the bacteria in 
plaque produce acids that attack the tooth enamel. After repeated 
attacks, the enamel breaks down, and a cavity (hole) is formed. There 
are several factors that increase an individual's risk for decay: \12\
      Recent history of dental decay
      Elevated oral bacteria count
      Inadequate exposure to fluorides
      Exposed roots
      Frequent sugar and carbohydrate intake
      Fair to poor oral hygiene
      Inadequate saliva flow
      Deep pits and fissures in the chewing surfaces of teeth
    Exposure to fluoride is not the only measure available to decrease 
the risk of decay. In formulating a decay prevention program, a number 
of intervention strategies may be recommended.
Ongoing Need for Water Fluoridation
    Because of the decay risk factors noted previously, many 
individuals and communities skill experience high levels of dental 
decay. Although water fluoridation demonstrates an impressive record of 
effectiveness and safety, only 62.2 percent of the United States 
population on public water supplies receives fluoridated water 
containing protective levels of fluoride.\13\ Unfortunately, some 
people continue to be confused about this effective public health 
measure. If the number of individuals drinking fluoridated water is to 
increase, the public must be accurately informed about its benefits.

    Question 1. What is fluoride and how does it reduce tooth decay?
    Answer. Fluoride is a naturally occurring element that prevents 
tooth decay systemically when ingested during tooth development and 
topically when applied to erupted teeth.
            Fact
    The fluoride ion comes from the element fluorine. Fluorine, the 
17th most abundant element in the earth's crust, is a gas and never 
occurs in its free state in nature. Fluorine exists only in combination 
with other elements as a fluoride compound. Fluoride compounds are 
constituents of minerals in rocks and soil. Water passes over rock 
formations and dissolves the fluoride compounds that are present, 
creating fluoride ions. The result is that small amounts of soluble 
fluoride ions are present in all water sources, including the oceans. 
Fluoride is present to some extent in all foods and beverages, but the 
concentrations vary widely. \14\ \15\ \16\
    Simply put, fluoride is obtained in two forms: topical and 
systemic. Topical fluorides strengthen teeth already present in the 
mouth. In this method of delivery, fluoride is incorporated into the 
surface of teeth making them more decay-resistant. Topically applied 
fluoride provides local protection on the tooth surface. Topical 
fluorides include toothpastes, mouthrinses and professionally applied 
fluoride gels and rinses.
    Systemic fluorides are those that are ingested into the body and 
become incorporated into forming tooth structures. In contrast to 
topical fluorides, systemic fluorides ingested regularly during the 
time when teeth are developing are deposited throughout the entire 
surface and provide longer-lasting protection than those applied 
topically.\17\ Systemic fluorides can also give topical protection 
because ingested fluoride is present in saliva, which continually 
bathes the teeth providing a reservoir of fluoride that can be 
incorporated into the tooth surface to prevent decay. Fluoride also 
becomes incorporated into dental plaque and facilitates further 
remineralization.\18\ Sources of systemic fluorides include water, 
dietary fluoride supplements in the forms of tablets, drops or 
lozenges, and fluoride present in food and beverages.
    Researchers have observed fluoride's decay preventive effects 
through three specific mechanisms:\19\ \20\
    1. it reduces the solubility of enamel in acid by converting 
hydroxyapatite into less soluble fluorapatite;
    2. it exerts an influence directly on dental plaque by reducing the 
ability of plaque organisms to produce acid; and
    3. it promotes the remineralization or repair of tooth enamel in 
areas that have been demineralized by acids.
    The remineralization effect of fluoride is of prime importance. 
Fluoride ions in and at the enamel surface result in fortified enamel 
that is not only more resistant to decay, but enamel that can repair or 
remineralize early dental decay caused by acids from decay-causing 
bacteria.\17\ \21\ \25\ Fluoride ions necessary for remineralization 
are provided by fluoridated water as well as various fluoride products 
such as toothpaste.
    Maximum decay reduction is produced when fluoride is available for 
incorporation during all stages of tooth formation (systemically) and 
by topical effect after eruption.\26\
    Question 2. What is water fluoridation?
    Answer. Water fluoridation is the adjustment of the natural 
fluoride concentration of fluoridedeficient water to the level 
recommended for optimal dental health.
            Fact
    Based on extensive research, the United States Public Health 
Service (USPHS) established the optimum concentration for fluoride in 
the water in the United States in the range of 0.7 to 1.2 parts per 
million.* This range effectively reduces tooth decay while minimizing 
the occurrence of dental fluorosis. The optimum level is dependent on 
the annual average of the maximum daily air temperature in the 
geographic area.\27\
    * One milligram per liter (mg/L) is identical to one part per 
million (ppm). At 1 ppm, one part of fluoride is diluted in a million 
parts of water. Large numbers such as a million can be difficult to 
visualize. While not exact, the following comparisons can be of 
assistance in comprehending one part per million:
      1 inch in 16 miles
      1 minute in 2 years
      1 cent in $10,000
    For clarity, the following terms and definitions are used in this 
booklet:
    Community water fluoridation is the adjustment of the natural 
fluoride concentration in water up to the level recommended for optimal 
dental health (a range of 0.7 to 1.2 ppm).Other terms used 
interchangeably in this booklet are water fluoridation, fluoridation 
and optimally fluoridated water. Optimal levels of fluoride (a range of 
0.7 to 1.2 ppm) may be present in the water naturally or by adjusted 
means. (Additional discussion on this topic may be found in Question 
3.)
    Sub-optimally fluoridated water is water that contains less than 
the optimal level (below 0.7 ppm) of fluoride. Other terms used 
interchangeably in this booklet are nonfluoridated water and 
fluoridedeficient water supplies.
    (Additional discussion on this topic may be found hi Question 32.)

    Question 3. Is there a difference in the effectiveness between 
naturally occurring fluoridated water (at optimal fluoride levels) and 
water that has fluoride added to reach the optimal level?
    Answer. No. The dental benefits of optimally fluoridated water 
occur regardless of the fluoride's source.
            Fact
    Fluoride is present in water as ``ions'' or electrically charged 
atoms.\27\ These ions are the same whether acquired by water as it 
seeps through rocks and sand or added to the water supply under 
carefully controlled conditions. When fluoride is added under 
controlled conditions to fluoride-deficient water, the dental benefits 
are the same as those obtained from naturally fluoridated water. 
Fluoridation is merely a supplementation of the naturally occurring 
fluoride present in all drinking water sources.
    Some individuals mistakenly use the term ``artificial 
fluoridation'' to imply that the process of water fluoridation is 
unnatural and that it delivers a foreign substance into a water supply 
when, in fact, all water sources contain some fluoride. Community water 
fluoridation is a natural way to improve oral health.\28\ (Additional 
discussion on this topic may be found in Question 32.)
    Prior to the initiation of ``adjusted'' water fluoridation, several 
classic epidemiological studies were conducted that compared naturally 
occurring fluoridated water to fluoride-deficient water. Strikingly low 
decay rates were found to be associated with the continuous use of 
water with fluoride content of 1 part per million.\5\
    A fluoridation study conducted in the Ontario, Canada, communities 
of Brantford (optimally fluoridated by adjustment), Stratford 
(optimally fluoridated naturally) and Sarnia (fluoridedeficient) 
revealed much lower decay rates in both Brantford and Stratford as 
compared to nonfluoridated Sarnia. There was no observable difference 
in decay-reducing effect between the naturally occurring fluoride and 
adjusted fluoride concentration water supplies, proving that dental 
benefits were similar regardless of the source of fluoride.\29\

    Question 4. Is further proof of the effectiveness of water 
fluoridation needed?
    Answer. Overwhelming evidence already exists to prove the 
effectiveness of water fluoridation.
            Fact
    The effectiveness of water fluoridation has been documented in 
scientific literature for well over 50 years. Even before the first 
community fluoridation program began in 1945, epidemiologic data from 
the 1930's and 1940's revealed lower decay rates in children consuming 
naturally occurring fluoridated water compared to children consuming 
fluoride deficient water.\4\ \5\ Since that time, numerous studies have 
been done which continue to prove fluoride's effectiveness in decay 
reduction. Three selected reviews of this work follow.
    In 1993, the results of 113 studies in 23 countries were compiled 
and analyzed.\30\ (Fifty-nine out of the 113 studies analyzed were 
conducted in the United States.) This review provided effectiveness 
data for 66 studies in primary teeth and for 86 studies in permanent 
teeth. Taken together, the most frequently reported decay reductions 
observed were:

    40-49 percent for primary teeth or baby teeth; and
    50-59 percent for permanent teeth or adult teeth.

    In a second review of studies conducted from 1976 through 1987,\3\ 
for different age groups were isolated, the decay reduction rates in 
fluoridated communities were:

    30-60 percent in the primary dentition or baby teeth;
    20-40 percent in the mixed dentition* (aged 8 to 12);
    15-35 percent in the permanent dentition or adult teeth (aged 14 to 
17); and
    15-35 percent in the permanent dentition (adults and seniors).
    (*A mixed dentition is composed of both baby teeth and adult 
teeth.)

    Lastly, a comprehensive analysis of the fifty-year history of 
community water fluoridation in the United States further demonstrated 
that the inverse relationship between higher fluoride concentration in 
drinking water and lower levels of dental decay discovered a half-
century ago continues to be true today.\32\
    (Additional discussion on this topic may be found in Question 6.)
    Many well-documented studies have compared the decay rates of 
children before and after fluoridation in the same community, as well 
as with children in naturally fluoridated and/or nonfluoridated 
communities. The earlier studies were conducted at a time when sources 
of topical fluoride, such as toothpastes, mouthrinses and 
professionally applied fluoride gels were not available. The results 
from these early studies were dramatic. Over the years, as sources of 
topical fluoride became more readily available, the decay reductions 
observed in these comparative evaluations, although still significant, 
tapered off. Because of the high geographic mobility of our populations 
and the widespread use of fluoride toothpastes, supplements and other 
topical agents, such comparisons are becoming more difficult to 
conduct.\31\
    Nevertheless, recent data continue to demonstrate that decay rates 
are higher for individuals who reside in nonfluoridated communities 
than that of individuals living in fluoridated communities.\30\ \33\ 
\36\ The following paragraphs provide a sample of studies conducted in 
the subsequent decades on the effectiveness of water fluoridation.
    In Grand Rapids, Michigan, the first city in the world to 
fluoridate its water supply, a 15-year landmark study showed that 
children who consumed fluoridated water from birth had 50-63 percent 
less tooth decay than children who had been examined during the 
original baseline survey.\37\
    Ten years after fluoridation in Newburgh, New York, 6- to 9-year-
olds had 58 percent less tooth decay than their counterparts in 
Kingston, New York, which was fluoride-deficient. After 15 years, 13- 
to 14-year-olds in Newburgh had 70 percent less decay than the children 
in Kingston.\33\
    After 14 years of fluoridation in Evanston, Illinois, 14-year-olds 
had 57 percent fewer decayed, missing or filled teeth than control 
groups drinking water low in fluoride.\39\
    In 1983, a study was undertaken in North Wales (Great Britain) to 
determine if the decay rate of fluoridated Anglesey continued to be 
lower than that of nonfluoridated Arfon, as had been indicated in a 
previous survey conducted in 1974. Decay rates of life-long residents 
in Anglesey aged 5, 12 and 15 were compared with decay rates of similar 
aged residents in nonfluoridated Arfon. Study results demonstrated that 
a decline in decay had occurred in both communities since the previous 
survey in 1974. However, the mean decay rate of the children in 
fluoridated Anglesey was still 45 percent lower than that of those 
living in nonfluoridated Arfon.\40\ These findings indicated a 
continuing need for fluoridation although decay levels had 
declined.\41\
    A controlled study conducted in 1990 demonstrated that average 
tooth decay experience among schoolchildren who were lifelong residents 
of communities having low fluoride levels in drinking water was 61-100 
percent higher as compared with tooth decay experience among 
schoolchildren who were lifelong residents of a community with an 
optimal level of fluoride in the drinking water.\36\ In addition, the 
findings of this study suggest that community water fluoridation still 
provides significant public health benefits and that dental sealants 
can play a significant role in preventing tooth decay.
    Using data from the dental surveys in 1991-2 and 1993-4, a British 
study predicted that on average, water fluoridation produces a 44 
percent reduction in tooth decay in 5-year-old children. The study 
further demonstrated that children in lower socioeconomic groups derive 
an even greater benefit from water fluoridation with an average 54 
percent reduction in tooth decay. Therefore, children with the greatest 
dental need benefit the most from water fluoridation.\42\
    In 1993-4, an oral health needs assessment of children in 
California found that children living in nonfluoridated areas had more 
tooth decay than those in fluoridated areas.\43\ Of most concern was 
the high decay rate affecting young children from low income families. 
Specifically, children in grades K-3, whose families were lifetime 
residents of nonfluoridated communities and whose income was below 200 
percent of the Federal Poverty Level, had 39 percent more decay in 
their baby teeth when compared to counterparts who were lifetime 
residents of optimally fluoridated areas.\35\

    Question 5. What happens if water fluoridation is discontinued?
    Answer. Dental decay can be expected to increase if water 
fluoridation in a community is discontinued for 1 year or more, even if 
topical products such as fluoride toothpaste and fluoride rinses are 
widely used.
            Fact
    The following paragraphs provide a summary of some of the 
historical studies that have been conducted on the discontinuation of 
water fluoridation. Antigo, Wisconsin began water fluoridation in June 
1949, and ceased adding fluoride to its water in November 1960. After 
5\1/2\ years without optimal levels of fluoride, second grade children 
had over 200 percent more decay, fourth graders 70 percent more, and 
sixth graders 91 percent more than those of the same ages in 1960. 
Residents of Antigo reinstituted water fluoridation in October 1965 on 
the basis of the severe deterioration of their children's oral 
health.\44\
    Because of a government decision in 1979, fluoridation in the 
northern Scotland town of Wick was discontinued after 8 years. The 
water was returned to its sub-optimal, naturally occurring fluoride 
level of 0.02 ppm. Data collected to monitor the oral health of Wick 
children clearly demonstrated a negative health effect from the 
discontinuation of water fluoridation. Five years after the cessation 
of water fluoridation, decay in permanent (adult) teeth had increased 
27 percent and decay in primary (baby) teeth increased 40 percent. This 
increase in decay occurred during a period when there had been a 
reported overall reduction in decay nationally and when fluoride 
toothpaste had been widely adopted.\45\ These data suggest that decay 
levels in children can be expected to rise where water fluoridation is 
interrupted or terminated, even when topical fluoride products are 
widely used.
    In a similar evaluation, the prevalence of decay in 10-year-old 
children in Stranraer, Scotland, increased after the discontinuation of 
water fluoridation, resulting in a 115 percent increase in the mean 
cost of restorative dental treatment for decay and a 21 percent 
increase in the mean cost of all dental treatment. These data support 
the important role water fluoridation plays in the reduction of dental 
decay.\46\
    A U.S. study of 6- and 7-year-old children who had resided in 
optimally fluoridated areas and then moved to the nonfluoridated 
community of Coldwater, Michigan, revealed an 11 percent increase in 
decayed, missing or filled tooth surfaces (DMFS) over a 3-year period 
from the time the children moved. These data reaffirm that relying only 
on topical forms of fluoride is not an effective or prudent public 
health practice.\47\ Decay reductions are greatest where water 
fluoridation is available in addition to topical fluorides, fluoride 
toothpaste and fluoride rinses.
    Finally, a study that reported the relationship between fluoridated 
water and decay prevalence focused on the city of Galesburg, Illinois, 
a community whose public water supply contained naturally occurring 
fluoride at 2.2 ppm.In 1959, Galesburg switched its community water 
source to the Mississippi River. This alternative water source provided 
the citizens of Galesburg a suboptimal level of fluoride at 
approximately 0.1 ppm. During the time when the fluoride content was 
below optimal levels, data revealed a 10 percent decrease in the number 
of decay-free 14-year-olds (oldest group observed), and a 38 percent 
increase in dental decay. Two years later, in 1961, the water was 
fluoridated at the recommended level of 1.0 ppm. \48\

    Question 6. Is water fluoridation still an effective method for 
preventing dental decay?
    Answer. Water fluoridation continues to be a very effective method 
for preventing tooth decay for children, adolescents and adults. 
Continued assessment, however, is important as the patterns and extent 
of dental decay change in populations. Although other forms of fluoride 
are available, persons in nonfluoridated communities continue to 
demonstrate higher dental decay rates than their counterparts in 
communities with water fluoridation.
            Fact
    Numerous recent studies indicate a trend toward decreased decay 
prevalence in children living in the United States. This trend also has 
been reported for children in other developed countries. One of several 
factors that explains these findings is the increased use of fluorides, 
including water fluoridation and fluoride toothpaste. In studies 
conducted from 1976 through 1987,\31\ the level of decay reduction 
achieved through water fluoridation in industrialized countries was:

    30-60 percent in the primary dentition or baby teeth;
    20-40 percent in the mixed dentition* (aged 8 to 12);
    15-35 percent in the permanent dentition or adult teeth (aged 14 to 
17); and
    15-35 percent in the permanent dentition (adults and seniors). (*A 
mixed dentition is composed of both baby teeth and adult teeth )
    (Additional discussion on this topic may be found in Question 4.)

    Community water fluoridation remains the safest, most cost-
effective and most equitable method of reducing tooth decay in a 
community in the United States and in other countries. \32\ \34\ \49\ 
\50\ \51\ \52\ A controlled study conducted in 1990 demonstrated that 
average tooth decay experience among schoolchildren who were lifelong 
residents of communities having low fluoride levels in drinking water 
was 61-100 percent higher as compared with tooth decay experience among 
schoolchildren who were lifelong residents of a community with an 
optimal level of fluoride in the drinking water.\36\ In addition, the 
findings of this study suggest that community water fluoridation still 
provides significant public health benefits and that dental sealants 
can play a significant role in preventing tooth decay.
    Baby bottle tooth decay is a severe type of early childhood decay 
that seriously affects babies and toddlers in some populations. Water 
fluoridation is highly effective in preventing decay in baby teeth, 
especially in children from low socioeconomic groups.\33\ For very 
young children, water fluoridation is the only means of prevention that 
does not require a dental visit or motivation of parents and 
caregivers.\53\
    In the 1940's, children in communities with optimally fluoridated 
drinking water had reductions in decay rates of approximately 60 
percent as compared to those living in non-fluoridated communities. At 
that time, drinking water was the only source of fluoride other than 
fluoride that occurs naturally in foods. Recent studies reveal that 
decay rates are lower in naturally or adjusted fluoridated areas and 
non-fluoridated areas as well because of the universal availability of 
fluoride from other sources including food, beverages, dental products 
and dietary supplements.\54\ Foods and beverages processed in optimally 
fluoridated cities can contain optimal levels of fluoride. These foods 
and beverages are consumed not only in the city where processed, but 
may be distributed to and consumed in non-fluoridated areas. ``halo'' 
or ``diffusion'' effect results in increased fluoride intake by people 
in nonfluoridated communities, providing them increased protection 
against dental decay.\32\ \52\ As a result of the widespread 
availability of these various sources of fluoride, the difference 
between decay rates in fluoridated areas and nonfluoridated areas is 
somewhat less than several decades ago but still significant.\55\
    A British study conducted in 1987 compared the decay scores for 14-
year-old children living in South Birmingham, fluoridated since 1964, 
with those of children the same age living in nonfluoridated Bolton. 
The two cities had similar social class profiles and similar 
proportions of unemployed residents and minority groups. The average 
decayed, missing, and filled tooth score for the children of South 
Birmingham was 2.26, compared to an average score of 3.79 for children 
in non-fluoridated Bolton. These scores indicate a statistically 
significant difference of 40 percent between the decay rates in the two 
cities. Because of the similarity in social and demographic factors, 
the investigators attributed difference in decay experience found in 
this study to differences in water fluoride level.\56\
    In the United States, an epidemiological survey of nearly 40,000 
schoolchildren was completed in 1987.\50\ Nearly 50 percent of the 
children in the study aged 5 to 17 years were decay-free in their 
permanent teeth, which was a major change from a similar survey in 1980 
in which approximately 37 percent were decayfree. This dramatic decline 
in decay rates was attributed primarily to the widespread use of 
fluoride in community water supplies, toothpastes, supplements and 
mouthrinses. Although decay rates had declined overall, data also 
revealed that the decay rate was 25 percent lower in children with 
continuous residence in fluoridated communities when the data was 
adjusted to control for fluoride exposure from supplements and topical 
treatments.
    More recently, data from the Third National Health and Nutrition 
Examination Survey (NHANES III), conducted from 1988 to 1991, yielded 
weighted estimates for over 58 million U.S. children. Nearly 55 percent 
of the children aged 5 to 17 years had no decay in their permanent 
teeth.\57\
    (Additional discussion on this topic may be found in Question 8.)

    Question 7. Is tooth decay still a serious problem?
    Answer. Yes. Tooth decay or dental decay is an infectious disease 
that continues to be a significant oral health problem.
            Fact
    Tooth decay is, by far, the most common and costly oral health 
problem in all age groups.\58\ It is one of the principal causes of 
tooth loss from early childhood through middle age. A dramatic increase 
in tooth loss occurs among people 35 through 44 years of age. The two 
leading causes of tooth loss in this age group are dental decay and 
periodontal diseases.\8\ Decay continues to be problematic for middle-
aged and older adults, particularly root decay because of receding 
gums. In addition to its effects in the mouth, dental decay can affect 
general well-being by interfering with an individual's ability to eat 
certain foods and by impacting an individual's emotional and social 
well-being by causing pain and discomfort. Tooth decay, particularly in 
the front teeth, can detract from appearance, thus affecting self-
esteem.
    Despite a decrease in the overall decay experience of U.S. 
schoolchildren over the past two decades, tooth decay is still a 
significant oral health problem, especially in certain segments of the 
population. The 1986-1987 National Institute of Dental Research (NIDR) 
survey of approximately 40,000 U.S. school children found that 25 
percent of students ages 5 to 17 accounted for 75 percent of the decay 
experienced in permanent teeth.\58\ Some of the risk factors that 
increase an individual's risk for decay are irregular dental visits, 
deep pits and fissures in the chewing surfaces of teeth, inadequate 
saliva flow, frequent sugar intake and very high oral bacteria counts.
    (Additional discussion on this topic may be found in the 
Introduction-Water Fluoridation's Role in Reducing Dental Decay.)
    Because dental decay is so common, it mistakenly tends to be 
regarded as an inevitable part of life. Data from NHANES III collected 
on adults aged 18 and older revealed that 94 percent showed evidence of 
past or present decay in the crowns of teeth, and 22.5 percent had 
evidence of root surface decay.\59\
    In addition to impacting emotional and social wellbeing, the 
consequences of dental disease are reflected in the cost of its 
treatment. The nation's dental health bill in 1997 was $50.6 billions 
the goal must be prevention rather than repair. Fluoridation is 
presently the most cost-effective method for the prevention of tooth 
decay for residents of a community in the United States.\61\ \62\

    Question 8. Do adults benefit from fluoridation?
    Answer. Fluoridation plays a protective role against dental decay 
throughout life, benefiting both children and adults. In fact, 
inadequate exposure to fluoride places children and adults in the high 
risk category for dental decay.
            Fact
    Fluoride has both a systemic and topical effect and is beneficial 
to adults in two ways. The first is through the remineralization 
process in enamel, in which early decay does not enlarge, and can even 
reverse, because of frequent exposure to small amounts of fluoride. 
Studies have clearly shown that the availability of topical fluoride in 
an adult's mouth during the initial formation of decay can not only 
stop the decay process, but also make the enamel surface more resistant 
to future acid attacks. Additionally, the presence of systemic fluoride 
in saliva provides a reservoir of fluoride ions that can be 
incorporated into the tooth surface to prevent decay.\63\ (Additional 
discussion on this topic may be found in Question 1.)
    Another protective benefit for adults is the prevention of root 
decay. Adults with gumline recession are at risk for root decay because 
the root surface becomes exposed to decay-causing bacteria in the 
mouth. Studies have demonstrated that fluoride is incorporated into the 
structure of the root surface, making it more resistant to decay.\19\ 
\63\ \64\ \65\ \66\ In Ontario, Canada, lifelong residents of the 
naturally fluoridated (1.6 ppm) community of Stratford had 
significantly lower root decay experience than those living in the 
matched, but nonfluoridated, community of Woodstock.\65\
    People in the United States are living longer and retaining more of 
their natural teeth than ever before. Because older adults experience 
more problems with gumline recession, the prevalence of root decay 
increases with age. A large number of exposed roots or a history of 
past root decay places an individual in the high risk category for 
decay.\12\ Data from the 1988-1991 National Health and Nutrition 
Examination Survey (NHANES III) showed that 22.5 percent of all adults 
with natural teeth experienced root decay. This percentage increased 
markedly with age:
    1. in the 18- to 24-year-old age group, only 6.9 percent 
experienced root decay;
    2. in the 35- to 44-year-old age group, 20.8 percent experienced 
root decay;
    3. in the 55- to 64-year-old age group, 38.2 percent showed 
evidence of root decay; and
    4. in the over-75 age group, nearly 56 percent had root decay.\59\
    In addition to gumline recession, older adults tend to experience 
decreased salivary flow, or xerostomia, due to the use of medications 
or medical conditions.\67\ \68\ Inadequate saliva flow places an 
individual in the high risk category for decay. This decrease in 
salivary flow can increase the likelihood of dental decay because 
saliva contains many elements necessary for early decay repair--
including fluoride.
    There are data to indicate that individuals who have consumed 
fluoridated water continuously from birth receive the maximum 
protection against dental decay. However, teeth present in the mouth 
when exposure to water fluoridation begins also benefit from the 
topical effects of exposure to fluoride. In 1989, a small study in the 
state of Washington suggested adults exposed to fluoridated water only 
during childhood had similar decay rates as adults exposed to 
fluoridated water only after age 14. This study lends credence to the 
topical and systemic benefits of water fluoridation. The topical 
effects are reflected in the decay rates of adults exposed to water 
fluoridation only after age 14. The study also demonstrates that the 
pre-eruptive, systemic effects of fluoridation have lifetime benefits 
as reflected in the decay rates of adults exposed to fluoridation only 
during childhood. The same study also noted a 31 percent reduction of 
dental disease (based on the average number of decayed or filled tooth 
surfaces) in adults with a continuous lifetime exposure to fluoridated 
water as compared to adults with no exposure to water fluoridation.\64\
    A Swedish study investigating decay activity among adults in 
optimal and low fluoride areas revealed that not only was decay 
experience significantly lower in the optimal fluoride area, but the 
difference could not be explained by differences in oral bacteria, 
buffer capacity of saliva or salivary flow. The fluoride concentration 
in the drinking water was solely responsible for decreased decay 
rates.\69\
    Water fluoridation contributes much more to overall health than 
simply reducing tooth decay: it prevents needless infection, pain, 
suffering and loss of teeth; improves the quality of life; and saves 
vast sums of money in dental treatment costs.'' Additionally, 
fluoridation conserves natural tooth structure by preventing the need 
for initial fillings and subsequent replacement fillings.\70\

    Question 9. Are dietary fluoride supplements effective?
    Answer. For children who do not live in fluoridated communities, 
dietary fluoride supplements are an effective alternative to water 
fluoridation for the prevention of tooth decay.\51\ \71\ \72\ \73\
            Fact
    Dietary fluoride supplements are available only by prescription and 
are intended for use by children living in nonfluoridated areas to 
increase their fluoride exposure so that it is similar to that by 
children who live in optimally fluoridated areas.\74\ Dietary fluoride 
supplements are available in two forms: drops for infants aged 6 months 
and up, and chewable tablets for children and adolescents.\12\ In order 
to decrease the risk of dental fluorosis in permanent teeth, fluoride 
supplements should only be prescribed for children living in 
nonfluoridated areas. The correct amount of a fluoride supplement is 
based on the child's age and the existing fluoride level in the 
drinking water. \16\ \54\ \75\ Consideration should also be given to 
the child's risk for decay and to all sources of fluoride exposure for 
children. (An excellent source of information regarding decay risk 
assessment and prevention is the American Dental Association's ``Caries 
Diagnosis and Risk Assessment: A Review of Preventive Strategies and 
Management.'' \12\)
    Because fluoride is so widely available, it is recommended that 
dietary fluoride supplements be used only according to the recommended 
dosage schedule and after consideration of all sources of fluoride 
exposure. For optimum benefits, use of supplements should begin at 6 
months of age and be continued daily until the child is at least 16 
years old.\12\ The current dietary fluoride supplement schedule is 
shown in Table 1.
    The need for compliance over an extended period of time is a major 
procedural and economic disadvantage of community-based fluoride 
supplement programs, one that makes them impractical as an alternative 
to water fluoridation as a public health measure. In a controlled 
situation, as shown in a study involving children of health 
professionals, fluoride supplements achieve effectiveness comparable to 
that of water fluoridation. However, even with this highly educated and 
motivated group of parents, only half continued to give their children 
fluoride tablets for the necessary number of years.\76\ Independent 
reports from several countries, including the United States, have 
demonstrated that community-wide trials of fluoride supplements in 
which tablets were distributed for use at home were largely 
unsuccessful because of poor compliance.\77\
    While total costs for the purchase of supplements and 
administration of a program are small (compared with the initial cost 
of the installation of water fluoridation equipment), the overall cost 
of supplements per child is much greater than the per capita cost of 
community fluoridation.\62\ In addition, community water fluoridation 
provides decay prevention benefits for the entire population regardless 
of age, socioeconomic status, educational attainment or other social 
variables.\11\ This is particularly important for families who do not 
have access to regular dental services.

                                                     Table 1
                                  Dietary Fluoride Supplement Schedule 1994\12\
    Approved by the American Dental Association American Academy of Pediatrics American Academy of Pediatric
                                                    Dentistry
----------------------------------------------------------------------------------------------------------------
                                                      Fluoride ion level in drinking wafer (ppm)*
                 Age                  --------------------------------------------------------------------------
                                               <0.3 ppm               0.3-0.6 ppm                >0.6 ppm
----------------------------------------------------------------------------------------------------------------
Birth-6 months.......................  None...................  None...................  None
6 months-3 years.....................  0.25 mg/day**..........  None...................  None
3-6 years............................  0.50 mg/day............  0.25 mg/day............  None
6-6 -16 years........................  1.0 mg/day.............  0.50 mg/day............  None
----------------------------------------------------------------------------------------------------------------
* 1.0 part per million (ppm) = 1 milligram/liter (mg/L)
** 2.2 mg sodium fluoride contains 1 mg fluoride ion.


    Question 10. In areas where water fluoridation is not feasible 
because of engineering constraints, are alternatives to water 
fluoridation available?
    Answer. Yes. Some countries outside the United States that do not 
have piped water supplies that can accommodate community water 
fluoridation have chosen to use salt fluoridation.
            Fact
    Studies evaluating the effectiveness of salt fluoridation outside 
the U.S. have concluded that fluoride delivered via salt produces decay 
reductions similar to that of optimally fluoridated water.\78\ Salt 
fluoridation is used in over 30 countries, including Switzerland, 
Columbia, Jamaica, Costa Pica, Mexico, France, Spain and Germany.\79\ 
\80\ Published results of studies in many of these countries show that, 
for 12-year-old children, the initial level of decay reduction due to 
salt fluoridation is between 35 percent and 80 percent.\81\ An 
advantage of salt fluoridation is that it does not require a 
centralized piped water system. This is of particular use in many 
developing countries that do not have such water systems. When both 
domestic salt and bulk salt (used by commercial bakeries, restaurants, 
institutions, and industrial food production) is fluoridated, the 
decay-reducing effect may be comparable to that of water fluoridation 
over an extended period of time.\81\ On the other hand, when only 
domestic salt is fluoridated, the decay-reducing effect may be 
diminished.\78\
    Salt fluoridation has several disadvantages that do not exist with 
water fluoridation. Challenges occur with implementation of salt 
fluoridation when there are multiple sources of drinking water in an 
area. The natural fluoride level of each source must be determined and, 
if the level is optimal or excessive, fluoridated salt should not be 
distributed in that area. Also, salt fluoridation requires refined salt 
produced with modern technology and technical expertise.\82\ Finally, 
there is general agreement that a high consumption of sodium is a risk 
factor for hypertension (high blood pressure).\83\ \34\ People who have 
hypertension or must restrict their salt intake may find salt 
fluoridation an unacceptable method of receiving fluoride.
    Fluoridated milk has been suggested as another alternative to 
community water fluoridation in countries outside the United States. 
Studies among small groups of children have demonstrated a decrease in 
dental decay rates due to consumption of fluoridated milk; however, 
these studies were not based on large-scale surveys. More research is 
needed before milk fluoridation can be recommended as an alternative to 
water or salt fluoridation.\85\ The rationale for adding fluoride to 
milk is that this method ``targets'' fluoride directly to children. 
Concerns have been raised about decreased widespread benefits due to 
the slower absorption of fluoride from milk than from water and the 
considerable number of persons, especially adults, who do not drink 
milk for various reasons.\86\ The monitoring of fluoride content in 
milk is technically more difficult than for drinking water because 
there are many more dairies than communal water supplies. In addition, 
because fluoridated milk should not be sold in areas having natural or 
adjusted fluoridation, regulation would be difficult, and established 
marketing patterns would be disrupted.\17\
    (Additional discussion on this topic may be found in Question 40.)

    Question 11. Can the consistent use of bottled water result in 
individuals missing the benefits of optimally fluoridated water?
    Answer. Yes. The majority of bottled waters on the market do not 
contain optimal levels (0.7-1.2 ppm) of fluoride.
            Fact
    Individuals who drink bottled water as their primary source of 
water could be missing the decay preventive effects of optimally 
fluoridated water available from their community water supply. 
Therefore, consumers should seek advice from their dentist about 
specific fluoride needs.
    The fluoride content of bottled water can vary greatly. A 1989 
study of pediatric dental patients and their use of bottled water found 
the fluoride content of bottled water from nine different sources 
varied from 0.04 ppm to 1.4 ppm.\87\ In a 1991 study of 39 bottled 
water samples, 34 had fluoride levels below 0.3 ppm. Over the 2 years 
the study was conducted, six products showed a two- to four-fold drop 
in fluoride contents In evaluating how bottled water consumption 
affects fluoride exposure, there are several factors to consider. First 
is the amount of bottled water consumed during the day. Second is 
whether bottled water is used for drinking, in meal preparation and for 
reconstituting soups, juices and other drinks. Third is whether another 
source of drinking water is accessed during the day such as an 
optimally fluoridated community water supply at daycare, school or 
work. A final important issue is determining the fluoride content of 
the bottled water. If the fluoride level is not shown on the label of 
the bottled water, the company can be contacted, or the water can be 
tested to obtain this information. The fluoride level should be tested 
periodically if the source of the bottled water changes and, at a 
minimum, on a yearly basis.\87\
    Information regarding the existing level of fluoride in a 
community's public water supply can be obtained by asking a local 
dentist, contacting the local or state health department, or contacting 
the local water supplier.

    Question 12. Can home water treatment systems (e.g. water filters) 
affect optimally fluoridated water supplies?
    Answer. Yes. Some types of home water treatment systems can reduce 
the fluoride levels in water supplies potentially decreasing the decay-
preventive effects of optimally fluoridated water.
            Fact
    There are many kinds of home water treatment systems including 
carafe filters, faucet filters, reverse osmosis systems, distillation 
units and water softeners. There has not been a large body of research 
regarding the extent to which these treatment systems affect 
fluoridated water. Available research is often conflicting and unclear. 
However, it has been consistently documented that reverse osmosis 
systems and distillation units remove significant amounts of fluoride 
from the water supply.\16\ \89\ On the other hand, a recent study 
regarding water softeners confirmed earlier research indicating the 
water softening process caused no significant change in fluoride 
levels.\90\ \91\ With water filters, the fluoride concentration 
remaining in the water depends on the type and quality of the filter 
being used, the status of the filter and the filter's age.
    Individuals who drink water processed by home water treatment 
systems as their primary source water could be losing the decay 
preventive effects of optimally fluoridated water available from their 
community water supply. Therefore, consumers should seek advice from 
their dentist about specific fluoride needs.
    Consumers using home water treatment systems should have their 
water tested at least annually to establish the fluoride level of the 
treated water. More frequent testing may be needed. Testing is 
available through local and state public health departments. Private 
laboratories may also offer testing for fluoride levels in water.
    Information regarding the existing level of fluoride in a 
community's public water system can be obtained by asking a local 
dentist, contacting your local or state health department, or 
contacting the local water supplier.
    Consumers should seek advice from their dentist about specific 
fluoride needs.
                                 Safety

    Question 13. Does fluoride in the water supply, at the levels 
recommended for the prevention of tooth decay, adversely affect human 
health?
    Answer. The overwhelming weight of scientific evidence indicates 
that fluoridation of community water supplies is both safe and 
effective.
            Fact
    For generations, millions of people have lived in areas where 
fluoride is found naturally in drinking water in concentrations as high 
or higher than those recommended to prevent tooth decay. Research 
conducted among these persons confirms the safety of fluoride in the 
water supply.\54\ \92\ \93\ \94\ \95\ In fact, in August 1993, the 
National Research Council, a branch of the National Academy of 
Sciences, released a report prepared for the Environmental Protection 
Agency (EPA) that confirmed that the currently allowed fluoride levels 
in drinking water do not pose a risk for health problems such as 
cancer, kidney failure or bone disease.\96\ Based on a review of 
available data on fluoride toxicity, the expert subcommittee that wrote 
the report concluded that the EPA's ceiling of 4 ppm for naturally 
occurring fluoride in drinking water was ``appropriate as an interim 
standard.''\96\ Subsequently, the EPA announced that the ceiling of 4 
ppm would protect against adverse health effects with an adequate 
margin of safety and published a notice of intent not to revise the 
fluoride drinking water standard in the Federal Register.\97\
    As with other nutrients, fluoride is safe and effective when used 
and consumed properly. No charge against the benefits and safety of 
fluoridation has ever been substantiated by generally accepted 
scientific knowledge. After 50 years of research and practical 
experience, the preponderance of scientific evidence indicates that 
fluoridation of community water supplies is both safe and 
effective.\98\ (Additional discussion on this topic may be found in 
Question 19 and Question 32.)
    Many organizations in the U.S. and around the world involved with 
health issues have recognized the benefits of community water 
fluoridation. The American Dental Association adopted its original 
resolution in support of fluoridation in 1950, and has repeatedly 
reaffirmed its position publicly and in its House of Delegates based on 
its continuing evaluation of the safety and effectiveness of 
fluoridation.\3\ The American Medical Association's (AMA) House of 
Delegates first endorsed fluoridation in 1951. In 1986, and again in 
1996, the AMA reaffirmed its support for fluoridation as an effective 
means of reducing dental decay.\99\ The World Health Organization, 
which initially recommended the practice of water fluoridation in 
1969,\100\ reaffirmed its support for fluoridation in 1994 stating 
that: ``Providing that a community has a piped water supply, water 
fluoridation is the most effective method of reaching the whole 
population, so that all social classes benefit without the need for 
active participation on the part of individuals.'''': Following a 
comprehensive 1991 review and evaluation of the public health benefits 
and risks of fluoride, the U.S. Public Health Service reaffirmed its 
support for fluoridation and continues to recommend the use of fluoride 
to prevent dental decay.\54\
    National and international health, service and professional 
organizations that recognize the public health benefits of community 
water fluoridation for preventing dental decay are listed on the inside 
back cover of this publication.

    Question 14. Are additional studies being conducted to determine 
the effects of fluorides in humans?
    Answer. Yes. Since its inception, fluoridation has undergone a 
nearly continuous process of reevaluation. As with other areas of 
science, additional studies on the effects of fluorides in humans can 
provide insight as to how to make more effective choices for the use of 
fluoride. The American Dental Association and the U.S. Public Health 
Service support this on-going research.
            Fact
    For the past 50 years, detailed reports have been published on all 
aspects of fluoridation.\54\ \96\ The accumulated dental, medical and 
public health evidence concerning fluoridation has been reviewed and 
evaluated numerous times by academicians, committees of experts, 
special councils of government and most of the world's major national 
and international health organizations. The verdict of the scientific 
community is that water fluoridation, at the recommended levels, 
provides major oral health benefits. The question of possible secondary 
health effects caused by fluorides consumed in optimal concentrations 
throughout life has been the object of thorough medical investigations 
which have failed to show any impairment of general health.\82\ 92-95
    In scientific research, there is no such thing as ``final 
knowledge.'' New information is continuously emerging and being 
disseminated. While research continues, the weight of scientific 
evidence indicates water fluoridation is safe and effective in 
preventing dental decay in humans.\54\
    (Additional discussion on this topic may be found in Question 36.)

    Question 15. Does the total intake of fluoride from air, water and 
food pose significant health risks?
    Answer. The total intake of fluoride from air, water and food in an 
optimally fluoridated community in the United States does not pose 
significant health risks.
            Fact
Fluoride from the Air
    The atmosphere normally contains negligible concentrations of 
airborne fluorides. Studies reporting the levels of fluoride in air in 
the United States suggest that ambient fluoride contributes little to 
an individual's overall fluoride intake.\101\ \102\

Fluoride from Water
    Fresh or ground water in the United States has naturally occurring 
fluoride levels that can vary widely from less than 0.1 to over 13 
parts per million. Few private well water sources exceed 7 ppm.\102\ 
Public water systems in the U.S. are monitored by the Environmental 
Protection Agency (EPA), which requires that public water systems not 
exceed fluoride levels of 4 ppm.\97\ The optimal concentration for 
fluoride in water in the United States has been established in the 
range of 0.7 to 1.2 ppm. This range will effectively reduce tooth decay 
while minimizing the occurrence of mild dental fluorosis. The optimal 
fluoride level is dependent on the annual average of the maximum daily 
air temperature in the geographic area.27 (Additional discussion on 
this topic may be found in Question 32.)
    Children living in a community with water fluoridation get a 
portion of their daily fluoride intake from fluoridated water and a 
portion from dietary sources which would include food and other 
beverages. When considering water fluoridation, an individual must 
consume one liter of water fluoridated at 1 part per million (1 ppm) to 
receive 1 milligram (1 ma) of fluoride.\17\ \103\ Children under 6 
years of age, on average, consume less than one-half liter of drinking 
water a day.\103\ Therefore, children under 6 years of age would 
consume, on average, less than 0.5 mg of fluoride a day from drinking 
optimally fluoridated water (at 1 ppm).
    A 10-year comparison study of long-time residents of Bartlett and 
Cameron, Texas, where the water supplies contained 8.0 and 0.4 parts 
per million of fluoride respectively, included examinations of organs, 
bones and tissues. Other than a higher prevalence of dental fluorosis 
in the Bartlett residents, the study indicated that long-term 
consumption of dietary fluoride (resident average length of fluoride 
exposure was 36.7 years), even at levels considerably higher than 
recommended for decay prevention, resulted in no clinically significant 
physiological or functional effects.\95\

Fluoride in Food
    The fluoride content of fresh solid foods in the United States 
generally ranges from 0.01 to 1.0 part per million.\104\ Fish, such as 
sardines, may contribute to higher dietary fluoride intake if the bones 
are ingested. Brewed teas may also contain fluoride concentrations of 1 
ppm to 6 ppm depending on the amount of dry tea used, the water 
fluoride concentration and the brewing time.\104\
    The average daily dietary intake of fluoride (expressed on a body 
weight basis) by children residing in optimally fluoridated (1 ppm) 
communities is 0.05 mg/kg/day; in communities without optimally 
fluoridated water, average intakes for children are about 50 percent 
lower.\74\ Dietary fluoride intake by adults in optimally fluoridated 
(1 ppm) areas averages 1.4 to 3.4 mg/day, and in nonfluoridated areas 
averages 0.3 to 1.0 mg/day.\74\
    A 1990 review of literature identified no significant increases in 
concentrations of fluoride in food associated with water 
fluoridation.\105\
    Questions concerning the possible concentration of fluoride through 
the biologic food chain have been addressed by the National Academy of 
Sciences, which concluded:\106\
    Indeed, domestic animals can serve as a protective barrier for 
humans. Approximately 99 percent of the fluoride retained in the body 
is stored in bone, and only slight increases in the concentration of 
soft tissue fluoride occur even at high levels of dietary fluoride 
intake. There is, therefore, little danger to humans from the 
consumption of meat or milk from domestic animals even if the animals 
have ingested excessive fluoride. A few meat and fish products prepared 
for human consumption contain portions of comminuted (crushed) bone 
that may contribute to a higher fluoride content. The proportion of the 
total diet represented by these products, however, would generally be 
very small indeed.
    The U.S. Food and Drug Administration has established ``market 
baskets'' which reflect the actual 14-day consumption of various food 
items by an average individual in different age groups from 6-month-old 
children to adults. In a nationwide study of market baskets from areas 
with varying levels of fluoride in water supplies, it was determined 
that little or no change in food fluoride content has occurred as a 
result of the fluoridation of U.S. water supplies.\107\ \108\

    Question 16. How much fluoride should an individual consume each 
day to reduce the occurrence of dental decay?
    Answer. The appropriate amount of daily fluoride intake varies with 
age and body weight. As with other nutrients, [Fluoride is safe and 
effective when used and consumed properly.
            Fact
    In 1997, the Food and Nutrition Board of the Institute of Medicine 
developed a comprehensive set of reference values for dietary nutrient 
intakes.\74\ These new reference values, the Dietary Reference Intakes 
(DRI), replace the Recommended Dietary Allowances (RDA) which had been 
set by the National Academy of Sciences since 1941. The new values 
present nutrient requirements to optimize health and, for the first 
time, set maximum-level guidelines to reduce the risk of adverse 
effects from excessive consumption of a nutrient. Along with calcium, 
phosphorous, magnesium and vitamin D, DRIs for fluoride were 
established because of its proven effect on tooth decay.
    As demonstrated in Table 2, fluoride intake in the United States 
has a large range of safety.
    The first DRI reference value is the Adequate Intake (AI) which 
establishes a goal for intake to sustain a desired indicator of health 
without causing side effects. In the case of fluoride, the AI is the 
daily intake level required to reduce tooth decay without causing 
moderate dental fluorosis. The AI for fluoride from all sources 
(fluoridated water, food, beverages, fluoride dental products and 
dietary fluoride supplements) is set at 0.05 mg/kg/day (milligram per 
kilogram of body weight per day).
    Using the established AI of 0.05 mg/kg, the amount of fluoride for 
optimal health to be consumed each day has been calculated by gender 
and age group (expressed as average weight). See Table 2 in this 
Question.
    The DRIs also established a second reference value for maximum-
level guidelines called tolerable upper intake levels (UL). The UL is 
higher than the AI and is not the recommended level of intake. The UL 
is the estimated maximum intake level that should not produce unwanted 
effects on health. The UL for fluoride from all sources (fluoridated 
water, food, beverages, fluoride dental products and dietary fluoride 
supplements) is set at 0.10 mg/kg/day (milligram per kilogram of body 
weight per day) for infants, toddlers, and children through 8 years of 
age. For older children and adults, who are no longer at risk for 
dental fluorosis, the UL for fluoride is set at 10 mg/day regardless of 
weight.

                                                     Table 2
                                       DIETARY REFERENCE INTAKES FLUORIDE
                          Food and Nutrition Board of the Institute of Medicine 199774
----------------------------------------------------------------------------------------------------------------
                                         Reference Weights kg     Adequate Intake (mg/    Tolerable Upper Intake
              Age Group                        (lbs) *                    day)                   (mg/day)
----------------------------------------------------------------------------------------------------------------
Infants 0-6 months...................  7 (16).................  0.01...................  0.7
Infants 6-12 months..................  9 (20).................  0.5....................  0.9
Children 1-3 years...................  13 (29)................  0.7....................  1.3
Children 4-8 years...................  22 (48)................  1.0....................  2.0
Children 9-13 years..................  40 (88)................  2.0....................  10
Boys 14-18 years.....................  64 (142)...............  3.0....................  3.0
Girls 14-18 years....................  57 (125)...............  10.....................  10
Males 19 years and over..............  76 (166)...............  4.0....................  10
Females 19 years and over............  61 (133)...............  3.0....................  10
----------------------------------------------------------------------------------------------------------------
*Value base on data collected during 1988-94 as part of the Third National Health and Nutrition Examination
  Survey (NHANES III) in the United States\74\

    Using the established ULs for fluoride, the amount of fluoride that 
may be consumed each day to reduce the risk of moderate dental 
fluorosis for children under eight, has been calculated by gender and 
age group (expressed as average weight). See Table 2.
    As a practical example, daily intake of 2 mg of fluoride is 
adequate for a nine to 13-year-old child weighing 88 pounds (40 kg). 
This was calculated by multiplying 0.05 mg/kg/day (AI) times 40 kg 
(weight) to equal 2 ma. At the same time, that 88 pound (40 kg) child 
could consume 10 mg of fluoride a day as a tolerable upper intake 
level.
    Children living in a community with water fluoridation get a 
portion of their daily fluoride intake from fluoridated water and a 
portion from dietary sources which would include food and other 
beverages. When considering water fluoridation, an individual must 
consume one liter of water fluoridated at 1 part per million (1 ppm) to 
receive 1 milligram (1 ma) of fluoride.\17\ \103\ Children under 6 
years of age, on average, consume less than one-half liter of drinking 
water a day.\103\ Therefore, children under 6 years of age would 
consume, on average, less than 0.5 mg of fluoride a day from drinking 
optimally fluoridated water (at 1 ppm).
    If a child lives in a nonfluoridated area, the dentist or physician 
may prescribe dietary fluoride supplements. As shown in Table 1 
``Dietary Fluoride Supplement Schedule 1994'' (See Question 9), the 
current dosage schedule recommends supplemental fluoride amounts that 
are below the AI for each age group. The dosage schedule was designed 
to offer the benefit of decay reduction with margin of safety to 
prevent mild to moderate dental fluorosis. For example, the AI for a 
child 3 years of age is 0.7 mg/day.The recommended dietary fluoride 
supplement dosage for a child 3 years of age in a nonfluoridated 
community is 0.5 mg/day. This provides leeway for some fluoride intake 
from processed food and beverages, and other sources.
    Decay rates are declining in many population groups because 
children today are being exposed to fluoride from a wider variety of 
sources than decades ago. Many of these sources are intended for 
topical use only; however, some fluoride is inadvertently ingested by 
children.\109\ Inappropriate ingestion of fluoride can be prevented, 
thus reducing the risk for dental fluorosis without jeopardizing the 
benefits to oral health.
    For example, it has been reported in a number of studies that young 
children inappropriately swallow an average of 0.30 mg of fluoride from 
fluoride toothpaste at each brushing.\110\ \111\ \112\ \113\ If a child 
brushes twice a day, 0.60 mg may be inappropriately ingested. This may 
slightly exceed the Adequate Intake (AI) values from Table 2. The 0.60 
mg consumption is 0.10 mg over the AI value for children 6 to 12 months 
and is 0.10 mg under the AI for children from 1-3 years of age.\74\ 
Although toothpaste is not meant to be swallowed, children may consume 
the daily recommended Adequate Intake amount of fluoride from 
toothpaste alone. In order to decrease the risk of dental fluorosis, 
the American Dental Association has since 1992 recommended that parents 
and caregivers put only one pea-sized amount of fluoride toothpaste on 
a young child's toothbrush at each brushing. Also, young children 
should be supervised while brushing and taught to spit out, rather than 
swallow, the toothpaste.
    It should be noted that the amounts of fluoride discussed here are 
intake, or ingested, amounts. When fluoride is ingested, a portion is 
retained in the body and a portion is excreted. This issue will be 
discussed further in Question 17.

    Question 17. When fluoride is ingested, where does it go?
    Answer. Much is excreted; almost all of the fluoride retained in 
the body is found in calcified (hard) tissues, such as bones and teeth.
    Fluoride helps to prevent dental decay when incorporated into the 
teeth.
            Fact
    After ingestion of fluoride, such as drinking a glass of optimally 
fluoridated water, the majority of the fluoride is absorbed from the 
stomach and small intestine into the blood stream.\114\ This causes a 
short-term increase in the fluoride levels in the blood. The fluoride 
levels increase quickly and reach a peak concentration within 20-60 
minutes.\115\ The concentration declines rapidly, usually within 3 to 6 
hours following the peak levels, due to the uptake of fluoride by hard 
tissue and efficient removal of fluoride by the kidneys.\104\ 
Approximately 50 percent of the fluoride absorbed each day by young or 
middle-aged adults becomes associated with hard tissues within 24 hours 
while virtually all of the remainder is excreted in the urine. 
Approximately 99 percent of the fluoride present in the body is 
associated with hard tissues.\114\
    Ingested or systemic fluoride becomes incorporated into forming 
tooth structures. Fluoride ingested regularly during the time when 
teeth are developing is deposited throughout the entire surface of the 
tooth and contributes to long lasting protection against dental 
decay.\17\ (Additional discussion on this topic may be found in 
Question 1.)
    An individual's age and stage of skeletal development will affect 
the rate of fluoride retention. The amount of fluoride taken up by bone 
and retained in the body is inversely related to age. More fluoride is 
retained in young bones than in the bones of older adults.\104\ \114\ 
\115\
    According to generally accepted scientific knowledge, the ingestion 
of optimally fluoridated water does not have an adverse effect on bone 
health.'' Evidence of advanced skeletal fluorosis, or crippling 
skeletal fluorosis, ``was not seen in communities in the United States 
where water supplies contained up to 20 ppm (natural levels of 
fluoride).''\74\ \121\ In these communities, daily fluoride intake of 
20 mg/day would not be uncommon.\74\ Crippling skeletal fluorosis is 
extremely rare in the United States and is not associated with 
optimally fluoridated water; only 5 cases have been confirmed during 
the last 35 years.\74\ (Additional discussion on this topic may be 
found in Question 18.)
    The kidneys play the major role in the removal of fluoride from the 
body. Normally kidneys are very efficient and excrete fluoride very 
rapidly. However, decreased fluoride removal may occur among persons 
with severely impaired kidney function who may not be on kidney 
dialysis.\96\ No cases of dental fluorosis or symptomatic skeletal 
fluorosis have been reported among persons with impaired kidney 
function; however, the overall health significance of reduced fluoride 
removal is uncertain and continued followup is recommended especially 
for children with impaired kidney function.\54\ (Additional discussion 
on this topic may be found in Question 31.)

    Question 18. Will the ingestion of optimally fluoridated water over 
a lifetime adversely affect bone health?
    Answer. According to generally accepted scientific knowledge, the 
ingestion of optimally fluoridated water does not have an adverse 
effect on bone health.\116\ \117\ \118\ \119\ \120\ \122\
            Fact
    The weight of scientific evidence does not supply an adequate basis 
for altering public health policy regarding fluoridation because of 
bone health concerns. A number of investigations have studied the 
effects on bone structure of individuals residing in communities with 
optimal and higher than optimal concentrations of fluoride in the 
drinking water. These studies have focused on whether there exists a 
possible link between fluoride and bone fractures. In addition, the 
role of fluoride in strengthening bone and preventing fractures has 
been investigated. Last, the possible association between fluoride and 
bone cancer has been studied.
Water Fluoridation Has No Significant Impact on Bone Mineral Density
    In 1991, a workshop, co-sponsored by the National Institute of 
Arthritis and Musculoskeletal and Skin Diseases and the National 
Institute of Dental Research, addressed the potential relationship of 
hip fracture and bone health in humans to fluoride exposure from 
drinking water. Meeting at the National Institutes of Health, 
researchers examined historic and contemporary research on fluoride 
exposure and bone health. At that time, participants concluded there 
was no basis for altering current public health policy regarding 
current guidelines for levels of fluoride in drinking water. 
Recommendations were made regarding additional research in several 
areas.\116\
    In 1993, two studies were published demonstrating that exposure to 
fluoridated water does not contribute to an increased risk for hip 
fractures. One study looked at the risk of hip fractures in residents 
of two similar communities in Alberta, Canada.\117\ In this study, 
researchers compared a city with fluoridated drinking water optimally 
adjusted to 1 ppm to a city whose residents drank water containing 
naturally occurring fluoride at a concentration of only 0.3 ppm. No 
significant difference was observed in the overall hip fracture 
hospitalization rates for residents of both cities. ``These findings 
suggest that fluoridation of drinking water has no impact, neither 
beneficial nor deleterious, on the risk of hip fracture.''\117\
    The second study examined the incidence of hip fracture rates 
before and after water fluoridation in Rochester, Minnesota.\118\ 
Researchers compared the hip fracture rates of men and women aged 50 
and older from 1950 to 1959 (before the city's water supply was 
fluoridated in 1960) with the 10-year period after fluoridation. Their 
findings showed that hip fracture rates had decreased, and that the 
decrease began before fluoridation was introduced, and then continued. 
These data demonstrate no increase in the risk of hip fracture 
associated with fluoridation of the public water supply in Rochester, 
Minnesota.
    Prior to 1993, the lead author of the 1993 Minnesota study had 
authored two earlier fluoridation-hip fracture studies showing a very 
slight increase in fracture risk in fluoridated communities.\123\ \124\ 
The 1990 study examined the regional variation within the United States 
in the incidence of hip fracture in women aged 65 and over. The 
analysis of hip fracture incidence data at the county level 
demonstrated a strong pattern of regional variation among women, with a 
band of increased risk in the southern United States. The results of 
the analysis suggested that soft and fluoridated water, poverty, 
reduced sunlight exposure and rural location all increased the risk of 
hip fracture. In the summary, the author stated that no presently 
recognized factor or factors adequately explained the geographic 
variation.\123\ The second study, published in 1992, was a national 
ecologic study of the association between water fluoridation and hip 
fractures in women and men aged 65 and over. (In ecological studies, 
groups of people are studied instead of individuals.) The study 
reported a small positive ecologic association between fluoridation of 
public water supplies and the incidence of hip fracture among the aged. 
The authors stated that this observation did not yet provide a firm 
platform for health policy, but stated further research was 
warranted.\124\
    In 1997, the lead author of the 1993 Minnesota study and the two 
studies noted in the preceding paragraph, issued a statement which 
concluded: ``To my knowledge, no study has demonstrated that the 
introduction of fluoride to the public water supplies has increased the 
risk of (hip) fracture, let alone a doubling of the risk.''\125\
    An ecological study conducted in eastern Germany compared the 
incidence of hip fractures for adults living in Chemnitz (optimally 
fluoridated) and Halle(fluoride-deficient). The results suggested the 
consumption of optimally fluoridated water reduced the incidence of hip 
fractures in elderly individuals, especially women over 84 years of 
age.\122\
    According to generally accepted scientific knowledge, the ingestion 
of optimally fluoridated water does not have an adverse effect on bone 
health.\116\ \120\ \122\ Exposure to fluoride at levels considered 
optimal for the prevention of dental decay appears to have no 
significant impact on bone mineral density.\126\
Fluoride's Role in Strengthening Bone
    The second major area of study regarding fluoride and bone health 
is the role of fluoride in strengthening bone and preventing fractures. 
For nearly 30 years, fluoride, primarily in the form of slowrelease 
sodium fluoride, has been used as an experimental therapy to treat 
osteoporosis, a condition characterized by a reduction in the amount of 
bone mass. Individuals with osteoporosis may suffer bone fractures as a 
result of what would be considered minimal trauma. Sodium fluoride 
therapy has been used in individuals in an effort to reduce further 
bone loss, or add to existing bone mass and prevent further 
fractures.'' The results of the clinical trials have been mixed as 
noted in the two following studies. The need for further research is 
indicated.
    In 1995, the final report of a 4-year study was published 
demonstrating the ability of fluoride to aid in an increase in bone 
mass.\127\ The study examined females with post-menopausal osteoporosis 
who took slow-release sodium fluoride (25 mg twice a day) and calcium 
citrate (400 mg twice a day) for 4 years in repeated 14 month cycles 
(12 months receiving treatment and 2 months not receiving treatment). 
The study concluded this treatment was safe and effective in reducing 
the number of new spinal fractures and adding new bone mass to the 
spine.\127\
    In a 6-year clinical trial in 50 postmenopausal women, treatment 
with sodium fluoride and supplemental calcium was not effective in the 
treatment of osteoporosis.\128\
No Association Between Fluoride and Bone Cancer
    Lastly, the possible association between fluoride and bone cancer 
has been studied. In the early 1990's, two studies were conducted to 
evaluate the carcinogenicity of sodium fluoride in laboratory animals. 
The first study was conducted by the National Toxicology Program (NTP) 
of the National Institute of Environmental Health Sciences.\129\ The 
second study was sponsored by the Proctor and Gamble Company.\130\ In 
both studies, higher than optimal concentrations of sodium fluoride 
were consumed by rats and mice. When the NTP and the Proctor and Gamble 
studies were combined, a total of eight individual sex/species groups 
became available for analysis. Seven of these groups showed no 
significant evidence of malignant tumor formation. One group, male rats 
from the NTP study, showed ``equivocal'' evidence of carcinogenicity, 
which is defined by NTP as a marginal increase in neoplasms--i.e., 
osteosarcomas (malignant tumors of the bone)--that may be chemically 
related. The Ad Hoc Subcommittee on Fluoride of the U.S. Public Health 
Service combined the results of the two studies and stated: ``Taken 
together, the two animal studies available at this time fail to 
establish an association between fluoride and cancer.\54\ (Additional 
discussion on this topic may be found in Question 22.)

    Question 19. What is dental fluorosis?
    Answer. Dental fluorosis is a change in the appearance of teeth and 
is caused when higher than optimal amounts of fluoride are ingested in 
early childhood while tooth enamel is forming. The risk of dental 
fluorosis can be greatly reduced by closely monitoring the proper use 
of fluoride products by young children.
            Fact
    Dental fluorosis is caused by a disruption in enamel formation 
which occurs during tooth development in early childhood.\104\ Enamel 
formation of permanent teeth, other than third molars (wisdom teeth), 
occurs from about the time of birth until approximately 5 years of age. 
After tooth enamel is completely formed, dental fluorosis cannot 
develop even if excessive fluoride is ingested.\131\ Older children and 
adults are not at risk for dental fluorosis. Dental fluorosis only 
becomes apparent when the teeth erupt. Because dental fluorosis occurs 
while teeth are forming under the gums, teeth that have erupted are not 
at risk for dental fluorosis.
    Dental fluorosis has been classified in a number of ways. One the 
most universally accepted classifications was developed by H.T. Dean in 
1942; its descriptions can be easily visualized by the public (See 
Table 3).\132\
    In using Dean's Fluorosis Index, each tooth present in an 
individual's mouth is rated according to the fluorosis index in Table 
3. The individual's fluorosis score is based upon the severest form of 
fluorosis recorded for two or more teeth.
    Very mild to mild fluorosis has no effect on tooth function and may 
make the tooth enamel more resistant to decay. This type of fluorosis 
is not readily apparent to the affected individual or casual observer 
and often requires a trained specialist to detect. In contrast, the 
moderate and severe forms of dental fluorosis are generally 
characterized by esthetically (cosmetically) objectionable changes in 
tooth color and surface irregularities. Most investigators regard even 
the more advanced forms of dental fluorosis as a cosmetic effect rather 
than a functional adverse effect.\74\ The EPA, in a decision supported 
by the U.S. Surgeon General, has determined that objectionable dental 
fluorosis is a cosmetic effect with no known health effects.\97\ Little 
research on the psychological effects of dental fluorosis on children 
and adults has been conducted, perhaps because the majority of those 
who have the milder forms of dental fluorosis are unaware of this 
condition.\54\

                                 Table 3
         DENTAL FLUOROSIS CLASSIFICATION BY H.T. DEAN-1942\132\
------------------------------------------------------------------------
         Classification               Criteria--Description of Enamel
------------------------------------------------------------------------
Normal..........................  Smooth, glossy, pale creamy-white
                                   translucent surface
Questionable....................  A few white flecks or white spots
Very Mild.......................  Small opaque, paper-white areas
                                   covering less than 25 percent of the
                                   tooth surface
Mild............................  Opaque white areas covering less than
                                   25 percent of the tooth surface
Moderate........................  All tooth surfaces affected; marked
                                   wear on biting, surfaces; brown stain
                                   may be present
Severe..........................  All tooth surfaces affected; discrete
                                   or confluent pitting; brown stain
                                   present
------------------------------------------------------------------------

    In a 1986-7 national survey of U.S. school children conducted by 
the National Institute of Dental Research, dental fluorosis was present 
in 22.3 percent of the children examined using Dean's Index.s4 These 
children were exposed to all sources of fluoride (fluoridated water, 
food, beverages, fluoride dental products and dietary supplements). The 
prevalence of the types of fluorosis were:

    Very mild fluorosis 17.0 percent
    Mild fluorosis 4.0 percent
    Moderate fluorosis 1.0 percent
    Severe fluorosis 0.3 percent
    Total cases of fluorosis 22.3 percent

    The incidence of moderate or severe fluorosis comprised a very 
small portion (6 percent) of the total amount of fluorosis. In other 
words, 94 percent of all dental fluorosis is the very mild to mild form 
of dental fluorosis.
    As with other nutrients, fluoride is safe and effective when used 
and consumed properly. The recommended optimum water fluoride 
concentration of 0.7 to 1.2 ppm was established to maximize the decay 
preventive benefits of fluoride, and the same time minimize the 
likelihood of mild dental fluorosis.\54\
    As with all public health measures, the benefits and risks of 
community water fluoridation have been examined. The benefits of water 
fluoridation are discussed extensively in the Benefits Section of this 
document and the safety of water fluoridation is discussed in great 
detail in the remainder of this (Safety) Section. In assessing the 
risks in regards to dental fluorosis, scientific evidence shows it is 
probable that approximately 10 percent of children consuming optimally 
fluoridated water, in the absence of fluoride from all other sources, 
will develop very mild dental fluorosis.?33 As defined in Table 3, very 
mild fluorosis is characterized by small opaque, paper-white areas 
covering less than 25 percent of the tooth surface. The risk of teeth 
forming with the very mildest form of fluorosis must be weighed against 
the benefit that the individual's teeth will also have a lower rate of 
dental decay thus saving dental treatment costs.\45\ In addition, the 
risk of fluorosis may be viewed as an alternative to having dental 
decay, which is a disease that may cause cosmetic problems much greater 
than fluorosis.\134\
    In 1994, a review of five recent studies indicated that the amount 
of dental fluorosis attributable to water fluoridation was 
approximately 13 percent. This represents the amount of fluorosis that 
might be eliminated if community water fluoridation was discontinued. 
In other words, the majority of dental fluorosis can be associated with 
other risk factors such as the inappropriate ingestion of fluoride 
products. (Additional discussion on this topic may be found in Question 
20.)
    The type of fluorosis seen today remains largely limited to the 
very mild and mild categories, although the prevalence of enamel 
fluorosis in both fluoridated and nonfluoridated communities in the 
United States is higher than it was when original epidemiological 
studies were done approximately 60 years ago. Because fluoride intake 
from water and the diet appears not to have increased since that time, 
the additional intake by children at risk for dental fluorosis is 
believed to be caused by consumer's inappropriate use of fluoride-
containing dental products. As the ADA has recommended, the risk of 
fluorosis can be greatly reduced by following label directions for the 
use of these fluoride products.\74\ \96\

    Question 20. Can fluorosis in children's teeth be prevented?
    Answer. Because risk factors have been identified and verified by 
generally accepted scientific knowledge, the occurrence of dental 
fluorosis in the United States can be reduced! without denying young 
children the decay prevention benefits of community water fluoridation.
            Fact
    During the period of enamel formation in young children (before 
teeth appear in the mouth), inappropriate ingestion of high levels of 
fluoride is the risk factor for dental fluorosis.\52\ \135\ Studies of 
fluoride intake from the diet including foods, beverages and water 
indicate that fluoride ingestion from these sources has remained 
relatively constant for over half a century and, therefore, is not 
likely to be associated with an observed increase in dental 
fluorosis.\104\ \107\
    Dental decay has decreased because children today are being exposed 
to fluoride from a wider variety of sources than decades ago. Many of 
these sources are intended for topical use only; however, some fluoride 
is inadvertently ingested by children.\109\ Inappropriate ingestion of 
topical fluoride can be prevented, thus reducing the risk for dental 
fluorosis without reducing decay prevention benefits.
    Since 1992, the American Dental Association has required 
manufacturers of toothpaste to include the phrase ``Use only a pea-
sized amount (of toothpaste) for children under six'' on fluoride 
toothpaste labels with the ADA Seal of Acceptance. The rationale for 
choosing 6 years of age for the toothpaste label is based on the fact 
that the swallowing reflex is not fully developed in children of 
preschool age and they may inadvertently swallow toothpaste during 
brushing. In addition, the enamel formation of permanent teeth is 
basically complete at six and so there is a decreased risk of 
fluorosis. Because dental fluorosis occurs while teeth are forming 
under the gums, individuals whose teeth have erupted are not at risk 
for dental fluorosis.
    (Additional discussion on this topic may be found in Question 16 
and Question 19.)
    Numerous studies have established a direct relationship between 
young children brushing with more than the recommended pea-sized amount 
of fluoride toothpaste and the risk of very mild or mild dental 
fluorosis.\136\ \137\ \138\ One study of 916 children residing in a 
fluoridated community revealed that an estimated 71 percent of 
identified fluorosis cases could be explained by a history of having 
brushed more than once a day with more than the recommended amount 
(only one pea-sized dab at each brushing) of fluoride toothpaste 
throughout the first 8 years of life.\139\ Parents and caregivers 
should put only one pea-sized amount of fluoride toothpaste on a young 
child's toothbrush at each brushing. Young children should be 
supervised while brushing and taught to spit out, rather than swallow, 
the toothpaste.
    Additionally, it has been shown that 25 percent of the fluorosis 
cases could be explained by a history of taking dietary fluoride 
supplements inappropriately (i.e., while also consuming fluoridated 
water) during the first 8 years of life.\139\ Dietary fluoride 
supplements should be prescribed as recommended in the Dietary Fluoride 
Supplement Schedule approved by the American Dental Association, the 
American Academy of Pediatrics and the American Academy of Pediatric 
Dentistry in 1994 (See Table 1 in Question 9).\12\ Fluoride supplements 
should only be prescribed for children living in nonfluoridated areas. 
Because of many sources of fluoride in the diet, proper prescribing of 
fluoride supplements can be complex. It is suggested that all sources 
of fluoride be evaluated with a thorough fluoride history before 
supplements are prescribed for a child.\73\ Included in that evaluation 
is the testing of the home water supply if the fluoride concentration 
is unknown.
    Parents, caregivers and health care professionals should 
judiciously monitor use of all fluoride-containing dental products by 
children under age six. As is the case with any therapeutic product, 
more is not always better. Care should be taken to adhere to label 
directions on fluoride prescriptions and over-the-counter products 
(e.g. fluoride toothpastes and rinses). The American Dental Association 
recommends the use of fluoride mouthrinses, but not for children under 
6 years of age because they may swallow the rinse. In addition, these 
products should be stored out of the reach of children.
    Finally, in areas where naturally occurring fluoride levels in 
ground water are higher than 2 ppm, consumers should consider action to 
lower the risk of dental fluorosis for young children. (Adults are not 
affected because dental fluorosis occurs only when developing teeth are 
exposed to elevated fluoride levels.) Families on community water 
systems should contact their water supplier to ask about the fluoride 
level. Consumers with private home wells should have the source tested 
to accurately determine the fluoride content. Consumers should consult 
with their dentist regarding water testing and discuss appropriate 
dental health care measures. In homes where young children are 
consuming water with a fluoride level greater than 2 ppm, families 
should use an alternative primary water source, such as bottled water, 
for drinking and cooking. Private wells should be tested at least 
yearly due to possible fluctuations in water tables. It is important to 
remember that the American Dental Association recommends dietary 
fluoride supplements only for children living in areas with less than 
optimally fluoridated water.
    (Additional discussion on this topic may be found in Question 9 and 
Question 32.)

    Question 21. Is fluoride, as provided by community water 
fluoridation, a toxic substance?
    Answer. Fluoride, at the concentrations found optimally fluoridated 
water, is not toxic according to generally accepted scientific 
knowledge.
            Fact
    Like many common substances essential to life and good health--
salt, iron, vitamins A and D, chlorine, oxygen and even water itself--
fluoride can be toxic in excessive quantities. Fluoride in the much 
lower concentrations (0.7 to 1.2 ppm) used in water fluoridation is not 
harmful or toxic.
    Acute fluoride toxicity occurring from the ingestion of optimally 
fluoridated water is impossible.''\104\ The amount of fluoride 
necessary to cause death for a human adult (155 pound man) has been 
estimated to be 5-10 grams of sodium fluoride, ingested at one 
time.\140\ This is more than 10,000-20,000 times as much fluoride as is 
consumed at one time in a single 8 ounce glass of optimally fluoridated 
water.
    Chronic fluoride toxicity may develop after 10 or more years of 
exposure to very high levels of fluoride, levels not associated with 
fluoride intake in drinking optimally fluoridated water. The primary 
functional adverse effect associated with long-term excess fluoride 
intake is skeletal fluorosis. The development of skeletal fluorosis and 
its severity is directly related to the level and duration of fluoride 
exposure. For example, the ingestion of water naturally fluoridated at 
approximately 5 ppm for 10 years or more is needed to produce clinical 
signs of osteosclerosis, a mild form of skeletal fluorosis, in the 
general population. In areas naturally fluoridated at 5 ppm, daily 
fluoride intake of 10 mg/day would not be uncommon.\74\ A survey of X-
rays from 170,000 people in Texas and Oklahoma whose drinking water had 
naturally occurring fluoride levels of 4 to 8 ppm revealed only 23 
cases of osteosclerosis and no cases of skeletal fluorosis.\141\ 
Evidence of advanced skeletal fluorosis, or crippling skeletal 
fluorosis, ``was not seen in communities in the United States where 
water supplies contained up to 20 ppm (natural levels of 
fluoride).''\74\ \121\ In these communities, daily fluoride intake of 
20 mg/day would not be uncommon.\74\ Crippling skeletal fluorosis is 
extremely rare in the United States and is not associated with 
optimally fluoridated water; only 5 cases have been confirmed during 
the last 35 years.\74\
    (Additional discussion of this topic may be found in Question 16 
and Question 32.)
    The possibility of adverse health effects from continuous low level 
consumption of fluoride over long periods has been extensively studied. 
As with other nutrients, fluoride is safe and effective when used and 
consumed properly. No charge against the benefits and safety of 
fluoridation has ever been substantiated by generally accepted 
scientific knowledge. After 50 years of research and practical 
experience, the preponderance of scientific evidence indicates that 
fluoridation of community water supplies is both safe and 
effective.\98\
    At one time, high concentrations of fluoride compounds were used in 
insecticides and rodenticides.\27\ Today fluoride compounds are rarely 
used in pesticides because more effective compounds have been 
developed.\104\ While large doses of fluoride may be toxic, it is 
important to recognize the difference in the effect of a massive dose 
of an extremely high level of fluoride versus the recommended amount of 
fluoride found in optimally fluoridated water. The implication that 
fluorides in large doses and in trace amounts have the same effect is 
completely unfounded. Many substances in widespread use are very 
beneficial in small amounts, but may be harmful in large doses-such as 
salt, chlorine and even water itself.

    Question 22. Does drinking optimally fluoridated water cause or 
accelerate the growth of cancer?
    Answer. According to generally accepted scientific knowledge, there 
is no connection between cancer rates in humans and adding fluoride to 
drinking water.\142\
            Fact
    Since community water fluoridation was introduced in 1945, more 
than 50 epidemiologic studies in different populations and at different 
times have failed to demonstrate an association between fluoridation 
and the risk of cancer.s4 Studies have been conducted in the United 
States,\143\ \144\ \145\ \146\ \147\ \147\ \148\ Japan,\149\ the United 
Kingdom,\150\ \151\ \152\ Canada \153\ and Australia.\154\ In addition, 
several independent bodies have conducted extensive reviews of the 
scientific literature and concluded that there is no relationship 
between fluoridation and cancer. \54\ \94\ \96\ \155\
    The United States Environmental Protection Agency (EPA) further 
commented on the safety of appropriate fluoride exposure in the 
December 5, 1997, Federal Register.\156\ In a notice of a final rule 
relating to fluoride compounds the EPA stated, ``. . . the weight of 
evidence from more than 50 epidemiological studies does not support the 
hypothesis of an association between fluoride exposure and increased 
cancer risk in humans. The EPA is in agreement with the conclusions 
reached by the National Academy of Sciences (NAS).''
    Despite the abundance of scientific evidence, claims of a link 
between fluoridation and increased cancer rates continue. This 
assertion is based on one study comparing cancer death rates in ten 
large fluoridated cities versus ten large nonfluoridated cities in the 
United States. The results of this study have been refuted by a number 
of organizations and researchers.\157\ The National Cancer Institute 
analyzed the same data and found that the original investigators failed 
to adjust their findings for variables, such as age and gender 
differences, that affect cancer rates. A review by other researchers 
pointed to further shortcomings in the study. The level of 
industrialization in the fluoridated cities was much higher than the 
nonfluoridated cities. Researchers noted that a higher level of 
industrialization is usually accompanied by a higher incidence of 
cancer. While the researchers noted that the fluoridated cities did 
have higher cancer rates over the 20-year study, the rate of increase 
in the nonfluoridated cities was exactly the same (15 percent) as the 
fluoridated cities. Following further reviews of the study, the 
consensus of the scientific community continues to support the 
conclusion that the incidence of cancer is unrelated to the 
introduction and duration of water fluoridation.\54\
    In the early 1990's, two studies using higher than optimal levels 
of fluoride were conducted to evaluate the carcinogenicity of sodium 
fluoride in laboratory animals. The first study was conducted by the 
National Toxicology Program (NTP) of the National Institute of 
Environmental Health Sciences.\129\ The second study was sponsored by 
the Proctor and Gamble Company.\130\ In both studies, higher than 
optimal concentrations of sodium fluoride were consumed by rats and 
mice. When the NTP and the Proctor and Gamble studies were combined, a 
total of eight individual sex/species groups became available for 
analysis. Seven of these groups showed no significant evidence of 
malignant tumor formation. One group, male rats from the NTP study, 
showed ``equivocal'' evidence of carcinogenicity, which is defined by 
NTP as a marginal increase in neoplasms-i.e., osteosarcomas (malignant 
tumors of the bone)that may be chemically related. The Ad Hoc 
Subcommittee on Fluoride of the U.S. Public Health Service combined the 
results of the two studies and stated: ``Taken together, the two animal 
studies available at this time fail to establish an association between 
fluoride and cancer.''\54\
    In a 1990 study, scientists at the National Cancer Institute 
evaluated the relationship between fluoridation of drinking water and 
cancer deaths in the United States during a 36-year period, and the 
relationship between fluoridation and the cancer rate during a 15-year 
period. After examining more than 2.3 million cancer death records and 
125,000 cancer case records in counties using fluoridated water, the 
researchers saw no indication of a cancer risk associated with 
fluoridated drinking water.\54\
    In a document entitled ``Fluoride and Drinking Water 
Fluoridation,'' the American Cancer Society states, ``Scientific 
studies show no connection between cancer rates in humans and adding 
fluoride to drinking water.''\142\

    Question 23. Does fluoride, as provided by community water 
fluoridation, inhibit the activity of enzymes in humans?
    Answer. Fluoride, in the amount provided through optimally 
fluoridated water, has no effect on human enzyme activity according to 
generally accepted scientific knowledge.
            Fact
    Enzymes are organic compounds that promote chemical change in the 
body. Generally accepted scientific knowledge has not indicated that 
optimally fluoridated water has any influence on human enzyme activity. 
There are no available data to indicate that, in humans drinking 
optimally fluoridated water, the fluoride affects enzyme activities 
with toxic consequences.\105\ The World Health Organization report, 
Fluorides and Human Health states, ``No evidence has yet been provided 
that fluoride ingested at 1 ppm in the drinking water affects 
intermediary metabolism of food stuffs, vitamin utilization or either 
hormonal or enzymatic activity.''\158\
    The concentrations of fluoride used in laboratory studies to 
produce significant inhibition of enzymes are hundreds of times greater 
than the concentration present in body fluids or tissues.\140\ While 
fluoride may affect enzymes in an artificial environment outside of a 
living organism in the laboratory, it is unlikely that adequate 
cellular levels of fluoride to alter enzyme activities would be 
attainable in a living organism.\105\ The two primary physiological 
mechanisms that maintain a low concentration of fluoride ion in body 
fluids are the rapid excretion of fluoride by the kidneys and the 
uptake of fluoride by calcified tissues.

    Question 24. Can fluoride, as found in optimally fluoridated 
drinking water, alter immune function or produce allergic reaction 
(hypersensitivity)?
    Answer. According to generally accepted scientific knowledge, there 
is no evidence of any adverse effect on specific immunity from 
fluoridation, nor have there been any confirmed reports of allergic 
reaction.\159\
            Fact
    There are no confirmed cases of allergy to fluoride, or of any 
positive skin testing in human or animal models.\159\ The American 
Academy of Allergy reviewed clinical reports of possible allergic 
responses to fluoride and concluded, ``There is no evidence of allergy 
or intolerance to fluorides as used in the fluoridation of community 
water supplies.''\160\ A committee of the National Academy of Sciences 
evaluated the same clinical data and reported, ``The reservation in 
accepting (claims of allergic reaction) at face value is the lack of 
similar reports in much larger numbers of people who have been exposed 
to considerably more fluoride than was involved in the original 
observations.''\14\ The World Health Organization also judged these 
cases to represent ``a variety of unrelated conditions'' and found no 
evidence of allergic reactions to fluoride.\161\ \162\
    A 1996 review of the literature on fluoride and white cell function 
examined numerous studies and concluded that there is no evidence of 
any harmful effect on specific immunity following fluoridation nor any 
confirmed reports of allergic reactions.\159\

    Question 25. Does drinking optimally fluoridated water cause AIDS?
    Answer. There is no generally accepted scientific evidence linking 
the consumption of optimally fluoridated water and AIDS (acquired 
immune deficiency syndrome).
            Fact
    AIDS is caused by a retrovirus known as the human immunodeficiency 
virus (HIV). The routes of transmission of HIV include unprotected 
sexual activity, exposure to contaminated blood or blood products and 
as a result of an infected woman passing the virus to the fetus during 
pregnancy or to the newborn at birth.\163\
    There is no scientific evidence linking HIV or AIDS with community 
water fluoridation.\164\

    Question 26. Is fluoride, as provided by community water 
fluoridation, a genetic hazard?
    Answer. Following a review of generally accepted scientific 
knowledge, the National Research Council of the National Academy of 
Sciences supports the conclusion that drinking optimally fluoridated 
water is not a genetic hazard.\96\
            Fact
    Chromosomes are the DNA-containing bodies of cells that are 
responsible for the determination and transmission of hereditary 
characteristics. Genes are the functional hereditary unit that occupy a 
fixed location on a chromosome. Many studies have examined the possible 
effects of fluoride on chromosome damage. While there are no published 
studies on the genotoxic (damage to DNA) effect of fluoride in humans, 
numerous studies have been done on mice.\96\ These studies have shown 
no evidence that fluoride damages chromosomes in bone marrow or sperm 
cells even at fluoride levels 100 times higher than that in fluoridated 
water.\165\ \166\ \167\ \168\ \169\ \170\ \171\ Another independent 
group of researchers reported a similar lack of fluoride-induced 
chromosomal damage to human white blood cells, which are especially 
sensitive to agents which cause genetic mutations. Not only did 
fluoride fail to damage chromosomes, it protected them against the 
effect of a known mutagen (an agent that causes changes in DNA).\172\ 
\173\ The genotoxic effects of fluoride were also studied in hamster 
bone marrow cells and cultured hamster ovarian cells. Again, the 
results supported the conclusion that fluoride does not cause 
chromosomal damage, and therefore, was not a genetic hazard.\174\ In 
further tests, fluoride has not caused genetic mutations in the most 
widely used bacterial mutagenesis assay (the Ames test) over a wide 
range of fluoride levels.\174\ \175\ \176\ \177\
    Occasional questions arise regarding fluoride's effects on human 
reproduction, fertility and birth rates. Very high levels of fluoride 
intake have been associated with adverse effects on reproductive 
outcomes in many animal species. Based on these findings, it appears 
that fluoride concentrations associated with adverse reproductive 
effects in animals are far higher (100-200 ppm) than those to which 
human populations are exposed. Consequently, there is insufficient 
scientific basis on which to conclude that ingestion of fluoride at 
levels found in community water fluoridation (0.7-1.2 ppm) would have 
adverse effects on human reproduction.\96\
    One human study compared county birth data with county fluoride 
levels greater than 3 ppm and attempted to show an association between 
high fluoride levels in drinking water and lower birth rates.\178\ 
However, because of serious limitations in design analysis, the 
investigation failed to demonstrate a positive correlation.\179\
    The National Research Council (NRC) of the National Academy of 
Sciences (NAS) supports the conclusion that drinking optimally 
fluoridated water is not a genetic hazard. In a statement summarizing 
its research, the NRC states, ``in vitro data indicate that:
    1. the genotoxicity of fluoride is limited primarily to doses much 
higher than those to which humans are exposed,
    2. even at high doses, genotoxiceffects are not always observed, 
and
    3. the preponderance of the genotoxic effects that have been 
reported are of the types that probably are of no or negligible genetic 
significance.\96\
    The lowest dose of fluoride reported to cause chromosomal changes 
in mammalian cells was approximately 170 times that found normally 
found in human cells in areas where drinking water is fluoridated, 
which indicates a very large margin of safety.\96\

    Question 27. Does drinking optimally fluoridated water cause an 
increase in the rate of children born with Down Syndrome?
    Answer. There is no generally accepted scientific knowledge 
establishing a relationship between Down Syndrome and the consumption 
of optimally fluoridated drinking water.
            Fact
    This question originally arose because of two studies published in 
1956 and 1963. Data collected in several Midwest states in 1956 formed 
the basis for two articles published in French journals, purporting to 
prove a relationship between fluoride in the water and Down 
Syndrome.\180\ \181\
    Experienced epidemiologists and dental researchers from the 
National Institute of Dental Research and staff members of the National 
Institute of Mental Health have found serious shortcomings in the 
statistical procedures and designs of these two studies. Among the most 
serious inadequacies is the fact that conclusions were based on the 
fluoridation status of the communities where the mothers gave birth, 
rather than the status of the rural areas where many of the women lived 
during their pregnancies.\140\ In addition, the number of Down Syndrome 
cases found in both fluoridated and nonfluoridated communities were 
much lower than the rates found in many other parts of the United 
States and the world, thus casting doubt on the validity of findings.
    The following paragraphs provide a summary of numerous studies that 
have been conducted which refute the conclusions of the 1956 studies.
    A British physician reviewed vital statistics and records from 
institutions and school health officers, and talked with public health 
nurses and others caring for children with Down Syndrome. The findings 
noted no indication of any relationship between Down Syndrome and the 
level of fluoride in water consumed by the mothers.\182\
    These findings were confirmed by a detailed study of approximately 
2,500 Down Syndrome births in Massachusetts. A rate of 1.5 cases per 
1,000 births was found in both fluoridated and nonfluoridated 
communities, providing strong evidence that fluoridation does not 
increase the risk of Down Syndrome.\183\
    Another large population-based study with data relating to nearly 
1.4 million births showed no association between water fluoridation and 
the incidence of congenital malformations including Down Syndrome.\184\
    In 1980, a 25-year review of the prevalence of congenital 
malformations was conducted in Birmingham, England. Although Birmingham 
initiated fluoridation in 1964, no changes in the prevalence of 
children born with Down Syndrome occurred since that time.\185\
    A comprehensive study of Down Syndrome births was conducted in 44 
U.S. cities over a 2-year period. Rates of Down Syndrome were 
comparable in both fluoridated and nonfluoridated cities.\186\

    Question 28. Does ingestion of optimally fluoridated water have any 
neurological impact?
    Answer. There is no generally accepted scientific knowledge 
establishing a causal relationship between consumption of optimally 
fluoridated water and central nervous system disorders, including 
effects on intelligence.
            Fact
    There have been claims that exposure to fluoride presents a 
neurotoxic (harmful or damaging to nerve tissue) risk or lowered 
intelligence. Such claims are based on a 1995 study in which rats were 
fed fluoride at levels up to 125 times greater than that found in 
optimally fluoridated water.\187\ The study attempted to demonstrate 
that rats fed extremely high levels of fluoride (75 ppm to 125 ppm in 
drinking water) showed behavior-specific changes related to cognitive 
deficits.
    In addition, the experiment also studied the offspring of rats who 
were injected two to three times a day with fluoride during their 
pregnancies in an effort to show that prenatal exposure resulted in 
hyperactivity in male offspring.
    However, two scientists who reviewed the 1995 study\188\ have 
suggested that the observations made can be readily explained by 
mechanisms that do not involve neurotoxicity. The scientists found 
inadequacies in experimental design that may have led to invalid 
conclusions. For example, the results of the experiment were not 
confirmed by the use of control groups which are an essential feature 
of test validation and experimental design. In summary the scientists 
stated, ``We do not believe the study by Mullenix et al. can be 
interpreted in any way as indicating the potential for NaF (sodium 
fluoride) to be a neurotoxicant.'' Another reviewer\104\ noted, ``. . . 
it seems more likely that the unusually high brain fluoride 
concentrations reported in Mullenix et al. were the result of some 
analytical error.''
    A 7-year study compared the health and behavior of children from 
birth through 6 years of age in communities with optimally fluoridated 
water with those of children the same age without exposure to optimally 
fluoridated water. Medical records were reviewed yearly during the 
study. At age six and seven, child behavior was measured using both 
maternal and teacher ratings. The results suggested that there was no 
evidence to indicate that exposure to optimally fluoridated water had 
any detectable adverse effect on children's health or behavior. These 
results did not differ even when data was controlled for family social 
background.\189\

    Question 29. Does drinking optimally fluoridated water cause 
Alzheimer's disease?
    Answer. Generally accepted science has not demonstrated an 
association between drinking optimally fluoridated water and 
Alzheimer's disease.
            Fact
    The exact cause of Alzheimer's disease (AD) has yet to be 
identified. Scientists have identified the major risk factors for AD as 
age and family history. Other possible risk factors include a serious 
head injury and lower levels of education. Scientists are also studying 
additional factors to see if they may be associated with the disease. 
These include genetic (inherited) factors, viruses and environmental 
factors such as aluminum, zinc and other metals. Researchers have found 
these metals in the brain tissue of people with AD, but it is not known 
if these metals cause AD or buildup in the brain as a result of the 
disease.\190\
    Because aluminum has been found in the brain tissue of people with 
AD, claims have been made that fluoridated water ``leaches'' out the 
aluminum in cookware when used for boiling water, thereby implicating 
fluoride as a co-factor in the development of AD. One experiment 
attempted to test this claim by measuring the release of aluminum from 
aluminum cookware under the most adverse conditions, with and without 
the presence of fluoride. Throughout these trials, scientists were 
unable to leach out significant amounts of aluminum from any of the 
cookware, including those that were exposed to extreme acidic or 
alkaline conditions.\191\
    A study published in 1998\192\ raised concerns about the potential 
relationship between fluoride and Alzheimer's disease. However, several 
flaws in the experimental design preclude any definitive conclusions 
from being drawn.\193\
    Interestingly, there is evidence that aluminum and fluoride are 
mutually antagonistic in competing for absorption in the human 
body.\17\ \194\ While a conclusion cannot be made that consumption of 
fluoridated water has a preventive effect on AD, there is no generally 
accepted scientific knowledge to show consumption of optimally 
fluoridated water is a risk factor for AD.

    Question 30. Does drinking optimally fluoridated water cause or 
contribute to heart disease?
    Answer. Broad national experience and generally accepted scientific 
knowledge demonstrate that drinking optimally fluoridated water is not 
a risk factor for cardiovascular disease.
            Fact
    This conclusion is supported by results of a study conducted by the 
National Heart and Lung Institute of the National Institutes of Health. 
Researchers examined a wide range of data from communities that have 
optimally fluoridated water and from areas with insufficient fluoride. 
The final report concluded that:
    Thus, the evidence from comparison of the health of fluoridating 
and nonfluoridating cities, from medical and pathological examination 
of persons exposed to a lifetime of naturally occurring fluorides or 
persons with high industrial exposures, and from broad national 
experience with fluoridation all consistently indicate no adverse 
effect on cardiovascular health.\195\
    The American Heart Association has reaffirmed its historical 
position that heart disease is not related to the amount of fluoride 
present in drinking water.\196\ The American Heart Association 
identifies cigarette and tobacco smoke, high blood cholesterol levels, 
high blood pressure, physical inactivity and obesity as major risk 
factors for cardiovascular disease.\197\
    A number of studies have considered trends in urban mortality in 
relation to fluoridation status. In one study, the mortality trends 
from 1950-70 were studied for 473 cities in the United States with 
populations of 25,000 or more. Findings showed no relationship between 
fluoridation and heart disease death rates over the 20-year 
period.\145\ In another study, the mortality rates for approximately 30 
million people in 24 fluoridated cities were compared with those of 22 
nonfluoridated cities for 2 years. No evidence was found of any harmful 
health effects, including heart disease, attributable to fluoridation. 
As in other studies, crude differences in the mortality experience of 
the cities with fluoridated and nonfluoridated water supplies were 
explainable by differences in age, gender and race composition.\144\

    Question 31. Is the consumption of optimally fluoridated water 
harmful to kidneys?
    Answer. Generally accepted scientific knowledge suggests that the 
consumption of optimally fluoridated water does not cause or worsen 
human kidney disease.
            Fact
    Approximately 50 percent of the fluoride ingested daily is removed 
from the body by the kidneys.\104\ \114\ \115\ Because the kidneys are 
constantly exposed to various fluoride concentrations, any health 
effects caused by fluoride would likely manifest themselves in kidney 
cells. However, several large community-based studies of people with 
long-term exposure to drinking water with fluoride concentrations up to 
8 ppm have failed to show an increase in kidney disease.\95\ \198\ 
\199\
    In a report issued in 1993 by the National Research Council, the 
Subcommittee on Health Effects of Ingested Fluoride stated that the 
threshold dose of fluoride in drinking water which causes kidney 
effects in animals is approximately 50 ppm-more than 12 times the 
maximum level allowed in drinking water by the Environmental Protection 
Agency. Therefore, they concluded that ``ingestion of fluoride at 
currently recommended concentrations is not likely to produce kidney 
toxicity in humans.''\96\
    Many people with kidney failure depend on hemodialysis (treatment 
with an artificial kidney machine) for their existence. During 
hemodialysis, the patient's blood is exposed to large amounts of water 
each week (280-560 quarts). Therefore, procedures have been designed to 
ensure that the water utilized in the process contain a minimum of 
dissolved substances that could diffuse indiscriminately into the 
patient's bloodstream.\200\
    Since the composition of water varies in different geographic 
locations in the United States, the U.S. Public Health Service 
recommends dialysis units use techniques such as reverse osmosis and 
deionization to remove excess iron, magnesium, aluminum, calcium, and 
other minerals, as well as fluoride, from tap water before the water is 
used for dialysis.\200\ \201\

    Question 32. Will the addition of fluoride affect the quality of 
drinking water?
    Answer. There is no scientific evidence that optimal levels of 
fluoride affect the quality of water. All ground and surface water in 
the United States contains some naturally occurring flouride.
            Fact
    Nearly all water supplies must undergo various water treatment 
processes to be safe and suitable for human consumption. The substances 
used for this purpose include aluminum sulfate, ferric chloride, ferric 
sulfate, activated carbon, lime, soda ash and, of course, chlorine. 
Fluoride is added only to water that has naturally occurring lower than 
optimal levels of this mineral.\27\
    Fluoridation is the adjustment of the fluoride concentration of 
fluoride-deficient water supplies to the recommended range of 0.7 to 
1.2 parts per million of fluoride for optimal dental health. The EPA 
has stated that fluoride in children's drinking water at levels of 
approximately 1.0 ppm reduces the number of dental cavities.\202\ The 
optimal level is dependent on the annual average of the maximum daily 
air temperature in the geographic area.\27\
    Under the Safe Drinking Water Act, the EPA has established drinking 
water standards for a number of substances, including fluoride, in 
order to protect the public's health. There are several areas in the 
United States where the ground water contains higher than optimal 
levels of naturally occurring fluoride. Therefore, Federal regulations 
were established to require that naturally occurring fluoride levels in 
a community water supply not exceed a concentration of 4.0 mg/L.\202\ 
Under the Safe Drinking Water Act, this upper limit is the Maximum 
Contaminant Level (MCL) for fluoride. Under the MCL standard, if the 
naturally occurring level of fluoride in a public water supply exceeds 
the MCL (4.0 mg/L for fluoride), the water supplier is required to 
lower the level of fluoride below the MCL. This process is called 
defluoridation.
    The EPA has also set a Secondary Maximum Contaminant Level (SMCL) 
of 2.0 mg/L, and requires consumer notification by the water supplier 
if the fluoride level exceeds 2.0 mg/L. The SMCL is intended to alert 
families that regular consumption of water with natural levels of 
fluoride greater than 2.0 mg/L by young children may cause dental 
fluorosis in the developing permanent teeth, a cosmetic condition with 
no known health effect.\202\ The notice to be used by water systems 
that exceed the SMCL must contain the following points:
    1. The notice is intended to alert families that children under 9 
years of age who are exposed to levels of fluoride greater than 2.0 mg/
liter may develop dental fluorosis.
    2. Adults are not affected because dental fluorosis occurs only 
when developing teeth are exposed to elevated fluoride levels.
    3. The water supplier can be contacted for information on 
alternative water source or treatments that will insure the drinking 
water would meet all standards (including the SMCL).
    The 1993 National Research Council report, ``Health Effects of 
Ingested Fluoride,'' reviewed fluoride toxicity and exposure data for 
the EPA and concluded that the current standard for fluoride at 4.0 mg/
L (set in 1986) was appropriate as an interim standard to protect the 
public healthy In the EPA's judgment, the combined weight of human and 
animal data support the current fluoride drinking water standard and, 
in December 1993, the EPA published a notice in the Federal Register 
stating the ceiling of 4 mg/L would protect against adverse health 
effects with an adequate margin of safety and published a notice of 
intent not to revise the fluoride drinking water standards in the 
Federal Register.\97\
    The EPA further commented on the safety of fluoride in the December 
5, 1997, Federal Register.\156\ In a notice of a final rule relating to 
fluoride compounds the EPA stated, ``There exists no directly 
applicable scientific documentation of adverse medical effects at 
levels of fluoride below 8 mg/L (0.23 mg/kg/day).'' The EPA's Maximum 
Concentration Limit (MCL) of 4.0 mg/L (0.114 mg/kg/day) is one half 
that amount, providing an adequate margin of safety.
    The EPA indirectly regulates the intentional fluoridation of 
drinking water by having an enforceable Federal standard for fluoride 
at 4.0 mg/L. As long as the 4.0 mg/L standard is not exceeded, State or 
local authorities determine whether or not to fluoridate.\237\
    (Additional discussion on this topic may be found in Question 2.)

    Question 33. Does fluoridation present difficult engineering 
problems?
    Answer. No. Properly maintained and monitored water fluoridation 
systems do not present difficult engineering problems.
            Fact
    With proper planning and maintenance of the system, fluoride 
adjustment is compatible with other water treatment processes. Today's 
equipment allows water treatment personnel to easily monitor and 
maintain the desired fluoride concentration. Automatic monitoring 
technology is available that can help to assure that the fluoride 
concentration of the water remains within the recommended range. 
Depending on the climate, the range for optimally fluoridated water is 
0.7-1.2 ppm for an individual water plant.\27\
    There are only three basic compounds used to fluoridate community 
drinking water: 1) sodium fluoride, a white, odorless crystalline 
material; 2) sodium fluorosilicate, a white or yellow-white, odorless 
crystalline powder; and 3) fluorosilicic acid, a white to straw-colored 
liquid. The three fluoride compounds are derived from the mineral 
apatite which is a mixture of calcium compounds. Apatite contains 3 
percent to 7 percent fluoride and is the main source of fluorides used 
in water fluoridation at the present time. Apatite is also the raw 
material used for production of phosphate fertilizers;\27\ \203\ 
however, standards and minimum requirements have been established for 
all three compounds used in water fluoridation.\204\
    From time to time, opponents of water fluoridation allege that the 
three compounds used in water fluoridation are impure or contain 
impurities at a level that may be potentially harmful. To help ensure 
the public's safety, compounds used for water fluoridation conform to 
standards established by the American Water Works Association.\204\ The 
American Water Works Association (AWWA) is an international nonprofit 
scientific and educational society dedicated to the improvement of 
drinking water quality and supply. Regarding impurities, the AWWA 
Standards state, ``The [fluoride compound] supplied under this standard 
shall contain no soluble materials or organic substances in quantities 
capable of producing deleterious or injurious effects on the health of 
those consuming water that has been properly treated with the [fluoride 
compound].'' Certified analyses of the compounds must be furnished by 
the manufacturer or supplier.\204\
    When added to community water supplies fluoride compounds become 
diluted to the recommended range of 0.7 to 1.2 parts per million. At 1 
ppm, one part of fluoride is diluted in a million parts of water. Large 
numbers such as a million can be difficult to visualize. While not 
exact, the following comparisons can be of assistance in comprehending 
one part per million:
      1 inch in 16 miles
      1 minute in 2 years
      1 cent in $10,000
    (Additional discussion on this topic may be found in Question 21.)
    Fluoride compounds are added to the water supply as liquids, but 
are measured by two basic types of devices, dry feeders or solution 
feeders (metering pumps). By design, and with proper maintenance and 
testing, water systems limit the amount of fluoride that can be added 
to the system (i.e., the use of a day tank that only holds 1 day's 
supply of fluoride) so prolonged over-fluoridation becomes a mechanical 
impossibility.\27\ It is very important that the water treatment 
operators responsible for monitoring the addition of fluoride to the 
water supply be appropriately trained, and that the equipment used for 
this process is adequately maintained.\203\ As with any mechanical 
equipment, water fluoridation equipment should be tested, maintained 
and replaced as needed. State health departments can procure Federal 
grant moneys for these purposes.
    While the optimal fluoride concentration found in drinking water 
has been proven safe, water plant operators and engineers may be 
exposed to much higher fluoride levels when handling fluoride compounds 
at the water treatment facility.\27\ In order to prevent overexposure 
to fluoride compounds by water plant operators, and ensure that 
fluoridated water systems provide optimal fluoride levels, the Centers 
for Disease Control and Prevention and the Occupational Safety and 
Health Administration provide guidelines/ recommendations for managers 
of fluoridated public water systems.\203\ \204\ Adherence to these 
guidelines should assure continuous levels of optimally fluoridated 
drinking water while maintaining safe operation of all fluoridated 
water systems.
    Allegations that fluoridation causes corrosion of water delivery 
systems are not supportable.\27\ Corrosion by drinking water is related 
primarily to dissolved oxygen concentration, pH, water temperature, 
alkalinity, hardness, salt concentration, hydrogen sulfide content and 
the presence of certain bacteria. Under some water quality conditions, 
a small increase in the corrosivity of drinking water that is already 
corrosive may be observed after treatment with alum, chlorine, 
fluorosilicic acid or sodium florosilicate. In such cases, further 
water treatment is indicated to adjust the pH upward. This is part of 
routine water plant operations.
                             Public Policy

    Question 34. Is water fluoridation a valuable public health 
measure?
    Answer. Yes. Fluoridation is a public health program that benefits 
people of all ages, is safe and is cost effective because it saves 
money.
            Fact
    A former Surgeon General of the United States, Dr. Luther Terry, 
called fluoridation as vital a public health measure as immunization 
again disease, pasteurization of milk and purification of water.\205\ 
Another former U.S. Surgeon General, Dr. C. Everett Koop, has stated, 
``Fluoridation is the single most important commitment that a community 
can make to the oral health of its citizens.'' In 1998, the U.S. Public 
Health Service revised national health objectives to be achieved by the 
year 2010. Included under oral health was an objective to significantly 
expand the fluoridation of public water supplies.\8\ Water fluoridation 
has been lauded as one the most economical preventive values in the 
nation,\9\ and today still has the greatest dental public health 
impact.\36\

    Question 35. Has the legality of water fluoridation been upheld by 
the courts?
    Answer. Yes. Fluoridation has been thoroughly tested in the United 
States' court system, and found to be a proper means of furthering 
public health and welfare. No court of last resort has ever determined 
fluoridation to be unlawful. Moreover, fluoridation has been clearly 
held not to be an unconstitutional invasion of religious freedom or 
other individual rights guaranteed by the First, Fifth or Fourteenth 
Amendments to the U.S. Constitution.
            Fact
    During the last 50 years, the legality of fluoridation in the 
United States has been thoroughly tested in our court systems. 
Fluoridation is viewed by the courts as a proper means of furthering 
public health and welfare.\206\ No court of last resort has ever 
rendered an opinion against fluoridation. The highest courts of more 
than a dozen states have confirmed the constitutionality of 
fluoridation.\207\ In 1984, the Illinois Supreme Court upheld the 
constitutionality of the state's mandatory fluoridation law, 
culminating 16 years of court action at a variety of judicial 
levels.\203\ Moreover, the U.S. Supreme Court has denied review of 
fluoridation cases 13 times, citing that no substantial Federal or 
constitutional questions were involved.\207\
    It has been the position of the American courts that a significant 
government interest in health and welfare of the public generally 
overrides individual objections to public health regulation.\207\ 
Consequently, the courts have rejected the contention that fluoridation 
ordinances are a deprivation of religious or individual freedoms 
guaranteed under the Constitution.\207\ \209\ In reviewing the legal 
aspects of fluoridation, the courts have dealt with this concern by 
ruling that: (1) fluoride is a nutrient, not a medication, and is 
present naturally in the environment; (2) no one is forced to drink 
fluoridated water as alternative sources are available; and (3) in 
cases where a person believes that fluoridation interferes with 
religious beliefs, there is a difference between the freedom to 
believe, which is absolute, and the freedom to practice beliefs, which 
may be restricted in the public's interest.\210\ \211\
    Fluoridation is the adjustment of a naturally occurring element 
found in water in order to prevent dental decay. Courts have 
consistently ruled that water fluoridation is not a form of compulsory 
mass medication or socialized medicine.\207\ \210\ \212\ A medication 
implies a substance used to treat disease. Fluoridation simply provides 
an individual with an increased level of protection against developing 
dental disease. Water that has been fortified with fluoride is similar 
to fortifying salt with iodine, milk with vitamin D and orange juice 
with vitamin C.

    Question 36. Why does opposition to community water fluoridation 
continue?
    Answer. Fluoridation is considered beneficial by the overwhelming 
majority of the health and scientific communities as well as the 
general public. However, a vocal minority continues to speak out 
against fluoridation of municipal water supplies. Some individuals may 
view fluoridation of public water as limiting their freedom of choice; 
other opposition can stem from misinterpretations or inappropriate 
extrapolations of the science behind the fluoridation issue.
            Fact
    A vast body of scientific literature endorses water fluoridation as 
a safe means of reducing the incidence of tooth decay. Support for 
fluoridation among scientists and health professionals, including 
physicians and dentists, is nearly universal. Recognition of the 
benefits of fluoridation by the American Dental Association, the 
American Medical Association, governmental agencies and other national 
health and civic organizations (see inside of back cover) continues as 
a result of published, peer-reviewed research.
    The majority of Americans also approves of water fluoridation. In 
June 1998, the Gallup Organization conducted a national survey of just 
over 1,000 adults on their attitudes toward community water 
fluoridation. When asked, ``Do you believe community water should be 
fluoridated?'', 70 percent answered yes, 18 percent answered no and 12 
percent responded don't know. Results characterized by U.S. Census 
Region showed the level of support for community water fluoridation to 
be relatively constant throughout the United States, with 73 percent in 
the Northeast, 72 percent in the Midwest, 68 percent in the South and 
70 percent in the West favoring community water fluoridation.\2\ These 
results are consistent with a December 1991 Gallup survey that asked 
1,200 parents, ``Whether or not you presently have fluoridated water, 
do you approve or disapprove of fluoridating drinking water?'' More 
than three-quarters (78 percent) of the responding parents approved, 10 
percent disapproved and 12 percent answered don't know or refused to 
answer the question. Disapproval ranged from 4 percent in communities 
where water was fluoridated to 16 percent in communities where it was 
not.\213\ \214\
    Opposition to fluoridation has existed since the initiation of the 
first community programs in 1945. An article that appeared in the local 
newspaper shortly after the first fluoridation program was implemented 
in Grand Rapids, Michigan, noted that the fluoridation program was 
slated to commence January 1 but did not actually begin until January 
15. Interestingly, health officials in Grand Rapids began receiving 
complaints of physical ailments attributed to fluoridation from 
citizens weeks before fluoride was actually added to the water.\7\
    Of the small faction that opposes water fluoridation for 
philosophical reasons, freedom of choice probably stands out as the 
most important single issue.\213\ Some individuals are opposed to 
community action on any health issue, others because of environmental 
or economic arguments and some because they are misinformed. Some 
opponents may knowingly or unknowingly use half-truths and innuendoes 
to support their opinions, either misquoting or applying statements out 
of context. The sometimes alarming statements used by some 
antifluoridationists, however, are not substantiated by general 
accepted scientific knowledge.\213\ \215\ \216\
    ``Junk science,'' a term coined by the press and used over the past 
decade to characterize data derived from atypical or questionable 
scientific techniques, also can play a role in provoking opposition to 
water fluoridation. In fact, decisionmakers have been persuaded to 
postpone action on several cost-effective public health measures after 
hypothetical risks have made their way into the public media.\217\ Junk 
science impacts public policy and costs society in immeasurable ways. 
More people, especially those involved in policy decisions, need to be 
able to distinguish junk science from legitimate scientific research. 
Reputable science is based on the scientific method of testing 
hypotheses in ways that can be reproduced and verified by others; junk 
science, which often provides too-simple answers to complex questions, 
often cannot be substantiated.
    In 1993 the U.S. Supreme Court issued a landmark decision that many 
view as likely to restrict the use of junk science in the courts. The 
Court determined that while ``general acceptance'' is not needed for 
scientific evidence to be admissible, Federal trial judges have the 
task of ensuring that an expert's testimony rests on a reasonable 
foundation and is relevant to the issue in question.
    According to the Supreme Court, many considerations will bear on 
whether the expert's underlying reasoning or methodology is 
scientifically valid and applicable in a given case. The Court set out 
four criteria judges could use when evaluating scientific testimony: 
(1) whether the expert's theory or technique can be (and has been) 
tested, using the scientific method, (2) whether it has been subject to 
peer review and publication (although failing this criteria alone is 
not necessarily grounds for disallowing the testimony), (3) its known 
or potential error rate and the existence and maintenance of standards 
in controlling its operation, and (4) whether it has attracted 
widespread acceptance within a relevant scientific community, since a 
known technique that has been able to attract only minimal support may 
properly be viewed with skepticism. The scientific validity and 
relevance of claims made by opponents of fluoridation might be best 
viewed when measured against these criteria.\218\
    Opinions are seldom unanimous on any scientific subject. In fact, 
there may be no such thing as ``final knowledge,'' since new 
information is continuously emerging and being disseminated. As such, 
the benefit evidence must be continually weighed against risk evidence. 
Health professionals, decisionmakers and the public should be 
cooperating partners in the quest for that accountability.\219\
    (Additional discussion on this topic may be found in the 
Introduction--Scientific Information on Fluoridation.)

    Question 37. Where can reliable information about water 
fluoridation be found on the Internet and World Wide Web?
    Answer. The American Dental Association, as well as other reputable 
health and science organizations, and government agencies have sites on 
the Internet/Web that provide information on fluorides and 
fluoridation. These sites provide information that is consistent with 
generally accepted scientific knowledge.
            Fact
    The Internet and World Wide Web are evolving as accessible sources 
of information. However, not all ``science'' posted on the Internet and 
Web is based on scientific fact. Searching the Internet for 
``fluoride'' or ``water fluoridation'' directs individuals to a number 
of Web sites. Some of the content found in the sites is scientifically 
sound. Other less scientific sites may look highly technical, but 
contain information based on science that is unconfirmed or has not 
gained widespread acceptance. Commercial interests, such as the sale of 
water filters, may also be promoted.
    One of the most widely respected sources for information regarding 
fluoridation and fluorides is the American Dental Association's (ADA) 
home page at . From the ADA Web site individuals 
can make contact with other Web sites for more information about 
fluoride.

    Question 38. Why does community water fluoridation sometimes lose 
when it is put to a public vote?
    Answer. Voter apathy, blurring of scientific issues, lack of 
leadership by elected officials and a lack of political campaign skills 
among health professionals are some of the reasons fluoridation votes 
are sometimes unsuccessful.
            Fact
    Despite the continuing growth of fluoridation in this country 
during the past decades, millions of Americans do not yet receive the 
protective benefits of fluoride in their drinking water. At the present 
time, only 62.2 percent of the population served by public water 
systems have access to fluoridated watery In 1992, approximately 70 
percent of all U.S. cities with populations of more than 100,000 
fluoridated their water, including 42 of the 50 largest cities.\220\ In 
1998, the U.S. Public Health Service revised national health objectives 
to be achieved by the year 2010. Oral Health Objective 10 deals 
specifically with community water fluoridation and states that at least 
85 percent of the population served by community water systems should 
be receiving the benefits of optimally fluoridated water by the year 
2010.\8\ At the time the objectives were revised, less than half of the 
states met the 85 percent goal.
    The adoption of fluoridation by communities has slowed during the 
past several decades. Social scientists have conducted numerous studies 
to determine why this phenomenon has occurred. Among the factors noted 
are lack of funding, public and professional apathy, the failure of 
many legislators and community leaders to take a stand because of 
perceived controversy, low voter turnout and the difficulty faced by an 
electorate in evaluating scientific information in the midst of 
emotional charges by opponents. Unfortunately, citizens may mistakenly 
believe their water contains optimal levels of fluoride when, in fact, 
it does not.
    Clever use of emotionally charged ``scare'' propaganda by fluoride 
opponents creates fear, confusion and doubt within a community when 
voters consider the use of fluoridation.\221\ \222\ Defeats of 
referenda or the discontinuance of fluoridation have occurred most 
often when a small, vocal and well organized group has used a barrage 
of fear-inspiring allegations designed to confuse the electorate. In 
addition to attempts to influence voters, opponents have also 
threatened community leaders with personal litigation.\215\ While no 
court of last resort has ever ruled against fluoridation, community 
leaders may be swayed by the threat of litigation due to the cost and 
time involved in defending even a groundless suit. In no instance has 
fluoridation been discontinued because it was proven harmful in any way 
as \215\ \216\ \223\
    Adoption of fluoridation is ultimately a decision of state or local 
decisionmakers, whether determined by elected officials, health 
officers or the voting public. Fluoridation can be enacted through 
state legislation, administrative regulation or a public referendum. 
Fluoridation is not legislated at the Federal level and is perceived in 
most states as a local issue. From 1989-94, 318 communities authorized 
fluoridation by administrative governmental action. In the same hme 
period, 32 referenda were held with fluoridation authorization approved 
in 19 and defeated in 13.\224\ As noted above, referenda can be 
unsuccessful for a variety of reasons. Nonetheless, a community's 
decision to protect the oral health and welfare of its citizens must, 
in some cases, override individual objections to implement appropriate 
public health measures.

    Question 39. Is community water fluoridation accepted by other 
countries?
    Answer. Yes. Water fluoridation is practiced in approximately 60 
countries benefiting over 360,000,000 (three hundred 60 million) 
people.!
            Fact
    The value of water fluoridation is recognized internationally. 
Countries and geographic regions with extensive fluoridation include 
the U.S., Australia, Brazil, Canada, Hong Kong, Malaysia, United 
Kingdom, Singapore, Chile, New Zealand, Israel, Columbia, Costa Rica 
and Ireland.\79\ The most recent county-wide decision for fluoridated 
drinking water occurred in South Africa.\225\ Following the 
recommendations of the World Health Organization (WHO), the initial 
phase of the project is expected to reach 40 percent of the country's 
population. By the year 2000, the goal is to reach 60 percent of the 
population which is widely spread in rural areas. Some of the most 
thorough investigations of fluoridation have been conducted in Britain 
and Australia. These investigations have resulted in a significant 
amount of published documentation which supports the safety and 
effectiveness of water fluoridation.\92\ \94\ \226\ Considering the 
extent to which fluoridation has already been implemented throughout 
the world, the lack of documentation of adverse health effects is 
remarkable testimony to its safety.\54\ \92\ \93\ \94\ \95\ \96\
    The World Health Organization (WHO) and the Pan American Health 
Organization have endorsed the practice of water fluoridation since 
1964. In 1994, an expert committee of WHO published a report which 
reaffirmed its support of fluoridation as being safe and effective in 
the prevention of tooth decay, and stated that ``provided a community 
has a piped water supply, water fluoridation is the most effective 
method of reaching the whole population, so that all social classes 
benefit without the need for active participation on the part of 
individuals.''\82\ In many parts of the world, fluoridation is not 
feasible or a high priority, usually due to the lack of a central water 
supply, the existence of more life threatening health needs and the 
lack of sufficient funds for startup and maintenance costs.
    Political actions contrary to the recommendations of health 
authorities should not be interpreted as a negative response to water 
fluoridation. For example, although fluoridation is not carried out in 
Sweden and the Netherlands, both countries support WHO's 
recommendations regarding fluoridation as a preventive health measure, 
in addition to the use of fluoride toothpastes, mouthrinses and dietary 
fluoride supplements.\82\ \227\

    Question 40. Is community water fluoridation banned in Europe?
    Answer. No country in Europe has banned community water 
fluoridation.
            Fact
    The claim that fluoridation is banned in Europe is frequently used 
by fluoridation opponents. In truth, European countries construct their 
own water quality regulations within the framework of the 1980 European 
Water Quality Directive. The Directive provides maximum admissible 
concentrations for many substances, one of which is fluoride. The 
Directive does not require or prohibit fluoridation, it merely requires 
that the fluoride concentration in water does not exceed the maximum 
permissible concentration.
    Many fluoridation systems that used to operate in Eastern and 
Central Europe did not function properly and, when the Iron Curtain 
fell in 1989-90, shut down because of obsolete technical equipment and 
lack of knowledge as to the benefits of fluoridated water.\229\ Water 
fluoridation is not practical in many European countries because of 
complex water systems with numerous water sources. As an alternative to 
water fluoridation, many European countries have opted for salt 
fluoridation, in addition to the use of fluoride toothpaste for topical 
benefits, as a means of bringing the protective benefits of fluoride to 
the public.
    (Additional discussion on this topic may be found in Question 10.)
    Again, no European country has specifically imposed a ``ban'' on 
fluoridation, it has simply not been implemented for a variety of 
technical or political reasons.
                           Cost Effectiveness

    Question 41. Is water fluoridation a cost-effective means of 
preventing tooth decay?
    Answer. Yes. Data from generally accepted scientific studies 
continue to confirm that fluoridLation has substantial lifelong decay 
preventive effects and is a highly cost-effective means of preventing 
tooth decay in the United States, regardless of socioeconomic 
status.\58\ \61\ \62\ \230\ \231\ \232\
            Fact
    It has been calculated that the annual cost of community water 
fluoridation in the U.S. is approximately $0.50 per person.\233\ The 
annual cost ranges between $0.12 and $5.41 per person, depending mostly 
on the size of a community, labor costs, and type of fluoride compounds 
and equipment utilized.\27\ \62\ \231\ \232\ \234\ It can be calculated 
from these data that the lifetime cost per person to fluoridate a water 
system is less than the cost of one dental filling. With the escalating 
cost of health care, fluoridation remains a preventive measure that 
benefits members of the community at minimal cost.
    Historically, the cost to purchase fluoride compounds has remained 
fairly constant over the years in contrast to the continued rising cost 
of dental care.\27\ School-based dental disease prevention activities 
(such as fluoride mouthrinse or tablet programs), professionally 
applied topical fluorides and dental health education are beneficial 
but have not been found to be as cost-effective in preventing tooth 
decay as community water fluoridation.\230\ Fluoridation remains the 
most cost-effective and practical form of preventing decay in the 
United States and other countries with established municipal water 
systems.\9\ \58\ \62\ \230\ \234\
    Due to the decay-reducing effects of fluoride, the need for 
restorative dental care is typically lower in fluoridated communities. 
Therefore, an individual residing in a fluoridated community will 
generally have fewer restorative dental expenditures during a lifetime. 
Health economists at a 1989 workshop concluded that fluoridation costs 
approximately $3.35 per tooth surface when decay is prevented, making 
fluoridation ``one of the very few public health procedures that 
actually saves more money than it costs.''\234\ Considering the fact 
that the national average fee for a two surface amalgam (silver) 
restoration in a permanent tooth placed by a general dentist is 
$75.84*, fluoridation clearly demonstrates significant cost 
savings.\235\
    The economic importance of fluoridation is underscored by the fact 
that frequently the cost of treating dental disease is paid not only by 
the affected individual, but also by the general public through 
services provided by health departments, welfare clinics, health 
insurance premiums, the military and other publicly supported medical 
programs.\61\
    Indirect benefits from the prevention of dental decay may include:
      freedom from dental pain
      a more positive self image
      fewer missing teeth
      fewer cases of malocclusion aggravated by tooth loss
      fewer teeth requiring root canal treatment
      reduced need for dentures and bridges
      less time lost from school or work due to dental pain or 
visits to the dentist
    These intangible benefits are difficult to measure economically, 
but are extremely importantly \58\ \231\
    The survey data should not be interpreted as conshtuhng a fee 
schedule in any way, and should not be used for that purpose. Dentists 
must establish their own fees based on their individual practice and 
market considerations.

    Question 42. Is it practical to fluoridate an entire water system?
    Answer. It is more practical to fluoridate an entire water supply 
than to attempt to treat individual water sources.
            Fact
    It is technically difficult, perhaps impossible, and certainly more 
costly to fluoridate only the water used for drinking. Community water 
that is chlorinated, softened, or in other ways treated is also used 
for watering lawns, washing cars and for most industrial purposes. The 
cost of compounds for fluoridating a community's water supply is 
inexpensive on a per capita basis; therefore, it is practical to 
fluoridate the entire water supply. Fluoride is but one of more than 40 
different chemicals that may be used to treat water in the United 
States.\27\ The American Water Works Association, an international 
nonprofit scientific and educational society dedicated to the 
improvement of drinking water quality and supply, supports the practice 
of fluoridation of public water supplies.\236\
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                               __________
                    American League of Anglers and Boaters,
                                                     July 18, 2000.

The Honorable Michael Crapo, Chairman,
Subcommittee on Fisheries, Wildlife and Drinking Water,
Committee on Environment and Public Works,
U.S. Senate,
Washington, DC 20510

Dear Mr. Chairman: The American League of Anglers and Boaters (ALAB) 
was created in 1984 to continue the partnership between national 
conservation and recreation organizations which successfully campaigned 
for the enactment of amendments to the Sport Fish Restoration Act of 
1950, better known as the Wallop-Breaux Act. We ask that our views be 
considered as your subcommittee conducts oversight hearings on the Fish 
and Wildlife Service's administration of the Federal Aid Program.
    The Sport Fish Restoration Program and the Pittman-Robertson 
Wildlife Restoration Program (upon which the initial sport fish program 
was modeled) are two of the most significant and successful programs in 
the history of fish and wildlife management in our country. The 
majority of funds are apportioned to the states to deliver on-the-
ground programs for the conservation of fish and wildlife resources. 
They are vitally important to state fish and wildlife management 
programs and, together with revenues from the sale of state hunting and 
fishing licenses, form the single most important funding source for 
state fish and wildlife agencies.
    There is no doubt that the U.S. Fish and Wildlife Service (F&WS) 
can and should do a better and more effective job of administering 
these national programs. H.R. 3671, recently passed by the House, 
clearly redefines the responsibilities of the F&WS in this regard and 
increases their accountability to Congress and the states. This 
legislative approach is needed and has the support of ALAB and our 
member organizations.
    The members of ALAB have a primary interest in the Sport Fish 
Restoration Program. However, since the Sport Fish and the Wildlife 
Restoration Programs are implemented by a single state Agency and are 
administered by a single unit of the F&WS, both programs are closely 
interrelated. Legislative changes to one of the programs can have 
indirect impacts on the other. Our interest, therefore, is directed 
toward the administration of both programs as reflected in H.R. 3671.
    ALAB would like to share its concerns about four areas of H.R. 
3671:
    1. H.R. 3671 would provide $5 million annually for a Multi-State 
Conservation Grants Program ($2.5 million from each fund). At least 
four existing programs (National Survey of Fishing, Hunting, and 
Wildlife-Associated Recreation, Management Assistance Team, 
Administrative Grants Program, and Library Reference Service), at the 
recommendation and concurrence of the states, have been funded for 
several years and would fall under this proposed program. The $5 
million provided by H.R. 3671 is not sufficient to fund these four 
programs or to include other projects of multi-state or national 
benefit that might need to be carried out collectively at much less 
expense than if each state conducted them individually. It is ALAB's 
recommendation that 2 percent of each fund (approximately $4.5 million 
each) be available annually for the Multi-State Conservation Grants 
Program.
    2. The Sport Fishing and Boating Partnership Council (SEBPC) was 
created to provide a mechanism to give advice to the Secretary of the 
Interior on sport fish restoration and other fishing and boating 
issues. The SFBPC has been widely recognized for its collaborative 
efforts and has undertaken mayor assignments by the Congress such as 
that called for in TEA-21. Those that contribute to the sport fish 
restoration fund, including a number of members of ALAB, deem the SFBPC 
an invaluable tool for ensuring that those that pay the tax are heard 
when critical decisions are made within the F&WS. The activities of the 
SFBPC have been funded by Sport Fish Restoration administrative funds 
at approximately $400,000 per year. It is ALAB's recommendation that 
language be included in H.R. 3671 specifying that funding be set aside 
for the work of the SFBPC.
    3. Under existing law, the F&WS can currently utilize up to 6 
percent of Sport Fish Restoration and 8 percent of Wildlife Restoration 
Funds to administer the two programs. H.R. 3671 would reduce this to a 
straight dollar amount of $14,180,000 the first year, with gradual 
reductions over the next 2 years to $12.6 million. This is a 
significant reduction In administrative funding and we are concerned it 
would have a negative impact on these two very successful programs. 
ALAB recommends that 3 percent of Wallop-Breaux and 4 percent of 
Pittman-Robertson funds, or $16 million, be available annually to the 
F&WS for administration of the program and delivery of apportioned 
funds to the states.
    4. Over the years, several grant programs have been added to the 
Sport Fish Restoration Program. These include the Clean Vessel Act 
Pumpout Program ($10 million/year), the Boating Infrastructure Grant 
Program ($8 million/year), and the National Outreach and Communications 
Program ($5-10 million/ year). Although funds for these programs are 
withdrawn from the Sport Fish Restoration Account before the 
calculation of administrative funds is made, no specific provision is 
made in H.R. 3671 for funds to administer these small grant programs. 
The F&WS is now considering using Sport Fish Restoration administrative 
funds to administer these programs. This would further weaken the 
administration of the Sport Fish Restoration Program. It is ALAB's 
recommendation that language be included in H.R. 3671 specifying that 
administrative costs for each small grant program be made available 
from the fund specified for each program and not from Sport Fish 
Restoration administrative funds.
    Implementation of the provisions of H.R. 3671 would improve the 
administration of the Sport Fish and Wildlife Restoration Programs. The 
four recommendations that we have made will bring improvements to the 
bill that will significantly enhance and ensure the continued success 
of these vital programs. Your consideration of our recommendations is 
sincerely appreciated.
            Sincerely,
                                Derrick Crandall, Co-Chair.

                                  Veronica Floyd, Co-Chair.
                                 ______
                                 
                       alab member organizations
American Fisheries Society (AFS)
American Recreation Coalition (ARC)
American Sportfishing Association (ASA)
Atlantic States Marine Fisheries Commission (ASMFC)
Bass Anglers Sportsman Society (B.A.S.S., INC)
Boat Owners Association of the United States (BOAT/US)
Boating Trades Association of Texas (BTAT)
Brunswick Corporation
Congressional Sportsmen's Foundation (CSF)
International Association of Fish & Wildlife Agencies (IAFWA)
International Game Fish Association
International Jet Sports Boating Association
Izaak Walton League of America (IWLA)
Marina Operators Association of America (MOM)
Marine Retailers Association of America (MRM)
National Association of State Boating Law Administrators (NASBLA)
National Boating Federation (NBF)
National Marine Manufacturers Association
National Recreation and Park Association
National Safe Boating Council
Personal Watercraft Industry Association
Sail America States Organization for Boating Access (SOBA)
Trout Unlimited
U.S. Sailing Association
                               __________
Statement of the California Water Association on the Proposed National 
              Primary Drinking Water Regulation for Radon
    The California Water Association (CWA) appreciates the opportunity 
to provide written comment to the Senate Environment and Public Works 
Committee, Subcommittee on Fisheries, Wildlife, and Water on the 
National Primary Drinking Water Regulation for Radon at the Safe 
Drinking Water Act Oversight Hearing, June 29, 2000. CWA is a 
professional organization representing a consortium of investor-owned 
water utilities providing high-caliber water utility services to more 
than 6,000,000 customers throughout California. With more than 52 
active member companies, CWA provides a forum for sharing best 
practices; a means of promoting sound, reasonable and science-based 
policymaking by regulatory agencies and legislators; support to small 
water systems; and opportunities for educating the public on efficient 
water use and protection of water resources.
    California water utilities are very concerned about the way in 
which EPA has proposed the NPDWR for Radon. CWA's comments (see 
attachments A and B) to EPA identify many of the deficiencies in EPA's 
proposed regulation and indicates the potential impact on CWA member 
utilities.
    CWA conducted a survey of its member and affiliated utilities 
regarding radon which revealed the following:

      173 groundwater systems responded
          responses addressed 1,555 water wells
          these wells pumped to 1,319 entry points
      Only 600 of these wells had been sampled for radon (39 
percent)
      Of these, 399 wells exceed the proposed radon MCL of 300 
pCi/L (67 percent)
      70 of 75 water systems that have sampled for radon had at 
least one source exceed the proposed radon MCL of 300 pCi/L (93 
percent) Of those entry points exceeding 300 pCi/L, 295 (74 percent) 
will require additional land purchases to build radon treatment plants.
          The range of land cost was from $50,000 to $500,000 
with an average of $150,000.
      The range of radon analyses were non-detect (<100 pCi/L) 
to 44,475 pCi/L
          The arithmetic mean of radon = 743 pCi/L
          The geometric mean of radon = 373 pCi/L
          EPA radon proposal assumed a mean radon level in 
California ground water to be 150 pCI/L to 300 pCi/L.

    It should be noted that the Association of California Water 
Agencies conducted an identical survey of their publicly owned water 
utility members, obtaining virtually identical results, thus validating 
the CWA survey. CWA will let the attached comments and study speak for 
themselves. It is clear from these studies that EPA's cost estimates 
for the proposed radon regulation do not accurately reflect the 
potential impact on California utilities.
    CWA believes that Congress did not intend for water utilities to be 
performing Multi-media mitigation (MMM) programs. While the water 
industry in general feels they do an outstanding job delivering high 
quality and affordable drinking water, we are not qualified to do 
indoor air radon mitigation. CWA believes that the correct path to 
implementation of MMM is to enhance the existing state voluntary indoor 
air programs to effectively deal with an air radon problem. CWA also 
believes that this was the intent of Congress when they directed EPA, 
as part of the 1996 SDWA amendments, to address indoor air problems 
with MMM if the MCL could not be set at the level equivalent to ambient 
outdoor air.
    CWA continues to believe that EPA has inappropriately treated 
smokers as a sensitive sub-population in the radon regulation as 85 
percent of the benefits of the regulation go to them. Smoking is a 
personal preference and should not qualify someone for sensitive sub-
population status. EPA uses an argument that smokers are members of the 
general population and therefore are not being treated as sensitive 
sub-population. However, the typical sensitive sub-population class of 
infants, the elderly, immuno-compromised, etc. are also members of the 
general population. The difference is that they have not chosen their 
situation as smokers have. EPA's position on smokers as a sensitive 
sub-population is not persuasive or defensible. CWA believes the MCL 
for radon should be determined without the inclusion of smokers as a 
sensitive sub-population in the risk assessment. The MCL should also 
reflect the minimal contribution (1 to 2 percent) that water makes to 
indoor air levels.
    CWA encourages the Committee to review the attached comments and 
radon study to obtain a sense of real numbers and their potential 
impact on California water utilities.
                                 ______
                                 
                               attachment
                              California Water Association,
                                                  January 20, 2000.

Comment Clerk, Radon-222
Docket Number W-99-08
Water Docket (MC-4101)
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460

Dear Sir or Madam: The California Water Association (CWA) appreciates 
the opportunity to comment on 40CFR, Parts 141 and 142, National 
Primary Drinking Water Regulations; Radon-222; proposed rule, published 
in the Federal Register, Volume 64, No. 211, November 2, 1999. CWA is a 
professional organization representing a consortium of investor-owned 
water utilities providing high-caliber water utility services to more 
than six million customers throughout California. With more than 52 
active member companies, CWA provides a forum for sharing best 
practices; a means of promoting sound, reasonable and science-based 
policymaking by regulatory agencies and legislators; support to small 
water systems; and opportunities for educating the public on efficient 
water use and protection of water resources.
    CWA first became aware of certain issues pertaining to the cost of 
the proposed radon regulation when the Radon in Drinking Water Health 
Risk Reduction and Cost Analysis was first noticed in the February 26, 
1999 Federal Register, Volume 64, No. 38. Because of concern over many 
of the cost issues, CWA performed a survey of it's members and 
affiliated utilities to ascertain certain facts about California 
investor-owned water utilities and radon. The study is enclosed 
(Attachment A) and contains the following conclusions:
      173 groundwater systems responded includes 1,555 wells
          includes 1,319 entry points 600 wells have been 
sampled for radon (39 percent)
           399 wells exceed the proposed radon MCL of 300 pCi/L 
(67 percent)
      70 of 75 water systems that have sampled for radon had at 
least one source exceed the proposed radon MCL of 300 pCi/L (93 
percent)
      Of those entry points exceeding 300 pCi/L, 295 (74 
percent) will require additional land purchases to build radon 
treatment plants
          Range of land cost: $50,000--$500,000. Avg. land cost 
= $150,000
      The range of radon analyses were non-detect (<100 pCi/L) 
to 44,475 pCi/L
          Arithmetic mean of radon = 743 pCi/L
          Geometric mean of radon = 373 pCi/L
    Except for the number of responding systems, these numbers reflect 
only utilities that provide at least 20 percent of their water as 
groundwater.
    Of great concern to CWA was the display in Table 5-4 of the 
February 1999 HRRCA, indicating EPA's estimates on average number of 
sites (wells) per ground water system by system size. This clearly did 
not fit the typical California ground water system and led to the CWA 
survey. CWA was pleased to find that EPA had significantly modified 
this estimate in Table XIII.3 of the proposed regulation. A comparison 
is shown below.

                                                CWA Radon Survey
----------------------------------------------------------------------------------------------------------------
                                                                                                        Table
                                                               Feb. 1999    CWA Survey   CWA Survey   XIII.3 EPA
                  System Size (population)                     HRRCA No.      No. of       No. of      Rn Prop.
                                                                of wells      wells        Entry        No. of
                                                                                           Points       wells
----------------------------------------------------------------------------------------------------------------
25-100......................................................          1.1          1.4          1.4          1.5
101-500.....................................................          1.2            2          1.8            2
501-1,000...................................................          1.4          2.5          2.3          2.3
1,001-3,300.................................................          1.7          3.4            3          3.1
3,301-10,000................................................          2.3          5.4            5          4.6
10,001-50,000...............................................          3.9         12.8         11.2          9.8
50,001-100,000..............................................          8.7         25.1         23.5         16.1
>1 00,000...................................................          8.8         57.5         40.3         49.9
----------------------------------------------------------------------------------------------------------------

    Below, you will find calculations of the total number of wells 
impacted by this regulation based on the number of ground water systems 
per system size (Table XIII.2 in the proposed regulation) and the 
estimated number of wells indicated in the EPA HRRCA estimates (Table 
5-4) versus the proposed regulation estimates (Table XIII.3).

 
----------------------------------------------------------------------------------------------------------------
                                                  Rn. Prop.                               Rn Prop.
                                                  Reg. Table   Feb. 1999   Total wells   Reg. Table  Total wells
                  System Size                     XIII.2 No.   HRRCA No.     based on    XIII.3 No.  based on Rn
                                                   of CWSs      of wells      HRRCA       of wells     proposal
----------------------------------------------------------------------------------------------------------------
25-100.........................................       14,232          1.1       15,655         1 .5       21,348
101-500........................................       15,070          1.2       18,084            2       30,140
501-1,000......................................        4,739          1.4        6,635          2.3       10,900
1,001-3,300....................................        5,726          1.7        9,734          3.1       17,751
3,301-10,000...................................        2,489          2.3        5,725          4.6       11,449
10,001-50,000..................................        1,282          3.9        5,000          9.8       12,564
50,001-100,000.................................          139          8.7        1,209         16.1        2,238
>100,000.......................................           72          8.8          634         49.9        3,593
                                                                          -------------             ------------
    Totals.....................................                                 62,676                   109,983
----------------------------------------------------------------------------------------------------------------

    Section 7.6.1 of the Regulatory Impact Analysis and Revised Health 
Risk Reduction and Cost Analysis for Radon in Drinking Water (RIA & 
Revised HRRCA) indicates that ``The number of sources per system that 
were used in the analysis (for capital and O&M costs) are summarized in 
Table 5-2''. These are the same numbers in Table XIII.3 in the proposed 
regulation. The calculations above indicate a 75 percent increase in 
the number of wells impacted from the February 1999 HRRCA to the 
proposed regulation. The Docket
    support document titled ``Methods, Occurrence, and Monitoring 
Document For Radon in Drinking Water--Addendum: Statistical Analysis of 
Radon Monitoring Requirements'', dated August 6, 1999 prepared by ICE 
Consulting, provides a determination of the numbers of wells in the 
proposed regulation package. The number in this document is 70,464 
wells and is used to calculate monitoring costs for the regulation. 
Clearly this number does not accurately reflect Table XIII.3 of the 
proposed regulation (which calculates to 109,983 wells). It is clear 
that EPA calculated the $14.1 million monitoring costs based on 70,464 
wells. This is clearly an error. Likewise, there is clearly an error in 
the way EPA calculated capital and O&M costs for this regulation, 
failing to reflect the 75 percent increase in the number of wells from 
the February 1999 HRRCA to the proposed regulation. EPA states in 
Section 5.1.2 of the RIA & Revised HRRCA ``. . .that the total number 
of sources (wells) is an important determinant of potential radon 
mitigation costs. . . '' and ``. . . it has been assumed in the 
mitigation cost analysis that each source out of compliance with the 
MCL or AMCL would need to install control equipment.'' It should be 
noted that in the RIA & Revised HRRCA, EPA equates ``sources'' with 
``wells''. The proposed regulation represents a 4 percent increase in 
the cost of the regulation from $373 million per year to $408 million 
per year. This does not properly reflect the 75 percent increase in the 
number of wells impacted by this regulation. CWA requests that EPA 
properly calculate the cost of the radon regulation using the correct 
number of sources (wells).
    CWA believes that EPA has underestimated the cost of the proposed 
radon regulation in the following areas:
      Cost of treatment. While more wells may mean lower flows 
per well impacted per EPA's calculations, this still represents a 
significant increase in the number of treatment plants. See discussion 
above.
      Cost of monitoring. The increase from $11 million in the 
February 1999 HRRCA to $14 in the proposed regulation does not reflect 
the 75 percent increase in the number of wells. See discussion above.
      Land acquisition. EPA states in the proposed regulation 
that they are considering the cost of land acquisition for large water 
systems (only small systems were included in the February 1999 HRRCA). 
There is no supporting documentation in the proposed regulation stating 
what level of land acquisition EPA has included in the cost estimates. 
For California investor-owned utilities, 399 wells exceed the MCL, of 
which 74 percent require land at an average cost of $150,000. This 
equates to $44 million, in itself far exceeding the 4 percent ($33 
million) increase from the February 1999 HRRCA to the proposed 
regulation. Additionally, only 39 percent of wells were sampled. These 
costs will increase.
      Aeration treatment off-eas permitting. EPA has 
incorrectly made the assumption that permits will not be required for 
aeration treatment facilities. The attached letter (Attachment B) from 
the South Coast Air Quality Management District in response to an 
inquiry from the City of Riverside clearly indicates EPA's error on 
this matter. This letter also indicates the potential requirement for 
water utilities to perform their own dispersion modeling to provide 
evidence that a proposed aeration treatment plant would not ``. . .pose 
a significant health threat'' to the community.
      Aeration treatment off-eas treatment. EPA has incorrectly 
made the assumption that the California Of rice of Environmental Health 
Hazard Assessment (OEHHA) will not develop unit risk estimates from 
off-gassing at aeration treatment plants. Conversations with OEHHA 
staff indicate that they will have no choice but to develop such 
estimates when it becomes necessary to build such treatment plants. 
Written documentation of this opinion will be forwarded to EPA when 
obtained from OEHHA. Off-gas treatment will likely be required in 
California. EPA has not identified a BAT for off-gas treatment in this 
regulation. CWA requests that EPA do so prior to promulgation of this 
regulation.
      Chlorination costs. EPA's estimates for percentages of 
water systems disinfecting are based on the Community Water System 
Survey of 1995 as reported in the Docket support document titled 
``Geometries and Characteristics of Public Water Systems'', dated 
August 15, 1999 and prepared by Science Applications International 
Corporation (SAIC). Approximately 50 percent of polled utilities 
(1,980) responded to the survey. After quality assurance checks, data 
from less than 1,500 community water systems were used for data 
analysis. This is out of more than 57,000 COOS's in the country (less 
than 3 percent). After reviewing the survey, a comprehensive and 
technical 20 page document, it is easy to see why EPA has incorrectly 
calculated the percentage of water systems disinfecting. The very 
systems lacking the desire or where-with-all to perform disinfection 
are obviously the ones who are least likely to return this complicated 
and lengthy survey to EPA. Given this obvious built-in bias, EPA could 
not help but misrepresent the facts. State regulatory agencies and 
water utilities have strongly stated disagreement with EPA on this 
issue, and EPA's own support document provides evidence that this 
disagreement is valid. CWA requests EPA to properly calculate 
disinfection requirements for this regulation.
      Iron and Manganese treatment. EPA has acknowledged its 
error in the February 1999 HRRCA. Unfortunately, the RIA & Revised 
HRRCA discusses sequestering Fe & Mn with polyphosphates. The 
California Department of Health Services (CDHS) does not recognize 
sequestering as ``treatment'' for high Fe & Mn, but requires oxidation/
filtration.
      Mixed Systems. EPA states that the number of systems they 
have determined to be impacted by the proposed radon regulation does 
not include mixed systems, those that use both groundwater and surface 
water. CWA believes that this may be cause for a significant under-
counting of the number of impacted systems and sources. The CWA radon 
survey found that many of our member utilities affected by the radon 
regulation are mixed systems. The chart below summarizes this.

                            CWA Radon Survey
------------------------------------------------------------------------
                                      No. of       No. of       Nof of
     System Size (population)         Mixed       Systems       Mixed
                                     Systems     Responding    Systems
------------------------------------------------------------------------
1,001-3,300......................            6           30           20
3,301-10,000.....................            2           21           10
10,001-50,000....................           10           34           23
50,001-100,000...................            8           16           50
>100,000.........................            7            8           88
------------------------------------------------------------------------

    The water systems noted in the above chart all produce a minimum of 
20 percent groundwater. Others that produce less than 20 percent were 
left out. CWA requests that EPA determine the number of mixed systems 
and include them in the cost estimates for the radon regulation.
      Annual household consumption. EPA has calculated radon 
treatment plant design capacity and associated O&M costs with an 
assumption that an average household uses 83,000 gallons of water per 
year. This is approximately 50 percent of what we know of in California 
and from other national organizations. CWA provides three examples. 
Attachment C is a typical 34 page water conservation education handbook 
used in middle schools in California. Page 17 references that ``It is 
estimated that each person in the United States uses about 150 gallons 
of water a day''. Using a conservative assumption of 3 persons per 
household, that equates to 450 gallons per day per household, or 
158,400 gallons per year. This figure is approximately twice the 
assumption used by EPA. Attachment D is ``Water Quality Glossary'' from 
a document produced by the National Association of Water Companies. 
This document states that ``An acre-foot (325,861 gallons) supplies a 
family of 5 for 1 year''. This figure is approximately four times the 
EPA assumption. More recent publications by Metropolitan Water District 
of Southern California (Attachment E) indicate that ``one acre-foot of 
water represents the needs of two average families, in and around the 
home, for 1 year''. This also is approximately twice the EPA 
assumption. There are probably hundreds of other references that 
reflect the same inaccurate assumption by EPA. CWA believes that EPA 
has under-estimated the average household use of water by at least 100 
percent and requests that EPA appropriately adjust their calculations 
for treatment plant sizing and O&M costs in the proposed radon 
regulation.
    CWA believes that the bulleted items above have lead to a gross 
under-estimation of the costs of the proposed radon regulation. CWA 
believes that EPA must make numerous re-calculations to properly 
determine the true costs of this regulation to enable a true cost-
benefit analysis to be performed.
    Additionally, CWA believes EPA must address the following issues in 
the proposed radon regulation:
      Radon is naturally occurring and ubiquitous to the 
environment in which we live. This makes radon unique to any other 
contaminant that has been regulated by EPA. People are exposed to radon 
virtually every minute of their lives. EPA should propose an MCL for 
radon in drinking water that properly reflects its minimal (1-2 percent 
according to the National Academy of Sciences) contribution to overall 
radon exposure.
      EPA has proposed a dual standard for radon. Utilities can 
either comply with the MCL or they can develop themselves or utilize a 
state Multi-media Mitigation (MMM) Program and comply with an 
alternative MCL (AMCL). This is precedent setting and potentially 
problematic. The NAS has expressed many concerns over the effectiveness 
of several components of the MMM programs in their ``Risk Assessment of 
Radon in Drinking Water'' published in 1999. CWA believes that EPA 
needs to address the NAS concerns and alleviate doubt about the various 
components of MMM programs before they base a National Primary Drinking 
Water Regulation on them.
      CWA believes that EPA continues to treat smokers 
inappropriately as a sensitive sub-population in this regulation. EPA 
estimates that 84 percent of the benefits of this regulation goes to 
smokers. EPA correctly states that smokers are members of the general 
population. This is likewise true for traditional members of sensitive 
sub-populations like immuno-compromised, infants and the elderly. EPA's 
argument is not persuasive. CWA believes that EPA should discount the 
benefits to smokers in the radon regulation.
    CWA believes there are several serious problems with the proposed 
radon regulation that needs attention prior to promulgation. CWA 
respectfully requests that EPA consider the testimony provided in this 
comment letter and make the appropriate and necessary changes to make 
this regulation a responsible one that provides the best benefit to 
water utility customers.
    Should you have any questions or require additional information, 
please feel free to contact me.
            Very truly yours,
                                 Ted Jones, Jr., President,
                                      California Water Association.
                               __________
           Statement of Roger D. Masters and Myron J. Coplan
             implementation of the safe drinking water act
    The authors of this submission (Dartmouth College Professor 
Emeritus Roger D. Masters and veteran chemist/chemical engineer Myron 
J. Coplan, PE), have been collaborating since 1997 on ecological 
analyses and statistical association between community use of 
silicofluorides for water fluoridation and increased prevalence rates 
of children with elevated blood lead as well as behavioral dysfunctions 
including learning disabilities, ADD/ADHD, violent crime, and cocaine 
use at time of criminal arrest. Preliminary reports of these ecological 
studies was published in the International Journal of Environmental 
Studies and Social Science Information. Our information has also been 
presented at scientific meetings, with growing acceptance.
    Further studies are at an advanced stage of preparation. Using 
diverse datasets, (including comprehensive state-wide blood lead 
surveys for Massachusetts and New York and county-level data for NHANES 
III as well as New Jersey data on osteosarcoma and a National 
Institutes of Justice study of cocaine use by criminals in 129 cities), 
results are almost always statistically significant at the level of 
better than 1000 to 1.
    We are well aware that correlation is not peruse proof of cause. 
However, because the results of our original study have now been 
replicated in several different populations using data collected by 
national and state health agencies, the ecological statistics strongly 
indicate a need for further research. We have considered a number of 
hypotheses for how the use of silicofluorides for water treatment may 
cause adverse health and behavioral effects. One that has begun to have 
increasing credibility for us is the likely presence of small amounts 
of radionuclides in drinking water. The radioactivity may be due either 
to natural events or anthropogenic in origin.
                       useful appendices enclosed
    The following are included herewith to provide background and 
guidance:
    A. Chart of nuclear decay phenomena associated with radon, 
illustrating why health risks from radioactive substances in water 
neither start nor end with radon;
    B. Chapters from ``Health Risks of RADON and Other Internally 
Deposited Alpha-Emitters'', a compilation by the National Research 
Council;
    C. Tables from ``NSF-60'', (regarded as the ``bible'' on tests for 
health safety of drinking water additives) showing what materials 
require tests for radioactivty;
    D. A recent study of several radioactive Spanish waters 
illustrating the geologic and hydrologic complexity of radionuclides 
associated with radon.
                   naturally occuring radon in water
    It is commonly believed in the lay community that radon is only a 
hazard as a gas which seeps into buildings through cracks in basement 
floors and walls. While there is some appreciation of the fact that 
local geology is responsible in some vague way for the presence of 
radon as a gas in soil, until now little, if any, consideration has 
been given to health threats of water-borne radon.
    Radon (222Rn), itself transient (3.8 days half-life), is a 
``marker'' for both its ``mother'' radium and its own''progeny'', 
radioactive lead (2'0Pb) and radioactive polonium, (typo). Thus, 
discussion of radon in water needs to consider a number of 
radionuclides.
    (1). Where radon occurs in a geological formation there must also 
have been other radionuclides. So water contacting that formation would 
have been likely to pick up some of radon's ``ancestors'' (uranium and 
radium) and some of its longer-lived ``descendants'' (2?0Pb and 2'0po) 
along with radon itself.
    (2). The ``mother'' radium atoms (226Ra) had to have been present 
for thousands of years before they decayed to radon, (222Rn) with 
release of one alpha particle each.
    (3). Virtually all the radon atoms produced by this step, whether 
dissolved in water or trapped in the geologic formation as a gas, 
remain as such for only a few days before they decay in several steps 
into 210Pb.
    (The 3.8 day ``half-life'' signifies that half the number of radon 
atoms produced at any one time decay into the next generation of radon 
progeny in 3.8 days. This doesn't mean that half decay all at once at 
the end of 3.8 days. Decay occurs one atom at a time with decreasing 
frequency if the original total number of radon atoms is not constantly 
replenished. The thing to bear in mind is that in the geological 
formation there is a virtually endless supply of latent ``mother'' 
radium atoms, which provide that source of replenishment because of 
their very slow decay rate (halflife of 1,600 years), and that they are 
backed up by 238uranium (half-life 4.5 billion years).
    (4). After the ``mother'' radium decays into a 222Rn atom, the 
latter decays in five quick steps (less than an hour) to 210Pb. Over 
that interval the 222Rn atom and its progeny have created three alpha 
particles, a couple of beta particles and some gamma rays.
    (5). The resulting radioactive lead atoms (210Pb) have a half-life 
of 22 years. This means that a fair number are still around after 50 
years, even though half had decayed in the first 22 years). The decay 
course of 210Pb includes release of a beta particle creating 210Bi 
atoms. These also release beta particles in a matter of days becoming 
210Po atoms. The radioactivity of these 210Po atoms is probably as 
important as that of radon.
                       polonium in the atomic age
    Polonium (210Po) occurs in nature. But it is also one of the by-
products of the production of nuclear materials for military use and 
power generation. It has been considered one of the most dangerous of 
the radionuclides to which man has knowingly exposed himself. In the 
early days of nuclear weapons and related developments, it was the 
subject of intensive study1-4 formechanism of exposure, routes of 
elimination, and health effects. It is stored in many tissues of the 
body because it behaves chemically like lead and calcium. 210Po decays 
over a few months, emitting alpha particles and gamma rays. It was 
considered to be 20 times more toxic than cyanide.
    Some ``experts'' address the problems of radon in water on the 
assumption that this risk is due to natural causes, independent of any 
anthropogenic considerations. This view requires careful scrutiny. It 
may not be immediately obvious, but there is a long history of 
relationships between fluoridation and radioactive water. The current 
concerns about waterborne radon must take this into account since there 
are sources of water-borne radon besides those due to established and 
traditional hydrologic/geologic causes.
    The nexus between radioactivity and fluoridated water was known 
shortly after the Curies discovered radionuclides in 1898 and named one 
of them Polonium. A 1906 reports noted that thermal mineral baths in 
Aachen contained fluoride (as silicofluoride) along with some 
unspecified radioactive substance. Although the species in which it is 
bound has not always been identified as silicofluoride, some form of 
fluoride has often been found to co-exist with ``natural'' 
radioactivity all over the world.6-8
    By the same token, naturally occurring fluoride has been reported 
to be in the form of silicofluoride without necessarily noting the 
presence of radioactivity.9 Nevertheless, it is not a big leap to 
postulate that radon and ``natural'' fluoride in the form of 
silicofluoride coexist in US drinking water supplies, although very few 
people drink naturally fluoridated water at the level of 1 ppm. In 
Massachusetts towns where that occurs, (in the vicinity of Ware) the 
prevalence of child elevated blood lead was comparable to that found in 
large urban centers such Boston and Worcester which have big city 
problems that are clearly not associated with radionuclides.
    However, when small rural communities which share a common geology 
providing naturally occurring fluoride, (such as the ``Ware Cluster''), 
exhibit childhood blood levels several times as high as those in 
similar non-fluoridated towns, it is reasonable to suspect that the 
naturally fluoridated water may carry the same substances that are 
suspected as responsible for adverse health and behavioral effects 
associated with deliberately added silicofluorides. The Massachusetts 
``Ware Cluster'' of child elevated blood lead suggests there is no 
reason to presume ``natural fluoride'' in a water supply to be 
innocuous, any more than it is logical to presume that ``natural 
arsenic'' in a water supply is innocuous.
                relevance of deliberately added fluoride
    Over the past 50 years, the practice of adding fluoride to public 
water supplies has been expanded to include systems serving nearly 70 
percent of the US population. There is an active plan to reach a goal 
of 100 percent. Paradoxically, except for UK Commonwealth nations and a 
few others, no other countries currently follow that practice. 
Meanwhile, 90 percent of US fluoridated municipal water is treated with 
a silicofluoride; less than 10 percent is treated with sodium fluoride, 
the agent first used after preliminary trials that were considered 
sufficient to establish the health safety of fluoridation.
    Without questioning whether the experiments with sodium fluoride 
were adequate, the fact is that no tests were conducted for health 
safety of chronic human exposure to the silicofluorides. Today, over 
140 million people are served by water systems that consume 200,000 
tons of the silicofluorides per year. 10 And this has occurred without 
any evidence of health safety supported by tests conducted on any 
mammals (let alone humans) subjected to long-term chronic low level 
exposure to silicofluorides. This is not trivial because these 
fluoridating agents, (fluosilicic acid and sodium fluosilicate), may 
also carry small amounts of the same radionuclides that accompany 
water-borne radon from ``natural'' sources.
    Silicofluorides are derived from ``phosphate rock,'' a mixture of 
calcium phosphate, calcium fluoride, silica-bearing material (sand, 
clays) and a few percent of uranium and radium. Mining and processing 
this ore releases radon into the environment. In the 1970's80's about 
75 percent of uranium produced in the US came from this ore. `` During 
conversion of the rock to phosphoric acid and subsequent extraction of 
uranium from this acid, fluoridebearing gases are released along with 
radon. These gases are extremely toxic and cannot be released into the 
atmosphere. They are conducted to a ``scrubber'' where they are 
absorbed in a water spray or similar system. Local well water is often 
in short supply so a scrubber may variably be fed with well water or 
``gypsum pond'' water to absorb the ``offgases'' from several stages of 
phosphate ore processing. 12
    These man-made ponds may contain solutes derived from the initial 
phosphate ore and ``inprocess'' derivatives of this ore including 
radionuclides. The term ``gypsum pond'' reflects the fact that collect 
water draining from very large piles (``gypsum stacks'', essentially 
small hills) of calcium sulfate, (``gypsum''). This product, known as 
``phosphogypsum'' is an unavoidable by-product of treating the ore with 
sulfuric acid. As such, it is a wet ``sludge'' carrying residues of the 
main desired product, namely the phosphoric acid from which both 
phosphate fertilizer and uranium are eventually derived.
    Rain washing through the gypsum stacks (hills), carries away some 
of the residual acid and a dilute stream of it is collected in the 
``gypsum pond.'' Thus, the scrubber product (``fluosilicic acid'') is 
not just a solution of fluoride gases (HF and SiF4), radon released 
from the ore, and mists of radionuclide aerosols. On some occasions it 
will, of necessity, also include radionuclides (and other substances) 
from gypsum pond water.
    Besides the nexus between fluoride and radon in both natural 
geology/hydrology and the industrial chemistry of silicofluoride and 
uranium derived from phosphate rock, a third matter calls for 
attention. Considerable documentation links people who were studying 
health effects of radionuclide exposure under the Manhattan Project, 
the AEC and the NRC with efforts to disseminate the idea that there are 
no health safety risks from drinking water treated with 
silicofluorides.
    A 1957 report,13 published in the Journal of Dental Research by the 
authors of significant studies on Polonium and Uranium health effects1-
4, 15 admits there had not been any actual studies of health effects 
studies of silicofluorides, but ``guarantees'' that it didn't matter 
because, (on theoretical chemical grounds), silicofluorides would be 
fully dissociated into free fluoride ion and silicic acid, at 1 ppm of 
fluoride.
    According to this thesis, upon dissociation of the silicofluoride 
anion, fluoridated water would be ``just like'' sodium fluoride treated 
water. Since sodium fluoride treated water had been found safe, 
silicofluoride treated water would be equally safe. Therefore animal 
health safety studies of silicofluoride were not required. It is 
interesting that no mention was made of radioactive substances as 
possible contaminants of fluosilicic acid.
    EPA and CDC chemists take the same position today, namely that 
silicofluorides dissociate into nothing but free fluoride and silicic 
acid. No mention is made of possible radioactive contaminants and there 
have still not been any tests for health effects in humans from chronic 
exposure to the silicofluorides. Indeed, although a Select Committee of 
the US Congress in 1952 had requested research on the effects of 
chronic exposure to fluoridated water, none has been conducted to date. 
Moreover, neither in 1957 nor 1999 did the ``experts'' take account of 
animal studies oft he 1930's 14 which showed profound adverse health 
effects to farm animals from exposure to silicofluorides as well as a 
difference between the metabolism of fluoride from sodium fluoride and 
that. From silicofluoride.
    It is interesting that the 1957 ``guarantee'' of silicofluoride 
health safety was offered by people concurrently doing animal studies 
of radionuclide toxicity for the AEC1--3, 15 One wonders how they could 
have reached that conclusion without animal tests, especially since 
silicofluoride was an important by-product of uranium production.
    This enigma persists. Supporters of fluoridation never say what 
agent is used to deliver the fluoride. This even applies to the staff 
of NIDR and Surgeon General. In fact, college chemistry professors, 
dentists, staff of the FDA and major academic dental research centers 
seem totally oblivious to the fact that silicofluorides are used and 
even state (erroneously, of course) that sodium fluoride or some other 
compound such as stannous fluoride or even fluorine gas is the 
fluoridating agent most widely used.
    It is even more curious that the specifications for health testing 
of water additives embodied in a document widely known as NSF-60 (see 
enclosure ``C'') call for radioactivity tests for two rarely (if ever) 
used fluoridating agents (calcium fluoride and ammonium fluosilicate) 
but do not require such tests for the two most widely used agents, 
sodium fluosilicate and fluosilicic acid.
    Because 140 million (or more) Americans are exposed to a likely 
anthropogenic source of radon and its associated radionuclides, it 
seems beyond question that a substantial program of animal testing and 
chemical studies is needed. Such research should be outside of the 
control of the bureaucracies that seem to have been oblivious to the 
problems, if not actually inclined to ignore them.
                               references
    (1) Stannard JN and Casarett GW (eds.); ``Metabolism and Biological 
Effects of An Alpha Particle Emitter, Polonium-210''; Radiation 
Research symposium Supplement 5, 1964; Academic Press; New York; 435 
pages.
    (2) Feldman I and Saunor P; ``Some in vitro Studies of Polonium-210 
Binding by Blood Constituents'': Radiation Research, Supp 5; pp 40-48; 
1964 (note: work probably performed 1954 and declassified for 
publication as a major compendium)
    (3) Morken DA; ``The Radiation Dose to the Kidney of the Rat from 
Inhaled Radon'' Archives of Industrial Health V 29; pp 505-509; 1959.
    (4) Morken DA; ``The Effect of Inhaled Radon on the Survival, Body 
Weight, and Hemogram of the Mouse Following Single Exposures''; 
University of Rochester Atomic Energy Project Report UR-593; June 1961.
    (5) Sahlbom N and Hinrichsen FW; 'nitration der 
Kieselfluorwasserstoffsaure''; Berichte; 1906, pp 2609-2611.
    (6) Fisher EL et al; ``Temporal and Spatial Variation of Waterborne 
Point-of-use 222Rn in Three Water-distribution Systems''; Health 
Physics 1998 Feb; 74 (2); pp 242-248.
    (7) Banks D et al; ``The Chemistry of Norwegian Groundwaters: I: 
The Distribution of Radon, Major and Minor Elements in 1604 Crystalline 
Bedrock Groundwaters''; Sci Total Environ 1998 Oct 15; 222(1-2); pp 71-
91.
    (8) Reimann C et al; ``Radon, Fluoride and 62 Elements as 
Determined by ICP-MS in Norwegian Hard Rock Groundwater Samples''; Sci 
Toral Environ 1996 Nov 29; 192 (1); pp 119.
    (9) Ockerse T; ``Fluorine and Dental Caries in South Africa''; 
Symposium Publication; ``Dental Caries and Fluorine''; Am Ass for the 
Adv of Sci; Subsection on Dentistry; Moulton FR, ed 1946; pp 36-42.
    (10) Reeves TG; ``Water Fluoridation; A Manual for Water Plant 
Operators''; US PHS, CDC Division of Oral Health; April 1994.
    (11) Randazzo AF and Jones DS; ``The Geology of Florida''; 
University of Fla Press; 1997.
    (12) Craig J M; ``Fluoride Removal from Wet-Process Phosphoric Acid 
Reactor Gases''; Ph. D. thesis; University of Florida, 1970.
    (13) Feldman I, Morken D and Hodge HC; ``The State of Fluoride in 
Drinking Water''; J. Dent Res. Vol 36 (2); pp 192-202; April 1957.
    (14) Kick CH et al; ``Fluorine in Animal Nutrition''; Bulletin 558, 
Ohio State Agricultural Experiment Station, Wooster OH; Nov 1935; 77 
pgs.
    (15) Hodge HC; ``Mechanism of Uranium Poisoning''; Arch. Ind. 
Health V 14; pp 4347; 1956.
                               __________

                 An Alliance for Discoveries in Health

                                                      July 12, 2000

The Honorable Michael D. Crapo Chairman,
Subcommittee on Wildlife, Fisheries and Drinking Water
Senate Office Building
Washington, DC 20510

Dear Senator Crapo: I write today in response to the Subcommittee's 
call for testimony regarding fluoridation of drinking water. Recent 
results of an oral health public opinion poll we commissioned indicate 
99 percent of the American public feel their oral health is very 
important to their overall health (see enclosed graph.); and 97 percent 
of Americans indicated that the desire to prevent oral disease was an 
important factor in determining whether or not to get dental care (see 
enclosed graph).
    According to a report by the Centers for Disease Control and 
Prevention, one of the top ten public health accomplishments of the 
last century was fluoridation of drinking water (see enclosed graph).
    One way to achieve better oral health and prevent oral disease for 
our nation's citizenry is by supporting community water fluoridation. 
Oral Health in America: A Report of the Surgeon General notes:
    Communities with fluoridated drinking water in the United States, 
Australia, Britain, Canada, Ireland and New Zealand show striking 
reductions in tooth decay--those with fluoridated drinking systems have 
15-40 percent less tooth decay;
Honorary Board
    Nearly all tooth decay can be prevented when fluoridation is 
combined with dental sealants and other fluoride products, such as 
toothpaste.
    It would be a shame to take a step backward in progress by not 
utilizing this great public health breakthrough.
    Sincerely,
                   Paul G. Rogers Chair, Research! America.



[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


                               __________




                        Fitzwilliam Village Water District,
                   P.O. Box 12 Fitzwilliam NH 03447, June 13, 2000.

Senate Committee on Environment and Public Works
Senate Office Building
Washington DC 20510

Dear Sirs: It is my understanding that you will be holding a hearing on 
June 29 on the proposed EPA Radon in Water Rule. The following are our 
comments that we wish to present at that hearing and be made a part of 
the record of the hearing.
    We have already filed a comment with the EPA which clearly states 
our opposition to the Radon in Water Rule and the reasons we feel it to 
be an ineffectual program. Rather than reiterate those arguments, we 
would like to take this opportunity to address the issue of some 
inequities in the distribution of costs if and when the EPA Radon Rule 
goes into effect.
1. The Inequity of Random Selection of Who Pays the Costs
    Under the proposed EPA rule, a public water system will fall into 
one of three categories.
    A. Those with less than 300 pico curies of radon per liter in their 
water will have to take no action.
    B. Those with between 300 and 4000 pico curies of radon per liter 
will be able to use the MMM program to-educate their customers as to 
the dangers of and treatment for radon in the air in their homes.
    C. Those with above 4000 pico curies of radon per liter will have 
to treat their water for radon. This will be an expensive process 
costing each water system thousands to hundreds of thousands of 
dollars.
    The category into which a water system falls is entirely determined 
by the chance location of the water system and where they have happened 
to have drilled their wells, In effect, they have participated in a 
well drilling lottery. There will be some winners and some losers. The 
winners won't have to do anything or will be able to escape with a 
relatively inexpensive public relations effort. The losers will 
typically have to pay thousands of dollars up front to install 
treatment equipment and more down the line to maintain this equipment. 
The EPA makes no provision to fund any of this cost. The states where 
the wells are located are under no obligation to provide any 
assistance.
    Is this situation an equitable one? Should there not be some form 
of financial assistance made available to those systems with the 
heaviest financial burden?
2. The Inequity of State Subsidies
    The EPA makes a provision in their proposed rule whereby the 
individual states can assume the burden of providing those water 
systems who qualify for the MMM program with a statewide MMM program 
they can participate in. This assistance represents a subsidy for those 
systems who would otherwise have to develop their own more expensive 
programs. Thus not only are those systems with the heaviest financial 
burden receiving no assistance, they can watch as those systems with a 
relatively light burden are financially assisted by their state 
governments! Is this an equitable arrangement?
3. The Inequity of Costs for Smaller Water Systems
    Water systems are businesses. They provide a service for fees which 
they collect from their customers. If and when the EPA Radon in Water 
rule goes into effect, many large and small water systems will have to 
treat their water for radon. The cost per capita for the larger systems 
will be generally lower than the cost per capita for the smaller 
systems. As an example, we estimate that our users will end up paying 
about $1000. per household for radon treatment. A small city having to 
treat for radon might have costs that run in the $10. to $50. per 
household range. Thus if and when the Radon in Water rule goes into 
effect, it will have the same effect as a business tax that lays a 
disproportion of its financial burden on small businesses. If such 
taxes are inequitable, why are EPA predicted expenses any different?
    We feel that the above items represent serious inequities in the 
distribution of the cost of the Radon Treatment program proposed by the 
EPA. We hope you will consider them in your recommendations.
            Sincerely,
                                            Frank Bequaert,
                                               James Dugan,
                                          John Fitzwilliam.
                                 ______
                                 
           Richard DiPentima, Manchester Health Department,
                                Manchester, NH 03101, July 7, 2000.

    Dear Sirs: For the record, my name is Richard DiPentima, RN, MPH, 
Deputy Public Health Director, Manchester NH Health Department. I have 
been working in public health for over 25 years including positions at 
the local, State and Federal level. Over the years I have witnessed the 
great public health benefits of water fluoridation as well as the great 
harm that occurs as a result of not providing fluoridation of community 
water supplies.
    The benefits and safety of fluoridation have been shown by over 
fifty years of practical experience and countless studies conducted by 
reputable mainstream scientists. This does not include the experience 
of individuals and communities that have benefited for far longer 
through consumption of naturally occurring fluoridated water. The vast 
majority of the scientific, medical, dental and public health community 
strongly support expanding the practice of fluoridation to prevent 
dental disease. The benefits of fluoridation in terms of reducing 
dental disease and saving billions of dollars has been well documented. 
The U. S. Centers for Disease Control and Prevention has listed 
community water fluoridation as one of the ten great achievements of 
the 20th Century!
    Not unlike the practices of immunization of children, 
pasteurization of milk and chlorination of water supplies, fluoridation 
has its critics. While these critics are few in number, they often are 
quite active and vocal in their opposition. Unfortunately, these 
critics do not always rely on sound science, truth or adhere to 
accepted standards. The goal of these critics is to produce fear, doubt 
and undue concern among the public by claiming that fluoridation is 
responsible for everything from AIDS to violence. Unfortunately, these 
critics have been all to successful in promoting propaganda over 
science.
    I urge the committee to review two recently released reports that 
may add to your appreciation of the scope of the oral health crisis in 
America. First, the Surgeon General's Report, ``Oral Health in 
America'' released in May 2000. Second, The GAO Report released in 
April 2000 ``Oral Health-Dental Disease is a Chronic Problem Among Low-
Income Populations.'' Both these documents will provide support for the 
need to continue and expand the availability of community water 
fluoridation. A retreat from this very important public health practice 
will have profound health and economic implications. At a time when 
health care costs continue to rise and millions of Americans lack 
access to dental care, the last thing we should do is curtail disease 
prevention activities.
    Thank you for providing me an opportunity to provide my comments. 
If you have any questions please contact me.
 Richard DiPentima, RN, MPH, Deputy Public Health Director,
                                      Manchester Health Department,
                                          795 Elm Street, Suite 302
                                              Manchester, NH 03101.
                                 ______
                                 
 Statement of Richard A. Castro, Chairman, Public Service Board of the 
                         city of El Paso, Texas
    On May 24 of this year, the Administrator of the Environmental 
Protection Agency signed a rule entitled National Primary Drinking 
Water Regulations: Arsenic and Clarifications to Compliance and New 
Source Monitoring. The proposed rule (Arsenic Rule) as written will 
have a major and profound impact on the city of El Paso and on many 
other western cities. The purpose of my testimony this day is to make 
known the significance of the proposed rule to El Paso and to describe 
certain deficiencies in the rule as proposed.
    Let me preface my testimony by stating emphatically that the El 
Paso Water Utilities Public Service Board supports safe drinking water. 
Furthermore, we support the efforts of the EPA to protect the health of 
our citizens through this rulemaking effort. At such time as a limit is 
proposed based on sound science, El Paso will fully support the 
proposal and will implement treatment measures necessary to meet that 
limit. In the proposed rule, the EPA indicates that they are proposing 
a Maximum Contaminant Level (MCL) for arsenic of 0.005 milligrams per 
liter which is equivalent to 5 micrograms per liter; although, they are 
requesting comments on limits equivalent to 3, 10 and 20 micrograms per 
liter as well.
    The service area of the El Paso Water Utilities presently includes 
approximately 695,000 people located within the city of El Paso and the 
areas of El Paso County surrounding the City. El Paso is located in the 
Chihuahuan Desert; and as such, is subject to limited availability of 
drinking water. We rely on a limited supply of groundwater for 55 
percent of our drinking wager supply. Our groundwater resources contain 
arsenic from 3 to 30 micrograms per liter depending on location, depth 
and other geologic features.
    Of the 139 wells utilized by the El Paso Water Utilities, 111 have 
arsenic in concentrations greater than or equal to 5 micrograms per 
liter. In order to provide arsenic removal treatment for those wells, 
the Citizens of El Paso would be required to provide $150 million in 
capital and an additional $8 million in annual operating expense. This 
cost represents a 40 percent rate increase for our customers. Moreover, 
the proposed rule is only one of many rules that the EPA will 
promulgate over the next few years. At the same time, El Paso Water 
Utilities is struggling to provide water to an ever-increasing 
population in this desert area. Just to supply the necessary water 
resources, our customers will see an 80 percent rate increase over the 
next 10 years riot including arsenic treatment costs. These are huge 
burdens to our citizens because El Paso has one of the lowest per 
capita income levels in the nation.
    Our analysis of the proposed rule shows the possibility that 
serious flaws have been incorporated into the science behind the rule. 
Rather than waiting for the completion of research work sponsored by 
the collective water utility industry, which will correct these flaws, 
the EPA is proceeding with the rule to meet a congressionally imposed 
deadline.
    However, our main concern with the proposed rule is the estimated 
compliance cost calculated by the EPA. The compliance cost estimations 
seriously underestimate the cost of compliance with the proposed rule. 
The EPA cost fails to include all the necessary supporting requirements 
to modify a water system for arsenic removal. For example, many El Paso 
wells are not collected to a central point prior to introduction into 
the distribution system. In order to provide treatment, extensive 
changes must be made to the water distribution system and new 
reservoirs must be constructed. The EPA compliance cost estimate does 
not consider those costs or the cost to purchase land, extend 
wastewater lines to treatment sites, site preparation costs and other 
large supporting costs. Also, any treatment used to remove arsenic from 
water will result in the formation of a residual into which the arsenic 
is concentrated. That residual may have to be disposed of in accordance 
with applicable hazardous waste rules. The use of ion exchange, the 
preferred treatment methodology as described in the proposed rule, 
requires the use of significant amounts of salt and the disposal 
thereof. Last, the establishment of a lower drinking water MCL for 
arsenic will result in lower stream standards and an increased level of 
treatment at Superfund sites. None of these costs are adequately 
addressed EPA's compliance cost estimates.
    El Paso would support an MCL of 20 micrograms per liter. Even this 
level will cost us several million dollars to implement, but would 
represent reduction to 40 percent of the current level. Until good-
science based studies justify a lower limit, we are very much opposed 
to the proposed MCL of 5 micrograms per liter.
                               __________
  Statement of the Association of State Drinking Water Administrators
    The Association of State Drinking Water Administrators (ASDWA) is 
pleased to provide written testimony on implementation of the Safe 
Drinking Water Act (SDWA) of 1996 to the Senate Committee on 
Environment and Public Works Subcommittee on Fisheries, Wildlife, and 
Drinking Water. ASDWA represents the state drinking water 
administrators in the 50 states and six territories who have 
responsibility for implementing the m?any provisions of the SDWA and 
ensuring the provision of safe drinking water. State drinking water 
programs are committed to providing safe drinking water and improved 
public health protection to the citizens of this nation. ASDWA's 
testimony will focus on the many successes that the states have 
achieved over the last 4 years as well as many of the disturbing trends 
that are emerging, and the challenges that remain.
    States have been protecting drinking water for more than 25 years, 
in some cases going back decades to the early U.S. Public Health 
Service standards. Since 1974, states have adopted and been 
implementing standards for 20 inorganic chemicals including lead and 
nitrate; 56 organic chemicals including pesticides, herbicides, and 
volatile chemicals; total trihalomethanes; total and fecal coliform; as 
well as implementing treatment requirements for surface water systems 
for turbidity, Giardia, and viruses. In addition, states have developed 
technical assistance programs, conducted sanitary surveys, and 
addressed operator certification, training, enforcement, emergency 
response, and review of water utilities plans and specifications.
    The 1996 reauthorization of the Safe Drinking Water Act contained 
numerous new requirements to continue to ensure safe drinking water in 
this country. These new requirements include: consumer confidence 
reports; revisions to the lead/copper rule; Stage 1 D/DBP rule; interim 
enhanced surface water treatment rule; source water assessments and 
delineations for all public water systems; unregulated contaminant 
monitoring requirements; a revised public notification rule; a long-
term enhanced surface water treatment rule; a filter backwash rule; a 
radon rule; a rule to protect ground water; an arsenic rule; a 
radionuclides rule; Stage 2 disinfection by-products rule; long-term 2 
enhanced surface water treatment rule; water system capacity 
development programs; and operator certification program revisions. In 
addition, the U.S. Environmental Protection Agency (EPA) is required to 
obtain data to make determinations on whether to regulate an additional 
five more contaminants every 6 years (see page 6).
    The states were willing players and partners in the discussions 
leading up to reauthorization in 1996 with the specific understanding 
that a significant new mandate such as this law, which encompasses 
sweeping new reforms and activities outside of the traditional drinking 
water program, must be accompanied by significant new resources and 
staff. While critical, resources alone are simply not enough. In 
addition, states need a reasonable regulatory schedule and the 
flexibility to allow states to shift staff and resources to new 
programs in a calculated and manageable fashion. Unfortunately, almost 
4 years into implementation, the states are seeing disturbing trends 
emerge from EPA that are preventing the states from achieving full 
implementation of the law. In fact, these trends are resulting in a 
dilution of public health protection efforts and the forced 
prioritization of state program activities.
    These trends include:
      Inadequate Funding and Unwillingness to Address 
Cumulative Costs and Program Integration
      Early Implementation
      Changing State Roles and Expectations
      Increasing Record Keeping and Reporting Burden
    Each of these topics is discussed in more detail below.
Inadequate Funding and Unwillingness to Address Cumulative Costs and 
        Program Integration
    On average, states have historically provided 6S percent of the 
total funding for the drinking water program while EPA has provided 
only 35 percent, even though the SDWA authorizes EPA to fund up to 75 
percent of the full costs of the program. Currently, about $271 million 
in state and Federal dollars is available to the state drinking water 
program. A Resource Needs Model, recently developed by the states and 
EPA, projects that state drinking water programs face a $100 million 
resource shortfall and a shortfall of almost 2,000 FTEs for fiscal year 
2001. These shortfalls almost double through 2005 based on anticipated 
state workloads for the plethora of new regulations and programs being 
promulgated (see page 7).
    To further compound the problem, EPA has not requested any increase 
in state PWSS program grants (current funding level is $90 million), 
that provides the reliable, sustainable base for state operations, 
since fiscal year 1996. In fact, the Agency has not even requested the 
full amount of $100 million as authorized in the SDWA. Although the 
Agency often looks to the drinking water SRF as a new source of funding 
for states, they do not fully recognize that states cannot hire 
permanent staff using a funding source that changes annually and the 
authority for which expires in 2003; that requires a 100 percent match 
of new state dollars; and that puts states in direct competition for 
the same pool of funding with water systems that have overwhelming 
infrastructure needs to improve public health protection.
    The practical outcome of failing to provide any new PWSS funds is 
that state funding bases have been eroded over the years due to 
inflation and indirect and direct cost increases. In addition, the 
growing economy has made hiring and retaining staff more difficult as 
state salary levels become less competitive in the marketplace. The 
state drinking water programs have never been fully and adequately 
funded and are now challenged to meet enormous new mandates without the 
significant new money and staff needed to ensure full and effective 
implementation of the new programs as well as maintenance of the 
existing core programs.
    The situation is further exacerbated by EPA's unwillingness or 
inability to fully address the cumulative costs to states for each of 
the very complex and comprehensive new programs and regulations being 
developed. There appears to be no acknowledgement that state program 
funding is finite and, in fact, already inadequate, nor a willingness 
to simplify and streamline regulations and provide adequate flexibility 
to reduce state implementation burdens. This attitude forces states to 
prioritize their activities based on available staff and resources and 
ensures that full implementation will likely not be realized.
    The states were committed in 1996 to take on the new mandates of 
the SDWA with the understanding that resources, staff, and needed tools 
would be available to ensure full and effective implementation of the 
new program as well as maintenance of the existing program. States are 
still committed to the improved public health protection opportunities 
envisioned in the law but are growing increasingly frustrated and angry 
that barriers are being erected to preclude their achievement of these 
goals.
    Recommendations: 1) EPA should work with the states to confirm the 
current staff and resources needed to fully implement the program; 2) 
EPA should work with the states and Congress to close the documented 
resource gap and ensure that adequate funding will be available in 
future years based on the individual and cumulative costs of new 
regulations and programs; 3) EPA must also work with states to 
streamline and simplify new regulations and programs to reduce 
increased burden to the greatest extent possible; and 4) in the event 
that the gaps cannot be closed, EPA must be willing to engage the 
states in discussions on how to prioritize and manage the new mandates 
with existing or inadequate resources.
Early Implementation
    The situation referenced above is further exacerbated by the 
Agency's continued insistence on early implementation of rule 
requirements prior to states adopting their own rules within the 
statutory framework of 2 years from the date of rule promulgation. This 
is especially troublesome with respect to the overwhelming number of 
rules EPA currently has out for review and the difficulty states and 
water systems will have complying with all of these new rules 
simultaneously. States need their rules in place in order to establish 
basic regulatory and enforcement authorities; to train operators and 
water system owners on Federal as well as state requirements; reprogram 
data management systems to accept new data reporting requirements, 
track compliance, and report to EPA; and ensure adequate laboratory 
capacity. Forty-nine of the 50 states have primacy and have the 
mechanisms in place to work with utilities within their state to 
achieve and maintain compliance. Inserting EPA Regions into the 
process, who are not onsite and do not have the resources, experience, 
and mechanisms in place to do much more than send letters and issue 
orders, greatly complicates the process and leaves the program in great 
disarray at the point when states must assume responsibility. This is a 
disservice to the states, the utilities, and the public across this 
country and brings into question the concept of primacy and state 
authority.
    Recommendations: 1) The Agency's use of Memoranda of Understanding 
(MOU) prior to state rule adoption is not acceptable and the Agency 
must immediately cease all activities directed at forcing states to 
implement requirements before state rules are adopted; 2) EPA should 
forego all attempts to require EPA Regions to assume interim 
implementation activities.
Changing State Roles and Expectations
    Of significant concern to ASDWA and the states is the expanding 
expectation of scale and scope being promoted by EPA that dramatically 
changes the state role from regulatory oversight to implementer of SDWA 
regulations. States have historically assured safe drinking water by 
conducting basic oversight and surveillance of water utilities and 
measuring utility compliance through performance measures such as 
compliance with public health standards of finished water. While some 
states have the capacity to be more involved in operations issues, for 
the most part, the daily operations and maintenance of utilities have 
primarily been left to the utility--using certified operators, licensed 
consulting engineers, and technical assistance from the states and 
other providers when needed. This has historically been the case 
because of resource and technical capacity limitations at the state 
level and liability issues associated with making process control 
decisions for the utilities that are regulated by the states.
    This direction represents a significant change from the majority of 
current state practices and must involve a meaningful dialog with state 
drinking water administrators, environmental commissioners, public 
health agency directors, Governors, Congress, and legislative bodies. 
The majority of state drinking water programs currently do not have the 
resources or sufficient staff with the technical expertise to work with 
individual utilities on a one-to-one basis to help make decisions on 
operating practices. If the Agency wants to make this change, then the 
states, including appropriate legislative bodies, must have buy-in to 
this process and there must be assurance that adequate numbers of 
trained state staff and resources will be made available to meet these 
new expectations.
    At a time when most citizens want government out of daily 
decisionmaking, EPA is establishing a structure to position government 
regulators to assume operational responsibility of our drinking water 
infrastructure. The Agency is not being honest with itself, Congress, 
and the public if it believes that state drinking water programs are 
currently in any position to fully implement these new provisions, even 
with a minimal oversight role, much less be able to assume a 
significant new role in water plant treatment, operations, and 
management decisionmaking.
    Recommendations: 1) Congress needs to consider the fundamental role 
for government regulators to play; and 2) EPA needs to recognize that 
they are promoting a significant change in scale and scope of the 
program with expectations that states need to increase their day-to-day 
management role of water utilities. This shift needs to be more fully 
explored by the states and EPA, and additional funding made available 
to support this expansion of state responsibility and staff technical 
capacity if this change is accepted.
Increasing Record Keeping and Reporting Burden
    Although ASDWA recognizes EPA's need to ensure, on the Federal 
level, that a rule is being implemented properly, EPA must recognize 
the increasing burden that is being placed on state data management 
programs with consideration for the number of upcoming rules. States, 
which should be EPA's partners in ensuring safe drinking water, are 
willing to submit necessary data elements to EPA to meet this need, but 
do not have the staff or resources to report extraneous data elements 
that are not necessary, and based on past experience, are typically not 
even used by the Agency. Therefore, prior to proposing a final rule, 
EPA must enter into a dialog with state drinking water program staff to 
evaluate what data must be collected by the water systems, what data 
must be reported to states, and the minimum data elements that must be 
reported to the Agency, and determine the impact these requirements 
will have on states and water systems. The cumulative costs and impacts 
of these continual data requests must also be evaluated to ascertain if 
collectively they are providing states and EPA with meaningful data 
linking rules to real public health improvements.
Successes
    In spite of the many roadblocks, hurdles, and challenges that state 
drinking water programs have faced over the last 4 years, and indeed 25 
years, states have attained a significant amount of success in 
implementing the provisions of the SDWA. For example,
    States have made significant progress in working with utilities 
using surface water supplies to install new treatment facilities to 
assure a much higher level of public health protection. Sources of lead 
from drinking water have been significantly reduced; the data and 
information about water system quality and compliance is now more 
readily available to the public through Consumer Confidence Reports, 
state compliance reports, the Envirofacts data base, and state web 
sites; the quality of water plant operators and water system capacity 
is being significantly improved; and an important source of funding for 
infrastructure improvements has been established in all states and 
loans are now being made to water systems to improve both their 
infrastructure and their ability to provide safe water to their 
consumers. States are also now beginning a very comprehensive and 
resource intensive effort to delineate and assess the quality of all 
source water being used for drinking water to ensure that local 
communities have the tools and information they need to protect their 
drinking water sources.
    States intend to do all they can to meet their existing and new 
commitments, however, the road blocks and barriers being placed before 
and upon states are beginning to take their toll. More and more states 
are vocalizing their frustrations with the excessive, and in many cases 
unrealistic, expectations that are appearing in new regulations; the 
unrealistic expectations that EPA has for early implementation of the 
rules; and most critically, the lack of sufficient funding and staff to 
fully and effectively meet their own expectations as well as those of 
EPA, Congress, and the public.
    The states are not interested in continuing to be the victims of 
GAO reports and IG investigations that find deficiencies in state 
programs when the staff, resources, and tools have not been made 
available for states to succeed. While quietly prioritizing and 
addressing implementation activities at the state and local level may 
meet the states' short-term needs, it is doubtful that ultimately it 
will meet the expectations of the public and Congress. States do not 
want to see the gains that have been made over the last 25 years eroded 
as focus and attention shifts from base, core public health activities 
to complex, new, and in many cases unimplementable regulations. The 
fundamental principles of the SDWA Amendments of 1996 are sound and, if 
correctly administered, have the potential to provide meaningful new 
public health protections. The states want the chance to succeed and 
they want the opportunity to help craft, as EPA's partners, the future 
direction of programs that will ensure the provision of safe drinking 
water in this country.




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