[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
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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
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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.
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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.
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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.
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drinking water. Environ. Health Perspect. 104:620-628 (1996a).
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Nicoli, H, Smith, AH, Bladder Cancer Mortality Associated with Arsenic
in Drinking Water in Argentina. Epidemiology 7:117-124 (1996b).
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excretion of arsenic species after exposure to arsenic present in
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toxic metalloids and metals. In: Chemical Toxicology and Clinical
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drinking water. Environ. Health Perspect. 97:259-267 (1992).
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Arsenic Concentrations in Well Water and Risk of Bladder and Kidney
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water. Am. J. Epidemiol., 147:660-669 (1998).
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skin cancer in an endemic area of chronic arsenism in Taiwan. J. Natl
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and Blackfoot Disease with arsenic. Environ. Health Perspect. 19:109-
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Geochem. Health 14: 55-58.
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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.
______
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
__________
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.
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__________
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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