[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]
PERCHLORATE: HEALTH AND ENVIRONMENTAL IMPACTS OF UNREGULATED EXPOSURE
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON ENVIRONMENT AND HAZARDOUS MATERIALS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
FIRST SESSION
__________
APRIL 25, 2007
__________
Serial No. 110-35
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
--------
U.S. GOVERNMENT PRINTING OFFICE
38-495 PDF WASHINGTON DC: 2008
---------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing
Office Internet: bookstore.gpo.gov Phone: toll free (866)512-1800
DC area (202)512-1800 Fax: (202) 512-2250 Mail Stop SSOP,
Washington, DC 20402-0001
COMMITTEE ON ENERGY AND COMMERCE
JOHN D. DINGELL, Michigan, Chairman
HENRY A. WAXMAN, California JOE BARTON, Texas
EDWARD J. MARKEY, Massachusetts Ranking Member
RICK BOUCHER, Virginia RALPH M. HALL, Texas
EDOLPHUS TOWNS, New York J. DENNIS HASTERT, Illinois
FRANK PALLONE, Jr., New Jersey FRED UPTON, Michigan
BART GORDON, Tennessee CLIFF STEARNS, Florida
BOBBY L. RUSH, Illinois NATHAN DEAL, Georgia
ANNA G. ESHOO, California ED WHITFIELD, Kentucky
BART STUPAK, Michigan BARBARA CUBIN, Wyoming
ELIOT L. ENGEL, New York JOHN SHIMKUS, Illinois
ALBERT R. WYNN, Maryland HEATHER WILSON, New Mexico
GENE GREEN, Texas JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado CHARLES W. ``CHIP'' PICKERING,
Vice Chairman Mississippi
LOIS CAPPS, California VITO FOSSELLA, New York
MIKE DOYLE, Pennsylvania STEVE BUYER, Indiana
JANE HARMAN, California GEORGE RADANOVICH, California
TOM ALLEN, Maine JOSEPH R. PITTS, Pennsylvania
JAN SCHAKOWSKY, Illinois MARY BONO, California
HILDA L. SOLIS, California GREG WALDEN, Oregon
CHARLES A. GONZALEZ, Texas LEE TERRY, Nebraska
JAY INSLEE, Washington MIKE FERGUSON, New Jersey
TAMMY BALDWIN, Wisconsin MIKE ROGERS, Michigan
MIKE ROSS, Arkansas SUE WILKINS MYRICK, North Carolina
DARLENE HOOLEY, Oregon JOHN SULLIVAN, Oklahoma
ANTHONY D. WEINER, New York TIM MURPHY, Pennsylvania
JIM MATHESON, Utah MICHAEL C. BURGESS, Texas
G.K. BUTTERFIELD, North Carolina MARSHA BLACKBURN, Tennessee
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
______
Professional Staff
Dennis B. Fitzgibbons, Chief of Staff
Gregg A. Rothschild, Chief Counsel
Sharon E. Davis, Chief Clerk
Bud Albright, Minority Staff Director
Subcommittee on Environment and Hazardous Materials
ALBERT R. WYNN, Maryland, Chairman
FRANK PALLONE, Jr., New Jersey JOHN SHIMKUS, Illinois
BART STUPAK, Michigan Ranking Member
LOIS CAPPS, California CLIFF STEARNS, Florida
TOM ALLEN, Maine NATHAN DEAL, Georgia
HILDA L. SOLIS, California HEATHER WILSON, New Mexico
Vice Chairman JOHN B. SHADEGG, Arizona
TAMMY BALDWIN, Wisconsin VITO FOSELLA, New York
G.K. BUTTERFIELD, North Carolina GEORGE RADANOVICH, California
JOHN BARROW, Georgia JOSEPH R. PITTS, Pennsylvania
BARON P. HILL, Indiana LEE TERRY, Nebraska
DIANA DeGETTE, Colorado MIKE ROGERS, Michigan
ANTHONY D. WEINER, New York JOHN SULLIVAN, Oklahoma
HENRY A. WAXMAN, California TIM MURPHY, Pennsylvania
GENE GREEN, Texas JOE BARTON, Texas (ex officio)
JAN SCHAKOWSKY, Illinois
JOHN D. DINGELL, Michigan (ex
officio)
C O N T E N T S
----------
Page
Hon. Albert R. Wynn, a Representative in Congress from the State
of Maryland, opening statement................................. 1
Hon. John Shimkus, a Representative in Congress from the State of
Illinois, opening statement.................................... 4
Hon. Bart Stupak, a Representative in Congress from the State of
Michigan, opening statement.................................... 5
Hon. Cliff Stearns, a Representative in Congress from the State
of Florida, opening statement.................................. 6
Hon. Hilda L. Solis, a Representative in Congress from the State
of California, opening statement............................... 7
Submitted material........................................... 148
Hon. Gene Green, a Representative in Congress from the State of
Texas, prepared statement...................................... 9
Witnesses
John Stephenson, Director, Natural Resources and Environment
Division, Government Accountability Office..................... 10
Prepared statement........................................... 12
Answers to submitted questions............................... 243
James Pirkle, M.D., Deputy Director, Science, the Centers for
Disease Control and Prevention................................. 27
Prepared statement........................................... 29
Answers to submitted questions............................... 232
Robert Brackett, Ph.D., Director, Center for Food Safety and
Applied Nutrition, the Food and Drug Administration............ 45
Prepared statement........................................... 48
Answers to submitted questions............................... 182
Benjamin H. Grumbles, Assistant Administrator, Office of Water,
U.S. Environmental Protection Agency........................... 58
Accompanied by:
Susan Bodine, Assistant Administrator, Office of Solid Waste
and Emergency Response
George Gray, Assistant Administrator, Office of Research and
Development
Prepared statement........................................... 61
Answers to submitted questions............................... 195
Alex Beehler, Assistant Deputy Under Secretary of Defense,
Environment, Safety, and Occupational Health, U.S. Department
of Defense..................................................... 72
Prepared statement........................................... 74
Answers to submitted questions............................... 149
Anila Jacob, M.D., senior scientist, Environmental Working Group. 92
Prepared statement........................................... 95
Answers to submitted questions............................... 223
Gary L. Ginsberg, Connecticut Department of Public Health........ 110
Prepared statement........................................... 112
Answers to submitted questions............................... 259
Robert Utiger, M.D., Harvard Institute of Medicine............... 126
Prepared statement........................................... 128
Answers to submitted questions............................... 251
PERCHLORATE: HEALTH AND ENVIRONMENTAL IMPACTS OF UNREGULATED EXPOSURE
----------
WEDNESDAY, APRIL 25, 2007
House of Representatives,
Subcommittee on Environment
and Hazardous Materials,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:00 a.m., in
room 2322 of the Rayburn House Office Building, Hon. Albert R.
Wynn (chairman) presiding.
Members present: Representatives Stupak, Capps, Solis,
Butterfield, Shimkus, Stearns, Shadegg, Radanovich, and Barton.
Staff present: Caroline Ahearn, Karen Torrent, Ann
Strickland, Richard Frandsen, Chris Treanor, Margaret Horn, and
Jerry Couri.
OPENING STATEMENT OF HON. ALBERT R. WYNN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MARYLAND
Mr. Wynn. I would like to call this hearing to order. Today
we have a hearing on Perchlorate: Health and Environmental
Impacts of Unregulated Exposure. As part of this hearing, we
will discuss H.R. 1747, introduced by one of our distinguished
members of the subcommittee, Representative Hilda Solis. For
purposes of making opening statements, the Chair, the ranking
members of the subcommittee, and the full committee will each
be recognized for 5 minutes. All other members of the
subcommittee will be recognized for 3 minutes. Those members
may waive the right to make an opening statement and when first
recognized to question witnesses, instead add those 3 minutes
to their time for questions.
Without objection, all members have 5 legislative days to
submit opening statements for the record. At this time, the
Chair would recognize himself for an opening statement.
As I indicated, we are here today to hold a hearing on this
very important bill, H.R. 1747, and the subject of perchlorate
regulation. For almost a decade, EPA has delayed taking action
to place safe limitations on the amount of perchlorate that is
present in our drinking water and in our environment.
Perchlorate presents a risk to human health in vulnerable
populations, including women and children by inhibiting the
uptake of iodine by the thyroid gland. Impairment of thyroid
function in pregnant women can affect the fetus and infants and
result in delayed development and decreased learning
capability.
In fact, since 1996, EPA has failed to promulgate any
drinking water standards for any new emerging contaminants,
except for those that had a statutory deadline or were court
ordered via consent decree. Nor, for that matter, has the
Agency even identified any new emerging contaminants. This
administration has consistently taken the position that
additional information is needed before any regulatory action
can be taken. This stalling approach is a recurrent theme that
continues to not only impair the health of our citizens, but
also contributes to the ongoing degradation of our environment.
It appears this administration has cleverly employed a
strategy of passing the issue around between relevant agencies
so to avoid setting a safe drinking water standard for
perchlorate. An examination of the regulatory history of
perchlorate reveals no other conclusion but that EPA has failed
to take appropriate regulatory action in a timely manner.
Beginning in 2002, EPA had set a recommended assessment of 4 to
18 parts per billion (ppb.), and a reference dose of 1 ppb. A
reference dose (RfD) is an estimate of the amount of chemical
that a person can be exposed to on a daily basis that is not
anticipated to cause adverse health effects over a person's
lifetime.
DOD, which has approximately 60 known sites with
perchlorate contamination, was less than enthusiastic about
EPA's proposed 1 ppb. assessment and advocated for a much
higher threshold, 200 ppb. Although DOD is sampling and
monitoring for perchlorate, to date there has not been one
completed remedial action for perchlorate at any of these
facilities. DOD's reason for not cleaning up is that they are
waiting for a Federal drinking water standard.
So in 2003, instead of moving the administrative process
forward in response to pressure from the administration and
from DOD, EPA agreed to divert the process by sending 2002
draft assessment to the National Research Council of the
National Academy of Sciences for review. Eighteen months later,
in January 2005, at a cost of taxpayers of a quarter million
dollars, the NAS issued a findings recommending 24.5 ppb. This
RfD is significantly higher than the 1 ppb. that EPA originally
recommended.
Now, as recently as a couple of weeks ago, EPA stated that
it is going to continue to delay on a decision on whether to
regulate perchlorate because it needs additional information to
fully characterize perchlorate exposure and determine whether
regulating perchlorate in drinking water presents a meaningful
opportunity for health risk reduction.
The additional information, that EPA alleges that it needs,
relates to other exposure pathways, such as the food supply and
breast milk and more study of the effect on human health. This
excuse, I believe, is suspect. In 2003, FDA began studying the
extent of perchlorate in our food supply and came out with
finding in 2004 about the existence of perchlorate in lettuce
and milk.
Based on these findings, FDA conducted an additional study
which was completed in 2005. Unfortunately, the FDA is not
publishing these findings. Instead, the FDA has indicated it
needs to do even more study to adequately determine the full
impact of perchlorate on our food supply.
CDC studies have found that there are at least 43 million
women who are iodine deficient, whose health is at risk through
the impact of perchlorate that prevents the uptake of needed
iodine. These studies and samplings undertaken by EPA, CDC,
FDA, and DOD leave no question that perchlorate contamination
is pervasive in our environment and that it has infiltrated our
Nation's drinking water supplies and food.
Consequently, the health of our citizens continues to be at
risk. Despite all this evidence, the EPA's inaction continues.
Because of the detrimental health and environmental impact of
perchlorate, we can no longer wait for EPA to take action. The
time to regulate perchlorate is now. We, as a country, can no
longer put the health of our citizens and the state of our
environment aside while information gathering exercises
continue.
For these reasons, we believe it is important to have this
hearing today to consider the legislation H.R. 1747, which puts
an end to this running time clock and enables us to move
forward. I applaud Congresswoman Solis for her leadership on
this issue and look forward to the testimony from our two
panels, who are here with us today.
At this time, I would like to recognize our distinguished
ranking member of the subcommittee, Mr. Shimkus.
Mr. Shimkus. Thank you, Mr. Chairman. Before I start my
time, if I could engage in a colloquy with you. If it is OK
with you, I would like to do that.
Mr. Wynn. Certainly.
Mr. Shimkus. A couple concerns, and I appreciate the time
you and I have spent on the floor last night and the time that
your staff met with my staff on just some process issues. One
is, as we know, the hearing was initially noticed as a hearing
and then changed to a legislative hearing, which causes us some
concern. Not concerns, I think, that we can't overcome, but a
lot of people who represent rural America, and this whole safe
drinking water issue is--and I still have people in my
congressional district that are on wells.
So there is an issue about natural occurring issues. How
safe is safe? What is the cost of hooking up people to water
systems that are on well systems right now? And a cost/benefit
analysis of that. How are the State regulators going to
regulate it? Who is going to bare the cost of testing,
especially in small areas.
And since the folks that we have here today, some of those
don't represent some of those issues, I would respectfully ask
that, as we move through this process and gather the
information needed, that we also take another run at making
sure some of the stakeholders, especially again the folks that
I am concerned with, some of the rural areas, that they have a
chance to look at the language and see what kind of costs are
incurred, address the natural occurring issues, and then we can
really move forward.
Because the bottom line is if it is hazardous to health, I
want to be on board and be supportive. We just want to make
sure that we have a normal process. And we will help you
expeditiously do this. I mean it is not an attempt to try to
delay this process, but I would like to make sure that the
other stakeholders get a chance to testify.
Mr. Wynn. Well, I want to thank you for your comments, and
I want to show you that I am very sensitive to the concerns of
rural America. You may not know this, but my family comes from
a rural background in North Carolina. And I certainly
appreciate the concern of people who may be operating on wells
or other situations in rural communities.
I would be happy to work with you on this to make sure that
we can get the input that the committee needs with regard to
concerns that those folks may have at State level, rural
communities, what have you. Because we want to have a fair
process. We also want to have a process that allows for the
maximum input from all segments of the community and the
country in order to come up with a process that works. In
addition, when the bill passes, there will be an 18-month
process of regulatory proceedings that will also provide for
additional input. So I think we will have a good opportunity to
make sure those concerns are addressed. But I do want to assure
that in this subcommittee, we will be happy to work with you to
get that done.
Mr. Shimkus. And I appreciate that. Maybe if it is a formal
process or an informal process, just one last effort to be able
to make sure that everyone has their say. And they may say
nothing, so then we can move forward.
Mr. Wynn. Well, as I said, I am happy to work with you on
that, and if you give me the information, we can sit down and
talk about how we can get that done. If the gentleman would
like to make a further opening statement.
OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF ARIZONA
Mr. Shimkus. I would. Thank you, Mr. Chairman. Mr.
Chairman, thank you for calling this hearing on the health and
environmental impacts of perchlorate, and I hope you would
recognize the complexity of the issue and prospectus, follow
the past practices and wishes and committee precedences.
Clearly, good legislation requires that Members understand
the issues enough to vote intelligently on them. And I think in
our colloquy, we have addressed some of those issues. As far as
perchlorate's presence in drinking water is concerned, I am
glad that we are holding this hearing. As I said before in our
first hearing, that protecting public health should be our core
work in this committee. We have known for decades that
perchlorate can inhibit the uptake of iodine from the thyroid.
In fact, in the past, it was even used to treat adults with
hyperthyroidism as a way to properly regulate iodine in the
thyroid. What is not known though is how much perchlorate
Americans are unintentionally ingesting and at what level it
becomes a public health problem. This question should be
resolved by credible, objective science. I am not a scientist
by training, nor are the majority of my colleagues here on this
panel. That is why I believe it isn't Congress's job to make
arbitrary decisions about when and how EPA should regulate
perchlorate.
In fact, EPA was so backlogged with unfinished yet mandated
regulations that Congress and the Safe Drinking Water Act
amendments of 1996, took itself out of the mandatory drinking
water regulation business, and replaced it with directions to
EPA that it use deliberate, rigorous and objective science in
making any further rules on drinking water contaminant levels.
This may not satisfy some who want rapid regulatory production
out of EPA, but it is where I think good public policy is best
served. I know that some Members in various parts of the
country are concerned that EPA is not moving with enough speed
to issue mandatory enforceable limits on perchlorate in
drinking water, especially because they think Superfund
cleanups in their communities have been delayed because of it.
I share their frustration, as I have a community identified
in the GAO in 2005 that sits just outside my district with very
elevated amounts of perchlorate in the ground water. But I do
not yet think we should legislate on this matter. A
congressional mandate to regulate a contaminant in drinking
water is no guarantee that it will occur soon.
Take radon as an example. In 1986, Congress mandated that a
Federal standard for radon in drinking water be established.
EPA first proposed a radon standard in 1991 but hadn't
completed it in 1996 when Congress told them to get one in
place by 2001. In 2007, there is still no Federal drinking
water standard for radon. If you accept the premise that
perchlorate levels in drinking water are a public health
problem and used any of the previous and conflicting studies on
it to set a maximum contaminant level for perchlorate in
drinking water, you would have either severely compromised
human health or required much more expansive water treatment
than was necessary to combat the problem. And that is the cost
issue that I am referring to.
Even now, both the National Academy of Sciences and the
Centers for Disease Control studies call for additional
research in their conclusion. We must get the science right
first, or we minimize the very goals we hope EPA can achieve. I
look forward to hearing the testimony of the witnesses. I
especially want to welcome Dr. Utiger and thank him for being
here today. Today I hope to learn how much of a public health
problem perchlorate ingestion is, but I am also interested to
hear the level of disagreement among scientists over the health
effects of perchlorate on humans.
Mr. Chairman, I thank you for this time. Thank you for the
colloquy, and I yield back.
Mr. Wynn. Thank the ranking member for his comments. At
this time, the Chair will recognize Mr. Stupak for an opening
statement.
OPENING STATEMENT OF HON. BART STUPAK, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Stupak. Well, thank you, Mr. Chairman, and I hope we no
longer delay this legislation. It has been going on for way,
way, way too long. I want to salute Ms. Solis for her
leadership.
While we don't have any public water systems in Michigan
that are affected by this perchlorate, it is a major concern.
Yesterday, I held a hearing in Oversight and Investigations on
food safety containing E. coli, salmonella, and other dangerous
contaminants. And the reason why I make the point is because
perchlorate has also been found. FDA has found perchlorate at
harmful levels in lettuce, tomatoes, milk, and other foods
processed where the water has been contaminated by this
chemical. Way back when, on Oversight and Investigations, we
had hearings on Camp Lejeune, NC, with the water contamination
down there. We send these young men off, and their children are
drinking the water. And we have cancer rates in Camp Lejeune,
which are way too high, which many people believe is due to the
perchlorate.
The EPA has basically chosen to ignore this problem. What
we have heard for years is that they are going to do something.
So what happens on April 11? They announce that they don't
believe there is enough information on perchlorate to set a
standard for drinking water. Enough is enough. Our agencies are
not protecting the American people, whether it is EPA, whether
it is FDA. This Congress must act. We have a new direction in
this Congress. I am glad Ms. Solis is taking the lead on this
for so many years. Let us move this legislation. There is time.
Everyone can be heard. They want to be heard, they could have
been heard. Let us move. No more delays. Move this legislation
please, Mr. Chairman. I am pleased to be part of this
committee. I look forward to working with you to move this
legislation as quickly as possible as we need it for the safety
of the American people.
Mr. Wynn. I thank the gentleman for his opening statement.
I want to assure him I share your sense of urgency, and I think
that is what our new majority is bringing to this issue, a
sense of urgency that we need to get things done, move this
process forward. We want to get the necessary information, but
we don't want to engage in stalling or delay. At this time, the
Chair will recognize Mr. Stearns for an opening statement.
OPENING STATEMENT OF HON. CLIFF STEARNS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF FLORIDA
Mr. Stearns. Thank you, Mr. Chairman. I thank you and the
ranking member, Mr. Shimkus, for calling this meeting. I hear
my colleague talking about the urgency of this, but I feel on
this side that we are concerned that we are not able to hear
testimony from States, water utilities, or any other
stakeholders before possibly considering legislation to
regulate such a complex issue.
Perchlorate has been found across the country, and in
recent years, has emerged as a contaminant of concern. I think
we all understand that. However, many questions remain about
when human health is affected by various levels of ingestion of
this perchlorate. Used in the 1950's, we know, to treat Graves
disease. Perchlorate is now widely used in rockets and missiles
and others. Perchlorate salts are widely used to manufacture
various products, including fireworks, airbags, and road
flares.
But perchlorate has also been found naturally to occur at
levels exceeding 1,000 parts per million in natural minerals in
New Mexico, California, Canada, and Bolivia. This prompted the
EPA to state in its latest assessment ``it is not clear at this
time what proportion of perchlorate found in public water
supplies or entering the food chain comes from natural
sources.''
In February 2005, the EPA established its official
reference dose of perchlorate and translated that number to a
drinking water equivalent level of 24.5 ppb., which is
consistent with the recommended reference dose included in the
National Academy of Science report. Ultimately for the EPA to
further regulate perchlorate with an MCL, it needs to meet
three statutory requirements. One, that perchlorate may have an
adverse effect on a person's health. Two, that perchlorate is
either known or is likely to occur in public drinking water
systems at levels of public health concern. And three,
regulation of perchlorate in drinking water systems presents a
meaningful opportunity for health risk reduction.
My colleagues, within the last month, EPA announced that it
needs further research on the health effects of perchlorate
before making a regulatory determination, stating ``EPA is not
able to make a preliminary determination for perchlorate at
this time because in order to evaluate it against the three
statutory criteria, the Agency believes additional information
may be needed to fully characterize perchlorate exposure and
determine whether regulating perchlorate in drinking water
presents a meaningful opportunity for health risk reduction.''
Mr. Chairman, the National Academy of Sciences, the Centers
for Disease Control, and the Environmental Protection Agency
have all recommended that further research be conducted on the
possible health effects of perchlorate. I think it would be
wise to listen to the advise of the experts and to not make
arbitrary decisions about when and how EPA should be regulating
perchlorate. And again I thank you for this hearing, and I look
forward to the testimony.
Mr. Wynn. I thank the gentleman for his testimony. I do
want to assure the minority that we presented the customary
opportunity to provide witnesses, and Dr. Utiger was presented
to us as a witness from the minority side. But, as I indicated
to the ranking member, we are certainly willing to consider
additional information that you wanted to provide.
At this time, I want to recognize the person who has been a
real champion on this issue, that brought this issue forward
and is spearheading the effort to get action on it. I am
pleased to recognize the vice chairman of the subcommittee,
Representative Hilda Solis.
OPENING STATEMENT OF HON. HILDA L. SOLIS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Ms. Solis. Thank you, Chairman Wynn. I really can't tell
you how my community and folks that I have talked to across the
country about this issue, what a precedent this is for us at
this moment. As a member on this committee for the last few
years, we have had discussions on this issue. And while we
haven't, in the minority, been able to actually present a bill,
I am glad to see that today the residents and constituents that
we are fighting for every single day will know that we made an
attempt here to present what I think is a very balanced bill.
I do want to correct, for the record, that I did receive a
letter from the Association of Metropolitan Water Agencies, and
I would like to quote the letter, one of their statements that
``we believe your bill will reduce potential health risks, save
water providers and rate payers future treatment expenses, and
protect sources of drinking water'' so I know that this will be
entered into the record. I know that the gentleman, Mr.
Shimkus, has stated that there wasn't an effort to fully bring
everybody to the table.
Mr. Shimkus. Would the gentlewoman yield?
Ms. Solis. Let me finish.
Mr. Shimkus. OK.
Ms. Solis. I would just like to state I think it is great
that today we have EPA and DOD here jointly to help us talk
about the issue. And my premise here is that safety and
protection are first and foremost, and that has always been my
attempt. I think that Members here do need to know more about
how perchlorate affects the drinking water system and the
health and well being of women and children. And people that we
also work with and tend to, as they serve on our military
bases. I remember very distinctly having that long discussion
here about Camp Lejeune and the fact that we did not have
adequate representation from DOD at that time, and did not, as
a result, get that information. So I am happy that we can begin
and embark on that right now.
I will yield very quickly because I only have----
Mr. Shimkus. Yes, I would say that is fine, but rural water
and no water. I have no water districts. I have places with
wells, so that is kind of the issue.
Ms. Solis. I would also like to just refer to a graph that
is up on the chart there. This is a public systems of
detectable perchlorate contamination throughout the country,
and we have highlighted different areas where members of our
committee have jurisdiction. So you can look and see for
yourself where this impact really is. I would like to submit it
for the record those letters, and really like to thank the
public because in the State of California, we have been a
leader in this issue.
And I know that there are other States that likewise have
done that, but they have waited so long, 11 years waiting to
see that EPA will come to the table and set some appropriate
standard. And I have yet to see that. I hope that this will
move us in the right direction. Yes, there will be costs that
will be paid, but the higher cost of not protecting our
environment, protecting the well being of our citizens, is
first and foremost. And that is what EPA is charged with.
So I hope that we can work in the spirit of cooperation,
and again I want to thank all the members of our committee that
have come on as cosponsors. This is a bipartisan bill. I do
want to make that very clear, and there are people that are
very, very much wanting to see something happen because the
cost for not cleaning up is also taken up by our consumers and
ratepayers. And those individuals in my particular district
have had to forego not having water provided, several wells
that have been shut down in one city in the community of
Baldwin Park, where we now have the first attempt to clean up
perchlorate, could be possibly a lead model for how we deal
with this issue across the country.
So again I want to thank all our witnesses for being here,
and I really want to thank our chairman for conducting this
hearing today. Thank you very much, and I yield back.
Mr. Wynn. I thank the gentlelady. Without objection, her
full statement and her correspondence will be entered into the
record. At this time, the Chair will recognize Mr. Butterfield
for an opening statement.
Mr. Butterfield. Mr. Chairman, I don't have a formal
opening statement, but I too want to thank you for convening
this hearing today and having these witnesses to come forward.
And looking at the material that was furnished to me in advance
of this hearing today, it looks like my State of North Carolina
is seriously impacted. And so I am looking forward to the
testimony of the witnesses. Thank you. I yield back.
Mr. Wynn. I thank the gentleman. The gentleman, Mr.
Radanovich, is recognized for an opening statement.
Mr. Radanovich. Thank you, Mr. Chairman. I will waive the
opening statement.
Mr. Wynn. Are there any other opening statements? Seeing
none, this will conclude opening statements by the Members. Any
other statements may be submitted for the record.
[The prepared statement of Mr. Green follows:]
Prepared Statement of Hon. Gene Green, a Representative in Congress
from the State of Texas
Thank you, Mr. Chairman, for holding this hearing on the
health and environmental impacts of perchlorate.
The debate surrounding perchlorate has been going on since
1998 when the EPA placed it on a list of contaminants for
regulation under the Safe Drinking Water Act.
Multiple studies have been conducted on perchlorate and it
was even placed on a second list of contaminants eligible for
regulation.
Yet, the EPA still feels that they do not have sufficient
information on whether perchlorate in drinking water or our
food is a potential health hazard.
In March 2007, the EPA stated that they will take no
further action on the issue of perchlorate.
In the absence of a national standard, the States have been
left to regulate perchlorate levels. In Texas, we have our own
perchlorate industrial clean up level.
Perchlorate remediation has occurred in some contamination
sites. But a clear federal remediation policy has not been
established.
The DOD has adopted its own perchlorate clean up policy
until a Federal or State clean up standard in place.
With no Federal standard and only one State clean up
standard, the DOD is essentially doing the EPA's work.
We all know that the EPA has a complicated system of both
scientific and policy procedures before they enact any new
regulations.
Sometimes this is helpful, but sometimes these procedures
leave both communities and industries unclear and uncertain
about the EPA decisions.
Currently, our office is wading through the process of
having a toxic waste site in our district declared a Superfund.
We are just beginning the process, but already we are
experiencing some unexplained delays.
Some people think that the EPA is delaying action on
perchlorate and not fully justifying themselves in the process.
Today is their opportunity to answer their critics.
Thank you Mr. Chairman, I yield back my time.
----------
Mr. Wynn. We would now like to turn to our first panel of
witnesses, and again I would like to welcome them and thank
them for appearing before us.
We have with us today Mr. John Stephenson, Director of the
Natural Resources and Environment and Prevention Division
Government Accountability Office. Dr. James Pirkle, Deputy
Director for Science, the Centers for Disease Control. Dr.
Robert Brackett, Director, Center for Food Safety and Applied
Nutrition, the Food and Drug Administration. Mr. Ben Grumbles,
Assistant Administrator, Office of Water, U.S. Environmental
Protection Agency. And Alex Beehler, Assistant Deputy Under
Secretary of Defense, Environmental Safety and Occupational
Health, U.S. Department of Defense.
Again we are delighted to have you here, and we will now
hear 5-minute opening statements from the panel. I am sorry,
Ms. Bodine, forgive me. And, Mr. Gray, as well. We are
delighted to have you here as well. We would like to have your
5-minute opening statements. Of course, your full testimony is
included in the record. Mr. Stephenson.
STATEMENT OF JOHN STEPHENSON, DIRECTOR, NATURAL RESOURCES AND
ENVIRONMENT, GOVERNMENT ACCOUNTABILITY OFFICE
Mr. Stephenson. Mr. Chairman and members of the
subcommittee, thank you for the opportunity to discuss GAO's
work on perchlorate. My testimony attempts to provide some
perspective for today's hearing by describing the extent of
perchlorate contamination in the United States and by
summarizing the numerous studies that have been conducted on
the health effects of perchlorate in the past decade.
Perchlorate, as you have already heard, is a primary
ingredient in rocket fuel. About 90 percent of the perchlorate
produced in the United States is manufactured for use by the
Department of Defense and NASA, with total production
quantities averaging several million pounds a year.
Private industry also has used perchlorate to manufacture
automobile airbags, fireworks, flares and commercial
explosives. Perchlorate forms salts that are readily dissolved
and transported in water. People are exposed to perchlorate
primarily by ingesting it in drinking water and food, or by
manufactured products that contain the chemical.
EPA does not systematically track or monitor perchlorate
releases or the status of clean-up activities. As a result, it
was difficult for us to determine the full extent of
perchlorate contamination in the United States. We analyzed
data from EPA, DOD, the U.S. geological survey, and State
agency, and as shown in--do you have a figure to put up there
on the board? We have a map. Well, it is a little bit difficult
to see, but as shown in this figure, we identified nearly 400
sites across the country where perchlorate has been found in
ground water, surface water, soil, and public drinking water
systems in concentrations ranging from 4 ppb. to more than 3.7
million ppb. As you can see, the red States are where most of
the incidents were found.
Although these sites are located across 37 States in U.S.
territories, more than half were in California and Texas.
Public drinking water systems accounted for more than one-third
of the sites. That is 153 public water systems serving a
population of nearly 17 million people who were exposed to
perchlorate.
The source of perchlorate contamination is very difficult
to determine. In fact, the source could not be determined for
over half of the 400 sites we identified. Figure 2, the next
figure please, shows that of those sites where the sources
could be identified, almost 65 percent of the contamination
came from defense and aerospace activities, such as propellant
manufacturing, rocket motor research, and test firing our
explosives disposal.
Although some cleanups are occurring on a case-by-case
basis, EPA and DOD both told us they do not routinely clean up
contaminant sites primarily because there is no Federal
standard or specific Federal requirement for doing so.
Meanwhile, at least nine States including Maryland and
Massachusetts have established drinking water standards or
advisories levels for perchlorate that have been used to
require cleanup.
In our May 2005 report, we also identified and summarized
the results of 90 studies published since 1998 on the health
risk of perchlorate. While many were inconclusive, 26 of the
studies indicated that perchlorate had an adverse effect on
human health, and in particular, thyroid function. A list of
these studies can be found in the appendix of our report. The
National Academy of Sciences reviewed many of the same studies
that we looked at in reaching its conclusion about the human
health effects of perchlorate ingestion and safe levels of
exposure. However, the Academy's call for additional research
to help resolve questions about its effects specifically on
pregnant women.
As you will hear from Dr. Pirkle next, how CDC's recent
research offers answers to some of these questions by
describing the effects of perchlorate on thyroid hormone in
women, and its subsequent effect on central nervous system
development in the fetus.
So, Mr. Chairman, notwithstanding the growing body of
research on perchlorate, EPA's position has not significantly
changed in the past 10 years. Perchlorate has remained on EPA's
contaminant of concern list under the Safe Drinking Water Act
since 1998. And on April 11, this year, as you mentioned, EPA
reaffirmed its decision not to regulate perchlorate, citing the
need for additional research.
Although we took no position in our report on the drinking
water standard, leaving that to the experts, we did recommend
that as a minimum, EPA work with DOD and the States to develop
a formal tracking mechanism of reliable information on sites
contaminated with perchlorate and the status of cleanup
efforts.
While both EPA and DOD disagreed with our recommendation,
we continued to believe that the inconsistency and omissions in
available data that we found during the course of our review
underscore the need for a systematic way to collect more
reliable information on the full extent of perchlorate
contamination.
Mr. Chairman, that concludes the summary of my prepared
statement, and I will be happy to answer questions at the
appropriate time.
[The prepared statement of Mr. Stephenson follows:]
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Mr. Wynn. Thank you. Dr. Pirkle.
STATEMENT OF JAMES PIRKLE, M.D., PH.D., DEPUTY DIRECTOR FOR
SCIENCE, NATIONAL CENTER FOR ENVIRONMENTAL HEALTH, THE CENTERS
FOR DISEASE CONTROL AND PREVENTION
Dr. Pirkle. I am pleased to be here today to discuss the
results of two studies by CDC researchers investigating
exposure to perchlorate in the U.S. population and the
relationship between exposure to perchlorate and thyroid
function.
Using a new method developed at CDC to measure perchlorate
in human urine, our laboratory measured perchlorate in the
urine of participants in CDC's national health and nutrition
examination survey in 2001 and 2002. This survey is designed to
provide health and nutritional information for the civilian,
non-institutionalized U.S. population.
The survey also measured in these people serum levels of
two thyroid hormones, Total Thyroxin, also called Total T4, and
Thyroid Stimulating Hormone, commonly referred to as TSH. From
their analyses of the results, CDC researchers published two
papers. The first paper examined perchlorate exposure in the
U.S. population for people age 6 years and older. Measurable
amounts of perchlorate were found in the urine of all 2,820
survey participants, indicating widespread human exposure in
the U.S. population.
Levels of perchlorate in children were higher than those
found in adolescents and adults, and this difference was
statistically significant. For adults, CDC researchers compared
the levels found in the population with the EPA reference dose.
We found that only 11 adults out of 1,532 had estimated dose
levels exceeding this reference dose. For adults, the median
estimated dose was about one-tenth the reference dose, and a
95th percentile was about one-third the EPA reference dose.
Similar calculations for children are not yet available,
pending evaluation of proper equations to make these dose
estimates for children.
The second paper examined the relationship between urine
perchlorate levels and thyroid hormone level, specifically
Total Thyroxin and TSH, for people age 12 years and older.
Perchlorate at high doses is already known to decrease thyroxin
levels, and, in fact, in the past, perchlorate was used
therapeutically to lower thyroxin levels. This study examined
perchlorate at levels common in the U.S. population,
perchlorate levels that are much lower than those used
therapeutically to intentionally reduce thyroxin.
The results of this study show that for men no relationship
was found between perchlorate levels and levels of thyroid
hormones. For women who had urine iodine levels less than 100
micrograms per liter, we found that perchlorate levels common
in the U.S. population were significantly associated with small
to medium-sized changes in both thyroxin and TSH levels. That
is, higher perchlorate levels were associated with decreased
levels of thyroxin and increased levels of TSH. 36 percent of
women in the U.S. population have these lower urinary iodine
levels, a percentage that corresponds to about 43 million
women.
For women with urinary iodine levels greater than 100
micrograms per liter, perchlorate levels showed a statistically
significant association with TSH but not with thyroxin. This
was the first study to evaluate perchlorate exposure and
thyroid function in women with these lower urinary iodine
levels. The finding of an association between perchlorate
exposure and thyroid hormone levels in these women was
unexpected based on previous research and will prompt further
study.
CDC researchers are planning a second study to affirm and
build upon their findings. Adequate intake of iodine has
previously been recognized as important for healthy thyroid
function. These study results would reinforce that
recommendation for women.
In summary, these two studies found low-level perchlorate
exposure to be widespread in the U.S. population. Among men,
perchlorate levels were not associated with changes in thyroid
hormone levels. Among women with lower levels of iodine in
their urine, perchlorate exposure that is common in the U.S.
population was associated with small to medium-sized changes in
thyroid hormone levels. Adequate intake of iodine substantially
diminishes the association of perchlorate with thyroid hormone
levels in women.
Mr. Chairman, this concludes my prepared statement, and I
will be happy to respond to any questions at the appropriate
time.
[The prepared statement of Dr. Pirkle follows:]
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Mr. Wynn. Dr. Brackett.
STATEMENT OF ROBERT BRACKETT, PH.D., DIRECTOR, CENTER FOR FOOD
SAFETY AND APPLIED NUTRITION, THE FOOD AND DRUG ADMINISTRATION
Mr. Brackett. Thank you and good morning, Mr. Chairman and
members of the subcommittee. I am Dr. Robert Brackett, director
for the Center of Food Safety and Applied Nutrition at FDA. I
want to thank you for the opportunity to testify about FDA's
efforts to measure and assess the presence of perchlorate in
food and beverages. And I am pleased to be here today with my
colleagues from CDC, EPA, and DOD.
All of us at FDA take our responsibility to protect the
Nation's food supply very seriously. And to better understand
the potential of food, as an exposure pathway of perchlorate,
we began in 2003 to sample and analyze a variety of foods to
determine the occurrence of perchlorate and estimate the
resulting human exposure through consumption of those foods.
These studies will allow us to characterize exposure to
perchlorate from foods and will be used in scientific support
for any further action that might be needed to protect public
health.
As a first step in our investigation, FDA developed a rapid
and scientifically accurate method to measure the presence of
perchlorate in foods, and this method can detect perchlorate at
levels as low as 1 ppb. for produce, 3 ppb. for milk, grain
products, and fish, and one-half ppb. for bottled water.
In December 2003, FDA began an initial exploratory survey
of a small number of domestically produced foods that we
anticipated might contain higher levels of perchlorate due to
the location of where the food was grown and its high water
content. The first collection of data, conducted from December
2003 through August 2004, involved two phases. In the first
phase of the survey, 150 samples of lettuce and 50 samples of
bottled water were collected and analyzed for perchlorate. In
the second phase on the survey, beginning in August of 2004, we
collected and analyzed the following: 120 samples of milk, 55
samples of tomato, 45 of carrot, 45 of cantaloupe, and 35 of
spinach.
To inform the public of FDA's progress and to share its
initial exploratory data, in November 2004, we posted on FDA's
Web site the initial set of perchlorate data. These data
included perchlorate levels found in our samples of lettuce,
bottled water, and milk. And FDA also posted a set of questions
and answers on perchlorate to explain the survey data and
provide better context to the public.
The values for perchlorate found in food stuff sampled in
2004 were similar to those reported by researchers outside the
Agency, and the data confirmed that we should continue to
investigate the occurrence of perchlorate in a greater variety
of foods and in other regions in the country.
In February 2005, FDA issued a second survey assignment to
obtain information on the distribution of the perchlorate in a
wider variety of foods. The survey called for a total 450
samples, domestic and imported, to be collected in two phases
during fiscal year 2005. The first phase was a collection of
additional samples of tomatoes, carrots, spinach, and
cantaloupe, and a collection of a wide variety of foods that
included fruits and fruit juices, vegetables, and grain
products. The second phase consisted of collecting additional
types of fruits, vegetables, and grain products as well as
aquaculture fish.
In a separate survey assignment issued in December 2004,
FDA collected and analyzed 105 farm milk samples, 105
associated feed samples, and 105 water samples from dairy farms
in top milk-producing States. And this was done in order to
determine the potential source of contamination at the farm
level.
In addition, we collected and analyzed 228 baby food
samples obtained in markets nationwide. Separately, we also
collected and analyzed 21 samples of infant formula, and we
plan to collect and analyze an additional 40 infant formula
samples in 2007.
FDA has compiled a preliminary mean perchlorate exposure
assessment for the general population, based on our 2004-05
exploratory survey data for 27 types of food and beverages. Our
analysis has been reviewed by three external government
experts, and it has been shared with the interagency working
group. And when finalized, we plan to release the exploratory
exposure assessment to the public. It is important to reiterate
that this preliminary exposure assessment is based on food data
that does not represent the complete diet of the U.S. and is
therefore not necessarily a reflection of perchlorate exposure
to the general U.S. population.
We do, however, expect to have representative exposure
estimates following our analysis of data collected under our
total dietary study or TDS. Through the TDS dietary intakes of
various nutrients and contaminants by the U.S. population can
be estimated. Since its inception in 1961, the TDS has grown to
encompass many substances, including pesticide residues,
industrial chemicals, and toxic and nutrient elements.
The foods collected in the TDS represent the major
components of the diet of U.S. populations, and in this, foods
are prepared as they normally would be and consumed prior to
analysis. So the analytical results provide the basis for a
realistic estimate of the dietary intake of the substances that
are under the study.
During fiscal year 2005 and 2006, FDA analyzed samples from
the total dietary survey for perchlorate, and we do plan to
publish in late 2007 an assessment of the exposure to
perchlorate from food based on the level found in the TDS
study. Because of the size of the data set and the design of
the study, these data will provide a more robust estimate of
the exposure of U.S. consumers to perchlorate through food
consumption.
Currently FDA is continuing to test samples of specific
food types collected through additional targeted surveys, as
described in my written testimony, and will continue to work
with our partners at USDA and EPA to determine the occurrence
of perchlorate in foods and conduct an assessment of the
dietary exposure. FDA is aware that other data on perchlorate
levels in foods are under development, and we welcome external
research that can assist us in describing the distribution of
perchlorate in foods and developing exposure estimates.
Consumers should not view the low levels of perchlorate in
their foods we have tested as an indicator of so-called risk of
eating certain foods. At this time, FDA continues to recommend
that consumers eat a balanced diet, choosing a variety of foods
that is low in trans fat and saturated fat and rich in high-
fiber grains, fruits, and vegetables.
Thank you for the opportunity to discuss this important
public health issue with you, and I will be happy to answer any
questions you may have.
[The prepared statement of Mr. Brackett follows:]
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Mr. Wynn. Thank you. Mr. Grumbles.
STATEMENT OF BENJAMIN H. GRUMBLES, OFFICE OF WATER, U.S.
ENVIRONMENTAL PROTECTION AGENCY, ACCOMPANIED BY SUSAN BODINE,
ASSISTANT ADMINISTRATOR, SOLD WASTE AND EMERGENCY RESPONSE,
ENVIRONMENTAL PROTECTION AGENCY, AND GEORGE GRAY, ASSISTANT
ADMINISTRATOR, RESEARCH AND DEVELOPMENT, ENVIRONMENTAL
PROTECTION AGENCY
Mr. Grumbles. Thank you, Mr. Chairman and members of the
subcommittee. I am Ben Grumbles, and I am accompanied by George
Gray and Susan Bodine, all of the U.S. Environmental Protection
Agency, and we appreciate the opportunity to testify on EPA's
important efforts regarding perchlorate. EPA is committed to
using the best available science on perchlorate and to ensure
that our policies continue to protect public health and the
environment. We have been working with other Federal agencies
to gather and understand data needed to assess the risk of
perchlorate to human health and the need for risk management
actions.
The first thing I would like to do is to mention the
efforts with respect to assessing health risks of perchlorate.
As you know and has been described by Members, the National
Academy of Science has reviewed the Agency's 2002 draft
perchlorate risk assessment. In the final report, published in
January 2005, the NAS recommended the Agency use a reference
dose of 0.0007 milligrams per kilogram per day. EPA endorsed
this recommendation and reviews the NAS report as the basis for
establishing our reference dose, which was subsequently posted
on the Integrated Risk Information System database in February
2005.
The NAS recommended the use of a human study conducted by
Greer as the principal study. Because this study was based on
healthy adult men and women, an uncertainty factor of 10 was
applied to the no observed effect level identified from the
Greer data to protect the most sensitive population, that is
the fetuses of pregnant women who might have hypothyroidism or
iodine deficiency. The NAS indicated that deriving the
reference dose to prevent a non-adverse precursor effect, which
would precede an adverse effect, is a conservative and health-
protective approach to perchlorate risk assessment.
EPA is very interested in the findings on perchlorate
exposure and thyroid function recently reported by CDC
researchers. They recommend additional research to affirm and
build upon the findings, and we look forward to reviewing the
studies. In the meantime, Mr. Chairman and members of this
committee, we believe the current reference dose is a
scientifically appropriate value for use in our decision-
making.
In addition, to reduce potential risks at contaminated
sites, EPA issued guidance in January 2006 that recommended a
revised preliminary remediation goal of 24.5 ppb. And again,
this was based on the reference dose adopted by the Agency
following the NAS study and was calculated based on standard
exposure values of 70 kilograms body weight and 2 liters of
water consumer per day.
I want to reiterate that the preliminary remediation goals
are not final cleanup levels. They are merely the starting
point for identifying site-specific goals. They are developed
based on readily available information and modified as
necessary as more information becomes available. And in
addition, if a State has promulgated a drinking water standard
for perchlorate, that value would be considered as an ARAR
[Applicable or Relevant and Appropriate Requirement] term under
the Superfund statute and used as the groundwater cleanup level
for sites in that State.
Perchlorate has been found at 49 NPL [National Priorities
List] sites out of 1,562 current and deleted sites. At
approximately 31 sites, perchlorate concentrations in
groundwater or drinking water exceed the 24.5 ppb. level.
Effective perchlorate treatment systems are in operation at a
number of sites, and EPA will continue to track the progress at
all NPL sites where a cleanup decision has not yet been made in
order to ensure the groundwater is treated to levels that are
protective of human health and the environment.
Now, with respect to Safe Drinking Water Act, EPA is
working to identify appropriate risk management actions for
perchlorate following the established process in the Safe
Drinking Water Act to determine whether Federal regulation
would present a meaningful opportunity for health risk
reduction. The Agency is placing a high priority on making a
regulatory determination for perchlorate as soon as possible.
Let me repeat that. The Agency is placing a high priority on
making a regulatory determination for perchlorate as soon as
possible.
As has been discussed in 1998, perchlorate was placed on
the first CCL list. When the first set of regulatory
determinations were released in 2003, EPA did not have
sufficient information to make a determination, and so we added
to the second contaminant candidate list. The administrator
recently signed a Federal registered notice with preliminary
regulatory determinations for contaminants on the second CCL
list. The notice describes why the Agency is not making a
preliminary determination on perchlorate at this time, and it
provides an extensive update on our research and review of the
issue.
Based on the reference dose, the Agency has sufficient
information on health effects to inform a regulatory
determination. We have sufficient data on the occurrence of
perchlorate in public water supplies; however, Mr. Chairman, we
still need to more fully characterize and understand
perchlorate exposure before a determination can be made.
EPA collected drinking water occurrence data during the
first round of the unregulated contaminant monitoring program,
which requires short-term monitoring for specific contaminants
to support regulatory development. A total of 3,858 water
systems were monitored for perchlorate from 2001 and 2003. It
was detected at levels above the minimum reporting level of 4
ppb. in approximately 2 percent of the more than 34,000 samples
analyzed. The average concentration detected was 9.8 ppb., and
the median concentration was 6.4 ppb.
Before the Agency can make a preliminary regulatory
determination, we need to better understand total perchlorate
exposure and the relative source contribution.
Mr. Chairman, I would just conclude by saying that all of
us share the goal of safe and affordable water. Clearly, there
are differences in how we achieve that goal. EPA is committed
to using the best available science and to making a regulatory
determination on perchlorate as soon as possible. Thank you,
Mr. Chairman.
[The prepared statement of Mr. Grumbles follows:]
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Mr. Wynn. Thank you. Mr. Beehler.
STATEMENT OF ALEX BEEHLER, ASSISTANT DEPUTY UNDER SECRETARY OF
DEFENSE, ENVIRONMENT, SAFETY, AND OCCUPATIONAL HEALTH, U.S.
DEPARTMENT OF DEFENSE
Mr. Beehler. Thank you, Chairman Wynn, Ranking Member
Shimkus, and distinguished members of the subcommittee. I
appreciate the opportunity to appear before you today to
address the Department of Defense activities relating to
perchlorate, especially as there continues to be some
misperceptions. I ask that my written testimony be submitted
for the record, and I will provide brief summary remarks.
Let me first start by introducing Ms. Shannon Cuniff, who
has been organizing the Department's response to perchlorate
since her arrival in March 2004.
DOD relies on perchlorate as an oxidizer in explosives,
pyrotechnics, rocket fuel, and missiles because it is by far
the most efficient and stable propellant oxidizer available.
Over the past several years, research has revealed a number
of non-DOD natural and manmade sources of perchlorate, such as
road flares, fireworks, certain natural mineral formations, and
fertilizers that can cause low-level, widespread contamination.
Now, that an ability to differentiate between different sources
of perchlorate exists, responsible parties can be identified
with greater confidence.
Since November 2002, DOD policy specifically directs
perchlorate assessment. DOD's most recent perchlorate policy of
January 2006 requires perchlorate sampling in drinking water,
groundwater, and wastewater discharges. The policy establishes
a 24 ppb. level of concern in water. That is based on EPA's
reference dose. This level of concern is simply a departure
point for site-specific risk analyses in the absence of any
applicable Federal or State standards. DOD has and will
continue to comply with applicable Federal and State standards
regarding perchlorate.
DOD has adopted a three-pronged approach to risk management
of perchlorate. Number 1, assessing potential releases. Number
2, taking appropriate response actions where necessary. And No.
3, investing in R&D. Through fiscal year 2006, perchlorate
sampling has been conducted at 237 DOD installations former
properties. The majority of samples taken at sites where
perchlorate releases may have occurred have resulted either in
non-detect or levels well below the current EPA reference dose.
DOD and the State of California have worked collaboratively
to develop a prioritization protocol where 924 current and
formerly used defense sites in California were jointly
reviewed. So far, 97 percent do not currently appear to pose a
threat to drinking water related to perchlorate. The remaining
3 percent are still under joint review.
Site-specific risk assessments are conducted under the
Defense Environmental Restoration Program (DERP) and CERCLA in
coordination with EPA and/or State regulators. The DERP Annual
Report to Congress provides summaries of cleanup actions at DOD
installations. Even before there was any clear regulatory
requirement, DOD began response actions at a number of bases
including Massachusetts Military Reserve, Redstone Arsenal,
Vandenburg, and Edwards Air Forces Bases, and the Naval Weapons
Industrial Reserve Plant.
DOD has invested over $114 million in research related to
perchlorate to advance the state of technology regarding
perchlorate treatment in water and has found suitable
substitutes for a number of military specific applications,
such as simulators that account for a majority of perchlorate
expended in Army training ranges. Work is also underway to
eliminate perchlorate in pyrotechnic flare compositions and in
solid rocket propellants.
DOD's six drinking water treatment technology
demonstrations in the Inland Empire have added approximately
5,000 gallons per minute of new treatment capacity with reduced
cost. DOD performed this work even though there is no evidence
that perchlorate found in this area results from current or
former DOD installations.
The latest round of DOD-wide perchlorate sampling data
shows that we are taking appropriate response actions and DOD
installations overall do not appear to be a significant source
of perchlorate releases to the Nation's drinking water. We
believe that DOD has acted responsibly as the science and
understanding of perchlorate has evolved.
In closing, Mr. Chairman, I sincerely thank you for this
opportunity to highlight the department's activities related to
perchlorate.
[The prepared statement of Mr. Beehler follows:]
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Mr. Wynn. Thank you, Mr. Beehler. This concludes the
opening statements of our first panel, and the Chair would like
to recognize himself now for 5 minutes of questioning. I want
to go directly to you, Mr. Beehler, because I was a bit
confused. Did you state in one of your statistical points that
97 percent of the sites did not pose a threat to human health?
Mr. Beehler. As far as the work that we have done in
conjunction with the State of California, we have reviewed in
the State of California 924 sites jointly.
Mr. Wynn. Well, did you say that 97 percent of them didn't
pose a threat? Is that your contention?
Mr. Beehler. That is what the State of California has
determined, and we agree with them.
Mr. Wynn. Did DOD determine or did California determine?
Mr. Beehler. The State of California determined jointly
with DOD.
Mr. Wynn. That there was no threat to human health?
Mr. Beehler. That is correct.
Mr. Wynn. All right. Well, if that is the case, why did you
say that you are waiting? And maybe this is not DOD's position,
but it was reported by Mr. Stephenson that DOD's position was
that you were waiting on EPA to develop a safe drinking water
standard.
Mr. Beehler. Mr. Chairman, we are not. We are stepping out.
We have stepped out over the past several years. That is why I
have indicated in my testimony, both written and oral, that we
have undertaken sampling.
Mr. Wynn. Let me just jump in. I think you are doing some
things to sample and monitor. I don't deny that. But my
question though is you said that there was substitutes
available for the use of perchlorate in your explosives. Why
aren't you using the substitutes?
Mr. Beehler. Mr. Chairman, what I said was that we have
spent millions of dollars developing technology to make sure
that in certain areas, for instance, we can come up with
substitutes such as----
Mr. Wynn. So you don't have them or you do have them?
Mr. Beehler. And these things have to be tested to make
sure that they are effective. In the case of simulators, the
testing is complete, and we are now basically substituting
those simulators so that within a matter of about 12 months
there will be no more simulators used by the Army that has
perchlorate. We are doing similar testing with the hope that in
propellants and flare compositions that we have the same
effective credibility, and therefore we can effectively make
the substitutes.
Mr. Wynn. Thank you. Mr. Stephenson, was it your position
that DOD was waiting on EPA? Was that your finding?
Mr. Stephenson. No, what we said is they are on a case-by-
case basis. They are doing some monitoring and cleanup. We
haven't looked at this in the last 18 months, so there may be
more action since our report was issued. What we said is that
until there is a standard, their position is that they are not
required to do anything.
Mr. Wynn. Well, isn't that the same as waiting on a
standard?
Mr. Stephenson. Well, to me it is. I don't----
Mr. Beehler. Well, I beg to differ with that testimony.
Mr. Wynn. Thank you. I am asking Mr. Stephenson. I think
the last comment clarified. He interpreted it as waiting on a
standard. Mr. Stephenson, what percent is caused by human
activity?
Mr. Stephenson. At the time we looked at the data of those
400 sites, there was almost half of them where the source could
not be determined. So some of that could be naturally
occurring, as Mr. Shimkus reported. But it is very difficult to
determine what the source is. That is why we are suggesting
that more comprehensive data needs to be developed.
Mr. Wynn. Well, the question I have is whether manmade or
naturally occurring, does it enter the drinking water supply?
Mr. Stephenson. Well, you can't say until you know the
sources of the contamination. We know of those 400 sites,
certainly at least half of them were manmade causes.
Mr. Wynn. All right.
Mr. Stephenson. And DOD accounts for 90 percent of the use
of the material.
Mr. Wynn. OK, Dr. Pirkle, you were saying that you felt
that there was widespread exposure to perchlorate. I think you
cited 43 million women, or was it 43 million individuals?
Dr. Pirkle. We actually found widespread exposure. Every
single person that we sampled in the survey 6 years and older,
2,820 people, 100 percent had measurable levels of perchlorate
in their urine. It was 43 million women who had low levels of
iodine, which put them in the at-risk group for changes in
thyroid hormone levels resulting from perchlorate exposure. But
in terms of widespread exposure, we found measurable levels of
perchlorate in all persons that we tested in our survey.
Mr. Wynn. Did you come to a conclusion about whether this
low iodine level posed a significant health risk?
Dr. Pirkle. The low iodine level?
Mr. Wynn. Yes. Wasn't that what you said that you found low
iodine level in 43 million women, in urine of 43 million women?
Dr. Pirkle. Right, the concept is that perchlorate is
likely to have a larger effect in people who have low amounts
of iodine since it blocks iodine uptake into the thyroid. And
so it was women with low urinary iodine that were at risk that
supported the finding of an association between perchlorate
exposure and changes in thyroid hormone levels. So, yes, 43
million women we would consider at risk for thyroid hormone
changes from exposure to perchlorate.
Mr. Wynn. That would seem to be a pretty significant
potential risk. I see my time has expired. I would like to call
on the ranking member, Mr. Shimkus.
Mr. Shimkus. Thank you, Mr. Chairman. The first thing, as a
conservative Republican, that I want to be accused of is
defending of bureaucracy. So I will not go in that direction,
but I do have some questions, and I would like to refer these
to Mr. Grumbles. This is the tried-and-true Chairman Dingell
approach. If you can answer with a ``yes'' and ``no'' answer, I
would appreciate it. Are you following the procedures laid out
in the Safe Drinking Water Act, as amended, in determining
whether to regulate perchlorate?
Mr. Grumbles. Yes.
Mr. Shimkus. Mr. Grumbles, some of my colleagues think that
you and the Agency are stalling. Are you stalling?
Mr. Grumbles. No.
Mr. Shimkus. Does the Agency believe that the regulatory
timelines of 1 year to propose an MCL for perchlorate and 18
months to go final with it are realistic and better serve the
goal of setting an appropriate standard?
Mr. Grumbles. Can I provide you something more than a
``yes'' or ``no'' on that? We don't have an official position
on the legislation.
Mr. Shimkus. But this is a legislative hearing.
Mr. Grumbles. I do have concerns.
Mr. Shimkus. This is a legislative hearing.
Mr. Grumbles. There is not an official----
Mr. Shimkus. Isn't it?
Mr. Wynn. If it is a legislative hearing, why don't you let
the witness answer?
Mr. Shimkus. Just asking.
Mr. Grumbles. I would have concerns about the schedule and
taking the decision away from the Agency. I think the general
approach should be to let the science drive the result, and so
I would have concerns about the schedule that is laid out.
Mr. Shimkus. Do you have a problem with the three legal
requirements of the Safe Drinking Water Act regarding to the
regulation of contaminants?
Mr. Grumbles. No.
Mr. Shimkus. Do you think that a statutory exemption to
them, not matter how well meaning, limits your ability to set a
health protection level?
Mr. Grumbles. Well, we are working with the 1996
amendments. We think that is a very good approach. It requires
a lot of effort, a lot of coordination. But we think it is the
vision of the subcommittee in 1996 to put that structure into
place, to look at health effects and occurrence and whether
there is a meaningful opportunity to reduce risks to human
health with public water systems is a good one that we should
continue to work through that process.
Mr. Shimkus. OK, let me ask you and, I think, Mr.
Stephenson. Assuming that we want credible science, real
science, to help dictate standards, and obviously the concerns
from my colleagues is we are not moving fast enough. What can
we do here to speed up the process so that if we move on a
standard, it is a credible, well-intentioned, scientifically-
based standard, and we are ready to assume those costs? Is
there anything we can do through language or through
expenditures of funds to help speed up this conglomeration of
scientific information and knowledge? Mr. Stephenson?
Mr. Stephenson. It is a complicated issue, but at a
minimum, what our work showed is it is very difficult to
determine how widespread perchlorate exposure is. So even
requiring better monitoring than it currently being done as Mr.
Grumbles mentioned there has been one look at drinking water
facilities over a 1-year period between 2001 and 2003. That was
enough evidence for them to answer that part of the requirement
to set a drinking water standard. Now, we are looking at more
research. We are not a scientific organization so----
Mr. Shimkus. Let me go to Mr. Grumbles. Is there anything
we can do to kind of speed this process up?
Mr. Grumbles. Well, I think we truly welcome the
congressional oversight and the interest in getting to the end
of this complex process that the statute envisioned in the 1996
amendments. And we are putting at a high priority on getting to
the end of that process, and what it really hinges on----
Mr. Shimkus. If you can summarize, I have two more points I
want to make before my time is up.
Mr. Grumbles. OK. Well, we think the key is to let the
scientists among the agencies inform the administrator so that
he can, in his sole judgment, make that determination about
meaningful opportunities to reduce risk.
Mr. Shimkus. Great, thank you. And we address this letter
from the Association of Metropolitan Water Agencies that was
submitted in support of legislation. And they represent huge
water companies. What we don't have is letters of support from
the NAWC, which is the for-profit water companies, the AWWA,
which is a mid-size, like the city of Springfield, the State
capital of Illinois, or even the rurals as I mentioned earlier.
And that is kind of my concern that we have everybody involved
with.
And just referring to the committee's staff, this comes
from the GAO on the map. We said MCL. The MCL will mandate
national standards and testing. And we have States that have no
perchlorate, none. But the burden of testing and research will
be placed upon the ratepayers and the citizens and may delay
deployment of water. Thank you, Mr. Chairman.
Mr. Wynn. The gentleman's time is--I believe Mr. Stupak is
next, but you wanted to defer. That would be fine. I would like
to call on Ms. Solis.
Ms. Solis. Thank you, Mr. Chairman. I would like to just
state for the record also that in fact we don't know where
perchlorate is. And in many cases, the ratepayers, because we
don't have any relief from the Federal Government or DOD, are
having to pay for much of the cleanup. In particular, in my
district, Riverside and San Bernardino where we are finding
more exposure. I can't understand why we continue to talk about
the science, the science, the science, when we know that
exposure does have devastating effect on communities.
I have a lot of questions. I probably won't be able to get
through all of them, but I want to begin with Mr. Grumbles, if
I might. The Metropolitan Water District in southern California
is one of the Nation's largest providers that treats drinking
water. They work with helping to move 1.5 billion gallons of
water through its distribution system, serving 18 million
people. In recent correspondence, Metropolitan stated that
perchlorate contamination of local groundwater basins remains a
serious threat to local water supplies.
According to your written testimony, one of Administrator
Johnson's key principles for EPA is to ``use the best available
science for decision making to accelerate the pace of
environmental protection.'' And as you are aware, the State
Drinking Water Act authorizes the U.S. EPA to set a national
health-based standard for drinking water to protect against
both naturally occurring and manmade contaminants.
Since the Act was last amended in 1996, has the EPA set
drinking water standards for any new emerging contaminants
which were not otherwise required by the Safe Drinking Water
Act or by consent decree? A yes or no.
Mr. Grumbles. The short answer is no.
Ms. Solis. OK.
Mr. Grumbles. The longer answer is that we have them on our
list for additional research and information and review.
Ms. Solis. OK, I would like to ask Mr. Beehler about
Department of Defense history regarding perchlorate
contamination. Beginning back in 2002, each year since, the
Department of Defense actively sought exemptions from public
health and environmental laws which protect drinking water
supplies from chemical constituents and military munitions,
including perchlorate.
In a letter dated June 27, 2003, the EPA reported that the
Defense Department is deferring any cleanup action, including
the interim measure, until completion of a final perchlorate
standard regarding cleanup at Aberdeen Proving Grounds.
And in May 2005, a GAO office report noted that according
to EPA and State officials, the Department of Defense has been
reluctant to sample on or near active installations because
there is no Federal regulatory standard for perchlorate.
According to the most recent DOD information that was provided
to the committee, there are 61 Superfund Federal facility sites
where either the soil, sediment, surface, or groundwater is
contaminated with perchlorate. Thirty-four of these are
Department of Defense facilities with sampling results that
exceed EPA's current reference dose guidance level of 24 ppb.
This includes facilities with extremely high levels of
perchlorate.
In fact, Mr. Grumbles's written testimony indicates ``no
record of decision on perchlorate cleanup levels have been
finalized at any Superfund site since EPA issued the revised
guidance of 2006.'' So my question is: at any of the 61 Federal
facilities, have they completed a record of decision under
CERCLA documenting the nature and extent of the contamination
or selected remedy?
Mr. Beehler. I will take that for the record. I would like
to say three things. Number 1, I was not at DOD prior to
January 2004. So I cannot comment on what transpired in 2003.
And we have since 2004 engaged in sampling. We have done
response actions at at least 12 different sites which we have
provided the House Energy Commerce Committee----
Ms. Solis. Thank you very much.
Mr. Beehler [continuing]. take action without having had--
--
Ms. Solis. Excuse me. I have limited time. My next question
is again for Mr. Grumbles. In a letter dated July 16, 2003, the
EPA region 10 relinquished its concurrent oversight role for
cleanup. In a letter, Region 10 noticed some disturbing
behavior patterns in the letter, which state ``on many issues,
the Army has not been responsive to EPA's comments. Significant
data gaps in procedurals at Camp Bonneville are the result of
lack of cooperation and collaboration in the base closure team
process. Again, the site lacks a necessary level of site
characterization information. We believe this information could
have been developed had the Army incorporated our comments into
their characterization, work plans, and related analysis over
the past 7 years.''
The letter notes that the Army's refusal to publish in any
Federal Superfund decision documents clear statements of
applicable requirements for cleanup actions taken, which are
needed for regulators and the public to track the Army's
compliance. It also noted that the Army unilaterally made field
changes without consulting regulators and in some cases
rendering field work useless. Rather than use its authority,
EPA relinquished its concurrent oversight role for cleanup.
To me, this case exemplifies the ongoing refusal of DOD to
cooperate and the failure of EPA to use its enforcement
authority. Mr. Beehler, why was the Army not responsive to
Region 10 comments?
Mr. Beehler. I will have to look into that. I will provide
the committee with the facts and the answer.
Ms. Solis. And, Mr. Grumbles, why did EPA walk away from
the table rather than use enforcement authority?
Mr. Grumbles. I am going to defer to Ms. Bodine.
Mr. Wynn. I would like Ms. Bodine to go ahead and complete
her answer, but then the gentlelady's time will have expired.
Ms. Bodine. Could you tell me the date of that letter
because I would like to state that since January 2006----
Ms. Solis. July 16, 2003.
Ms. Bodine. Since January 2006, when EPA put out its
preliminary goal, DOD also put out guidance on perchlorate also
establishing the 24.5 as a level of concern. We haven't had the
same problems with DOD being willing to go out and sample. Now,
we have responsibilities for oversight at NPL sites. We have to
make sure that CERCLA is being met. We have some
responsibilities at BRAC sites. We do have order authority if
there is an imminent and substantial endangerment. But as to
this specific site, I will too take the question for the
record. But I do want to say that with respect to the debate
over whether perchlorate is a contaminant of concern, that
debate is over. Obviously EPA believes that. We aren't hearing
from DOD that it is not a contaminant.
Ms. Solis. Mr. Chairman, I just want to submit the letter
that is dated July 16 for the record.
Mr. Wynn. Certainly. Without objection the letter is
admitted for the record.
Mr. Wynn. The Chair is pleased to recognize the ranking
member of the full committee, the gentleman from Texas, Mr.
Barton.
Mr. Barton. Thank you, Mr. Chairman. I am not so much going
to ask questions. Just make a brief statement. I understand
that you and Ranking Member Shimkus had a dialog at the
beginning of this hearing in which Mr. Shimkus expressed some
consternation that what was an oversight hearing has turned
into a legislative hearing. We are certainly not opposed to
legislating in this area, but if that is the will of you and
Mr. Dingell, we do want to use regular order. And I understand
that you and Mr. Shimkus have agreed to have a second hearing,
and if we are going to do this, let us do it right.
This is a serious issue. Ms. Solis has a bill that she has
put in. We had, on the minority, several other witnesses. If we
had known it was a legislative hearing, we would have liked to
have asked, and as far as I know, you and Mr. Dingell would
have approved their appearance. So I am told at the staff level
that you and Mr. Shimkus have an agreement, and we will go
forward.
But we know that you get to set the agenda, but we like to
know what the agenda is so that we can work with you because
this is an issue that has been around, and it needs to be
addressed in a bipartisan comprehensive fashion. And I would be
happy to yield to you for any comments if you would like to
respond to that.
Mr. Wynn. I thank the ranking member. I want to clarify we
did not agree to a second hearing. We agreed that we would work
together to get any input that was felt was lacking. At the
staff level--and you are right--there is some staff level
considerations. It was discussed as early as April 9 that this
hearing would cover the legislative bill before us today. We
also provided the standard opportunity for the minority to
offer witnesses. They have offered one witness, but the other
witnesses weren't mentioned to us at that time.
We have followed essentially regular order in proceeding is
my opinion. But the point is we want to work together in a
bipartisan fashion. We realize that there are concerns. Ranking
Member Shimkus talked about the concerns of rural communities.
We certainly don't want to ignore them. We want to find ways to
make sure that those concerns or the concerns of the States are
included in our deliberations. So my commitment to him was that
I would work with him to make sure any concerns that he had
were taken under consideration.
Mr. Barton. Are you ruling now that a second hearing is
purely a legislative hearing? Is that something that you are
not interested in doing?
Mr. Wynn. I don't know that that is necessary at this time.
I am willing to have further conversations with Mr. Shimkus,
but given the nature of the bill, the bill is not attempting to
regulate itself. The substance of the bill is basically to ask
EPA to regulate. So it is not as though we are making any real
decisions here, other than saying EPA needs to adopt a sense of
urgency and move forward. So there is no content on which a
second hearing could----
Mr. Barton. Well, we don't have any utilities represented.
There is only one representative from a State. There is a
gentleman on one of the panels from Connecticut, I believe. I
really do think if the intent is to legislate, we need to be a
little bit more public about it, and I would hope that we could
have at least one more hearing. But I don't want to belabor the
point. Just that I was a little surprised. Now, maybe it is my
job these days to be surprised so----
Mr. Wynn. No, we don't want there to be any surprises, and
I certainly hope that there wouldn't be any. And, as I said, I
certainly would like to hear what Mr. Shimkus or your side has
to offer in terms of additional information. But we did make a
standard and regular procedure offer of witnesses.
Mr. Barton. Well, I yield back my time, Mr. Chairman. We
look forward to working with you.
Ms. Solis. Mr. Chairman, would you yield just for 1 minute?
Mr. Wynn. I am happy to yield to you.
Mr. Barton. Well, it is my time, but I will be happy to
yield to the gentlelady from California.
Ms. Solis. Thank you, Mr. Barton. I would just like to
offer that we have heard from the utilities, and we do have
letters of support that are going to be included in the record.
And we certainly want to hear from rural America. We certainly
want to hear from other interested parties, but we have had
this discussion time and time again in as many years as I have
served on this committee. And I think that we are not forcing
EPA to set one standard. We are saying you have a job for due
diligence, and that should be carried out. We have waited 11
years. Thank you, Mr. Chairman.
Mr. Barton. I yield back.
Mr. Wynn. I thank the gentleman. At this time, recognize
the gentleman from Michigan, Mr. Stupak.
Mr. Stupak. Thank you, Mr. Chairman. Dr. Brackett, you
indicated to your 2004 and 2005 studies, where do the tomatoes,
lettuce, spinach, what part of the country did that come from?
Mr. Brackett. That initially came from the areas that we
thought might have the highest risk so it would be the western
States.
Mr. Stupak. Western States, Salinas Valley?
Mr. Brackett. I don't recall exactly where. I think there
were some from Salinas, some from Arizona as well.
Mr. Stupak. Well, Salinas Valley was the subject of our
hearing yesterday again with all the E. coli, salmonella, and
now perchlorate. Has the EPA ever looked at quarantining this
area for leafy produce and vegetables, things like that?
Mr. Brackett. EPA, FDA?
Mr. Stupak. Yes, FDA.
Mr. Brackett. At this point, we don't have quarantine
authority to do that if there was something like that.
Mr. Stupak. OK, is that something you would like to have?
Mr. Brackett. Well, I guess we would have to look at
finding out why one would need it or how one could----
Mr. Stupak. Well, you had 20 outbreaks in 10 years in that
area. And according to your testimony you found perchlorate in
lettuce, tomatoes, and spinach in the produce being produced in
this area. Is that concerning?
Mr. Brackett. Does it concern us that we have that problem,
perchlorate? Well, we are interested in finding out. But the
important----
Mr. Stupak. Well, doesn't it concern you when you put
perchlorate with the E. coli, with the salmonella in the same
part of the country?
Mr. Brackett. No, because they are independent sort of
problems. In the case of E. coli and salmonella, those are
serious problems. We know that there is a serious health
effect. In the case of perchlorate, much of our survey is to
establish the baseline.
Mr. Stupak. But perchlorate doesn't aggravate or exacerbate
that problem?
Mr. Brackett. Not to my knowledge.
Mr. Stupak. Has the FDA tested that?
Mr. Brackett. Tested whether it aggravates----
Mr. Stupak. Perchlorate and E. coli found in similar
plants, or do you just do one test for E. coli and one for
salmonella?
Mr. Brackett. They are separate analyses. When we go and do
an assignment for perchlorate, it is just for perchlorate
unless it is part of the TDS and with a whole range of
different ingredients.
Mr. Stupak. So you would only do it for perchlorate. You
wouldn't do it for E. coli then?
Mr. Brackett. No, these are surveillance samples to
establish baseline. We actually have done that for E. coli as
well in certain assignments.
Mr. Stupak. Alright, have you thought about putting out any
public alert about the presence of perchlorate in food supply?
Mr. Brackett. Not at this point. Once our assessment of
exposure and working with our colleagues at EPA and with CDC,
if we identify that it actually presents a risk, at that point,
we have some options that we would do including alerting the
public, at least certain subpopulations.
Mr. Stupak. Well, are you concerned that perchlorate is a
concern for developing fetuses and young children?
Mr. Brackett. Absolutely. We are concerned, but we want to
make sure that there is in fact a true risk there that we would
have to take an action for.
Mr. Stupak. What is going to determine the risk?
Mr. Brackett. Well, I think that the scientists that
evaluated this. We rely a lot on our colleagues at CDC to take
the data that we have----
Mr. Stupak. Well, when do you think that will be taking
place, when you will make some determination whether or not
perchlorate is a risk to fetuses?
Mr. Brackett. Well, I think it will have to wait until all
of the exposure assessments are done.
Mr. Stupak. And when is that going to be?
Mr. Brackett. Well, the one based on our analyses of the
2004-05 is imminent. The report will come out anytime soon.
Mr. Stupak. Any time soon, can you define that? The last
time I asked, the EPA took 13 years, and we are still waiting.
Mr. Brackett. Well, I would say it is at the end of the
pipeline. We are just waiting for it to be published.
Mr. Stupak. Is the pipeline sooner than soon?
Mr. Brackett. I would say within months at the longest.
Mr. Stupak. OK.
Mr. Brackett. But the more important part is really the TDS
data where you have a broad representation of the human diet,
and that will take later in the year in the form of a
scientific publication.
Mr. Stupak. And, Ms. Bodine, when you move from a standard
of 4 ppb. to 24 ppb., why that increase?
Ms. Bodine. In 1999 and then reaffirmed in 2003, there was
a risk range between 4 ppb. and 18 ppb.
Mr. Stupak. Right.
Ms. Bodine. That was based on a provisional RfD that had
been developed by EPA.
Mr. Stupak. And now it went to 24, right?
Ms. Bodine. Because the Agency adopted a final reference
dose, and so we changed our preliminary remediation goal to
reflect that final reference dose. And, in fact, that was the
only change that we made.
Mr. Stupak. To 24 though? That's a significant change. That
is 25 percent increase in the ppb. Did Department of Defense
have input in increasing that to 24 ppb.?
Ms. Bodine. No, we took the ORD reference dose that was in
our IRIS system and translated that into the preliminary
remediation goal, just as we had done when we had the range of
4 ppb. to 18 ppb. We used exactly the same methodology. It was
just using the final RfD reference dose that EPA had adopted.
Mr. Stupak. OK. Mr. Beehler, in answering Ms. Solis, there
has been no RODS on any military sites. There has been no
records of decisions for cleanup on any, right? You have moved
a little dirt. You have done some test pilots, but there has
been no real cleanup. There has been no RODS entered.
Mr. Beehler. Well, No. 1, I said earlier that I would take
for the record to confirm whether or not there had been RODS.
Number 2, as I said earlier, you can do response actions. You
don't need RODS, and as we have provided the staff, we have
done response actions at at least 12 different sites that have
affected----
Mr. Stupak. No cleanups? None have been completed? Nothing
has been cleaned up?
Mr. Beehler. Yes, there is a complete at the Navy
Industrial Site in McGregor, TX, that has been given an EPA
complete. Also, at White Oak, which did have a ROD--there White
Oak in Maryland in the chairman's district. We performed
cleanup there for perchlorate-contaminated soil, and that has
also been completed.
Mr. Stupak. OK.
Mr. Wynn. The gentleman's time has expired. At this time,
the Chair will recognize Mrs. Capps from California.
Mrs. Capps. I want to thank you, Mr. Chairman, for having
this hearing today and for the testimony of the witnesses, both
in this panel and the one to come.
We know that perchlorate can damage the mental and physical
development of people. Even very low levels of this dangerous
chemical block the ability to produce hormones that are
essential for brain function and development.
In my first question, I want to ask about how the exposure
to perchlorate interferes with the thyroid gland. Dr. Pirkle,
in your testimony today, you gave a very detailed explanation
of CDC's thyroid study. Can you tell me whether CDC has a high
level of confidence in the findings of that study? It is a
simple answer.
Dr. Pirkle. A high level of confidence? I would say the
simple answer is ``yes''.
Mrs. Capps. Thank you. Mr. Gray, I would like to ask about
your Agency. If you had used the CDC study, is it your belief
that the reference dose might have decreased?
Mr. Gray. Our reference dose is based upon advice that we
received from the National Academy of Sciences that was
designed to protect the most sensitive subpopulation with a
margin of safety----
Mrs. Capps. But you are aware--I mean you listened to the
testimony?
Mr. Gray. Sure, and the work that has been done by CDC is
top quality data, one of the leading----
Mrs. Capps. Would it have affected the reference dose?
Mr. Gray. It would have been considered as part of the
broad range of scientific information.
Mrs. Capps. That is kind of not a straight answer.
Mr. Gray. No, it would have been considered, but I would
suggest that a lot of scientists might agree, in fact, with the
CDC conclusions that their results were unexpected and that
further research is needed to confirm them.
Mrs. Capps. All right, I am going to move on, but I think
that is very important to establish because the CDC has a high
level of confidence in their study. I would love to talk now
about children's health as it has been described today. And I
want to thank Dr. Ginsberg for the written statement that he
has prepared for the second panel.
Last year, EPA's Children Health Protection Advisory
Committee expressed concern with EPA's preliminary remediation
goal of 24.5 ppb. They said the goal was not protective of
children's health, and that is a quote, because among other
reasons, it failed to account for perchlorate exposures from
food such as milk and lettuce. They also asked EPA to issue a
maximum contaminant level for perchlorate in the interim. A
health advisory for potable water that takes into account early
life exposure. Unfortunately, EPA rejected this advisory
committee's request. EPA says its guidance is protected because
the NAS study, upon which the guidance is based, built in a
factor of 10 to address the risk of the most sensitive
populations, infants and children.
It also said that prospective Superfund sites should
consider site-specific data including impacts to food supplies.
I am concerned that public health is not being served here. My
question to you, Mr. Grumbles, isn't it true that the built-in
safety factor of 10 that EPA is relying on applies only to an
individual's susceptibility in water and does not address other
pathways of exposure, such as breast milk and food? Just a
``yes'' or ``no'' answer is good.
Mr. Grumbles. I would say that what you said about us
rejecting the advice from the Children's Health Office is not
entirely accurate. We are still looking at options such as the
health advisory.
Mrs. Capps. Right, you are looking at options, but you
didn't take it under immediate consideration.
Mr. Grumbles. Well, we have adopted the National Academy of
Sciences's recommendations on reference dose because of a
couple things, the conservative approach and looking at iodine
uptake integration. It is a tenfold safety factor----
Mrs. Capps. Can I get to that point?
Mr. Grumbles. Sure.
Mrs. Capps. Is it true that your tenfold safety factor is
based upon exposure just to water and not to other pathways
such as breast milk and food?
Mr. Gray. I would like to address that if I may please. Our
reference doses are set irrespective of the exposures that are
out there, the way in which the exposure occurs. What we then
have to determine, and part of what Mr. Grumbles's office is
trying to understand, is the relative contribution to exposure
that comes from food and what comes from water. But all of
those go together in determining whether an exposure approaches
the reference dose. The reference dose is independent of the
route of exposure.
Mrs. Capps. You mean so it is inclusive then of food,
breast milk, and water?
Mr. Gray. Or any other source of exposure that might occur.
Mrs. Capps. So it is done on adults and children? Is this
universe so inclusive then for children, for nursing infants?
Mr. Gray. What we have done was our reference dose is an
attempt in the way in which the Agency always proceeds to find
a level of exposure that we believe--though there is some
uncertainty around it--a level of exposure below which no
adverse effects should occur. We got advice from the National
Academies, and we adopted that level. The next thing we have to
do to understand the situation that may be happening in the
world is to understand how much exposure might be happening and
how close we are coming to that reference dose. That is what we
are actively doing right now.
Mrs. Capps. All right. Now, I am prevented from asking what
I think is the most substantive question, but I am going to
make it in the form of a final statement, if I could, one more
second. To me, given the serious health threat posed by
documented widespread exposures, I believe it is true that as
early as 2005, the EPA was in a position to issue a drinking
water standard for perchlorate. And my question is why has this
not happened?
Mr. Gray. During the period 2004-05 as the Agency has been
focused on completing the statutory process that this
subcommittee put into the statute and that we embrace, the key
question was is there a meaningful opportunity to reduce the
risk of human health for those consuming public water systems.
And the key for us is the relative source contribution. That is
what we are focused on, and so during that period of time,
2004-05, we were sharing information with scientists from other
agencies, such as CDC and FDA. We are very much aware there
were some very important new information coming onto the scene.
New science, the Total Diet Study that Dr. Brackett was
referring to. And that, to us, has been the key. I understand
Congresswoman Solis is frustrated and wants us to make a
``yes'' or ``no'' answer on regulation, but the key for us has
been over the last couple years and months to get a better
sense of the total exposure. We have the data we need on
occurrence. We have a reference dose, and the key has been the
additional routes of exposure.
Mrs. Capps. With all due respect, sir, until you have a
standard, there is no way to enforce it. And we could have a
standard now. It is not going to be perfect, but we owe it to
this country to have an established standard----
Mr. Wynn. The gentlelady's time is concluded. I don't
believe there are any other questions of this panel; however, I
know, because of the time limitations, the members of the
committee have other questions that they want answers. So
without objection, I would like to have members of the
committee submit written questions to all of the panelists as
they see fit. And I would request to the panelists that they
respond accordingly. Without objection, so ordered. And I want
to again thank the panelists for their participation today.
Which will bring us to our second panel. I would like to
introduce the panel first. We have with us Dr. Anila Jacob, the
senior scientist at the Environmental Working Group. It is a
delight to have her. Also we have Dr. Gary Ginsberg from the
Connecticut Department of Public Health, and Dr. Robert Utiger
from the Harvard Institute of Medicine. What we would like to
do is have 5-minute opening statements from each of our
witnesses, and that will be then followed by questions from the
members. Dr. Jacob.
STATEMENT OF ANILA JACOB, M.D., SENIOR SCIENTIST, ENVIRONMENTAL
WORKING GROUP
Dr. Jacob. Thank you. Mr. Chairman, distinguished members
of the subcommittee, I am a senior scientist at the
Environmental Working Group, a non-profit research and advocacy
organization. I am also a practicing physician with board
certification in internal medicine. Thank you for this
opportunity to testify. The main points that I am going to make
today are perchlorate contamination in the environment poses a
significant threat to the health of millions of U.S. residents,
particularly pregnant women and infants, and children have a
right to be protected from environmental contaminants that may
interfere with their optimal growth and cognitive development.
Perchlorate contamination in the environment has become a
significant threat to public health. Many in the public health
community have suspected this for years, but a recent series of
major studies by scientists at the Centers for Disease Control
and Prevention and academic institutions have confirmed these
concerns.
These studies establish that exposure to perchlorate is
widespread and that levels of perchlorate that are found in
people are associated with significant decreases in thyroid
hormone levels. Perchlorate has long been established in the
medical literature as a potent compound with a proven capacity
to lower thyroid hormone levels. This is important because
lower thyroid hormone levels in pregnant women and infants are
an established risk factor for abnormal brain development in
the fetus and intellectual deficits in children.
The issue that has challenged public health officials over
the last decade has been establishing the significance of the
public health threat presented by the levels of perchlorate
that are actually found in people. In the past year, this
question has largely been answered. Two critical 2006 studies
from the CDC have established that exposure to perchlorate is
widespread and that the levels found in people are associated
with statistically significant, measurable, and adverse changes
in thyroid hormone levels.
In the first study, the CDC tested the urine of almost
3,000 people and found that perchlorate was in every person
that they tested. They also found that perchlorate levels in
children were 60 percent higher than in adults, meaning that
kids are exposed to more perchlorate than adults, relative to
their size.
In the second study, the CDC looked at the association
between thyroid hormone levels and perchlorate in over 2,000
people. That found that levels currently considered ``safe'' by
the EPA were strongly associated with lowered thyroid hormone
levels in a particularly vulnerable group of women, those with
lower iodine levels. One-third of American women fall into this
category. This is the first study to identify this group of
women as particularly vulnerable to perchlorate.
Based on these CDC results, perchlorate exposure at just 5
ppb. could alter thyroid hormone levels in more than 2 million
women of childbearing age in the U.S. from the normal into the
abnormal range. If this happens during pregnancy, they would
require medication to restore their thyroid hormone levels to
the normal range to avoid adverse effects on brain development
in their fetus.
Even more alarming are results from three recent CDC and
academic studies on the content of perchlorate in U.S. breast
milk. In all three studies, every single sample of breast milk
tested was found to contain perchlorate. In addition, the
average levels of perchlorate in breast milk in all three
studies would expose infants to a level that exceeds the EPA
RfD or safe daily dose. Breast milk seems to contain relatively
higher concentrations of perchlorate when compared with average
blood and urine levels in the population. This means that
infants get a larger dose relative to their small size, not
unlike an infant taking an adult dose of medicine, except in
this case, it is a larger dose of a toxic compound.
To summarize, recent studies show that exposure to
perchlorate at levels considered safe by the EPA are associated
with significant harmful effects on thyroid hormone levels in
adult women with lower iodine levels. Studies on U.S. breast
milk by CDC and academic scientists show universal
contamination in tested samples and strongly indicate that a
significant number of breast-fed infants may be regularly
exposed to perchlorate levels, which exceed EPA's safe dose.
This raises an important question. If perchlorate exposure
far below the EPA RfD is linked to significant thyroid hormone
changes in adult women, wouldn't one expect that perchlorate
levels in breast milk that are well above the EPA RfD would
present greater risk to breast-fed infants? The overwhelming
weight of the evidence suggests that yes, these levels of
perchlorate in breast milk will alter normal thyroid hormone
levels and present a real threat to exposed infants. These
findings elevate perchlorate into the first tier of known
environmental hazards, along with compounds like mercury and
lead, where the science clearly justifies strong protective
measures by public health agencies.
These findings also demonstrate that the current EPA RfD of
24.5 ppb. is not protective of public health. It is not
``safe.'' Recent research demonstrates that exposure to
perchlorate at environmentally relevant levels poses a
significant health threat to millions of U.S. residents,
particularly pregnant women and infants. Therefore, I strongly
support the efforts of Representative Solis and the cosponsors
of the Safe Drinking Water for Healthy Communities Act of 2007.
We must find the political will to enact this legislation,
which is a critical step in establishing a health protective
drinking water standard for perchlorate.
Our children have a right to be protected from
environmental contaminants that may interfere with their
optimal development. As a physician, I believe that a safe
drinking water standard or maximum contaminant level of no
higher than 1 ppb. is necessary.
Thank you, Mr. Chairman. This concludes my prepared
statement.
[The prepared statement of Dr. Jacob follows:]
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Mr. Wynn. Thank you very much. Dr. Ginsberg.
STATEMENT OF GARY L. GINSBERG, PH.D., CONNECTICUT DEPARTMENT OF
PUBLIC HEALTH
Mr. Ginsberg. Thank you, Mr. Chairman and subcommittee
members. I am Gary Ginsberg. I am a toxicologist at the
Connecticut Department of Public Health. I also am an adjunct
faculty at Yale University, and I am assistant clinical
professor of medicine at the University of Connecticut School
of Community Medicine. I serve on one National Academy of
Sciences panel right now, which is on improving EPA's risk
assessment and technology. And I just finished up serving on
the NAS panel on biomonitoring, which released its report to
Congress in 2006.
And I want to emphasize that just for one moment because
one of the things that is really pressing right now with the
release of the CDC data are how we are going to understand the
levels of perchlorate in urine in terms of an exposure dose.
And the NAS panel and the biomonitoring report that I helped
write presents a road map on how to do that. And actually I
just published a paper in 2007 that takes the CDC urinary data
in conjunction with the Chilean urinary data and provides a
methodology on how to understand exposure in the general U.S.
population, not just exposure in one person or exposure at the
median or the mean, but the full distribution of exposure and
how to bring that biomonitoring data into a holistic risk
assessment in which one can then understand how we can protect
at the 90th percentile or the 95th percentile the population in
terms of the background levels of exposure. So to say at this
point that we don't have enough exposure information when, as a
biomonitoring person, which is where I come from in the State
department of public health that has a lot of biomonitoring
research going on, to say that we don't have enough exposure
information and we need to wait for another FDA report, which
will have lots of uncertainties because whenever you try to
construct exposure pathways based upon how much is in
cantaloupe, how much is in grapes, how much do people eat, what
is the 90th percentile for this food source and that food
source.
As a State risk assessor and health official, I don't want
to have to tell people well, we have to worry a little bit
about you eating that much cantaloupe during pregnancy. We want
to be able to have standards and enough conservativisms and
enough of the biomonitoring data in our risk assessment that we
are not basing it upon how much is in a certain food source and
what we think certain people are eating. Because we know
people, especially during pregnancy, will do different things
than what the assumptions are.
Now, a lot of this, and the basic gist of my testimony is
that it is smart public health policy to regulate perchlorate
as quickly as possible because if we don't do that, and we are
already not doing that, it leaves the potential open that our
children won't be so smart and that we will have more children
left behind academically.
When environmental threats to intelligence have surfaced in
the past, action has been taken to decrease that threat,
whether it has been lead, mercury, or PCBs. To be honest with
you, the level of emergence of the perchlorate database is not
where it is with the 50, 60, 70 years worth of data we have for
lead or mercury. But nevertheless, it is quite strong and, I
think, compelling in terms of understanding that exposure is
very widespread, that exposure is at levels of potential health
concern not only to in-utero development, which has been
recognized as the perhaps most sensitive period, but also to
post-natal and breast-fed infants.
And the reason for that is twofold. Number 1, breast milk
is the critical source of iodine for the nursing infant. There
is hardly any thyroid hormone in breast milk so the neo-nate is
on its own, and this delicate arrangement is going to be
interfered with by perchlorate in two ways. One, perchlorate
itself is actively transported into breast milk. It sort of an
excretory pathway for the breastfeeding woman. So it is being
excreted into the nursing infant. And then the second concern
is that it is blocking iodine excretion into breast milk. So it
is a double jeopardy for the nursing infant, which makes that
life stage--because brain development is actively occurring at
that point--makes that life stage a particular concern. And we
do have good data on neo-nates and how sensitive they are to
decreases in thyroid hormone levels.
So then there is the toxicology. For EPA to set an MCL out,
they have to have a good grip on the toxicology. And what the
CDC study has done is it has shown us that since the National
Academy of Sciences report came out, the NAS gave us some sense
of comfort that there is a safety factor involved with the
standard, with the RfD. However, what CDC has done is they have
shown us that there really isn't that kind of a safety margin
or that kind of comfort level with where the RfD was set.
In fact, I published a commentary in 2005 that said that I
didn't think at that point that the NAS RfD was even set,
considering all the uncertainties and all the health
implications. And then we go to 2006, and we see the CDC
report. And that says that there really is no margin of safety.
There is no comfort level with the current RfD, and in fact,
they should be lowering it.
Then on top of that, we have the exposure profile, and we
know from the UCMR that were sampled a lot of public water
supplies in 2001 and 2005, that there is widespread exposure to
roughly 5 to 15 million people in this country to elevated
levels of perchlorate.
But then we have places like Foxboro, MA, which would not
be normally sampled if it wasn't for the proactive work of
State regulators to sample municipal wells in small districts,
finding 1,300 ppb. of perchlorate in an area that would not
normally get tested. So without having a Federal----
Mr. Wynn. Dr. Ginsberg, I think you----
Mr. Ginsberg. The bottom line is without having a Federal
MCL, there is no testing. The women in Foxboro, MA, would have
no way of knowing that they were at risk if it wasn't for some
proactive work by some State risk assessors. And so that is the
reason why we need an MCL right away because there is ongoing
exposure and no testing.
[The prepared statement of Mr. Ginsberg follows:]
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Mr. Wynn. Thank you for your testimony. Dr. Utiger.
Dr. Utiger. Often said as ``you tiger.''
Mr. Wynn. You tiger, alright.
STATEMENT OF ROBERT UTIGER, M.D., HARVARD INSTITUTE OF MEDICINE
Dr. Utiger. Mr. Chairman, members of the committee, my name
is Robert D. Utiger. I am trained in internal medicine and
subsequently in endocrinology. In my career, I have been
interested in the thyroid for over 40 years, and my research
and clinical activities have been in the areas of thyroid
physiology and thyroid disease.
I was a member of the NAS committee on the health
implications of perchlorate, and I participated in the
discussion and the review of the literature. I, of course, in
no way speak for the committee. And as you all know, it was
disbanded on completion of its report in 2005.
In looking at the data at that time, we focused on five
prospective studies in which known amounts of perchlorate were
given to normal human subjects in doses ranging from 0.007
milligrams per kilogram to as high as 9 milligrams per
kilogram. The first study I mentioned looked at iodine uptake
by the thyroid in 2 weeks. The longest study looked at iodine
uptake and serum thyroid hormone at TSH concentrations for 6
months in people given 0.04 milligrams per kilogram of body
weight. The 0.007 milligrams per kilogram body dose had no
effect on the thyroid at an uptake, nor on serum thyroid
hormone or DSH concentrations. The 6-month study at a much
higher dose had no effect on any of those measurements at all.
We chose as our--I guess I would call it departure point--
the 0.07 milligrams per kilo because it involved perhaps the
most extensive studies. There were higher doses, and higher
doses did have a small effect on thyroid uptake of iodine. But
again no change in thyroid hormone concentrations in that 2-
week interval.
We then added an uncertainty factor of 10, reaching what we
called a reference dose of 0.007 milligrams per kilo. And this
was, in our view, the limit, if you will, for the total dose
whatever the source. And we didn't examine the sources. We knew
that there was perchlorate in water supplies in somewhere.
There was just a little bit of data about food available at
that time, but we didn't deal with any sources or any
particular sources.
The EPA used that number to generate, I guess, a proposed
water standard, but that is entirely out of the realm of the
committee. I continue to believe that that reference dose,
0.007 milligrams per kilo, which includes a factor of 10 to
protect those who might be more vulnerable, is quite adequate.
Part of the reason, I think, that is that we chose no
inhibition of iodine uptake as the mechanism, if you will. And
we didn't consider that an adverse effect, but even if it was
an adverse effect, the pituitary thyroid system had very
sufficient compensatory ability. So if something inhibits the
production of thyroid hormone by 10 or 15 percent, there is a
defense for it, and the defense is fairly rapidly activated and
generally quite effective, particularly if the thyroid gland is
fundamentally normal, as it is in people who are taking
perchlorate.
Perchlorate does one thing to the thyroid and one thing
only in sufficient dose, and that is inhibit iodine uptake. So
as I said, I continue to support that value as an overall
reference dose. How it is distributed, of course, is something
that we were not charged to address and certainly did not
address.
Thank you, Mr. Chairman.
[The prepared statement of Dr. Utiger follows:]
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Mr. Wynn. I thank you for your testimony. I would like to
thank all the witnesses. And now I would like to ask a few
questions. Dr. Utiger, I just want to make sure I am
understanding you. Are you basically saying that there is no
perchlorate problem in this country?
Dr. Utiger. Well, in certain areas there is where we know
the water content is very high. So there probably is in some
places.
Mr. Wynn. So in the situation such as Ms. Solis, it could
be a serious problem?
Dr. Utiger. In certain areas where the water and food stuff
content is very high, yes, there could be a problem.
Mr. Wynn. How many people were in your study?
Dr. Utiger. In the five studies that I mentioned, there
were a total of about 80. Most of them were very small, five,
six subjects in each of these groups.
Mr. Wynn. All right, thank you.
Let me ask you, Dr. Jacob. I want to make sure that you are
clear. You believe that 24.5 RfD is inadequate. Is that your
position?
Dr. Jacob. Correct.
Mr. Wynn. And the reason for your position is--why do you
believe it is unacceptable?
Dr. Jacob. We find through the CDC studies, which had
almost 2,000 people, 2,000 to 3,000 people, depending on the
study that you are looking at. We find that women that are
exposed to levels far below that have significant changes in
their thyroid hormone levels.
Mr. Wynn. The existence of perchlorate in breast milk,
would you have any position or thoughts on how that occurs,
what is the pathway involved there?
Dr. Jacob. Well, as Dr. Ginsberg mentioned, there is a
particular transporter within breast tissue that actually
transports perchlorate into breast milk. And when we compare
the levels in breast milk versus levels in blood and urine, the
are actually higher on average. So it seems like it is actually
concentrating perchlorate. And babies are so much smaller than
adults, so any dose they get is going to be magnified, and that
is why their doses are actually above the RfD.
Mr. Wynn. Dr. Utiger, did you deal with infants in your
study?
Dr. Utiger. I am sorry?
Mr. Wynn. Did you deal with infants in your study?
Dr. Utiger. There have been no prospective studies in which
infants were given perchlorate. There is a community in Chile--
--
Mr. Wynn. Well, that is fine. I don't want to go to Chile
at this point. I just wanted to ask a couple of questions. Dr.
Ginsberg, can you elaborate a little bit more on the brain
development issue? Because I thought that was something that
the committee ought to know more about in terms of how
perchlorate is affecting brain development.
Mr. Ginsberg. Well, brain development certainly occurs in
utero and then also post-natally. There is arguments about
whether brain development, where it stops. But certainly in the
early post-natal period when a nursing infant is going to be
exposed through breast milk, there are very important windows
of brain development.
Mr. Wynn. Now, do you concur with Dr. Jacob with respect to
RfD or the inadequacy of the RfD?
Mr. Ginsberg. Yes, in 2005, our commentary on environmental
health perspective said that the National Academy of Sciences
study didn't fully consider the uncertainties, and in fact, in
the 2002 EPA risk assessment, they considered the low dose that
NAS used as an effect level. And the National Academy decided
that that was a no effect level. We found in reviewing that
that the low dose probably was an effect level for four out of
the seven people that were exposed, which is a very small
sample. But that probably was an effect level for four of those
people.
Mr. Wynn. OK, and I think you really have kind of focused
in on the key question that seems to be emerging at this
hearing is do we wait until we determine whether it is
cantaloupes or water before we make a drinking water standard.
Was that basically your position that we should move forward?
Mr. Ginsberg. That and the fact that there are millions of
people exposed right now that we don't know who they are. We
don't know what to tell them because we can't identify them. So
without having an MCL, there is no requirement to test in large
and small public water systems. If we knew where they were, a
State like mine could then set our own standard and say that at
least from that perspective, these water systems need to
prevent exposure because at least we would know who is exposed.
Mr. Wynn. OK, thank you. I don't think I have any further
questions. Yield to the ranking member for questions.
Mr. Shimkus. Thank you, Mr. Chairman. Dr. Ginsberg, you
know that some States have set a standard?
Mr. Ginsberg. Exactly, yes.
Mr. Shimkus. The other question I have is are you speaking
on behalf of the Connecticut Department of Public Health?
Mr. Ginsberg. No, I am not.
Mr. Shimkus. Not with Dr. Galvin or Dr. Iwan?
Mr. Ginsberg. No, they certainly know that I am here today.
Mr. Shimkus. But you are not speaking on behalf of the
State government, the State organization?
Mr. Ginsberg. That is true.
Mr. Shimkus. Thank you. And this is really a pretty good
slide, this GAO slide that is in the majority. How much
perchlorate is identified in the State of Connecticut on this
map?
Mr. Ginsberg. The public water systems were tested in 2001
and 2003, and there were no detections above 4 ppb.
Mr. Shimkus. Thanks. I appreciate that. And, Dr. Jacob, you
support--and talk about the CDC study, 2,000, which is a good
sample size. How many of those were under 6 years old?
Dr. Jacob. None were under 6.
Mr. Shimkus. So if we are talking about children and the
impact on children and unborn children--I am a pro-life Member
of Congress. I am very concerned about the unborn children.
Then don't you think we should do some research on folks 6 and
under? I mean we do that for prescription drugs. We have a
special pathway to make sure that prescription drugs have
efficacy for them. So in the CDC, which has a good sample size,
if we are going to say, I think, research on the effects of
children under six might be meritorious, don't you think?
Dr. Jacob. I agree, but----
Mr. Shimkus. Thank you. I appreciate that. Dr. Utiger, is
the United States an iodine-sufficient country? And you have to
be quick because I have no time.
Dr. Utiger. It is considered such according to the World
Health Organization.
Mr. Shimkus. Let me go to the next question. How important
and simple is getting more iodine in your diet to solving
thyroid-related illnesses?
Dr. Utiger. Eating more foods that contain iodine, taking
multivitamins that contain iodine----
Mr. Shimkus. OK, let me go to the next question. Are there
medical treatments to help iodine deficiency or hypothyroidism?
Can't even say the word.
Dr. Utiger. Well, you can treat iodine deficiency by giving
iodine. We treat hypothyroidism by giving thyroid hormone if
the thyroid gland is damaged, et cetera.
Mr. Shimkus. Is thyroid enlargement the truest test of
thyroid malfunction?
Dr. Utiger. No.
Mr. Shimkus. How do you test for thyroid enlargement?
Dr. Utiger. It is done by a physical examination or
ultrasonography, and it is not very accurate.
Mr. Shimkus. Can you do this test on pregnant women?
Dr. Utiger. Those tests, yes.
Mr. Shimkus. Are you aware of any perchlorate studies that
have culled their data from thyroid enlargement?
Dr. Utiger. No.
Mr. Shimkus. You mentioned that the conversion of T4 to T3
in many non-thyroid tissues is regulated by nutritional and
illness-related factors. Can you explain the illness factors
that play a role?
Dr. Utiger. Poor nutrition, a whole array of illnesses may
result in inhibition of the conversion of thyroxin, T4, to
tritothyronine in many individual tissues. Amongst them is
hypothyroidism which actually increases in tissues, including
the brain, the conversion of thyroxin to tritothyronine which
is the most active thyroid hormone in tissues.
Mr. Shimkus. Thank you. And I will end with this series of
questions. If the EPA were to set an MCL, what would be the
cost of a water district to test for that? Dr. Jacob, do you
know?
Dr. Jacob. My concerns are more with the health effects.
Mr. Shimkus. So the answer is no, you don't know?
Dr. Jacob. Correct.
Mr. Shimkus. Dr. Ginsberg?
Mr. Ginsberg. The analytical costs are coming down. Right
now, you can get down to about 1 ppb. for about $125.
Mr. Shimkus. One ppb. per--for just the test?
Mr. Ginsberg. For the test itself.
Mr. Shimkus. And in States like Connecticut that really
have no significant exposure, that cost would be incurred by?
Mr. Ginsberg. Well, that was limited sampling in
Connecticut, and that was a detection level of 4.
Mr. Shimkus. OK.
Mr. Ginsberg. The cost would go to the ratepayers.
Mr. Shimkus. Dr. Utiger, you don't know?
Dr. Utiger. I don't know anything about the cost, sir.
Mr. Shimkus. Let me ask if there is perchlorate in the
drinking water, what is the cost to reduce it? And I will give
you an option. Based upon this map, we have various levels. We
have no perchlorate, 4 to 100 ppb., 4 to 1,000 ppb., 4 to 5,000
ppb., 4 to 100,000 ppb. So what would be the cost to clean up
drinking water to each one of these standards? Dr. Jacob, do
you know?
Dr. Jacob. Again, I am more concerned with the cost in
terms of health.
Mr. Shimkus. Dr. Ginsberg?
Mr. Ginsberg. It is fairly straightforward ion exchange
resin columns.
Mr. Shimkus. So what would be the cost for each one? And is
there a multiple cost for the increased----
Mr. Ginsberg. Yes, that is beyond my expertise.
Mr. Shimkus. OK, you don't----
Mr. Ginsberg. But the methodology exists.
Mr. Shimkus. Dr. Utiger?
Dr. Utiger. I don't know, sir.
Mr. Shimkus. OK, thank you, Mr. Chairman. I yield back my
time.
Mr. Wynn. Thank you. At this time, I recognize Ms. Solis
for questions.
Ms. Solis. Thank you. My question actually is for Dr.
Jacob. Dr. Jacob, we heard a lot about the different tests that
were being done by EPA previously in other studies. And they
typically looked at adults weighing in between an average, I
believe, of 150 pounds. Could you distinguish for me what it
would mean if we tested infants or someone that weighed 10
pounds, 7 pounds? What are we talking about here in difference
of the exposure of perchlorate?
Dr. Jacob. It would mean that if the same dose were given
to me and then given to say a 10-pound baby, it would probably
have 10 times the effect, or the blood levels would be
significantly higher in the baby because they are much smaller.
Is that the question that you are asking?
Ms. Solis. Do you think that the standard that is currently
set at 24 ppb. now, is not adequate? I mean because, as you
said in your statement, that there is potential harm. And I
think you mentioned 1 point. Is it 0.1 or----
Dr. Jacob. We are asking for no higher than 1 ppb. to keep
those protected.
Ms. Solis. You know we had a representative from FDA, and I
didn't get a chance to really ask him a question, but in terms
of finding where the sources are, the groundwater in the
district that I represent is contaminated with perchlorate. And
we have several fields, strawberry fields and other
agriculture, smaller agricultural areas. I wonder about those
larger facilities that have been exposed to perchlorate and
adjacent to those farming areas, what might happen to, say, a
woman who is giving birth there and the multiple effects here.
I mean drinking water, and then eating perhaps some of the
products that are being grown there. And I look as an example
right now in the State of California in Fresno where this is a
very, very contentious issue right now. Could you comment on
that?
Dr. Jacob. I agree that contribution from food is
significant, but that shouldn't delay your decision on water.
Actually for the people that are getting exposure from food and
water, at least if we can regulate it to the best that we can
do in water, it will minimize their exposure from that source
at least. So for the millions of people that are exposed again
from food and water, at least we can start with the water and
then move on.
Ms. Solis. Dr. Ginsberg, in terms of some of the
questioning that occurred here, we don't know where all the
sources of perchlorate are or might be?
Mr. Ginsberg. Right, and I am saying that biomonitoring
studies such as has been done by CDC already is giving us a
fairly good picture of how much baseline exposure from the diet
because in their study, they knew that most of those people
were not exposed from drinking water. So we have a dietary
background exposure as broadcast in their urine results, and
that could be used to move on in a risk assessment context to
say here is what is coming from baseline diet, and now what
percentage of the RfD is that? Whatever RfD you pick, which I
think the current RfD is on the high side, but even with that
RfD, you could then say this is the baseline exposure from diet
that we understand from CDC. Now, that takes up to 30 percent,
50 percent, 80 percent, whatever percentage of the RfD that is,
the rest of that is what is left behind that you can attribute
to and allow to come from water. And that is how you set your
MCL. We have that information. The level of uncertainty
currently in the database for perchlorate is smaller than we
typically have for most other things we already have MCLs for.
Ms. Solis. I just want to state also for the record that
many of the water purveyors in my area and my district have
gone way beyond what they are required to do. I think they
really tried to do as much as they can to provide for healthy,
safe standard for our drinking water. We have had so many wells
that have been shut down where literally the impact has been on
DOD vendor type services that have been provided in a very
heavy industrialized mixed-use community where you have houses,
you have homes, you have schools, you have these facilities
that neighbor our communities.
We do understand that there is an urgency and that many of
our water purveyors understand that when this is reported, that
wells have to be closed. There is a very serious approach that
has to be taken, and obviously I think that is what the basis
of this hearing is about.
I do want to mention one last thing though that in the
testimony that was provided by the EPA Assistant Administrator,
he notes the Greer study that was done in 2002, and my question
is for Dr. Jacob again. The study is based on healthy adults
and women with an uncertainty factor of 10 that was applied.
Again, we have heard about the study in previous years here in
this committee, and I would just ask you again is it a standard
approach to just look at the adult population and not the
infant population?
Dr. Jacob. With regard to the Greer study, no. The Greer
study had far fewer number of participants than the CDC study,
and they did not look at the iodine status of individuals. Now,
we know that that is very important.
Ms. Solis. So it is somewhat inadequate then is what you
are saying?
Dr. Jacob. I believe so.
Ms. Solis. Thank you very much. I will yield back my time.
Mr. Wynn. I thank the gentlelady. The Chair will recognize
the gentlelady from California, Mrs. Capps.
Mrs. Capps. Thank you. I want to concentrate on the topic
that was just briefly touched upon at the end of my time with
questioning the first panel for the bulk of my 5 minutes. But
just to clarify, Dr. Jacob, clarification of your statement
about testing on children. I want to ask--you are not saying
you support testing children for non-therapeutic testing of
chemicals. Correct? Right?
Dr. Jacob. Correct.
Mrs. Capps. We extrapolate for children. This is based on a
long history with lead, right, for children when we extrapolate
for children?
Dr. Jacob. And I would like to say that we know enough
about children's physiology to know that they would probably be
even more vulnerable to the effects of perchlorate than adults.
Mrs. Capps. And another clarification. Dr. Ginsberg, do you
agree with Dr. Utiger that people should eat more salt to solve
the perchlorate problem?
Mr. Ginsberg. Well, it is sort of like fluoridating water.
We decided to fluoridate water so that there would be a uniform
level of protection of dental hygiene, knowing that people can
get fluoride in various ways in their own personal life. People
can get iodine through various ways in their own personal life,
but we don't have any control over that. But by regulating
perchlorate to make sure that is not a major risk factor, that
takes that out of the equation.
Mrs. Capps. Well, I have been troubled sitting here
thinking about over the years what we have known about lead and
how we, as a society, have responded to that. And you are here
to advise us. And thinking about now how much we know about
lead and what steps we have had to take as a society to
remediate and even more recently. But pregnant women know to
avoid fish now because of mercury content. Unfortunately, that
is a health factor. And I was troubled to hear perchlorate
mentioned in the same way, in the same breath, so to speak, in
terms of that we have a responsibility here that we have some
contamination that most of the public has no idea about.
Now, the first step to doing that is to establish a
standard, and that is what I am so concerned about. The serious
health threat is known, correct? I mean this exposure, as early
as 2005, EPA had data that was in a position to issue a
drinking water standard. And I asked the first panel why has
that not happened. I want to ask you to give us advice. Is it
serious enough that we should be dealing with this? I am going
to concentrate, Dr. Utiger, on Dr. Jacob and Dr. Ginsberg just
because you said already that you think it is safe based on the
NAS study. And then if you want to talk about the safety factor
of 10 which leads to the covering of children too.
Dr. Jacob. As I stated earlier, I do believe this is a
serious health threat. I think we need to be proactive about
public health threats, and I am sorry about the uncertainty
factor.
Mrs. Capps. Well, that is what I heard from the first
panel, that they are not quite sure yet. I will ask you. Is
there enough data that we can be certain and that we should
establish a standard?
Dr. Jacob. I believe the CDC data and the breast milk
studies are more than adequate.
Mrs. Capps. So that we are irresponsible if we do not have
a standard in this country?
Dr. Jacob. We should hasten the process.
Mrs. Capps. And what about the risk factor of 10?
Dr. Jacob. Well, we know that that is not protective of
breast-fed infants because simply the levels that are being
found in breast milk exceed that.
Mrs. Capps. So that was an attempt to cover children, but
it really doesn't address that situation. And for your opinion,
Dr. Ginsberg?
Mr. Ginsberg. Well, you asked about whether we knew enough
in 2005. We actually had EPA's risk assessment in 2002, which
was targeting towards a drinking water number of 1 ppb.. And
then that got taken into the National Academy process and came
back with 24.5 ppb. And we think that--in Connecticut at
least--or at least I think that they had it closer to being
right originally and that going through all of this discussion
and debate and process has lead to some confusion about how
much weight to put on a particular study, the Greer study of an
N of seven at the low dose level, which is being called a no-
effect level, which is, which we see from the CDC study is far
from a no-effect level in the general population.
So I think that to move forward in this, EPA needs to fully
take a stock of the CDC study, look at the no-effect level from
that study and make a determination if one can be determined,
and make a determination of what the proper RfD is when you
fully consider the population data that we have got and then
look at the exposure information that is also in the CDC study.
And then they can set a relative source contribution from that,
which we published in our 2007 paper as a model way of how to
proceed forward.
Mrs. Capps. And do you have any further things to say on
the factor of 10?
Mr. Ginsberg. Well, I don't want that to be confused with
the exposure pathways analysis. That is separate, as Dr. Gray
talked about earlier. The factor of 10, I think, is inadequate
because, No. 1, it is not based upon a no-effect level. It is
based upon a low-effect level, and it does not take into
account how long people are exposed. Those people were exposed
for 14 days.
Mrs. Capps. Well, Mr. Chairman, I know my time is up, but I
would just like to address to you that I know there is some
misunderstanding of what kind of a hearing this is. But I feel
impressed enough by what I have heard today that I would
encourage our subcommittee to either have a real hearing on
legislation, because I am very frustrated with the EPA's stance
at the moment, or just go right into a markup. That would be my
humble suggestion.
Mr. Wynn. Well, your point is well taken.
Mrs. Capps. Thank you.
Mr. Wynn. This is a real hearing though.
Mrs. Capps. This is a real hearing? Thank you.
Mr. Shimkus. Thank you, Mr. Chairman, and I am not going to
ask any additional questions. I want to thank the panelists. I
want to thank you. I do think this was a very good hearing. I
think a lot of questions got aired out, a good debate, and my
final point, just to keep this in perspective, we just helped
with a rural water district in my district that got a USDA
rural development loan for $201,000 to do a water line out 10
miles to hook up 15 households. We just need to understand that
what is happening in Los Angeles, we still have people in well
systems. And that is kind of the point of my debate, and I know
you all are concerned with public health and safety issues. So
thank you, Mr. Chairman.
Mr. Wynn. I thank the gentleman for his observation. I
would note that, believe it or not, my district also has some
rural areas that we are concerned about. Mainly though I want
to thank the witnesses for their testimony. It was very helpful
for us today. There are no further witnesses. I would remind
Members that they may submit additional questions for the
record to be answered by the relevant witnesses. The questions
should be submitted to the committee clerk in electronic form
within the next 10 days. The clerk will notify the offices of
the procedures. This concludes our questions and concludes our
hearing for today. Thank you.
[Whereupon, at 12:20 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]