[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

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                    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:]

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