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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

COMMITTEE ON ENERGY AND COMMERCE

JOHN D. DINGELL, Michigan, Chairman

HENRY A. WAXMAN, California

EDWARD J. MARKEY, Massachusetts

RICK BOUCHER, Virginia

EDOLPHUS TOWNS, New York

FRANK PALLONE, JR., New Jersey

BART GORDON, Tennessee

BOBBY L. RUSH, Illinois

ANNA G. ESHOO, California

BART STUPAK, Michigan

ELIOT L. ENGEL, New York

ALBERT R. WYNN, Maryland

GENE GREEN, Texas

DIANA DEGETTE, Colorado

Vice Chairman

LOIS CAPPS, California

MIKE DOYLE, Pennsylvania

JANE HARMAN, California

TOM ALLEN, Maine

JAN SCHAKOWSKY, Illinois

HILDA L. SOLIS, California

CHARLES A. GONZALEZ, Texas

JAY INSLEE, Washington

TAMMY BALDWIN, Wisconsin

MIKE ROSS, Arkansas

DARLENE HOOLEY, Oregon

ANTHONY D. WEINER, New York

JIM MATHESON, Utah

G.K. BUTTERFIELD, North Carolina

CHARLIE MELANCON, Louisiana

JOHN BARROW, Georgia

BARON P. HILL, Indiana

JOE BARTON, Texas

Ranking Member

RALPH M. HALL, Texas

J. DENNIS HASTERT, Illinois

FRED UPTON, Michigan

CLIFF STEARNS, Florida

NATHAN DEAL, Georgia

ED WHITFIELD, Kentucky

BARBARA CUBIN, Wyoming

JOHN SHIMKUS, Illinois

HEATHER WILSON, New Mexico

JOHN B. SHADEGG, Arizona

CHARLES W. ‘‘CHIP’’ PICKERING,

Mississippi

VITO FOSSELLA, New York

STEVE BUYER, Indiana

GEORGE RADANOVICH, California

JOSEPH R. PITTS, Pennsylvania

MARY BONO, California

GREG WALDEN, Oregon

LEE TERRY, Nebraska

MIKE FERGUSON, New Jersey

MIKE ROGERS, Michigan

SUE WILKINS MYRICK, North Carolina

JOHN SULLIVAN, Oklahoma

TIM MURPHY, Pennsylvania

MICHAEL C. BURGESS, Texas

MARSHA BLACKBURN, Tennessee

PROFESSIONAL STAFF

DENNIS B. FITZGIBBONS, Chief of Staff

GREGG A. ROTHSCHILD, Chief Counsel

SHARON E. DAVIS, Chief Clerk

BUD ALBRIGHT, Minority Staff Director

(III)

SUBCOMMITTEE ON ENVIRONMENT AND HAZARDOUS MATERIALS

ALBERT R. WYNN, Maryland, Chairman

FRANK PALLONE, JR., New Jersey

BART STUPAK, Michigan

LOIS CAPPS, California

TOM ALLEN, Maine

HILDA L. SOLIS, California

Vice Chairman

TAMMY BALDWIN, Wisconsin

G.K. BUTTERFIELD, North Carolina

JOHN BARROW, Georgia

BARON P. HILL, Indiana

DIANA DEGETTE, Colorado

ANTHONY D. WEINER, New York

HENRY A. WAXMAN, California

GENE GREEN, Texas

JAN SCHAKOWSKY, Illinois

JOHN D. DINGELL, Michigan (ex officio)

JOHN SHIMKUS, Illinois

Ranking Member

CLIFF STEARNS, Florida

NATHAN DEAL, Georgia

HEATHER WILSON, New Mexico

JOHN B. SHADEGG, Arizona

VITO FOSELLA, New York

GEORGE RADANOVICH, California

JOSEPH R. PITTS, Pennsylvania

LEE TERRY, Nebraska

MIKE ROGERS, Michigan

JOHN SULLIVAN, Oklahoma

TIM MURPHY, Pennsylvania

JOE BARTON, Texas (ex officio)

(V)

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

(1)

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

2

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

3

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

4

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.

5

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 conVerDate 11-SEP-98 11:32 Mar 27, 2008 Jkt 000000 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 Q:\DOCS\110-35 SCOM1 PsN: SCOM1
6

taining 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.’’

7

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

8

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.

9

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.

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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.

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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:]

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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 onetenth 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.

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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:]

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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

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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 consumVerDate 11-SEP-98 11:32 Mar 27, 2008 Jkt 000000 PO 00000 Frm 00051 Fmt 6633 Sfmt 6633 Q:\DOCS\110-35 SCOM1 PsN: SCOM1
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ers 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:]

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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

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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 difVerDate 11-SEP-98 11:32 Mar 27, 2008 Jkt 000000 PO 00000 Frm 00064 Fmt 6633 Sfmt 6633 Q:\DOCS\110-35 SCOM1 PsN: SCOM1
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ferences 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:]

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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

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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:]

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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?

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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.

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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, wellintentioned, 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.

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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 authorVerDate 11-SEP-98 11:32 Mar 27, 2008 Jkt 000000 PO 00000 Frm 00088 Fmt 6633 Sfmt 6633 Q:\DOCS\110-35 SCOM1 PsN: SCOM1
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izes 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

85

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.

86

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.

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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?

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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?

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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——

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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 sitespecific 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

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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

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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

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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.

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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:]

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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

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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:]

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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.

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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:]

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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 postnatal period when a nursing infant is going to be exposed through

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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

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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 thyroidrelated 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?

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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

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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

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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

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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 breastfed 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,

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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.]

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