ATSDR: PROBLEMS IN THE PAST,

POTENTIAL FOR THE FUTURE?

HEARING

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SUBCOMMITTEE ON INVESTIGATIONS AND

OVERSIGHT

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HOUSE OF REPRESENTATIVES

ONE HUNDRED ELEVENTH CONGRESS

FIRST SESSION

MARCH 12, 2009

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ATSDR: PROBLEMS IN THE PAST,

POTENTIAL FOR THE FUTURE?

HEARING

BEFORE THE

SUBCOMMITTEE ON INVESTIGATIONS AND

OVERSIGHT

COMMITTEE ON SCIENCE AND

TECHNOLOGY

HOUSE OF REPRESENTATIVES

ONE HUNDRED ELEVENTH CONGRESS

FIRST SESSION

MARCH 12, 2009

Serial No. 111–10

Printed for the use of the Committee on Science and Technology

(

Available via the World Wide Web: http://www.science.house.gov

(II)

COMMITTEE ON SCIENCE AND TECHNOLOGY

HON. BART GORDON, Tennessee, Chair

JERRY F. COSTELLO, Illinois

EDDIE BERNICE JOHNSON, Texas

LYNN C. WOOLSEY, California

DAVID WU, Oregon

BRIAN BAIRD, Washington

BRAD MILLER, North Carolina

DANIEL LIPINSKI, Illinois

GABRIELLE GIFFORDS, Arizona

DONNA F. EDWARDS, Maryland

MARCIA L. FUDGE, Ohio

BEN R. LUJA ́ N, New Mexico

PAUL D. TONKO, New York

PARKER GRIFFITH, Alabama

STEVEN R. ROTHMAN, New Jersey

JIM MATHESON, Utah

LINCOLN DAVIS, Tennessee

BEN CHANDLER, Kentucky

RUSS CARNAHAN, Missouri

BARON P. HILL, Indiana

HARRY E. MITCHELL, Arizona

CHARLES A. WILSON, Ohio

KATHLEEN DAHLKEMPER, Pennsylvania

ALAN GRAYSON, Florida

SUZANNE M. KOSMAS, Florida

GARY C. PETERS, Michigan

VACANCY

RALPH M. HALL, Texas

F. JAMES SENSENBRENNER JR.,

Wisconsin

LAMAR S. SMITH, Texas

DANA ROHRABACHER, California

ROSCOE G. BARTLETT, Maryland

VERNON J. EHLERS, Michigan

FRANK D. LUCAS, Oklahoma

JUDY BIGGERT, Illinois

W. TODD AKIN, Missouri

RANDY NEUGEBAUER, Texas

BOB INGLIS, South Carolina

MICHAEL T. MCCAUL, Texas

MARIO DIAZ-BALART, Florida

BRIAN P. BILBRAY, California

ADRIAN SMITH, Nebraska

PAUL C. BROUN, Georgia

PETE OLSON, Texas

SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT

HON. BRAD MILLER, North Carolina, Chair

STEVEN R. ROTHMAN, New Jersey

LINCOLN DAVIS, Tennessee

CHARLES A. WILSON, Ohio

KATHY DAHLKEMPER, Pennsylvania

ALAN GRAYSON, Florida

BART GORDON, Tennessee

PAUL C. BROUN, Georgia

BRIAN P. BILBRAY, California

VACANCY

RALPH M. HALL, Texas

DAN PEARSON Subcommittee Staff Director

EDITH HOLLEMAN Subcommittee Counsel

JAMES PAUL Democratic Professional Staff Member

DOUGLAS S. PASTERNAK Democratic Professional Staff Member

KEN JACOBSON Democratic Professional Staff Member

TOM HAMMOND Republican Professional Staff Member

JANE WISE Research Assistant

(III)

C O N T E N T S

March 12, 2009

Page

Witness List ............................................................................................................. 2

Hearing Charter ...................................................................................................... 3

Opening Statements

Prepared statement by Representative Bart Gordon, Chair, Committee on

Science and Technology, U.S. House of Representatives .................................. 30

Statement by Representative Brad Miller, Chair, Subcommittee on Investigations and Oversight, Committee on Science and Technology, U.S. House

of Representatives ................................................................................................ 5

Written Statement ............................................................................................ 6

Statement by Representative Paul C. Broun, Ranking Minority Member, Subcommittee on Investigations and Oversight, Committee on Science and

Technology, U.S. House of Representatives ....................................................... 28

Written Statement ............................................................................................ 29

Panel I:

Mr. Salvador Mier, Local Resident, Midlothian, Texas; Former Director of

Prevention, Centers for Disease Control

Oral Statement ................................................................................................. 31

Written Statement ............................................................................................ 33

Biography .......................................................................................................... 166

Dr. Randall R. Parrish, Head, Natural Environmental Research Council

(NERC) Isotope Geosciences Laboratory, British Geological Survey

Oral Statement ................................................................................................. 166

Written Statement ............................................................................................ 168

Biography .......................................................................................................... 232

Mr. Jeffrey C. Camplin, President, Camplin Environmental Services, Inc.

Oral Statement ................................................................................................. 233

Written Statement ............................................................................................ 235

Biography .......................................................................................................... 240

Dr. Ronald Hoffman, Albert A. and Vera G. List Professor of Medicine,

Mount Sinai School of Medicine; Director, Myeloproliferative Disorders Program, Tisch Cancer Institute, Mount Sinai Medical Center

Oral Statement ................................................................................................. 240

Written Statement ............................................................................................ 243

Biography .......................................................................................................... 247

Discussion

Explanations of ATSDR’s Deficiencies ............................................................... 248

Peer Review .......................................................................................................... 248

More Explanation of Deficiencies ....................................................................... 249

Potential Fixes ...................................................................................................... 249

Geographic Prevalence of Deficiencies ............................................................... 251

Public Awareness ................................................................................................. 252

Asbestos ................................................................................................................ 253

Local Health Protection ....................................................................................... 254

Vieques, Puerto Rico ............................................................................................ 254

Colonie, New York ............................................................................................... 256

Animals as Sentinels of Human Health ............................................................. 259

Page

IV

Panel II:

Dr. Ronnie D. Wilson, Associate Professor, Central Michigan University;

Former Ombudsman, Agency for Toxic Substances and Disease Registry

Oral Statement ................................................................................................. 260

Written Statement ............................................................................................ 262

Biography .......................................................................................................... 263

Dr. David Ozonoff, Professor of Environmental Health, Boston University

School of Public Health

Oral Statement ................................................................................................. 264

Written Statement ............................................................................................ 266

Biography .......................................................................................................... 268

Dr. Henry S. Cole, President, Henry S. Cole & Associates, Inc., Upper Marlboro, Maryland

Oral Statement ................................................................................................. 269

Written Statement ............................................................................................ 271

Biography .......................................................................................................... 301

Discussion

More Animals as Sentinels of Human Health ................................................... 302

Peer Review .......................................................................................................... 302

Information Access ............................................................................................... 303

Difficulty With Epidemiology .............................................................................. 303

Potential Fixes ...................................................................................................... 304

Panel III:

Dr. Howard Frumkin, Director, National Center for Environmental Health

and Agency for Toxic Substances and Disease Registry (NCEH/ATSDR)

Oral Statement ................................................................................................. 307

Written Statement ............................................................................................ 309

Biography .......................................................................................................... 317

Discussion

More on Animals as Sentinels of Human Health .............................................. 318

More on Peer Review ........................................................................................... 319

Hindrances to ATSDR’s Performance ................................................................. 320

More on Potential Fixes ....................................................................................... 321

More on Vieques, Puerto Rico ............................................................................. 322

Changes in Response to Criticism ...................................................................... 323

Closing .................................................................................................................. 324

Appendix 1: Answers to Post-Hearing Questions

Mr. Salvador Mier, Local Resident, Midlothian, Texas; Former Director of

Prevention, Centers for Disease Control ............................................................ 326

Dr. Randall R. Parrish, Head, Natural Environmental Research Council

(NERC) Isotope Geosciences Laboratory, British Geological Survey ............... 334

Mr. Jeffrey C. Camplin, President, Camplin Environmental Services, Inc. ....... 338

Dr. Ronnie D. Wilson, Associate Professor, Central Michigan University;

Former Ombudsman, Agency for Toxic Substances and Disease Registry ..... 342

Dr. Henry S. Cole, President, Henry S. Cole & Associates, Inc., Upper Marlboro, Maryland ..................................................................................................... 347

Dr. Howard Frumkin, Director, National Center for Environmental Health

and Agency for Toxic Substances and Disease Registry (NCEH/ATSDR) ....... 351

(1)

ATSDR: PROBLEMS IN THE PAST, POTENTIAL

FOR THE FUTURE?

THURSDAY, MARCH 12, 2009

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT,

COMMITTEE ON SCIENCE AND TECHNOLOGY,

Washington, DC.

The Subcommittee met, pursuant to call, at 10:05 a.m., in Room

2318 of the Rayburn House Office Building, Hon. Brad Miller

[Chair of the Subcommittee] presiding.

2

3

HEARING CHARTER

SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT

COMMITTEE ON SCIENCE AND TECHNOLOGY

U.S. HOUSE OF REPRESENTATIVES

ATSDR: Problems in the Past,

Potential for the Future?

THURSDAY, MARCH 12, 2009

10:00 A.M.–12:00 P.M.

2318 RAYBURN HOUSE OFFICE BUILDING

Purpose

Chairman Brad Miller of the Investigations and Oversight Subcommittee of the

House Committee on Science and Technology will convene a hearing at 10:00 a.m.

on Thursday, March 12, 2009, to examine the Agency for Toxic Substances and Disease Registry’s (ATSDR). Last year, the Subcommittee held a hearing and issued

a staff report on how the Agency came to issue a scientifically flawed formaldehyde

health consultation for the Federal Emergency Management Agency (FEMA). The

flawed report and ATSDR’s botched response resulted in tens of thousands of survivors of Hurricanes Katrina and Rita remaining in travel trailers laden with high

levels of formaldehyde for more than one year longer than necessary.

This hearing will consist of three panels and eight witnesses, including Dr. Howard Frumkin, Director of ATSDR. It will examine ongoing problems at ATSDR, specific cases where local community members, scientists and physicians are critical of

the Agency’s scientific methods, conclusions and lack of follow-up actions. The hearing will also hear from individuals who have either worked for or with the Agency

in the past, including the former ATSDR ombudsman, who will provide their insight

into the cause of systematic problems at the Nation’s public health agency and potential remedies.

The hearing will explore why ATSDR has refused to change portions of a health

report, described by the EPA as ‘‘questionable’’ and ‘‘misleading,’’ regarding asbestos

contamination on a beach on Lake Michigan in Chicago. There will be testimony

from a well-respected medical expert on a rare type of cancer who says the Agency

has refused to acknowledge a link between a cancer cluster in Pennsylvania and environmental contamination despite persuasive evidence.

In addition, a British scientist will describe the flawed methods ATSDR used to

investigate depleted uranium exposures among residents in Colonie, New York and

how he and colleagues succeeded in discovering depleted uranium exposures among

20 percent of the resident population they tested there. A local resident from

Midlothian, Texas, known as the cement capital of the world, will explain how and

why he and the local community have lost faith in ATSDR’s ability to independently

and scientifically investigate the health problems that the town’s population, particularly its children and animals, have been suffering from that they believe have

been caused by the one billion pounds of toxic emissions the town’s industries have

unleashed into the environment since 1990.

Witnesses:

Panel I

• Mr. Jeffrey Camplin, President, Camplin Environmental Services, Inc.

• Dr. Ronald Hoffman, Professor, Tisch Cancer Institute, Department of Medicine, Mount Sinai School of Medicine, New York

• Dr. Randall Parrish, Head, NERC Isotope Geosciences Laboratory, British

Geological Survey

• Mr. Salvador Mier, Local Resident, Midlothian, Texas, and Former Director

of Prevention, Center for Disease Control

4

Panel II

• Dr. Henry S. Cole, President, Henry S. Cole & Associates, Inc.

• Dr. David Ozonoff, Chair Emeritus, Department of Environmental Health,

Boston University School of Public Health

• Dr. Ronnie Wilson, Former Ombudsman, Agency for Toxic Substances and

Disease Registry

Panel III

• Dr. Howard Frumkin, Director, National Center for Environmental Health/

Agency for Toxic Substances and Disease Registry

5

Chair MILLER. This hearing will now come to order.

Good morning and welcome to today’s hearing. The title is

ATSDR: Problems in the Past, Potential for the Future? The stated

mission of the Agency for Toxic Substances and Disease Registry,

ATSDR, is to serve the public by using the best science, taking responsive public health actions and providing trusted health information to prevent harmful exposures and disease-related exposures

to toxic substances.

The relatively obscure Federal Government agency first came to

this subcommittee’s attention a year or so ago as a result of

ATSDR’s health assessment for formaldehyde exposure by Katrina

and Rita victims living in FEMA trailers. Government at all levels

failed the victims of Katrina and Rita in many ways, but ATSDR’s

failure was perhaps the most unforgivable. ATSDR’s health assessment certainly failed any test of scientific rigor but ATSDR’s failure was worse than just jackleg science. ATSDR’s failure was a

failure not just of the head but of the heart.

FEMA requested the health assessment to use in litigation and

requested that the assessment assume an exposure of less than two

weeks, knowing that Katrina and Rita victims had already been exposed to formaldehyde fumes for more than a year, and that there

was no end in sight to their exposure. Stunningly, ATSDR obliged.

Their report gave FEMA just what FEMA asked for. Let me repeat

that to let it sink in. FEMA came to ATSDR and said we have been

sued, we need a health assessment for exposure to formaldehyde

fumes. The folks that have been exposed to those fumes have been

exposed for more than a year already and God only knows how

long they will be exposed into the future but we want you to assume they were exposed for less than two weeks, and ATSDR said

no problem, okay, we can do that. Now, obviously I have had to

shorten that story a little bit, but the facts that I have left out are

not exculpatory. They are more damning still.

It gets worse from there. FEMA touted the assessment to assure

families living in the FEMA trailers that the formaldehyde fumes

were nothing to worry about. Dr. Howard Frumkin, who is here

today and will be a witness today, was then and is still the director

of ATSDR. Dr. Frumkin held a dozen senior staff meetings on the

formaldehyde issue over a 6-month period after ATSDR issued the

report in February 2007. Only after unflattering scrutiny by Congressional committees including this subcommittee did ATSDR correct the health assessment.

Since then, this subcommittee has heard from many sources of

other examples of jackleg science by ATSDR and a keenness to

please industries and government agencies that prefer to minimize

public health consequences of environmental exposures. Our

sources have included outside scientists, residents of communities

exposed to various chemicals, and ATSDR’s own scientists. Now,

one ATSDR staff scientist told our subcommittee staff, ‘‘It seems

like the goal is to disprove the communities’ concerns rather than

actually trying to prove exposures.’’

Today we will hear about a small number of the cases that have

been called to our attention and about problems at ATSDR that

date from the Agency’s creation.

6

And then there is the question of what to do about ATSDR.

When federal agencies fail in their mission, the problem is usually

a lack of resources. There is no reason to believe that more funding

or more staff for ATSDR would result in anything other than a

greater volume of jackleg assessments saying not to worry.

We hope that the Obama Administration will take a hard look

at ATSDR and we may want to consider legislative fixes. First,

there is a possibility of peer review, outside, independent peer review. The statute now neither requires nor forbids ATSDR from

getting an independent peer review, and in fact, ATSDR very rarely, if ever, gets a peer review. Most scientists see peer review as

helpful, as constructive criticism. ATSDR on the other hand apparently sees opinions of outside scientists as unwelcome, meddling,

and as a result, according to the scientists we have talked to, the

research design and methodology is often flawed and the research

is frequently not sound, accurate or complete. Congress may well

want to consider requiring peer review, at least in some circumstances, by legislation. It is hard to know, however, how Congress can require ATSDR’s leadership to have the guts to resist political pressure and insist of scientific integrity.

The American people deserve better and so do the many scientists at ATSDR who have dedicated their lives to protecting the

public health and devoutly wish that ATSDR faithfully and effectively perform the Agency’s stated mission.

[The prepared statement of Chair Miller follows:]

PREPARED STATEMENT OF CHAIR BRAD MILLER

The stated mission of the Agency for Toxic Substances and Disease Registry

(‘‘ATSDR’’) ‘‘is to serve the public by using the best science, taking responsive public

health actions, and providing trusted health information to prevent harmful exposures and disease related exposures to toxic substances.’’

The relatively obscure Federal Government agency first came to this subcommittee’s attention a year and a half or so ago as a result of ATSDR’s health assessment

for formaldehyde exposure by Katrina and Rita victims living in FEMA trailers.

Government at all levels failed the victims of Katrina and Rita in many ways, but

ATSDR’s failure was perhaps the most unforgivable. ATSDR’s health assessment

certainly failed any test of scientific rigor, but ATSDR’s failure was worse than just

jackleg science. ATSDR’s failure was a failure not just of the head but of the heart.

FEMA requested the health assessment to use in litigation, and requested that

the assessment assume an exposure of less than two weeks, knowing that Katrina

and Rita victims had already been exposed to formaldehyde fumes for more than

a year and that there was no end in sight to their exposure. Stunningly, ATSDR’s

report gave FEMA just what FEMA asked for.

FEMA touted the assessment to assure families living in the FEMA trailers that

the formaldehyde fumes were nothing to worry about. Dr. Howard Frumkin, then

and still the Director of ATSDR, will testify today. Dr. Frumkin held a dozen senior

staff meetings on the formaldehyde issue over a six-month period after ATSDR

issued the flawed report in February 2007. Only after unflattering scrutiny congressional committees did ATSDR correct the health assessment.

Since then, this subcommittee has heard from many sources of other examples of

jackleg science by ATSDR and a keenness to please industries and government

agencies that prefer to minimize public health consequences of environmental exposures. Our sources have included outside scientists, residents of communities exposed to various chemicals, and ATSDR’s own scientists. One ATSDR staff scientist

told our subcommittee staff ‘‘It seems like the goal is to disprove the communities’

concerns rather than actually trying to prove exposures.’’

Today we will hear about a small number of the cases that have been called to

our attention, and about problems at ATSDR that date from the Agency’s creation.

Then there is the question what to do about ATSDR. When federal agencies fail

in their mission, the problem is usually a lack of necessary resources. There is no

7

1 ‘‘Toxic Trailers: Have the Centers for Disease Control Failed to Protect Public Health?,’’

Hearing before the Subcommittee on Investigations and Oversight, Committee on Science and

Technology, U.S. House of Representatives, April 1, 2008, available here: http://

science.house.gov/publications/hearings¥markups¥details.aspx?NewsID=2133 2 ‘‘Toxic Trailers—Toxic Lethargy: How the Centers for Disease Control and Prevention Has

Failed to Protect the Public Health,’’ Majority Staff Report, Subcommittee on Investigations and

Oversight, Committee on Science and Technology, U.S. House of Representatives, September

2008, available here: http://democrats.science.house.gov/Media/File/Commdocs/

ATSDR¥Staff¥Report¥9.22.08.pdf

reason to believe that more funding or more staff would result in anything other

than a greater volume of jackleg assessments saying ‘‘not to worry.’’ We hope the new Obama Administration will take a hard look at ATSDR. We may also consider legislative fixes. ATSDR was exempted from forced peer review for its

‘‘health assessments,’’ but the statute never forbid scientific review and the vast majority of ATSDR’s health reports do not go through independent review today. Most

scientists see peer review as helpful, constructive criticism. ATSDR, on the other

hand, apparently sees the opinions of outside scientists as unwelcome meddling. As

a result, ATSDR’s research design and methodology is often flawed, according to

other scientists, and ATSDR’s research is frequently not sound, accurate or complete. Perhaps Congress could require peer review by legislation. But it is hard to

know how Congress can require ATSDR’s leadership to have the guts to resist political pressure and insist on scientific integrity. The American people deserve better, and so do the many scientists at ATSDR who have dedicated their lives to protecting the public’s health, and devoutly wish that

ATSDR faithfully and effectively perform the Agency’s stated mission.

Chair MILLER. I will recognize Mr. Broun in a second, but first we will include the staff report that this subcommittee staff has

prepared and will be included along with my statement in the

record.

[The information follows:]

The Agency for Toxic Substances and

Disease Registry (ATSDR): Problems in

the Past, Potential for the Future?

REPORT BY THE MAJORITY STAFF OF THE

SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT

COMMITTEE ON SCIENCE AND TECHNOLOGY

U.S. HOUSE OF REPRESENTATIVES

TO SUBCOMMITTEE CHAIRMAN BRAD MILLER

MARCH 10, 2009

Introduction

Last April the Subcommittee on Investigations and Oversight held a hearing on

the Agency for Toxic Substances and Disease Registry (ATSDR), a sister agency of

the Centers for Disease Control and Prevention (CDC). The hearing looked at how

the Agency produced a scientifically flawed and misleading health consultation on

the health hazards of potential formaldehyde exposures by survivors of Hurricanes

Katrina and Rita living in travel trailers provided by the Federal Emergency Management Agency (FEMA).1 Last September the Subcommittee issued a detailed staff

report on our investigation which found that: ‘‘The leadership of ATSDR obfuscated

their role in reviewing and approving the February 2007 health consultation and

attempted to abdicate their own responsibility for the Agency’s fundamental failure

to protect the public’s health. Most disturbingly, as the Agency’s troubled response

to the formaldehyde fiasco unraveled, the leadership of ATSDR attempted to shift

blame for the inappropriate handling of the incident to others, primarily [whistleblower Dr. Chris] De Rosa and his staff.’’ 2 Unfortunately, the poor scientific integrity of ATSDR’s formaldehyde health consultation and the weak leadership at the

Agency that permitted the production of this misleading report which went uncorVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00015 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
8

3 ‘‘Statement of Mission,’’ Agency for Toxic Substances and Disease Registry, undated, available here: http://www.atsdr.cdc.gov/about/mission.html 4 ‘‘What You Can Expect From ATSDR,’’ Agency for Toxic Substances and Disease Registry,

May 2002, available here: http://www.atsdr.cdc.gov/COM/expect.pdf 5 ‘‘Interim Report on Establishment of the Agency for Toxic Substances and Disease Registry

and the Adequacy of Superfund Staff Resources,’’ U.S. General Accounting Office, GAO/HRD–

83–81, August 10, 1983, p. 1, available here: http://archive.gao.gov/f0302/122111.pdf 6 Ibid, p. 3, available here: http://archive.gao.gov/f0302/122111.pdf. The name of the General

Accounting Office was changed in 2004 to the Government Accountability Office (GAO). 7 Ibid, p. 2, available here: http://archive.gao.gov/f0302/122111.pdf 8 Ibid, p. 3, available here: http://archive.gao.gov/f0302/122111.pdf

rected for so long—keeping the public in harm’s way for a year longer than necessary—was not an isolated incident.

The Agency’s mission ‘‘is to serve the public by using the best science, taking responsive public health actions, and providing trusted health information to prevent

harmful exposures and disease related to toxic substances.’’3 On paper, according to

ATSDR, the Agency is deeply involved with the local communities it is intended to

help protect, it makes independent, objective health decisions based on the best

science available, it conducts exposure investigations to assess health impacts of environmental toxins and it provides and explains the results of their evaluations,

medical consultations and investigations to local communities and tribes.4 In reality,

across the Nation local community groups believe that ATSDR has failed to protect

them from toxic exposures and independent scientists are often aghast at the lack

of scientific rigor in its health consultations and assessments. The studies lack the

ability to properly attribute illness to toxic exposures and the methodologies used

by the Agency to identify suspected environmental exposures to hazardous chemicals are doomed from the start.

The Subcommittee staff is not suggesting that ATSDR find problems where none

exist or that ATSDR should or can identify the sources of a possible cancer cluster,

disease or other health hazard in every instance or where the potential source of

toxic exposures are ambiguous or elusive. Yet time and time again ATSDR appears

to avoid clearly and directly confronting the most obvious toxic culprits that harm

the health of local communities throughout the Nation. Instead, they deny, delay,

minimize, trivialize or ignore legitimate concerns and health considerations of local

communities and well respected scientists and medical professionals.

Many independent scientists, medical professionals, local environmental groups

and public health advocates believe that rather than objectively and aggressively

trying to identify the source of reported health problems, ATSDR often seeks ways

to avoid linking local health problems to specific sources of hazardous chemicals. Instead, says one current ATSDR scientist who spoke to the Committee on the condition of anonymity: ‘‘It seems like the goal is to disprove the communities’ concerns

rather than actually trying to prove exposures.’’ None of these problems are new to

ATSDR but it will require a new will and desire to fix them on the part of ATSDR’s

leadership.

Background

In 1980 Congress created the Agency for Toxic Substances and Disease Registry

(ATSDR) through the enactment of the Comprehensive Environmental Response,

Compensation, and Liability Act of 1980 (CERCLA) (Public Law 96–510) commonly

referred to as ‘‘Superfund.’’ CERCLA authorized the Environmental Protection

Agency (EPA) to clean up nationally identified toxic waste (Superfund) sites and

Section 104(i) required the Department of Health and Human Services’ (HHS) Public Health Service to establish a new agency to carry out health-related activities

at these waste sites.5 Thus, ATSDR was created to help determine the potential

human health consequences of releases of toxic chemicals at these sites.

Although ATSDR was created with the best of intentions, it had an extremely difficult birth and has struggled ever since. The EPA and HHS provided it with little

support and at times tried to subvert it. It took three years after enactment of the

law that authorized the creation of ATSDR for the Agency to actually emerge. By

June 1983 the HHS’ Public Health Service ‘‘had developed few detailed procedures

concerning the new agency and how the Superfund responsibilities would be carried

out,’’ according to a report from Congress’s investigative arm, the U.S. General Accounting Office (GAO).6 ‘‘HHS objected to establishing a separate agency to carry

out its Superfund responsibilities, contending it was not necessary.’’ 7 In fact, HHS

never wanted ATSDR to have its own staff and tried to reign in the new agency’s

independence by detailing CDC staff to ATSDR and forcing it to use CDC’s administrative and support structure.8

9

9 Ibid, p. 7, available here: http://archive.gao.gov/f0302/122111.pdf 10 ‘‘SUPERFUND: Funding for the Agency for Toxic Substances and Disease Registry,’’ U.S.

General Accounting Office, GAO/RCED–87–112BR, March 1987, p. 2. available here: http://archive.gao.gov/t2pbat22/132595.pdf 11 ‘‘Superfund: Public Health Assessments Incomplete and of Questionable Value,’’ General Accounting Office, RCED–91–178, August 1, 1991, p. 13, available here: http://archive.gao.gov/

t2pbat7/144755.pdf 12 Ibid, p. 18, available here: http://archive.gao.gov/t2pbat7/144755.pdf 13 Ibid, p. 28, available here: http://archive.gao.gov/t2pbat7/144755.pdf

In addition, because the Office of Management and Budget (OMB) reduced the

number of HHS requested staffing positions in 1984 to ATSDR, CDC officials told

GAO’s investigators that because of limited staff ‘‘they expected to eliminate virtually all [of ATSDR’s planned] long-term health studies, [health] registries, and

laboratory projects.’’ 9 During this same time-frame both EPA and OMB consistently

reduced ATSDR’s annual budget.10 Three years after ATSDR was physically established, a new law was passed, the Superfund Amendments and Reauthorization Act

of 1986 (SARA) that set an arbitrary deadline of December 1988 for the Agency to

conduct health assessments at 951 Superfund sites. The law was necessary at the

time, many believed, because ATSDR had made zero headway in accomplishing

these tasks. As a result of the new law ATSDR developed ‘‘initial mandate assessments’’ at 950 sites within a little over two years. The Agency achieved a quantitative victory in producing so many assessments is so little time.

But Congress’s desire to force the new understaffed agency to become more effective, efficient and responsive to fulfilling its initial mandate had unintended qualitative consequences. In order to prepare health assessments on 951 Superfund sites

within this time period ATSDR wrote 785 assessments in 15 months and ‘‘labeled

165 previously prepared documents in its files as health assessments’’ even though

some were several years old, according to GAO. To accomplish this massive effort,

ATSDR ignored ‘‘its own guidance requiring visits to sites’’ and instead conducted

‘‘desk’’ assessments, GAO found. The Agency, for instance, labeled previously produced documents not intended to be full health assessments as ‘‘assessments.’’ ‘‘In

the rush to complete these assessments, ATSDR dropped plans to do full internal

quality checks on its assessments, and no review was made by outside experts,’’ according to GAO.11

When GAO reviewed the quality and usefulness of ATSDR’s health assessments

in 1991 they hired five independent experts to evaluate 15 of the Agency’s assessments. What they found was that the initial mandate assessments ‘‘were seriously

deficient overall.’’ Although follow up assessments were improved over the earlier

assessments GAO’s expert reviewers ‘‘continued to find deficiencies in evidence or

analysis, such as unsupported conclusions.’’

GAO concluded that ATSDR needed to improve its quality controls and to establish ‘‘some independent peer review.’’ It found that ATSDR should involve local communities more in developing assessments. The GAO panel also found the reports it

reviewed contained ‘‘(1) inadequate descriptions or analyses of health risks, (2) failures to indicate whether communities had been exposed to contaminants, (3) overly

general recommendations, and (4) inattention to the sufficiency of data.’’ 12 One of

the GAO panel members said that ‘‘regardless of the wide diversity of sites that we

studied [the assessments] come up with the same conclusion: that there is a potential problem.’’ Incredibly out of the 951 initial assessments ATSDR conducted it

found just 13 sites as posing a ‘‘significant health risk.’’ 13

In the rush to push out nearly 1,000 health assessments in two years time the

Agency developed a check-box mentality that helped to undermine virtually everything the Agency did. Quality became an after-thought to the ability to produce public health documents quickly. The integrity of the data, assessment of the public

health risks and credibility of the conclusions all suffered deeply as a result.

Unfortunately, the past problems identified by GAO have not disappeared. Reviews of the FEMA trailer health consultation on formaldehyde, as well as other

health reports from ATSDR, appears to suggest the Agency has never recovered

from the initial problems that overshadowed its birth. Internally, many ATSDR employees have told the Subcommittee over the past year that the Agency lacks appropriate quality controls, it conducts inadequate analyses of health risks to local communities and they often do not collect and analyze the most relevant and revealing

data about potential environmental health hazards. Externally, the local communities that ATSDR was created to help protect often believe the Agency does more

harm than good by offering them reassuring but unfounded and unsound advice and

analysis which simply creates an artificial perception of safety to the public that is

not supported by scientific inquiry or independent examination.

10

14 ‘‘Birth Defects Monitoring 2005 Report Summary,’’ Texas Department of State Health Services and ‘‘Cancer Registry 2005 Report Summary,’’ Texas Department of State Health Services

both available here: http://www.dshs.state.tx.us/epitox/midlothian/reports.shtml 15 ‘‘Midlothian Petition Community Site Update, Texas Department of State Health Services,

December 2005, available here: http://www.dshs.state.tx.us/epitox/midlothian/december¥update.pdf 16 ‘‘Midlothian Petition Community Site Update, Texas Department of State Health Services,

February 2006, available here: http://www.dshs.state.tx.us/epitox/midlothian/update206.pdf 17 ‘‘Health Consultation: Public Comment Release, Midlothian Area Air Quality Part 1: Volatile Organic Compounds & Metals, Midlothian, Ellis County, Texas, December 11, 2007, available here: http://www.dshs.state.tx.us/epitox/midlothian/updates.shtm

Investigating environmental public health issues is a difficult and daunting task.

Local communities expect State or federal public health agencies to identify the

cause of their specific health concerns, provide medical or other support and eradicate the environmental hazard. In some cases it is exceedingly difficult to establish

a definitive link between specific toxic exposures and health problems. In other

cases it may be difficult to quantify an actual health problem and in some instances

the scientific evidence may not identify any problem let alone the specific cause of

a health problem. But in many, many cases ATSDR seems to get the science wrong,

ignores community complaints or both.

Midlothian, Texas—Cement Kilns

Mr. Sal Mier is a local resident of Midlothian, Texas and former official at the

Centers for Disease Control and Prevention (CDC). Midlothian is known as the cement capital of the world and is home to three cement plants and one steel mill.

These plants have released nearly one billion pounds of toxic chemicals into the

local environment since 1990. The Texas Commission on Environmental Quality

(TCEQ) began environmental monitoring in Midlothian in 1991. In June 2005, the

Texas Department of State Health Services (DSHS) completed a review of the Texas

Birth Defects registry and found that one type of birth defect related to urinary

tract development (hypospadias or epispadias) was statistically elevated. The previous month DSHS completed a cancer cluster investigation that found no elevation

in cancers when it examined residents in three zip codes in Midlothian and two

other towns.14 But by expanding the pool of individuals in this investigation to those

outside of Midlothian, critics say the study diminished the ability to specifically

identify increased rates of cancers among Midlothian residents.

In 2005, Mr. Mier petitioned ATSDR to look into health issues in Midlothian. In

August 2005, ATSDR agreed to conduct a health assessment on the potential health

effects of toxic substances released from Midlothian’s cement kilns. Under a cooperative agreement with ATSDR, DSHS would conduct the health investigation along

with some support, review and final concurrence by ATSDR. In December 2005,

DSHS said that the health consultation would be completed and reviewed by

ATSDR and released for public comment by ‘‘the first part of February 2006.’’ 15 In

February 2006 the document’s release date was pushed back to March 2006 ‘‘due

to the large volume of information to be reviewed.’’ 16

In December 2007, 27 months after ATSDR began their investigation, the Agency

finally released a ‘‘draft’’ health consultation for ‘‘public comment.’’ The report found

that for the vast majority of chemicals they examined there was no public health

hazard. They concluded, for instance, that there was ‘‘no evidence to suggest that

adverse health effects would be anticipated as a result of any of the short-term or

peak exposures to VOCs [Volatile Organic Compounds] or Metals’’ being emitted

from the plants in Midlothian. The Agency’s overall conclusion was that the air in

Midlothian posed an ‘‘Indeterminate Public Health Hazard.’’ 17 A ‘‘final’’ version of

that study is planned to be released in the next couple of months—more than three

and one half years after the investigation began.

Mr. Mier received comments on this document from several independent scientists

who concluded it was deeply flawed. Dr. Stuart Batterman, Associate Chairman of

the Department of Environmental Health Sciences, School of Public Health at the

University of Michigan, wrote: ‘‘The Health Consultation is biased. It contains overarching statements that discount all indications that emissions from local industry

and environmental conditions might or do pose a health concern in the community.’’

Dr. Peter L. deFur, a Research Associate Professor in the Center for Environmental

Studies at Virginia Commonwealth University agreed. ‘‘Throughout the document,

ATSDR attempts to marginalize or disregard data that indicate that compounds

produce human health risks. ATSDR has more than enough data to classify the site

as a ‘‘Public Health Hazard.’’ For the past fifteen months ATSDR has been reviewing these and many other public comments they received on their draft health conVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00018 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
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18 Amanda Caldwell and Susan Waskey, ‘‘Midlothian Industrial Plant: Emission Data,’’ Geog- raphy Special Problems, University of North Texas, July 25, 2008. 19Marvin Legator, et al., ‘‘The Health Effects of Living Near Cement Kilns; A Symptom Sur- vey in Midlothian, Texas,’’ Toxicology and Industrial Health, Vol. 14, No. 6, 1998. 20Marvin S. Legator and Amanda M. Howells-Daniel, ‘‘A Deliberate Smokescreen,’’ Archives

of Environmental Health, Vol. 49 (No. 3), May/June 1994. 21 USA Today Special Report, ‘‘The Smokestack Effect: Toxic Air and America’s Schools,’’ December 8, 2008, http://content.usatoday.com/news/nation/environment/smokestack/index? loc=interstitialskip

sultation and intend to release the final version of their report in the next couple

of months.

It is clear that the release of toxic material from the three cement plants and steel

mill in Midlothian has been enormous over the years. Using State and federal

records from the Environmental Protection Agency’s (EPA) Toxics Release Inventory

(TRI) and TCEQ’s Emission Inventory two graduate students at the University of

North Texas, Amanda Caldwell and Susan Waskey, conducted a study of the local

emissions from Midlothian for the local environmental non-profit group

Downwinders At Risk. The study found that between 1990 and 2006 these four industrial plants released more than one billion pounds of toxic emissions to the environment. The emissions were a brew of toxic substances, including millions of

pounds of manganese, lead and sulfuric acid, as well as hundreds of thousands of

pounds of trichloroethylene, zinc compounds, mercury, benzene, hydrochloric acid,

formaldehyde, toluene and other hazardous chemicals.18 Tying down specific health effects to individual industrial plants in Midlothian would be a difficult undertaking. But Midlothian residents are frustrated that ATSDR has ignored critical

signs of potential health problems in the community and has essentially given the

community a clean bill of health despite many indications that the community may

be suffering from health problems due to exposures to industrial pollutants. Sue Pope, a Midlothian resident and one of the creators of Downwinders At Risk,

had hair samples of 55 people living in or near Midlothian, many of them infants

and young children, analyzed for toxic substances between 1988 and 1993. What the

tests revealed was that many of the residents had high levels of aluminum, lead,

cadmium and nickel. She turned over copies of these documents to Texas State authorities who were investigating health issues in Midlothian, but she says nothing

ever came of it.

Other residents and independent scientists have chronicled health problems in

Midlothian too. In 1998, scientists led by Dr. Marvin Legator at the University of

Texas Medical Branch, Division of Environmental Toxicology published a peer-reviewed paper in the journal Toxicology and Industrial Health titled: ‘‘The Health Effects of Living Near Cement Kilns; A Symptom Survey in Midlothian, Texas.’’ The

study found that respiratory illnesses in Midlothian were three times more common

than in neighboring Waxahatchie.19

Two years earlier, Legator published an editorial in the Archives of Environmental

Health, titled: ‘‘A Deliberate Smokescreen,’’ which criticized the scientific integrity of ATSDR’s studies and the methods ATSDR uses in an attempt to investigate potential environmental exposures. In the article Legator and a colleague recommended ‘‘that careful evaluation be made of a significant number of ATSDR or

ATSDR-sponsored studies to determine how well the victims of chemical exposure

and our taxpayers have been served by this agency.’’ 20

Last December USA Today ran an in-depth special report titled ‘‘The Smokestack

Effect: Toxic Air and America’s Schools,’’ that used the same EPA data as the report

on Midlothian’s toxic emissions by Caldwell and Waskey to track the path of industrial pollution and then mapped the locations of almost 128,000 schools to determine

the levels of toxic chemicals in their path. The USA Today report’s interactive map

of the United States shows that of the nine schools located in Midlothian, Texas,

two of them were ranked in the 1st percentile of the schools exposed to the most

toxic chemicals in the Nation, three of the schools were ranked in the third percentile and each of the others were ranked in the 6th, 14th, 21st and 32nd percentiles. According to the USA Today report only 174 of the Nation’s 127,809 schools they ranked had worse toxic air exposures than the Mt. Peak Elementary School

in Midlothian, for instance.21

Anecdotally, many Midlothian children apparently have severe cases of asthma, cancer cases are wide-ranging among the population and there has been a history

of poor health problems among cattle, horses and other animals in the area. Debra

Markwardt, a local Midlothian dog breeder, recently suggested to ATSDR’s Director,

Dr. Howard Frumkin, that his agency examine her dogs as an indicator of what is

happening to the human population in Midlothian. Markwardt moved to Midlothian

in 1988. Her dogs soon started experiencing a wide-range of disturbing health probVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00019 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
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22 ‘‘Animals as Sentinels of Environmental Health Hazards,’’ Committee on Animals as Monitors of Environmental Hazards, National Research Council, National Academy Press, Washington, D.C., 1991, available here: http://www.nap.edu/catalog.php?record¥id=1351 23 ‘‘HEALTH CONSULTATION: Response to Community Inquires Regarding Nitrate, Lead,

Thallium and Chromium Levels in Water from Private Domestic Wells near the Pacific Gas and

Electric Facility in Hinkley, California—Pacific Gas and Electric Facility, Hinkley, San

Bernardino County, California,’’ Prepared By: California Department of Health Services, Under

a Cooperative Agreement with the Agency for Toxic Substances and Disease Registry, April 25,

2003, available here: http://www.atsdr.cdc.gov/HAC/pha/pganderesp/pge¥toc.html

lems. The photos of her dogs are troubling. Some were born with missing limbs,

many had skin problems, and others were born with organs outside of their bodies

and entire litters died shortly after birth. Most surprisingly, dogs that were sold and

moved off of her property with severe skin problems began to regain their health

within months but those that stayed continued to suffer from ill-health effects. (See

photos of Markwardt’s dogs in attachment).

Recently, Markwardt had herself and some of her dogs tested for heavy metals.

Over the past few years, veterinarians have found high levels of aluminum in her

animals, she says. In May 2007, Ms. Markwardt’s own doctor wrote: ‘‘She has lived

in a home that has very high levels of aluminum in the soil and in the dust that

is found in the home. She has had a urinalysis that shows her aluminum level to

be markedly elevated and it should be zero,’’ wrote her doctor. Last July, her veterinarian wrote: ‘‘It is my opinion that these dogs need to be moved off of the property.

Since nothing medical has helped, it is highly probable that this is an environmental problem.’’

On December 19, 2008, Dr. William Cibulas, the Director of ATSDR’s Division of

Health Assessment & Consultation (DHAC) wrote to Ms. Markwardt on behalf of

Dr. Frumkin. ‘‘ATSDR is sympathetic toward the plight of your animals, however,

veterinary and animal issues are outside of our mandated domain,’’ he wrote. Clearly frustrated by this response Ms. Markwardt exchanged some more e-mails with

ATSDR.

On January 22, 2009, Markwardt wrote back to ATSDR and copied Dr. Frumkin

on the e-mail. ‘‘Please do not tell me again that veterinary and animal issues are

outside of [your] mandated domain. You know full well (or should) that the potential

impact on people is the issue that I raised,’’ wrote Markwardt. ‘‘All that we have

asked you to do is to provide trusted health information. Do you feel that an honest

conclusion in the Midlothian Public Health Consultation can be reached by pretending what is happening to these animals is not happening; therefore, it cannot

be an indicator of what is happening to human health?’’

The next day, on January 23, 2009, a technical officer in DHAC, Alan Yarbrough,

responded. ‘‘Again, ATSDR is sympathetic to the plight of your animals,’’ he wrote,

‘‘but studies involving animals, even as sentinels for human health issues, are not

activities engaged in or funded by our agency.’’

In 1991, however, the National Academies of Sciences’ Committee on Animals as

Monitors of Environmental Hazards was charged by ATSDR ‘‘to review and evaluate

the usefulness of animal epidemiologic studies for human risk assessment and to

recommend types of data that should be collected to perform risk assessments for

human populations.’’ In their final 176-page report for ATSDR, the academy wrote

that animals can be ‘‘used to monitor concentrations of pollutants’’ and ‘‘can yield

a better evaluation of hazard to humans’’ than ‘‘mechanical devices can.’’ In fact, the

academy concluded: ‘‘An investigator planning an environmental assessment should

always consider using an animal sentinel system, when it is practicable, as an adjunct to conventional assessment procedures. Animal sentinel data are likely to be

especially useful in circumstances where the conventional procedures are most

prone to uncertainty, including assessing accumulated chemicals, complex mixtures,

complex exposures, uncertain bioavailability, and poorly characterized agents.’’ 22

Since then ATSDR has published numerous health consultations involving animals. In April 2003 under a cooperative agreement with the California Department

of Health Services, ATSDR released a health consultation regarding contamination

in the private water wells of residents near the Pacific Gas and Electric Facility in

Hinkley, California, made famous by environmental investigator and activist Erin

Brockovich. In that instance, the health consultation did examine the potential

health impact on horses, cows, dogs and cats from the exposures to Nitrate, Lead,

Thallium and Chromium.23 In March 2005, ATSDR released a health consultation

that investigated potential exposures from TCE in private well water of both humans and animals in the City of Cliff Village, Missouri. The investigation began

after several residents and domestic animals in the Cliff Village area experienced

13

24 ‘‘HEALTH CONSULTATION: Cliff Village Wells Site, City of Cliff Village, Newton, Mis- souri, March 21, 2005, Agency for Toxic Substances and Disease Registry, available here: http:/

/www.atsdr.cdc.gov/HAC/pha/CliffVillageWellsSite/CliffVillageWellsHC.pdf 25 ‘‘HEALTH CONSULTATION: Pesticide Contamination of Residential Soil—Des Moines,

Polk County, Iowa,’’ December 8, 2005, U.S. Department of Health and Human Services, Public

Health Service, Agency for Toxic Substances and Disease Registry, available here:

www.atsdr.cdc.gov/HAC/pha/PesticideContamination120805/

PesticideContaminationSoilHC120805.pdf 26 ‘‘Federal Agency Releases Results of Polycythemia Vera Investigation,’’ ATSDR Media An- nouncement, Agency for Toxic Substances and Disease Registry, October 24, 2007, available

here: http://www.atsdr.cdc.gov/NEWS/schuykillpa102407.html

unusual health problems that resulted in the death of a domestic animal.24 In December, 2005, ATSDR issued a health consultation that investigated the poisoning

of a 97-pound Siberian Husky in Des Moines, Iowa.25

The above cases were gleaned from a cursory search of ATSDR’s web-page by the Subcommittee. Why ATSDR refused Debra Markwardt’s request is unclear, but

there is certainly precedent for ATSDR to examine animals, particularly when there

health and safety are closely tied to the health and safety of people. On February 6, 2009, ATSDR’s Yarbrough responded again to Ms. Markwardt. But this time, the Agency’s rationale for refusing to investigate the health of

Markwardt’s dogs changed slightly. Originally, Markwardt was told ‘‘veterinary and

animal issues are outside of our mandated domain,’’ wrote ATSDR. This time,

Yarbrough wrote: ‘‘ATSDR’s enabling legislation does not prohibit our conduct of

animal studies; however, ATSDR and the Texas Department of State Health Services do not have the expertise to conduct the appropriate animal studies,’’ he wrote.

Instead, ATSDR told Markwardt that they referred her case to two veterinarians

with Texas A&M. But the researchers do not yet have any funding to support an

investigation and they have not yet contacted her.

Polycythemia Vera Cancer Cluster in Eastern Pennsylvania

Dr. Ronald Hoffman, MD, is Professor of Medicine, Hematology/Oncology Section, at the Tisch Cancer Institute and Professor of Gene and Cell Medicine at Mt. Sinai

School of Medicine in New York. He is also the former President of the American

Society of Hematology. Dr. Hoffman is a leading expert on a rare cancer called polycythemia vera (PV). He had never heard of ATSDR before being called by ATSDR

staff in 2006 to lend his expertise to an investigation it was conducting in eastern

Pennsylvania examining a potential cluster of PV cases. In October 2006, ATSDR began assisting the Pennsylvania Department of Health in investigating the high number of reported PV cases in three counties in Pennsylvania—Carbon, Luzerne and Schuylkill counties. The area ATSDR investigated is

home to seven Superfund hazardous waste sites that are either closed or in the

process of being remediated and seven waste coal burning power plants, which emit

polycyclic aromatic hydrocarbons (PAHs). Recent research has suggested PAHs may

potentially contribute to polycythemia vera. The local community has suspected that environmental pollution in the area has a contributor to health problems there for a long time. By the fall of 2007, ATSDR

had confirmed more than three dozen cases of PV in the area, more than four times

the level outside the region. The Agency also discovered four cases of PV on one twomile stretch of road not far from the former McAdoo superfund site. None of the

PV patients on Ben Titus Road in Northeast Schuylkill County were blood relatives.

Two of them, who both passed away last year, were husband and wife. The environmental significance of this tight grouping of PV cases on a single road and the proximity to a hazardous waste site seemed obvious to many, including Dr. Ronald Hoffman. But that connection did not appear so obvious to ATSDR. The lead ATSDR official

in charge of the investigation, Dr. Steven Dearwent, described it to Subcommittee

staff as ‘‘compelling’’ information, but nothing more. On October 24, 2007, ATSDR

released a ‘‘media announcement’’ regarding their PV investigation. The Agency confirmed more than three dozen cases of PV in Schuylkill, Luzerne and Carbon counties in Pennsylvania but assured the public: ‘‘ATSDR found no link between environmental factors and PV in this area.’’ 26 The Agency also failed to mention in the media announcement the four PV cases it found along Ben Titus Road near a former

Superfund site, although they had already confirmed these cases at the time. So, when Dr. Hoffman presented an abstract of the PV investigation at the annual meeting of the American Society of Hematology in Atlanta in December 2007 titled:

‘‘Evidence for an Environmental Influence Leading to the Development of

JAK2V617F–Positive Polycythemia Vera: A Molecular Epidemiological Study,’’ this

apparent contradiction did not sit well with some ATSDR officials. The Agency says

14

27Mike Stobbe and Michael Rubinkam, ‘‘Feds hedge on environmental link to Pennsylvania illnesses,’’ Associated Press (AP), December 7, 2007, available here: http://

www1.phillyburbs.com/pb-dyn/articlePrint.cfm?id=1452897 28 ‘‘Response to the American Hematology Society Abstract,’’ Agency for Toxic Substances and

Disease Registry, available here: http://www.atsdr.cdc.gov/sites/polycythemia—vera/abstract.html 29Polycythemia Vera Investigation, Agency for Toxic Substances and Disease Registry, http:/

/www.atsdr.cdc.gov/sites/polycythemia¥vera/ 30 ‘‘Public Health Assessment, McAdoo Associates, McAdoo, Schuylkill County, Pennsylvania,’’

Prepared By: Pennsylvania Department of Health Under Cooperative Agreement with the Agency for Toxic Substances and Disease Registry, September 29, 1993, available here: http://

www.atsdr.cdc.gov/HAC/pha/mcadoo/mca¥p1.html#SUMMARY

the paper, which included the names of ATSDR scientists, did not go through

ATSDR’s ‘‘clearance process.’’

In December 2007, the Associated Press reported that ATSDR was distancing itself from Dr. Hoffman and his paper. Dr. Dearwent, the senior ATSDR official in

charge of the PV cluster investigation told the AP: ‘‘We’re going to have to retract

the abstract to correct the record because it is erroneous information.’’ Dr. Dearwent

claimed that the abstract had been written early in the summer and that subsequent analysis of the data did not support the conclusion of an environmental

link.27 In fact, it seems nothing had actually changed regarding the data but that ATSDR did not feel comfortable drawing any connection between the PV cluster and

potential chemical exposures in the environment. Dr. Dearwent told Subcommittee

staff that because Dr. Hoffman is a ‘‘clinician’’ and not an epidemiologist he may

have viewed the PV cluster differently than the Agency. Dr. Dearwent said that ‘‘we

had nothing telling us at the time nor do we now’’ that this cluster is somehow

linked to environmental exposures.

To his credit, Dr. Hoffman presented his abstract at the American Society of He- matology conference despite efforts by ATSDR to interfere with his presentation.

Last year, ATSDR posted an oddly worded statement about the abstract on its

website. The Agency said that the conclusions in the abstract differed from what

ATSDR told the public in October 2007 and that it ‘‘prematurely’’ inferred certain

conclusions about the PV cluster. Yet, it concluded: ‘‘The presentation made at the

American Hematology Society meeting accurately reflected ATSDR’s current assessment of the data.’’ 28

In January 2008 Dr. Hoffman e-mailed Dr. Howard Frumkin, the director of ATSDR, about his experience with the PV investigation. ‘‘I believe that some members of your staff are unable, incapable or unwilling to objectively looking [sic] at

this data,’’ wrote Hoffman. ‘‘This nonscientific approach has led to a state of denial

and paralysis in you [sic] organization which has resulted in the present confusion

about this matter in the community and the press. There are important issues here

and objectivity is required,’’ wrote Hoffman. ‘‘I hope that the cynical and nihilistic

behavior of some of your staff is not a reflection of the scientific veracity of the

Agency[.]’’ In this case, ATSDR finally acknowledged that a cancer cluster existed in the area of Eastern Pennsylvania they investigated. The Agency released the final results of

their investigation last August and found residents in the three counties in Pennsylvania that they assessed were more than four times more likely to develop polycythemia vera than people living outside those counties. And while ATSDR said

‘‘There were potential environmental exposure sources common to some of the highrate areas,’’ they concluded that: ‘‘It is not known whether a relationship exists between any of these sources and the PV cases.’’ 29 The Agency said future studies may attempt to investigate the environmental connection further. Dr. Hoffman says

that ATSDR continually sought to downplay and minimize any links between the

PV cases and the environment suggesting it was just an unusual circumstance. He

described their behavior as ‘‘very odd and counter-intuitive.’’ Interestingly, in 1993 ATSDR conducted a public health assessment on the McAdoo Associates Superfund site. That site had ceased operations in 1979, was remediated and taken off of the Superfund list in 2001. The 1993 ATSDR public

health assessment of the site found: ‘‘Site-related contamination poses no public

health hazard because there is no evidence of current or past exposures, and future

exposures to contaminants at levels of public health concern are unlikely.’’ 30 Ben

Titus Road where ATSDR investigators discovered four unrelated PV cases is close

to this site. But conceding that there may be an environmental health hazard

present in this community today could put ATSDR in the awkward position of acknowledging mistakes with their past public health conclusions.

In the wake of internal disagreements between Dr. Hoffman and ATSDR regarding the potential link between environmental contamination and the PV cluster, Dr.

15

31Dr. Vincent Seaman, et. al., ‘‘Use of Molecular Testing to Identify a Cluster of Patients with

Polycythemia Vera in Eastern Pennsylvania,’’ Cancer Epidemiology Biomarkers & Prevention, 18(2), February 2009, available here, http://cebp.aacrjournals.org/cgi/content/abstract/18/2/

53432 ‘‘Region 5 Superfund (SF) National Priorities List Fact Sheet: Johns-Manville Corp.,’’ Environmental Protection Agency, Last Updated: June, 2008, available here: http://www.epa.gov/

region5superfund/npl/illinois/ILD005443544.htm 33See: ‘‘Asbestos washes up on beach at state’s most popular park,’’ Associated Press, February 3, 1998; and Charles Nicodemus, ‘‘State moves in on asbestos//4 agencies study danger

to beach,’’ Chicago Sun-Times, February 4, 1998. 34 ‘‘Public Health Assessment: Asbestos Contamination at Illinois Beach State Park,’’ Prepared

by: Illinois Department of Public Health Under Cooperative Agreement with the Agency for

Toxic Substances and Disease Registry, May 23, 2000, available here: http://

www.atsdr.cdc.gov/HAC/pha/illinoisbeach/ibp¥toc.html

Hoffman says he pushed to publish a peer-reviewed article of the PV investigation’s

findings, fearing that ATSDR was not willing or able to acknowledge the significance of the PV cluster in Pennsylvania. Last month the work of Dr. Hoffman,

ATSDR scientists and other colleagues at the University of Illinois College of Medicine, published their findings in the journal Cancer, Epidemiology, Biomarkers and

Prevention. The paper reported that the risk of developing PV was 4.3 times greater for the residents living inside the three Pennsylvania counties they examined than

for those living outside the area. The article concluded: ‘‘The close proximity of this

cluster to known areas of hazardous material exposure raises concern that such environmental factors might play a role in the origin of polycythemia vera.’’ 31 Dr.

Dearwent, who was not an author on the paper, contends that ‘‘some of the language in the manuscript that we opposed made it back in to the paper.’’ Dr. Hoffman and other authors of the paper deny that.

Asbestos Beach—Illinois State Beach Park in Chicago

Mr. Jeffery Camplin is President of Camplin Environmental Services and tech- nical consultant to the Dunesland Preservation Society in Illinois. Since 2003 he has

been investigating asbestos contamination on the Illinois shoreline of Lake Michigan

and has filed several complaints with ATSDR regarding the inadequacies of their

studies of asbestos contamination at the Illinois State Beach Park in Chicago. He

is a certified safety professional (C.S.P.), certified professional environmental auditor (C.P.E.A.) and has been an accredited instructor in asbestos abatement by the

Environmental Protection Agency (EPA) for more than 20 years. In 2006 he was

named Environmental Safety Professional of the year by the American Society of

Safety Engineers (ASSE). He is also the lead safety volunteer for the Illinois Medical Emergency Response Team (IMERT). In Illinois there has been a long history of asbestos containing materials and fi- bers washing up on the shoreline of Lake Michigan for more than one decade. The

Johns-Manville Corporation built a large plant on the shore of Lake Michigan that

produced insulation products containing asbestos beginning in the 1920s. The plant,

which included a 150-acre asbestos disposal area containing approximately three

million cubic yards of asbestos-containing waste, was declared a Superfund site in

1983 and ceased operations in 1998. The asbestos disposal area was covered with

soil to prevent its spread. But since then seven areas containing asbestos-containing

material from the plant were discovered off-site.32

Around the same time as the plant’s closure, asbestos debris began washing up along the shoreline at the Illinois Beach State Park, the state’s most popular park

at two to three million visitors per year.33 In May 2000, the Illinois Department of Public Health under a cooperative agreement with ATSDR released a public health

assessment regarding asbestos contamination at the State park. The report did find

that asbestos containing material had been found scattered along the beach at the

park and that material containing ‘‘low asbestos levels’’ had been discovered, but not

at levels that would be expected to cause adverse health effects in Park workers or

visitors,’’ it said. The report concluded: ‘‘no apparent public health hazard exists related to asbestos contamination at Illinois Beach State Park.’’ 34

But the discovery of asbestos material on the public beach at the State park never ceased. Portions of the State park were cleared of asbestos in March 2006. In the

summer of 2006 ATSDR used grading equipment to churn up the sand and air filters to capture and measure any potential asbestos fibers. The tests discovered fibers of amphibole asbestos, the most toxic kind of asbestos.

In 2007 ATSDR wrote a draft health consultation based on their findings which

said there was no health hazard from the asbestos. In April 2007, local EPA officials

submitted written comments of the report to ATSDR. The letter, written by Brad

Bradley, the EPA’s Remedial Project Manager in the Agency’s Region 5 section and

16

35Letter from Brad Bradley, Remedial Project Manager, Environmental Protection Agency, Region 5, to Mark Johnson, Regional Representative, Agency for Toxic Substances and Disease

Registry, April 24 2007. 36 Randall R. Parrish, et al., ‘‘Depleted uranium contamination by inhalation exposure and its detection after ∼20 years: Implications for human health assessment,’’ Society of the Total Envi- ronment, September 2007, available here: http://www.albany.edu/news/pdf¥files/Depleted¥Uranium¥Article.pdf 37 ‘‘Health Consultation: Colonie Site (Aliases: Colonie Interim Storage Site and Formerly Na- tional Lead Industries) Colonie, Albany County, New York, Agency for Toxic Substances and

Disease Registry, October 5, 2004, available here: http://www.atsdr.cdc.gov/HAC/pha/ ColonieSite100504-NY/ColonieSite100504HC-NY.pdf

the EPA’s lead asbestos expert covering Illinois, Indiana, Michigan, Minnesota,

Ohio, and Wisconsin, was written to Mark Johnson, ATSDR’s regional representative in Chicago, on behalf of the entire EPA Region 5 staff. The letter identified 13

items they believed needed clarification or correction. Many of them were not subtle

editorial fixes but significant issues revolving around safety and health issues and

the scientific integrity of the ATSDR report. The letter said many of the statements

by ATSDR were ‘‘misleading,’’ ‘‘questionable’’ and contained ‘‘inconsistencies.’’ 35

‘‘The paragraph on page 12, which states that ‘‘Based on the bulk analysis of sand samples collected, the sand in [and] of itself does not appear to pose a significant

source of asbestos fibers’’ is a little misleading,’’ wrote Bradley. ‘‘The air samples

near the beach grading equipment were significantly elevated; therefore, this would

indicate that there might be a problem with this statement,’’ he wrote. But the final

ATSDR health consultation read: ‘‘Based on the bulk analysis of sand samples collected, the sand does not appear to pose a significant source of asbestos fibers.’’ The

public health agency ignored the EPA’s concerns about the public’s health. The EPA noted other problems that ATSDR also simply chose to ignore. In his April 2007 letter, Bradley wrote: ‘‘13) Regarding the human health safety statements in the Report, the Executive Summary states that it is within the acceptable

risk range under certain conditions to use the IBSP [Illinois Beach State Park]

beaches for the general public BUT for maintenance activities they should be conducted when sand surface is wet or closed to the public. It is also stated that the

IDNR [Illinois Department of Natural Resources] should continue asbestos removal

from the beach. These inconsistencies and the actual air monitoring results raise

concerns regarding the safety of human use of the beaches. There is ACM [Asbestos

Containing Material] on the beach and it should be removed, the maintenance workers should take precautions but it is OK for the public and especially children to

play with and on the beach. What is going on here, either the beach is safe or the

safety is questionable,’’ Bradley wrote. But ATSDR cleared up the answer to that

question in their final report. ‘‘What are the conclusions of the EI [Environmental

Exposure Investigation]?’’ asked ATSDR. ‘‘The activities simulated at the beaches at

IBSP pose no apparent public health hazard,’’ they declared. In an interview with Subcommittee staff ATSDR’s Mark Johnson acknowledged that his agency did not include all of the suggestions submitted by the EPA officials.

It is an ATSDR document, he said, and the ultimate decision of what is in the

health consultation rests with the Agency for Toxic Substances and Disease Registry. ATSDR is now in the process of reviewing new sampling data of the beaches

and expects to release their new health consultation any day, according to ATSDR.

Depleted Uranium (DU) Contamination in Colonie, New York

Professor Randall R. Parrish, Ph.D., is the head of the British Geologic Survey’s Natural Environment Research Council’s (NERC) Isotope Geoscience Laboratories in

Nottingham, England and Professor of Isotope Geology at the University of Leicester. In 2007 he was the lead author of a peer-reviewed journal article that investigated depleted uranium (DU) inhalation exposures in Colonie, New York, home to

National Lead, Inc., which produced depleted uranium for U.S. military munitions

from 1958 to 1984, when the site was closed due to violations of environmental

emission standards.36 In 2006, the Federal Government completed a $190 million

cleanup of the site.

A 2004 ATSDR health consultation found that past emissions from the site ‘‘could

have increased the risk of health effects—especially kidney disease—for people living near the plant’’ and found that ‘‘the combination of inhaling DU dust and cigarette smoke could have increased the risk of lung cancer.’’ But because the plant

had ceased operating, ATSDR concluded that there was ‘‘no apparent public health

hazard.’’ In addition, they rejected a request to conduct a health survey because

they said it would not ‘‘answer the community’s questions about whether or not the

NL plant impacted their health.’’37 In 2007, however, Professor Parrish and researchers at the University of Albany—using a newly developed method—detected

17

38 ‘‘A Summary of ATSDR’s Environmental Health Evaluations for the Isla de Vieques Bomb- ing Range, Vieques, Puerto Rico,’’ Agency for Toxic Substances and Disease Registry (ATSDR),

November 2003, available here: http://www.atsdr.cdc.gov/sites/vieques/vieques¥profile.pdf 39See: ‘‘Link between unexploded munitions in oceans and cancer-causing toxins determined,’’

the University of Georgia, News Release, February 18, 2009, available here: http://

www.uga.edu/aboutUGA/research-bombs.html; Maria Miranda Sierra, ‘‘Carcinogens found in

marine life in island of Vieques in Puerto Rico,’’ Caribbean Net News, February 21, 2009, available here: http://www.caribbeannetnews.com/news-14429¥21-21¥.html; John Lindsay-Poland,

‘‘Health and the Navy in Vieques,’’ Fellowship of Reconciliation, Puerto Rico Update, Number

32, Spring 2001, available here: http://www.forusa.org/programs/puertorico/archives/

0401healthnavy.html; Azadeh Ansari, ‘‘Undersea bombs threaten marine life,’’ CNN, February

26, 2009, available here: http://www.cnn.com/2009/TECH/science/02/26/undersea.munitions.cleanup/index.html 40Dr. Arturo Massol-Deya, et. al., ‘‘Trace Elements Analysis in Forage Samples from a U.S.

Navy Bombing Range (Vieques, Puerto Rico), International Journal of Environmental Research

and Public Health, August 14, 2005; available here: http://www.mdpi.com/1660-4601/2/2/263

DU exposures in 100 percent of the former workers at the site they tested and 20

percent of the residents they tested, in addition to DU in the soil found miles away

from the site.

Parrish’s paper said that the ‘‘ATSDR Health Consultation concluded that further

investigations were unjustified because it would be impossible to determine the incidence of DU contamination after such a long period of time since the inhalation hazard no longer existed.’’ But Parrish’s paper showed it was possible and the authors

recommended that ATSDR do a follow-up study with a larger group of nearby residents to access their ‘‘potential health outcomes.’’ Although ATSDR’s mission statement says it ‘‘serves the public by using the best science,’’ scientists at ATSDR told

Subcommittee staff that they are unswayed by Professor Parrish’s findings and say

they do not see a need to re-examine the Colonie, New York residents for potential

DU exposures. They say that the amount of depleted uranium detected in the residents was so small that it would not result in any health hazard, thereby confirming

the conclusions of their earlier health consultation. Professor Parrish says this argument does not take into account what these individuals were exposed to in the past.

Parrish says that with further analysis of his work scientists can attempt to calculate the cumulative exposures of individuals to help determine what their exposures were in the past and what the health risk to them might be today.

Vieques Island, Puerto Rico

For years, ATSDR has investigated potential environmental hazards on and off

the coast of the island of Vieques in Puerto Rico. The U.S. Navy engaged in live

bombing practice activities on and off the coast of Vieques from 1941 to 2003

spreading munitions containing depleted uranium and other toxic chemicals into the

sea and local ecosystem. In November 2003, ATSDR issued a summary of its work

on the island. ‘‘Residents of Vieques have not been exposed to harmful levels of

chemicals resulting from Navy training activities at the former Live Impact Area,’’

ATSDR concluded. ‘‘It is safe to eat seafood from the coastal waters and near-shore

lands on Vieques,’’ they said.38

Many independent scientists and health experts question those findings. Most recently, Professor James Porter, Associate Dean at the Odum School of Ecology, University of Georgia, presented findings at a conference last month that found

unexploded munitions from the U.S. Navy around the island were, in fact, leaking

toxic cancer causing substances into the ocean endangering sea life. Professor Porter

found that sea urchins and ‘‘feather duster worms’’ closest to unexploded bombs or

bomb fragments off the coast of Vieques had extraordinarily high toxic levels of various chemicals. Some of the materials were nearly 100,000 times over established

safe limits. Professor Porter cautioned that he performed a ‘‘point source study,’’

meaning he took measurements close to the residual bomb materials and that

ATSDR has performed ‘‘broad spectrum’’ tests that measure toxic chemicals in a

much wider arena.

That explains the discrepancies in what Professor Porter found and what ATSDR

discovered. Although Professor Porter cautioned that it is still unclear what sort of

impact these toxins have had on the dinner plate some studies have shown that

residents on Vieques Island have a 23 percent higher cancer rate than those on the

main island of Puerto Rico.39 Other studies have found that plants on the island

have high concentrations of lead, mercury, cadmium, uranium, cobalt, manganese

and aluminum.40 Vieques residents question the integrity of the studies conducted

by ATSDR, as do many Puerto Rican and other independent scientists.

18

41 ‘‘Public Health Assessment, Kelly Air Force Base, San Antonio, Bexar County, Texas,’’ Pre- pared by Agency for Toxic Substances and Disease Registry, September 9, 1999, available here:

http://www.atsdr.cdc.gov/HAC/pha/kelly/kel¥toc.html 42 ‘‘Technical Review of the Public Health Assessment, Phase I for Kelly Air Force Base, San

Antonio, Bexar County, Texas, Conducted by Division of Health Assessment and Consultation,

Agency for Toxic Substances and Disease Registry (ATSDR), Released for Public Comment, September, 1999,’’ Prepared by Katherine S. Squibb, Ph.D., Program in Toxicology, University of

Maryland, Baltimore (undated), available here: https://afrpaar.lackland.af.mil/ar/getdoc/

KELLY/KELLY¥AR¥3299.pdf 43 ‘‘Review of ATSDR Petitioned Public Health Assessment, Kelly Air Force Base,’’ Conducted

by Katherine S. Squibb, Ph.D., Program in Toxicology, University of Maryland, Baltimore, June

11, 2002, available here: https://afrpaar.lackland.af.mil/ar/getdoc/KELLY/

KELLY¥AR¥3278.pdf 44 Roddy Stinson, ‘‘Round on the Kelly-toxins mystery trail: ‘dioxins and furans,’ ’’ San Antonio

Express-News, March 26, 2002. 45 Anton Caputo, ‘‘Kelly area homes retested by EPA,’’ San Antonio Express-News, February

6, 2009, available here: http://www.mysanantonio.com/news/environment/39182822.html 46 ‘‘Public Health Assessment for Lusher Avenue Groundwater Contamination, Elkhart, Elkhart County, Indiana,’’ Public Comment Release, Prepared by: U.S. Department of Health and

Human Services, Agency for Toxic Substances and Disease Registry, March 1, 2009, p. 21, (hereafter referred to as ATSDR Lusher Site PHA, available here: http://www.atsdr.cdc.gov/NEWS/

lusher¥03022009.html 47 ‘‘Consumer Factsheet on: TRICHLOROETHYLENE,’’ U.S. Environmental Protection Agency, available here: http://www.epa.gov/OGWDW/dwh/c-voc/trichlor.html

Kelly Air Force Base, San Antonio, Texas

Issuing public health documents that fail to include relevant information, are based on incomplete or deficient investigations, or omit critical public health data

can contribute to the environmental exposure of the public. In 1999 an ATSDR report that examined cancer incidence around the Kelly Air Force Base in San Antonio, Texas, found increased levels of liver and kidney cancer as well as leukemia.41

But none of ATSDR’s studies on the former Air Force Base linked the illnesses to

the toxins from the base that have leached into these neighborhoods. In a critique of the ATSDR report, Dr. Katherine Squibb, a toxicologist at the Uni- versity of Maryland, found that the Agency’s conclusions were based on minimal information, some Air Force studies ATSDR relied on for its conclusions failed to

measure important exposure pathways, and ATSDR failed to conduct an adequate

assessment of whether or not some chemicals migrated off-base. ‘‘It is questionable

as to whether ATSDR’s conclusion that no public exposure to contaminants occurred

through the domestic use of groundwater in the past is correct,’’ wrote Squibb.42

In a 2002 critique of another ATSDR report on the Kelly Air Force Base, Squibb found that ATSDR did not evaluate cumulative risks of exposure for certain chemicals.43 She also told a local reporter that ATSDR examined health risks from exposure to soil from a part of the base only after the site had been cleaned up and remediated. ‘‘It does not appear that ATSDR has considered health risks associated

with soil that migrated from this site prior to remediation,’’ said Squibb.44

Seven years after Dr. Squibb’s comments, the issues of off-site contamination at Kelly Air Force Base were still swirling around the local community. ‘‘I don’t know

much about science,’’ San Miguel, one local resident said last month, ‘‘but there are

13 homes on this block and 11 of those families have had someone die from cancer.

That is what is bothering me,’’ he said. ‘‘Where did that come from?’’45

Trichloroethylene (TCE) Groundwater Contamination in Elkhart, Indiana

Earlier this month, ATSDR released a draft Public Health Assessment (PHA) on

groundwater contamination from trichloroethylene (TCE) and other chemicals at

what is known as the Lusher Avenue Site in Elkhart, Indiana. Contamination in

the area has stretched back to the mid-1980s and last year EPA designated it a

Superfund site and placed it on the National Priorities List (NPL). There are a number of potential sources of environmental pollution in the area including a rail yard,

pharmaceutical manufacturer, plastic and metal fabrication plants and a musical instrument fabrication facility. The area has a population of 2,597 people, including

286 children six years old or younger.46

In 1989, EPA established a drinking water standard or Maximum Contaminant Level (MCL) for TCE of five parts-per-billion (5 ppb). Municipal water systems are

required to test water for TCE concentrations every three months. If any levels exceed the MCL, they are required to notify the public via newspapers, radio, TV networks and other means and to provide alternative drinking water supplies to the

public.47 In the past, TCE contamination in the drinking water systems in Lusher were discovered in many of the several hundred private wells in the area. Residents

were provided with alternative water supplies or filtration systems were installed.

19

48 ATSDR Lusher Site PHA, p. 12. 49 ‘‘Toxicological Profile for Trichloroethylene,’’ U.S. Department of Health and Human Serv- ices, Agency for Toxic Substances and Disease Registry, September 1997, p. 84, (hereafter referred to as ATSDR TCE Tox Profile) available here: http://www.atsdr.cdc.gov/toxprofiles/

tp19.pdf 50 ATSDR TCE Tox Profile, p. 85. 51 ATSDR Lusher Site PHA, p. 13. 52 ATSDR Lusher Site PHA, pp. 14–15. 53 ATSDR TCE Tox Profile, pp. 90–91. 54 ‘‘Public Health Assessment for Lusher Avenue Groundwater Contamination, Elkhart, Elkhart County, Indiana,’’ Public Comment Release, Prepared by: U.S. Department of Health and

Human Services, Agency for Toxic Substances and Disease Registry, March 1, 2009, p. 21, available here: http://www.atsdr.cdc.gov/NEWS/lusher¥03022009.html

A new round of sampling in 2005 and 2006 found some wells had TCE levels of up

to 700 ppb, exposing an estimated 200 people to these contaminants.

The recent ATSDR health assessment concluded that: ‘‘Most adverse health outcomes are not anticipated at Lusher because the TCE concentration in most private

wells is less than 100 ppb.’’ 48 However, ATSDR’s own 1997 Toxicological Profile on

trichloroethylene cites several studies showing associations between exposures to

much lower levels of TCE exposure and health effects, such as neural tube defects,

for instance.49 In addition, it cites another study of residents in Tucson, Arizona

that were exposed to TCE levels between six and 239 ppb. The study found that

the children of mothers who lived in this area in their first trimester of pregnancy

were two and one-half times more likely to develop congenital heart defects than

children of mothers not exposed to TCE during pregnancy.50 Yet, the ATSDR health

assessment says that there have been exposures at the Lusher site as high as 700

ppb, ‘‘However, most TCE exposures at Lusher were and are less than 100 ppb and

indicate little to no risk for heart defects in newborns.’’ [Emphasis in the original].51

The ATSDR assessment does say: ‘‘People drinking well water which contains

TCE at levels greater than 300 ppb have an increased risk of developing cancer.’’

It bases this assertion on another ATSDR study that examined a cancer cluster in

Woburn, Massachusetts in 1986 and found that there were more than twice as

many childhood cases of leukemia as expected while the TCE contamination in the

water was only 267 ppb. How ATSDR now justifies asserting that there is no increased risk of cancer below 300 ppb or that there is no risk of heart defects in

newborns from the exposures in Lusher appears to be scientifically unfounded and

misleading.52

The Public Health Assessment also failed to mention a 1994 study cited in

ATSDR’s own Toxicological Profile of trichloroethylene. The study found that in a

review of 1.5 million residents in 75 towns monitored for TCE levels between 1979

and 1987, females exposed to drinking water in excess of the EPA maximum contaminant level (MCL) of five ppb had a significant elevation of total leukemias, including childhood leukemias, acute lymphatic leukemias, and non-Hodgkin’s

lymphoma. The recent ATSDR report also failed to mention that a 1996 study by

the Massachusetts Department of Health found that the risk of leukemia in the

group of Woburn, Massachusetts women exposed to TCE in utero were eight times

higher than a control group.53

While none of these studies in and of themselves are conclusive evidence of clear

links between TCE exposures and these specific health problems, they are part of

the scientific public health record on these issues. Omitting them from a public

health document that is trying to assess the public health threats from TCE to the

community in and around the Lusher site appears short-sighted at best and scientifically misleading.

In the end, ATSDR’s conclusions on the Lusher site seem fuzzy at best. Inconsistencies in other ATSDR reports have been a long standing frustration by both local

communities and other federal agencies, particularly EPA. In its conclusions on the

Lusher site, for instance, ATSDR wrote: ‘‘ATSDR categorizes the site as a past public health hazard. Due to uncertainties concerning sources, continuing migration of

contaminants, and private well use, the site could pose a future public health hazard. Currently, exposure has been mitigated or lessened through provision of alternate water and filter systems for private well users with contaminated water. However, there may be private wells that still need to be tested.’’ 54 Until ATSDR begins

to focus on the scientific integrity and basic clarity of its public health documents

with renewed energy, care and focus the Agency will continue to be mired down in

problems and garner distrust from the local communities it is supposed to serve.

20

55 Howard Frumkin, M.D., M.P.H., Dr.P.H., ‘‘The Public Health Approach to Chemical Exposures: A National Conversation,’’ Journal of Environmental Health, Volume 71, Number 7,

March 2009. 56 ‘‘Report on a Meeting Between ATSDR and Community Representatives,’’ Citizen’s Clearinghouse for Hazardous Wastes, June 30, 1990, Washington, D.C. 57 ‘‘Promises, Promises: ASTDR . . . Don’t Ask . . . Don’t Tell . . . Don’t Pursue,’’ Stephen

Lester, Science Director, Citizens Clearinghouse for Hazardous Waste (renamed Center for

Health, Environment and Justice), Everyone’s Backyard Newsletter, March/April 1994, p. 15–16.

Dr. Frumkin’s National Conversation

In recent weeks Dr. Frumkin has unveiled an NCEH/ATSDR initiative he calls:

‘‘The National Conversation on Public Health and Chemical Exposures.’’ He has

grand plans. ‘‘[N]ow is an opportune time to revitalize the public health approach

to chemical exposures,’’ he wrote recently in the Journal of Environmental Health.55

As part of this effort he wants to have a broad dialogue that aims to identify gaps

in the public health approach to chemical exposures and identify solutions for

strengthening the public health approach to chemical exposures. Dr. Frumkin has held several internal ATSDR ‘‘all hands meetings’’ where he has briefed agency employees on his initiative and he organized a small meeting in

Washington, D.C. on Friday, March 6th with environmental organizations. He has

personally met with many public health and environmental groups in an attempt

to drum up support for his initiative.

A few weeks ago he met with Stephen Lester, Science Director of the Center for Health, Environment and Justice and its Executive Director, Lois Gibbs, the local

activist from Love Canal in New York who spearheaded an environmental investigation when she discovered her children’s elementary school was built on a toxic waste

dump. Dr. Frumkin was apparently seeking advice on how to help reorganize or reform ATSDR to make it more responsive to the concerns of local communities. Lester told him that all he needed to do was follow the recommendations he and other

local community groups gave to ATSDR back in 1990. Virtually nothing has

changed, Lester says. The problems, as well as many of the solutions, remain the

same. Lester had been through this once before and is not very hopeful that any

real change will come to the Agency. For a twelve-year period from 1986 to 1998, Dr. Barry Johnson served as the As- sistant Administrator of ATSDR and by all accounts he was a deeply dedicated and

compassionate public servant. In 1990 he attempted to reach out to local community

groups to begin a dialogue in order to help rectify the Agency’s poor image and to

move the Agency into a new direction, producing scientifically valid studies, identifying causes of environmental contamination causing harm to human health and obtaining the respect and trust of the local communities ATSDR is supposed to protect. Dr. Johnson had contacted the Center for Health, Environment and Justice

(then called the Citizen’s Clearinghouse for Hazardous Wastes). Because of Lois

Gibbs’ presence, the organization had clout with many local environmental groups

and communities.

There were several meetings between ATSDR and local community groups as a

result of Barry Johnson’s organizing efforts. The groups produced a long-list of problems, observations and recommendations. Many of them seem to have withstood the

test of time and are equally relevant and significant today. ‘‘Health officials look for

every possible reason other than the obvious as the causative factor in evaluating

health problems.’’ ‘‘Studies do not address problems and do not lead to action; instead they seem to look for ways to dismiss problems.’’ One asked: ‘‘Is there a need

for ATSDR? Should ATSDR exist given that it is not providing what citizens want

and need.’’ 56

The momentum from those meetings soon faded. Four years later Lester wrote:

‘‘Today we continue to see many of the same investigation strategies that ATSDR

and CDC has been using for years—investigating health problems with scientific

methods that are highly questionable and inappropriate. They consistently ask the

wrong questions, use inappropriate comparison groups, dilute exposed populations

with unexposed populations, eliminate exposed people from their studies and use

other ill-conceived scientific methods to evaluate health problems in communities.

In the end, they find no health problems because they used methods destined to fail

from the beginning and because their studies are often ‘‘inconclusive by design.’’ 57

The integrity of the data ATSDR produces is critical to gaining the public’s trust

and successfully addressing important environmental public health issues. These

flawed reports have very direct impacts on the safety and health of the public. The

public health documents emanating from ATSDR should adhere to a clear, consistent and scientifically credible and defensible standard. Yet, in far too many instances that is not the case.

21

58 ‘‘Public Health Assessment for ABC One Hour Cleaners, Jacksonville, Onslow County,

North Carolina,’’ Department of Health and Human Services, Agency for Toxic Substances and

Disease Registry, 1990. 59 ‘‘Public Health Assessment for U.S. Marine Corps Base at Camp Lejeune, Military Reservation, Camp Lejeune, Onslow County, North Carolina,’’ Agency for Toxic Substances and Disease

Registry, 1997, available here: http://www.atsdr.cdc.gov/HAC/pha/usmclejeune/clej¥toc.html 60For a good summary of the environmental issues at Camp Lejeune see: J. Wang, et. al.,

‘‘Camp Lejeune (NC) Environmental Contamination and Management,’’ Multimedia Environmental Simulations Laboratory, Georgia Institute of Technology, available here: http://

mesl.ce.gatech.edu/RESEARCH/CampL¥GW.htm 61 ‘‘Camp Lejeune, North Carolina: Home,’’ Agency for Toxic Substances and Disease Registry,

available here: http://www.atsdr.cdc.gov/sites/lejeune 62Letter from William A. Pierce, Deputy Assistant Secretary for Public Affairs/Media, Department of Health and Human Services to Mr. Thomas Townsend, November 25, 2003.

ATSDR’s Leadership Today

Many of the challenges that ATSDR faces every day are not simple. Accurately

assessing public health implications from environmental contamination is difficult.

The state of the science may not be able to determine the exact cause of a cluster

of illnesses no matter how many hours are invested or how high a priority investigating the issue is to ATSDR, a local community or anyone else. But these are

not now, nor have they ever been the criticisms that have been leveled against the

Agency. The criticisms swirl around the simple mistakes, the careless research, the

critical scientific omissions, the poorly contrived methods used by the Agency to

identify the cause of a community’s public health concerns and the lack of appropriate fundamental agency policies, such as having a thorough and independent review of ATSDR’s public health documents before they are released to the public.

None of these problems will ever evaporate or disappear until ATSDR has strong

leaders who are committed to ensuring that the Agency fulfills its mission and at

the same time creates a public health culture that is bolstered by sound science,

careful review and an eagerness to actually identify the potential environmental

causes of illnesses, ailments or diseases that impact local communities and affect

their health and safety. The problems that embroil ATSDR have been present for

many years and did not simply emerge under the leadership of Dr. Frumkin.

However, it is apparent from both Dr. Frumkin’s handling of the formaldehyde

issue as well as other incidents that Dr. Frumkin’s actions have contributed to a

culture where scientific integrity appears to take a back seat to political expediency

and uncomplicated conclusions regardless of their accuracy or potential impact upon

the public’s health. As the Subcommittee said in its staff report on formaldehyde

last year: ‘‘It seems unlikely that ATSDR will be capable of fulfilling its core mission

of protecting the public health until they have capable leaders willing and able to

lead the Agency and serve the public.’’ The cases below all reveal the approach

taken by the current leadership and their commitment to scientific integrity.

Camp Lejeune, North Carolina

In 1990 ATSDR published a public health assessment that showed a dry-cleaning

facility just outside of Camp Lejeune in North Carolina had inappropriately disposed of trichloroethylene (TCE) which contaminated the base’s water supply.58 In

1997 ATSDR wrote a public health assessment on the potential environmental exposures of U.S. military personnel and veterans who had served at Camp Lejeune in

North Carolina and were potentially exposed to TCEs and a host of other toxic substances.59 The report, based on flawed data that was available at the time, showed

that the levels of exposures believed to have occurred would not pose a health hazard for adults. But it did recommend a follow-up study to evaluate potential health

effects to mothers exposed during pregnancy and their children.60 ATSDR has conducted numerous health studies on Camp Lejeune since then.61

In 2003 a Camp Lejeune veteran wrote to the Department of Health and Human

Services requesting records referenced in ATSDR’s 1997 public health assessment

on Camp Lejeunne under a Freedom of Information Act (FOIA) request. The response he got back said the records ‘‘are no longer in CDC’s possession. Specifically,

the records were lost during a 1998 office move,’’ an HHS official wrote. ‘‘As a result,

CDC no longer has records that would respond to your request, other than the public health assessment itself.’’ 62 However, an ATSDR FOIA officer offered a slightly

different explanation. On June 2, 2003, she wrote, ‘‘A search of our record failed to

reveal any documents pertaining to your request. Program staff stated that the refVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00029 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
22

63Letter from Lynn Armstrong, CDC/ATSDR FOIA Officer, Office of Communication, Depart- ment of Health and Human Services, Centers for Disease Control and Prevention (CDC) to

Thomas Townsend, June 2, 2003. 64Denita L. McCall, Represented by Disabled American Veterans before Department of Veterans Affairs, Rating Decision, January 17, 2007. 65 E-mail from Dr. Dan Middleton to Dr. Tom Sinks (cc’d to Dr. Howard Frumkin and other

ATSDR officials), Tuesday, February 7, 2006, 9:38 a.m. 66 E-mail from Dr. Howard Frumkin to Dr. Tom Sinks, Tuesday, February 7, 2006 11:15 a.m. 67 E-mail from Dr. Dan Middleton to Dr. Tom Sinks, Subject: machine shop workers, Wednesday, June 14, 2006, 4:54 p.m.

erenced material was either destroyed or misplaced during an agency physical move

this past October [2002].’’ 63

Finally, Dr. Frumkin responded to Camp Lejeunne veteran and activist Jerry

Ensminger about the FOIA responses and the validity of the 1997 Public Health Assessment on May 4, 2007. ‘‘As a scientific public health agency, it is important to

us that our reports contain the most current and scientifically correct information

available at the time,’’ wrote Dr. Frumkin. ‘‘We acknowledge that the references

used for the development of the 1997 public health assessment are no longer available in the Agency for Toxic Substances and Disease Registry’s (ATSDR) files. A

move of ATSDR staff resulted in our files of Camp Lejeune-related documents being

temporarily relocated. A private contractor mistakenly disposed of the documents,’’

said Dr. Frumkin. ‘‘Although unfortunate that the material referenced in the public

health assessment is no longer available in ATSDR’s files, the original information

and data, with the exception of original ATSDR references, may still be available

from their original sources.’’

Mr. Ensminger legitimately questions how the leader of a federal scientific public

health agency can stand behind a document which contains no supporting information or data. He is particularly perturbed by how cavalier Dr. Frumkin has been

to this and other critical public health issues. The impact of ATSDR’s work has realworld implications for U.S. Veterans and other members of the public. In this instance, the U.S. Veterans Administration has specifically cited the flawed ATSDR

public health assessment to deny at least one veteran medical benefit’s for illnesses

they believe were due to toxic exposures while based at Camp Lejeune on several

occasions.64

Brush Wellman, Elmore, Ohio—Beryllium Tests

However, in some instances it is clear that Dr. Frumkin and his deputy Dr. Tom

Sinks have intentionally tried to diminish the scope and integrity of some of the

Agency’s health consultations. In one investigation that examined potential exposures to beryllium in Elmore, Ohio, Dr. Frumkin and Dr. Sinks clearly prevented

ATSDR staff from more adequately informing the local community about the availability of free blood tests in order to test them for potential exposure. Publicly,

ATSDR said that it offered up to 200 free tests but that only about 20 individuals

responded. But internally, e-mails obtained by the Subcommittee show that Dr.

Frumkin and Dr. Sinks intentionally limited advertising the availability of the tests

despite strong and repeated arguments from some ATSDR staff scientists.

In February 2006, Dr. Dan Middleton was finally at wits end. In an e-mail to Dr.

Sinks, in which Dr. Frumkin and others were copied he wrote: ‘‘After a prolonged

struggle to bring this investigation forward and innumerable revisions, I find myself

at a loss as to how to proceed—I cannot in good conscience lead an investigation

that has little chance of success.’’ Middleton said he would like to resolve the issue

constructively and suggested a meeting with Dr. Frumkin and Dr. Sinks.65

But Dr. Frumkin’s reply to Dr. Sinks about the e-mail was less than encouraging.

‘‘Tom: Dan is probably right. We need a meeting. This is because he clearly hasn’t

gotten the message. This study is OFF. There will not be a study along the lines

Dan has contemplated. There will be a limited clinical service offered to those (probably few) members of the community who want it. That service will consist of a

blood test to look for beryllium sensitization among eligible persons. The outcome

will be this: people who are sensitized will be informed of that fact (as will those

who are not sensitized), and if they wish their doctors will also be informed. We will

provide information to local doctors to help them interpret and act on the results.

With that we will be done. Period. Howie.’’ 66

In mid-June, 2006 Dr. Middleton attempted to gain permission from Dr. Sinks to

specifically inform workers in one local machine shop about the beryllium tests.

‘‘Isn’t it the right thing to do?’’ Dr. Middleton asked.67 In his e-mail response, Dr.

23

68 E-mail from Dr. Tom Sinks to Dr. Dan Middleton, Subject: RE: machine shop workers,

Thursday, June 15, 2006, 5:02 p.m. 69 E-mail from Dr. Dan Middleton to Dr. Tom Sinks, Friday, June 23, 2006, 3:01 p.m. 70 E-mail from Dr. Howard Frumkin to Dr. Tom Sinks, Saturday, June 24, 2006, 11:49 a.m. 71 ‘‘Subcommittee Investigates CDC’s Handling of Beryllium Exposure Investigation,’’ April 11,

2008, available here: http://science.house.gov/press/PRArticle.aspx?NewsID=2154 72David Nakamura, ‘‘Water in D.C. Exceeds EPA Lead Limit; Random Tests Last Summer

Found High Levels in 4,000 Homes Throughout City,’’ The Washington Post, January 31, 2004,

p. A1. 73 ‘‘Blood Lead Levels in Residents of Homes with Elevated Lead in Tap Water—District of

Columbia, 2004,’’ Morbidity and Mortality Weekly Report, MMWR Dispatch, Vol. 53/March 30,

2004, Department of Health and Human Services, Centers for Disease Control and Prevention,

available here: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5312a6.htm 74 ‘‘Important Facts For Lead Service Replacement: Program Review,’’ District of Columbia

Water and Sewer Authority, February 2008, available here: http://www.dcwasa.com/

site¥archive/news/documents/LSR%20Program%20Facts.pdf

Sinks wrote: ‘‘good try—no. Let’s run the advertisement. It will include machinists

and they may call us.’’ 68

In the end, only a small number of individuals asked to be tested. A week later,

Dr. Sinks was informed by Dr. Middleton that they had completed 27 interviews for

the test and that 21 people are eligible.69 Dr. Sinks then forwarded the e-mail to

Dr. Frumkin with the subject line: ‘‘beryllium testing’’ saying ‘‘pretty good guess!’’

Dr. Frumkin’s reply to Dr. Sinks, ‘‘Wow. I think 20 was our estimate, no?’’ 70 The

Subcommittee investigated the beryllium issue last year.71

The design of any scientific study is a critical element in determining the validity

of its outcome and ability of the study to identify a problem. Until ATSDR has

strong dedicated leaders who are more concerned about the integrity of the reports

the Agency produces than the potential backlash the Agency may receive from corporations, federal agencies or local environmental groups unhappy or dissatisfied

with the results of their work ATSDR will never gain the public’s trust or the confidence of independent scientists and public health professionals.

Lead in Washington, D.C.’s Drinking Water

Based on almost two years of work, it is the Subcommittee’s staff’s conclusion that

Dr. Frumkin has shown a laissez-faire attitude towards the scientific integrity of the

documents and data his agency relies upon to make critical public health decisions.

In several instances he has appeared to be more inclined to defend the agencies he

directs, the Agency for Toxic Substances and Disease Registry (ATSDR) as well as

the CDC’s National Center for Environmental Health (NCEH), than protecting the

public’s health by diligently investigating and analyzing potential public health

threats based upon sound scientific procedures and methods. His inexcusable defense of the Agency’s actions in the formaldehyde issue is perhaps the most glaring

example, but there have been others.

In 2002 a change in the drinking water filtration system in Washington, D.C. led

to a sharp increase in the levels of lead in the city’s drinking water. This spike

which may have presented a health hazard to city residents was not reported by

the Washington D.C. Water and Sewer Authority (WASA) or the Environmental

Protection Agency (EPA). By early 2004 tests indicated that most homes tested had

water lead levels above EPA’s recommended level of 15 parts per billion (ppb). The

public first became aware of the high lead levels in a 2004 story in The Washington

Post.72

In March 2004, scientists at the CDC’s National Center for Environmental

Health, which Dr. Frumkin came to lead the following year, reported that of 201

residents from 98 homes with high water lead levels they tested, none of them had

lead levels in their blood that reached a ‘‘level of concern.’’ 73 Most people interpreted this CDC report as claiming that there was no health threat from drinking

Washington, D.C.’s water. A WASA fact-sheet in February 2008, for instance, said:

‘‘According to the CDC report, there were no children, from a sample group of 201,

identified with blood lead levels above the CDC level of concern (>10 micrograms/

deciliter) that were not explained by other sources, primarily the conditions of the

household paint.’’ 74

But last month a peer-reviewed paper was released by Marc Edward, a civil and

environmental engineering professor at Virginia Tech and collaborators at Children’s National Medical Center that showed, in fact, children in D.C. clearly had

high levels of lead in there blood as a result of the D.C. water crisis. They also found

that 50 percent of the data CDC relied on from the D.C. Department of Health reVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00031 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
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75Marc Edwards, et. al., ‘‘Elevated Blood Lead in Young Children Due to Lead-Contaminated

Drinking Water: Washington, DC, 2001–2004,’’ Environmental Science & Technology, January

27, 2009. 76 Rebecca Renner, ‘‘Mapping out lead’s legacy,’’ Environmental Science & Technology, February 11, 2009, available here: http://pubs.acs.org/doi/full/10.1021/es8037017 77 ‘‘CRS Report for Congress: Lead in Drinking Water: Washington, DC; Issues and Broader

Regulatory Implications,’’ Mary Tiemann, Specialist in Environmental Policy, Resources,

Science, and Industry Division, Congressional Research Service, Updated January 19, 2005,

available here: http://ncseonline.org/NLE/CRSreports/05jan/RS21831.pdf

garding the blood tests and water lead levels was flawed.75 In addition, it was discovered that more than 6,500 blood tests for a critical period in 2003 and 2004 were

lost. Still, Dr. Frumkin told a reporter for Environmental Science & Technology, the

journal where the article was published, that even if the data used for the CDC

analysis was deeply flawed it would not impact the CDC’s conclusions. ‘‘No publichealth database is perfect,’’ he said. ‘‘But this database is not so flawed that it fails.

We did a sensitivity analysis to see what happens if data are misclassified. That

sensitivity analysis shows that there would need to be a very large amount of data

misclassification to alter the conclusions of the study,’’ argued Frumkin.76

Dr. Frumkin’s statement that a ‘‘sensitivity analysis’’ showed that even flawed data would not change the conclusions of the CDC report struck Professor Marc Edwards as incredible for the leader of a public health agency. Professor Edwards says

considering half of the data had flaws in it, it seems highly unlikely that those flaws

did not impact the CDC’s findings. He says his new report clearly shows that the

data and therefore CDC’s conclusions were wrong. Dr. Frumkin and the CDC began

to back away from their initial claims that were widely interpreted to mean the

drinking water was safe.

In the aftermath of the criticism of the CDC report, Dr. Frumkin said the report

had a ‘‘clear message,’’ that ‘‘there is no threshold for lead exposure.’’ Edwards, a

civil and environmental engineering Professor was named a MacArthur Fellow last

summer by the John D. and Catherine T. MacArthur Foundation and granted

$500,000 (often called a ‘‘Genius Grant’’) to study drinking water safety issues. Edwards has written several letters to the CDC alleging ‘‘possible scientific misconduct

by CDC Scientists and Officials’’ regarding the D.C. lead—drinking water issue. He

has not named Dr. Frumkin in these complaints.

But Dr. Frumkin’s public response to his involvement in the D.C. lead drinking

water issue is remarkably similar to his actions and inactions undertaken during

ATSDR’s response to the formaldehyde issue. In that instance, he argued, after

being confronted by Congress that it was not his agency’s fault for issuing a deeply

flawed health consultation, but FEMA’s fault for ‘‘misinterpreting’’ the data in the

undeniably flawed report. On the D.C. lead issue, Dr. Frumkin e-mailed Ralph

Scott, the Community Project Director for the Alliance for Healthy Homes, on Monday, February 16, 2009 and said: ‘‘In the Post article of February 11, WASA General

Manager Jerry Johnson attributed to CDC the view that ‘‘residents’ health had not

been affected’’ by elevated lead levels in DC’s water supply from 2001 to 2004. As

I am sure you agree, this persistent misstatement by WASA is regrettable,’’ wrote

Dr. Frumkin. He then went on to defend the CDC report on D.C.’s lead level in

drinking water saying the report actually said no levels of lead are safe for children.

Like the formaldehyde report, the CDC report was simply ‘‘misinterpreted’’ by the

public and apparently officials at the D.C. Water and Sewer Authority, according

to Dr. Frumkin. And like the formaldehyde report, the CDC report on lead levels

in D.C.’s drinking water has had health related consequences. School officials in

New York and Seattle have cited the flawed CDC report as justification for not appropriately responding to high levels of lead in their water, for instance. Congress’s

investigative arm, the Government Accountability Office (GAO) also cited the flawed

CDC report and the Congressional Research Service (CRS) used the flawed data in

the CDC report because they believed it was scientifically sound and accurate.

‘‘None of the 201 persons tested who live in homes with the highest levels of lead

in drinking water (i.e., above 300 ppb) had blood lead levels above CDC’s levels of

concern,’’ the CRS report said.77 But Professor Edwards’ paper now shows that that

conclusion was based on flawed data and is wrong.

Scientific Integrity?

For a public health agency whose mission is to protect the health of the public

from toxic chemicals, the integrity of the science upon which ATSDR bases their decisions and the scientific integrity of the public health documents they release to

the public should be sacrosanct. But in its investigations of how ATSDR’s leadership

handled its health consultation on formaldehyde for FEMA last year the SubVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00032 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
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78 ‘‘Toxic Trailers—Toxic Lethargy: How the Centers for Disease Control and Prevention Has

Failed to Protect the Public Health,’’ Majority Staff Report, Subcommittee on Investigations and

Oversight, Committee on Science and Technology, U.S. House of Representatives, September

2008, available here: http://democrats.science.house.gov/Media/File/Commdocs/

ATSDR¥Staff¥Report¥9.22.08.pdf

committee found a haphazard approach to clearing, vetting and approving the release of its public health documents. In addition, there was an astounding absence

of independent scientific review of documents that are supposed to play a critical

role in protecting the public’s health and in establishing an appropriate federal response to environmentally threatened communities.78 Largely in response to the Subcommittee’s investigation Dr. Frumkin asked ATSDR’s Board of Scientific Counselors to examine the Agency’s ‘‘Peer Review and Clearance Policies and Practices.’’

The board issued a draft report last October.

The Agency’s Office of Science, in charge of clearing agency documents for public release, has a small staff and an enormous volume of documents it is supposed to

clear, the board’s report said. As a result, it lacks the ability to provide in depth

scientific expertise to review many documents. Several people told the board that

they were concerned that the reviews that took place above the division level were

‘‘cursory.’’ In addition, the board wrote that ‘‘scientists expressed concern that in trying to achieve its objectives, the Office of Communication Science’s wordsmithing

can change the intended scientific message in a document.’’ The board also found

that there is no clearly written guidance on what documents should be submitted

for external peer-review.

But the Board of Scientific Counselors was severely hampered in its review. Inter- views were conducted with groups not individuals, for instance. ‘‘[S]ome participants

may have felt constrained in offering their frank opinions,’’ the board acknowledged.

The board also recognized that it received ‘‘primarily a management perspective’’

and did not gather much insight into the concerns or worries of staff scientists. ‘‘Approximately 24 managers/team leaders and seven staff scientists were interviewed

across the three panels,’’ according to the board’s report. ‘‘Moreover, only one agency

employee attended the open session for walk-in comments,’’ the report says. In fact, it seems to the Subcommittee staff that the major focus of the board’s re- view, initiated at the direction of Dr. Howard Frumkin, received an inevitably

skewed assessment of these issues. It is unclear if the board received an accurate

portrayal of how ATSDR’s public health documents are vetted and released to the

public by not hearing from the staff scientists and other ATSDR employees who

have expressed deep and wide-ranging concerns about this issue for a long time. The

fact that a single employee showed up for the board’s ‘‘open session’’ suggests that

a large cadre of these scientists remains fearful about raising critical issues with

ATSDR’s leadership involving the scientific integrity of the Agency’s public health

documents and perceived flaws in the scientific design and methodology used to investigate potential public health hazards. In the past year, for instance, the Subcommittee has received numerous communications from ATSDR staff scientists who

have raised serious concerns about the willingness, ability and desire of ATSDR’s

leaders to ensure that only well vetted public health documents based on scientifically defensible positions and assumptions are released to the public.

Conclusion

Protecting the public’s health from potential exposures to toxic substances is not an easy task. It can be scientifically challenging, time consuming and resource intensive. The Subcommittee staff suggests that legislative fixes may be necessary to

address long-standing structural, procedural and technical issues that appear to

have hampered ATSDR’s effectiveness and harmed the communities it is supposed

to protect.

But more than anything, it is apparent that no fundamental changes will occur until the nearly thousand employees at the NCEH and ATSDR, the vast majority

of whom are truly dedicated and committed to protecting the public’s health, have

leadership that they can follow. The longer ATSDR continues to pursue its role in

protecting the public’s health as it has for the past three decades, issuing deeply

flawed scientific reports, not responding to the concerns of local communities and

approaching potential environmental exposures with a mindset that endeavors to

disprove any link between the public’s ill-health effects and potential exposures to

environmental contaminants or toxins, the more people will suffer. After four years

leading ATSDR, not only has Dr. Frumkin taken no effective steps to confront those

issues, on some specific cases he has contributed to the problems detailed in this

staff report. In many instances, ATSDR seems to represent a clear and present danger to the public’s health rather than a strong advocate and sound scientific body

26

that endeavors to protect it. Without a leader able and willing to confront those

issues, the public’s health will continue to be harmed.

27

28

Chair MILLER. Dr. Broun, the Ranking Member.

Mr. BROUN. I thank the Chair.

Good morning. I want to welcome the witnesses here today and

thank the Chair for holding this hearing. I share the Chair’s concern with public health and safety issues not only as a legislator

but also as a physician and a scientist. Our constituents deserve

to know whether their families are being exposed to harmful levels

of toxic chemicals.

As the Chair noted, ATSDR is no stranger to this committee. The

Subcommittee’s previous inquiry into the health consultation report

for FEMA regarding formaldehyde in trailers and the Agency’s

work regarding toxic releases into the Great Lakes region pointed

to weaknesses in ATSDR’s scientific review process as well as how

they convey information to the public. Because of these concerns,

ATSDR initiated several internal reviews of these efforts and the

Committee asked GAO to review the Agency’s processes. Dr.

Frumkin will update us on his agency’s efforts today, but we will

have to wait for GAO’s results for a few months. Until then, I hope

the witnesses here today can help this committee and the general

public better understand the Agency’s original mandate and how it

has evolved since its inception, the public’s expectations for the

Agency and the effects of an increasing number of petitions to the

Agency.

Understanding and communicating these fundamental points are

the first steps in evaluating the effectiveness of ATSDR. While the

work of the Agency is critically important, it is also very difficult.

Determining causation and making health risk determinations is

not always black and white. Despite the complexity of their work,

29

the public deserves to have an agency that they can trust. The

issues that we discuss today are not simply academic. Much like the witnesses on the first panel today, many of my constituents turn to ATSDR for answers about the effects on their

local environment and on their families’ health. Recently, Jill

McElheney, a constituent of mine, contacted me regarding her experiences with ATSDR, the EPA and the State of Georgia. The

heartbreaking story of her son’s battle with childhood leukemia and

the possibility that chemicals from a nearby industrial facility

could have influenced his condition is cause enough for all of us to

take notice.

I hope this hearing will help us shed light not only on how the

Agency can better protect public health and safety but also how it

can adapt to its evolving mission and the appropriateness of this

evolution. Additionally, I hope the witnesses can help us understand how the Agency can better coordinate with community organizations, other executive branch agencies and State and local departments of health as well as other government facilities on the

State and local level. Aside from assuring the science is always at

the center of the Agency’s work, understanding expectations and effectively communicating with the public is key to making sure that

ATSDR is an effective agency in the future.

In closing, I want to thank our witnesses for appearing here

today as well as all the hardworking folks at ATSDR.

Thank you, Mr. Chair, and I yield back the rest of my time.

[The prepared statement of Mr. Broun follows:]

PREPARED STATEMENT OF REPRESENTATIVE PAUL C. BROUN

Good morning. I want to welcome our witnesses here today, and thank the Chairman for holding this hearing. I share the Chairman’s concern with public health and

safety issues, not only as a legislator, but also as a physician. Our constituents deserve to know whether their families are being exposed to harmful levels of toxic

chemicals.

As the Chairman noted, Agency for Toxic Substances and Disease Registry

(ATSDR) is no stranger to this committee. The Subcommittee’s previous inquiry into

the health consultation report for the Federal Emergency Management Agency

(FEMA) regarding formaldehyde in trailers, and the Agency’s work regarding toxic

releases in the Great Lakes Region, pointed to weaknesses in ATSDR’s scientific review process as well as how they convey information to the public.

Because of these concerns, ATSDR initiated internal reviews of these efforts and

the Committee tasked GAO to review the Agency’s processes. Dr. Frumkin will update us on his Agency’s efforts today, but we will have to wait for GAO’s results

for a few more months.

Until then, I hope the witnesses here today can help this committee, and the general public, better understand:

• the Agency’s original mandate and how that has evolved since it’s inception,

• the public’s expectations for the Agency, and

• the effects of increasing numbers of petitions to the Agency.

Understanding and communicating these fundamental points are the first steps

in evaluating the effectiveness of ATSDR. While the work the Agency does is crucially important, it is also very difficult. Determining causation and making health

risk determinations is not always black-and-white. Despite the complexity of their

work, the public deserves to have an agency they trust.

The issues we discuss today are not simply academic. Much like the witnesses on

the first panel today, many of my constituents turn to ATSDR for answers about

the effects of their local environment on their family’s health. Recently, Jill

McElheney, a constituent of mine, contacted me regarding her experiences with

ATSDR, the EPA, and the State of Georgia. The heartbreaking story of her son’s

battle with childhood leukemia and the possibility that chemicals from a nearby inVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00037 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
30

dustrial facility could have influenced his condition is cause enough for all of us to

take notice.

I hope this hearing will help us shed light not only on how the Agency can better

protect public health and safety, but also how it can adapt to its evolving mission,

and the appropriateness of this evolution. Additionally, I hope the witnesses can

help us understand how the Agency can better coordinate with community organizations, other Executive Branch Agencies, and State and local health departments.

Aside from ensuring that science is always at the center of the Agency’s work, understanding expectations and effectively communicating with the public is key to

making sure ATSDR is an effective agency in the future.

In closing, I want to thank our witnesses for appearing here today, as well as all

the hard-working folks at ATSDR. Thank you Mr. Chairman, I yield back the rest

of my time.

Chair MILLER. Thank you, and I look forward to working with

Dr. Broun on this committee. I welcome his expertise, his scientific

expertise, and if I was able to get along with Mr. Sensenbrenner,

I certainly think I can get along with Dr. Broun.

Mr. BROUN. I look forward to working with the Chair. There are

some theoretical scientists on our scientific committee that don’t

think that physicians are scientists but I will take exception to that

because we do scientific theory, et cetera, and I appreciate the opportunity of working with the Chair.

Chair MILLER. As a recovering lawyer, I am certainly in no position to sneer at your scientific credentials. I will certainly accept

you as a scientist.

I understand Mr. Wilson has no opening statement but we will

accept opening statements for the record without objection that

may be included later.

[The prepared statement of Chair Gordon follows:]

PREPARED STATEMENT OF CHAIR BART GORDON

I want to thank Mr. Miller for calling this hearing. This subcommittee has done

good work in keeping the pressure on the Centers for Disease Control and the Agency for Toxic Substances and Disease Registry (ATSDR) to get the science right when

protecting the public’s health.

Chemicals of all kinds pollute our water, our air, our soil, and also enter the food

chain. Some are benign and some are dangerous.

For a community that has had a toxic spill or long-standing pollution issues, worrying that you or your family may get sick because of something they eat or breath

or drink is a part of your everyday existence. If you live in such a place, you live

with worry and fear and maybe even a sense of guilt that by choosing to live there

you are exposing your family to something that could make them sick or even kill

them.

When Congress established ATSDR in the 1980s, we hoped that it would be like

the cavalry riding over the horizon to come and tell a community that everything

was alright, or at least to let you know how bad the situation is. We expected them

to use the best science and develop ever more innovative ways to establish whether

some environmental problem was becoming a public health problem.

Unfortunately, ATSDR seems to be the gang that can’t shoot straight. They come

into local communities, often ignore the health complaints of local citizens, seem to

ignore obvious ways to determine what might be happening, and more often than

not go away saying there is nothing to worry about because they couldn’t find anything. As witnesses today will testify, ATSDR seems to resist developing new scientific methods for doing their work.

The American public deserves better than this for their $74 million a year—that

is ATSDR’s budget—and I believe this agency can do better.

There are many, many dedicated public health professionals at ATSDR who would

love to call it as they see it.

There is ample room to improve the Agency’s scientific methods, and to be more

creative in how they do science, so that the public is better served.

It is past time that we hold this agency to higher standards.

31

Panel I:

Chair MILLER. It is now my pleasure to introduce our first panel

of witnesses. Dr. Salvador Mier is the former Director of Prevention for the Centers for Disease Control and a local resident of

Midlothian, Texas. Professor Randall Parrish is the head of the

British Geologic Survey’s Natural Environmental Research Council’s Isotope Geoscience Laboratories in Nottingham, England. I

hope he doesn’t repeat all that at every cocktail party. He participated in an innovative study of community exposure to depleted

uranium in Colonie, New York. Mr. Jeffery Camplin is the President of Camplin Environmental Services Incorporated, a safety and

environmental consulting firm in Rosemont, Illinois, and is a licensed asbestos consultant for the Illinois Dunesland Preservation

Society. Dr. Ronald Hoffman is the Albert A. and Vera G. List Professor of Medicine at the Mount Sinai School of Medicine, the Director of Myeloproliferative Disorders——

Mr. BROUN. If you need some help with that, I will——

Chair MILLER. Perhaps Dr. Broun could introduce Dr. Hoffman.

I think it is easier now. Programs at the Tisch Cancer Institute at

Mount Sinai and formerly the President of the American Society of

Hematology.

It is the practice of the Subcommittee to take testimony under

oath. Do any of you have any objection to being sworn in? We also

provide that you may be represented by counsel. Are any of you

represented by counsel today? We ask you these questions to put

you at ease.

If you would now all rise and raise your right hand. Do you

swear to tell the truth and nothing but the truth? Let the record

reflect that each of the witnesses responded in the affirmative. You

now have five minutes each for your spoken testimony. Your full

written testimony will be included in the record of the hearing.

When you complete your testimony, we will begin with questions

and each Member will have five minutes to question the panel.

Mr. Mier, please begin.

STATEMENT OF MR. SALVADOR MIER, LOCAL RESIDENT,

MIDLOTHIAN, TEXAS; FORMER DIRECTOR OF PREVENTION,

CENTERS FOR DISEASE CONTROL

Mr. MIER. Thank you, Chair Miller, Dr. Broun and other Committee Members. Because other Midlothian residents, Midlothian,

Texas, were not able to be here today at this hearing, they asked

me to bring a short video that depicts some of the animal and dog

health issues that we have had concern with, and I would like to

request your permission, sir, to show that brief video.

Chair MILLER. Thank you. I believe that we have talked about

this at the staff level but the video is only a little more than three

minutes, three and one-half minutes.

Mr. MIER. Three minutes.

Chair MILLER. And what I propose is to allow Mr. Mier to show

the video and have that not counted against his five minutes for

testimony. Without objection, Mr. Mier.

[Video.]

32

Mr. MIER. Our community is on a treadmill to nowhere. Our

human and animal health issues have been festering for years. Our

environmental agency declares industrial emissions are harmless

and our health agency uses this as a refuge to look no further. In

my 40-year public health career, mostly with CDC, I never experienced such a lack of will to determine sources of illnesses. There

was never a quarrel about finding a cause caused by a bacteria or

a virus, but when a potential source is involved in industry, dynamics change drastically.

For answers I look toward my former employer, CDC. Thus we

petitioned ATSDR for a public health assessment in July 2005. But

instead of getting the trusted health information promised by

ATSDR in their mission statement, we ended up further from the

truth. ATSDR has demonstrated they are not committed to the responsibilities inherent in their mission statement or they are not

willing to overcome external pressures and act independently to

abide by the commitments of this mission statement.

Midlothian, Texas, is a small town with one of the largest steel

mills in the United States and the highest concentration of cement

manufacturing in the Nation with three plants, one of which is the

largest in the United States. These industries, in addition to traditional fuel and other refuse, incinerate whole and shredded tires

and hazardous waste, tons of hazardous waste, in kilns never designed for burning hazardous waste. Daily, tons of toxic emissions

pour out of 10 cement kilns and two steel industry stacks. Using

an EPA screening model in 2005, Toxic Release Inventory, USA

Today in collaboration with researchers and scientists at the University of Massachusetts, Johns Hopkins and the University of

Maryland ranked all schools in Midlothian in the upper third percentile of the Nation’s most toxic schools. Two ranked in the first

percentile and two ranked in the third. After hazardous waste became a fuel source in Midlothian, physicians began seeing more patients complaining of upper respiratory problems. Ranchers reported breeding problems, aborted fetuses and deformed offspring

in both horses and cattle. A statistically significant cluster of Down

Syndrome babies was identified in 1995. A study of respiratory illnesses in Midlothian performed by the University of Texas surfaced

a 35 percent higher incidence of respiratory problems in Midlothian

as compared to a control group. A study in 2005 found the prevalence of overall birth defects for Midlothian was one and a half

times that of Texas, and the prevalence of hypospadias and

epispadias, congenital defects in which the urinary outlet opens

above or below the penis or on the perineum, was three and a half

times that of the State of Texas. A local dog breeder experiences

in her animals large number of immune-deficiency illnesses, deformed offspring, litters born dead, cancers and failure to thrive.

Questions about a suspect air monitoring system were dismissed.

What about all of the empirical evidence that was surfacing? No

answers came.

When ATSDR agreed to do the assessment, they said they would

ask the State health department to help. Once the state became involved, the assessment morphed into a consultation and the responsibility for making the decision was relegated to the state. The

same individuals who had for years declared our environment

33

posed no health problems were going to look at once more. Furthermore, the decision was to be based on State monitoring data, the

same questionable data. By morphing the assessment to a consultation and using the same data, the same folks could pretend

not to see or totally ignore health problems and empirical evidence

by using the same familiar refuge. Air monitoring does not support

any one being sick. ATSDR never intended to be an active participant with this consultation. We were never going to get off that

treadmill, at least not with ATSDR’s help.

The consultation was finally released for public comment December 11, 2007. Scientists who reviewed it made the following comments. Dr. Stewart Batterman, University of Michigan, states,

‘‘The health consultation is biased. It contains overarching statements that discount all indications that emissions from local industry and environmental conditions might or do pose a health concern

in our community. It should not be issued by ATSDR.’’ Dr. Peter

deFur, of Virginia Commonwealth University, states, ‘‘ATSDR’s

classification of this site as an indeterminate public health hazard

is in direct contradiction with the data the Agency presents in the

report. Throughout the document ATSDR attempts to marginalize

or disregard data that indicate that compounds produce human

health risk. ATSDR has more than enough data to classify the site

as a public health hazard.’’ Dr. Neil Carman, a scientist who formally worked at the Texas State Environmental Agency, states, ‘‘It

fails to seriously acknowledge the numerous gaps in the ambient

air monitoring in the Midlothian area.’’

We naively expected an objective and scientific evaluation that

would provide trusted health information. We were wrong. Instead,

ATSDR abdicated its responsibilities to the state and never questioned the science behind the collection of the data and the reliability for making public health determinations. If ATSDR does not

have commitment or capacity to objectively temper and counter external forces that dissuade them from their mission to serve the

public by using the best science and provided trusted health information, then ATSDR needs to get out of the public health and consultation business. To maintain the status quo will only continue

to risk the public health of many U.S. communities.

[The prepared statement of Mr. Mier follows:]

PREPARED STATEMENT OF SALVADOR MIER

We are on a treadmill to nowhere. Our community’s human and animal health

issues have been ‘‘festering’’ for a long time. Time and time again the Texas Department of State Health Services (TDSHS) tell citizens of Midlothian the Texas Commission on Environmental Quality (TCEQ) affirms toxic emissions from industries

are too low to endanger public health—hence there is no point in looking at their

health issues. Pleas for help die at EPA, TDSHS and TCEQ doorsteps.

In my 37-year public health career—most of which was with the Centers of Disease Control (CDC)—I never experienced such a reluctance or lack of will to determine sources of illnesses. There was never a quarrel about finding the source when

you were dealing with a bacteria or a virus. But when the potential source involves

an industry, dynamics change drastically. This is why I decided to look back towards my prior employer (CDC) for answers. Thus, we turned to ATSDR, the purported ultimate environmental public health agency, for help.

Instead of getting help promised by ATSDR in their mission statement, we found

ourselves catapulted right back on to that treadmill and further from the truth.

ATSDR has demonstrated they either do not want the responsibilities inherent in

their mission statement or they do not have the will and commitment to overcome

34

external pressures and act independently to abide by the promises of this mission

statement.

The Industries

Midlothian, Texas, has the largest concentration of cement manufacturing in the United States. The town and schools are nestled amid three cement manufacturers—Dallas-based TXI’s Midlothian cement plant, with five kilns, boasts to be the

biggest in the U.S.; Ash Grove of Kansas, with three older wet kilns and Swiss company Holcim, with two kilns, are nearby. Limestone, cement’s main component, is

mined locally. Cement kiln dust is buried in local unlined quarries. These industries

incinerate, among traditional fuels and other refuse, petroleum coke, whole and

shredded tires, and hazardous waste—tons of hazardous waste—in kilns never designed to burn hazardous waste. Adjacent to TXI, Brazilian-owned Gerdau Ameristeel, one of the largest steel mills in North America, melts trainloads of scrap metal and crushed cars into new structural steel.

Daily, tons of toxic emissions pour out of ten cement kilns and two steel industry stacks.

In late 1980 TXI became one of the Nation’s largest hazardous-waste-combustion facilities accepting commercial hazardous waste. Cement kilns were authorized by

EPA in a 1996 MACT rule to operate under weaker, less protective MACT standards

for Hazardous Waste Combustors (HWC) compared to hazardous waste incinerators. In a statement (attached) Dr. Neil Carman, Ph.D., comments:

‘‘Cement kilns burn up to 1,000 degrees hotter than incinerators and a concern

is they may burn too hot for metals causing higher mass emissions due to greater metal volatility at higher temperatures. . . . Exposure to toxic metals is consistent with some health problems reported at Midlothian.’’

Contradictions in Data

In a report ‘‘Midlothian Industrial Plant Emission Data,’’ Amanda Caldwell and Susan Waskey, two University of North Texas (UNT) graduate students added up

all emission reports submitted to State and Federal Government by the three cement plants and adjacent steel mill in Midlothian. They spotlighted differences in

reported volumes of air pollution when industry submits emissions reports to the

State versus the Federal Government. These students discovered:

‘‘A cursory examination of EPA air release data in Figure 56 (Total Air Releases

per Firm 1990–2006) and TCEQ air release data in Figure 60 (Total Hazardous

Air Pollutants per Firm 1990–2006), show strikingly different results. For this

reporting period, the EPA data shows TXI to be the firm with the largest

amount of toxic chemicals released to the air (5,287,384 lbs.), while the state’s

data show Holcim to be the largest emitter of hazardous air pollutants

(1,507,663 lbs).

According to the plants’ TRI [Toxic Release Inventory] reports, there were almost 48,000 pounds of lead air pollution released by all four facilities over the entire 16 years, versus the over 90,000 pounds of lead the same plants reported sending up their stacks to the TCEQ and its predecessors during the

same period.

According to the plant’s TRI reports, there were approximately 5,000 pounds

of Mercury air pollution released by all four facilities from 1990 to 2006 versus the approximately 10,000 pounds of Mercury air pollution reported

to the state over the same time.’’

EPA has recently acknowledged total mercury emissions from cement plants in the U.S. are twice as high as reported to the TRI. Based on the two UNT students

report, TRI emissions appear not to match State records. Differences like these

should give rise to questions.

Midlothian Schools

Approximately 7,000 students attend nine schools situated in Midlothian.

USA Today in collaboration with the University of Massachusetts, the University of Maryland and Johns Hopkins University employed EPA Model, ‘‘Risk Screening

Environmental Indicators,’’ in an attempt to measure the extent of chemicals children were being exposed to while attending school. This model relied on EPA TRI

data for calendar year 2005. In this analysis, all schools rated in Midlothian ranked

in the upper third percentile of the Nation’s most toxic schools. Two ranked in the

first percentile of the Nation’s most toxic schools, two ranked in the third percentile.

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Their findings ‘‘Toxic Air and America’s Schools’’ were published in the USA Today

December 2008.

Risk Assessments

In order to allay community anxiety caused by the burning of hazardous waste,

in November 1995, the TNRCC (now TCEQ) prepared the Screening Risk Analysis

for the Texas Industries (TXI) Facility in Midlothian, Texas and the Critical Evaluation of the Potential Impact of Emissions From Midlothian Industries: A Summary

Report.

The American Lung Association contracted with Dr. Stuart Batterman, Ph.D., Environmental and Industrial Health, University of Michigan, to do an evaluation of

this risk analysis. In Dr. Batterman’s 70-page de novo analyses he warns:

‘‘. . . Based on risk assessment techniques, other environmental impact assessment methodologies, and an assessment of existing environmental monitoring

data, we conclude that the environmental and health impacts have and are likely to occur in the Midlothian area from industrial activity, including the combustion of hazardous waste at TXI. That TXI, the other cement kilns and

steel smelter in Midlothian cause impacts is inescapable.’’ [emphasis

mine]

Dr. Batterman further states:

‘‘. . . Some of the monitoring programs appear entirely reasonable. . .. Others,

however, are highly deficient with respect to study design, execution, data quality and data analysis. Overall, the monitoring program is not impressive given

the scale of industry and waste combustion in Midlothian and the degree of

public concern.’’

‘‘. . . The serious deficiencies in the Screening Risk Analysis and Summary Report indicate that the ability of the TNRCC to conduct an objective assessment is compromised, and the record demonstrates significant concerns

regarding the effectiveness of the TNRCC in regulating the combustion of hazardous waste at TXI.’’

Illness Surfacing

Beginning in the late 1980’s and early 1990’s, shortly after TXI started burning

hazardous waste:

• Physicians began observing increases in office visits from patients complaining of upper respiratory problems.

• Ranchers started reporting breeding problems, aborted fetuses and deformed

offspring in both horses and cattle.

• A Statistically Significant cluster of Down syndrome babies was identified in

1995.

• A peer-reviewed study of respiratory illnesses in Midlothian, conducted by

University of Texas Medical Branch and authored by Dr. Marvin Legator in

1996, concluded a 35 percent higher incidence of respiratory problems in

Midlothian than the control group.

• Based on a study completed in 2005, the prevalence of overall birth defects

from 1999 through 2003 for Midlothian was 150 percent that of Texas and

the prevalence of hypospadias/epispadias (congenital defects in which the urinary outlet opens above or below the penis or on the perineum) in Midlothian

was 350 percent that of the State.

• Since 1990 and continuing, Ms. Debra Markwardt, a local dog breeder experiences large numbers of illness in her animals that are related to immune system deficiency issues, aborted fetuses, failure to thrive, cancers and deformed

offspring. Local veterinarians have attributed these problems to environmental factors. (See addendum for her statement.)

• In 1994 a group of mothers concerned for their children and the community

pleaded with EPA that EPA at least do an animal health study. Poorly

planned and based on a questionable methodology of execution, EPA initiated

an animal health survey. Ultimately, the survey was abandoned and no conclusions drawn. The study did, however, identify an apparent high level of

animal health problems in the study area in horses at one ranch. This rancher had seven to ten horses in any given year and reported between 50–88 percent of the animals had reproductive health problems during the survey period. The majority of these horses had estrous/cyclic problems. One mare reVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00043 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
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peatedly had problems giving birth or keeping the foals after birth. This horse

died shortly before the survey was conducted and a necropsy was performed.

An inflamed ovary and a cyst on the ovary were discovered. There was also

chronic enlargement of the lymph glands in the head, neck and under the

throat. The mare exhibited a muscular line on the side of the abdomen indicative of labored breathing problems. (Note: Problems experienced by this

rancher are similar to problems experienced by Ms. Markwardt and other

livestock owners.)

ATSDR, TDSHS, TCEQ refuse to look at or even acknowledge the existence of any empirical evidence for fear a link may be related to industrial emissions and some

responsibility may ensue. They instead take refuge in theoretical mathematical computations based on questionable air monitoring data.

Seeking Answers

For years, citizens turned to TDSHS for help. TCEQ eagerly and staunchly de- clared emissions from industries were safe and TDSHS used this as a refuge to look

no further. No answers came.

Questions about a suspect air monitoring system and how air monitors not placed in predominant wind patterns could produce valid readings went unanswered. What

about all the empirical evidence that was surfacing? No answers came. Year after

year this cycle kept repeating. The search for a scientifically validated response could not get off the treadmill. To many in the community, TCEQ’s methodology for collecting air monitoring data appeared to be designed to avoid major emissions and to create an illusion of

ambient air purity. Could this data’s reliability to assess community impact and

public health withstand the scrutiny of objective unbiased scientists? We thought we

would find that objectivity when we turned to ATSDR.

ATSDR Involvement

In July 2005, our petition went before an ATSDR panel. The panel deemed it met the criteria for a public health assessment.

On August 10, 2005, we received a letter from ATSDR stating that ‘‘they’’ would

be doing a Public Health Assessment as authorized under the CERCLA. ATSDR

indicated that they planned ‘‘to ask TDSHS for help’’ responding to our concerns. This was disconcerting; however, ATSDR was a federal health-based agency with a

mission statement that promised the use of the best science and to provide trusted

health information—and they would be in control. ‘‘So, maybe,’’ we thought, ‘‘there

was hope.’’

Sadly, as the assessment started to slowly roll out, objectives began to morph into paths that dodged addressing critical issues such as the need for a scientific assessment of the monitoring data and an evaluation of the empirical evidence. Example:

1. Initially ATSDR promised to do a Public Health Assessment ‘‘to more fully characterize the emissions from multiple large industries in the area and

evaluate potential health risks resulting from individual and aggregate

chemical exposures.’’

2. Once the State became involved, things started to morph. The ‘‘Public

Health Assessment’’ changed to something new. On Sept. 12, 2005, we received a letter from ATSDR stating that because of ‘‘*community health

concerns’’ they would be conducting instead a health consultation. They

further implied that a health consultation would allow for a ‘‘timely response (early 2006).’’ In this letter ATSDR indicated that they were deferring the decision back to the State. ATSDR would review and certify it. In

addition (even though one major concern we expressed was the inadequacy of the State monitoring data for evaluating public health

issues) they stated they would rely on State monitoring data to make conclusions. It was at this point I realized we were catapulted right back

on to that treadmill going nowhere.

(*Note: I am still puzzled about what ATSDR meant by ‘‘community health

concerns.’’ The community was concerned that no one was looking at their

health issues and asking the question, ‘‘Could something by awry with the

monitoring data in which TDSHS and TCEQ take refuge to declare there

were no public health issues?’’ Obviously the community’s ‘‘health concerns’’

and ATSDR’s health concern did not run a parallel path.)

An assessment requires a closer examination of community health issues

and may even entail some epidemiological activities; whereas, theoretically

37

a consultation is done when time is of essence and a rapid decision is necessary. The value of a consultation from ATSDR’s/TDSHS’ perspective

would be that if air-monitoring data did not support any adverse health effects, the job ends there. All empirical evidence and epidemiological data can then be ignored. All other red flags indicating health problems such as high birth defects, immune system deficiencies, animal issues,

UTMB Study on Upper Respiratory illness, etc., can be dismissed as irrelevant. Since ATSDR/TDSHS were going to accept monitoring data at face

value and if this monitoring data is purported to reflect the cleanest air in

Texas, the simplicity of the conclusions was promising.

3. To further simplify the task, the scope of the consultation narrows to looking

at air data only.

4. Toxins in the air can be tricky—entering a body in more ways than one. So to avoid any possible complications, the scope must now be further narrowed

to the ‘‘inhalation’’ pathway only.

Empirical evidence and epidemiological data has been deemed non-rel- evant for this consultation. It has been treated like an untouchable pariah. To

include it would mean someone would have to address whether something is awry.

This is a challenge that apparently ATSDR nor the State want to face. I finally realized that regardless of what arguments are made or regardless of what empirical evidence is presented, the bottom line on this public health consultation was determined before it even began. The entire process would just be a matter

of making documentation support the bottom line.

We needed input from objective unbiased reputable scientists. Shortly before the consultation was due to be released, I reached out begging for help. Six scientists responded and offered their time and skills to critique the draft consultation

report.

A draft decision with an ‘‘Indeterminate Public Health Hazard’’ was finally posted

for comments on December 11, 2007.

What the Scientists Said

The scientists who reviewed the draft were all highly critical of the product.

Dr. Stuart Batterman, Ph.D., Professor of Environmental Health in the School

of Public Health and Professor of Civil and Environmental Engineering at the College of Engineering, both at the University of Michigan, comments: ‘‘. . . This

Health Consultation has so many omissions, inconsistencies, and inadequate, flawed,

or misleading analyses and language that my best suggestion, given in advance of

my comments, is that it should not be issued by ATSDR. . . . The Health Consultation is biased. It contains overarching statements that discount all indications that

emissions from local industry and environmental conditions might or do pose a

health concern in the community. The Health Consultation should be objective yet

maintain the health-protective stance which is appropriate for health-based agencies

like ATSDR. . . . The Health Consultation relies exclusively on air quality monitoring results measured at four monitors. It does not discuss, in any coherent way,

the adequacy of the spatial and temporal coverage of this network. This includes, for

example, the ability to identify hotspots, the appropriateness of the network, the adequacy of the monitored parameters, the quality of the data, and the need for additional monitoring sites. . . . There is little mention of meteorology. The area shows

very persistent and directional winds, which means that monitors that are not directly downwind are likely to not show impacts from local sources. The Health Consultation should include appropriate wind roses and other analyses that indicate the

likely impact areas vis-a ́-vis monitoring sites. . . . In its present form, however, I

find so many biases and deficiencies that I do not believe that the Health Consultation achieves its aims and, as stated above, I would urge that ATSDR reconsider its

issuance.

I do hope that ATSDR sponsorship and oversight provides a means to correct these

problems . . ..’’

Dr. Peter L. deFur, Ph.D., and Kyle Newman, Environmental Stewardship

Concepts, comment: ‘‘. . . ATSDR’s classification of this site as an ‘‘Indeterminate

Public Health Hazard’’ is in direct contradiction with the data the Agency presents

in the report. Throughout the document, ATSDR attempts to marginalize or disregard data that indicate that compounds produce human health risks. ATSDR has

more than enough data to classify the site as a ‘‘Public Health Hazard. . . . The

problems with this assessment are numerous, and the most serious problem with the

interpretation is that ATSDR discounts their own metrics of health effects, ignoring

the data that exceed health levels.

38

For a number of chemicals, the air concentrations are in excess of the health levels,

but ATSDR dismisses the excess toxic chemicals as not a problem because the number or people harmed is small, despite the fact that the risks exceed the levels used

to protect people from environmental threats (i.e., one in a million) . . .’’

Dr. Neil Carman, Ph.D., Program Director, Lone Star Chapter of Sierra Club and former employee of the Texas State environmental agency, comments: ‘‘I find

the report highly inadequate for a variety of reasons [listed in full in comments] and

fails to seriously acknowledge the numerous gaps in the ambient air monitoring in

the Midlothian area. . . . A basic concern here is that asthma, allergies, immune system deficiencies, and other health problems in adults and children are not being

evaluated and yet these kinds of adverse health effects are being reported by

Midlothian residents . . .’’

Dr. Dennis Cesarotti, Ph.D., Northern Illinois University, comments: ‘‘It appears that the DSHS (State Public Health) set out to prove that there were no health issues

in Midlothian, Texas.’’

Dr. Al Armendariz, Ph.D., Environmental Engineer, Southern Methodist University comments: ‘‘The report lacks an analysis of the impact of dioxin and furan emissions from local industry to the public health of the community . . . however,

dioxin and furan emissions are an extremely significant component of the emissions

from the local industry. . . . a significant fraction of the mercury emitted by the industrial sources in the area is likely to be emitted in gaseous form, given the volatile

nature of mercury, and the temperatures of the stack gases. The gaseous mercury will

not be collected in the particulate filters, leading to further underestimates of the true atmospheric concentrations of mercury. In addition, the gaseous mercury will not be

detected by the techniques used to identify the VOC compounds.’’ Debra L. Morris, Ph.D., Adjunct Assistant Professor in the Department of Pre- ventive Medicine and Community at the University of Texas Medical Branch in Galveston, comments: ‘‘A symptom survey of residents in the geographical area that this document covers has been conducted and published (Legator et al., 1998). The results

of this study showed that residents in this area had more respiratory symptoms than

individuals in a control region. However, I am unaware that any attempt has been

made to follow up on the results of the study using methodology that directly addresses and measures the health concerns of the community. Because the individuals

in this area are exposed to a combination of chemicals, studies of health effects in

this population would be much more revealing than an approach that makes mathematical approximations of the health risks based on measurements of individual

chemicals.’’ [Dr. Morris was a participant in this study.]

TCEQ Response

The Texas environmental agency (TCEQ) was highly critical of the ‘‘Indetermi- nate’’ finding. In comments to EPA, posted on their website TCEQ complains:

‘‘POTENTIAL IMPACT ON TCEQ: The Indeterminate Public Health Hazard

finding regarding air toxics in Midlothian may lead citizens and elected officials

to believe the air quality is causing health impacts when air toxics monitoring

in the Midlothian area not only indicates acceptable air quality but also better

air quality than most monitored areas of the country. This concern could lead

to pressure on TCEQ to shift resources from areas of concern in order to expend

more resources in the Midlothian area.’’

As of this date (March 12, 2009), the public health consultation has not been finalized.

Due to this Administration’s proposed strategy to rebuild the Nation’s in- frastructure, the steel and cement industries are in a position to boom. In

the last year, however, all local industries in Midlothian have severely cut back on

production of concrete and steel. As of October 2008, TXI has temporarily, idled its

four older wet kilns and has temporarily suspended burning hazardous waste. What

is coming out of the industries now does not represent what the community has

been exposed to or what they will be exposed to once production accelerates and

once burning of hazardous waste resumes. If you want a less than adequate pic- ture of emissions to which the public has been exposed and to which they

will be exposed—now is the time to monitor.

In an effort to get the ‘‘Indeterminate Public Health Hazard’’ lifted, TCEQ em- barked on a $349,000 project purportedly to ‘‘answer some of the community’s questions’’ and determine the percent of chromium-6 in the identified chromium emissions (a major unknown factor that lead to the indeterminate finding).

The first of four five-day monitoring periods scheduled over a year took place in

December 2008—right after TXI temporarily idled its four older wet kilns

and temporarily suspended incineration of hazardous waste. ‘‘TXI’s status

39

might affect the chromium’s numbers depending on whether the older kilns are operating during any testing,’’ TCEQ officials conceded to a reporter from the Dallas

Morning News.

Any monitoring during the time hazardous waste is not being incinerated

would skew more than just the chromium numbers. It would also not capture

emissions with the highest levels of concern—those resulting from the incineration

of hazardous waste. What information will this data provide? Perhaps it will provide

a baseline for comparison when hazardous waste incineration is revived.

The fact that this data will not be representative of actual emissions to which the

public was exposed, or will be exposed, appears not to be a material consideration

in the scheduling of air monitoring. How ATSDR/TDSHS plan to retrofit this

data into the conclusions of the public health consultation remains questionable.

When ATSDR was questioned about the reliability of any data collected during

the idling of these kilns, during decline in production, and during the temporary

suspension of hazardous waste incineration, the response was, ‘‘We have no control

over changes in plant operations due to economic conditions. Couple this with the

fact that State agencies often have a limited window within which funds made

available for a project must be spent.’’ Spending funds seemed more important

than the quality of the data and evaluating public health impact to real exposures. What appears to be important is that the money be spent now.

ATSDR critically missed the boat at step one. They failed to validate the science

behind the methodology used to determine the placement of the air monitors. If they

could not validate the data at the initial step, of what value are any ensuing conclusions? The deficiencies in this consultation indicate ATSDR’s ability to conduct an objective assessment is compromised.

We never asked anyone to find a problem if one did not exist. We just wanted

an unbiased objective assessment. We expected an assessment incorporating the

most recent science, logic, common sense and objectivity. We did not get this.

Instead of exercising due diligence by becoming an active participant in the evaluation, ATSDR relegated their responsibility without question back to the State.

The assessment of Midlothian’s public health ended up back in the hands of the

same decision-makers who over the years staunchly and flagrantly turned a deaf ear

and blind eye to the empirical evidence handed them. Science was not going to

be factored in.

It appears ATSDR divorced themselves from their mission statement. There was

no value added to ATSDR’s involvement. ATSDR’s involvement only served to keep

the public at bay for another four years. It was a costly waste of taxpayers’ money.

This involvement only elongated a process to nowhere and gave credence to impediments in the system that block science and truth.

If ATSDR does not have the commitment or capacity to objectively temper and

counter external forces that dissuade them from their mission to serve the public

by using the best science and providing trusted health information—then ATSDR

needs to get out of the Public Health Assessment and Consultation business. Maintaining the status quo will only continue risking the public health of many U.S.

communities.

U.S. communities desperately need an external environmental public health entity able to carry out the mission assigned to ATSDR. Perhaps contracting with a

University or a School of Public Health would be a better alternative. We need an

entity that is proactive and not just merely an acquiescing observer.

Addendum

1. March 17, 2009: Letter from Mr. Mier to the Honorable Brad Miller, Subcommittee Chairman, Subcommittee on Investigations and Oversight.

2. Comments and photos of animals as sentinels for environmental health hazards,

from Ms. Debbie Markwardt, dog breeder and local resident of Midlothian, TX.

3. January–February 2009: E-mails between Debbie Markwardt, Alan Yarbrough,

ATSDR, and John Villinaci, Texas Department of State health Services, carbon

copied to Dr. Howard Frumkin, Director, ATSDR.

4. March 11, 2008 letter: Sierra Club, Lonestar Chapter to Texas Department of

State Health Services, Re: Comments on 2007 Public Health Consultation for

Midlothian, Texas.

5. May 1, 1996 Risk Analysis: Executive Summary extracted from evaluation of

the Screening Risk Analysis for the Texas Industries (TXI Facility) In

Midlothian, Texas, released November 1995. Written by the Texas Natural Resource Conservation Commission, And Other Materials Related to the Texas InVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00047 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
40

dustries Facility by Stuart A. Batterman, Ph.D., Yuli Huang, M.S., Environmental and Industrial Health, The University of Michigan.

6. March 9, 2009: Comments on ATSDR December 11, 2007 report, Health Consultation—Midlothian Area Air Quality Park 1: Volatile Organic Compounds

and Metals’’ from Stuart Batterman, Ph.D., Professor of Environmental Health

in the School of Public Health and of Civil and Environmental Engineering,

University of Michigan.

7. March 11, 2008: Comments on ATSDR Public Health Consultation of

Midlothian, Texas. Prepared by: Peter L. deFur, Ph.D., and Kyle Newman, Environmental Stewardship Concepts, Richmond, VA.

8. March 2009: Written Testimony of Neil J. Carman, Ph.D., Former State of

Texas Air Pollution Control Agency Regional Field Investigator of Industrial

Plants Including Portland Cement Kilns and Waste Incinerators in 1980s–90s:

The EPA’s Sham (Bifurcated) Hazardous Waste Combustor MACT Rule and Enforcement Failures by EPA and State of Texas are Related to Health Hazards

from Toxic Waste Incineration in Cement Kilns at Midlothian, Texas.

9. February 3, 2008: Sal and Grace Mier, Midlothian TX, response to ATSDR/

DSHS study on Midlothian Area Air Quality Park I: Volatile Organ Compounds

and Metals, December 11, 2007.

10. September 9, 2008: Not ‘‘Just Steam’’: A Review of ‘‘Emissions Data from

Midlothian Industry’’ for the Texas State Natural Resources Committee.

11. June 29, 2005: Texas Department of State Health Services Birth Defects Investigation Report—Birth Defects Among Deliveries to Residents of Midlothian,

Venus, & Cedar Hill, Texas, 1997–2001. Prepared by Mary Ethen, Epidemiologist, Birth Defects Epidemiology and Surveillance Branch, DSHS.

12. May 19, 2005: Midlothian Cancer Cluster Report #05026—Summary of Investigation into the Occurrence of Cancer, Zip Codes 76065, 75104, and 76084,

Midlothian, Cedar Hill, and Venus, TX in Ellis, Dallas, and Johnson Counties,

Texas, from 1993–2002.

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Addendum #1

42

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Addendum #2

STATEMENT OF DEBRA MARKWARDT

MIDLOTHIAN, TEXAS

AREA DOG BREEDER

I am Debra Markwardt, a professional dog breeder since 1982. When I moved my

home and business to Midlothian in 1988 my animals were all thriving. Over the

years my animals started manifesting health issues. They did not seem to thrive

as well. Entire litters were dying. (Last year I lost 75 percent of my litters.) Pups

were being born with strange birth defects that I had not previously seen in my animals. Birth defects such as large domed heads, external intestines, extra or missing

limbs, blindness, missing testicles, distorted genitalia, no visible signs of urinary

outlet, etc., became common.

Hair analysis for me and for some of my animals was done. Varying degrees of

heavy metals have been identified in all of these tests. Every one of these tests reflected extremely high levels of aluminum. High aluminum in their systems causes

extreme mineral imbalances depleting their body of essential nutrients. Aluminum,

lead, and mercury go to the brain and nervous system, thereby poisoning every

organ of the body. As the immune systems deteriorate diseases manifest.

My animals also started manifesting severe problems with their coats. They were

becoming emaciated and failing to thrive. Problems were more evident in the very

young and in the older animals. Pups were born with heavy metals in their system

and weaker immune systems. If a pup survived past six to eight months it survived

relatively well. My vet explained that some pups had stronger immune systems

than others. If their survival passed that critical period, it was an indicator of a

stronger immune system. I have lost about 75 young adult dogs since I moved to

Midlothian.

Ranchers in the community were having similar problems with their livestock. Efforts to get these issues addressed died at the doorsteps of EPA, Texas Department

of State Health Services (TDSHS), and the Texas Commission on Environmental

Quality (TCEQ). TCEQ said our environment in no way posed a problem and this

was the reason TDSHS could comfortably walk away.

When ATSDR became involved we had hopes that we finally had an agency that

would look at our problems and give us a scientific answer.

Midlothian is experiencing birth defects in their children at a rate 150 percent

that of the state. They are experiencing hypospadia/epispadias at a rate 350 percent

that of the state. I believe birth defects in my animals parallel birth defects seen

in children born in Midlothian. I also felt that immune system deficiencies documented in my dogs parallel problems people in the community were alleging.

I cannot understand why ATSDR and TDSHS do not believe what is happening

to my animals is relevant to the assessment of this community’s public health. What

is happening to my animals could be happening to the people of Midlothian. I keep

getting a brush-off from ATSDR with comments like ‘‘. . . veterinary and animal

issues are outside of our mandated domain’’ and ‘‘. . . studies involving animals,

even as sentinels for human health issues, are not activities engaged in or funded

by our agency’’ and ultimately ‘‘. . . ATSDR and the Texas Department of State

Health Services do not have the expertise to conduct the appropriate animal studies.’’

I was not asking them to do an animal study. I offered my data for use in the

ATSDR public health consultation as possible sentinels to what could and may be

happening to the community. ATSDR firmly stated that there would be no association of these animals with the public health consultation they were doing for

Midlothian. There are children who are waiting to be born. These animals could

be a key to their future. Who will help these children?

Below, are examples of what I have been experiencing—different birth defects, results of immune system deficiencies, and examples of how animals with weakened

immune system respond when raised away or removed from Midlothian. I too am

experiencing health problems. On the last page is a statement from my doctor.

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Addendum #4

SIERRA CLUB

Lone Star Chapter

March 11, 2008

Environmental and Injury Epidemiology and Toxicology Program

Texas Department of State Health Services

1100 West 49th Street, Room T–702

Austin, TX 78756

Re: Comments on 2007 Public Health Consultation for Midlothian, Texas

Dear Texas Department of State Health Services Consultation staff:

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I am writing to share serious concerns over the gaps and inadequacies presented

in the Texas Department of State Health Services (TDHS) and the Agency for Toxic

Substances and Disease Registry (ATSDR) report titled ‘‘Health Consultation—

Midlothian Area Air Quality Part 1: Volatile Organic Compounds & Metals.’’ I find

the report highly inadequate for a variety of reasons and fails to seriously acknowledge the numerous gaps in the ambient air monitoring in the Midlothian area.

Background Levels: Waste Incineration Conducted at Kaufman, TX

‘‘We obtained background levels for many of the contaminants from TCEQ

monitoring results for the town of Kaufman, TX, a town of similar

population size, no large industry, and which is only rarely downwind from Midlothian.’’

At least one serious concern about using Kaufman, TX is the fact that relatively

large-scale waste incineration has been conducted for many years in this community. Incinerators operated in Kaufman include municipal waste combustion facilities or medical waste incineration or both, which emit many of the same products

of incomplete combustion (PICs) as do cement kiln hazardous waste incinerators

such as Dioxins, Dibenzofurans, Polychlorinated Biphenyls, Polycyclic Aromatic Hydrocarbons and Metals. I recommend that you consult with TCEQ about how many

waste incineration facilities were operated or are still operating in Kaufman, TX.

However, I have no details or information about the siting of the TCEQ’s Kaufman monitor relative to the waste incineration facilities and whether the monitor

was downwind or upwind of the incineration facilities. But the fact that large-scale

waste incinerators may have been operating in Kaufman over many years indicates

that the use of Kaufman, TX is inappropriate for any comparisons to Midlothian,

TX.

PART I

Sampling every six days for VOCs & metals. May 1981–March 2005.

1. Sampling site selection for TCEO ambient air monitoring raises many issues. A

number of the Midlothian and Ellis County TCEQ sampling sites are not selected

for suitable sampling suits as to be downwind of the Midlothian industrial plant

emissions plumes and will not provide valid downwind ambient air concentrations

to measure emissions from the industrial plants. How many Midlothian and Ellis

County TCEQ sampling sites are actually in the general downwind area of the

plants and how far in feet are these?

2. Sampling frequency raises another set of ambient air monitoring issues. Sampling

on a once in six day sample duty cycle only looks at most at 16.7 percent of the

days for air pollution and excludes for analysis 83.3 percent of the time period every

year.

3. Sampling—protocol of flow rate and analytical limitations also present a number

of additional ambient air monitoring issues that need to be addressed. Many air contaminants are excluded from laboratory analysis and many are not detected due to

minimum detection limits set above threshold where many toxic air contaminants

may be present such as dioxins, dibenzofurans, polychlorinated biphenyls, polycyclic

aromatic hydrocarbons, and others.

A.1. While it is true that ‘‘all the chemicals being released from cement

kilns and steel mills have not been fully identified,’’ this health consultation has evaluated 237 individual contaminants including 119 VOCs and

108 metals and other inorganic substances.

Another concern surrounds the question of whether the TDSHS scientists have

any prior experience in performing an evaluation of a commercial or private hazardous waste combustion facility in Texas before this current Midlothian effort.

Since this is not a responsibility typically involving the TDSHS scientists, the consultation may be partly compromised by the inability to comprehend the complex

emissions hazards associated with such hazardous waste storage, treatment and disposal facilities as exist at Midlothian. For example, downwind air monitoring sites

may be too far away from the hazardous waste facilities to be able to detect ground

level fugitive hazardous waste emissions leaks from the transfer, storage and piping

system at such a facility. However, having myself visited Midlothian many times

and having been downwind of the hazardous waste facilities, I definitely noticed

during each visit that there were in my opinion distinct fugitive gaseous emissions

from these operations that produced instant severe headaches. While I cannot state

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for certain if such fugitive gaseous emissions were associated with the hazardous

waste operations, I did not notice similar fugitive gaseous emissions from the two

non-hazardous waste cement kilns at Midlothian. As a result, I maintain that the

fugitive gaseous emissions from the hazardous waste cement kiln were associated

with its hazardous waste operations.

Hazardous waste chemistry is highly complex and may become more complex dur- ing and immediately after the incineration process. Hazardous waste consists of

toxic soup mixtures of innumerable organic and inorganic chemicals, elemental

chemicals, metals, acids, bases, salts, waste water and other wastes from complex

industrial manufacturing processes. Hazardous waste incineration has the potential to take the thousands of organic and inorganic chemicals and chemically transform them into thousands and thousands of incompletely burned compounds. The consultation did not include consideration of the need to sample the air,

water and food chains for known species of the following twenty groups of halogenated organic chemicals that are toxicologically known to cause adverse biological

effects through the Ah-r-mediated mechanism of action:

Polychlorinated dibenzo-p-dioxins

Polychlorinated dibenzo-furans

Polychlorinated biphenyls

Polychlorinated naphthalenes

Polychlorinated diphenyltoluenes

Polychlorinated diphenyl ethers

Polychlorinated anisoles

Polychlorinated xanthenes

Polychlorinated xanthones

Polychlorinated anthracenes

Polychlorinated fluorenes

Polychlorinated dihydroanthracenes

Polychlorinated diphenylmethanes

Polychlorinated phenylxylylethanes

Polychlorinated dibenzothiophenes

Polychlorinated quarterphenyls

Polychlorinated quarterphenyl ethers

Polychlorinated biphenylenes

Polybrommated diphenyl ethers

Polychlorinated azoanthracenes

Cite: Table 4—Compounds that May, Based on Experimental Evidence or Struc- ture, Be Expected to Have the Potential to Cause Adverse Effects through the Ahr-mediated mechanism of action, p. 266 in Chapter 9, ‘‘Dioxins, Dibenzofurans,

PCBs and Colonial, Fish-Eating Water Birds’’ by John P. Giesy, James P. Ludwig,

and Donald E. Tillin, published in Dioxins and Health edited by Arnold Schecter,

Plenum Press, New York, 1994.

There may be other possible organics including polybrominated aromatic compounds, polychlorinated-brominated aromatic compounds, polyfluorinated aromatic

compounds, polychlorinated-fluorinated aromatic compounds, and other polycyclic

aromatic hydrocarbons (all lumped together as ‘‘dioxins’’ here).

The large-scale hazardous waste incineration activities conducted at Midlothian

for approximately twenty years create unique circumstances for producing the air

emissions of a large number of exceptionally toxic substances since there is no such

thing as 100 percent combustion efficiency and total organic chemical destruction

in any incineration devices let alone cement kilns. A basic concern is that the consultation has seriously underestimated and downplayed the dangers of large scale

incineration of hazardous waste for a local community. The large scale incineration

of hazardous waste has an expected potential to create thousands of unusual byproducts of incomplete combustion (some of these organic compounds are created by

partial thermal decomposition of the waste mixtures and other compounds are created by rapid ‘‘de novo synthesis’’ in the cooling stack gas phase) with many occurring at levels below the frequently used one part per billion detectability limit in

organic analytical equipment. But most of these unusual byproducts of incomplete

combustion are not measured or identified due to their difficult chemical characteristics, which need highly specialized analysis at extremely low concentrations below

most VOC analyzers. Of course, dioxin and dibenzofuran analytical equipment go

well below the 1.0 ppb level down in the low parts per trillion levels and parts per

quadrillion range. It’s not feasible to conclude if the 119 VOCs reviewed represent

50 percent of the total VOC species emitted or 25 percent or 10 percent or less.

Without a more comprehensive VOC analysis of the total low part per trillion range

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VOC species, highly toxic organics like the dioxins are being ignored completely in

the consultation.

Some of these VOCs will be bound to the particulate matter emitted and this represents another fraction of the total VOCs in the ambient air. But VOC sampling

that collects only gaseous phase organics and not the particle phase organics will

miss a fraction of the VOC compounds in the air.

Reviewers need to ask: What is the range of possible types of VOCs produced from large-scale hazardous waste incineration? What is the range of the possible concentrations of the VOCs produced from large-scale hazardous waste incineration?

Are these VOCs being detected? Yes, some VOC byproducts are being detected as

indicated by 119 VOCs, but the concern is that many VOCs (several thousand more

VOCs) are not being detected due to the high detectability limits in the analytical

equipment such as 1.0 ppb and the potential for similar VOC species to overlap.

The same applies to inorganic compounds and metals, and in many monitoring sites, inorganic compounds and metals were not even collected. The TCEQ has no laboratory facilities specifically established for conducting dioxin and dibenzofuran analyses, and due to the costs of such analyses, it’s typically not required by the TCEQ on most environmental samples due to the expense

of such laboratory analysis. The EPA has recognized along with the organic chemistry science that any form of chlorine (organic and inorganic) in combination with carbon in a combustion process will produce the expected dioxins and dibenzofurans by rapid ‘‘de novo synthesis.’’ The large-scale hazardous wastes burned at Midlothian have routinely contained numerous organic chlorinated residues and inorganic chemicals which would

be expected to produce certain stack concentrations of dioxins and dibenzofurans by

rapid ‘‘de novo synthesis.’’ Some dioxins and dibenzofurans may also be present

among the chlorinated hydrocarbons and inorganic chlorine compounds in the largescale hazardous wastes burned and could be emitted as undestroyed chemicals.

A.2. It is also true that ‘‘All the chemicals currently being incinerated and

released have not been tested for carcinogenicity and endocrine disrupting

potential.’’ However, based on historical reviews of cancer incidence and/

or mortality rates in Midlothian and Ellis County, no individual or aggregate cancer rates were significantly elevated with respect to the rest of the

state.

Several problems exist with the Texas Cancer Registry databases and the conclu- sion of ‘‘no individual or aggregate cancer rates were significantly elevated with respect to the rest of the state’’ seems premature and an unscientific statements. The Cancer Registry is significantly flawed itself in its omissions and tracking system. Many people do not show up in this database. The EPA’s recent Endocrine Screening, Testing Advisory Committee (EDSTAC) only recommended testing of potential endocrine disrupting chemicals for interference in three human hormonal pathways of estrogen, thyroid and androgen. All

other hormones were excluded by endocrine testing and screening.

A.4., C.3., & D.3. The community was concerned about the health effects of

dioxins, metals, and mixtures of compounds. Air data for dioxins are not

routinely collected in Texas; therefore it was not possible to evaluate the

potential adverse health effects associated with these compounds. We evaluated available VOCs and metals air contaminant data with respect to its

potential for causing adverse health effects in humans due to acute, intermediate, and/or chronic exposures. Only manganese exceeded its health

based screening value for chronic inhalation exposures. However, based

upon a review of the toxicological data, we would not expect to see adverse

health effects due to either long-term or short-term exposure to manganese. Mixtures of compounds also were evaluated in this consultation.

Long-term aggregate exposures to air contaminants in Midlothian are not

expected to result in adverse non-cancer or cancer health effects.

I find the conclusion on the VOC’s seriously flawed and unsound since too many

organic chemicals are not even monitored for in Midlothian. I don’t think that

TDSHS has any idea or even an intelligent guess as to how many organic chemicals

were not being detected due to their presence below the detectability analytical limits of the lab equipment or were not being analyzed for at all such as all of the

dioxin-related compounds. See more comments under A–1.

This conclusion is not scientific and is based on extremely limited data that cannot logically support or confirm such a broad sweeping conclusion: ‘‘Mixtures of

compounds also were evaluated in this consultation. Long-term aggregate

exposures to air contaminants in Midlothian are not expected to result in

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adverse non-cancer or cancer health effects.’’ One reason is that not all of the

mixtures can possibly be determined without a great deal more ambient air monitoring and far more sophisticated laboratory analyses looking at many more products of incomplete combustion including levels in the parts per trillion where many

toxic dioxin-related compounds occur or even lower levels.

A.5., A.7., & C.1. In this health consultation, DSHS has analyzed each and

every individual air sampling result collected from all TCEQ sampling locations in the Midlothian area and has not relied on any TCEQ-summarized

data. Also, DSHS has not relied on any of the TCEQ’s effects screening levels (ESLs) for determining potential health risks associated with exposures

to airborne contaminants in Midlothian.

Significant limitations exist with the sampling and analysis program in

Midlothian.

A.6. & D.4. The community was concerned that the potential for adverse

health effects may be underestimated due to averaging of contaminant

data over time. The initial screening of the air data involved comparing the

maximum concentration for each contaminant to its most conservative

health-based screening value. Contaminants whose maximum concentrations exceeded the most conservative health-based screening value were

evaluated for acute, intermediate, and long-term exposures. None of the

compounds examined (with the exception of benzene) had a single 24-hour

measurement that exceeded its acute exposure guideline. The acute inhalation MRL for benzene was exceeded three isolated times in 13 years. Consequently, after reviewing all of the available data (which includes 94,932

individual 24-hour measurements), we find no evidence to suggest that adverse health effects would be anticipated as a result of any of the shortterm or peak exposures to VOCs or Metals. The potential for adverse health

effects due to exposure to EPA’s NAAQS compounds will be evaluated in a

future health consultation.

This conclusion is totally inconsistent with the real world experiences of many

Midlothian area residents as well as myself and does not recognize the serious limitations of the available data. Especially in view of the significant limitations exist

with the sampling and analysis program in Midlothian.

A.8., B.4., C.4., & D.1. The community was concerned about asthma, allergies, immune system deficiencies, and other health problems in adults as

well as children. Data for these health problems are not routinely collected

in Texas. Therefore, we were not able to systematically assess whether the

levels of these conditions in Midlothian are different than in other areas

of the state.

A basic concern here is that asthma, allergies, immune system deficiencies, and

other health problems in adults and children are not being evaluated and yet these

kinds of adverse health effects are being reported by Midlothian residents. The

TDSHS should conclude no adverse health effects are expected when so many types

of health outcomes are excluded from the consultation. Hazardous emissions and

toxic contaminants could certainly be contributing or causing adverse health effects

based on the information about many of these pollutants. Did the consultation consider fatalities from asthmatic attacks or allergies?

B.1., B.2., & D.2. Over the years, the Texas Cancer Registry and Texas Birth

Defects Registry have conducted incidence, mortality, and prevalence investigations to determine if cancer and birth defect rates were higher or

lower in the Midlothian area compared to the rest of the state (Appendix

D). No statistically significant elevations of specific or total cancers were

found. The prevalences for a few birth defects were higher than expected

and for a few other birth defects were lower than expected based on State

rates. These higher prevalence rates were not unique to Midlothian/Ellis

County but were also observed throughout Health Service Region 3 (which

includes 18 other counties primarily north and west of Ellis County). Because of the numerous factors involved, it is not possible to determine if

these increases are due to environmental exposures or differences in reporting practices in this region compared with the rest of the state. Furthermore, it should be noted that only three of the 99 compounds with

health based comparison values (i.e., ethylbenzene, 2-butanone, and methyl

isobutyl ketone) listed ‘‘developmental effects’’ as the critical effect (i.e., the

first observable physiological or adverse health effect occurring at the lowVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00106 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
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est exposure dose known to produce any effect at all). Hazard quotients for

those three compounds were 0.000352, 0.0000653, and 0.00000793 respectively, levels that are far below levels that might be expected to result in

an increased risk for birth defects.

This conclusion is somewhat illogical, especially in view of the significant limitations that exist with the monitoring siting, monitor distances, sampling and analysis

program in Midlothian.

General Findings #1, #2, #3, and #4 are conclusions that are highly deficient for

their numerous omissions and flawed considerations of data gaps.

Why am I concerned about industrial air pollution impacting the Midlothian community and rural residents?

In the 1990s I developed a recognition that the industrial air pollution at

Midlothian was clearly causing significant adverse health effects to area residents

and often their animals based on my previous professional experience as a State investigator for twelve years at other types of industrial facilities, based on many visits to Midlothian to investigate the conditions there, based on reviewing emissions

information and permits for the Midlothian plants, based on analysis of monitoring

information, and based on interviews with many citizens. I emphasize this background because during my professional experience with the Texas Air Control Board

from 1980–1992, I investigated about 1,000 citizen complaints of air pollution and

citizens generally complained when the industrial air pollution was so egregious

that people were suffering adverse health effects from something in the air and

therefore they were strongly compelled to file complaints in order to seek action to

abate the problems. Once corrective measures occurred to reasonably abate the alleged air pollution events effecting their health and their residences, citizens typically complained less or no more at all. Nonetheless many residents were trying to

deal with local toxic nightmares of one degree to another. In several cases, abatement of pollution events producing citizen complaints required months and even

several years before the problems were reasonably abated.

In my opinion, the Midlothian toxic nightmare fits into a pattern I have encountered elsewhere in Texas. Since leaving the Texas Air Control Board in 1992 after

inspecting industrial facilities for twelve years in West Texas and which included

a cement manufacturing plant with two cement kilns, I have been regularly interacting with Midlothian residents regarding their health and environmental concerns

with the significant toxic emissions from three local cement kilns and the steel mill.

I am familiar with the locations of each of the four plant sites and have reviewed

emissions associated with the facilities. Although I previously worked for the state

environmental agency known as the Texas Commission on Environmental Quality

(TCEQ), I have developed grave concerns about the bias that routinely creeps into

the Agency’s scientific efforts such as certain aspects of the ambient air monitoring

activities at Midlothian and the Agency’s generally egregious failure to protect public health from impacts due to exposure to a range of toxic contaminants. In addition, I have experienced severe headaches near the TXI facility during brief exposures to industrial emissions next to the TXI facility, which for me raises troubling

questions about the abysmal lack of regulatory oversight by the TCEQ and a lack

of concerns about the health and safety of Midlothian residents.

I have reviewed previous reports of November 2, 1995 report: The Screening Risk

Analysis for the Texas Industries (TXI) Facility in Midlothian, Texas, by the Office

of Air Quality/Toxicology and Risk Assessment Section, Texas Natural Resource

Conservation Commission, and a November, 1995 report: The Critical Evaluation of

the Potential Impact of Emissions From Midlothian Industries by the Texas Natural

Resource Conservation Commission. Even the January 31, 1996 federal report was

severely flawed for similar problems and errors: Midlothian Cumulative Risk Assessment Volume 1, by the Multimedia Planning and Permitting Division, U.S. Environmental Protection Agency, Region 6, Dallas, Texas.

Risk assessments in Texas (the TCEQ’s Screening Risk Analysis and the Summary Report, 1995 for Midlothian, TX) are poor starting points for future studies

and actions aimed at protecting public health and the environment due to the innumerable flaws, omissions, gaps, poor science and errors. However if viewed as ‘‘technical support’’ documents to justify EPA and State declarations of no substantial

risk to public health due to pollution in Midlothian, they must be criticized due to

their many serious omissions, inconsistencies and inadequate or misleading analyses. The federal and State peer review process is an abysmal failure in the

Midlothian case.

Based on de novo analysis at TXI, we conclude that environmental and health impacts have and are likely to occur in the Midlothian area from industrial activity,

including the combustion of hazardous waste at TXI. There is high likelihood that

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the environmental and health impacts are significant, as demonstrated by exposures

and risks that greatly exceed U.S. EPA target exposure levels for a variety of exposure scenarios and source assumptions at a large number of sites. Exceedances of

acceptable risk levels for children at all residential locations is especially noteworthy.

Because predicted health risks exceed target levels, continued waste combustion

at TXI requires more stringent controls, e.g., more effective air pollution control

technology, waste feed limitations, and/or modified operating practices.

The serious deficiencies in the Screening Risk Analysis and Summary Report for

TXI indicate that the ability of EPA Region 6 to conduct an objective assessment

is compromised, and the record demonstrates significant concerns regarding the effectiveness of the EPA Regions and states like Texas in regulating combustion of

hazardous waste at these cement kilns.

The EPA Region with oversight for state like Texas must be strongly criticized

for the tendency to go far beyond what is scientifically supportable by the existing

data in making sweeping generalizations regarding the present and future safety of

waste combustion in communities. Statements with little or a frail scientific basis

show a disregard for the protection of public health, and serve to diminish the EPA’s

and states credibility among the public.

I strongly support concerns of local residents regarding hazardous waste pollution

emitted by cement kilns, which have already impacted communities in the area and

surrounding water and land use. In addition, a potential for more far reaching environmental impacts to air and water quality and ecological systems is a significant

concern of the Sierra Club and we support the obvious need to reduce emissions.

Respectfully yours,

NEIL J. CARMAN, PH.D.

Clean Air Program Director

Lone Star Chapter of Sierra Club

1202 San Antonio Street

Austin, Texas 78701

E-mail: Neil¥Cayman@greenbuilder.com

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Addendum #7

MIDLOTHIAN, TX—COMMENTS ON ATSDR PUBLIC HEALTH CONSULTATION

PREPARED BY: PETER L. DEFUR, PH.D. AND KYLE NEWMAN

ENVIRONMENTAL STEWARDSHIP CONCEPTS, RICHMOND VA 23238

MARCH 11, 2008

Personal information:

We are submitting these comments on the ATSDR Public Health Consultation for Midlothian, TX out of concern for the role of scientific data in public health assessments and how data are used in environmental management. We learned of this

document from colleagues in the area and reporters who asked if we had seen the

report. Environmental Stewardship Concepts (ESC) provides technical consultation

to citizen groups and agencies regarding the cleanup of contaminated sites across

the Nation. At present, our work includes Superfund sites, RCRA sites, State cleanups, contaminated rivers under TMDL cleanup, and operating permits for sites that

handle contaminated materials. We are intimately familiar with CERCLA and the

work the ATSDR has done regarding contaminated site health assessments. Biographical sketches for Dr. deFur and Mr. Newman are appended at the end of the

comments.

Summary

ATSDR’s classification of this site as an ‘‘Indeterminate Public Health Hazard’’ is

in direct contradiction with the data the Agency presents in the report. Throughout

the document, ATSDR attempts to marginalize or disregard data that indicate that

compounds produce human health risks. ATSDR has more than enough data to classify the site as a ‘‘Public Health Hazard.’’

The problems with this assessment are numerous, and the most serious problem

with the interpretation is that ATSDR discounts their own metrics of health effects,

ignoring the data that exceed health levels. For a number of chemicals, the air concentrations are in excess of the health levels, but ATSDR dismisses the excess toxic

chemicals as not a problem because the number or people harmed is small, despite

the fact that the risks exceed the levels used to protect people from environmental

threats (i.e., one in a million).

The most glaringly obvious example of ignoring relevant data is the disregard of

aggregate exposures on cancer health effect where ATSDR claimed that even though

risks exceeded the regulatory threshold, results were inconclusive since the specific

species of chromium measured in the air could not be identified with any certainty.

Since the cement kiln is known to utilize hazardous waste fuel in its operation, it

is hardly an unreasonable assumption to assume that the more toxic forms are

being released. ATSDR also provides no information to support the conclusion that

if risks from chromium were excluded cancer risks would no longer exceed the regulatory threshold. ATSDR’s own data do not support this attempt at marginalizing

the risks.

Non-cancer health effects are dismissed just as easily. For example, when health

risks for manganese were found to be unacceptable, ATSDR concluded that actual

risks were low because health screening values incorporated safety margins based

on uncertainties in the toxicity data. Lowering screening values based on uncertainty is common practice at EPA and other agencies responsible for public health.

Does ATSDR disagree with this approach? The rational for dismissing risks from

manganese certainly implies that ATSDR is prepared to replace EPA’s official determination and EPA’s scientific expertise with their own. What exactly what does

ATSDR believe the purpose of incorporating uncertainty into screening values is?

ATSDR was brought in to evaluate health risks to the community of Midlothian, not

to evaluate how human health screening values are calculated. This dismissal, combined with the approach for evaluating the non-cancer effects of aggregate exposures

that assumed compounds only target a single organ system provides further evidence that ATSDR’s evaluation and conclusions are deeply flawed.

Background levels are inappropriately calculated and do not reflect true background conditions. Urban concentrations are not appropriate for a rural Texas community. ATSDR’s decision to average these background concentrations from highly

industrialized areas no doubt further inflated background concentrations. This error

in methodology in turn led to the dismissal of risks from a number of toxic chemicals since they were ‘‘not significantly above background levels.’’

EPA did NOT conduct a cumulative risk assessment in the document cited by

ATSDR, per EPA official methodology. The EPA conducted an exposure analysis as

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a case study or example for the Cumulative Risk Framework. Dr. deFur chaired the

peer review of the Framework document and has subsequently worked on cumulative risk assessment implementation. The analysis at Midlothian, TX did not follow the Cumulative Risk Framework, nor could it have followed the Framework because the Midlothian assessment was conducted before EPA finalized the Framework.

Cumulative risk assessment (see the May 2007 issue of Environmental Health Perspectives for a mini-monograph on cumulative risk) requires more than an attempt to combine the air emissions from four major sources. A proper cumulative

risk assessment incorporates health status, community infra-structure evaluations,

examination of the history of the sources and much more than was done for the exposure analysis done by EPA at Midlothian, TX more than a decade ago. The report makes no attempt to deal with the chemicals for which there are no

regulatory numbers, i.e., no HAL on which to base a health evaluation. This omission is not even handled in an uncertainty section that could be used to make up

for the data gaps and weaknesses in quantitative evaluation. The report further indicates an ability to conduct an uncertainty analysis by using a Monte Carlo analysis, the software for which would provide a feature for conducting a quantitative

uncertainty analysis. 59 organics and 28 metals or inorganic chemicals had no

health based screen but 16 organics and two inorganics exceed background, per

Table 3a.

The report also fails to grasp the biological basis for the action of multiple chemi- cals acting over many years on the same people and on the same physiological systems. The metals are mostly all neurotoxins and affect the brain, especially the developing brain in fetuses and young children. ATSDR could have sought at least a

qualitative analysis of the combined effects of so many neurotoxins over long periods.

It is unclear why the conventional air pollutants were not included in the anal- ysis. These data should be available now for the area, and for all of Texas. In particular, PM2.5 is most significant because of the toxic chemicals associated with the particles, and because the particles themselves are deadly. Indeed, recent health investigations in the peer-reviewed literature indicate there is no threshold for PM2.5, thus any exposure will cause such problems as increased heart attack, increased

stroke, and increased asthma attacks with possible mortality. The report has no data on dioxins, furans, PCBs, phthalates, pesticides, a number

of other compounds and these are dismissed in the text on page 70, A4, C3 and D3

response. Cement kilns are known sources of dioxins and furans, according toe the

most recent EPA Dioxin Reassessment (see source and exposure section). Even if

ATSDR did not bother to spend the money and take air samples, the EPA database

has sufficient information on sources to make an informed estimate of dioxin and

furan emissions. As for the other chemicals, if ATSDR did not take fresh samples,

then they should have contacted EPA for data that could be used to make an estimate.

The Monte Carlo analysis of data is not valid and is intended to skew the inter- pretation of the data. I doubt that this analysis was done according to EPA guidelines for probabilistic assessments, but there are no methods given, so it is not possible to assess what ATSDR did in the Monte Carlo analysis.

Specific Comments

Fig. 1 and 2: where is the wind rose? Where are the residences? ATSDR should have used wind data from the facilities, the closest weather station or airport.

Enough time has elapsed since the beginning of the investigation that ATSDR could have installed a weather station in an appropriate location in Midlothian.

Page 22: Why is there not a single list of chemicals? Code the measured, above and below diction and which no toxicology data. Present display is too hard to interpret—What are the Region III risk based air levels and the numbers from the IRIS

listing? The report needs to provide these two sets of values that are commonly accepted as applicable around the county. Page 17: There is a big difference between ATSDR MRL values and the IRIS list- ings. ATSDR MRL’s are always higher, less protective, less conservative than the

IRIS values.

Page 19: Averaging the numbers from four collecting locations is NOT conservative Taking the maximum value recorded is conservative. Taking the upper 95 percent C.I. of all values is OK. But the data are so oddly collected in time and space,

and so skewed in distribution that some adjustments should have been made to account for these patterns and attempt to get some sense of representative data.

Tables 1a/1b show a sampling distribution that is skewed as to be bizarre. Of the

13 sites, one has 9,294 samples in 11 years and 22,956 for organics for six of those

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years and another site had five metal samples one year. Organics were sampled and

measured only at four sites and 13 years and not all the sampling was equal. The

analysis must not give all samples equivalency.

The 95 percent UCL of all samples is not useful when the data are so clearly

skewed in sampling distribution among locations and across time (years).

The graphical depiction of actual data in Fig. 3–23 is useful and when merged

with data from Table 4b reveals the following information on detections and levels

that exceed the HAL’s:

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All of the chemicals listed above show maximum values that exceed the HAC and

the HAL. Many of these chemicals had many measurements in excess of the concentration determined to be without effect—in essence the level for protecting public

health. In several cases, all measurements exceeded the regulatory limit.

The interpretation by ATSDR that there is no health problem defies logic and all

sense of public health assessment. Citizens are exposed to 19 chemicals at times in

excess of cancer guidelines or non-cancer. No attempt to put these all together. In

spite of the CDC conclusion that these is no safe lead exposure, ATSDR disagrees

and is not concerned with children developing neurological problems.

The non-cancer aggregate on p. 68 is wholly unsatisfactory in method but even

where found an HI greater than one, discounted because Manganese is the chemical

and the MRL is less than the NOAEL (animals v. humans). So the MRL was ignored because ATSDR did not like the answer or the method, or some other thing.

What about children’s development?

ATSDR did not even report or measure PM2.5 for which there is no threshold for

health effects.

Cancer p. 69: This statement is dismissive at best, callous and wrong at worst.

The 1x10–4 cancer threshold given by ATSDR is for Superfund sites—Does ATSDR

propose the residents of Midlothian live on a Superfund site? I am sure there will

be both dismay and relief that some agency has finally admitted the nature and

magnitude of the problem. Now, clean it up and make the industries and EPA pay.

This Monte Carlo is a joke. Where are the cumulative probability distributions?

Other data need to be displayed compared to ALL regulatory levels. Most such analyses present the probability density functions.

A8—Not measuring does not make the effect go away or diminish.

No soil sample results were presented by ATSDR, only a statement that there was

nothing wrong with the soil.

p. 74 Overall At best, the risks are hard to quantify on the basis of the data presented. Most likely there are clear health effects, both cancer and non-cancer, from

the air emissions. The non-cancer effects are likely neurological.

No where does ATSDR attempt to determine the effects of a lifetime of breathing

contaminated air—and let’s add on PM2.5 to the toxic chemicals measured here.

Biographical Sketch for Peter L. deFur

Dr. Peter L. deFur is President of Environmental Stewardship Concepts, an independent private consulting firm, and is an Affiliate Associate Professor and Graduate Coordinator in the Center for Environmental Studies at Virginia Commonwealth University where he conducts research on environmental health and ecological risk assessment. Dr. deFur has served on numerous State and federal advisory

committees.

Dr. deFur presently serves as technical advisor to citizen organizations concerning

the cleanup of contaminated sites at FUDS, CERCLA and RCRA sites around the

country. His projects include the Housatonic River, MA; the Delaware River; Lower

Duwamish River, WA; Rayonier site in Port Angeles, WA; and the Spring Valley site

in Washington, DC. Many of these sites, and others on which he has worked are

contaminated with PCBs and/or dioxins.

Dr. deFur received B.S. and M.A. degrees in Biology from the College of William

and Mary, in Virginia, and a Ph.D. in Biology (1980) from the University of Calgary,

Alberta. He was a postdoctoral fellow in neurophysiology in the Department of Medicine at the University of Calgary, and an environmental fellow at AAAS in 1989.

Dr. deFur held faculty positions at George Mason University and Southeastern Louisiana University before joining the staff of the Environmental Defense Fund (EDF)

in Washington, DC. In 1996, deFur formed ESC and accepted a part-time position

at VCU.

Dr. deFur has extensive experience in risk assessment and ecological risk assessment regulations, guidance and policy. He served on the NAS/NRC Risk Characterization Committee that prepared Understanding Risk. Dr. deFur served on a number of scientific reviews of EPA ecological and human health risk assessments, including the Framework for Cumulative Risk Assessment, the assessment for the

WTI incinerator in Ohio and EPA’s Ecological Risk Assessment Guidelines. deFur

served on three federal advisory committees for EPA’s Endocrine Disruptor Screening and Testing Program.

Kyle Newman has worked at Environmental Stewardship Concepts since 2004,

where he has held the position of Environmental Scientist since 2006. He has

worked in the environmental field since 1999 when he first worked for the consulting company Advent Inc., and has developed expertise in risk assessment, freshwater ecology, toxicology, soil contamination, and conservation biology.

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Kyle graduated from Virginia Commonwealth University in 2003 with a B.S. in

Biology. He is currently finishing his Masters of Science at VCU’s Center for Environmental Studies and performing research on the relationship between ecological

vulnerability and stream macro-invertebrate community structure. In addition to his

work at ESC, Kyle is also the senior Recitation Leader for VCU’s groundbreaking

Life Science 101 course on systems biology.

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Addendum #8

STATEMENT OF NEIL J. CARMAN, PH.D.

Former State of Texas Air Pollution Control Agency Regional Field Investigator of Industrial Plants Including Portland Cement Kilns and Waste Incinerators in

1980s–90s

The EPA’s Sham (Bifurcated) Hazardous Waste Combustor MACT Rule and

Enforcement Failures by EPA and State of Texas are Related to

Health Hazards from Toxic Waste Incineration in Cement Kilns at

Midlothian, Texas

The sham EPA MACT rule for toxic waste incineration has created a tragic mess for communities like Midlothian, TX. In addition, State and EPA enforcement failures have led to over a decade of unsafe air pollution and plant upsets impacting

citizens close to Midlothian cement kilns that are allowed to incinerate up to 200

million pounds a year of hazardous waste. Known kiln stack air pollutants include

carcinogenic metals. Result is Midlothian residents have been living a fifteen-year

toxic nightmare created by broken regulatory systems at EPA and State of Texas

both failing to fix dirty air problems. As a former State of Texas air pollution investigator, the Midlothian situation is as appalling as I have encountered in thirty

years of environmental work in Texas and other states. Egregious toxic air pollution is due to a bad MACT rule and laxness in fixing the upsets (24-hour baghouse failures) at Texas Industries, Inc’s (TXI) four cement kilns

burning hazardous waste as fuels. In 1996, EPA made a regretful decision to allow

cement kilns to serve as commercial hazardous waste incinerators and, in hindsight, EPA’s decision was exceptionally poor public health policy for communities like

Midlothian’s. It led to a serious failure under the Clean Air Act and RCRA to protect

public health. Adding to bad MACT rule-making is EPA and Texas officials turned

a blind eye to years of repeated citizen complaints of health problems, alleging

something was rotten at TXI’s plant because residents and their animals suffered

serious illnesses and their animals often died prematurely. Unsafe levels of air pollution such as toxic metals and other substances from TXI’s poorly regulated toxic

waste incineration are the primary suspect in my opinion.

Incineration of wastes is a dangerous activity, but even more dangerous is cement

kilns incinerating hazardous waste under sham MACT rules. Hazardous waste incineration is inherently dangerous, because combustion of such waste produces

thousands of toxic byproducts spewed into the air. Cement kilns were not designed,

built or intended for use as commercial toxic waste incinerators since EPA has a

RCRA program for permitting of toxic waste incinerators. Cement kilns are designed

to make cement and possess different designs and operations from dedicated hazardous waste incinerators. The EPA needs new MACT standards and strict enforcement to fix its egregious 1996 MACT mistake.

Why are Cement Kilns unsafe to communities as quasi-hazardous waste incinerators?

Cement kilns were authorized by EPA in a 1996 MACT rule to run under weaker,

less protective MACT standards for Hazardous Waste Combustors (HWC) compared

to hazardous waste incinerators. By bifurcating the MACT rule and adopting weaker incineration rules for cement kilns, EPA turned a small group of Cement plants

(less than 20 percent in the U.S.) into dangerous toxic waste incinerators with higher mass emissions of toxic substances than more stringently regulated hazardous

waste incinerators. The MACT HWC rule set standards for Hazardous Air Pollutants such as mercury, arsenic, cadmium, chromium VI, lead, dioxins, chlorine, total

hydrocarbons (CO), particulate matter, DRE of 99.99 percent, opacity, etc. Cement

kilns raced to get RCRA permits to burn toxic waste.

Cement kilns burn up to 1,000 degrees hotter than incinerators and a concern is

they may burn too hot for metals causing higher mass emissions due to greater

metal volatility at higher temperatures. Adding to this concern is TXI had several

baghouse failures lasting for hours, and in my view higher toxic metal emissions

would have likely occurred. Exposure to toxic metals is consistent with some health

problems reported at Midlothian.

March 2009 Status of EPA’s Hazardous Waste Combustor MACT rule:

(1) EPA’s HWC rule is currently under review after Federal Court litigation resulted in a remand back to EPA for agency action to fix the sham HWC

MACT rule;

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(2) EPA having admitted that more than half the MACT emission standards

that the HWC rule contains are unlawful, the Agency is now deciding

whether to defend the rest or take the whole HWC rule back to fix it;

(3) One of the issues raised in the HWC MACT rule-making is whether EPA

should keep the specially lenient standards that allow cement kilns to burn

hazardous waste; and

(4) EPA deliberately set MACT standards at a level that would ensure new

hazardous waste burning kilns would be built to keep burning hazardous

waste.

In my thirty years professional experience investigating industrial plants and

community health complaints from neighborhoods and downwind residents, I

interacted with many communities in Texas seeing first hand how air pollution

harms communities. I observed that toxic waste burning cement kilns like

Midlothian’s are especially dirty facilities spewing out a dangerous soup of toxins,

known carcinogens, and harmful chemical mixtures that are poorly known for

human health effects. Arsenic, aluminum, cadmium, chromium, lead, mercury, nickel and selenium are among toxic heavy metals emitted by TXI due to receipt of bulk

hazardous waste and its incineration.

Conclusion:

As a former Texas investigator with 12 years inspecting over 200 industrial plants

a year including waste incinerators and cement kilns, I regard incineration as a

dangerous activity based on investigations of incinerators with problems while

working for the State of Texas air pollution control agency. Even more dangerous

is cement kilns incinerating toxic wastes classified as ‘‘hazardous waste’’ by EPA.

EPA needs to set more stringent MACT rules for all Hazardous Waste Combustors,

and notably cement kilns and protect public health in these badly impacted communities. Note attached list of toxic substances associated with hazardous waste incineration.

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Addendum #9

Midlothian Area Air Quality Part I:

Volatile Organ Compounds & Metals

December 11, 2007

Response: Sal and Grace Mier, Midlothian, Texas: February 03, 2008

Preface:

We recognize that a great deal of valuable time, energy and resources were ex- pended in the development of this report. However, we are generally very disappointed that an effort to make such critical judgments regarding the public health

of our community was based on such poor and weak air monitoring data—and even

more disappointing was the fact that the primary author(s) of this Report do not

appear to have made any serious effort to validate and challenge the quality of this

data but nevertheless were comfortable in making sweeping generalizations as if the

data were sound.

Any product, whether it be a building, a document, or a report such as this is

only as good as the foundation upon which it is constructed. Step one of this assessment should have been to assure the base (the air monitoring data) upon which

all analyses for this report would evolve was solid and contained data that accurately reflected a complete picture of emissions. Thus, it is perplexing and deeply

disappointing to discover that the Texas Department of State Health Services

(TDSHS) and the Agency for Toxic Substances and Disease Registry (ATSDR) have

produced a Public Health document which was based on deficient air monitoring

data, the collection of which was not designed to analyze community impact and not

designed to adequately capture complete emissions.

It is not our intent to imply that it is ATSDR’s or TDSHS’ fault that the proper

air monitoring data upon which to base a sound public health assessment does not

exist. We assume that it was the best you had available to you. However, we would

like to believe that at step one TDSHS would have attempted to verify the methodology incorporated to position air monitors to optimally capture emissions (i.e., populace, wind rose patterns, etc.) and the impact on the community before they proceeded. When you review selection of monitoring sites, history, wind rose patterns,

location of major emission sources, etc., it is obvious scientific methodology to capture community exposure and impact was not a prerequisite to the placement of the

Midlothian air monitors. Consequently, TDSHS’ attempt (with the enabling of

ATSDR) to retrofit a methodology and create the illusion of adequacy is extremely

disappointing and makes a statement that the true assessment of public health in

Midlothian many not have been the major priority.

We realize it is not within TDSHS’ purview to dictate to TCEQ a methodology

for establishing an air monitoring system. However it is TDSHS’ responsibility to

properly critique its adequacy for assessing public health. If we cannot rely

on our public health agencies to do the right thing, rather than becoming a solution

to the problem, they become part of the problem.

We want to emphasize, we do not want you to find a problem if one does

not exist. However, it was our hope that we would get a solid, sound, unbiased decision based on solid sound data. The foundation upon which the

findings of this report are based is seriously wanting and flawed.

You have already pointed out many of the inadequacies of the monitoring sites

in this report.

(1) Tayman Drive: No metals and inorganic compounds were collected at

this site. (This is the one site that was best positioned to capture emissions

from all major industries, but its data was limited.)

(2) CAMS–52: No metals and inorganic compounds were collected. (This

site is capable of capturing some emissions from TXI and Chaparral Steel,

but inadequately placed for capturing the majority of emissions from the

other industries.)

(3) CAMS–302: Metals and inorganic parameters were analyzed from

*PM10. (This site is not in a prevailing wind pattern for any of the emission

sources. No indication that TSP was sampled for metal speciation.)

(4) CAMS–94: Not in a prevailing wind pattern for any of the emission sources.

This site was selected as a background monitor for the DFW metroplex because it’s south of and upwind from all industries. *No speciation of metVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00128 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
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als from particulate matter greater than PM2.5. (This may be adequate for regulatory purpose; however, this data does not present an adequate picture of local exposure.) Monitors smaller than TSP monitors are not adequate for determining level of heavy metals in ambient air.

TSP monitors were last used in 1998.

Insufficient data available to evaluate metals—Mercury as an example: Reliable data to determine the amount of mercury in the ambient air does not exist.

Note the only readings reflected in the air monitoring data for mercury were based

on PM2.5 speciation for metals. These readings are for the most part ‘‘non-detect.’’ Given the amount of mercury that is self-reported by the industries these ‘non-detect’ readings are questionable. In 2004 the industries ‘‘self-reported’’ air release of

mercury compounds per pounds as follows: Chaparral Steel—709, Ashgrove—150,

Holcim—59, TXI—10. This demonstrates: 1) the inadequacy of the monitoring loca- tion to capture complete emissions, and 2) the inadequacy of relying on PM2.5 for

speciation of metals.

*According to the Office of Air Quality Planning and Standards (OAQPS) final staff paper released in December, there is a distinction in TSP, PM2.5 and PM10 and

the adequacy of anything less than TSP to evaluate total lead in ambient air. Refer

to http://www.epa.gov/ttn/naaqs/standards/pb/data/20071101¥pb¥staff.pdf on page 17 (2.3) Air Monitoring. 2.3.1.1 Inlet Design (last paragraph) reads:

‘‘Sampling systems employing inlets other than the TSP inlet will not collect Pb

contained in the PM larger than the size cutpoint. Therefore, they do not provide

an estimate of the total Pb in the ambient air. This is particularly important

near sources which may emit Pb in the larger PM size fractions (e.g., fugitive

dust from materials handling and storage).’’

With our petition, we submitted a document: Evaluation of The Screening Risk Analysis for the Texas Industries Facility in Midlothian by Dr. Stuart Batterman, et al. This document evaluates risk assessments, monitoring, soil sampling, etc.,

done in Midlothian and presented in this consultation as activities engaged in the

assessment of the community’s public health. Dr. Batterman’s evaluation reflects

many of our concerns regarding the quality of these activities. Therefore, we are requesting that the entire document be considered as part of our comments. Inhalation is not the only exposure route for toxins in the air. There is no indica- tion in the analyses that skin absorption and ingestion was factored in when evaluating impact. Because of the critical deficiencies in the air monitoring data, to comment any fur- ther on the analyses of public health impact of the toxins would be an exercise in

futility as we believe it to be a moot issue. Therefore, we will make comments on

general issues.

Response to Petitioner and Community Health Concerns

A.1. While it is true that ‘‘all the chemicals being released from cement kilns and

steel mills have not been fully identified,’’ this health consultation has evaluated

237 individual contaminants including 119 VOCs and 108 metals and other inorganic substances.

Response: There are over 1,000 regulated chemicals; reviewing 237 is a start. We

appreciate the fact that this report has concluded that we cannot disregard the potential impact of the unknown regarding the remainder of the chemicals. However,

should this statement simply read, ‘‘Of the over 1,000 regulated chemicals, we are

proud to state we have evaluated 237’’?

A.2. (1) It is also true that, ‘‘All the chemicals currently being incinerated and released have not been tested for carcinogenicity and endocrine disrupting potential.’’

(2) However, based on historical reviews of cancer incidence and/or mortality rates

in Midlothian and Ellis County, no individual or aggregate cancer rates were significantly elevated with respect to the rest of the state.

Response:

(1) We appreciate your acknowledgement of the deficiency in the extent of

chemical testing. We agree with you that many chemicals (as well as heavy

metals) being incinerated have not been tested for endocrine disrupting potential; however, many have been tested or are in the process of being tested. Recent scientific studies have raised red flags regarding endocrine disruption potential for many of the toxins already identified and at levels significantly lower than the current ‘‘No Observed Adverse Effect Levels’’ used

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in health risk assessments. Recent science has cast doubt on the current

regulatory standards.

(2) How does the testing of chemicals for carcinogenicity and endocrine dis- rupting potential correlate solely to cancer incidence in Midlothian? There

are illnesses other than cancer that are of concern. (a) Birth defects (BDs)

have consistently been significantly higher in Ellis County than the State

of Texas for the five years (1999 through 2004). Health Region 3 has the

highest overall BD rate of all the eleven health regions in Texas—there appears to be a common denominator here—and that is air pollution. Although we cannot say that this higher rate of BDs is definitely attributed

to air pollution—we cannot definitely say that it is not. (b) Collection

of quality cancer data in the State of Texas is still in its developing stages

of surveillance. Unlike the BD data collection system, Texas collection of

cancer data is passive. In other words the cancer surveillance system has

to depend on the good will of physicians, hospitals and treatment facilities

to report and many of these providers do not yet have electronic databases

to facilitate this reporting. (c) Major complaints involve asthmas and other respiratory problems as well as immune system deficiencies. A peer-reviewed study regarding respiratory illnesses in Midlothian, ‘‘The Health Effects of Living Near Cement Kilns; A Symptom Survey in Midlothian’’ performed by UTMB and authored by Dr. Marvin Legator, et al., was submitted as part of this petition. This study reflected a higher incidence of respiratory problems in Midlothian than the control group.

A.4., C.3., & D.3. The community was concerned about the health effects of dioxins,

metals, and mixtures of compounds. (1) Air data for dioxins are not routinely collected in Texas; therefore it was not possible to evaluate the potential adverse

health effects associated with these compounds. (2) We evaluated available VOCs

and metals air contaminant data with respect to its potential for causing adverse

health effects in humans due to acute, intermediate, and/or chronic exposures. Only

manganese exceeded its health based screening value for chronic inhalation exposures. (3) However, based upon a review of the toxicological data, we would not expect to see adverse health effects due to either long-term or short-term exposure to

manganese. (4) Mixtures of compounds also were evaluated in this consultation. (5)

Long-term aggregate exposures to air contaminants in Midlothian are not expected

to result in adverse non-cancer or cancer health effects.

(1) TCDD is considered by science to be one of the most, if not the most, toxic man-made substances. No safe level has been identified. It has been

shown to disrupt multiple endocrine functions and has negative outcomes

for the fetus. Although you cannot evaluate it, you cannot disregard it.

(2) Based on the placement of the air monitors, it does not appear assessing true community exposure was a factor in the collection of the data analyzed.

There are too many deficiencies and weaknesses in the air monitoring data

to make an informed evaluation.

(3) Health issues are surfacing, whether you expect them or not. Some such

as respiratory problems, immune system deficiencies, reproductive and birth

defect issues in animals, etc., remain ‘‘anecdotal’’ because our guardian

agencies refuse to acknowledge them. Others are well documented—for example, the continually significantly higher incidence of birth defect rates; increased respiratory symptoms in Midlothian documented by Dr. Legator, et

al.

(4) Did you mean to say, ‘‘Additive effect of some mixtures of compounds also

were evaluated in this consultation’’? As you acknowledge only mixtures with available HAC values were evaluated—and as if only an additive ef- fect were possible. There appears to be an apparent false presumption

that synergistic effects are not an issue. Synergistic effects were not evaluated here. Can we assume dioxin (in addition to many other chemicals)

was not considered in the mix? When so many factors are missing from the equation, how can you logically compute data to make such a

strong declaration, ‘‘Long-term aggregate exposures to air contaminants in Midlothian are not expected to result in adverse non-cancer or cancer

health effects’’? Perhaps this statement should read: If we knew monitoring

data accurately reflects industrial emissions and community exposure, and

if we assume there are no synergistic effects of aggregate exposure, and if

we can say no empirical data exists that may indicate otherwise, we could

assume long-term aggregate exposures to air contaminants in Midlothian

are not expected to result in adverse non-cancer or cancer health effects.

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A.5., A.7., & C.1. In this health consultation, DSHS has analyzed each and every

individual air sampling result collected from all TCEQ sampling locations in the

Midlothian area and has not relied on any TCEQ-summarized data. Also, DSHS has

not relied on any of the TCEQ’s effects screening levels (ESLs) for determining potential health risks associated with exposures to airborne contaminants in

Midlothian.

Response: Thank you for not using the ESLs. It is obvious that you reviewed a large amount of data. However, it is the adequacy of the data that is of issue—not the

quantity.

A.6. & D.4. (1) (2) The community was concerned that the potential for adverse

health effects may be underestimated due to averaging of contaminant data over

time. The initial screening of the air data involved comparing the maximum concentration for each contaminant to its most conservative health-based screening

value. Contaminants whose maximum concentrations exceeded the most conservative health-based screening value were evaluated for acute, intermediate, and longterm exposures. None of the compounds examined (with the exception of benzene)

had a single 24-hour measurement that exceeded its acute exposure guideline. (3)

The acute inhalation MRL for benzene was exceeded three isolated times in 13

years. Consequently, after reviewing all of the available data (which includes 94,932

individual 24-hour measurements), we find no evidence to suggest that adverse

health effects would be anticipated as a result of any of the short-term or peak exposures to VOCs or Metals. (4) The potential for adverse health effects due to exposure

to EPA’s NAAQS compounds will be evaluated in a future health consultation.

Response:

(1) Although not listed here, A.6 Reflects our concern that TCEQ monitors may

not be representative of actual exposures because collection sites may not

be optimally positioned to accurately characterize air emissions in

Midlothian. This remains our major concern and the Achilles hill of

this report. See our prior discussion regarding placement of air monitors.

(2) Averaging still remains a concern because in your analyses this is

actually what was done—except for even longer periods of time—

years. The toxicity of a given element depends upon when and to whom it

is delivered. A minute dose delivered at a specific time in development (for

example to the fetus) can yield physical and mental abnormalities quite evident at birth, or may not be detected until later in life. Exposure during

fixed time frames when programming of the endocrine system is occurring

may result in deleterious life altering effects. There are too many questions

and red flags raised by scientific research related to the short ‘‘windows of

vulnerability’’ when chemical exposure can have a negative impact on the

developing fetus, a pregnant mother or the immune suppressed. Time

frames for these ‘‘windows of vulnerability’’ are generally measured in days

and weeks—not years. This extended averaging concept removes life’s

reality from the formula.

(3) ‘‘The acute inhalation MRL for benzene was exceeded three isolated times

in 13 years . . .’’—that you know of! This is a misstatement. It should

read, ‘‘Based on the limited available data, the acute inhalation MRL for

benzene was exceeded at least three times in a 13-year period . . .’’ The

data that you have represents snapshots by the monitors of selected short

periods in time and in ‘‘select’’ locations. There is a high probability benzene

exceeded the acute inhalation MRL also when the monitors were not running. There is a higher probability that if air monitors were methodically

situated to gather data based on prevailing winds, fallout patterns and community exposure, results would be very different. At all three sites (0007,

0015, 0016) the CREG was exceeded 94 percent, 98 percent, 99 percent (respectively) of the time with spikes up to 118, 512, 319 (respectively) times

higher than the CREG. Exposure to benzene is Midlothian is consistent 24

hours per day and long-term. Low-level long-term exposure (over two years)

has been shown to lead to anemia and affect the immune system. A safe

level for the fetus has not been established. Benzene passes the placental

barrier and cause breaks in chromosomes and change in chromosome number. Animal studies suggest benzene can cause low-birth weight, bone marrow damage, and delayed bone formation in the fetus.

(4) Whether the analyses of the NAAQS data is an exercise in futility or whether it produces a reliable indicator of the impact on public health depends

on several factors: (a) direction and speed of prevailing wind for each samVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00131 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
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ple; (b) whether current science—not regulatory levels—are used to determine impact on public health (c) whether readings of upwind samples are

averaged with readings from downwind samples to dilute the impact (d)

whether air monitors collecting NAAQS data are capable of completely capturing total lead emissions.

A.8., B.4., C.4., & D.1. The community was concerned about asthma, allergies, immune system deficiencies, and other health problems in adults as well as children.

Data for these health problems are not routinely collected in Texas. Therefore, we

were not able to systematically assess whether the levels of these conditions in

Midlothian are different than in other areas of the state.

Response: Would it make any difference (other than to disregard it) if you did have

an assessment of this condition? There appears to be a propensity in this report towards trivializing empirical data. There is no indication that anyone is asking, ‘‘Is

there something we are missing?’’ Note the wording below.

B.1., B.2., & D.2. Over the years, the Texas Cancer Registry and Texas Birth Defects Registry have conducted incidence, mortality, and prevalence investigations to

determine if cancer and birth defect rates were higher or lower in the Midlothian

area compared to the rest of the state (Appendix D). No statistically significant elevations of specific or total cancers were found. (1) The prevalence for a few birth

defects were higher than expected and for a few other birth defects were lower than

expected based on state rates. These higher prevalence rates were not unique to

Midlothian/Ellis County but were also observed throughout Health Service Region

3 (which includes 18 other counties primarily north and west of Ellis County). (2)

Because of the numerous factors involved, it is not possible to determine if these

increases are due to environmental exposures or differences in reporting practices

in this region compared with the rest of the state. (3) Furthermore, it should be

noted that only three of the 99 compounds with health based comparison values

(i.e., ethylbenzene, 2-butanone, and methyl isobutyl ketone) listed ‘‘developmental

effects’’ as the critical effect (i.e., the first observable physiological or adverse health

effect occurring at the lowest exposure dose known to produce any effect at all).

Hazard quotients for those three compounds were 0.000352, 0.0000653, and

0.00000793 respectively, levels that are far below levels that might be expected to

result in an increased risk for birth defects.

Response:

(1) Prevalences for only a ‘‘few’’ birth defects were higher? How ‘‘few’’ is few enough?

The attempted play on words here is insulting and appears to be an intent to downplay and obscure the significantly higher impact of birth defects in the community

and downwind neighbors. This wording is reminiscent of the wording in the infamous ‘‘Cafeteria Talk’’ (see discussion below under section Past DSHS & ATSDR Involvement and Data Review). The fact is that the prevalence of total birth defects

for our entire region is significantly higher than the State—that is the point

we have been making. Ellis County’s total birth defect rate is higher than the region

and has been significantly higher than the State for all years 1999–2003. And

there were no ‘‘few’’ significantly lower—there was only one in Public Health Region 3. In 2002 the unadjusted prevalence for birth defect rates in Ellis County

(689.1) was 186 percent that of Texas (370). In 2002 Ellis County had the highest birth defect rate in Public Health Region 3.

(2) It is understandable if you contend that because of the numerous factors involved you cannot say environmental exposure is (as well as you cannot say it

is not) involved—but the most perplexing excuse of all is ‘‘because it is not possible

to determine if these increases are due to environmental exposures or differences

in reporting practices in this region compared with the rest of the state.’’

According to Texas DSHS own website: http://www.dshs.state.tx.us/birthdefects/

BD¥—data.shtm

‘‘The Birth Defects Epidemiology and Surveillance Branch (BDES) uses active

surveillance. This means it does not require reporting by hospitals or medical

professionals. Instead, trained program staff members regularly visit medical

facilities where they have the authority to review log books, hospital discharge

lists, and other records. From this review, a list of potential cases is created.

Program staff then review medical charts for each potential case identified. If

the infant or fetus has a birth defect covered by the registry, detailed demographic and diagnostic information is abstracted. That information is entered

into the computer and submitted for processing into the registry. Quality conVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00132 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
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trol procedures for finding cases, abstracting information, and coding

defects help ensure completeness and accuracy.’’

Unlike the Cancer Registry, Texas BDES Registry does not depend on the good

will of medical facilities nor their ‘‘better reporting practices.’’ Their data collection efforts and active surveillance have been statewide since 1999. Because of

the method of collection, this database presents the best empirical evidence

available to TDSHS to determine whether and where health issues are surfacing.

(3) Furthermore, a multitude of teratogenic and mutagenic toxins being emitted into

the local air are known to cause birth defects and are known endocrine disruptors.

Current science continues to produce evidence that raises questions regarding the

adequacy of current levels that are deemed safe. There are many unanswered questions regarding the synergy of these toxins and their impact on the fetus during certain stages of development. There is significant scientific evidence surfacing that

makes it impossible to state with the slightest degree of certainty that these toxins

that are known to be endocrine disruptors and known to cause birth defects do not

contribute to the significantly higher birth defects in Ellis and the surrounding

downwind counties in Region 3. This statement is especially true when you

factor in the fact that you do not have a complete picture of the emissions.

B.3. It has been suggested that the Down syndrome cluster reported in Ellis, Hood,

and Somervell Counties in 1991–1994 may have been related to a cesium-137 source

melt that occurred at Chaparral Steel on September 16, 1993. This might seem

plausible in that one of the risk factors for Down syndrome is exposure of the mother or the father to excessive radiation prior to conception of the child. However, the

time line is not right for this to have been a possibility, because the non-disjunction

of chromosome 21 that results in the manifestations of Down syndrome would have

had to have occurred prior to the date of the cesium-137 source melt for 15 out of

18 of the reported Down syndrome cases (based on the estimated date of conception

for each of the children with Down syndrome). Also, analysis of the wind rose patterns for Midlothian during a similar time period to the cluster (i.e., 1992–94), revealed that the wind would have been blowing in the direction of one of the Down

syndrome cases for less than two percent of the time during the three-year period.

Although the precise wind direction on the exact day of the source melt in not

known, the prevailing winds are out of the SSE during September, which would

have been blowing toward none of the three Down syndrome cases whose estimated

date of conception was after the cesium-137 source melt (two of these cases were

from Granbury, which is approximately 44 miles west of Midlothian, and the other

was from Palmer which is 21 miles ESE of Midlothian). And finally, although the

exact quantity of radiation released is unknown, modeling of this release as though

the entire source (approximately 89 millicuries of cesium-137) was vaporized and released into the air (and not caught in baghouse dust as most of it was), indicates

that the additional radiation would not have been detectable above background radiation levels.

1. No one in this community raised the issue regarding the two other Down Syndrome clusters in Somervell or Hood County. The only issue raised was the cluster along FM 664 in northern Ellis County. Furthermore, the lone ‘‘September

1993’’ incineration of cesium-137 correlation to this cluster surfaced solely in-house

at TDSHS.

2. According to the study, the conception dates for the mothers in Ellis County occurred in March 1991, February and March 1992, February and March 1993 and

February 1994. Ten of the 12 dates of delivery occurred in 1993 and the first half

of 1994. Documented in the study, cesium-137 was reported to have been in scrap

material that went into the steel mill at Chaparral Steel in Midlothian on at least

two known occasions in 1991–1994. (Note reference above to timeline of exposure.)

The cluster along the Ovilla Road corridor is east and north of Chaparral Steel. It

is accurate that this area is not in a prevailing wind pattern; however, what percentage of the time must the wind blow in this direction for there to be a potential

problem? [Incidentally, the same concept regarding probabilities and wind patterns

should be applied when evaluating the adequacy of the air monitoring data.]

3. The study concluded that the median distance (12 miles) between Chaparral Steel

and the cluster was too far to be impacted by the cesium-137 release—and this is

also implied in your analyses above regarding cases in Palmer and Granbury. It appears that cesium-137’s ability to stay aloft and travel long distances was disregarded.

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4. The point to this issue has been missed. This issue was raised to point out the

gaps in our public health efforts, the inability or reluctance to associate health

issues with the environment and the too often inaccurate characterizations related

to the transport of constituents via air. In this Down Syndrome study, traditional

factors were ruled out—the only factor that was not ruled out was the environment.

In this study, cesium-137 was disregarded because of the distance between the Ellis

County cases and the source. Cesium-137 was raised as an example of a constituent

associated with aneuploidy that stays aloft and travels a long distance before it

reaches the ground. Below is an excerpt from our petition letter to Dr. Sanchez

dated July 11, 2005.

The TDSHS also conducted one Down Syndrome study in Ellis County. A concerned parent living in northern Ellis county reported that he was aware of eight

children with Down Syndrome that had been born in the immediate area during

1992 to 1994; an additional four cases were identified via the Texas Department

of Health Bureau of Vital Statistics. Eleven were live births and one was a fetal

death. The observed 12 cases were 2.78 times the expected number of 4.32 cases.

This finding was considered ‘‘statistically significant.’’ Unlike the cancer clusters

identified in Ellis County, this cluster was deemed to be ‘‘statistically significant’’

and thus progressed to a higher level of epidemiological investigation. Other traditional factors that have been known to be linked to Down syndrome were reviewed but ruled out. Unfortunately the study was not designed to review the potential association of environmental factors to Down Syndrome; even though

these are probably the only major variables left to consider. The primary investigator made the point that this cluster occurred several miles away from the

Midlothian industries and thus it was not likely that there would have been an

association. This assertion could be correct but again, keep in mind that the

study was not designed to review the impact of environmental factors. There

could also have been some unlikely occurrences related to wind direction and velocity that could have occurred during the Spring of 1993 when most of the children were conceived. Just because the ‘‘prevailing’’ winds are from south to north

doesn’t mean that the winds blow in this direction 100 percent of the time. Also,

some constituents are more ‘‘persistent’’ than others. For example, cesium-137

was known to have been incinerated by Chaparral Steel during this time period

and this element has a known association to Down Syndrome and leukemia. The

ATSDR Public Health Statement on cesium-137 also states that this element has

the ability to travel a long distance in the air before being brought back to the

Earth by rainfall and gravitational settlings. Cesium has a half-life of 30 years.

I am not saying that cesium-137 caused the cluster of Down Syndrome,

but this, again, emphasizes not only the gaps in our air monitoring but

the inaccurate perceptions related to the transport of constituents via

air. We do not monitor for all elements and we do not take into account

the ability of certain elements to travel at time, rate and speed beyond

the ability of the monitors to capture their full impact.

Also note: Author of this section (B.3) still seems to have an inaccurate understanding of cesium-137’s persistency to stay aloft for long periods of time and to

travel a considerable distance before being brought back to earth. It is also known

that shielded cesium-137 (example a gauge encased in lead) was difficult to detect

prior to incineration. Since a certain percentage of cesium-137 continued to show up

in the EAF dust one would question whether encased cecium-137 continued to be

incinerated. Again, this is not to say that cesium-137 is the cause of these Down

Syndrome babies—but to stress the gaps in the system. [Again, the concern

about wind rose patterns expressed here is to be complimented. The same attitude

should prevail when assessing the adequacy of the monitoring data.]

C.2. This concern turned out to be unfounded, in that all three CAMS monitoring

locations have collected air sampling data on 97–99 of the 119 different VOCs,

amounting to 60,396 individual contaminant measurements. The CAMS–94 location

collected air sampling data on 52 metals or other inorganics present in PM2.5 particulate matter amounting to 8,164 individual contaminant measurements, and the

CAMS–302 location collected air sampling data on 24 metals or other inorganics

present in PM10 particulate matter, amounting to 4,344 individual contaminant

measurements. Only the CAMS–52 location collected no air samples for metals or

other inorganics present in particulate matter. The confusion may have arisen because the CAM sites only collect data for the NAAQS compounds on a continuous

basis (i.e., 24 one-hour-average levels per day). The other contaminants (VOCs and

metals) are collected noncontinuously as one 24-hour-average level collected once

every six days.

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The concern that we were given conflicting data by TCEQ was not un- founded. Refer to documentation (e-mails from TCEQ) in the petition file. The source of confusion was not the petitioner but TCEQ. However, you have pointed out one of the inadequacies of the data for 8,164 contaminant measurements for 52

metals and other inorganics collected at CAMS–94 and 4,344 individual measurements for metals or other inorganics collected at CAMS–302. PM2.5 and PM10 are not adequate for determining the amount of metals released into the ambient air

because the larger particulate matter to which these metals bind are screened out.

This is particularly true in assessing local impact since these larger particles have

a tendency to settle closer to the source. This data may satisfy regulatory obligations, but is not reflective of true public exposure. Again, it is quality not quantity

that should be of essence here.

C.4. & D.5. (1) Health problems reported in domesticated animals and livestock

were shared with veterinarians at Texas A&M University. (2) While DSHS does not

have animal-species-specific health-based comparison values to evaluate the risks

for health effects in animals, many of the health-based comparison values used in

our evaluation of human exposures are derived from animal studies and consequently, we would expect these human HAC values to be equally conservative in

protecting animal health for most common domestic and farm animals.

(1) So you talked to veterinarians at Texas A&M . . . and? You were presented with strong empirical evidence that should prompt the following questions.

‘‘Are these animals sentinels to what may be happening to people?

Are there deficiencies in the data we are reviewing? Are we missing

something?’’ The casual dismissal of this issue is extremely disconcerting

especially when some local veterinarians are pointing to the environment as

the potential source of the problems. We would have expected that the inherent scientific curiosity (and ethical obligation) of the author (s) of this report would have automatically ‘‘kicked in’’ and that this issue would have

been aggressively pursued.

(2) This response avoids the issue as to why concerns of health effects in animals have been surfacing throughout the years. The community was concerned that the effects they were seeing in the animals paralleled health

problems in the community. The question was, ‘‘Are these animals canaries in the coal mine?’’ Animals are exhibiting immune symptoms, reproduction problems, inability to carry offspring to term, low birth weights,

birth defects, etc. An example http://midlothiannow.com/

MY¥DOGS¥¥¥MYSELF.html. This was some of the documentation provided with the petition. Levels of toxins in the blood samples and hair analysis from these animals and manifestation of disease do not match the findings and ‘‘assumptions’’ of this report. Again, ‘‘Are we missing something?’’

Past DSHS Health Data Reviews

(1) Maternal age- and race/ethnicity-adjusted prevalence rates for total birth defects

and for hypospadias/epispadias in Midlothian were significantly elevated with respect to Texas. Similarly adjusted prevalence rates for total birth defects and for

craniosynostosis were significantly elevated in Ellis County with respect to Texas.

Similarly adjusted prevalence rates for total birth defects, craniosynostosis,

microcephaly, hypospadias/epispadias, and obstructive genitourinary defects were

significantly elevated in Health Service Region 3 with respect to Texas. (2) Similarly

adjusted prevalence rates for pyloric stenosis were significantly lower in Health

Service Region 3 than in Texas as a whole.

(1) We appreciate the fact that you acknowledge significantly elevated birth defect rates in Midlothian, Ellis County and Public Health Region 3.

(2) It is fascinating the number of times you have mentioned this one insignificant fact in this report as if though it should trivialize and negate the preponderance of evidence that establishes the significantly higher birth defect

rates.

General Findings

1. One hundred thirteen contaminants (47 VOCs and 66 metals or other inorganic

compounds) had no levels exceeding the most conservative HAC value (or had no

reported levels above the detection limit). No known health effects are associated

with exposure to these contaminants at the concentrations measured in Midlothian;

therefore, exposure to these contaminants would not be expected to result in adverse

health effects.

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Response: . . . therefore, exposure to these contaminants would not be expected to

result in adverse health effects. Any respectable scientist would question and challenge whether data reviewed represents true and complete emissions and community exposure. Unless you can assure that the data reviewed accurately captures

emissions and reflects community exposure, a statement like ‘‘. . . therefore, exposure to these contaminants would not be expected to result in adverse health effects’’ is without a solid scientific basis.

2. Health based screening values were not available for 87 contaminants (59 VOCs

and 28 metals or other inorganic compounds). Additional information is needed to

determine the public health significance of these contaminants.

Response: We appreciate that you acknowledge screening values were not available for a large number of regulated contaminants.

3. Thirteen VOCs had one or more measured level above the most protective healthbased screening value. Three of the VOCs (1,1,2-trimethylbenzene; 1,3,5-

trimethylbenzene; and m- and p-xylene) had one or more level above the most conservative contaminant-specific non-cancer screening value. Ten of the VOCs (ben- zene; 1,3-butadiene; carbon tetrachloride; chloroform; 1,2,-dibromoethane; 1,2-

dichloroethane; methylene chloride; 1,1,2,2-tetrachloroethane; 1,1,2-trichloroethane;

and vinyl chloride) had one or more level above the most conservative contaminantspecific cancer screening value.

Response: Statements like ‘‘. . . had one or more level above the most conservative contaminant-specific cancer screening value . . .’’ although technically true, sound so trivializing, especially when the data shows that benzene levels exceeded

this ‘‘most conservative screening value’’ over 97 percent of the time. Again, the only issue is not just what you found. We remain concerned about what may not have been identified due to the inadequacy of data due to the placement

of the monitors. Comment in #1. above applies here.

4. Fourteen metals or other inorganic compounds had one or more measured level

above the most protective health-based screening value. Four of the metals or other

inorganic compounds [chlorine (PM2.5), lead (TSP), manganese (TSP), and man- ganese (PM10)] had one or more level above the most conservative contaminant-spe- cific non-cancer screening value. Ten metals [arsenic (PM10), arsenic PM2.5), arsenic

(TSP), beryllium (PM10), cadmium (PM10), cadmium (PM2.5), cadmium (TSP), chromium (PM10), chromium (PM2.5), and chromium (TSP)] had one or more level above

the most conservative contaminant-specific cancer screening value.

Response: The response to item #1 above also applies here. Metal speciation based

on PM2.5 and PM10 does not adequately capture true levels of metals in the ambient air. The last year metal speciation was based on TSP was 1998.

Individual Contaminants—Non-Cancer Health Effects Evaluation

Using reasonable maximum exposure scenarios, only manganese (both as PM10

and as TSP) exceeded ATSDR’s chronic inhalation MRL by a small margin. After

an in-depth review of the toxicological information and the uncertainty factors used

in deriving the chronic inhalation MRL, we concluded that it is highly unlikely that

the manganese levels seen in Midlothian would result in any observable adverse

health effects, even after long-term exposure.

Response: The response to item #3 above also applies here.

Individual Contaminants—Cancer Health Effects Evaluation

Exposures Prior to 1982:

Based on ambient air samples collected prior to calendar year 1982, the estimated excess lifetime cancer risks associated with reasonable maximal exposure to arsenic

(TSP), cadmium (TSP), and chromium (TSP) ranged from 5.38x10–5 (a total of 1 excess cancer in 18,597 people exposed for 70 years) to 9.30x10–5 (a total of one excess

cancer in 10,748 people exposed for 70 years). If these exposures were to continue

for 70 years, they would pose a low increased lifetime risk for cancer and would not

be expected to result in measurable harmful health effects. Past exposures to these

compounds (prior to 1982) therefore posed ‘‘no apparent public health hazard.’’

Response: ‘‘Based on exposures prior to 1982 . . .’’ Are you referring to the 1981 monitoring at site 0001 (City Hall roof)? If yes, then this should be stated as thus.

Also, do you believe, based on prevailing wind patterns, this monitor was adequately

situated to capture true emissions from Ash Grove, TXI and Chaparral Steel? It

should be pointed out: 1) that ambient air data prior to 1982 was limited to 1981

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and was scarce (practically non-existent) since monitoring for most heavy metals

and VOCS was not done and 2) there is insufficient data to make an informed statement regarding public health impact. And why would we say, ‘‘. . . and if these exposures continue . . .’’ when we know they did not!—We know that population,

industry, production, mobile sources, etc. increased.

Exposures 1982 through 1992:

This time span should not have been omitted. It should be noted that for a critical

six-year period ambient air data for heavy metals and VOC’s is missing. This period

is of particular concern to the community because Ashgrove unsafely burned hazardous waste derived fuel (HWDF) from 1986 to 1992. It was not until after

Ashgrove’s ‘‘trial burn’’ in 1992 that it was determined that this facility could not

safely burn HWDF. Holcim went online in 1987. Also, during this period EPA

issued citations to TXI for violations involving hazardous waste burning.

Exposures 1993 through 2005:

In the entire history of air monitoring in Midlothian, site 007 (Tayman Drive) was

the only site in a prevailing wind pattern that had the potential to facilitate capturing data from all industries. There is no data from this site for metals. Data was

collected only for 1993–1997. A large number of samples were collected upwind of

all the industries at CAMS–94. Averaging in readings from CAMS–94 when the

wind is blowing out of the south only serves to dilute the true impact.

Ongoing Exposures:

It would be prudent to ask what monitoring is currently taking place. Are the

sites in position to collect data that accurately reflects true public impact from all

sources? The response may give insight to TCEQ’s intent and attitude regarding

public health.

Overall Conclusions

We found that the majority of the risks associated with exposure to the chemicals

analyzed in this health consultation were low. However, we are classifying this site

as an Indeterminate Public Health Hazard because further information is needed to

fully characterize the extent of the public health hazard posed by air contaminants

in Midlothian. This classification is based on the following facts:

Overall Response to this section:

Response: We truly appreciate the fact that it was recognized that insufficient data exists to make a solid conclusion whether a public health hazard

does or does not exist. It is quite evident (through no fault of ATSDR or TDSHS)

that the collection of data to assess public health or to capture a complete picture

of emissions and true public impact was not a factor in the placement of air monitoring stations. Consequently, the data is insufficient and inadequate for this purpose. Adequate data does not exist that would permit TDSHS to make a sound analysis that would warrant a call in either a safe or unsafe direction. Thus, it is quite

disconcerting that an effort was made to assess public health impact to any degree.

This serves only to discredit ATSDR’s and TDSHS’ purported mission to protect

public health.

Again, it is not our intent to insist a public health problem be identified

if one does not exist. However, it was our hope that all conclusions or statements derived regarding the community’s public health would be based on

the recent and developing science and on solid data appropriate to identifying real public exposure.

1. Sixteen out of 59 VOCs and two out of 28 metals or other inorganic compounds

for which health-based screening values were not available had average levels above

average background (levels obtained from other areas in Texas and/or the U.S.). Additional information is needed to determine the public health significance of these

contaminants.

2. While individual contaminants produced, at most, a low increased lifetime risk

for cancer and no apparent public health hazard, under the aggregate exposure scenario, total excess lifetime cancer risk for all cancers combined could be interpreted

as posing a public health hazard. However, this conclusion is based on the assumption that all the chromium detected in the air is of the most toxic form [i.e., chromium (VI)], an assumption that is inconsistent with information obtained from

other areas of the state. The relative proportions of chromium (III) and chromium

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(VI) will need to be determined in order to accurately define the risk estimate for

total cancer (all sites combined).

3. While this health consultation reviewed the majority of the contaminants measured in Midlothian air (119 VOCs and 108 metals and other inorganics), EPA’s

NAAQS compounds still need to be evaluated in a future consultation.

4. There are data gaps both in sampling locations and parameters of interest. No

air data for the analysis of VOCs were collected prior to 1993. Air data for the analysis of metals and other inorganic compounds were collected at only one location

from 1981 through 1984. No air data for these contaminants were collected prior

to 1981 and none were collected between 1985 and 1992. For the time periods when

air data does exist, data were collected from a limited number of monitoring stations

and may not reflect conditions throughout the community. (2) However, since the

major monitoring locations were relatively close to one or more of the primary emission sources, we do not anticipate that air pollutant levels for much of the city

would be too much higher than those observed.

Response:

(1) You are right to assert ‘‘. . . data was collected from a limited number of

monitoring stations and may not reflect conditions throughout the community,’’ because it definitely does not. The only monitoring site capable of

collecting emissions from all sources was 0007 on Tayman Drive and its

data limitations are quite obvious.

(2) ‘‘Relatively close’’ does not suffice. Monitor placement in relationship to

both the source(s) and wind rose patterns should be the criteria. Other than

Tayman Drive (site 007), no monitors were ‘‘close to’’ or in a prevailing wind

pattern to adequately capture emissions from Ashgrove and Holcim. Most

of the metals were monitored at CAMS–94 (site 0015) which is upwind

from all sources. Based on the wind rose patterns this is the one spot that

is least likely to capture data representative of local emissions. The second

site (based on the wind rose patterns) least likely to capture emissions is

CAMS–302 which is west of TXI/Chaparral Steel and south of the other industries. The majority of the VOC’s were collected at site 0015 and 0016.

Site 0016 is south of Holcim and Ashgrove and again (based on prevailing

winds) not in an ideal location to capture emissions from Ashgrove or

Holcim. TSP monitoring for metal speciation was limited before 1998 and

non-existent after 1998.

Recommendations

We have made the following recommendations in response to these findings:

1. As resources allow, research the toxicology literature for contaminants measured

in Midlothian air for which health-based screening values were not available, and

determine the potential public health impact of exposures to these substances.

2. Collect additional ambient air samples from previously sampled locations to determine the specific distribution of chromium species and to refine the risk estimates for this contaminant.

Response: Since previously sampled locations were obviously not optimally situated to capture true emissions, is there some logic to limiting collection to the

previously sampled site?

3. Evaluate the levels of EPA’s NAAQS compounds in the continuous air monitoring

data.

Response: Although we appreciate your efforts, if data was collected at CAMS–

94, which is obviously not in an ideal position to capture true emissions from

the industries, of what value would it be when assessing public health impact?

It would just be another exercise in futility. Also, it is not possible to determine

a community’s true lead impact from ambient air based on anything other than

TSP readings.

4. Where possible identify and fill data gaps with additional data from TCEQ to

identify any additional air contaminants that might need evaluation and/or sampling.

Response: This report has surfaced deficiencies in the system that should already

have been identified by TCEQ. Before we proceed to identify additional air contaminants that need evaluation we need to get a firm handle on the ones that

have already been identified. Current TCEQ monitoring does not give an accuVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00138 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
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rate picture of total emissions and public impact. If public health is a concern, and if there is a serious intent to assess community impact, a

methodology based on wind rose patterns, terrain, emission sources,

populace, etc., needs to be scientifically devised and implemented.

Actions Completed

Historically, the TCEQ has collected a vast amount of environmental data in

Midlothian, Texas, including air monitoring samples, soil samples, vegetation samples, and others dating back to the early 1980’s.

Response:

(1) Historically TCEQ has shown that this agency’s ties and loyalty lies with

industry and that public health cannot be allowed to trump economic welfare. The lack of monitoring sites placed in and around Midlothian as a result of a methodology scientifically based on prevailing winds, major emissions sources, populace, etc., testifies to this. This brings us to problems

faced in this consultation—data that does not measure true impact of emissions—data deficient for assessing public health. One can only presume this

was part of the design.

(2) The Evaluation of the Screening Risk Analysis for the Texas Industries Facility in Midlothian, by Dr. Stuart Batterman, et al., points out that the

monitoring system was deficient considering the scale of industry and waste

combustion. Furthermore this evaluation documents inconsistencies and deficiencies/omissions in many of the emissions and soil sampling/analyses.

TCEQ was criticized for its tendency to go far beyond what is scientifically

supportable by the existing data in making sweeping generalizations regarding the present and future safety of waste combustion in Midlothian. This

document was submitted with the petition and should have been a factor

in the analysis of data quality/adequacy of the TCEQ data.

2. Earlier data were analyzed by the TCEQ using EPA methodology and TCEQ’s

screening levels [4, 10].

Response: Again, refer to The Evaluation of the Screening Risk Analysis for the

Texas Industries Facility in Midlothian, by Stuart Batterman, et al. This was part

of the petition package and part of the evidence submitted. It should not have been

ignored. It critically reviews the documents referred to here [4, 10]. This evaluation

points out TCEQ’s failures at times to use EPA methodology. It sheds a light on

serious omissions, inconsistencies, selective use of critical data; sampling times,

techniques and locations inappropriate to characterize impact; meteorological and

other data not presented to interpret monitoring data; advance notice given to industry prior to ambient air monitoring, etc.

3. DSHS staff reviewed summarized monitoring data (1993 through 1995), attended

numerous meetings with TCEQ staff and area residents, and distributed questionnaires to see if there were consistent reports of odors, or signs or symptoms of illnesses that might be related to environmental pollution.

Response: See our response below under Past Environmental Sampling and Data

Review regarding actions and results of TDSHS involvement during this period.

4. The Texas Cancer Registry analyzed cancer morbidity and mortality data for

Midlothian and Ellis County, looking for any significant increases in cancer rates

in this area over the period 1993 through 2002.

5. The Texas Birth Defects Registry analyzed birth defect data for Midlothian, Ellis

County, and Health Service Region 3, looking for any significant birth defect elevations during the period 1999 through 2003.

6. ***

7. DSHS staff obtained detailed (not summarized) TCEQ air monitoring data from

1981 through 1984 and from January 1993 through March 2005 in an electronic format and created a database of monitoring results. With the completion of this

health consultation, DSHS has analyzed this data for VOCs and metals or other inorganic compounds and compared these data to health-based screening levels published by ATSDR and EPA. A conservative exposure scenario was generated, and

carcinogenic and non-carcinogenic risk estimates were calculated, assuming 70-year

lifetime and/or chronic exposures at the *reasonable maximal exposure levels seen

in the Midlothian area.

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Response: Sufficient data was not available to adequately determine ‘‘reasonable

maximal exposure levels seen in the Midlothian area.’’

Actions Under Way

***

Actions Planned

1. DSHS and ATSDR will make this health consultation available to the public,

local industries, the local government, and State and federal health/environmental

agencies.

2. DSHS and ATSDR will continue to address the community’s health concerns relating to air quality.

Response: ‘‘Continue . . .’’? The only way to credibly address a community’s health

concerns relating to air quality is to have an adequate air monitoring system truly

representative of air emissions to which the community is exposed. A scientifically

devised system based on a methodology that incorporates prevailing winds as they

relate to emission sources, terrain, populace, etc. has never been in place in

Midlothian. More of the same is of little value.

3. ***

4. DSHS will discuss with TCEQ the potential for determining the specific distribution of chromium species in Midlothian air. Hopefully we will get a complete picture

of the true emissions first.

5. DSHS will discuss with TCEQ the potential for identifying and filling data gaps

and identifying any additional air contaminants that might need evaluation and/or

sampling.

This community needs an adequate air monitoring system that is based on a scientific methodology designed to capture the total emissions as they impact the community. Then, and only then will our health agencies be able to make a viable evaluation as it relates to public health.

6. DSHS will complete the analysis of the hourly NAAQS data. If this data was collected at upwind monitoring stations situated where the majority of emissions will

be missed, this will be an exercise in futility. Also, unless data was collected at a

site(s) where (based on prevailing wind) true emissions from all sources are captured it will be of little value in assessing impact on public health.

Appendix D—Birth Defects and Cancer Registries Report Summaries

Birth Defects Registry Report Summaries

A Down syndrome cluster investigation released in 1996 reported that the number

of Down syndrome cases in Ellis, Hood, and Somervell Counties among deliveries

in 1992 through 1994 was 3.4 times higher than expected based on statewide rates

[74]. Those results, which included adjustment for maternal age, were statistically

significant at the 95 percent level. While that study did not provide evidence that

environmental factors were associated with the excess occurrence of Down syndrome

cases, its ability to do so was limited.

Response: We take this as a statement that the environment could not be

ruled out. We agree with this fact. Also, are we talking about three separate clusters here that occurred in Public Health Region 3 during the same period?

In response to a citizen request, the DSHS Texas Birth Defects registry completed

an additional review of birth defects registry data in June 2005 [75]. They examined

the occurrence of 48 specific types of birth defects as well as ‘‘any monitored birth

defect’’ among deliveries to residents of Midlothian, Venus, and Cedar Hill over the

period from 1997 through 2001 and compared those rates to the state as a whole

(1999 through 2001). Adjusting for maternal age, the prevalence rate for the occurrence of one type of birth defect related to urinary tract development (hypospadias

or epispadias) was approximately 3.7 times higher than the prevalence rate observed for Texas (1999 through 2001). Adjusting for maternal race/ethnicity, the

prevalence rate for hypospadias or epispadias was approximately 4.2 times higher

than the prevalence rate observed for Texas (1999 through 2001). These results

were statistically significant at the 95 percent level. Similarly, the prevalence of any

monitored birth defect among Midlothian residents (1997 through 2001), adjusted

for maternal age, was 1.5 times the prevalence rate for Texas (1999 through 2001),

and the result was statistically significant at the 95 percent level. However, adjustVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00140 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
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ing for maternal race/ethnicity, caused the prevalence ratio to drop to 1.2, and the

result was no longer statistically significant. It is not clear what effect if any the

different time periods for data inclusion in Midlothian vs. Texas may have had on

the birth defect prevalence rates.

In response to additional inquiries in August and October 2006, DSHS Texas

Birth Defects registry completed an additional review of birth defects registry data

in November 2006. They examined the prevalence of total birth defects as well as

48 specific types of birth defects in the 11 Health Service Regions of Texas over the

period from 1999 through 2003.

The standardized prevalence ratio (SPR) for any monitored birth defect, adjusted

for maternal age and race/ethnicity, in Health Service Region 3 (which includes

Ellis County and 18 other counties in the Dallas-Fort Worth area) was found to be

18 percent higher than the state as a whole, and those results were statistically significant at the 95 percent level. Specific defects found to be significantly elevated

at the 95 percent level included hypospadias/epispadias (SPR=1.14), obstructive

genitourinary defects (SPR=1.11), microcephaly (SPR=1.31), and

craniosynostosis (SPR=1.33). [Pyloric stenosis was significantly lower in Health

Service Region 3 than Texas as a whole (SPR=0.84). What is not mentioned here

is that of all the eleven Health Service Regions in Texas, Public Health Region 3 continues to reflect the highest birth defect rate.

The maternal age and race/ethnicity adjusted prevalence rate (per 10,000 live

births) for total birth defects in Ellis County was 483.66 compared with 360.70

in Texas as a whole (SPR=1.34); these results also were statistically significant at

the 95 percent level. Out of 48 specific birth defects (after adjustment for maternal

age and race/ethnicity), only craniosynostosis (SPR=3.61) was significantly elevated in Ellis County with respect to Texas as a whole.

We assume you are referring to the cumulative average rates for periods 1999

through 2003. An interesting point that should be made here is that in 2002 the

unadjusted prevalence for birth defect rates in Ellis County (689.1) was 186

percent that of Texas (370). In 2002 Ellis County also had the highest birth defect

rate in Public Health Region 3.

Cancer Registry Report Summaries

The Texas Department of State Health Services completed cancer incidence and/

or mortality investigations . . .. The incidence and mortality of the other cancer

types were not significantly different than what would be expected when compared

to the rest of the state.

Response: This report made a comment that the higher birth defect rates in Health

Service Region 3 and Ellis County may be due to the difference in reporting practices. Should not the same logic be applied here to the cancer rates. Since, the cancer surveillance depends on the good will of the health providers, is it not possible

that there is a difference in reporting practice in the rural areas such as Ellis County and your picture of cancer case may not be complete?

Past Environmental Sampling and Data Reviews

Air monitoring data were collected every six days for a variety of metals and other

inorganic constituents of particulates in the Midlothian area sporadically from 1981

to 1984 in accordance with the national schedule. Samples were collected from the

roof of the City Hall on North 8th Street and were analyzed for approximately 30

different parameters including total suspended particulates (TSP) adjusted for

standard temperature and pressure (STP). No air data were available for the time

period from January 1985 through December 1992.

In 1991, the TNRCC initiated an environmental monitoring program in and

around Midlothian to evaluate soil, vegetation, slag, and stack emissions for 18 different metals and/or polychlorinated dibenzo-p-dioxins (PCDDs) and dibenzofurans

(PCDFs). Of the 175 soil samples collected between 1991 and 1995, one sample exceeded the TNRCC’s soil screening level for lead (400 ppm), and six out of 140 soil

samples exceeded the TNRCC’s soil screening level for arsenic (20 ppm). Measurements for all other soil metals were below their respective soil screening levels.

Response: So based on tests taken 17 years ago, excessive lead and arsenic were

identified in the soil? What were the PCDD levels? This paragraph is silent regarding findings in stack emissions. Refer to Batterman, et al., Sections 5.2–5.3.1 analysis of these soil sampling. See Section 4.3.9 Dioxin/furans. These sections all point

out questionable quality assurance/quality control and raises questions regarding

discrepancies between various soil sampling techniques and discrepancies in airflow

and temperatures during stack testing for dioxins/furans, etc.

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Additional samples were collected in the vicinity of Chaparral Steel. Results from

these samples show that two out of 22 soil samples collected just outside of the

Chaparral property line exceeded the TNRCC’s soil screening level for lead (400

ppm), and one out of 22 soil samples exceeded the soil screening level for cadmium

(40 ppm) [4, 10]. All other soil metals were below the TNRCC’s respective soil

screening levels.

Response: So excessive levels of lead and cadmium were identified in the soil.

Among 60 soil samples tested, the Toxicity Equivalency Quotient (TEQ) for

PCDDs and PCDFs ranged from 0.3–17.9 parts per trillion (ppt); all were below the

ATSDR’s health-based soil guidance level of 50 ppt.

Response: It appears that dioxin was identified in all 60 soil samples. Dioxin is the

deadliest of all man-made chemicals. There is no known safe level for dioxins—what

is ATSDR’s basis for deeming a ‘‘safe’’ level? How is PCDD’s synergistic effects and

the endocrine disrupting factor calculated into this ‘‘safe level’’?

Slag (a by-product of steel production) samples were collected and analyzed for 13

different metals; none exceeded their respective soil screening levels.

As part of the Chaparral Steel special study, hay, wheat, and other vegetation

samples were collected from the fields surrounding the steel mill. With the exception

of aluminum, cadmium, and iron in samples collected in the field immediately south

of Chaparral, all measured metal concentrations were below their respective maximum tolerable levels for cattle.3

Response: So an issue with aluminum and cadmium and iron surfaced? What about

lead?

A letter regarding this study from Dr. Lund dated September 22, 1994 states:

‘‘Soil samples collected from the hay field contained elevated levels of cadmium,

manganese, and lead. Cadmium, manganese, and lead levels exceeded the

human soil ingestion comparison values by up to 2.1, 1.1, and 6.2 times respectively. Human ingestion of soil from the hay field with the measured metal concentrations may result in adverse health effects. In addition to exposure through

hay and vegetation consumption, animal ingestion of soil during grazing may increase the total metal exposure in the animal.

This letter also indicates eight additional hay-bale samples (four 0–3 inch depth

samples and four 3–6 inch depth samples were collected from the rows of hay-bales

stored at site #8. The results show that iron, manganese, cadmium, lead and titanium levels in surface samples (0–3 inch depth) were significantly greater than

samples collected from three to six inches within the hay bales. These results suggest aerial deposition of the metals.

Stack samples were collected from all three cement manufacturing facilities while

they were burning different combinations of coal, HWDF, and/or tire-derived fuel.

The total 2,3,7,8-Tetrachlorodibenzodioxin (TCDD) Toxicity Equivalency Quotient

(TEQ) concentrations estimated for each of the test conditions were all below the

TNRCC’s screening levels.

Response: Again, TCDD is the deadliest of all man-made chemicals. There is no

known safe level for dioxins—what level does TCEQ (TNRCC) ESLs deem acceptable.

Starting in 1993, the TNRCC began collecting air samples for VOCs, particulates,

metals, and other inorganic compounds from various locations or Continuous Air

Monitoring Stations (CAMS) around the city as follows (see Appendix E, Tables 1a

& 1b and Appendix C, Figure 2):

Tayman Drive (Site 0007): PM10 Total Particulates (0 to 10 μm), 1993 through

1996 (231 results) Metals & Inorganic Compounds, None VOCs (78 species),

1993 through 1997 (11,135 results)

CAMS–94 (Site 0015): PM10 Total Particulates (0 to 10 μm), 1994 through 2004

(690 results) PM2.5 Fine Particulates (0 to 2.5 μm), 2002 through 2004 (157 results) Metals & Inorganics in PM2.5 (52 species), 2002 through 2004 (8,164 results) VOCs (98 species), 1999 through 2005 (22,955 results)

CAMS–52 (Site 0016): PM10 Total Particulates (0 to 10 μm), 1994 through 2004

(685 results) Metals & Inorganic Compounds, None VOCs (99 species), 1997

through 2004 (34,842 results)

CAMS–302 (Site 0017): PM10 Total Particulates (0 to 10 μm), 1999 through 2004

(262 results) Metals Inorganics in PM10 (24 species), 2001 through 2004 & (4,344

results) VOCs (97 species), 2004 through 2005 (2,599 results)

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Note: Tayman Drive (007) is the only location (based on prevailing wind patterns) capable of capturing ambient air data representative of public exposure. All others

are upwind of Holcim and Ashgrove. CAMS–94 is upwind of all industries and metal

speciation is based on PM2.5 only. There does not appear to be any TSP monitoring for metal speciation at any of these sites. In 1996, the United States Environmental Protection Agency (EPA) conducted a cumulative risk assessment using air modeling data based upon estimated emissions for the industries in the area during 1985 and 1987 through 1990. In their

report, no increased risk for developing cancer or potential for developing non-cancer

health effects were identified above the EPA’s regulatory standards for acceptable

risk [11].

Response: The EPA assessment was a theoretical mathematical model conducted for

regulatory purposes and should not be relied upon to determine public health implications. This assessment was based on estimated data that was already 6–11 years

old when the report was issued. How were permit violations factored in? Was

Ashgrove’s permit violation and failed efforts at burning of hazardous waste in its

wet kilns factored in? Much has changed since 1990. Production has increased.

Types of fuels have changed. Incineration of hazardous waste and tire-derived fuel

has increased. Mobile emissions sources have increased. Population has increased.

Emissions have increased. Findings are obsolete. Empirical data should trump

any theoretical estimate.

Past DSHS and ATSDR Involvement and Data Reviews

(2) Between 1992 and 1995 TDH and ATSDR periodically evaluated the air monitoring data collected in the Midlothian area and attended community meetings. The

majority of samples were below the (1) screening levels considered to be health protective at that time [12]. (3) Although no consistent pattern of symptoms or illnesses were noted among area residents, there were common complaints among

the residents about sulfur odors and excessive dust. At the request of various citizens groups, DSHS Birth Defects and Cancer Registries have analyzed data from

Midlothian, Venus, Cedar Hill, Ellis County, and Health Service Region 3 to determine prevalence rates for various types of birth defects and the standardized incidence and mortality rates for various types of cancers in the aforementioned areas.

Reports were written by the respective registries and summaries of those reports

are presented in Appendix D.

(1) What do you know about screening levels now that you didn’t know then? It is noted that data available for review at that time was very limited.

However VOC collection on Tayman Drive indicated that 94 percent of the

benzene emissions exceeded the CREG values and benzene emissions spiked

to an acute chronic inhalation RfC of 20.57 ppb in May 1995. Ashgrove

burned hazardous waste derived fuel (HWDF) from 1986 to 1992. It was not

until after the ‘‘trial burn’’ in 1992 that it was determined that this facility

could not safely burn HWDF. Holcim went online in 1987. Also, it was during this period that EPA issued citations to TXI for violations involving hazardous waste burning. Refer to ‘‘Cafeteria Talk’’ below and how this

was trivialized.

(2) The results of these visits that culminated in the infamous ‘‘Cafeteria Talk’’

presented November 2, 1995 at the Midlothian Middle School Cafetorium

was a source of extreme frustration and disappointment for the community.

It was not just in the dismissive and condescending manner in which it was

presented with sweeping generalizations and statements not appar- ently supported by science. (Statements like: ‘‘Contrary to some of the claims you may have heard . . . dioxin exposure is not a significant

health risk in Midlothian.’’ ‘‘ESLs are generally 100 fold or more

lower than the LOAEL.’’ ‘‘If it has been determined that environmental pollutants in an area are not consistently elevated into a

range expected to cause adverse health-effects, then it is a foregone

conclusion that differences in disease prevalences cannot be validly

attributed to environmental pollution.’’ ‘‘After 120 years of study,

there are no reports in the medical/scientific literature linking

Down Syndrome to any sort of chemical exposure or industrial pollution.’’)

What was even more frustrating was that the community’s concerns regarding

lack of adequate monitoring and health problems surfacing in both the people and

the livestock were trivialized. Results of a poorly designed and analyzed questionnaire was embraced to rule out the alleged asthma and breathing problems while

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the only peer-reviewed study, The Health Effects of Living Near Cement Kilns: A

Symptom Survey in Midlothian showing a higher incidence of respiratory problems

in Midlothian was totally ignored. A poorly executed and failed Animal Health Survey (which incidentally did surface breeding problems) was abandoned as a failure.

The eagerness to place emphasis on the negative and the dismissiveness of potential

links was very worrisome.

Troubling are statements made during this ‘‘Cafeteria Talk’’ (like: ‘‘The TNRCC’s

environmental sampling program in Midlothian has been unprecedented!’’ ‘‘Never

before in history has the Agency, or its predecessor, the Texas Air Control Board

collected so many environmental samples, from so many different media, from so

many sampling locations, analyzing for so many different compounds and finding so

few of even the mildest of health concerns.’’) This is troubling, not only from the

perspective that the review of the environmental data (especially the air monitoring

data) reveals significant gaps and deficiencies that should have been obvious then.

But, what is most troubling and of great concern is whether the author of

this ‘‘Cafeteria Talk’’ could develop and maintain sufficient objectivity to

adequately evaluate the currently available data and arrive at objective

scientific conclusions without bias in this current public health consultation.

(3) It was acknowledged that levels of sulfur compounds were ‘‘on occasion’’

above the odor threshold levels. The complaints regarding excessive odors

(not given credence then) were substantiated.

Methods Used in This Consultation

Because of the diversity of the health and environmental concerns and the volume

of data available for the Midlothian area, several health consultations will be needed to address these concerns. In this consultation we reviewed available air monitoring data with respect to volatile organic compounds (VOCs), metals, and other

inorganic compounds. Subsequent consultations are planned to address EPA’s National Ambient Air Quality Standards (NAAQS) compounds and (*) consideration of

wind patterns and other weather data. Additional consultations may be added based

on the results of these analyses.

Response: *This holds promise. This same consideration/logic should be applied to

the data analyzed for this report.

Environmental Data

We reviewed air monitoring data collected by the TCEQ in the Midlothian area

from 1981 through 1984 and from January 1993 through March 2005. Air data were

not available prior to 1981 or between January 1985 through December 1992. These

data, collected every six days in accordance with the national schedule, include 119

VOCs collected from four different monitoring locations and 108 particulate and

metal parameters collected from 13 different sampling locations (most data were collected from six locations) in and around Midlothian. Current sampling locations and

historical sampling sites are shown in Appendix C, *Figures 1 and 2. Monitoring

site locations and the number of measurements made for VOCs and for metals/inorganic compounds at each site are shown in Appendix E, Tables 1a and 1b, respectively.

Response: See our prior remarks regarding adequacy of monitoring sites to capture

complete emissions. *Reference figure 2. The ‘‘artist’’ that overlayed this aerial photo

with king-size pictures of canisters should be complimented with his ability to create an illusion. At first glance, one is inspired by what really looks like heavy monitoring in most of the critical spots is taking place. Unfortunately a review of the

actual air monitoring data and what each of these ‘‘canisters’’ represents, burst the

bubble.

Quality Assurance/Quality Control

We obtained detailed (not summarized) ambient air quality data that TCEQ collected in the Midlothian area from May 1981 through March 2005. In preparing this

report, DSHS/ATSDR relied on the data provided to us by the TCEQ and (1) assumed adequate quality assurance/quality control (QA/QC) procedures were followed

with regard to data collection, chain of custody, laboratory procedures, and data reporting. (2) For the purpose of analysis, concentrations reported as ‘‘ND’’ (or not detected) were assigned numerical values equal to one half the detection limit for the

compound.

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(1) Assuming QA/QC is a leap of faith especially when it comes to public health issues versus industrial welfare.

(2) When direction of wind and fallout patterns would not support a reading other than a possible non-detect, the non-detect readings should have been

discarded. Including them only serves to dilute true concentrations and distort findings. This is true even with uncustomarily low concentrations reflected on days when (based on wind direction) a true measurement cannot

be expected.

Health-Based Assessment Comparison (HAC) Values

Media-specific health-based assessment comparison (HAC) values for non-cancer health effects are generally based on ATSDR’s minimal risk levels (MRLs), EPA’s

reference doses (RfDs), or for air, EPA’s reference concentrations (RfCs). MRLs,

RfDs, and RfCs (1) all are based on the assumption that there is an identifiable exposure dose for individuals including sensitive sub-populations, such as pregnant

women, infants, children, the elderly, or the immuno-suppressed, that is likely to

be without appreciable risk for non-cancer health effects even if exposure occurs for

a lifetime [13].

When a substance is listed as a carcinogen, the lowest available HAC value usu- ally proves to be the cancer risk evaluation guide or CREG. CREGs are based on

EPA’s chemical specific cancer slope factor (CSF) and represent the concentration

[for airborne contaminants, usually expressed as micrograms per cubic meter (μg/ m3)] that would result in a daily exposure dose [expressed as milligrams per kilo- gram per day (mg/kg/day)] and theoretical lifetime cancer risk level of one additional

cancer case in one million people exposed (a risk of 1x10–6), assuming a 70 kg per- son breathes an average of 20 cubic meters (m3) of air per day over a 70 year lifetime [13].

Response: This does not appear to be true of all constituents. Take lead for example.

An exposure dose that is likely to be without appreciable risk for health effects

(even for short periods of time—such as the ‘‘window of vulnerability for the fetus’’

or for a child in his first few years of life) has not been identified. A provisional RfC) 0.375 μg/m3 was created for evaluating lead based on a long-ago outdated level (quarterly average) 1.5 μg/m to protect a long-ago outdated once acceptable blood lead level of 30 μg/dl. In addition a blood lead level of 10 μg/dl was used as a com- parative value of safety when all reputable science and even CDC say it is not an

acceptable level of lead poisoning. According to the Office of Air Quality Planning and Standards (OAQPS) final staff paper, evidence of a differing sensitivity of the immune system to Pb across and

within different periods of life stages indicates a potential importance of exposures

as short as weeks to months duration. For example, the animal evidence suggests

that the gestation period is the most sensitive life stage followed by early neonatal

stage, and within these life stages, critical windows of vulnerability are likely to

exist.

OAQPS final staff paper indicates (based on peer-reviewed scientific studies) that

for neurological effects on the developing nervous system), no threshold levels can

be discerned from the evidence. OAQPS concludes, ‘‘Thus, to the extent one places

weight on risk estimates for the lower standard levels, we believe these risk results

may suggest consideration of a range of levels that extend down to the lowest levels

assessed in the risk assessment, 0.02 to 0.05 μg/m3.’’

OAQPS states: ‘‘In conclusion, staff judges that a level for the standard set in the

upper part of our recommended range (0.1–0.2 μg/m3), particularly with a monthly

averaging time) is well supported by the evidence and also supported by estimates

of risk associated with policy-relevant Pb that overlap with the range of IQ loss that

may reasonably be judged to be highly significant from a public health perspective,

and is judged to be so by CASAC. A standard set in the lower part of the range

would be more precautionary in nature in that it would place weight on the more

highly uncertain range of estimates from the risk assessment.’’

In general, comparison values are derived for substances for which adequate toxicity data exist for the exposure route of interest. All substances were evaluated as

if inhalation was the only exposure route. Breathing is not the only exposure route

for toxins in ambient air to enter the body. Toxins in the air are also absorbed by

dermal exposure and ingestion. This is especially relevant to toxins that are persistent in the environment and are continually re-suspended.

Comparison values may be available for up to three different exposure durations:

acute (14 days or less), intermediate (15 to 365 days), and chronic (more that 365

days). Usually, HAC values based on long-term exposure guidelines are lower (more

conservative) than HAC values based on short-term exposure guidelines. Thus, the

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initial screen usually involves comparing each discrete (i.e., short-term) contaminant

level with a HAC value based on a long-term exposure guideline. What is the acute,

intermediate or chronic long-term exposure for a fetus and its critical ‘‘windows of

vulnerability’’?

Health-Based Screening

Estimation of Long-Term Exposure Levels

Nearly all air samples collected for the measurement of VOCs, metals, and other inorganic substances have come from four primary sampling locations (1) (sites

0007, 0015, 0016, and 0017). Site 0007 is approximately 1.2 miles northeast of Ash Grove and 1.6 miles northwest of Holcim. Sites 0015, 0016, and 0017 are approximately 1.6 miles south, 1.5 miles north, and 1.2 miles northwest of the TXI/Chap- arral facilities respectively (see Appendix C, Figure 2 and Appendix E, Tables 1a

& 1b). (2) Some Midlothian neighborhoods are located within 1–1.5 miles of one of

the major industrial facilities but most are farther away. (3) Since emission levels tend to drop off with distance from the emission source, we expect the levels measured at the 4 primary sampling locations to be fairly representative of the upper

range of levels to which the majority of the residents of Midlothian would be exposed. Of course individual exposure concentrations will vary from day-to-day due

to changes in emission levels, wind speed and direction, and the movement of people

around the city. (4) Consequently, we have averaged the sample results from all

monitoring sites together to give the best approximation of the average concentration to which Midlothian residents may have been exposed over extended periods

of time.

Response: It appears these sites were established in response to needs other than

monitoring public health impact.

Tayman Drive (Site 07) was the only monitor logically placed to capture emissions

from all industries and is the only monitoring site that was in a prevailing wind

pattern capable of capturing most emissions from Holcim and Ashgrove. Unfortunately this data is 10 to 15 years old and is not reflective of current exposure. Industrial activity has increased significantly since this data was collected and tire derived fuel and other hazardous materials have been added to the mix. Metals and

inorganic compounds were not sampled here. The majority of the data for metals was taken upwind from all the industries (site 0015, CAMS–94). Site 302 (almost directly west of TXI) also is not in line with prevailing wind rose patterns. TSP

monitoring (sites 0001 and 0012) for metals was very limited (six out of the last 27

years) and none in the vicinity of Ashgrove and Holcim. TSP monitoring ended in

1998.

Site 015 is upwind of the town, schools, and the majority of the population. Furthermore, it is upwind from all industrial activity. The site was selected as a

background monitor for DFW because of its upwind location and is not in a position

to capture the majority of the local emissions; however, it could be useful in determining what blows in from the Houston area. Metals and inorganics were measured here for only three years and these measurements were based on

PM2.

5. The major contribution that data from this site gives to this study is a dilution of all constituents evaluated and a distortion of true public health impact.

Site 016 is in a position to capture some emissions from TXI and Chaparral Steel,

but rarely Holcim and Ashgrove. Unfortunately, metals and inorganic compounds were not sampled here.

CAMS–302 (Site 0017). Placed almost directly west and just slightly north. This

site is not in a prevailing wind pattern for any of the industries. Metals speciation

was from PM10—no TSP monitor.

The argument ‘‘. . . we expect the levels measured at the four primary sampling

locations to be fairly representative of the upper range of levels to which the majority of the residents of Midlothian would be exposed’’ could hold weight: 1) if data

was more representative of emissions from all industries (specifically Holcim and

Ashgrove) and at monitoring sites established based on prevailing wind; 2) if all

data was simultaneously collected to represent the same level of industrial activity

for a given period; and 3) if there were not so many inconsistencies in the data (example: metal sampling). Furthermore, readings captured at CAMS–94 (and possibly

CAMS–302) should be disregarded when the wind is blowing out of the south. These

readings do not capture community exposure and generally serve only to dilute true

impact.

‘‘. . . Since emission levels tend to drop off with distance from the emission . . ..’’

This is not true of all emissions. Some constituents can stay aloft and travel for

great distances and when and where they come down depends on many variables.

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For many constituents, it depends on what size PM to which they attach. Take lead

(or any heavy metal) for example. Lead attached to the larger particulate matter

(greater than PM10) has a tendency to settle in closer proximity (depending on wind

speed) to the source while lead attached to PM2.5 becomes aerosol and can stay aloft

indefinitely and travel long distances. If you were analyzing data collected on a TSP

monitor, this statement could to some degree hold more weight. Unfortunately no

TSP monitoring took place at the sites listed above.

‘‘. . . Of course individual exposure concentrations will vary from day-to-day due

to changes in emission levels, wind speed and direction, and the movement of people

around the city.’’ While this is true, some locations are more heavily exposed to total

emissions for longer periods of time than others. Locations located closer to Holcim

and Ashgrove realize a higher impact of total emissions. Unfortunately, monitoring

adequate to capture these exposures is severely limited and missing for many constituents (example heavy metals). There could be some logic in evaluating impact

on communities within 1.5 miles of the individual monitoring sites—but only for

those constituents that were adequately monitored and tend to settle close to the

emission site. There are too many variances (created by time lapses, increases in

production and TDF increases, lack of metal analysis, limited data capturing emissions from industries on north side of Midlothian, etc.) in monitoring sites to average across the board.

‘‘. . . Consequently, we have averaged the sample results from all monitoring

sites together . . ..’’ Since when do people get exposed to ‘‘averages’’? People are exposed to whatever is in the air at the time. What is the average ‘‘window of vulnerability’’ for a fetus?

Evaluating Exposure to Chemical Mixtures

While risk assessments often focus on identifying risks from single contaminant

exposures, real-life situations such as the one in Midlothian involve the simultaneous exposure to multiple contaminants. Consequently, in addition to assessing the

risks associated with exposure to individual contaminants, we also evaluated aggregate exposures from multiple contaminants for the Midlothian area, both for noncarcinogenic and for carcinogenic effects.

Simultaneous exposures to multiple chemicals may have additive effects (where

the combined effect is equal to the sum of the effects of each agent alone), synergistic effects (where the combined effect is greater than the sum of the effects of

each agent alone), or antagonistic effects (in which one substance interferes with the

effects of another producing a less toxic effect), when compared to a single chemical

exposure alone. In general, aggregate exposures to multiple chemicals at levels

below their thresholds for minimal effects would, at most, be expected to produce

a simple additive effect. Consequently, aggregate exposures to multiple chemicals

were evaluated assuming an additive effect. It was also assumed that all compounds

contributing to the exposure were elevated in unison and that people were exposed

to all the chemicals at the same time.

Response: ‘‘Consequently, aggregate exposures were evaluated assuming an additive

effect’’? How does this tie in to your explanation of synergistic effects? Does ‘‘Consequently . . .’’ mean consequently synergistic effects are not real? The bottom line

is that total aggregate effects were not really evaluated unless you have ‘‘assumed’’

synergistic effects and endocrine disruption activity are not possible.

Chemical Mixtures and Non-Carcinogenic Effects

To estimate the potential public health significance of simultaneous exposures to

multiple chemicals, we tabulated all of the critical effects for each contaminant listed by the EPA on the Integrated Risk Information System (IRIS) database which

were the basis for deriving the RfD or the RfC. We also tabulated all of the critical

effects listed by the ATSDR in their Toxicological Profile series which were the basis

for deriving their inhalation MRLs. The 95 percent UCL of the estimated average

daily exposure dose was divided by the appropriate health-based value to calculate

the 95 percent UCL on the Hazard Quotient (HQ) for a particular critical effect (e.g.,

CNS effects, developmental effects, liver toxicity, etc.). HQs from multiple contaminants known to produce critical effects of a similar nature or on the same organ

system were summed to arrive at the Hazard Index (HI) for each critical effect as

a result of exposure to the chemical mixture. Aggregate exposures with an HI less

than 1.0 were considered to be without appreciable risk for adverse health effects.

Aggregate exposures with an HI greater than 1.0 were subjected to further analysis

to determine the potential public health significance.

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Response: How are synergistic effects and endocrine disrupting activity factored into

this formula?

Chemical Mixtures and Carcinogenic Effects

To estimate theoretical excess lifetime cancer risks associated with simultaneous

exposures to multiple carcinogens, we tabulated all of the cancer critical effects for

each contaminant listed by the EPA on the IRIS database which were the basis for

deriving the IUR or the oral slope factor (if applicable). For each contaminant, the

95 percent UCL on the estimated average daily exposure was multiplied by the IUR

to calculate the theoretical lifetime risk of developing certain types of cancer (e.g.,

lung, liver, kidney, etc.), assuming a continuous, 70-year exposure. Risks from exposures to multiple contaminants known to produce the same type of cancer were

summed to obtain an estimate of the total excess risk of developing that cancer as

a result of exposure to the chemical mixture. Finally, all of the individual cancer

risks were summed to obtain a cumulative cancer risk estimate. Aggregate exposures with a cumulative cancer risk estimate less than 1x10–4 were considered to

be without appreciable risk for adverse health effects. Aggregate exposures with a

cumulative cancer risk estimate greater than 1x10–4 were subjected to further analysis to determine the potential public health significance.

Response: How are synergistic effects and endocrine disrupting activity factored into

this formula? If you have not factored in these two facets, do you believe you have

scientifically evaluated aggregate exposures?

Child Health Considerations

In communities faced with air, water, or food contamination, the many physical

differences between children and adults demand special emphasis. Children could

be at greater risk than are adults from certain kinds of exposure to hazardous substances. Children play outdoors and sometimes engage in hand-to-mouth behaviors

that increase their exposure potential. Children are shorter than are adults; this

means they breathe dust, soil, and vapors close to the ground. A child’s lower body

weight and higher intake rate results in a greater dose of hazardous substance per

unit of body weight. If toxic exposure levels are high enough during critical growth

stages, the developing body systems of children can sustain permanent damage. Finally, children are dependent on adults for access to housing, for access to medical

care, and for risk identification. Thus adults need as much information as possible

to make informed decisions regarding their children’s health.

Health-based assessment comparison values such as the MRLs, RfDs, and RfCs

used in this health consultation are all based on the (1) assumption that there is

an identifiable exposure dose for individuals including sensitive sub-populations

(such as pregnant women, infants, children, the elderly, or the immuno-suppressed)

that is likely to be without appreciable risk for non-cancer health effects, even if

exposure occurs for a lifetime. Each of these HAC values employs an uncertainty

factor designed to account for human variability or sensitive sub-populations, including children. (2) With regard to CREG values and potentially increased carcinogenic risks for children, only one of the carcinogens observed in Midlothian air

(vinyl chloride) is listed by the EPA as having a mutagenic mode of action. Using

the recommended additional age-dependent adjustment factors of 10 for exposures

occurring between birth and 2.0 years, and three for exposures occurring between

the ages of 2.0 and 6.0 years, we would anticipate a 31.3 percent higher lifetime

risk than that calculated by conventional methods.

(1) This should read: ‘‘Though there is evidence to the contrary that an identifiable exposure dose of many toxins exists for individuals including sensitive sub-populations (such as pregnant women, infants, children, the elderly, or the immuno-suppressed) that is likely to be without appreciable risk

for non-cancer health effects, even if exposure occurs for a lifetime, we proceed in our assumptions as if there were.’’ Note: prior discussions regarding

lead. ATSDR has consistently flown in the face of science by condoning a

blood-lead level of 10 μgL as an acceptable level of lead poisoning though

science has established (and CDC concurs) that it is not.

(2) The point to this statement is obscure and the information is confusing. Are

you saying that cancer is the only issue of concern for children? A large

number of the toxins in Midlothian air are known fetotoxins, neurotoxins,

endocrine disrupters, teratogens. Mercury, lead, arsenic, benzene, cadmium,

chromium have all been associated with mutagenic effects. Safe levels for

the fetus for most of these chemicals has not been determined.

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Other

On page 29 under Results

Carbon tetrachloride was detected at quantifiable levels in 711 (7.46 percent) of

the 952 ambient . . .. Did you mean 74.60 percent—appears to be a typo in both

places within this paragraph.

ADDENDUM To Prior Comments Submitted February 3, 2008

MIDLOTHIAN AREA AIR QUALITY PART I:

VOLATILE ORGAN COMPOUNDS & METALS

DECEMBER 11, 2007

Prepared by Sal and Grace Mier, Midlothian, Texas

As addendum to February 03, 2008 Comments

Date: March 09, 2008

Suggestions:

For reasons outlined in our prior comments, air monitoring data collected in

Midlothian by TCEQ cannot be scientifically justified as adequate to determine public health implications. Therefore, it is suggested that Under Section Results and

Discussions (starting on page 22 up through 67) all ‘‘Public Health Implications’’

based on this air monitoring data be removed.

Response to Petitioner and Community Health Concerns (starting on page 5):

All responses reflecting an analysis based on TCEQ air monitoring data collected

in Midlothian should be revised to reflect adequate data was not available to arrive

at a scientific conclusion.

General Findings (page 8) should reflect that TCEQ air monitoring data collected

in Midlothian was inadequate to arrive at a scientific conclusion of public health impact of toxic emissions in the air. All conclusions using TCEQ air monitoring data

as a basis should be deleted.

Individual Contaminants—Non-Cancer Health Effects Evaluation (page 9):

This section should reflect that TCEQ air monitoring data provided insufficient data

to evaluate non-cancer health effects. All analyses based on TCEQ data should be

deleted.

Individual Contaminants—Cancer Health Effects Evaluation (page 9): This

section should reflect TCEQ air monitoring data collected in Midlothian was inadequate to arrive at a scientific conclusion of public health impact of toxins in the

ambient air. All analysis based on TCEQ air monitoring data should be deleted.

Aggregate Exposures—Non-Cancer Health Effects (page 9): This section should

reflect that due to absence of critical data such as dioxin/furans, VOCs, heavy metals (especially mercury and lead), questions regarding critical windows of vulnerability, questions regarding endocrine disruptive activity and the overall inadequacy

of the air monitoring data, aggregate exposures and the impact on public health

could not be scientifically evaluated.

Aggregate Exposures—Cancer Health Effects (page 10): This section should reflect that due to absence of critical data such as dioxin/furans, heavy metals (especially mercury and lead), questions regarding critical windows of vulnerability, questions regarding endocrine disruptive activity and the overall inadequacy of the air

monitoring data, aggregate exposures and the impact on public health could not be

scientifically evaluated. (Note: Estimate on cancer risks considering only chromium

(VI) is understated.

Overall Conclusions (page 10): Basis for classification of an ‘‘Indeterminate Public

Health Hazard’’ should be revised to reflect all deficiencies that preclude a scientific

public health evaluation. Inadequacy of TCEQ air monitoring data for assessing

public health precludes such statements as, ‘‘We found majority of risks associated

with exposure to chemicals analyzed in this health consultation as low.’’ All conclusions and inferences relating to public health based on the TCEQ air monitoring

data should be removed.

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1. Paragraph 1. It should be reflected that the number of VOCs and metals exceeding background levels could be significantly higher if adequate air monitoring data were available.

2. Paragraph 2. ‘‘. . . Under the aggregate exposure scenario, total excess lifetime cancer risk for all cancers combined could be interpreted as posing a

public health hazard . . .’’ This scenario is understated by inferring

that this interpretation is based on the assumption that all chromium detected in the air is chromium (VI). A major omission is the

impact of the deadliest of all man-made toxins—dioxins/furans. The

statement regarding a possible public health hazard should reflect

this omission. This statement should also reflect an assumption was

made that all data reviewed adequately reflected a complete picture

of toxic exposure (which it does not) and there are no synergistic effects of these aggregate exposures. (Have other pathways for exposure such as dermal or ingestion been factored in?)

3. Paragraph 3. The adequacy of the EPA NAAQS to capture true public exposure and adequacy for evaluating public health should be scientifically evaluated before proceeding.

4. Paragraph 4. ATSDR should request assistance of a reliable independent scientist for help in evaluating the TCEQ Midlothian air monitoring for adequacy of capturing public impact and for adequacy in evaluating the public

health of the community. An assessment for the need for additional and appropriate monitoring could also be recommended.

Recommendations (Page 11):

Please recommend that TCEQ establish a monitoring system that captures a complete picture of toxic emissions from all sources and data adequate for monitoring

public health.

Actions Under Way (page 12):

Action to effectuate an adequate monitoring system in Midlothian should be undertaken. DSHS should discuss with TCEQ a methodology for establishing a monitoring system that captures emissions from all major sources and produces data

adequate for monitoring public health.

Conclusions (Starting on page 72):

All findings should reflect the inadequacy of TCEQ air monitoring data to capture

total emissions and the inadequacy for evaluating public health. All findings based

on this inadequate data should be withdrawn.

Aggregate Exposures—Non-Cancer Health Effects (page 73)

The CNS/neurological effects are grossly understated. How were dioxins factored

in? How were synergistic effects factored in? Up-wind readings for mercury give you

for all intent and purpose zero data on mercury. By the sheer nature of the cement

industries and incineration of hazardous waste and tire-derived fuel, you know that

the emissions of these toxins are significant. It is not becoming of an agency charged

with public health to make such a deficient statement. This statement should be revised to reflect the deficiencies in the data reviewed.

**********

Below are corrections to statements made in our original comments submitted on February 3, 2008. It is requested that you substitute statements as

amended below. The change is highlighted in bold.

On page 5 in paragraph (3) the reference to the time benzene exceeded the CREG,

the sentence should read as follows:

At all three sites (0007, 0015, 0016) the CREG was exceeded 94 percent, 98 percent, 99 percent (respectively) of the time with spikes up to 118, 512, 319 (respectively) times higher than the CREG.

On page 11 under response to item 3, the first sentence should read:

Statements like ‘‘. . . had one or more level above the most conservative contaminant-specific cancer screening value . . .’’ although technically true, sound so

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trivializing, especially when the data shows that benzene levels exceeded this ‘‘most

conservative screening value’’ over 97 percent of the time.

On page 19 under paragraph in first paragraph (1) response, sentence should

read:

However VOC collection on Tayman Drive indicated that 94 percent of the benzene emissions exceeded the CREG values and benzene emissions spiked to an acute

chronic inhalation RfC of 20.57 ppb in May 1995.

**********

During these last couple of years, there has been much speculation in the community regarding the delay of this report. The initial anticipated completion period of

three months was stretched to six months, and then went on indefinitely for over

two years on an apparent merry-go-round between TDSHS and ATDSR.

Speculation for the delay ranged from ‘‘possible political interference’’ to ‘‘a delay

is a form of non-response—a method to keep the community at bay for as long as

possible.’’ TDSHS’ reason for delay was, ‘‘The data was so comprehensive that it

would take a very long time to complete the analyses.’’

It was obvious to the community from the onset that based on the positions of

the air monitors, data collected by TCEQ would not be adequate for assessing public

health. It was our naı ̈ve hope that adequate data based on sound science was being

collected. As it turned out, this was not the case. This consultation was based on

readily available data that could be pulled into Access and/or Excel databases along

with the comparison data and easily manipulated to generate the results provided

in this report. Readily available references were used. Prior TDSHS documents

should have been easily accessible. Community visits were completed in the first

three months. Can you provide some logic to the delay? Or was this delay just an

effort to keep the community pacified and at bay?

Final Comment:

We truly appreciate the fact that ATSDR/TDSHS acknowledged that a finding

less than an ‘‘Indeterminate Public Health Hazard’’ is not appropriate. However, the

basis for this finding omits the most glaring and pertinent deficiencies—the lack of

valid data to make an appropriate health assessment of any kind. Premature assessments (based on deficient air monitoring data) of a finding of ‘‘no apparent

health hazard’’ for many of the constituents evaluated in this consultation are very

disconcerting.

I refuse to be so cynical to imply that ATSDR/TDSHS are not concerned about

public health, because there are many professionals working for these agencies who

have demonstrated their commitment. However there appears to be a pervasive institutionalized philosophy and culture that does not allow public health issues to

surface if they will trump economic and industrial goals. Your agencies, professionals and the communities to which you have a public health obligation deserve

better than this.

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Addendum #10

NOT ‘‘JUST STEAM’’

A Review of ‘‘Emissions Data from Midlothian Industry’’

FOR THE TEXAS SENATE NATURAL RESOURCES COMMITTEE,

SEPTEMBER 9TH, 2008

In the summer of 2008 Amanda Caldwell and Susan Waskey, two University of North Texas Geography graduate students, did something no one had previously

done. They added up all the emission reports submitted to State and Federal Government by the three cement plants and adjacent steel mill in Midlothian. Their report, ‘‘Midlothian Industrial Plant Emission Data’’ was the first to try to document

the cumulative impact from what is the largest concentration of smokestack industries in North Texas.

Although there has been an operating cement plant in Midlothian since 1960, emission data was only available from the state beginning in 1990, and from the

EPA beginning in 1988. The last available data from both sources is currently 2006.

Besides providing an idea of the total pollution burden imposed by these facilities

for the first time, Caldwell and Waskey also spotlight the differences in reported

volumes of air pollution when industry submits emissions reports to the State

versus the Federal governments. The two databases reveal some interesting contrasts in tracking 16 years of air pollution emissions that call for closer examination.

Caldwell and Waskey’s work definitively puts to rest the oft-repeated unofficial explanation by the companies and their boosters that that plant’s emissions are

‘‘just steam.’’ In fact, pollution from the smokestacks of these facilities is the largest

industrial threat to public health in North Texas, and has been for decades.

1. The Facilities

Texas Industries, Inc. (TXI) cement plant

One dry kiln

Four wet kilns

Fuel: coal, hazardous waste, permitted for tires

Holcim US Inc. cement plant

Two dry kilns

Fuel: coal, tires, oil filter fluff, petroleum coke, used oils

Ash Grove Texas L.P. cement plant

Three wet kilns

Fuel: coal and tires

Gerdau Ameristeel, (formally Chaparral Steel)

Electric Arc Furnace Steel Mill

2. The Emissions Reports

A) USEPA’s Toxic Release Inventory (TRI)

Toxic Release Inventory reports are generated by industries as required by the

Emergency Planning and Community Right-to-Know Act (EPCRA), enacted in 1986.

According to the EPA,

‘‘EPCRA’s primary purpose is to inform communities and citizens of chemical

hazards in their areas. EPCRA Section 313 requires EPA and the states to annually collect data on releases and transfers of certain toxic chemicals from industrial facilities, and make the data available to the public in the Toxic Release Inventory (TRI) . . . EPA compiles the TRI data each year and makes it

available through several data access tools, including the TRI Explorer.’’

(USEPA 2008)

The release data used in this project are self-reported by each facility, and neither

the quality of the data, nor the quantities reported should be assumed to be precisely accurate.

Caution should be taken in interpreting trends from the TRl reports as the list

of ‘‘reportable’’ chemicals has changed over the years. Since its inception in 1987,

the list of toxic chemicals that must be reported has doubled to more than 650, with

most of the additions occurring in 1995. Also, numerous changes have been made

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to the list, including de-listing some chemicals and modifying reporting thresholds

of others.

B) Texas Commission on Environmental Quality’s Annual Contaminant

Summary Reports

The second half of the data collection effort was focused on the State of Texas’

Contaminant Summary Report. Again, like the federal data, 2006 is the latest reporting year for which data are available. Reported data earlier than 1990 do not

exist from the state, according to a conversation with the Emissions Assessment

Section Manager at TCEQ. Data was also not collected in 1991 at the State level,

for reasons not readily known to the TCEQ manager.

The Contaminant Summary Report contains data detailed in three sections: Criteria Emissions Total, Contaminant Summary Report, and Hazardous Air Pollutants (RAPS) Summary Report. The Criteria Emissions Total section lists data for

seven ‘‘Pollutant Classes,’’ namely:

PM2.5—suspended particulate matter of a size 2.5 microns or less (requirement

added in 2000),

PM10—suspended particulate matter of a size 10 microns or less,

VOC—volatile organic compounds,

CO—carbon monoxide,

NOΧ—nitrous oxides,

SO2—sulfur dioxide, and

PB—lead.

These requirements originate from the National Ambient Air Quality Standards

(NAAQS), established by the USEPA under the direction of the Clean Air Act, and

annual reporting is further required under the Texas Clean Air Act.

The Hazardous Air Pollutants (HAPS) Summary reports chemicals for which both

the federal and State Clean Air Act requires annual reporting. Data from both the

Criteria Emissions Total and HAPS Summary Report were included in this report.

The third section titled ‘‘Contaminant Summary Report’’ is a catch-all listing of

chemicals required by a mix of requirement, sources, including Criteria Emissions,

HAPS, permit, and other requirements, according to the TCEQ manager Kevin

Cauble. Chemicals unique to this listing are not included in this project’s analysis.

3. The Volume of Pollution

Between 1990 and 2006, the three cement plants and steel mill reported to State

and/or Federal Government that their facilities released approximately one billion

pounds—986,509,069—of harmful air pollution into the North Texas skies, including:

10,000 pounds of Mercury

91,000 pounds of lead

Over seven million pounds of ‘‘ EPA-classified toxic’’ air pollution

Approximately 35 million pounds of respirable Particulate Matter

Over 134 million pounds of global waning gases

Over 300 million pounds of smog-forming Nitrogen Oxide

Approximately 400 million pounds of acid rain causing Sulfur Dioxide

That’s an average of over 61 million pounds of air pollution released every year,

7000 pounds an hour, 117 pounds per minute, two pounds per second over 16 years.

And yet, the position of the Texas Committee on Environmental Quality is that

Midlothian has some of the cleanest air in the state.

Because it’s heavier than the gaseous pollution released by the Midlothian plants,

Particulate Matter contaminated with metals and other combustion residues will

usually fall out within 10 miles of the source, with the heaviest concentrations in

the areas most consistently downwind of the cement plants, or in very close proximity of the plants themselves.

A 10-mile radius around the Midlothian cement plants would include portions of

Arlington, Cedar Hill, DeSoto, Grand Prairie, Mansfield, Midlothian, Red Oak, and

Venus, and incorporate 314 square miles.

34,903,092 pounds of PM10, or soot, from all four facilities is enough to deposit

111,156 pounds on each square mile in that 10-mile radius over the last 16 years.

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Almost all of the Lead and Mercury released by the cement plants is emitted as

Particulate Matter pollution. 91,000 pounds of lead is enough to deposit 289 pounds

of the poison on each square mile. 10,103 pounds of Mercury is enough for 32

pounds to be deposited on each square mile in that same area.

334,816,276 pounds of Nitrogen Oxide is the equivalent smog-forming pollution

from the annual emissions of nine million automobiles.

402,516,432 pounds of Sulfur Dioxide is the equivalent to the SOΧ released by 20

coal plants in a year.

4. Toxicity of Selected Pollutants

A) Particulate Matter, or soot, is toxic in its own right, more so when other toxins

are hitching a ride on its surface—almost all of the Lead and Mercury released by

the cement plants is emitted as Particulate Matter pollution. Soot from engines, or

industrial processes like cement manufacturing is much smaller than the sand dust

or fire soot which evolution equipped human beings to expel. Because it’s smaller

it remains deep in the lungs, doing damage.

In the last few years, PM pollution has been linked by scientists to lung damage,

asthma, heart attacks, strokes, blood clots, brain cancer, genetic damage, and Parkinson’s Disease. Toxicologists specializing in PM pollution believe to be no ‘‘safe’’

level of exposure to PM pollution.

B) Mercury does not decompose or exit the environment once it’s been released

into the atmosphere. It is deposited back onto the ground, where it persists in soil

and water, and bio-accumulates in fish and wildlife.

According to leading scientists, as little as 1/24th of an ounce of Mercury can contaminate a 20-acre lake and all the fish in it. Using this measuring stick, 10,000

pounds of Mercury is enough to contaminate over 133,000,000 20-acre lakes. Joe

Pool Lake is within five miles of all the Midlothian cement plants and steel mill,

and the closest plant is within two miles of the Lake.

C) Lead and lead compounds can be highly toxic when eaten or inhaled. Although

lead is absorbed very slowly into the body, its rate of excretion is even slower. With

constant exposure, lead accumulates gradually in the body. It is absorbed by the red

blood cells and circulated through the body where it becomes concentrated in soft

tissues, especially the liver and kidneys. Lead can cause lesions in the central nervous system and apparently can damage the cells making up the blood-brain barrier

that protects the brain from many harmful chemicals. Most of the leading scientists

specializing in lead poisoning believe there is no safe level of exposure to lead—that

is no level that is not capable of causing some neurological or physiological effect.

D) According to the Agency of Toxic Substances and Disease Registry, long-term

exposure to Sulfur Dioxide

‘‘can affect your health. Lung function changes were seen in some workers exposed to low levels of sulfur dioxide for 20 years or more. However, these workers were also exposed to other chemicals, so their health effects may not have

been from sulfur dioxide alone. Asthmatics have also been shown to be sensitive

to the respiratory effects of low concentrations of sulfur dioxide.

Animal studies also show respiratory effects from breathing sulfur dioxide. Animals exposed to high concentrations of sulfur dioxide showed decreased respiration, inflammation of the airways, and destruction of areas of the lung.

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5. Specific Plants and Pollutants

A) TXI

TOTAL AIR POLLUTION 1990–2006: 336,979,556 pounds

TXI is the largest cement plant, and largest industrial facility among the four examined in this analysis, so it’s not surprising it would lead in total pollution.

In general, the amount of TRI chemicals released to the environment through the

air by TXI spiked in the year 2000, to over 1.2 million pounds.

This coincided with TXFs bringing the fifth cement kiln into operation at their

Midlothian plant. Subsequently, TRI releases stabilized at a level lower than one

million pounds after 2000, but at a significantly higher rate than in the past (more

than 480,000 lb/yr).

In 1999, reporter Steve Brown wrote in The Dallas Morning News that TXI had

promised that this $200 million expansion to add the 5th kiln to their operation

‘‘would not increase pollution,’’ and it would ‘‘have advanced pollution controls that

would keep the project from harming air quality’’ (Brown 1999). The data from both

the EPA Toxic Release Inventory and the State Hazardous Air Pollutants reports

show a different outcome. Air releases from both reports are higher than prior to

2000.

B) Holcim

TOTAL AIR POLLUTION 1990–2006: 307,966,836 pounds

Holcim’s TRI releases and state emissions inventory consist mostly of Toluene

(404,288 lbs.), Benzene (232,109 lbs.), Sulfuric Acid (172,145 lbs.) and unspeciated/

mixed Xylenes (145,982 lbs.). Holcim has also had lesser amounts of on-site landfill

releases over the years.

Holcim’s State air emissions (HAPS emissions consist mostly of Toluene (508,429

lbs.), Benzene (329,279 lbs.), Xylenes (248,103 lbs.), and Hydrochloric Acid (196,566

lbs.).

C) Ash Grove

TOTAL AIR POLLUTION 1990–2006: 263,141,444 pounds

Ash Grove’s toxic air emissions consist mostly of sulfuric acid (872,185 lbs) and

hydrochloric acid (171,473 lbs). On-site landfill releases are also of note , consisting

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mostly of Magnesium and Magnesium Compounds (1,903,018 lbs.), and smaller

amounts of Chromium (34,464 lbs.) and Lead (8224 lbs.).

The State Air Emissions Inventory (HAPS) shows that most prevalent toxic chem- ical released over the 17-year reporting period was Hydrogen Chloride (334,655 lbs.)

Ash Grove’s state Criteria Emissions Releases show that Sulfur Dioxide (SOΧ) and

Nitrous Oxides (NOΧ) were the most prevalent components of these emissions. Furthermore, there is a discouraging upward trend in released amounts of Sulfur Dioxide during the recent past. What remarkable about Ash Grove’s numbers are that they’re so large for the smallest cement plant. It has more SOΧ, NOΧ and PM10 than Holcim, which is twice

its size.

D) Ameristeel

TOTAL AIR POLLUTION 1990–2006: 89,655,098 pounds

Most air releases were Zinc (352,076 lbs), Lead (47,238 lbs) or Manganese (46,904 lbs). Chaparral’s releases are primarily ‘‘off-site,’’ with zinc releases over the 17-year

period approaching 50 million pounds. The State air emissions inventory (HAPS) consist mostly of Manganese Dioxide (58,609 lbs.) or PM10–Manganese Dioxide (72,583 lbs.), and Lead Oxide (50,337 lbs.)

or PM10–Lead Oxide (38,237 lbs.). The Nitrous Oxide (NOΧ) component of those

emissions seems to beholding steady at one million pounds per year.

6. These are Underestimates

The fact that there is absolutely no emissions data from either EPA or the state

for the first 30 years of industrial operations in Midlothian—including the first four

years of hazardous waste-burning at two cement plants—means that the large numbers reported here for the first time are inherently vast underestimates of the total

pollution burden produced by heavy industry in the town since 1960. This is anything but a comprehensive review.

Even when records begin in 1990, there are large discrepancies in the data reported to both the State and Federal governments. TRI and State emissions data

for several of the companies were not reported for many of the years during the

project time period:

Chaparral did not report TRI data in 1990.

Holcim did not report TRI data for the years 1990–1999.

Ash Grove did not report TRI data for the years 1990 and 1993–1995.

Holcim did not report Hazardous Air Pollutants data to the state for the years

1990–1999.

It is unlikely that these facilities were not releasing anything worthy of reporting

to either the USEPA or State databases during these years. Omissions such as these

ensure that, even during the period when records do exist, this analysis only gives

a glimpse into the actual pollution burden caused by the four facilities.

7. Contradictions in Data

A cursory examination of EPA air release data in Figure 56 (Total Air Releases

per Firm 1990–2006) and TCEQ air release data in Figure 60 (Total Hazardous Air

Pollutants per Firm 1990–2006), show strikingly different results. For this reporting

period, the EPA data shows TXI to be the firm with the largest amount of toxic

chemicals released to the air (5,287,384 lbs.), while the state’s data show Holcim to

be the largest emitter of hazardous air pollutants (1,507,663 lbs).

According to the plants’ TRI reports, there were almost 48,000 pounds of lead air

pollution released by all four facilities over the entire 16 years, versus the over

90,000 pounds of lead the same plants reported sending up their stacks to the

TCEQ and its predecessors during the same period.

According to the plant’s TRI reports, there were approximately 5000 pounds of

Mercury air pollution released by all four facilities from 1990 to 2006 versus the

approximately 10,000 pounds of Mercury air pollution reported to the state over the

same time.

Even within the same reporting system, the method used to calculate or estimate

reported quantities for various chemicals may have differed from firm to firm and

year to year, making comparisons or trend analysis difficult. Take the case of Volatile Organic Compounds at the cement plants that are literally across the street

from each other. When Holcim finally began reporting volumes for TRI in 2000, it

immediately cited large numbers for VOCs such as Toluene, Xylene, and Benzene.

It has been Holcim’s position that these VOCs come from the limestone itself and

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testing done over the last three years generally supports this conclusion. On the

other hand, neither TXI nor Ash Grove have ever reported the large numbers of

these VOCs that Holcim has, despite mining and using the same Midlothian limestone. The result is that even though Holcim did not report ANY emissions for nine

of the 16 years covered in this analysis, it is the largest historical VOC polluter in

the study, with VOC totals that are at least five times that of the next cement

plant. Is Holcim’s limestone that much different than the other two plants, or are

TXI and Ash Grove under-reporting their emissions?

Some of these calculation differences could be investigated further, as could the

apparent reporting gaps (missing data) from some of the firms. Also, the companyto-company differences in what chemical substance get reported in which section of

the annual report to the state could be evaluated. Those chemicals from the state’s

Contaminant Summary Report block that are not included in the HAPS or Criteria

Emissions blocks of data could also be scrutinized for inclusion in this dataset.

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Addendum #11

BIRTH DEFECT INVESTIGATION REPORT

Birth Defects Among Deliveries to Residents of

Midlothian, Venus, & Cedar Hill, Texas, 1997–2001

PREPARED JUNE 29, 2005 BY MARY ETHEN, EPIDEMIOLOGIST

BIRTH DEFECTS EPIDEMIOLOGY AND SURVEILLANCE BRANCH

TEXAS DEPARTMENT OF STATE HEALTH SERVICES

BACKGROUND

A community member expressed concern over birth defects in Midlothian (Ellis County), Venus (Johnson County), and Cedar Hill (Ellis and Dallas Counties),

Texas. The community member also expressed concern about pollution from cement

kilns in or near these three communities and a steel mill in or near Venus, Texas.

METHODS

Case Definition

The areas of interest are south of Dallas and Fort Worth. The Texas Birth Defects

Registry began collecting information in this part of the state with deliveries in January 1997, and the most recent delivery year for which the registry has completed

data collection is 2001.

Based on this information, a case was defined as an infant or fetus . . .

• with any of 48 specific birth defects, or with any birth defect monitored by

the registry;

• born between January 1997 and December 2001;

• born to a mother who resided in Midlothian, Venus, or Cedar Hill at the time

of delivery.

Each community was examined separately from the other two communities.

Case Finding

The Texas Birth Defects Registry was searched to find cases meeting the case definition. The mother’s place of residence at the time of delivery was based on information reported on the child’s birth or fetal death certificate, when available. If a

birth or fetal death certificate could not be found, the mother’s place of residence

at the time of delivery was based on information in the Texas Birth Defects Registry

that had been abstracted from hospital medical records.

Occurrence Evaluation

Unadjusted Prevalence: Cases in the registry were used to calculate prevalence rates

per 10,000 live births for 48 specific birth defects and for infants and fetuses with

any birth defect monitored by the registry. Calculations were done for the three

communities separately. The 95 percent confidence interval for each prevalence was

calculated based on the Poisson distribution. In order to determine if there was a

statistically significant elevation in the occurrence of birth defects, the prevalence

rates for the areas and time period of interest were compared to the prevalence

rates for all of Texas during January 1999 through December 2001. Prevalence rates

were considered statistically significantly different if their 95 percent confidence intervals did not overlap.

Adjusted Prevalence: The occurrence of many types of birth defects is known to vary

between mothers of different age groups, mothers of different racial/ethnic groups,

and between male and female infants. For each type of birth defect that was statistically significantly elevated based on the unadjusted prevalence, we calculated

prevalence rates adjusted separately for age, race/ethnicity, and sex. Adjustment accounts for any differences in the age, racial/ethnic, or sex composition of populations

being compared, in this case, differences between the communities of interest during

1997–2001 and all of Texas during 1999–2001.

Using the direct method of standardization, maternal age-specific rates for the

area of interest were standardized (adjusted) to the maternal age distribution of all

Texas resident live births during 1999–2001. The resulting adjusted rate is the hypothetical rate that would have been observed in the area of interest if that area

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1 Abramson JH, Gahlinger PM. Computer Programs for Epidemiologists: PEPI, version 4.0.

!Salt Lake City, Utah: Sagebrush Press, 2001.

had the same maternal age distribution as Texas overall in 1999–2001. Similarly,

maternal racial/ethnic-specific rates for the area of interest were standardized to the

maternal race/ethnic distribution of Texas resident live births during 1999–2001,

yielding the hypothetical rate that would have been observed if the area of interest

had the same maternal race/ethnic distribution as Texas. Finally, adjustment for infant sex was accomplished in the same manner.

The DIRST module of Computer Programs for Epidemiologists,1 version 4.0, was

used to calculate directly standardized rates and their associated 95 percent confidence intervals.

Age-, Race-, and Sex-specific Prevalence: For the types of birth defects that were statistically significantly elevated based on the unadjusted prevalence and that remained statistically significant after adjustment, we have shown prevalence by maternal age group, maternal racial/ethnic group, and infant sex, plus 95 percent confidence intervals based on the Poisson distribution.

Estimated Date of Conception: The estimated date of conception was calculated and

graphed for cases having the types of birth defects that remained statistically significantly elevated after adjustment. If the last menstrual period (LMP) date was

available, the estimated date of conception was calculated as the LMP date plus 14

days. If LMP date was not available, the estimated date of conception was calculated as the expected date of delivery minus 266 days.

Spot Map: For the types of birth defects that remained statistically significant after

adjustment, a spot map was made using the mother’s residence address at the time

of delivery, as reported on the child’s birth or fetal death certificate. The map is not

included in this report to protect the privacy of the families.

RESULTS

Unadjusted Prevalence: We examined the occurrence of 48 types of birth defects and

any birth defect monitored by the registry among deliveries during January 1997

through December 2001 to residents of Midlothian, Venus, and Cedar Hill separately.

For Venus and for Cedar Hill during 1997–2001, none of the birth defects examined was statistically significantly higher than the statewide prevalence in 1999–

2001. The prevalence of any monitored birth defect also was not statistically significantly elevated in Venus or Cedar Hill, compared to the entire state.

For Midlothian during 1997–2001, two categories of birth defects were statistically

significantly higher than the statewide prevalence in 1999–2001.

The unadjusted prevalence of hypospadias or epispadias among Midlothian resident deliveries during 1997–2001 was 102.39 cases per 10,000 live births (95 percent confidence interval 52.91–178.85) (Table 1), which was 3.5 times the prevalence

for Texas in 1999–2001 (28.87 cases per 10,000 live births, 95 percent CI 27.86–

29.88) and statistically significant.

The unadjusted prevalence of any monitored birth defect among Midlothian resident deliveries during 1997–2001 was 511.95 cases per 10,000 live births (95 percent CI 390.61–658.96) (Table 2). This was 1.5 times the prevalence for Texas in

1999–2001 (350.12 cases per 10,000 live births, 95 percent CI 346.59–353.65) and

statistically significant.

Adjusted Prevalence: Adjusted prevalences were calculated for hypospadias or

epispadias and for any monitored birth defect among Midlothian resident deliveries

during 1997–2001.

For hypospadias or epispadias (Table 1), adjusting for infant sex had no impact

on the prevalence, yielding a sex-adjusted prevalence of 102.75 cases per 10,000 live

births, which was essentially unchanged from the unadjusted prevalence of 102.39

cases per 10,000 live births. Adjusting for maternal age group caused the prevalence

of hypospadias or epispadias to increase very slightly, from 102.39 unadjusted to

106.02 after adjustment. Adjusting for maternal race/ethnicity caused the prevalence of hypospadias/epispadias to increase from 102.39 unadjusted to 119.86 after

adjustment.

This means that the elevation observed in Midlothian during 1997–2001 for

hypospadias or epispadias cannot be attributed to differences between Midlothian

and Texas overall in the proportion of boys and girls being born, or in the race/ethnic or age distribution of women having children. The prevalence of hypospadias or

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epispadias remained statistically significantly elevated in Midlothian after adjustment for sex, maternal age, and maternal race/ethnicity.

For any monitored birth defect (Table 2), adjusting for sex had no impact on the

prevalence. The sex-adjusted prevalence, 512.58 cases per 10,000 live births, was

nearly the same as the unadjusted prevalence, 511.95. Likewise, adjusting for maternal age group had no impact on the prevalence of any monitored defect (511.95

unadjusted compared to 513.71 after adjustment).

Adjusting for maternal race/ethnicity caused the prevalence of any monitored

birth defect to decrease from 511.95 per 10,000 unadjusted to 402.69 adjusted (95

percent CI 256.37–549.01) (Table 2). Further, the adjusted prevalence was no longer

statistically significantly elevated compared to Texas in 1999–2001 (350.12; 95 percent CI 346.59–353.65).

This means that the elevation observed in Midlothian during 1997–2001 for any

monitored birth defect can be explained by differences between Midlothian and

Texas overall in the race/ethnic distribution of women having children. In

Midlothian, 83.2 percent of mothers who gave birth in 1997–2001 were non-Hispanic

White women, while in Texas during 1999-2001, only 39.2 percent of births were

to non-Hispanic White mothers. Further, in Texas overall during 1999–2001, the

prevalence of any monitored birth defect was statistically significantly higher among

non-Hispanic White mothers (374.16 per 10,000 live births; 95 percent CI 368.33–

380.00) than among African American mothers (339.69; 95 percent CI 329.34–

350.04) or Hispanic mothers (340.34; 95 percent CI 335.21–345.48). Because most

Midlothian mothers are non-Hispanic White women, and because the prevalence of

any monitored birth defect is higher among mothers of this race/ethnic group, the

unadjusted prevalence of any monitored birth defect in Midlothian was higher than

the Texas prevalence, and it decreased after adjustment for race/ethnicity.

Age-, Race-, and Sex-specific Prevalence: Since hypospadias or epispadias was the

only type of birth defect that was statistically significantly elevated after adjustment, we took a closer look at it. Table 3 shows the prevalence of hypospadias or

epispadias by maternal age group, maternal race/ethnicity, and infant sex among

Midlothian resident deliveries during 1997–2001. Data for Texas in 1999–2001 are

also presented for comparison.

The mothers of Midlothian children with hypospadias or epispadias ranged in age

from 17 to 37. The prevalence of hypospadias or epispadias among mothers less

than 20 years old was statistically significantly higher in Midlothian than in Texas.

For all other maternal age groups, the Midlothian prevalences did not attain statistical significance.

Midlothian mothers of ‘Other’ race/ethnicity were significantly more likely to have

a child with hypospadias or epispadias than mothers of ‘Other’ race/ethnicity statewide. This was the only racial/ethnic group that was statistically significantly higher than the state.

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The prevalence of hypospadias or epispadias among male infants was also statistically significantly higher in Midlothian than Texas.

Estimated Dates of Conception: The 12 Midlothian children born during 1997–2001

with hypospadias or epispadias were estimated to have been conceived from September 1996 through April 2000. No more than one case was conceived in any given

month during this time period, nor was there any other evidence of clustering in

time (Figure 1).

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Spot map: The spot map of maternal residence address at time of delivery for the

12 Midlothian children born during 1997–2001 with hypospadias or epispadias did

not show any strong evidence of geographic clustering within Midlothian. Seven of

the residences were distributed within the current Midlothian city limits and five

were outside the city limits. The map is not included in this report to protect the

privacy of the families.

DISCUSSION

Using data in the Texas Birth Defects Registry, we examined the occurrence of

48 specific birth defects and any defect monitored by the registry among deliveries

during 1997–2001 to residents of Midlothian, Venus, and Cedar Hill, Texas. None

of the birth defects examined were statistically significantly elevated in Venus or

Cedar Hill. Any monitored birth defect and hypospadias or epispadias were elevated

in Midlothian during 1997–2001.

The prevalence of any monitored defect in Midlothian decreased and was no

longer statistically significantly elevated after adjusting for maternal race/ethnicity.

This indicates that the elevation observed in Midlothian for any monitored birth defect can be attributed to differences between Midlothian and Texas in the race/ethnic distribution of women having children. If Midlothian had the same maternal

race/ethnic distribution as Texas, the prevalence of any monitored birth defect in

Midlothian would have been within the range of what is expected.

Hypospadias or epispadias remained statistically significantly elevated in

Midlothian after adjustment for sex, race/ethnicity, and age, meaning that this elevation cannot be explained by differences between Midlothian and the state in the

proportion of boys and girls being born, or in the race/ethnic or age distribution of

women having children.

Hypospadias is a congenital defect in which the urinary meatus (urinary outlet)

is on the underside of the penis or on the perineum (the area between the genitals

and the anus). In epispadias, the urinary meatus opens above (dorsal to) the normal

position. The corresponding defects in females are very rare.

All of the 12 Midlothian children had hypospadias, rather than epispadias.

A spot map did not indicate geographic clustering within Midlothian of the residences of the mothers of children with hypospadias, and a graph of estimated conception dates did not indicate clustering in time of conception.

We made 147 comparisons of community level birth defects data to statewide data

(48 birth defects plus any monitored defect, times three communities). At the 95

percent level of significance, we would expect five percent of the 147 comparisons,

or seven comparisons, to have been statistically significant due to chance. We found

two that were statistically significant, and one that remained significant after adjustment for sex, maternal race/ethnicity, and maternal age.

Although hypospadias/epispadias was elevated in Midlothian, it does not meet criteria to continue this investigation and thus further study at this time is unlikely

to yield useful results. To continue, our protocol requires at least three cases with

a documented biologically plausible exposure that the cases have in common, or at

least five cases with an observed rate of more than 10 times the expected rate. However, because of the elevation, the Texas Birth Defects Registry will continue to

monitor hypospadias. As more years of data become available in the future, we will

re-examine the prevalence of hypospadias in the area.

CONCLUSIONS

Hypospadias or epispadias was elevated among Midlothian resident deliveries

during 1997–2001. We will re-examine the occurrence of hypospadias or epispadias

after subsequent delivery years are completed in the Texas Birth Defects Registry.

For more information, contact Mary Ethen at the Birth Defects Epidemiology and

Surveillance Branch at 512–458–7111, ext. 2052, or e-mail

mary.ethen@dshs.state.tx.us, or visit our web site at http://www.dshs.state.tx.us/

birthdefects/

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1Guidelines for Investigating Clusters of Health Events, Centers for Disease Control and Prevention, MMWR 1990; 39 (RR–11): 1–16.

Addendum #12

Summary of Investigation into the Occurrence of Cancer

Zip Codes 76065, 75104, and 76084,

Midlothian, Cedar Hill, and Venus

Ellis, Dallas, and Johnson County, Texas

1993–2002

MAY 19, 2005

Background:

Concern about a possible excess of cancer prompted the Texas Cancer Registry (TCR) Branch of the Texas Department of State Health Services (DSHS) to examine

the occurrence of cancer in zip codes 76065, 75104, 76084, Midlothian, Cedar Hill,

and Venus, Texas. Local residents were concerned that benzene, 1, 3 butadiene, and

radiation from the nearby cement plants may be causing cancer among residents.

Laryngeal cancer has been associated with workers exposed to cement dust. Benzene has shown an association with acute myeloid leukemia and non-Hodgkin’s

lymphoma in the scientific literature, while radiation has been weakly linked with

several leukemia subtypes, non-Hodgkin’s lymphoma, and brain cancer. Exposure to

1, 3 butadiene has been associated with leukemia. The TCR evaluated 1995–2002

incidence data and 1993–2002 mortality data for cancers of the female breast, prostate, lung and bronchus, colon and rectum, male bladder, corpus and uterus, nonHodgkin’s lymphoma, brain/CNS, larynx, selected leukemia subtypes, and total

childhood cancers. Incidence data are the best indicator of the occurrence of cancer

in an area because they show how many cancers were diagnosed each year. Cancer

mortality data are used as a supplemental measure and are complete for the entire

state through 2002. The rest of this report examines the investigative methods the

TCR used, the results of the investigation, recommendations, and general information on cancer risk factors.

Methodology:

According to the National Cancer Institute, a cancer cluster is a greater than ex- pected number of cancers among people who live or work in the same area and who

develop or die from the same cancer within a short time of each other. The cancer

cluster investigation is the primary tool used by the TCR to investigate the possibility of excess cancer in a community. The cancer cluster investigation cannot determine that cancer was associated with or caused by environmental or other risk

factors. Instead, the cancer cluster investigation is specifically intended to address

the question ‘‘Is there an excess of cancer in the area or population of concern?’’

The TCR follows guidelines recommended by the Centers for Disease Control and Prevention for investigating cancer clusters1 and often works with the DSHS Environmental and Injury Epidemiology and Toxicology Branch, as well as other state

and federal agencies. In order to determine if an excess of cancer is occurring and

if further study is recommended, biologic and epidemiologic evidence are considered.

Such evidence may include documented exposures; the toxicity of the exposures;

plausible routes by which exposures can reach people (ingesting, touching, breathing); the actual amount of exposure to the people which can lead to absorption in

the body; the time from exposure to development of cancer; the statistical significance of the findings; the magnitude of the effect observed; risk factors; and the consistency of the findings over time. The occurrence of rare cancers or unlikely cancers

in certain age groups may also indicate a cluster needing further study. Because excesses of cancer may occur by chance alone, the role of chance is considered in the

statistical analysis. If further study is indicated, the TCR will determine the feasibility of conducting further epidemiologic study. If the epidemiologic study is feasible, the final step is

to recommend and/or perform an etiologic investigation to see if the cancer(s) can

be related to an exposure. Very few cancer cluster investigations in the United

States proceed to this stage. To determine whether a statistically significant excess of cancer existed in the geographic areas of concern, the number of observed cases and deaths was compared

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to what would be ‘‘expected’’ based on the state cancer rates. Calculating the expected number(s) of cancer cases takes into consideration the race, sex, and ages of

people who are diagnosed or die from cancer. This is important because peoples’

race, sex, and age all impact cancer rates. If we are trying to determine if there

is more or less cancer in a community compared to the rest of the state, we must

make sure that the difference in cancer rates is not simply due to one of these factors.

The attached Tables 1–6 present the number of observed cases and deaths for

males and females, the number of ‘‘expected’’ cases and deaths, the standardized incidence ratio (SIR) or standardized mortality ratio (SMR), and the corresponding 99

percent confidence interval. The standardized incidence or mortality ratio (SIR,

SMR) is simply the number of observed cases or deaths compared to the number

of ‘‘expected’’ cases or deaths. When the SIR or SMR of a selected cancer is equal

to 1.00, then the number of observed cases or deaths is equal to the expected number of cases or deaths, based on the incidence or mortality in the rest of the state.

When the SIR or SMR is less than 1.00, fewer people developed or died of cancer

than we would have expected. Conversely, an SIR or SMR greater than 1.00 indicates that more people developed or died of cancer than we would have expected.

To determine if an SIR or SMR greater than 1.00 or less than 1.00 is statistically

significant or outside the variation likely to be due to chance, confidence intervals

are also calculated.

A 99 percent confidence interval is used for statistical significance and takes the

likelihood that the result occurred by chance into account. It also indicates the

range in which we would expect the SIR or SMR to fall 99 percent of the time. If

the confidence interval contains a range that includes 1.00, no statistically significant excess of cancer is indicated. The confidence intervals are particularly important when trying to interpret small numbers of cases. If only one or two cases are

expected for a particular cancer, then the report of three or four observed cases will

result in a very large SIR or SMR. As long as the 99 percent confidence interval

contains 1.00, this indicates that the SIR or SMR is still within the range one might

expect and, therefore, not statistically significant.

Results:

The analysis of incidence data for zip codes 76065, 75104, and 76084, Midlothian,

Cedar Hill, and Venus, Texas, from January 1, 1995–December 31, 2002, and mortality data from January 1, 1993–December 31, 2002, found cancers of the breast,

lung and bronchus, corpus and uterus, brain/CNS, bladder, colorectal, non-Hodgkin’s

lymphoma, selected leukemia subtypes, and total childhood cancers (0–19) to be

within normal ranges in both males and females. Prostate cancer mortality was statistically significantly lower than expected in zip code 76065 males while prostate

cancer incidence was statistically significantly lower than expected in zip code 76084

males. Analysis summaries are presented in Tables 1–6.

Discussion:

Like other studies, this cancer cluster investigation had limitations. The number

of years of incidence data examined was limited to eight years and did not include

data for the most recent years. Ten years of mortality data were examined as a supplemental measure. Also, cancer incidence data are based on residence at the time

of diagnosis and mortality data the residence at the time of death. It is possible that

some residents who may have been exposed and developed cancer no longer lived

in the area at the time of diagnosis or death, so were not included in the analyses.

However, it is also possible that people may have moved into the area and then developed or died from cancer because of an exposure from a prior residential location

or other factors. These cases and deaths are included in the investigation.

Recommendations:

Based on the findings and the information discussed above, it is not recommended

at this time to further examine the cancers in zip codes 76065, 75104, 76084,

Midlothian, Cedar Hill, and Venus, Texas. As new data or additional information

become available, consideration will be given to updating or re-evaluating this investigation.

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2 American Cancer Society website: http://www.cancer.org/docroot/CRI/content/

CRI¥2¥4¥1x¥Who¥gets¥cancer.asp?sitearea=. Accessed 04/15/05. 3 National Cancer Institute website: http://cis.nci.nih.gov/fact/3—58.htm. Accessed 04/15/05. 4 Cancer: What Causes It, What Doesn’t. American Cancer Society website: http://

www.cancer.org/docroot/PUB/content/PUB¥1¥1¥Cancer¥What¥Causes¥It¥What¥Doesnt.asp 5Doll R, Peto R. The Causes of Cancer. Oxford: Oxford University Press, 1990. 6 Harvard Reports on Cancer Prevention. Harvard Center for Cancer Prevention. Volume 1:

Human Causes of Cancer. Harvard School of Public Health website: http://

www.hsph.harvard.edu/cancer/publications/reports/vo11¥summary.html 7 2001 Cancer Progress Report. National Cancer Institute website: http://

progressreport.cancer.gov/doc 8 Cancer and the Environment. National Cancer Institute website: http://www.cancer.gov/images/Documents/5d17e03e-b39f-4b40-a214- e9e9099c4220/

Cancer%20and%20the%20Environment.pdf 9 American Cancer Society website. http://www.cancer.org. Accessed 03/31/2005. 10 National Cancer Institute website: http://www.nci.nih.gov/. Accessed 03/31/2005.

Information on Cancer and Cancer Risk Factors:

Overall, the occurrence of cancer is common, with approximately two out of every

five persons alive today predicted to develop some type of cancer in their lifetime.2

In Texas, as in the United States, cancer is the second leading cause of death, exceeded only by heart disease. Also, cancer is not one disease, but many different diseases. Different types of cancer are generally thought to have different causes. If

a person develops cancer, it is probably not due to one factor but to a combination

of factors such as heredity; diet, tobacco use, and other lifestyle factors; infectious

agents; chemical exposures; and radiation exposures. Although cancer may impact

individuals of all ages, it primarily is a disease of older persons with over one-half

of cancer cases and two-thirds of cancer deaths occurring in persons 65 and older.

Finally, it takes time for cancer to develop, more than 10 years can go by between

the exposure to a carcinogen and a diagnosis of cancer.3

The chances of a person developing cancer as a result of exposure to an environmental contaminant are slight. Most experts agree that exposure to pollution, occupational, and industrial hazards account for fewer than 10 percent of cancer cases.4

According to Richard Doll and Richard Peto, renowned epidemiologists at the University of Oxford, pollution and occupational exposures are estimated to collectively

cause four to six percent of all cancer deaths.5 The Harvard Center for Cancer Prevention estimates five percent of cancer deaths are due to occupational factors, two

percent to environmental pollution and two percent to ionizing/ultraviolet radiation.6 Additionally much of the evidence that pollutants and pesticide residues increase cancer risk is presently considered quite weak and inconsistent. In contrast,

the National Cancer Institute estimates that lifestyle factors such as tobacco use

and diet cause 50 to 75 percent of cancer deaths.7 Eating a healthy diet and refraining from tobacco are the best ways to prevent many kinds of cancer. One-third of

all cancer deaths in this country could be prevented by eliminating the use of tobacco products. Additionally, about 25 to 30 percent of the cases of several major

cancers are associated with obesity and physical inactivity.8

Known Risk Factors for Cancers Examined in This Investigation:

The following is a brief discussion summarized from the American Cancer Society

and the National Cancer Institute about cancer risk factors for the specific cancers

studied in this investigation.9,10

The occurrence of cancer may vary by race/ethnicity, gender, type of cancer, geographic location, population group, and a variety of other factors. Scientific studies

have identified a number of factors for various cancers that may increase an individual’s risk of developing a specific type of cancer. These factors are known as risk

factors. Some risk factors we can do nothing about, but many are a matter of choice.

Prostate Cancer

Prostate cancer is the most common type of malignant cancer (other than skin)

diagnosed in men, affecting an estimated one in five American men. Risk factors for

prostate cancer include aging, a high fat diet, physical inactivity, and a family history of prostate cancer. African American men are at higher risk of acquiring prostate cancer and dying from it. Prostate cancer is most common in North America

and northwestern Europe. It is less common in Asia, Africa, Central America, and

South America.

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Breast Cancer

Simply being a woman is the main risk factor for developing breast cancer. Breast

cancer can affect men, but this disease is about 100 times more common among

women than men. White women are slightly more likely to develop breast cancer

than are African-American women, but African Americans are more likely to die of

this cancer because they are often diagnosed at an advanced stage when breast cancer is harder to treat and cure. Other risk factors for breast cancer include aging,

presence of genetic markers such as the BRCA1 and BRCA2 genes, personal and

family history of breast cancer, previous breast biopsies, previous breast irradiation,

diethylstilbestrol therapy, oral contraceptive use, not having children, hormone replacement therapy, alcohol, and obesity. Currently, research does not show a link

between breast cancer risk and environmental pollutants such as the pesticide DDE

(chemically related to DDT) and PCBs (polychlorinated biphenyls).

Lung and Bronchus Cancer

The greatest single risk factor for lung cancer is smoking. The American Caner

Society estimates that 87 percent of lung cancer is due to smoking. Several studies

have shown that the lung cells of women have a genetic predisposition to develop

cancer when they are exposed to tobacco smoke. Other risk factors include secondhand smoke, asbestos exposure, radon exposure, carcinogenic agents in the workplace such as arsenic or vinyl chloride, marijuana smoking, recurring inflammation

of the lungs, exposure to industrial grade talc, people with silicosis and berylliosis,

personal and family history of lung cancer, diet, and air pollution.

Brain/CNS Cancer

The large majority of brain cancers are not associated with any risk factors. Most

brain cancers simply happen for no apparent reason. A few risk factors associated

with brain cancer are known and include radiation treatment, occupational exposure

to vinyl chloride, immune system disorders, and family history of brain and spinal

cord cancers. Possible risk factors include exposure to aspartame (a sugar substitute) and exposure to electromagnetic fields from cellular telephones or high-tension wires.

Bladder Cancer

The greatest risk factor for bladder cancer is smoking. Smokers are more than

twice as likely to get bladder cancer as nonsmokers. Whites are two times more likely to develop bladder cancer than are African Americans. Other risk factors for bladder cancer include occupational exposure to aromatic amines such as benzidine and

beta-napthylamine, aging, chronic bladder inflammation, personal history of

urothelial carcinomas, birth defects involving the bladder and umbilicus, high doses

of certain chemotherapy drugs, and use of the herb Aristocholia Fangchi.

Colon and Rectum Cancer

Colorectal cancer is the second leading cause of cancer death in both men and

women. Researchers have identified several risk factors that increase a person’s

chance of developing colorectal cancer: family and personal history of colorectal cancer, hereditary conditions such as familial adenomatous polyposis, personal history

of intestinal polyps and chronic inflammatory bowel disease, aging, a diet mostly

from animal sources, physical inactivity, obesity, smoking, and heavy use of alcohol.

People with diabetes have a 30 percent–40 percent increased chance of developing

colon cancer. Recent research has found a genetic mutation leading to colorectal cancer in Jews of Eastern European descent (Ashkenazi Jews).

Laryngeal Cancer

Risk factors for laryngeal and hypopharynx cancer include tobacco use, alcohol

abuse, poor nutrition, infection with human papillomavirus, a weakened immune

system, and occupational exposure. Men who are aging and African Americans are

more likely to be diagnosed with this cancer.

Acute Lymphocytic Leukemia

Possible risk factors for ALL include the following: being male, being white, being

older than 70 years of age, past treatment with chemotherapy or radiation therapy,

exposure to atomic bomb radiation, or having a certain genetic disorder such as

Down syndrome.

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Chronic Lymphocytic Leukemia

Possible risk factors for CLL include the following: being middle-aged or older,

male, or white; a family history of CLL or cancer of the lymph system; having relatives who are Russian Jews or Eastern European Jews; or having exposure to herbicides or insecticides including Agent Orange, an herbicide used during the Vietnam War.

Acute Myeloid Leukemia

Possible risk factors for AML include the following: being male; smoking, especially after age 60; having had treatment with chemotherapy or radiation therapy

in the past; having treatment for childhood ALL in the past; being exposed to atomic

bomb radiation or the chemical benzene; or having a history of a blood disorder such

as myelodysplastic syndrome.

Chronic Myeloid Leukemia

Most people with CML have a gene mutation (change) called the Philadelphia

chromosome. The Philadelphia chromosome is not passed from parent to child.

Non-Hodgkin’s Lymphoma

Risk factors for non-Hodgkin’s lymphoma include infection with Helicobacter

pylori, human immunodeficiency virus (HIV), human T-cell leukemia/lymphoma

virus (HTVL–1), or the Epstein-Barr virus and malaria. Other possible risk factors

include certain genetic diseases, radiation exposure, immuno-suppressant drugs

after organ transplantation, benzene exposure, the drug Dilantin, exposure to certain pesticides, a diet high in meats or fat, or certain chemotherapy drugs.

For additional information about cancer, visit the ‘‘Resources’’ link on our web site

at http://www.dshs.state.tx.us/tcr/.

Questions or comments regarding this investigation may be directed to Ms. Brenda Mokry, Texas Cancer Registry, at 1–800–252–8059 or brenda.mokry@

dshs.state.tx.us

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BIOGRAPHY FOR SALVADOR MIER

Sal Mier lives in Midlothian, Texas with his wife Grace.

Sal’s 37-year career in public health started with the Centers for Disease Control

(CDC) in New Orleans, shortly after he graduated from the University of New Mexico. This career took him to Puerto Rico, Arkansas and New Mexico where he had

a temporary assignment to the Navajo Nation.

Sal worked for an interim period with the U.S. Public Health Service, Health Resources and Services Administration, for a short period. He returned to work with

CDC where he ended his federal career as Director, Division of Prevention Region

VI, in Dallas, Texas.

After retiring from CDC, Sal was a private public health consultant with a focus

on U.S./Mexico Public Health issues, HIV and STDs.

Sal and his wife Grace have worked tirelessly these last five years trying to get

answers from what he refers to as ‘‘our guardian agencies’’ about health issues that

are surfacing in the community. ‘‘Our only motivation is the health of our children,

our grandchildren and those yet to be born,’’ he explains.

Chair MILLER. Thank you, Mr. Mier.

Professor Parrish.

STATEMENT OF DR. RANDALL R. PARRISH, HEAD, NATURAL

ENVIRONMENTAL RESEARCH COUNCIL (NERC) ISOTOPE

GEOSCIENCES LABORATORY, BRITISH GEOLOGICAL SURVEY

Dr. PARRISH. It is a privilege to be here and I thank you for the

opportunity. It is an interesting contrast to my day job as research

professor at University of Leicester and I run a large environmental isotope analysis facility in the U.K. My role here today is

really just to provide you with my perspective on the Colonie, New

York, that is a suburb of Albany, New York, health consultation as

a result of my conducting research there on depleted uranium pollution at the site as part of a broader investigation of depleted uranium and health issues.

What I want to do is really just emphasize some of the most relevant and compelling facts and issues about the health consultation. As illustrated on the side panels, depleted uranium munitions

and other uranium manufactured items were made at the National

Lead Industries plant in Colonie, New York, from 1958 to 1984

when the plant was closed due to the company’s environmental

negligence from release of excessive radioactive uranium oxide

aerosols on the surrounding community, and the community can be

seen to surround the remediated plant. In about the mid-1980s the

Federal Government accepted responsibility for this site and up to

2006 has spent approximately $200 million remediating the site. In

response to the community concerns expressed to the Army Corps

of Engineers, the ATSDR concluded a health consultation in 2004

and its fundamental conclusion was that in the active years of

emissions, these emissions endangered the local population and

workers’ health by the risk of inhalation exposure to uranium

oxide. On this conclusion, there is general broad agreement.

With regards to the health consultation that ATSDR did at the

site, let me just mention a few specific outcomes. You will recognize

some themes here that are common to other health consultations.

The Agency decided not to conduct any new research as part of its

health consultation and did not pursue any further environmental

investigations or health surveillance activities. It misunderstood or

was unaware of the analytical tools available at the time to identify

the presence of depleted uranium in urine bioassays via isotope

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analysis. It concluded that the 20-year length of time from the 1984

closure would make identification of any DU exposure, DU meaning depleted uranium, impossible. It also concluded that it simply

wasn’t feasible or possible to identify the cohort of workers and

residents with the highest exposure. It gave also incomplete and in

part unbalanced descriptions of the relative health importance of

the two exposure pathways, one being the relatively benign ingestion pathway, that is, coming into contact with contaminated soil,

and the other being the more insidious inhalation pathway which

has higher health risks associated with it. In short, the Agency appeared to dismiss the viability of conducting any further health

studies on the exposed population.

Now, the difference in the Colonie situation with respect to some

other sites where health consultations have taken place and probably the reason I am here is that our research group has, so to

speak, sort of picked up the pieces of the situation following the

health consultation and we have conducted some of the work that

ATSDR could and should have done. For example, we determined

the chemical form for some of the particulates and showed that it

was the least soluble of all forms of uranium oxide. We also used

a high-sensitivity method for uranium isotope urine testing that we

had previously developed in the U.K., and we showed that depleted

uranium could be identified in the urine of exposed individuals and

it can be quantified, even more than 20 years after these people

were exposed. We extended substantially the existing 1980s vintage environmental surveys and we worked in a collaborative fashion with the community to identify a portion of the historically exposed cohort. In short, we in part accomplished what ATSDR said

was not possible and we did this with very modest resources and

actually at no expense to the U.S. taxpayer. This brings this whole

issue into even sharper focus about the shortcomings of the health

consultation.

Sort of taking a step back, there is a larger perspective about depleted uranium and health issues that relates to broader issues

such as Gulf War illness that affects veterans and the continued

use of depleted uranium munitions by the U.S. military. ATSDR

did not appear to recognize an opportunity at Colonie to shed further light on these broader issues, the opportunity being to study

long-term health consequences, if any, of exposure to inhaled depleted uranium oxides. The exposure to DU has been an ongoing

issue in the media and government with respect to exposure of soldiers to this toxin and its health consequences, and the issue does

not have sufficient study at present. A comprehensive study could

have added new knowledge to help resolve this issue and it is

therefore part of the government’s duty of care to soldiers and veterans who have unselfishly served the Nation.

Considering the acknowledged risks to health at Colonie that

arose partly that were obvious in the first place but also confirmed

by the health consultation, the lack of any resources devoted to targeted health studies at Colonie when compared to the $200 million

spent on remediation is, if one is being generous, grossly imbalanced, and if you are shedding it in the worst light, you could say

that this is somewhat immoral and perverse.

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Let me just conclude with a few general comments about ATSDR and perhaps the way forward. The ATSDR remit sets quite a high

bar to reach, that is, basically effectively protecting the health of

the Nation. This is a complicated and potentially very expensive

challenge. The pattern of performance in recent years as I have

gathered simply from reading documents in the past few weeks and

learning more about this committee appears to suggest that this

standard is not being achieved. So it seems to me there are two options. One is that we partly admit that some of this high bar, this

high standard of performance may be unachievable, in which case,

you know, it should be redefined so that ATSDR can actually have

realistic goals. Alternatively, if the remit of ATSDR is a valid, you know, public service imperative, then it seems to me you have to do three things

and they have to be coordinated and done effectively together. The

first is that the Agency has got to have a strong vision, it has to

have strong leadership and especially needs commitment throughout the organization to its mission and it has to basically embrace

that ethos. The second point is that the Agency needs to have the

resources to pursue its investigations to their logical and defensible

conclusions and be able to resist interference. Both of these two

recommendations, it seems to me, are essential to restore the credibility of the Agency. The third thing that needs to be done in concert with the rest is that the Agency needs to find and implement

a mechanism that effectively and defensibly prioritizes its investigations and resources so that it actually can deliver its remit.

This external review prior to release of documents could form a

component of that. This third one basically would allow the Agency

to maintain credibility once it establishes a renewed sort of presence for the future.

So that is the end of my statement. I will be glad to answer ques- tions later on. Thank you. [The prepared statement of Dr. Parrish follows:]

PREPARED STATEMENT OF RANDALL R. PARRISH

Summary

National Lead Industries (NLI) contracted with the Department of Energy and processed uranium at Colonie NY in the period 1958–84, but in its latter years was

environmentally negligent, badly polluting with depleted uranium aerosols the surrounding site and community. The amount of Depleted Uranium (DU) aerosol emissions were comparable to the total respirable DU released in the entire 1991 Gulf

War, highlighting the significant pollution issue. In 2003–04, the ATSDR conducted

a relatively superficial examination of the health consequences of the pollution of

this site. The report lacked depth and substance, failed to address community concerns with adequate scientific data and explanation, it conducted no new research

at the site, and presented a confusing picture of the toxic hazards. It did not draw

upon the best science available. The site was remediated (completion 2007) by the

Army Corps of Engineers, costing more than $190M. The ATSDR consultation significantly concluded that there was a real and significant health risk to the public

from depleted uranium oxide emissions from the plant stack during its active years

(1958–1982), but it decided not to pursue any environmental surveying or health

surveillance activities for poorly articulated reasons. Planned actions related to uranium were not done subsequent to the report’s publication. The liaison with the

local community appeared to be relatively poor, delivering little in the way of satisfactory communication, and no perceived benefit. No new insight on the situation

was presented that was not already apparent and the nature of uranium toxicology

was not well balanced. In several respects it failed to take advantage of the best

science available to address the issues at the site. It offered little in the way of comment on how to redress the health concerns of the community. In most respects

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other than providing information on toxins, it failed to deliver its remit for the

Colonie site.

My UK research group, beginning in 2004, investigated the nature of the uranium

aerosols, made isotope measurements that documented the isotope characteristics of

the source emissions, studied particle dissolution in the natural environment—a parameter relevant to their solubility, extended the survey of uranium pollution much

more widely, and studied the mobility of uranium in soils and plants, all in order

to gain a better understanding of the environmental pollution. We also worked

closely with the community to identify former workers and residents who lived or

worked in or near the plant for many years during its operation, in order to gather

oral history of events and practices in the plant and to identify part of the exposed

cohort for potential health screening. TSDR evidently decided that this type of approach was not possible or would not be a productive activity. It was instead feasible

and useful, and not particularly costly. We had already developed a urine uranium

isotope test that was capable of detecting trace depleted uranium in urine. We then

tested a small cohort of residents and former workers and clearly showed that our

method was capable of identifying a substantial exposure to depleted uranium

aerosols more than 20 years after exposure. This clearly offered a way forward to

link health outcomes to exposures at Colonie, something ATSDR in 2004 decided

was not possible.

There is a breath-taking lack of environmental and community justice in the

Colonie situation. While the polluter, National Lead Industries, was absolved two

decades ago by the U.S. Government of responsibility and while the Army Corps of

Engineers spent nearly λ200M on site cleanup, no Federal Government monies have

been spent on even a modest-scope targeted health study to identify what if any

health outcomes have occurred for the exposed cohort of people who for years lived

near or worked in the site during its active years of uranium pollution. The community has been left with no research, no credible way forward, little or no redress,

and a significant environmental pollution legacy with a reasonable probability of

some consequences to health of those affected.

Much could have been learned about the environmental health issue of aerosol depleted uranium emissions had ATSDR acted differently; this could have informed

U.S. Government policy as it pertains to Veterans’ Health related to DU munitions

exposure in the battlefield (Gulf Wars I and II) and potentially helped provide vital

data to test any potential connection between Gulf War Illness and depleted uranium exposure. It would certainly have improved the medical knowledge database

on the inhalation hazard of respirable uranium oxide particles, a relatively rare toxicological pathway which does not currently have benefit of any systematic study of

an exposed population, to my knowledge. The need for additional research at the

Colonie site is as acute now as it was in 2003–04 when the ATSDR conducted its

Health Consultation.

My remit—instructions from Congressional subcommittee

The Subcommittee has asked me to do two things: summarize my investigations

into the National Lead Industries (NLI) Colonie NY site and critique the 2004

Colonie ATSDR report and suggest how to improve its environmental health assessments in the future. My contribution herein is largely concerned with the uranium

issues at Colonie, not the full menu of pollution-related toxins.

Background and current position; summary of expertise

I am Randall R. Parrish and occupy a joint position of Professor of Isotope Geoscience, University of Leicester (UK) and Head of the UK Natural Environment Research Council Isotope Geosciences Laboratory, a national isotope research and

analysis facility serving the UK scientific, mainly the academic scientific community. I have occupied this joint post since 1996. More details on my expertise, skills,

publications, research and so forth is contained in the CV and biography provided

as part of the requested testimony.

I conduct research in many areas of geo- and environmental science, but have a

particular expertise in analysis of uranium and lead isotopes using high sensitivity

mass spectrometry and am a recognized authority in this area. I have published extensively using such methods, mainly in geoscience in the field of geochronology—

the determination of the age of rocks and minerals using radioactive decay of Uranium. Although most of my research has been and continues to be in Earth science,

since 2003 I have applied this expertise to environmental health research on topics

that relate to the issue of depleted uranium (DU) pollution and health. Our work

has had some impact on how the UK government approaches its duty of care to the

UK soldiers that may have been exposed to depleted uranium munitions and its enVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00177 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
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vironmental consequences. I developed a keen interest in this problem because of

the lack of thorough relevant studies, its novelty, and the fact that it was and still

is an issue in dire need of sound scientific data to combat the huge amount of media

and political noise surrounding ‘depleted uranium’ and its potential relationship to

Gulf War Illness.

The wider justification for study of the Colonie site

The overriding reason that I got involved in research at the National Lead Indus- tries Colonie NY site was to try to solve a long-standing problem: how long does

inhaled DU oxide reside in the human body and what relationship, if any, does such

an exposure have on human health and how might it be quantified? In spite of notions to the contrary, this problem has not been solved because no cohort of people exposed by inhalation to this particular toxin has been adequately

studied. As it turns out the NLI Colonie NY site is virtually unique in its relevance to this issue, quite apart from the intrinsic need to address the environmental stewardship and potential health issues of this highly polluted site. My role has been

to provide the analytical and environmental science to address this problem. I hope

my testimony will clarify your understanding of the problem and the perspective I

have on the 2004 Colonie ATSDR Health Consultation.

Some observations about the Colonie situation

• The uranium pollution at Colonie originated at the former National Lead Industries site; all agencies appear to accept that there is no other credible

source for the uranium pollution there. From my knowledge base, I agree.

• The uranium pollution is primarily composed of depleted uranium oxide aerosol particles, which have a distinctive isotope composition with some limited

variability; we have measured this extensively in our studies. My Ph.D. student published an article on this just last week—it is appended in these documents.

• The uranium pollution at Colonie occurred as a result of environmental negligence of National Lead Industries through inadequate filtration and capture

of combusted depleted uranium metal waste.

• The period of active pollution was ∼1958–1982 and aerosol pollution ceased

with plant closure, though re-suspension of polluted soil undoubtedly occurred

after plant closure.

• Our recent research has shown that household dust may have unacceptably

high levels of DU; this may be a risk to health if disturbed—a potential

health issue, and certainly a perceived concern of the community at the

present time.

• ATSDR’s 2004 principle conclusion of merit was that the level of airborne radioactivity emitted from the plant represented a distinct health risk during

plant operation. The ATSDR report’s lack of recommendations concerning

past risk to health was a puzzling omission from the report and an obvious

source of frustration to the community.

• The ATSDR 2004 report has an overemphasis on ingestion exposure to DU

by comparison with the acknowledged more hazardous inhalation pathway,

because the latter may lead to long-term internal radiation whilst the former

is likely to be cleared quickly in the intestinal tract. This is all the more important since our recent research has shown that the uranium aerosol pollution at Colonie is very weakly soluble, and contains a significant proportion

of respirable particles. This de-emphasis of the inhalation exposure pathway

is a significant weakness of the report.

• In the assessment of health risks and exposures, what is important is getting

at an estimate of the cumulative inhalation uranium exposure of workers and

residents; this is not simple. It needs to be appreciated that it is entirely

wrong to conclude that because urinary uranium levels are relatively low now

that there was/is no health issue. In this ‘historic exposure situation’ the comparison of current excretion levels in relation to the overall population is a

flawed basis for health risk assessment.

• The task of calculating a cumulative historic inhalation uranium oxide dose

is complex, but can be modelled using existing, relatively well accepted biokinetic models along with a range of solubilities of DU oxide particles, using

experimental data, and estimates of excretion of inhaled DU. The U.S. Army

Capstone (∼2004) report specifically investigated this issue; the ATSDR report

was apparently unaware of it and in any case chose not to pursue this avenue

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of investigation. A fairly thorough discussion of this topic was available in the

period 2000–2004 and for example is contained in the Royal Society report

on DU (2001). I have included an explanation of this later in the written testimony explaining how current excretion levels of DU can be used to calculate

the much larger quantities of inhaled uranium during an historic exposure.

• The detection of depleted uranium as a component of the urinary uranium excreted by affected people is a challenging but feasible measurement; it was

feasible in 2003–04 (via for example the UK DUOB website) when ATSDR

concluded there was no method available, but it had yet to be published in

the refereed literature.

• The quantity of inhalable DU oxide deposited in the vicinity of the Colonie

Plant is comparable to the total aerosolized inhalable DU oxide produced in

the entire 1991 Gulf War conflict; in Colonie, >95 percent of this quantity was

deposited within 2km radius of the NLI plant; in the 1991 Gulf conflict, the

area of dispersion in Iraq-Kuwait was very much larger and partly in sparsely inhabited areas along the Basra Road. Thus the environmental pollution

and health risk is likely to have been much higher for Colonie residents than

for Gulf War veterans. This sobering perspective has never been appreciated

or recognized and is all the more unbalanced when considering how funds

have been spent on research into DU and health.

• No credible well-designed health assessment has been funded or conducted at

Colonie; yet, >$190M has been spent on the NLI cleanup within its perimeter

fence, not to mention funding allocated to ATSDR for its Health Consultation

and that dedicated to other DU-Health research such as the Capstone study

of the U.S. Army. This whole funding situation appears perverse, misdirected,

and lacking a natural sense of balance (one could say fairness & justice), in

my opinion.

• In my opinion the ‘zip code’ based cancer occurrence ‘studies’ cited by the

ATSDR Health Consultation and conducted by NY State agencies were unlikely to accurately identify any significant rise in illness that might have

arisen from long-term significant inhalation exposure to DU from the NLI

plant of a cohort of heavily exposed workers or residents. The movement of

people with time in and out of the area, the lack of tracking of the most exposed few hundred individuals, and the study of former workers unlikely to

have lived nearby meant that this type of study was doomed from the beginning of delivering insight. Why ATSDR opted to not design a more targeted

study or to more intelligently discuss the shortcomings of these NY State

studies is baffling to me, and no doubt a serious source of frustration to the

community.

• The studies that I and my team have conducted at Colonie, both urinary testing (on a small scale) and environmental surveying, have been modest in

scale and cost, and were entirely feasible at the time of the 2004 ATSDR Consultation; the ATSDR paper made no recommendations to undertake any such

study.

• Unfortunately the 2004 ATSDR Health Consultation undertook no new research and seemed uninterested in such follow-up work; while clearly recognizing the inherent health risk of the plant, the paper concluded without recommending any way of redressing the community concerns about uranium

pollution, whether well-founded or not. It is no wonder that the report satisfied few.

• I have solicited feedback about the 2004 report by the Community Concerned

about National Lead; their comments are very critical of ATSDR. This is primarily because while the health hazard was clearly admitted, no recommendations for new research or health screening were made, for reasons

that were poorly articulated and justified. As a scientist, I too find a puzzling

lack of credible justification for the lack of action arising from the report. The

report has therefore made little if any contribution to knowledge or public understanding of the scientific and health issues of the Colonie site that were

not already available.

Our research at Colonie 2004–2009

With information from several sources, in ∼2004 I recognized the unique situation

of significant historic uranium aerosol inhalation exposure of a large urban population in Colonie, a mixed industrial-residential part of Albany NY. Its attributes

of interest were:

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(1) there was a great amount of uranium pollution;

(2) the nature of the pollution was primarily by aerosol deposition of combusted uranium oxide particles;

(3) it took place over a long period of time but ceased more than 25 years ago;

(4) many individuals who had lived through the active period of aerosol deposi- tion were still living in the area; and,

(5) it seemed certain that if individuals living there also had aerosol-contami- nated soil, then they would have inhaled the toxin over a long period of

time. It thus appeared to be a well-controlled experiment where one had an opportunity to address the health impacts of those exposed to inhaled DU, and that such study

might have a bearing on the larger issue of inhaled DU and Veterans’ Health.

Though this latter problem falls outside of the remit of ATSDR, I think it is important for Members of the Committee to gain a perspective on how the Colonie example could benefit and contribute to other scientific issues of acute interest to the

American Government, namely the health of Gulf War(s) Veterans.

Chronological perspective on DU research and the Colonie site

To provide a better perspective, I will outline the pertinent events leading up to the present that bear on my research at Colonie, DU and Health, and the ATSDR

consultation.

In chronological order, they are:

• 1958–1982: Colonie site uranium pollution;

• ∼1984; U.S. Government accepts responsibility of site from the polluter, National Lead; DU munitions production shifts to other U.S. plants.

• 1982–2007: Assessment of site and major remediation by Army Corps of Engineers within the former National Lead Industries site costing >$190M.

• 2001: publication of the WHO and Royal Society papers on Depleted Uranium

and Health, during a period when DU was a major issue in the American,

Canadian, and UK media.

• 2001: UK government established the Depleted Uranium Oversight Board

(DUOB) to oversee and undertake a voluntary program of testing of veterans

who may have been exposed to DU through service primarily in the 1991 Gulf

Conflict. The minutes of this Board were available.

• The DUOB undertook to establish a reliable urinary DU exposure test that

could potentially detect a milligram-sized inhaled DU dose after 10 years had

passed, in order to satisfy the concerns of potentially exposed veterans. This

test was available as of late 2003. This was to be a much more sensitive test

than was available any where else in the world. The program of testing took

place between 2004 and 2006. To my knowledge this capability currently exists only in the UK and possibly Germany.

• The NIGL laboratory of which I am Director was one facility offering this test

and it was engaged in the analysis of many hundreds of urine samples during

this period. I played a key role in this development and testing.

• The Final Report of the DUOB testing program (published eventually in

2007) showed that no individual tested in the program was DU-positive.

• Because of the preponderance of DU-negative results, even in 2004 part way

through the program, I felt that there were two explanations possible for

these results:

(1) Some of the veterans were significantly exposed to DU but the passage

of time had ensured that residual DU contamination was undetectable;

thus health harm may have occurred without a DU-positive test.

(2) The veterans with DU-negative test results were not significantly exposed to DU.

Unfortunately there was no study available at the time to quantify the residence time of inhaled DU oxide particles, and both alternatives remained viable explanations of the data; the debate in the UK concerning DU exposure

and Health therefore could not yet be fully resolved.

• In the period around 2001–2004 unpublished information became available

from Iraqi medical officials of an apparently progressive and significant rise

in unusual cancers and birth defects throughout the 1990s; this was not clearly verified but Iraqi and some western medical officials attributed this to DU

exposure. This added some anecdotal evidence that there might be a DU–

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Health connection even though other reports were suggesting that the connection between DU and Gulf War Illness was weak.

• In 2004 I learned of the Colonie site; as noted earlier in this testimony, it

appeared to involve a significant aerosol DU oxide pollution footprint in an

urban area, with the implication that it was likely that many people had a

DU oxide inhalation exposure; thus it to me seemed worth pursuing since it

offered a way to resolve the alternatives expressed above about the interpretation of the DUOB DU-negative results.

• With considerable anticipation of new insight, I read the ATSDR 2004 report,

and while pleased to read of its conclusion that the uranium emissions during

the plant’s active period was hazardous, I was quite disappointed with its

lack of new data/research and its lack of tangible actions and recommendations for the future. To my knowledge no follow up work was done by ATSDR

related to uranium.

• In 2004 I initiated a research project at Colonie, aimed at providing (1) a

modern environmental study to document the nature and mobility in the environment of the DU oxide aerosols and (2) urinary tests of potentially significantly exposed individuals (former workers of the plant and residents who

had lived nearby for years) to determine whether any urinary DU could be

detected. A Ph.D. student (Nicholas Lloyd) was given the environmentally-oriented project, while I undertook the urinary testing. We cooperated in these

studies with colleagues at the University at Albany (Dr. David Carpenter and

Dr. John Arnason). Funding for this work was provided by the British Geological Survey and the UK Natural Environment Research Council.

• In latest 2004 the analysis of the Colonie urine samples showed that it was

possible to detect DU in humans more than 20–25 years following exposure

(eventually published in 2008). This allowed one to favor one interpretation

of the DUOB-tested Gulf War veterans—that they had not acquired a significant DU inhalation dose. We knew in latest 2004 that our method of testing

offered a way forward to identify and potentially quantify the cumulative inhalation dose of DU for the Colonie exposed population; this conclusion had

very important implications for any follow-on actions arising from the 2004

ATSDR report.

• Our environmental study data was progressively completed in the period

2005–2008; it had several important conclusions, namely:

(1) DU in soil profiles has very limited mobility, indicating a lack of rapid

dissolution of DU in the natural environment;

(2) Particles of DU oxide aerosol could be located and studied in contaminated soil, and in household dry dusts, and after study (using a synchrotron X-ray source), it was confirmed that UO2 was the principle

chemical component, a finding that is expected in thoroughly combusted

material; UO2 is the least soluble of any uranium oxide.

(3) UO2 particles form a minor component of the man-made metal oxide

aerosol particles contained in soil; the bulk of the remainder mainly

consists of lead particles.

(4) Particles of UO2 within soil were found to have suffered minor (generally <10 percent) dissolution by being subject to natural weathering

for more than 25 years; this confirms that the combustion product aerosol emissions from Colonie were relatively insoluble.

(5) Samples of trees, plants, berries, etc., growing on contaminated soil contain DU; this indicates that some component of DU is soluble and taken

up in plants.

(6) No sample of soil collected to date, including those up to seven km

(minus five miles) from the NLI site, is free of DU; the pollution plume

is much larger than was originally thought.

(7) With our data, a calculation of the total mass of DU emitted from the

plant was made, the resultant quantity being approximately 10 metric

tons (give or take a few). This is comparable to the total aerosolized DU

oxide produced by the Allied Forces in the entire 1991 Gulf Conflict,

demonstrating the relative magnitude and concentration of DU in the

Colonie site.

• 2008: Publication of the Parrish et al. paper on the Colonie site in Science

of the Total Environment; this study when combined with the efforts of the

Community Concerned about National Lead (CCNL), resulted in a renewed

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effort to obtain NY State funding for a credible targeted follow-up health

study of affected residents/workers of the NLI site; this activity is ongoing.

Critique of the ATSDR Health Consultation

Prior to making some criticism of the document, it is important to note the

strengths of the 2004 ATSDR Colonie Health Consultation, namely:

• It provided a good review and summary of the history of the site and all previous investigations, and brought together information from a variety of

sources.

• It used measurements of emissions of radioactivity from the site available

from environmental monitoring to conclude that there was a significant

health risk to those who lived nearby during the period of active emissions.

• It made an effort to have meetings with the community to present its findings, take note of concerns before preparing its final report.

• It recommended two specific actions related to the NLI plant, namely,

(1) ATSDR will work with local physicians and provide information on taking patients’ environmental exposure histories. ATSDR will also make

available resources related to environmental exposure, including contaminant-specific case studies and fact sheets.

(2) ATSDR is evaluating the feasibility of conducting a study that would

compare the mortality rates of former NL workers to the mortality rates

of the general public. Former workers likely received the highest exposures to depleted uranium from 1958 to 1984 during operation of the

facility. Currently, ATSDR is determining whether relevant past worker

records exist.

Unfortunately it also had many shortcomings. I will outline what I feel are

the most important problems rather than undertake a detailed critique.

• The study presents a skewed and narrow portrayal of the potential hazards

of DU in that it over-emphasized the ingestion-related pathway and underplayed the inhalation hazard. This may have been influenced by the lack of

published literature on health impacts to cohorts exposed to inhaled DU—a

situation arising because of the rarity of such incidents. The report appears

to have used the lack of literature to downplay the importance of this problem

instead of undertaking a credible analysis of the inhalation hazard with available data and models. This should have been done, but was not. The analysis

of the Royal Society (2001), WHO (2001) and Depleted Uranium Oversight

Boards (website 2001 onwards) had fairly thorough treatment of this issue,

but these sources of information evidently failed to influence the report.

• The discussion on pages 15–16 concerns the health risks of exposure, pathways of exposure, and health survey design analysis. It has undoubtedly left

members of the public confused because it contains inconsistencies, is partly

wrong, lacks detailed logic and explanation, and is sort of a shopping list of

assertions and conclusions without satisfactory elaboration.

This section should have explained the inhalation hazard and its consequences in detail, since this was the main exposure pathway for the Colonie

area (i.e., by breathing aerosols during the plants operation). In my opinion,

addressing the health hazard of DU oxide inhalation exposure is the single

most important reason to have conducted this Health Consultation. Therefore

it should have noted the relative magnitude of pollution of the site—one of

the largest concentrations of DU aerosol pollution in the world, if not the

largest. It should have explained that the consequences of inhalation of respirable particles of DU oxide would lead to long residence times in the lungs,

on the order of years, with consequent internal organ irradiation by alpha

emitters and the likely illness that a major dose of such radiation could have

led to. It should have sharply contrasted the differences between the inhalation and ingestion pathways and their implications of short (with ingestion)

and long (with inhalation) residence times in lungs. It should have mentioned

the consequences to subsequent urinary testing of these two ingestion and inhalation scenarios. It could have and should have summarized biokinetic

models that are in theory capable of modelling (i.e., predicting retrospectively) the magnitude of cumulative inhalation dose if the time elapsed since

exposure was known and if the daily excretion of DU can be determined. It

should also have outlined generally the method of detection (i.e., explained

what bioassays methods were available, especially the isotope tests) and their

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detection limits, to explain to the public whether or not tests available at the

time were capable of detecting such residual DU in urine. It should have acknowledged that a urinary measurement made more than 20 years after exposure would be expected, even with very large initial exposure, to be orders

of magnitude lower in concentration than it would have been initially. There

is much missing in this section; only ATSDR officials can provide the rationale for such a superficial treatment of some of these issues. The section appears to avoid dealing with the main issue.

• The statement on top of page 16 states that if DU had been found in urinary

tests, that such tests would be incapable of indicating ‘where the DU came

from.’ This is largely wrong; isotope analysis is a very powerful technique to

establish plausible links (or refute them) between sources and exposures. This

is all the more surprising since they discuss the NLI plant as the only source

of DU for the uranium pollution of the site (on page 19). There is essentially

a dismissal of the role that isotope analysis of uranium could play in testing

this link. The report shows a lack of insight and understanding of this whole

area of measurement. This is all the more surprising since analytical laboratories within CDC itself are conducting research into such measurements of

uranium in urine. Perhaps there is a lack of joined up communication within

CDC in this regard. One could be forgiven for concluding that they just were

not interested in recommending any kind of urinary uranium testing.

• Pages 16–17 discuss the issue of existing health surveys and the possibility

of a new health assessment. I found this an exceptional frustrating aspect of

the study and the single most disappointing part of the paper. Having concluded already that there was a significant health risk from uranium aerosols

during the plant’s emission history, they use these two pages to first explain

why the earlier zip code surveys of NY State officials could not have worked

in identifying any possible excess of cancers arising from the plant. I would

have thought this would have prompted them to explain how a well-designed

health survey ought to be designed for this situation, but they failed to do

this. Instead, on page 17 the report appears to signal a resignation that no

possible survey could be designed that might identify whether or not excess

illness might have arisen in the cohort of exposed individuals. This is not a

satisfactory outcome of a Health Consultation of this type.

To provide a satisfactory basis for doing nothing, they needed to explain why

it would have been impossible to conduct a survey to locate former workers

at the plant and individuals who lived in close proximity to the plant for

many years. These people could have been ranked in terms of potential exposure by duration of exposure, and proximity to areas of very high uranium

in soil (as a proxy for the aerosol uranium concentration).

Ironically the Concerned Citizens about National Lead group was able to

gather a lot of this sort of information and had some of it at the time of the

report’s writing. In our work we used their information effectively. In my

time dealing with the Colonie site, I have had conversations with residents

of a street adjacent the site in the heavily exposed pollution halo who communicated an alarming number of health issues (mainly cancers) and deaths in

the past 25 years in houses in that particular area. Precautionary instincts

suggest this ought to be investigated as a priority. No questions of this type

were asked by the Consultation. This to me seems a major oversight.

• Part of the reason not to pursue further health assessments appears to have

been predicated on the perceived inability to detect a low percentage of excess

cancers that might be attributed to the pollution in a much larger cohort population (thousands of people). I fully agree that to use the thousands of people

in a current zip code as the ‘exposed population’ is a poor experimental design

for a health assessment of the Colonie situation. Such an approach stands no

chance of succeeding in being insightful for the Colonie situation where only

a relatively small number of individuals (probably less than 1,000) was likely

to have suffered a significant inhalation dose. This is in essence the flaw with

the former NY State surveys. However, to do nothing and recommend nothing

in the face of this is not a satisfactory option or outcome.

Instead, the report should have recommended conducting a survey on the

most exposed group of people; it should have located the several hundred

most heavily exposed individuals, wherever they might now live, in addition

to collecting death statistics from cancer (for example) from those who formerly lived near the site during its active years. This type of systematic census work is both necessary and feasible. The health issues with this targeted

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cohort could have been studied to either (1) discover any alarming illness patterns) relative to the general population, or (2) show that nothing was identifiably anomalous. Had the survey identified excess illnesses, then a campaign

of appropriate-sensitivity uranium isotope testing could have been commissioned to see whether DU could be identified as part of the excreted uranium,

in order to provide quantitative data on possible past exposure to DU. This

is the sort of investigation that would have been a satisfactory outcome to the

ATSDR report; it needn’t have been hugely expensive or undertake the work.

• The ATSDR authors were aware of inhalation exposure computer models that

could be used to make predictions on exposure of an inhaled compound using

particle grain size, airborne concentration at the point of emission, density of

particles, and meteorological data. They could have made assumptions about

particle size and density and used existing meteorological data to do this, but

they did not. Give the relative ease with which our own research was able

to isolate particles from contaminated soil or household dust, and study their

general size, shape and composition, the lack of interest or awareness of this

avenue of investigation represents a significant oversight, and may indicate

a lack of interest in pursuing a credible, reasonably in-depth investigation

into the DU pollution.

• On pages 30–31 in addressing direct concerns of the community the report

provides a misleading answer by failing to mention the dangers of internal

alpha radiation (in lungs in inhalation exposure) after noting that airborne

emissions were the main hazard; the report obfuscates the issue here by appealing to the benign nature of alpha radiation to skin, which mixes up internal and external doses. This confusion was entirely unnecessary.

• On page 35 in addressing the 5th concern of the community, the report explains the challenges in designing a health survey and attributing any outcomes to NLI pollution. A lot of the reason the report recommends that no

health survey would work is because the report concluded there was no

means of establishing a distinct exposure to DU. The authors would have

known that standard existing uranium bioassays and uranium isotope urine

tests had defined limits of detection that would limit the ability of these tests

to detect DU. They should have realized that significant progress had been

made on method improvement and that further improvement in reducing detection limits would be likely. They should have noted this in the report and

recommended that should methods become available that could potentially

quantify the past exposure via a urine test, that this whole issue should have

been revisited. They should have recommended this be done.

• On page 37–38 are the conclusive recommendations and ‘planned actions’

arising from the Consultation. No recommendations are made with regards

to DU exposure at all. In the planned actions are mentioned the following two

items:

1) ATSDR will work with local physicians and provide information on taking patients’ environmental exposure histories. ATSDR will also make

available resources related to environmental exposure, including contaminant-specific case studies and fact sheets.

2) ATSDR is evaluating the feasibility of conducting a study that would

compare the mortality rates of former NL workers to the mortality rates

of the general public. Former workers likely received the highest exposures to depleted uranium from 1958 to 1984 during operation of the facility. Currently, ATSDR is determining whether relevant past worker

records exist.

I am not aware that there has been any progress on these two ‘planned actions’;

I have also checked with CCNL, the main community group and they agree that

no action on these was done following the publication of the Consultation. This has

increased the sense of frustration by the community and is to say the least, puzzling. ATSDR should comment on this lack of follow-up actions, if in fact this is the

case.

Scientific Recommendations to address environmental health issues at NLI

Colonie NY site

The ATSDR report has failed to resolve any of the outstanding environmental

health issues arising from NLI pollution at Colonie. A sensible course of action for

ATSDR for the future would be to embrace the shortcomings of its report and take

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a new approach putting in place a number of actions to make some substantial

progress. For example,

• Community consultation in light of this hearing and recent research

• Establish funding for limited health assessment study

• Exposure screening of cohort with highest likelihood of significant inhalation

exposures—workers and residents, perhaps several hundred individuals

• Design and implement targeted health assessment of cohort, including investigation of death statistics of those likely to have had a relatively heavy exposure

• Evaluate health data using precautionary ethos given the small cohort size

• Investigate further cleanup of indoor and outdoor properties where resuspension of heavily contaminated dust could be a problem.

Comments on the ATSDR mission/remit and its performance

The remit of ATSDR Health Consultations is articulated in the ATSDR website

is to ‘‘serve the public by using the best science, taking responsive public health actions, and providing trusted health information to prevent harmful exposures and

diseases related to toxic substances’’.

At Colonie, while noting the useful case history of the site and especially its main

conclusion that there existing a substantial health risk from uranium emissions during the active years of the NLI plant, the Agency in my opinion has failed to locate,

present, and apply the best science to Colonie, and when combined with the lack

of any identifiable responsive health actions arising from its investment of resources, it is hard to conclude that in this case, it has come anywhere near fulfilling

its mission.

Recommendations to Congress concerning ATSDR

ATSDR’s remit forms an important component of public health policy and mitigation in the United States by undertaking prompt assessment and recommending a

course of action to mitigate toxic hazard risks and derive new knowledge concerning

unusual toxin situations. The work is important and needs to be highly credible and

to reflect the best knowledge available anywhere.

The Colonie example shows that ATSDR needs to work considerably harder in

order deliver credible assessments and solutions commensurate with its remit.

In cases like Colonie where it appears it had insufficient experience with an unusual hazard (in this case the inhalation hazard of uranium oxides) it needs to ensure that it taps into the best knowledge available, not just the in house expertise.

The Colonie consultation could have been miles better if it had acquired an up to

date knowledge of concurrent activities taking place on this same hazard in other

government agencies (U.S. Army research on DU inhalation; CDC uranium isotope

measurement; National Academy of Sciences reports on DU) and in other countries

(UK DUOB screening program, Royal Society biokinetic models of inhaled uranium

exposure and health risks for example). They appear to have failed to ‘leave no reasonable stone unturned’ in the Colonie study.

Governments (and certain industries) may fear what they might uncover by doing

a thorough study into a politically-charged issue like depleted uranium. My view is

that it is best to be transparent, face up to the risks of doing the credible science

where it appears justified both fiscally and scientifically, do it well, and communicate clearly the issues, risks and conclusions. I think it is likely that the science

will put some issues to bed instead of letting them fester without resolution for

years. The public deserve this transparency, and responsible environmental stewardship dictates that we should understand the environmental consequences of industrial processes (and negligence) and assess risks properly in order to decide how

best to find credible solutions to these issues.

Other Supporting Documents

Summary of current community concerns

The following is a letter with concerns of the community submitted to ATSDR

arising from the Health Consultation. It is my impression that most if not all of

these concerns are still current because they were not addressed in the report or

in any follow-up actions. I have relied on Anne Rabe of the Community Concerned

with National Lead for this input.

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Other materials/research relevant to the Colonie site.

• Illustrations of aspects of the Colonie site, urine testing, particles emitted by

the NLI plant, etc.

• 2003 DUOB extract—summary and annex on biokinetic models

• 2006 Health Physics paper on the measurement of uranium isotopes in urine

• 2008 Science of the Total Environment on the Colonie site and urine tests

there

• 2009 Journal of Atomic and Analytical Spectroscopy paper on the Colonie uranium oxide particles and their isotope composition.

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BIOGRAPHY FOR RANDALL R. PARRISH

American by birth (in 1952), the son of parents in the medical business, I lived in the U.S. for all of my youth (Oklahoma, Colorado, Arizona, Vermont). My geoscience career began at Middlebury College (Vermont) during my BA degree studying Geology. I opted to undertake graduate degrees in Canada at the University of

British Columbia to study with the late R.L. Armstrong, a most insightful geologist

and isotope geochemist. During the period 1974–83 I undertook field work and research in the western Cordillera of Canada (British Columbia mainly) where I combined field work in tectonics with laboratory and theoretical work in the university

environment, with a spell teaching at a community college in southern British Columbia. I did my Ph.D. thesis on the rise of the Coast Mountains of British Columbia, which involved a lot of hard field work in remote places. I fortunately escaped

any dangerous incidents with bears, rivers, aircraft crashes and so forth that are

known in this profession. My first substantial real job was at the Geological Survey

of Canada in Ottawa where I was employed from 1983–1996 extending my work

that combined geochronology (the dating of rocks and minerals to work out geological history) and field and tectonic studies (in western Cordillera of Canada, much

of Canada’s vast Precambrian Shield, Saskatchewan, NW Territories, Baffin island,

Northern Quebec, Ontario and Quebec, Yukon Territories, but also other studies in

the U.S., & Nepalese Himalaya). I also supervised research at Carleton University

Ottawa in geoscience. My work in Canada is best known for the tectonic research

in British Columbia and for the innovations to mass spectrometry and

geochronology methods that I and my colleague the late J. Chris Roddick were

largely responsible for, including the synthesis of rare isotopes for geochronology

(205Pb).

With the downturn in fiscal climate in Canada in the mid-1990s that required

major down-sizing of the public service, I managed change there as Head of the

Geochronology Research Facility, but subsequently in 1996 moved to Britain to lead

the Natural Environment Research Council’s Isotope Geoscience Laboratory, co-sited

at the British Geological Survey in Nottinghamshire in a cross appointment arrangement through the University of Leicester, my main employer. This is still my

current position. In this capacity I have shouldered a range of responsibilities including re-structuring of the facility, renewing its scientific program and its liaison

with the UK geoscience academic community, raising funding for staff growth, program growth, and instrumentation upgrading and expansion (we have 13 mass spectrometers and equipment worth about £6M). Our facility is not a research ‘empire’

but a collaborative research facility that scientists all over the UK can access—we

therefore know how to cooperate and collaborate effectively. Every five years we get

put through a very rigorous funding review; each time our performance has improved with the facility now being very stable and well funded. I do a lot of Ph.D.

student training both in the field and laboratory environment as part of our remit.

My responsibilities expanded in the UK to include a diversified research portfolio

extending well beyond traditional geology and geochronology to include heavy metal

pollution, different methods of geochronology, innovating methods of analysis in geoscience using laser ablation ICP–MS techniques, climate change, provision of solutions made to a very high calibration standard to worldwide laboratories for interlaboratory comparisons, and lately, applying my analytical and scientific expertise

to issues of depleted uranium and health, and the screening of veterans for exposure. I applied my skills to working out a method to detect DU in urine following

an exposure more than 20 years prior; this was a major improvement to prior methods. Once I began the depleted uranium and health work, I have tried to make good

measurements the cornerstone of the science, let the direction of the work be guided

by advances and insights gained through those results, and to follow the science of

DU and health until I become satisfied that I have done all that I could to provide

insight. This has put me on variable sides of the shifting political fence, with the

testimony of this hearing being an interesting collateral task.

I hold research grants in the UK to study a wide variety of problems, mainly involving the evolution of the geology and landscape in the eastern Himalaya, and in

improved calibration of the geological time scale through a joint NIGL–MIT–NSF

project called EarthTime. My DU research has been funded through piecemeal small

grants and contracts, and a funded Ph.D. studentship. I coordinate the thematic research program of the Natural Environment Research Council concerned with depleted uranium and will write a major review report on this topic this year. Our

largest contract in the DU business was that to measure uranium isotopes in urine

for the Depleted Uranium Oversight Board and we played a part in that major government program funded by the Ministry of Defense. That program was aimed towards the military’s duty of care to UK military veterans.

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I have led our national facility and worked with its talented staff to move the fa- cility to considerable prominence as an environmental science isotope facility of

international stature where a number of research areas are on par with the best

world labs. These include the DU work, high precision U–Pb geochronology, laser

ablation in situ U–Pb geochronology, multi-element isotope analysis in support of

climate research in the recent geological record, and silicon isotope analysis. In the past five years, I have increasingly been involved with grant proposal adju- dication in the UK and elsewhere, editorial duties, and undertaking strategic reviews of facilities, management and operation of portions of large research centers

within the UK, including my host institution the British Geological Survey. I consider myself a very good scientific leader and manager gained through experience

with colleagues during employment, and guided by common sense. Unusually, I continue to maintain an active role in research and innovative analytical duties; this

has extended my period of credibility as a scientist, thankfully! Further information about our facility is available from http://www.bgs.ac.uk/ nigl/index.htm

Chair MILLER. Thank you, Professor Parrish. Your use of the phrase ‘‘immoral and perverse’’ made me feel better about perhaps

my opening statement being a bit harsh, and I do want to thank

you for coming a considerable distance to come to this hearing

today.

Dr. PARRISH. It was my pleasure.

Chair MILLER. We have been joined by the Ranking Member of

the Full Committee, Mr. Hall. Mr. Hall, do you have any statement?

Mr. HALL. Chair Miller, thank you for having this hearing and

bringing these men before us here. I was particularly interested in

Sal Mier’s testimony, his long-time service at the Centers for Disease Control. I listened to him, and you are welcome to come by

my office, and I thank Dr. Broun. I appreciate it. I don’t have any

questions because I don’t know what other questions you will have,

but I will try to get back here and listen to one of the other panels,

but I thank you very much.

Chair MILLER. Thank you. You don’t represent Midlothian, do

you?

Mr. HALL. No, but when the legislature is in session, you never

know where you are going to be.

Chair MILLER. Mr. Hall covering all bets.

Mr. Camplin.

STATEMENT OF MR. JEFFREY C. CAMPLIN, PRESIDENT,

CAMPLIN ENVIRONMENTAL SERVICES, INC.

Mr. CAMPLIN. Good morning. I would like to thank the Subcommittee Members and staff for holding such an important hearing on the lax behavior and misuse of science by ATSDR leadership

and staff. My name is Jeffery Camplin and I am President of

Camplin Environmental Services Inc., a safety and environmental

consulting firm based in Rosemont, Illinois. My chosen research

specialty is asbestos. I have been a volunteer for the Illinois

Dunesland Preservation Society since 2003 investigating why

ATSDR purposely downplays the chronic asbestos exposure of millions of Illinois citizens each year.

My story begins in 1993 when I brought my wife and three kids

to Illinois Beach State Park located on the Illinois Lake Michigan

shoreline north of Chicago. After building sandcastles and burying

each other in the sand, I heard my wife exclaim ‘‘Look in the car.

It is full of sand. It is in the kids’ hair, it is in their ears, it is in

234

their shoes, it is everywhere.’’ Sand eventually ended up in our

laundry room as well. Little did I know at the time that my wife

along with millions of other families should have been saying,

‘‘Look at the asbestos contamination from the beaches. It is in our

car, it is on our kids, it is in our home.’’

I have been working for the last six years with Mr. Paul Kakuris,

President of the Illinois Dunesland Preservation Society. Our research indicates that ATSDR has violated its mission to serve the

public by purposely not using valid science, by not taking responsive public health actions and by providing untrustworthy health

information. Specifically, ATSDR has become a complacent agency,

choosing to produce outdated, inferior work products when they

know more-valid science exists. When ATSDR’s ethics and competence are challenged, a great wall of arrogance and denial appears from their leadership to strenuously fend off requests for accountability. ATSDR also takes advantage of the public’s gullibility

to trust an agency that is ethically bankrupt. The egotistical leadership and complacent culture at this once great agency needs a

total overhaul. However, that is not enough.

We are here today to demand accountability for the harm caused

to public health by inexcusable and deliberate behavior of ATSDR

staff in downplaying elevated levels of toxic microscopic asbestos

along the entire Illinois Lake Michigan shoreline. Evidence demonstrates that U.S. EPA and the State of Illinois along with

ATSDR bungled the cleanup of an asbestos Superfund site at the

south end of Illinois Beach State Park, allowing trillions of asbestos

fibers to be released from an unfiltered pipe into Lake Michigan to

this very day. Their incompetence also allowed large areas of asbestos-contaminated lake sediments to be dredged and dumped on and

offshore at heavily visited public beaches. Federal agencies and the

State of Illinois then generated rigged data to conclude the massive

asbestos contamination they created was not hazardous to the millions of citizens who frequent these areas. Illinois is well known for

nurturing a culture of public officials with less than honest and

ethical behavior. Illinois citizens seized upon the opportunity—I am

sorry—Illinois officials seized upon the opportunity presented by

the complacent culture at ATSDR to protect their unethically symbiotic agendas. They obtained rubber-stamped approval of their intentionally flawed federal and State reports.

In order to conceal the unethical behavior of their staff, ATSDR

will tell you the science is still developing while they knowingly

continue to use severely flawed and outdated asbestos risk assessments. What they don’t tell you is, the current science completely

discredits and invalidates all of their past asbestos human health

evaluations in Illinois as well as hundreds of other sites throughout

the Nation. ATSDR stubbornly refuses to acknowledge this fact.

Just this week ATSDR arrogantly issued another health consultation which intentionally fails to warn the public about deadly

microscopic amphibole minerals they found in beach sand and air.

Instead, ATSDR recklessly continues to invite families to a shoreline chronically contaminated with asbestos, that is, as long as they

don’t touch the visible pieces of debris during their visit. Yet there

is no recommendation to the public regarding the microscopic asbestos that gets on our kids, gets in our cars, gets in our homes

235

and ultimately enters our lungs. Maybe Dr. Frumkin can explain

his staff’s findings that deceitfully concealed the hazard from the

public.

Another example of ATSDR’s indiscretion includes the review of

one of their beach asbestos results in 2006 that the EPA identified

as potentially harmful to health. ATSDR dismissed the criticism by

the U.S. EPA, stating the beaches were safe anyway.

The fraudulent findings of ATSDR create a welcome permission

slip for the continuing dredging of toxic asbestos-contaminated

sand in Illinois. Spreading the contaminated dredge material on

the shoreline increases the risk of mesothelioma cancer rates in

Lake and Cook counties along Lake Michigan that already have

elevated mesothelioma rates when compared to national averages.

How high must the body count get before ATSDR admits there is

a problem?

In 2004, then-Illinois State Senator Barack Obama best summed

up our feelings when asked by a reporter about the asbestos contamination along the Illinois shoreline. Our current President said

at the time, we can’t have our kids swimming in areas that might

be contaminated with asbestos, and then he stated they should consider shutting down the asbestos-contaminated shoreline.

Precautionary protections are necessary to address the continuing public health disaster and egregious violations of public

trust from getting any worse. The first step is for ATSDR to acknowledge their past studies are flawed. Next, limit the public’s exposure to asbestos-laden shoreline beaches until scientifically valid

exposure assessments can be completed in an open, inclusive and

transparent manner. The final step is to hold all parties liable for

their actions. ATSDR officials Mark Johnson, Jim Durant, John

Wheeler and Howard Frumkin along with State of Illinois and U.S.

EPA officials must be held accountable for their egregious and potentially criminal behavior that resulted in millions of innocent

families being unwittingly exposed to deadly amphibole fibers.

On behalf of the Illinois Dunesland Preservation Society and the

citizens of Illinois, I want to thank you for this hearing.

[The prepared statement of Mr. Camplin follows:]

PREPARED STATEMENT OF JEFFERY C. CAMPLIN

Good morning. I would like to thank the Subcommittee Members and, staff for

holding such an important hearing on the lax behavior and misuse of science by

ATSDR/CDC leadership and staff. My name is Jeffery Camplin, and I am President

of Camplin Environmental Services, Inc., a safety and environmental consulting

firm based in Rosemont, Illinois. My chosen research specialty is asbestos. I have

been a volunteer for the Illinois Dunesland Preservation Society since 2003, investigating why ATSDR purposefully downplays the chronic asbestos exposures of millions of Illinois citizens each year.

My story begins in 1993 when I brought my wife and three children (two to three

years old) to Illinois Beach State Park, located on the Illinois Lake Michigan shoreline north of Chicago. After building sand castles and burying each other in the

sand I heard my wife exclaim, ‘‘Look in the car, it’s full of sand. It’s in the kids’

hair, in their ears, and in their shoes . . . it’s everywhere.’’ Sand eventually ended

up in our laundry room as well. Little did I know at the time that my wife, along

with millions of other families, should have been saying, ‘‘Look at the asbestos contamination from the beaches. It’s in our car, it’s on our kids, and it’s in our home.’’

I have been working for the last six years with Mr. Paul Kakuris, President of

the Illinois Dunesland Preservation Society. Our research indicates that ATSDR has

violated its mission to serve the public by purposefully not using valid science, by

236

not taking responsive public health actions, and by providing untrustworthy health

information. Specifically:

• ATSDR has become a complacent agency, choosing to produce outdated, inferior work products when they know that more valid science exists.

• When ATSDR’s ethics and competence are challenged, a great wall of arrogance and denials appears from their leadership to strenuously fend off requests for accountability.

• ATSDR also takes advantage of the public’s gullibility to trust in an Agency

that is ethically bankrupt.

The egotistical leadership and complacent cultured this once great agency needs

a total overhaul. However, that is not enough: We are here today to demand accountability for the harm caused to public health by the inexcusable and

deliberate behavior of ATSDR staff in downplaying elevated levels of toxic

microscopic asbestos along the entire Illinois Lake Michigan shoreline.

Evidence demonstrates the USEPA and the State of Illinois, along with ATSDR,

bungled the cleanup of an asbestos Superfund site at the south end of Illinois Beach

State Park, allowing trillions of asbestos fibers to be released from an unfiltered

pipe into Lake Michigan to this very day. Their incompetency also allowed large

areas of asbestos-contaminated lake sediments to be dredged and dumped on and

off shore at heavily visited public beaches. Federal agencies and the State of Illinois

then generated rigged data to conclude the massive asbestos-contamination they

created was not hazardous to the millions of citizens who frequent these areas. Illinois is well known for nurturing a culture of public officials with less than honest

and ethical behavior. Illinois officials seized upon the opportunity presented by the

complacent culture at ATSDR to protect their unethically symbiotic agendas. They

obtained ‘‘rubber stamped’’ approval of their intentionally flawed federal and State

reports.

In order to conceal the unethical behavior of their staff, ATSDR will tell you that

‘‘the science is still developing’’ while they knowingly continue to use severely flawed

and outdated asbestos risk assessment methods. What they don’t tell you is that

current science completely discredits and invalidates ALL of their past asbestos

human health evaluations in Illinois and at hundreds of others sites throughout the

Nation. Yet, ATSDR stubbornly refuses to acknowledge this fact.

Just this week, ATSDR has arrogantly issued another ‘‘Health Consultation’’

which intentionally fails to warn the public about the deadly microscopic amphibole

mineral fibers they found in beach sand and air. Instead, ATSDR’s recklessly continues to invite families to a shoreline chronically contaminated with asbestos . . .

that is as long as they don’t touch the visible pieces of asbestos debris during their

visit. Yet there is no recommendation to the public regarding the microscopic asbestos that get on our kids, get in our car, get in our homes, and ultimately enters

our lungs. Maybe Dr. Frumkin can explain his staff’s findings that deceitfully conceal this hazard from the public.

Examples of other indiscretions by ATSDR include:

1. ATSDR generated beach asbestos exposure results in 2006 that the USEPA

identified as potentially harmful to human health. ATSDR dismissed the

criticism by the USEPA along with our ethics violation charges and published the report stating the beaches were safe anyway.

2. In over a decade of testing, ATSDR has never performed or reviewed any air

sampling data that was obtained during the hot, dry, dusty months of June

through mid-August. They intentionally test outside the beach season when

the beaches are damp and cooler.

3. ATSDR found no elevated risk to human health from the rare but virulent

asbestos fiber called tremolite found on Chicago’s Oak Street Beach.

Tremolite asbestos-contamination has already devastated the town of Libby,

Montana with one of the highest mesothelioma cancer rates in the Nation.

The fraudulent findings of ATSDR created a welcome permission slip for the continued dredging of toxic asbestos contaminated sand in Illinois. Spreading the contaminated dredge material on the shoreline increases the risk of mesothelioma cancer rates in Lake and Cook counties along Lake Michigan that are already elevated

when compared to the national average. How high must the body count get before

ATSDR admits there is a problem?

In 2004, then Illinois State Senator Barrack Obama best summed up our feelings

when asked by a reporter about the asbestos contamination along the Illinois shoreline: Our current President said at the time, ‘‘We can’t have our kids swimming in

237

areas that might be contaminated with asbestos.’’ He then stated they should consider shutting down the asbestos contaminated shoreline.

Precautionary protections are necessary to address this continuing public health

disaster and egregious violation of the public trust from getting any worse.

• The first urgent step is for ATSDR to acknowledge that their past studies are

flawed.

• Next, limit the public’s exposure to the asbestos-laden shoreline beaches until

scientifically valid exposure assessments can be completed in an open, inclusive, and transparent manner.

• The final step is to hold all parties liable for their actions. ATSDR officials

(Mark Johnson, Jim Durant, John Wheeler, and Howard Frumkin), along

with State of Illinois and USEPA officials must be held accountable for their

egregious and potentially criminal behavior that has resulted in millions of

innocent families being unwittingly exposed to deadly amphibole asbestos fibers.

On behalf of the Illinois Dunesland Preservation Society and the citizens of Illinois, I want to thank you for this opportunity.

I will now address any questions you may have.

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BIOGRAPHY FOR JEFFERY C. CAMPLIN

Since 1991, Jeff has been President of Camplin Environmental Services, Inc. He is a Certified Safety Professional (CSP) and Certified Professional Environmental

Auditor (CPEA). He has been a licensed asbestos professional in the State of Illinois

since 1986. Jeff is a nationally recognized safety and health expert who is an accomplished author and public speaker. Jeff has been an instructor of USEPA accredited

asbestos abatement training courses for over 20 years.

In 2003, Mr. Camplin became a non-paid consultant for the Illinois Dunesland

Preservation Society involved with evaluating issues related to the presence of statistically elevated levels of visible and microscopic asbestos and other amphibole asbestos fibers present in beach sand along the Illinois Lake Michigan shoreline. He

determined that asbestos public health assessments published by ATSDR in 2000

and 2006 were not based upon scientifically valid data. Mr. Camplin has challenged

several of these ATSDR studies without receiving credible responses from the Agency.

Mr. Camplin has uncovered evidence of ATSDR staff rigging asbestos studies by

manipulating sampling protocol, analytical methods, and risk models used in their

studies. Examples of this rigging includes sampling during and immediately after

rain events, using larger pore sized filter media in violation of standard protocols,

and avoiding air sample testing during the hot, dry, beach season of June through

mid-August. He also caught ATSDR staff on video violating ethical standards by exposing the unprotected public to high levels of asbestos fibers during ATSDR’s activity-based asbestos testing on public beaches. These findings not only discredit health

evaluations performed at Illinois Beach State Park and Oak Street Beach (Chicago),

but also hundreds of other asbestos health evaluations performed by ATSDR

throughout the United States using the same flawed and unscientifically sound protocols.

Mr. Camplin has been interviewed by the USEPA’s Inspector General’s Office who

is currently completing a nearly two-year investigation into the asbestos contamination issues along the Illinois Lake Michigan shoreline. The investigation focuses on

the manipulation and rigging of studies by the State of Illinois, USEPA, and ATSDR

to fraudulently conclude that the statistically elevated levels of microscopic asbestos

fibers present in beach sand is safe for the public to disturb. He seeks to have proper scientifically supported studies performed in the future in an open, publicly inclusive, transparent manner, with independent third party peer review. Mr. Camplin

and the Illinois Dunesland Preservation Society also seek to have those members

of ATSDR held accountable for their egregious ethical and professional conduct violations during their manipulation of data in the creation of scientifically unsound

human health studies.

Chair MILLER. My opening statement seems more and more temperate.

Dr. Hoffman.

STATEMENT OF DR. RONALD HOFFMAN, ALBERT A. AND VERA

G. LIST PROFESSOR OF MEDICINE, MOUNT SINAI SCHOOL

OF MEDICINE; DIRECTOR, MYELOPROLIFERATIVE DISORDERS PROGRAM, TISCH CANCER INSTITUTE, MOUNT

SINAI MEDICAL CENTER

Dr. HOFFMAN. Thank you. For the last 30 years my research and

clinical practice have revolved around the investigation of a group

of chronic blood disorders termed myeloproliferative disorders,

which include polycythemia vera, essential thrombocythemia and

primary myelofibrosis. These are serious disorders characterized by

excessive production of red cells, platelets and white blood cells and

are associated with excessive blood clotting, bleeding and eventual

evolution to acute leukemia.

In 2005, a mutation in an intracellular kinase termed JAK2 was

found to be present in patients with myeloproliferative disorders

and was shown to play a role in the development of this particular

group of disorders. The mutation allows blood cell production to

occur in myeloproliferative disorders in the absence of signals proVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00248 Fmt 6633 Sfmt 6601 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
241

vided by hormones that normally control blood cell production leading to the production of too many red cells, white cells or platelets

in patients with this disorder. Most importantly for this discussion,

the JAK2V617F mutation has been shown to provide an almost

foolproof means of diagnosing patients with myeloproliferative neoplasms, since it can be detected using molecular methods in over

95 percent of patients with polycythemia vera. Since there are numerous other causes of too many red cells or polycythemia other

than this form of blood cancer, physicians frequently had great difficulty in making this diagnosis. With the advent of the molecular

test for JAK2V617F, the accuracy of definitively diagnosing this

disorder has been greatly elevated. Although blood cells with

JAK2V617F are occasionally observed in patients with other kinds

of blood cancers, it is rarely, if ever, observed in normal people.

My first contact with the Agency for Toxic Substances and Disease Registry began in the summer of 2006. Dr. Vince Seaman, an

epidemiologist and toxicologist at ATSDR, first called me to ask me

some questions about the nature of polycythemia vera and about

the possibility of environmental insults increasing the incidence of

this blood cancer. I was a bit skeptical about the significance of this

polycythemia vera cluster that Dr. Seaman and his colleagues were

then investigating in Carbon, Luzerne and Schuylkill counts in

eastern Pennsylvania in response to an invitation made by the

Pennsylvania Department of Public Health. After a series of phone

calls with Dr. Seaman, I gained a greater degree of comfort with

these investigations, that this cluster was potentially important

from a scientific point of view and that it presented a possible public health danger to the citizens of the State of Pennsylvania. In

the past, links between environmental exposures and clusters of

polycythemia vera have not been well documented. In my discussions with Dr. Seaman, I emphasized the difficulty of making the

clinical diagnosis of polycythemia vera and that the newly described molecular assay would provide a simple, inexpensive means

of making this diagnosis with certainty merely by testing blood

drawn from the study subjects. Dr. Seaman agreed and we set out

to create a means of obtaining blood specimens for subjects who

agreed to participate in the study. We proceeded with the JAK2V61

testing due to my belief that these studies were the state-of-the-art

in 2009, although there was initial pushback on the part of the

Agency and I felt that it was important to do this test to confirm

the diagnosis of polycythemia vera. By the end of 2007, these analyses had been completed showing that about 53 percent of the subjects in this study area fulfilled both clinical and molecular diagnostic criteria of having this hematologic cancer. One patient had

diagnostic features of polycythemia as determined by a committee

of experts but did not have the JAK2 mutation. The confirmed

cases appeared to be clustered around numerous EPA Superfund

sites and sites of waste coal power plants in the tri-county area.

Remarkably, to me, at least, four of the reported cases of polycythemia vera were located along Ben Titus Road, a stretch of

about 100 homes scattered along a two-mile stretch. Each of these

cases were confirmed to be JAK2V617F positive and therefore to

indeed have polycythemia vera. Remarkably, the greatest number

of cases of polycythemia vera were in the Tamaqua area, a sparsely

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populated area not in the area of greatest population near WilkesBarre.

With this data in hand, I and Dr. Seaman wrote an abstract in

August 2007 for consideration for presentation at the 2007 meeting

of the American Society of Hematology to be held, ironically, in Atlanta, Georgia, in December. Several conference calls were held

with numerous members of the ATSDR staff who checked the data

and went over the content of the abstract word by word and agreed

with the data and conclusions of the abstract vocally during these

numerous conversations. The abstract——

Chair MILLER. Dr. Hoffman, there is a five-minute limitation. We

are reasonably generous with it. Your whole written statement will

be part of the record. Could you summarize in perhaps a paragraph?

Dr. HOFFMAN. Sure. The abstract eventually was accepted by the

Society in November of that year and it was accepted as an oral

presentation. I then went on to create this presentation that was

presented before the Society in December of 2007. A representative

of the Agency management team was to appear at the presentation

but at the last moment, although he was based in Atlanta, he refused to attend or wasn’t able to attend. Several days prior to my

presentation at Atlanta, the ATSDR unbeknownst to me issued a

press release stating that the abstract presented results that were

premature and scientifically flawed. Medical colleagues in Hazleton

called me to inform me of this disclaimer because reports had appeared in the local press. I was of course shocked and was incredulous about the lack of forthrightness demonstrated to me by my

presumed collaborators at ATSDR. After my arrival in Atlanta I

was contacted on my cell phone on repeated occasions by officials

at ATSDR requesting that I either withdraw the abstract entirely,

state prior to my presentation that the Agency disagreed with my

conclusions or present an abridged version of the data. I presented

the abstract in its entirety and it was well accepted by the audience at the American Society of Hematology. In order to obtain further peer review, we then went about upon Dr. Seaman’s return

from a trip to Mozambique on ATSDR business to submit this publication to a peer-review journal. Prior to that submission, the

Agency insisted of Dr. Seaman and myself to perform further

geospatial analyses which to a statistical point of view confirmed

the findings that were present in our abstract showing that there

was a higher incidence of polycythemia vera in this area and that

those cases were essentially around these areas of high toxic exposure.

From my point of view, the mission of the Agency is to generate

and communicate credible scientific information about the relationship between hazardous substances and adverse events that affect

human health and to promote responsive public health actions. My

experience was that in the case of polycythemia vera in eastern

Pennsylvania was that the ATSDR did not accomplish this goal but

only accomplished it eventually with relentless prodding to complete the needed investigations. My sense was that if the Agency

was left to themselves, they would have preferred to ignore the

whole problem. ATSDR seemed to be committed to a course of ignoring and discrediting a mounting body of evidence which sugVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00250 Fmt 6633 Sfmt 6601 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
243

gested the presence of a cluster of polycythemia vera patients in

this tri-county area. With the full publication of our paper in February of 2009, the Agency really I think greatly turned around and

began to become much more serious about these investigations and

hopefully in the future we will be able to expand this area, which

I think is of great interest. Thank you for your time.

[The prepared statement of Dr. Hoffman follows:]

PREPARED STATEMENT OF RONALD HOFFMAN

My name is Dr. Ronald Hoffman. I am the Albert A. and Vera G. List Professor

of Medicine at the Tisch Cancer Institute of the Mount Sinai School of Medicine in

New York, NY. At that institution I am Director of the Myeloproliferative Disorders

Program. For over 31 years I have been a practicing clinical hematologist. Hematology is the study of the diseases of the blood. In addition, I am a laboratory based

scientist who has investigated the stem cell origins of blood cancers. I am an author

of over 400 scientific papers and have served as the President of both the International Society of Experimental Hematology and the American Society of Hematology. I am the lead editor of the textbook Hematology, Basic Principles and Practice, which is in its 5th edition and is the leading textbook of hematology in the

United States and Europe. I have held prior faculty positions at Yale University

School of Medicine, Indiana University School of Medicine, Stanford University

School of Medicine and the University Of Illinois College Of Medicine.

For the last 30 years my research and clinical practice has revolved around the

investigation of a group of chronic blood cancers, termed the myeloproliferative disorders with include polycythemia vera, essential thrombocythemia and primary

myelofibrosis. These disorders are characterized by excessive production of red cells,

platelets and white blood cells. These disorders are frequently associated with excessive blood clotting or bleeding and evolution to acute leukemia. These disorders are

now known to be blood cancers which originate at the level of blood stem cells. In

2005 a mutation of an intracellular kinase termed JAK2 was found to be present

in patients with myeloproliferative disorders. JAK2 is responsible for transmitting

signals to blood cell elements inducing them to produce greater numbers of such

cells in response to hormones that normally regulate blood cell production. The

JAK2 mutation was discovered by a group in France headed by Dr. William

Vainchenker. The mutation allows blood cell production to occur in

myeloproliferative disorder marrow cells in the absence of the signals provided by

the hormones that normally control blood cell production, thereby leading to the production of too many red cells, white cells or platelets in patients with these blood

cancers. This JAK2V627F mutation also been shown to provide an almost fool proof

means of diagnosing patients with myeloproliferative neoplasms since it can be detected using molecular methods in over 95 percent of patients with polycythemia

vera, and 50 percent of patients with essential thrombocythemia and primary

myelofibrosis. Previously, polycythemia vera was diagnosed based upon a variety of

costly diagnostic tests as well as relatively nonspecific clinical signs and symptoms.

Since there are numerous other causes of too many red cells or polycythemia other

than this form of blood cancer, physicians frequently had great difficulty in definitively making this diagnosis. With the advent of the molecular test for JAK2V617F,

the accuracy of definitively diagnosing polycythemia vera has been greatly enhanced. Although blood cells with the JAK2V617F are occasionally observed in patients with other kinds of blood cancers it is rarely if ever observed in normal people.

My first contact with the Agency for Toxic Substances and Disease Registry

(ATSDR) began in the summer in 2006. Dr. Vince Seaman, an epidemiologist and

toxicologist at ATSDR first called me to ask me some questions about the nature

of polycythemia vera and about the possibility of environmental insults increasing

in the incidence of this blood cancer. I had never heard of the ATSDR and at that

time had not been previously acquainted with Dr. Seaman. I was a bit skeptical

about the significance of a cluster of polycythemia vera patients that Dr. Seaman

and his colleagues were then investigating in Carbon, Luzerne and Schuylkill counties in Eastern Pennsylvania in response to an invitation made by the Pennsylvania

Department of Public Health. After a series of phone calls with Dr. Seaman, I

gained a greater degree of comfort with these investigations and became concerned

about this high incidence of polycythemia vera in this area that had been initially

identified by the Pennsylvania Department of Public Health. I thought that this

cluster was potentially important from a scientific point of view and that it preVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00251 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
244

sented a possible public health danger to the citizens of Pennsylvania. In the past,

links between environmental toxic exposures and clusters of polycythemia vera had

not been well documented. In my discussions with Dr. Seaman I emphasized the difficulty of making the clinical diagnosis of polycythemia vera and that the newly described molecular assay for JAK2V167F would provide a simple inexpensive means

of making this diagnosis with certainty merely by testing blood drawn from the

study subjects. Dr. Seaman agreed and we set about to create a means of obtaining

blood specimens from the subjects who agreed to participate in the study. Specimens

were collected in Tamaqua, shipped to my laboratory and analyzed for JAK2V617F

during the period from December 2006 through April 2007. These specimens were

shipped in a de-identified manner to my laboratory and the assays were performed

without knowledge of the patient source. Initially I had asked that ATSDR to provide some support to cover the expenses for the performance of these assays. To my

surprise the Agency administrators were unwilling to supply such funds and were

actually resistant to their performance. Their unwillingness to receive input about

the significance of the extraordinarily large numbers of patients with this

hematological cancer in this small area of Pennsylvania or to consider the value of

a molecular epidemiological tool to make their task easier surprised me. Their lack

of comfort in collaborating with scientists outside their community or their area of

expertise and to readily incorporate new scientific advances into their research efforts while investigating a possible cluster of blood cancer patterns seemed odd, and

closed minded in nature. I frequently felt that the members of the Agency management team viewed that this molecular epidemiological approach was overkill and

unnecessary since they had already concluded that the cluster was not significant

or worthy of further investigation. We proceeded with the JAK2V617F testing without the support of the Agency due to my belief that these studies were the stateof-the-art in 2009 and were required to confirm the diagnosis of polycythemia vera

The molecular testing for JAK2V617F was supported with funds that I had received

from the Myeloproliferative Disorders Research Foundation for different purposes.

The Foundation agreed to this diversion of resources. Dr. Seaman and his team sent

us fifty six blood specimens which we evaluated for the JAK2V617F mutation. Over

half of these specimens were JAK2V617F positive and an additional five patients

from the area were shown to be JAK2V617F positive based upon information

present in their medical records; I also assisted ATSDR in establishing a committee

of medical experts to examine the medical records of the participants in the study

be certain that the clinical characteristics of these individuals were consistent with

a diagnosis of polycythemia vera. By the end of April 2007 these molecular analyses had been completed showing that about 53 percent of the subjects in the study area fulfilled both clinical and

molecular diagnostic criteria of having polycythemia vera. One patient had diagnostic features of polycythemia vera as determined by our committee of experts but

did not have the JAK2V617F mutation The confirmed cases appeared to be clustered around the EPA superfund sites and sites of waste coal power plants in the

tri-county area. Remarkably, four of the reported cases of polycythemia vera were

located along Ben Titus Road, a stretch of about 100 homes scattered over a distance of mile; each of these cases was confirmed as being JAK2V617F positive indicating that these patients did indeed have polycythemia vera. Remarkably, the

greatest numbers of cases of polycythemia vera were in the Tamaqua area, a sparsely populated area, not in the area of greatest population density near Wilkes-Barre

where the cancer registry data (which is based upon diagnoses being made using

clinical criteria) had indicated that the greatest numbers of patients had lived. With

this data in hand, I and Dr. Seaman wrote an abstract in August 2007 for consideration for presentation at the 2007 meeting of The American Society of Hematology

Meeting which was to be held in December 2007 in Atlanta, Georgia. Over 20,000

hematologists from around the world usually attend this meeting. Several conference calls were held with numerous members of the ATSDR staff who checked

the data and went over the content of the abstract word by word and agreed with

the data and the conclusions of the abstract vocally during these numerous conversations prior to its submission. The abstract was then submitted for consideration for presentation at the American Society of Hematology Meeting. Although numerous ATSDR staff were aware of this submission and its content, Dr. Seaman,

without my knowledge, apparently did not have the abstract formally cleared by the

Agency. Dr. Seaman explained to me that he was new at the Agency and was not

fully aware of the clearance process for documents of this type. This omission was

surprising to me and appeared to represent a technicality since so many of the

ATSDR staff had gone over the content of this abstract and had already agreed with

its content during our numerous phone conversations. In October of 2007 I attended

a community meeting dealing with this subject which was organized by the ATSDR

245

and the Pennsylvania Department of Health in Hazelton, Pennsylvania. Prior to the

meeting I had lunch with many of the junior staff of ATSDR who had come to

Hazelton. My collaborator at the Agency, Dr. Vince Seaman was noticeably absent.

Several weeks prior to the meeting he had been sent to Mozambique for a mandatory training period dealing with agency business. I felt that the timing of Dr. Seaman’s trip was odd and showed poor judgment on the part of the Agency. Dr. Seaman had participated in the field of work that led to the report and had the confidence and trust of the community. Many of the community members saw Dr. Seaman as a so called ‘‘straight shooter.’’ At the lunch many of the junior staff of the

ATSDR bemoaned Dr. Seaman’s absence, but were energized by the findings that

had resulted from the collaboration between Dr. Seaman and my laboratory . About

75–100 community members attended the meeting and there were a series of presentations, some by the professionals in the community, by ATSDR senior staff and

by myself. The conclusions articulated by the ATSDR spokesperson seemed at odds

with the results summarized in our abstract that had just been submitted to the

American Society of Hematology. The ATSDR claimed that groups of polycythemia

vera cases were scattered throughout the tri-county area in no predictable pattern.

They also emphasized that only half of the reported cases actually had polycythemia

vera based upon our molecular analyses but failed to mention that even with this

caveat in mind that the incidence of polycythemia vera was still extraordinarily high

in this region. ATSDR appeared to minimize the importance of these findings and

concluded that it would be virtually impossible to identify the inciting agent that

might possibly have led to the polycythemia vera cluster. The ATSDR spokesperson

seemed to feel that this was a fruitless effort and was not really worthy of further

attention. I was impressed by the anger of the community at the meeting, there

sense of futility and betrayal. At the meeting I mentioned to the audience that we

have submitted an abstract to the American Society of Hematology about our findings and that the scientific community would assess the validity of our conclusions.

I attempted to inform them that if this material was found scientifically meritorious

that the scientific community would demand further investigation of the problem.

They appeared skeptical. As I drove back to New York that evening with my scientific colleague at Mount Sinai, Dr. Mingjiang Xu we talked about the experiences

of the day. We commented how we felt, that the ATSDR had misinterpreted and

prematurely drawn conclusions about the data that we had participated in generating. We commented that many of the ATSDR management were unwilling to

think out of the box and how their unwillingness to investigate the unknown or to

address difficult problems was the antithesis to the type of scientific investigation

that we were so familiar with in the biological and medical sciences. Also we questioned if there was some outside constituency who ATSDR was responding to that

made them act like they just wanted this whole matter to go away. Instead of viewing this as a challenging and important scientific problem of possible importance,

we felt that they had concluded that it was not important or that it was futile to

try to further investigate its origins.. Their lack of familiarity with the power of

modern cellular and molecular biology and their unwillingness to apply these tools

in an innovative fashion to this problem was surprising to me. I concluded that this

type of nihilism was antithetical to the performance of good science.

In the middle of November I was e-mailed by the American Society of Hematology

that our abstract had been accepted as an oral presentation. Only 12 percent of the

thousands of abstracts submitted to this meeting receive a high enough grade to be

presented at an oral session. I immediately informed Vince Seaman of the acceptance. Vince was in Mozambique on assignment but he and several other ATSDR

staff members helped me create the presentation and reviewed its content and repeatedly altered the content until they approved it and the written speech that I

was to present at the meeting. There were repeated attempts and requests on the

part of ATSDR management to avoid showing maps which might indicate a geographic relationship between the cases of polycythemia vera and the known EPA

super fund sites.

A representative of the Agency management team was to appear at the presentation but at the last moment, although he was based in Atlanta, he stated that

it was not necessary and that he would not be attending. Several days prior to my

presentation at the Atlanta meeting the ATSDR—unknownst to me—issued a press

release stating that the abstract presented results that were premature and scientifically flawed. Medical colleagues in Hazelton called me and informed me about this

disclaimer by the Agency, reports of which had appeared in the local press in Pennsylvania and asked me what I was going to do. I was a bit shocked and was incredulous about the lack of forthrightness demonstrated to me by my presumed scientific collaborators at ATSDR. I told the physicians in Hazelton that I still believed

that the data were correct and that I intended to present the information and let

246

the scientific community evaluate its merit. I must tell you I felt betrayed by the

leadership of ATSDR since I had made great efforts to get these leaders involved

in the content of the abstract and obtain their approval. After my arrival in Atlanta,

I was contacted on my cell phone on repeated occasions by officials of ATSDR requesting that I either withdraw the abstract entirely, state prior to my presentation

that the Agency disagreed with my conclusions or present an abridged version of

the data. I was intimidated by these frequent calls by government officials which

created a great degree of stress and anxiety for me. I was also outraged at this obvious attempt at intimidation. I refused to alter the presentation and presented it in

its entirety although ATSDR continued to undermine its validity in the press. I felt

justified in these actions since numerous members of the Agency had previously repeatedly approved the content of the abstract. The presentation was well received

and the scientific community accepted the possibility that environmental contaminants might play a role in the development of polycythemia vera in the patients in

the Tamaqua area.

After receiving this positive feedback from the members of the American Society of Hematology, I realized that the only way that I could further validate the data

was for it to be published in a peer reviewed journal so that once and for all this

data would be in the public domain and be open to further scientific input and criticism. Upon Dr. Seaman’s return from Mozambique we began writing this manuscript. The senior leadership of the Agency continued to doubt these conclusions and

insisted that the Agency’s biostatisticians perform sophisticated geospatial analyses

to further test the validity of our findings. I strongly agreed with their scientific

rigor not wanting to be associated with incorrect information. This cluster analysis

was done using Satscan, a geospatial software tool developed by the National Cancer Institute for the detection of cancer clusters. The chance of the likelihood of the

polycythemia vera cluster being a random event based on the total number of cases

in the tri-county area was calculated by the Agency statisticians independently of

my input or that of Dr. Seaman. A single statistically significant cluster of polycythemia vera patients (p<0.001) was identified near the geographic center of the

three counties. The incidence of polycythemia vera in the cluster area was 4.3 times

higher than that in the rest of the county. The probability of one finding greater

than 15 cases of polycythemia vera in this area and 18 cases in the remainder of

the tri-county area was one in 220,000. The probability of the cluster being a random event based on the total number of confirmed cases in the tri-county area was

1/2000. Several sources of hazardous materials were located in or near the high rate

area of polycythemia vera. Seven of the 16 waste coal power plants in the United

States are located in or within this area or within a few miles of the area. Seven

U.S. Environmental Protection Agency super fund sites are contained within this

area and another possible cluster area that was identified. This manuscript was

completed and revised on numerous occasions with the participation of members of

the ATSDR and the Epidemiology Branch of the Pennsylvania Department of Public

Health. Numerous revisions were made on the manuscript based upon the suggestions of the ATSDR and the Pennsylvania Department of Public Health without

compromising the validity of the information presented. The manuscript was reviewed and revised word by word during several teleconferences. This manuscript

was accepted by the peer reviewed journal, Cancer, Epidemiology, Biomarkers and

Prevention published in February 2009. During the submission process, a number

of minor changes were made in the manuscript to accommodate the Journal’s reviewers and specific publication format requirements. This is a routine process and

ATSDR did not require the final version of the manuscript to be re-cleared. After

the manuscript was published, the chief epidemiologist at the Pennsylvania Department of Health, who had actively participated in the word-by-word editing of the

manuscript even though he was not an author, became very upset when he found

that the manuscript had been altered. He made numerous calls to high-placed officials at ATSDR in an effort to get them to discredit the manuscript. The ATSDR

management resisted these efforts as they recognized that the manuscript contained

factual, scientifically valid information and there was no basis for the claims being

made by the Pennsylvania Department of Health.

I also participated in a round table discussion of expert researchers convened by

ATSDR and the Pennsylvania Department of Public Health in Philadelphia later in

2008 to identify research priorities about further investigating the extent of the

cluster of cases of polycythemia vera in the tri-county area and determining possible

factors that might have led to this cluster. The data that was presented in the paper

published in Cancer, Epidemiology, Biomarkers and Prevention I believe is important and valid. I believe that it provides information which justifies continued realistic concerns that there is a relationship between a cluster of cases of polycythemia

vera and serious environmental exposures in the tri-county area. This concern clearVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00254 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
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ly merits careful, additional, detailed objective rigorous scientific investigation to

better define the magnitude of this problem and what are the possible causes of

such an event. This information is of potential importance not only for the population of this tri-county area but to all citizens of the United States because it provides a possible link between the environment and blood cancers, an association

that has not to date been well documented.

ATSDR is the leading federal public health agency responsible for determining

human health effects associated with toxic exposures, preventing continued exposures and mitigating associated human health risks at the 1200 National Priorities

hazard waste sites targeted for cleanup by the U.S. Environmental Protection Agency. The mission of the ATSDR is stated to be ‘‘to generate and communicate credible

scientific information about the relationship between hazardous substances and adverse human health effects and to promote responsive public health actions.’’ My experience was that in the case of the polycythemia vera cluster in Eastern Pennsylvania that ATSDR accomplished this goal only because of the relentless prodding

to complete the needed investigations due in part to the efforts of some of the talented staff at the Agency working in collaboration with our group at the Mount

Sinai School of Medicine in New York and the continued input of the physicians in

the tri-county area and of course the residents of this area. My sense was that if

the Agency was left to themselves they would have preferred to ignore the whole

problem. ATSDR seemed committed to a course of ignoring and discrediting a

mounting body of evidence which suggested the presence of a cluster of polycythemia vera patients in the tri-county area. The Agency appeared to be overly responsive to possible outside influences which compromised its ability to evaluate the

severity of this problem. Rather than questioning the validity of this cancer cluster

in a pro-active manner, their initial response was to discount its significance and

to express on numerous occasions the futility in attempting to link the cluster of

these cases of polycythemia vera to any specific environmental toxins. This type of

work is obviously difficult and time consuming but appears to be the core function

of this agency. If the Agency is not willing to evaluate such clusters in a pro-active

and objective fashion and closely interact with individuals with different and complementary areas of expertise then the possibility of their accomplishing their stated

goals is very small. The scientific nihilism and lack of respect for the integrity of

scientific investigation initially displayed by members of the Agency surely compromises the stated mission of this agency. Their unwillingness to look objectively

at the compelling data generated by our investigations is puzzling and disturbing

to me. The Agency has many talented, skilled energetic professionals in its ranks

who have expressed to me frustration and concern about their being held back from

fully investigating the polycythemia vera cluster in Pennsylvania. The reasons for

these actions and their rationale remain unclear. Most recently the Agency has become increasingly more committed to more vigorously investigating the polycythemia vera cluster and its causes. I congratulate them on this recent change in

policy. This behavior is much more appropriate and consistent with the stated mission of the Agency and will likely to lead to a growth of a valid body of information

that will provide new insight into the significance of the polycythemia vera cluster

in Eastern Pennsylvania and its possible causes. In addition these investigations

will likely provide new information about a possible link between blood cancers and

environmental toxins. Such information will hopefully be helpful in decreasing in

the future the incidence of such deadly cancers in areas of such high risk for exposure to environmental toxins.

BIOGRAPHY FOR RONALD HOFFMAN

Dr. Ronald Hoffman is the Albert A. and Vera G. List Professor of Medicine at

the Mount Sinai School of Medicine, and Director of the Myeloproliferative Disorders Program at the Tisch Cancer Institute, Mount Sinai Medical Center. He is

the principal investigator of the Myeloproliferative Disorders Research Consortium,

with an NCI funded program project dealing with myeloproliferative disorders. His

research interests deal with stem cell biology and myeloproliferative disorders. He

is a former president of the American Society of Hematology and the International

Society of Experimental Hematology.

DISCUSSION

Chair MILLER. I want to thank all the witnesses for your testimony and for appearing here today. We will now recognize each

248

Member present for five minutes of questioning. The Chair now

recognizes himself. I now recognize myself for five minutes of questioning.

EXPLANATIONS OF ATSDR’S DEFICIENCIES

Dr. Hoffman, do you have an impression, an opinion of what accounts for ATSDR’s unwillingness to look at the data from the cancer cluster that you looked at? Do you think it is the leadership of

ATSDR or do you think it is the culture of ATSDR? Is there external pressure? Is there a reason that comes to your mind to explain

their reluctance to acknowledge or find environmental exposure

that may cause the cluster, the cancer cluster?

Dr. HOFFMAN. Well, first of all, I want to state that I think there

is a number of very talented investigators there and there is a very

talented staff so there is a lot of good folks there. My sense is that

they felt that it was a futile effort since there were so many environmental toxins in that area to essentially develop a one-to-one

relationship between a particular environmental toxin and the development of polycythemia vera. That led to a sense of futility.

What was articulated to me on numerous occasions was that even

if we found out that the incidence of polycythemia vera was greatest in this area, what were we really going to do about it, could

we essentially define an additional—the known agent. That kind of

thinking or neolism, I would call it, is very foreign to me because

I am used to in a laboratory at least solving or trying to attack

very complex scientific problems, and I really thought that that attitude was pervasive, this feeling that one could not identify the

toxic agent, and that led to, you know, sort of snowballed into sort

of talking away or speaking away or downplaying the significance

of this cluster. I think what was also not perceived was the importance of the cluster. The importance of the cluster really went beyond just this particular area because it linked very conclusively,

especially with the sophisticated statistical analysis that I congratulate them on performing which was very hard science showing

that it was highly unlikely that this was random. So what it really

shows is that blood cancers in general could be related to environmental toxins. That is a very important question and observation.

The point is, is this a futile event? No, it is not a futile event making this association because if we are aware of this, then we can

essentially define the cause of this and hopefully develop

chemopreventive agents to prevent additional patients from getting

these cancers. So I think they were essentially frozen in time, and

because of this sense of futility and perhaps a sense of understanding the whole gamut of hematologic malignancies, they didn’t

really appreciate the importance of it.

PEER REVIEW

Chair MILLER. Dr. Hoffman, you congratulated ATSDR on their

statistical analysis and on the unlikely possibility that it would be

random.

Dr. HOFFMAN. Right.

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Chair MILLER. You have had your work peer reviewed. I assume

you are competent to do peer review. Have you looked at enough

of ATSDR’s work to know how well it would fare in peer review?

Dr. HOFFMAN. Mr. Miller, I am really not an epidemiologist. I

mean, I am a hematologist and a blood scientist. Prior to this interaction which started on 2006, I had never heard of this agency so

I am really incapable of evaluating their other work.

Chair MILLER. Do you think that there would be a value in requiring peer review for at least some of their assessments?

Dr. HOFFMAN. I felt from my perspective, I wanted my work evaluated by outside reviewers. I wanted it evaluated and presented at

a scientific meeting where I could get feedback from my peers. I

also wanted it to go to a scientific journal where people could show

me that I was wrong because I was not really interested in presenting or publishing incorrect data. That is the way I was brought

up scientifically. I think that is a healthy way to act within any

kind of investigative effort if you are going to do real science.

MORE EXPLANATION OF DEFICIENCIES

Chair MILLER. Mr. Mier, you used to work for the CDC. You

never heard of ATSDR but you were inclined to assume that they

would do reliable work and that assumption you do not think

proved to be correct. What do you think is the reason for that?

What do you think happened? Why do you think they do not do the

job that you thought they would do?

Mr. MIER. You know, I don’t know if it is just their reluctance

to go after an industry. I know that in Texas, at least my feeling

is that there is not much balance between the need to prosper economically, to have jobs, and the need to care for public health and

the environment, and in our state my biggest concern is with the

State environmental agency and my biggest concern was why

ATSDR did not closer evaluate the data that they were looking at

upon which to make sweeping generalizations about public health.

To me, the air monitoring system was so suspect. I am not a scientist, but based on other scientists that I have dealt with have always told me that, and there is so much tinkering that can be done

with the various aspects of the monitoring system. And why they

would not—not just ATSDR but the State public health agency

with which they have a cooperative agreement with in Texas, why

they would not look at the empirical evidence. I always felt that

the best monitors were the animals in our community, much better

than any mechanical device that we could have, but why they

would just not want to look at our animal issues as the potential

for a sentinel for human health.

Chair MILLER. My time has expired, and I will try to be reasonably indulgent with the other Members as a result.

Dr. Broun for five minutes.

Mr. BROUN. Thank you, Chair Miller. I appreciate it.

POTENTIAL FIXES

We each have five minutes to ask questions so I am going to ask

a pretty broad question of each of you all and so if you would, try

to answer it within 30 seconds and we will go forward. If you were

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a dictator, how would you fix ATSDR? What would you do? I will

start with Mr. Mier.

Mr. MIER. Boy, you know, to me it is a cultural thing. Someone

needs to go in there to let them know that——

Chair MILLER. I am sorry, Mr. Mier, your mic is not on.

Mr. MIER. Oh, I am sorry. There is nothing wrong in going after

or looking at an illness closely when it might potentially be related

to an industry. I think there is a tremendous reluctance to do that.

I understand it is a very complicated science but to run away from

it and not look at strong empirical evidence, to me I just can’t understand that. When I was dealing in my own humble way looking

at viruses or bacteria and the issues that I dealt with when I

worked with CDC, there was never any quarrel, but the dynamics

changed drastically when you point a finger at an industry.

Mr. BROUN. Thank you, Mr. Mier. We need to fix it if there is

a problem, which obviously you all think there is a huge problem

there. We are trying to look to try to find out—this is an investigation and oversight committee. We need to have some—I would like

to hear some suggestions of how to fix the problem and not just

wonder. So Professor, do you have any suggestions of how we can

fix this problem?

Dr. PARRISH. I mean, I think big organizations have inertia and

if you want to change them, I think the first thing I would do if

I was dictating would be to—I would clarify what the remit is,

what is the mission of the Agency and what is its relationship to

other public health agencies and states, for example. I know this

because ATSDR bumps up against these other things from time to

time. So you need to clarify what your boundaries are, and then I

think once you have that mission really clear, you have to recruit

the leadership and the senior management team to implement the

vision for the Agency and make sure they have the resources so

they can actually pursue that mission with vigor. That is what I

would do.

Mr. BROUN. Mr. Camplin.

Mr. CAMPLIN. Two things. One, I would recommend that they

open up the process a little bit more on the very front end so there

is a little bit more agreement and buy-in along the whole way as

well as having that third party oversight, the peer review oversight. We have requested that on numerous occasions and it falls

upon deaf ears. The other side of it is accountability. There are

policies and procedures in place that they are supposed to be following and there doesn’t seem to be any kind of accountability and

I know in our case at the Illinois Beach State Park, we would love

for this committee to request the FBI to meet with myself along

with Mr. Paul Kakuris of the Illinois Dunesland Preservation Society so we can turn over evidence of what we believe is criminal activity as well.

Mr. BROUN. Doctor, I would love to talk to you about the JAK2

mutation and all those things as a fellow physician, but again, if

you were dictator, what would you do to fix this? And I certainly

believe in peer review as a physician. We look at those types of

things. And I congratulate you on your research in this—into these

blood diseases.

251

Dr. HOFFMAN. Well, I guess I am a little bit more optimistic about this culture. I think there are—again, I will repeat, there are

excellent people there. This is not a deficiency in the talent of the

staff. I think what they really need to be is basically cut loose and

be told to do good science and unrestricted science. I think the submission of work to peer review journals should be encouraged because once that was accomplished and once the paper was accepted, everything turned around, and in fact when the Pennsylvania

Department of Health when they finally saw our manuscript were

upset about some of the conclusions that were made. ATSDR to

their credit actually said that they weren’t going to change or deny

anything because they had shown that it was correct and it was

peer reviewed. So from my perspective, going through this over a

couple of years with them, I think they need consultants that have

a lot of scientific information and can bring more to the table and

then they should be cut loose to essentially test whether these

things are scientifically valid. If not, their resources will be depleted. They have to find out what is really, really important and

then they have to go after it as a scientific mission.

Mr. BROUN. Thank you all. Chair, I am about out of time and I just—we are going to submit written questions for you all to look

at. I am sure that I look forward to your answers further. Chair MILLER. Thank you, Dr. Broun. In the last Congress, Mr. Rohrabacher was a Member of the Committee so everyone else’s

adherence to the five-minute rule looked pretty strict by comparison but if everyone adheres to the five-minute rule, I am going to

have to change my own conduct. Mr. Grayson. Oh, I am sorry. Ms. Dahlkemper is next.

Ms. DAHLKEMPER. Thank you, Mr. Chair.

GEOGRAPHIC PREVALENCE OF DEFICIENCIES

I believe one of the biggest roles of government is public safety, and each of you are from a different area of the country. I am from

Pennsylvania where obviously Dr. Hoffman is from, but you are all

from different parts of the country and we are seeing sort of a retelling of the story. Do any of you have other areas where you have

talked with colleagues kind of dealing with this same type of issue

in terms of the conduct of ATSDR? It is open to any of you.

Dr. PARRISH. I will just say, first of all, I don’t because I live in the United Kingdom so I will drop out of that.

Mr. CAMPLIN. I will mention that at least on the asbestos side

of things, I have talked with many of the people over in Libby,

Montana, where there is currently an investigation going on with

W.R. Grace and their exposure to asbestos there, and the persons

I have talked to, they consider ATSDR and EPA more of the dark

side or the evil side than the actual polluters, W.R. Grace themselves. They do not agree with their science and they do not agree

with the politics that are there as well.

Ms. DAHLKEMPER. Mr. Mier or Dr. Hoffman, have either one of

you had any talk with other colleagues in other areas of the country who have had problems with this agency?

Mr. MIER. I talked to a few in Louisiana and other parts of Texas

but frankly, my wife and I have been—we are retired grandparents

and we have been so busy researching and addressing this issue

252

that I haven’t spent a lot of time talking to other people except that

when I felt that we were going to have the same people looking at

it again in the same old way and not getting an objective new look

at it, that is when I begged for help from scientists around the

country that were familiar with these issues and had them review

our draft consultation report.

PUBLIC AWARENESS

Ms. DAHLKEMPER. And my other question to all four of you, I guess, is, the people in the communities where you are dealing

with, how much of this information has been put out to the general

public, what is the reaction. You know, Mr. Mier, you still live in

Midlothian. I mean——

Mr. MIER. I tell you, this is a very sensitive issue in our commu- nity. When we are talking about potentially implicating four industries with as many employees and family members as are involved,

it is a very sensitive issue and so they are very defensive about

pointing any fingers at any of the industries so it is a very sensitive issue to discuss in our community both at city government

and even on the school board. So there are very few of us that are

actually working on it and addressing it and we are looked at in

a very different, negative light, I think but a lot of people in the

community, unfortunately, and our only concern frankly is our

grandchildren and other children and children yet to be born in our

community and that is why are we looking at it. We are not satisfied with the answers that we are getting and we think that there

may be some problems and we are not satisfied with the way it has

been looked at so far.

Ms. DAHLKEMPER. Thank you for your courage. Chair MILLER. Each of the witnesses and our Members can make

a point of taking the microphone. Although we can hear you, there

are others who are watching this on the Internet, et cetera, and it

is helpful for recording the hearing later.

Mr. CAMPLIN. I would like to make one point about that. Without

a doubt, the public does give the Agency a lot of credibility when

they put any kind of report out and so there is a doubt. When we

challenge anything that they say, they tend to get the benefit of the

doubt and it isn’t until we are able to prove motive—because that

is what they would say, why would an agency like this, such a

prominent agency, put out such faulty reports. And when we explain the motives, then it becomes very clear. But that is one of the

problems in the community is, they believe in these agencies. They

believe in what this agency at least used to stand for.

Ms. DAHLKEMPER. Yes?

Dr. PARRISH. I mean, I could just say that in the situation of

Colonie, New York, the industry that did the polluting is long gone,

so it is a legacy issue, and I think generally the health consultation

done there added very little new knowledge. It didn’t seem—it

caused a great deal of frustration in a way because I think expectations were very high that this was going to add new insight, provide solutions and so forth and it basically did none of those things.

And so, you know, on the one hand I know there are a lot of people

in that area in government and industry that basically would like

the whole issue to sort of go away and be buried but on the other

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hand, in particular the research that we did certainly served to

raise awareness of the issues and, you know, by undermining part

of the methodology that ATSDR used in their health consultation,

it has actually sort of in a certain portion of the community provided a way forward, I think, for progress in the future that was

otherwise completely stalled.

Ms. DAHLKEMPER. Thank you. Chair MILLER. The gentlelady’s time had only expired by a little bit.

Mr. Bilbray.

Mr. BILBRAY. Thank you, Mr. Chair. Dr. Hoffman, I want to thank you for not just your testimony but also highlighting again that coal-fired power plants leave a legacy

of destruction far beyond air pollution and a sad state of affairs,

if I may say it again, that while we talk about the executive branch

not doing enough oversight here and not looking at this issue, at

the same time the legislative branch, this Congress is still buying

coal-fired electricity to power our lights overhead, and never pass

up a chance to take a cheap shot, so I want to put that out. You

know, clean coal is as logical as safe cigarettes, and thank you for

bringing up that there are other issues.

ASBESTOS

Mr. Camplin, your work with the asbestos problem here, specifi- cally this site, just for my own information, are we talking short

fiber, long fiber or is it a mixture of both at this site that you were

working with?

Mr. CAMPLIN. It is not only a mixture of short and long fibers but they are finding predominantly amphibole minerals, which are

much, much more toxic, and that is even more disturbing because

they put disclaimers in a lot of their reports saying in fact that the

risk modeling may significantly underestimate these minerals that

are there, so there is some debate on what type of asbestos is toxic.

However, what they are finding on the beach there is no debate

about it. It is the most virulent, amphibole forms of the mineral.

Mr. BILBRAY. Yes, in California ARB, we found there was a distinct separation that has to be, you know, to really be precise on

this. Of course, at the same time we are talking about that, our

roads are paved with serpentine, which is all asbestos and everybody that drives down a back road in the Sierra Nevadas is being

exposed.

Mr. CAMPLIN. Well, it is the State mineral of California.

Mr. BILBRAY. Yeah. Well, I guess it is appropriate with our air

quality. But traditionally with toxicology there are two major measurements. One is level exposure and duration of exposure, and

though asbestos is different because certain fibers, certain types

can lodge in the lungs and maintain there and continue to irritate

and create the problem. Do you think that the Agency might have

been using like your instance the short duration of exposure as a

justification to reduce the risk level from the toxicology point of

view?

Mr. CAMPLIN. It is even more obvious than that. If you were

going to test beach activities, I would ask maybe Dr. Frumkin why

his team has never reviewed data from June, July or early August,

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which we would consider the beach season, and why approximately

30 to 40 percent of the time that they do air monitoring it happens

to be either raining or it just did rain. So that alone we think

skews the data tremendously, and then getting into their protocols

themselves and the outdated risk models they use, that just complicates things even further.

Mr. BILBRAY. Okay. Well, coming from southern California, my

perception is it is always raining in your part of the world.

Mr. CAMPLIN. It is.

Mr. BILBRAY. That is the challenge that we get over there.

You know, the Texas model I guess really kind of highlights too

the fact that when we get into these groups that somehow when

we try to get this agency to straighten out, we are treating a symptom of a deeper problem, and that is, places like Texas not having

clean, inexpensive electricity so we can stop drawing on these dirty,

cheap sources that create the problem. But I appreciate all your

testimony.

LOCAL HEALTH PROTECTION

Mr. Chair, my biggest concern is that when we talk about public

health protection as the gentlelady said and we say it is government, I just would like to remind all of us as somebody who comes

from a background of being the Agency in the neighborhood, the

frontline of health protection is not those of us in the Federal Government. We are the last line of protection. The first line is the

local community, the local environmental health department, the

local air district, and one of the biggest things I want to do is make

sure that the Feds are there to support the local effort. We have

seen with Katrina what happens when the locals wait for the Feds

to show up, as opposed to what you saw in San Diego during our

fires, they kept saying FEMA did so well. It is only because the

locals didn’t wait for FEMA to do it, FEMA came in and helped,

and one of the things I want to make sure is that when we reform

this approach that it is one of coming in and helping the local community protect their own neighborhoods as opposed to waiting for

the Feds. Because the biggest shock I had when I moved out of San

Diego to Washington, D.C., is I look around the environment in

this community and the environmental health around this community and let me assure you, I do not want my neighborhoods to be

controlled by the people who are taking care of the environment in

Washington, D.C., right now, and that is one of those things that

I think all of us should work at empowering the local community

to address these issues and hopefully we can use this review as a

way of doing more of that.

I yield back, Mr. Chair.

Chair MILLER. Thank you, Mr. Bilbray.

Mr. Grayson for five minutes.

VIEQUES, PUERTO RICO

Mr. GRAYSON. Thank you, Mr. Chair. I appreciate the members

of this panel and what they have done to highlight the failures of

the ATSDR but I would like to talk about a different circumstance

that has come up that I think further underlines the situation.

255

That is the situation that I am talking about regarding Vieques,

which is an island off the coast of Puerto Rico. Vieques is a beautiful place. Its economy is based on fishing and tourism, and for 62

years it served as a military testing ground for the Navy. And now

it is the subject of a great debate concerning the accuracy of

ATSDR testing. The military used among other weapons chemicals

such as napalm, Agent Orange and depleted uranium in and

around the waters of Vieques. In 2003 the Navy stopped that military testing and the area has become a Superfund site because of

the heavy presence of metals and toxins in the area. It is being

cleaned up but there is a lot of chemical residue that remains.

There are dangerous levels of heavy metals and toxins that have

shown up in the crabs, in the fish, in the goats, in the wild horses

that roam the island and the vegetation and in the people who live

there. The health statistic in Vieques show the consequences of

those toxins compared to normal residents of Puerto Rico. Residents of Vieques have a 269 percent increased chance of cancer and

a 73 percent increased chance of heart disease and many other

health problems. Infant mortality in most of Puerto Rico is decreasing, but in Vieques it is increasing and it has been increasing since

1980. And a 2001 study looking at the hair of the residents in

Vieques showed that 73 percent of these human beings were contaminated with aluminum and 30 percent of the children under 10

years old showed toxic levels of mercury.

One of my constituents, Rubin Ojeda, a former fisherman in the

area, told me almost every person that he knows in Vieques has

cancer or a family member who has cancer or other serious illness.

Rubin fished while the Navy dropped bombs around him and he

suffers from heart and respiratory disease as well as deafness. His

mother has anemia, high blood pressure and diabetes. His uncle

died of cancer and several of his fellow fisherman have also died

of cancer at young ages. In other words, in Vieques, heavy metal

poisons the land and the water and the population carries that poison in its bloodstream and there is no real debate about this anymore.

But somehow when this agency, ATSDR, tested the area, it stated that the poisons in the fish and the crabs and the vegetation

somehow posed no threat or no danger to the residents. This agency, which is supposed to protect our children form poisons at

Superfund sites, actually wrote that it is safe to eat the seafood

from the coastal waters and near-shore lands and that residents

have not been exposed to harmful levels of chemicals resulting

from Navy training activities. These remarkable statements should

not come as a surprise for anybody who actually knows this agency.

It is famous for ignoring the dangers of formaldehyde in the trailers used by Katrina victims, and for that the Agency was publicly

chided by its own chief toxicologist, who had been cut out of the

loop after raising concerns about the scientific basis for the Agency’s analysis.

In case after case documented in an excellent report put together

by the Science and Technology Oversight and Investigations Subcommittee, this agency has trivialized health concerns and failed to

stop the ingestion of poison and the spreading of cancer. In other

words, Vieques is not an isolated incident. There is a problem of

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leadership, structure and agency culture, and from its inception in

the early 1980s this agency has fought with bureaucratic rivals,

shortchanged science and public health, and as a result it has let

children be poisoned, and this too should come to us as no surprise

because the Reagan Administration, which oversaw the creation of

this agency, never found an environmental protection that it did

not try to dismantle. Despite that origin, there are good and conscientious employees within the Agency and I am hopeful that we

can work to restructure this agency so that its leadership is committed to protecting the public from harm. They should at the very

least start with the acknowledgement that its work in Vieques is

flawed and it should start with a commitment to reassess that site

and take into account the various independent studies which show

elevated health risks in the area.

You know, we try so hard as Members of Congress to improve people’s lives. When I look at what has happened in Vieques, when

I see all the health problems that Navy testing there has caused

and the health problems that have been perpetuated by the failure

of this agency to do anything about it, I am reminded of the Hippocratic oath. Maybe the first thing we should to do as Members of

Congress is very simple. The first thing that the government

should try to do is very simple: first, do no harm. Thank you. Chair MILLER. Thank you, Mr. Grayson. Mr. Tonko is not a Member of this subcommittee. He is a Member of the Full Committee, and as a courtesy the Chair is happy

to recognize Mr. Tonko for a round of questioning. He does have

a particular interest in this subject today.

COLONIE, NEW YORK

Mr. TONKO. Thank you, Mr. Chair, for this very valuable hear- ing, and to the panelists, thank you for being here. I represent

Colonie, New York, via the 21st Congressional District in New

York, and so my questions are directed towards Professor Parrish. Professor, so I can be perfectly clear on this issue, the ATSDR people, did they test at all, did they use a certain method or did

they not test workers and residents?

Dr. PARRISH. They did not test.

Mr. TONKO. So you were the only group that tested?

Dr. PARRISH. That is correct.

Mr. TONKO. And when your system that you offered to ATSDR was exchanged with their people information-wise——

Dr. PARRISH. I have had no contact at all with ATSDR.

Mr. TONKO. None at all?

Dr. PARRISH. None at all.

Mr. TONKO. So did they—do you know if anyone reviewed the

system you used?

Dr. PARRISH. Well, our work first went through considerable peer

review in the U.K. to do with interlaboratory comparisons and so

forth and that work was published in 2006. The method was developed in 2003 and it was applied to basically a very large cohort of

U.K. Gulf War veterans in the period 2004 to 2006. So we tested

hundreds of U.K. veterans for depleted uranium in their urine during that period of time. I mean, this is the whole reason I started

working in Colonie is to pursue this topic that I got involved in in

257

the U.K. as a result of working with the government to test veterans of the first Gulf War. And what we found in that particular

situation is we failed to find a single person who had had a DU

positive result. Everybody was normal. And this raised a really important question. The question really was, were the veterans of the

1991 conflict never exposed to DU in the battlefield or were they

actually exposed, did they acquire harm, for example, but has it

been too long a period of time since the testing in order to detect

the signature. So we needed—the reason we went to Colonie was

to follow this issue until it logically was concluded, and the reason

that Colonie is important is, there is undoubtedly a very significant

exposure to a lot of people to the inhalation of depleted uranium

oxides is arising because of the manufacturing at the plant, so we

knew there was an exposed population, so we went there to try to

find out, can we see the signature in their urine? Even after 20

years, and the answer was yes, we could.

Mr. TONKO. Now, my question to you also, were there any opinions offered as to that method by professionals from ATSDR, formal or informal, that were exchanged with you?

Dr. PARRISH. No, because I have had no contact, none whatsoever.

Mr. TONKO. So is there anything that we can do to go forward

with the town of Colonie? Should there be any concerns or fears

that the town residents—there are some theories that as many as

2,000 homes, if not more, I hear many oftentimes 2,000 homes

being in the area of the factory and of course the factory workers,

should they still have concerns about depleted uranium?

Dr. PARRISH. Well, let me first say that, you know, I am not a

medical doctor so don’t misconstrue my opinions here, but I suppose my general view is that the heaviest pollution took place in

the 1970s and affected probably in the neighborhood of less than

perhaps 1,000 people, and I am sort of drawing a line around, you

know, perhaps 600 to 800 meters around the plant, but there were

lots of houses and the residential area is extensive. Sorry.

Mr. TONKO. No, I was just going to ask, has the Agency ever contacted you to discuss your findings?

Dr. PARRISH. No, they have not.

Mr. TONKO. Do you think they were aware of your findings?

Dr. PARRISH. They are—I mean, I know that they—people have

told me that there has been some contact with ATSDR about my

paper but they have not contacted me.

Mr. TONKO. And should the Agency go back to the area?

Dr. PARRISH. Well, I think somebody should go back. If the Agency has got a different attitude, then they should go back and redo

some of the work, and some of the things they need to do are to

find the people who lived there and were most heavily exposed, regardless of where they live now. They need to find these people.

Then they need to do basically a health kind of census, what is the

state of health and death results, for example, in the area that is

closest to the plant. If there is something untoward going on in

terms of that, then they could institute a series of testing programs

to find out whether depleted uranium, for example, could be a correlated feature to those health problems. So I think there is a way

forward to do this whole program there.

258

Mr. TONKO. Now, the Agency claims that, in quotes, it ‘‘serves

the public by using the best science.’’ Have they avoided the best

science? Have they used the best science?

Dr. PARRISH. Well, I think my words were, they either chose not

to or were unaware of the analysis tools at the time they did their

report in order to determine whether people had an exposure. This

was possible now. It certainly is possible now. They concluded it

wasn’t possible——

Mr. TONKO. And if we use——

Dr. PARRISH.—in their report.

Mr. TONKO. I am sorry. If we use your base number of 1,000 for

round terms, is there an estimated cost that the Agency should assume will be borne upon it?

Dr. PARRISH. You know, I suppose—I have been asked question

and I would have thought that you could commit something like

perhaps $1 million or something, and with that sort of money you

could undertake a census to find the individuals, look at their

health and other death statistics as well as conduct urinary tests

for uranium isotope exposure on perhaps several hundred people.

You could certainly go some distance to make progress towards the

resolution of the issue.

Mr. TONKO. As I understand it, the Federal Government spent

nearly $200 million——

Dr. PARRISH. That is correct, on the cleanup.

Mr. TONKO.—on the cleanup. Is that cleanup sufficient? Do you

have any sense professionally whether or not——

Dr. PARRISH. I think—the Army Corps of Engineers did the

cleanup. I think they did a good job. What they did is remediate

the site so that it could then be turned over eventually for some

other purpose, but the primary health danger that was at the site

arose during the plant’s original operation in the 1960s and 1970s

and early 1980s and so once the plant stopped operating, the immediate health risk, as I understand it, diminished considerably

because emissions of depleted uranium oxide particulates that were

inhalable then more or less ceased, and so the ongoing issues relate

to sort of secondary ingestion of contaminated soil or perhaps resuspension of dust. But we have also found that there are high levels of settled dust in attics and basements and houses and so forth,

and this may be an ongoing health issue. I don’t know.

Mr. TONKO. Just one quick final question, and I appreciate your

tolerance, Mr. Chair, but it is very important to this community

and to the district. There were allegations that the company had

bypassed smokestack filters.

Dr. PARRISH. Yes.

Mr. TONKO. Do you have an opinion on that?

Dr. PARRISH. I have been told this is a fact, and I have no doubt

that it is.

Mr. TONKO. Well, obviously it is an issue that still needs to

be——

Dr. PARRISH. I think the—is it New York Department of Environmental Conservation, I believe, they documented this at the time

in the late 1970s so there is no doubt that this has taken place.

Mr. TONKO. Thank you, Professor.

Thank you, Mr. Chair.

259

Chair MILLER. Thank you, Mr. Tonko. You were still well short

of Mr. Rohrabacher’s territory.

Dr. Broun, if you would give me the indulgence of just one last

question, not a whole other round.

ANIMALS AS SENTINELS OF HUMAN HEALTH

Mr. Mier, Professor Parrish just discussed the willingness of

ATSDR to contact him and talk to him. Has ATSDR looked at the

animals that were in your film?

Mr. MIER. No, sir.

Chair MILLER. Have you asked them to?

Mr. MIER. Yes, we have.

Chair MILLER. And what did they say?

Mr. MIER. Initially the response was that it wasn’t within their

mandated domain. Afterwards we were told that neither ATSDR

nor the Texas Department of State Health Services had the expertise, and the latest communication was that the Texas Department

of Health has contacted a couple of researchers at Texas A&M

School of Veterinary Medicine who might be interested in pursuing

but that first of all they have to write a proposal and then hopefully seek grant funds to do that.

Chair MILLER. I am not sure that Mr. Mier is the best—Mr. Mier

is not a scientist. Perhaps Dr. Hoffman is the best to direct this

question to. Is there a value, a recognized value in medical research that effects on animals are an indicator, a sentinel for effects on humans?

Dr. HOFFMAN. In certain situations they are. There is not necessarily 100 percent correlation between the effects on small animals and humans, but I mean, you know, as was shown on that

film, I think it is of concern. I mean, I have no idea what the incidence of similar abnormalities are in that area in Texas but obviously that would be of more substantive data to examine.

Chair MILLER. It would get your attention?

Dr. HOFFMAN. Well, as it did in the area in Pennsylvania, yes.

Chair MILLER. Thank you to all the members of this panel for

your testimony, for coming here and for answering our questions

as well. We will now take a fairly short break before the next

panel. Thank you.

[Recess.]

Panel II:

Chair MILLER. I would like to introduce our second panel. Dr.

Ronnie Wilson, in addition to being a former country music disc

jockey as he told me in the break, probably more pertinent to this

hearing was the Ombudsman as ATSDR from 1998 to 2005 and

teaches now full time at Central Michigan University. Dr. David

Ozonoff is a Professor of Environmental Health at the Boston University School of Public Health, and Dr. Henry S. Cole is the President of Henry S. Cole & Associates, an environmental consulting

firm in Upper Marlboro and a former senior scientist with U.S.

EPA’s Office of Air Quality Planning and Standards. As I said earlier, it is the practice of the Subcommittee to take testimony under

260

oath. Do any of you have any objection being sworn in, to swearing

an oath? No? We also provide that you may be represented by

counsel. Do any of you have counsel at today’s hearings? All right.

If you would now all please stand and raise your right hand? Do

you swear to tell the truth and nothing but the truth? Let the

record reflect that all of the witnesses answered in the affirmative.

Mr. Wilson, you may begin.

STATEMENT OF DR. RONNIE D. WILSON, ASSOCIATE PROFESSOR, CENTRAL MICHIGAN UNIVERSITY; FORMER OMBUDSMAN, AGENCY FOR TOXIC SUBSTANCES AND DISEASE

REGISTRY

Dr. WILSON. Thank you, Mr. Chair. Thank you for the invitation

to speak with your committee regarding ATSDR. I am retired now

from the government and the Army Reserves, and I am an Associate Professor at Central Michigan University. I hold a degree in

journalism, a Juris Doctorate, and a Masters of Science in Administration in Health Services.

I would like to acknowledge the quality science products developed by the professionals within ATSDR who serve the public well

in developing toxicological profiles, health education, health studies, emergency response, and public health assessments. However,

as my testimony will describe, there are serious problems with and

within the Agency.

After serving as the Regional Ombudsman and in enforcement

and public affairs role for 23 and a half years with EPA, I became

the ATSDR Ombudsman. I was selected to build a neutral force to

serve the public in their need to be heard.

In 1999, citizens in Tarpon Springs, Florida, asked me to review

whether an appropriate health assessment had been conducted at

the Stauffer Chemical Company site. The site had been found to be

a public health hazard. The company and community were so hardened in their stance that there was no way to find mutual grounds

for an agreement. So after a year of investigating, I published a

196-page report, gathering evidence which the company, the state

and ATSDR had never seen. I found that the public health had not

been properly studied, and the use of asbestos in vast amounts had

not been considered.

After my report was issued, ATSDR moved quickly to review the

health of the community and the former workers, finding and a

spike of mesothelioma in women who had lived near the plant and

the workers who had likely had their health compromised.

This report is used to point out some issues within ATSDR.

ATSDR was a wonderful idea, a group of scientists who were independent of EPA to look at the public health around hazardous

waste and other kinds of hazardous substance release sites. However, the Agency was never fully staffed or funded and was administratively tethered to the Centers for Disease Control and Prevention, yoking two agencies with different missions. The State’s abilities to dictate the Agency’s ability to assess the heath of the public

was detrimental.

I questioned the author of the original Stauffer Site Public

Health Assessment, a State employee, who produced the report

pursuant to a cooperative agreement. He drafted the report to meet

261

the requirements of the state being paid but without looking at the

details. He was busy on another site with public and press interest.

In gathering materials for the Stauffer report, I asked the state

for information about former employees. Although the public had

been given the data, upon advice of the Florida General Counsel,

the state would not provide the data to me. I asked if ATSDR had

the authority to issue letters commanding the production of information under section 104(e) of the Superfund legislation. No one

knew the answer. The CDC General Counsel’s office advised that

the authority did exist and that a presentation had been made in

1989 regarding the tool. A 104(e) policy was drafted, went to the CDC General Counsel

for review and died because ATSDR was not an enforcement agency. With no policy, the Agency remains unprepared to command the

production of data needed to properly assess the public’s health.

ATSDR is a dichotomy. In one world are the well-run divisions

of the public health, toxicology and education, and I seldom ever

heard a complaint about those. Then there was the Division of

Health Assessment and Consultation, or DHAC, the largest portion

of the Agency, a ‘‘fiefdom’’ managed with an iron fist.

Talented, dedicated professionals in DHAC were not to listen to

the public and could not get products to completion. DHAC leadership delayed the completion of Health Assessments until they were

worded exactly the way leadership felt things should be, not the

way they were. The Division’s science officer sought to develop new

science to be applied by the assessors, ignoring the established levels of the Division of Toxicology and other science agencies.

One Division leader became concerned about this delay and developed a spread sheet to analyze the days that it took to get a

completed public health assessment that was, on average, well over

400 days.

DHAC employees also informed me of the large number of health

assessments that were developed at the beginning stages of the

Agency. The public’s health at this large number of sites was assessed by applying a basic template, documents called interim or

temporary assessments. Most of these documents have never been

revisited or simply received a permanent cover.

DHAC Leadership presented a beautiful picture to the Agency

executives but the public revealed a different story. This conflict

led executives to the development of an Ombudsman program, a

mechanism to provide the public a voice and a hearing.

The Stauffer report highlights an effective Ombudsman program.

The public then had a neutral person they could call with their

complaints. By the end of fiscal year 2005, the public complaints

to the Ombudsman had dropped as the Agency had begun to actually include the citizens in that decision-making process. However,

this favorable report soon ended as the program ceased to exist.

If Congress wishes to impact the health of persons living near or

at hazardous waste sites, reorganize ATSDR. My suggestions simply are: legislate a merger for ATSDR and the National Center for

Environmental Health, or dictate the separation of the two. Make

the Agency independent of CDC. Dictate the establishment of a

permanent, independent Ombudsman office for ATSDR and CDC.

Restrict the use of cooperative agreements with states to hire conVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00269 Fmt 6633 Sfmt 6601 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
262

tractors and dictate the recovery of the dollars spent for flawed reports.

This concludes my remarks, and I will be happy to answer ques- tions at the end of the session.

[The prepared statement of Dr. Wilson follows:]

PREPARED STATEMENT OF RONNIE D. WILSON

Thank you for your invitation to speak with the Committee regarding ATSDR.

I am retired from the government and the Army Reserves and I am an Associate Professor for Central Michigan University. I hold a Journalism degree, a Juris Doctorate, and a Masters of Science in Administration in Health Services.

I acknowledge the quality science products developed by the professionals within ATSDR who serve the public well in developing toxicological profiles, health education, health studies, emergency response, and public health assessments. However, as my testimony describes, there are serious problems with, and within the

Agency. After serving as the Regional Ombudsman and in enforcement and public affairs roles for 23.5 years with the Environmental Protection Agency, I became the ATSDR

Ombudsman. I was selected to build a neutral force to serve the public in their need

to be heard.

In 1999, citizens in Tarpon Springs, Florida, asked me to review whether an ap- propriate health assessment had been conducted at the Stauffer Chemical Company

site. The assessment found the site to be a public health hazard. The company and

community were so hardened in their stance that there was no way to find mutual

grounds of agreement. After a year of investigating, I published a 196-page report, gathering evidence which the Company, the state and ATSDR had never seen. I found that public

health had not been properly studied, and the use of asbestos in vast amounts had

not been considered. After my report was issued, ATSDR moved quickly to review

the health of the former workers and community, finding and a spike of mesothelioma in women who lived near the plant and that worker health was likely compromised.

The report is used to point out some of the many issues at ATSDR. ATSDR was

a wonderful idea, a group of scientists who were independent of EPA to look at the

public health around hazardous waste and other kinds of hazardous substance release sites. However, the Agency was never fully staffed or funded and was administratively tethered to the Centers for Disease Control and Prevention, yoking two

agencies with very different missions.

The State’s ability to dictate to the Agency was detrimental to the assessment of

public health.

I questioned the author of the original Stauffer Site Public Health Assessment,

a State employee, who produced the report pursuant to a cooperative agreement. He

drafted the report to meet the requirements for the state to be paid, without looking

into the details. He was busy on another site with public and press interest.

In gathering materials for the Stauffer report, I asked the state for information

regarding former employees. Although the public had provided me the data, upon

advice of the Florida General Counsel, the state would not. I asked if ATSDR had

authority to issue letters commanding production of information under section

104(e) of the Superfund legislation. No one knew the answer. The CDC General

Counsel’s office advised that the authority did exist and that a presentation had

been made in 1989 regarding the tool.

A 104(e) policy was drafted, went to the CDC General Counsel for review and died

because ‘‘ATSDR is not an enforcement agency.’’ With no policy, the Agency remains

unprepared to command the production of data needed to properly assess the

public’s health.

ATSDR is a dichotomy. In one world is the well-run Divisions of Health Studies,

of Toxicology and Education, about which I seldom heard citizen’s complaints. Then

there was the Division of Health Assessment and Consultation, or DHAC, the largest portion of the Agency, a ‘fiefdom,’ managed with an iron fist. Talented, dedicated

professionals in DHAC were not to listen to the public and could not get products

to completion.

DHAC leadership delayed completion of Health Assessments until they were

worded the way leadership felt things ‘‘should be,’’ not as the facts were. The Division’s science officer sought to develop new science to be applied by the assessors,

ignoring established levels of the Division of Toxicology and other science agencies.

One Division leader became concerned about this delay and developed a spread

263

sheet to analyze the number of days taken to complete a health assessment, an average of more than 400 days.

DHAC employees informed me of the large number of Health Assessments developed at the beginning stages of the Agency. The Public’s health at this large number

of sites was assessed by the application of basic template and documents called interim or temporary assessments. Most temporary documents have never been revisited or simply received a new, permanent cover.

DHAC Leadership presented a beautiful picture to the Agency executives but the

public revealed a different story. This conflict led executives to develop an Ombudsman program as a mechanism to provide the public a voice and a hearing.

The Stauffer report highlights an effective Ombudsman program. The public had

a neutral person to call to hear their complaints. By the end of FY05, public complaints to the Ombudsman had dropped as the Agency had begun to include the

public in the decision-making process. This favorable report soon ended as the program ceased to exist.

If Congress wishes to impact the health of persons living at or near hazardous

waste sites, reorganize ATSDR. My suggestions are:

• Legislate a merger for ATSDR and the National Center for Environmental

Health, or dictate the separation of the two entities.

• Make the Agency independent of CDC.

• Dictate the establishment of permanent, independent Ombudsman offices for

CDC and ATSDR, and

• Restrict the use of cooperative agreements with states as a tool to hire contractor and dictate the recovery of funding not properly earned.

This concludes my remarks. Thank you for your time and consideration of the

public and the professionals at ATSDR. I would be happy to answer your questions.

BIOGRAPHY FOR RONNIE D. WILSON

Dr. Ronnie Wilson has become a recognized expert in two fields that impact

health services administration. Due to his governmental and legal experience, Dr.

Wilson has become known for his ability to assist others in how to avoid negligence

or malpractice

Dr. Wilson has been on the staff at Central Michigan, teaching at the graduate

(Master’s) level since September 1995. Central Michigan University added Dr. Wilson to the full-time staff in 2005 after a 33.5-year career with the Federal Government.

While on loan from the Agency for Toxic Substances and Disease Registry

(ATSDR), Dr. Wilson served as the Executive Director of the Delta Regional Authority, a federal/State partnership seeking to improve the lives of 10 million people in

eight states along the Mississippi River.

Prior to working with the Delta Regional Authority, Dr. Wilson’s most recent position was Ombudsman for the federal agency that conducts health studies around

hazardous waste sites. In that role he spent more than a year investigating a waste

site in Florida and produced a 196-page report to Congress and the head of the

ATSDR. He was given an award by the Florida Sierra Club for his effort to protect

the public health and the environment in Florida.

Dr. Wilson came to the ATSDR after more than 23 years with the Environmental

Protection Agency (EPA). At EPA he served in a variety of roles, including that of

Regional Ombudsman.

On a volunteer basis, Dr. Wilson served as the National Vice President of the

Spina Bifida Association of America for two years, as a National Board member for

five years.

As an Army Reserve officer, he is the holder of three Meritorious Service Medals,

and a Humanitarian Service Medal and he commanded an Army History Detachment. He holds a BS degree in Journalism from Arkansas State University, a Juris

Doctorate from Woodrow Wilson College of Law and a Master’s of Science in Administration, Health Services, from Central Michigan University.

Chair MILLER. Thank you, Mr. Wilson. Dr. Ozonoff.

264

STATEMENT OF DR. DAVID OZONOFF, PROFESSOR OF ENVIRONMENTAL HEALTH, BOSTON UNIVERSITY SCHOOL OF

PUBLIC HEALTH

Dr. OZONOFF. Thank you, Chair Miller, Dr. Broun. My name is David Ozonoff. I am a physician and Professor of Environmental

Health at Boston University School of Public Health, and by trade

over the last 30, 40 years, I am a cancer epidemiologist. At Boston

University I was the founding Chair of the department that teaches and researches the effects of chemicals on health, a department

which I led for 26 years and where I continue to work as a full professor directing a multi-million dollar research program on health

and the environmental effects of chemicals, funded by NIH. I am

therefore intimately familiar with the underlying science which is

beneath ATSDR’s work, and I know its formidable technical difficulty well. In 1991, Congress asked the GAO to examine how well ATSDR was performing those public health evaluations around Superfund

sites that were required by the 1986 SARA legislation, and I was

a member of the GAO expert panel whose judgments formed the

basis for the report’s main findings. Those findings concluded that

ATSDR health assessments required more time and care and better

consideration of community health concerns, that there should be

independent peer review of the assessments, that the contents of

the assessments were redundant of EPA reports and not useful to

EPA or the community, and that the assessments were incomplete

and not reliable for indicating when follow-up studies were needed. Because of our relationship in the department, we worked there

for many years, decades in fact, with community groups around the

country, essentially one of the few if not the only academic unit

who did that. During that same period of the GAO report, we were

engaged by ATSDR via a cooperative agreement to assist them in

community involvement activities around several federal facilities.

In the course of that work, we met frequently with community

members, both with and without ATSDR at community sites. Our

assistance was requested by ATSDR because of persistent complaints. These are complaints that go back to the very inception of

the active work of the Agency in 1986, that public health assessments were flawed, unhelpful, and/or misleading. A common view

was that somebody else had already shot the arrow, and ATSDR

was dutifully painting the target around it.

To prepare for my appearance today and to get as objective a

view as I could, I made a number of calls to people both in the environmental health professions and those connected in communities

with toxic problems to see what has changed since that experience.

The bottom line is this: not very much. The health assessments are

somewhat better on average than the earliest years, but they remain extremely uneven. Some are unsatisfactory. The Vieques example, mentioned earlier by Mr. Grayson, is a notorious example

whose reputation is now rebounding around the environmental

health community.

Recent ones that I have seen are incomplete. They give insufficient weight to the most up-to-date human information, and maybe

because I am in epidemiology, I am sensitive about this subject, but

they do not pay sufficient attention to epidemiology. And although

265

the focus of the public health assessment is rightfully on current

potential exposures, the reports often do a less-than-satisfactory job

of characterizing at least as well as they can past potential exposures. Reports are difficult to read for community members, and

they have a one-size-fits-all format which doesn’t convey the feeling

that the special concerns of the community have been heard or understood.

And while ATSDR provides a short public comment period, the

health assessment documents desperately need independent peer

review from independent experts. At the very least the reports

have a tendency to miss the most current information or adopt lowest common denominator judgments when evidence conflicts. And

in addition, there is insufficient breadth and depth of technical expertise among the health assessors. These are a handful of people

at each site and with each health assessment who are required to

know sciences as disparate as hydrogeology, meteorology, architecture, industrial hygiene, toxicology, epidemiology, sociology, social

psychology just to name a few. And as good as some of them are

and as truly dreadful as some others are, this is almost an impossible task for one or a few people responsible for drafting the average health assessment.

And not all health assessments are done by ATSDR staff. A serious problem is that a number of states, in fact, almost half of the

states I believe, do ATSDR health assessments under cooperative

agreement, a practice which carries with it substantial risk which

we’ve seen, realized any number of times, that State-based pressures are going to affect the results.

I have made several concrete suggestions about what to do in my

written testimony as well as some more general observations.

So to conclude, I would like to just answer a question that you

asked me via letter about my net opinion about whether ATSDR

is meeting its mission. In my own view and the view of most community members I consulted, the routine work of ATSDR remains

deeply disappointing. I say remains because this is not a new situation, as you have heard. And at the core of it is a deep lost of trust

from the communities that ATSDR is supposed to serve. Despite

this, I remain strongly of the view that it is vitally important that

there continue to be an agency whose job it is to look at community

chemical exposures from the public health viewpoint. EPA is primarily a regulatory agency. It is ATSDR’s job to ensure that public

health activities are effective. To do this, it needs the support and

trust of the public to conduct studies and to recommend actions

that are focused solely on protecting public health. Public health

has the word public in it, and the public indeed should be the main

focus of ATSDR’s activities.

In the context of the enormous problems that we face today that

are in the news every day, ATSDR’s problems probably seem

minor, and in terms of cost, they are essentially trivial compared

to the sums that are being discussed daily. But for the affected

communities, they are far from trivial. In some cases, they are matters of life, death, and certainly the happiness of people in those

communities.

In 30 or 40 years of observing this, one of the things that I have

seen is that chemical contamination doesn’t just take lives, as terVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00273 Fmt 6633 Sfmt 6601 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
266

rible as that is, and as a physician, that causes me great pain to

see. But in addition to that it also wrecks lives, something that I

have seen all too often. I would be glad to answer questions after

the panel has made their statements. And I thank you for your interest in this urgent matter. [The prepared statement of Dr. Ozonoff follows:]

PREPARED STATEMENT OF DAVID OZONOFF

Chairman Miller, Member Broun and Members of the Subcommittee. My name is David Ozonoff. I am a physician and Professor of Environmental Health in the

Department of Environmental Health at the Boston University School of Public

Health. I was the founding Chair of the Department that teaches and researches

the effects of chemicals on health, a Department which I led for 26 years. I continue

at Boston University as a full Professor where I direct a multi-million dollar research program on the health and environmental effects of chemicals, funded by

NIH.

By way of background, I received my undergraduate degree in mathematics from the University of Wisconsin in 1962, my MD degree from Cornell in 1967 and my

Master of Public Health degree from Johns Hopkins School of Hygiene and Public

Health (now the Bloomberg School) in 1968. I spent the first ten years of my career

at MIT, where I taught and did research, before moving to Boston University in

1977. The Department I founded there had as its focus understanding the health

effects of chemicals on communities. We were then, and remain today, 30 years

later, one of the few academic units specializing in this subject. Most investigations

of community health effects are carried out in the public sector by State and federal

agencies, one of which is ATSDR. In most of our research and technical assistance

we have worked closely with communities and while this helped me to see the problem from their perspective, I am also intimately familiar with the underlying science

and its formidable technical difficulty. I know quite well that judgments that appear

straightforward on the surface are anything but. Difficult as such work may be, there have been persistent problems with how ATSDR carries it out. In 1991 Congress asked the GAO to examine how well

ATSDR was performing the public health evaluations around superfund sites required by the 1986 SARA legislation. Public health assessments are meant to determine if hazardous waste sites were causing harmful exposures to surrounding communities and, if so, whether these exposures should be stopped or reduced. I was

a member of the GAO expert panel whose judgments formed the basis for the report’s main findings. The GAO concluded that ATSDR health assessments required

more time and care on the technical aspects and better consideration of community

health concerns; that there should be independent peer review of the assessments;

that the contents of the assessments were redundant of EPA efforts and not useful

to EPA or the community; and that the assessments were incomplete and not reliable for indicating when follow-up studies were needed. A number of recommendations were made, including that Congress should check back later on progress. I see

this hearing as fulfilling that recommendation. Because of our relationship and reputation working with communities, in the 1990s we were engaged by ATSDR via a Cooperative Agreement to assist them in

community involvement activities around several federal facilities. In the course of

that work we met frequently with community members at community sites. Dr.

Cole, the next panelist, helped us with some of that work. Our assistance was requested because there continued to be persistent complaints from communities that

ATSDR’s public health assessments were flawed, unhelpful or misleading. A common view was that someone had already shot the arrow and ATSDR was dutifully

painting the target around it.

As a result of this background I have seen the problem from several different perspectives, an experience which surely tempers my judgments. I think I have a good

feeling for what it is like to be in ATSDR’s shoes, always useful for fairness. I also

have the advantage of distance from the immediate fray. As my Department grew,

my research group expanded greatly and other problems began to claim my attention. As a result I have spent considerably less time in recent years with either the

communities served by ATSDR or the Agency itself. I remain close to many community activists and their leaders for whom ATSDR represents, at the least, a serious

problem. I have the greatest respect for these residents and activists and for their

dedication to making their communities safer for themselves, their families and

their neighbors. The toll this takes on them is very large and their stories are heart

wrenching. I am not just a scientist but I am a spouse, a father and a grandfather,

267

and it takes little imagination for me to identify with their concerns. I also know

many of the principal players from both the early days of ATSDR and the current

leadership. To prepare for my appearance today and to get as objective a view as

I could, I made a number of calls to people, both in the environmental health profession and those connected to communities with toxics problems, to see what has

changed in recent years. The bottom line is this: not very much. The health assessments are better on av- erage than in the early years but their quality remains uneven and some are unsatisfactory. Some of the recent ones I have seen are incomplete and do not give sufficient weight to the most up-to-date human information, tending to de-emphasize epidemiology while spending disproportionate time on toxicology and animal evidence.

Often much of the detail involves exposure analysis, a function of at least three

things: the experience and training of many of the health assessors is more in the

area of Earth science and engineering; site-specific detail is available from parallel

EPA efforts; and the lack of experience and training that makes assessors more dependent on summary statements like ATSDR toxicology profiles and fact sheets, a

number of which are dated or even obsolete. And although the focus of the public

health assessments is rightfully on current potential exposures, the reports often do

a less than satisfactory job characterizing (or addressing as well as they can) past

potential exposures. Finally, the reports are difficult to read for community members and have a one-size-fits-all feel which does not convey the feeling that the special concerns of the community have been heard and understood.

While ATSDR provides a short public comment period on its reports, the health

assessment documents need independent peer review from experts. At the very least

the reports have a tendency to miss the most current information or adopt lowest

common denominator judgments when evidence conflicts. In addition, there is insufficient breadth and depth of technical expertise among the health assessors who are

required to know sciences as disparate as hydrogeology, meteorology, architecture,

industrial hygiene, toxicology, epidemiology, social psychology and sociology, to

name a few. As good as some of them are (or as inadequate as are others), this is

almost an impossible task for the one or a few people responsible for drafting the

average health assessment. There also needs to be a full review of ATSDR Fact

Sheets used for public education for relevance to the concerns of communities and

their overall usefulness and appropriateness in specific situations.

Not all health assessments are done by ATSDR staff. The Agency out-sources the

health assessment task to a number of states under Cooperative Agreements. This

practice is beneficial for building capacity in cash strapped State health departments but carries with it the risk that local pressures from the Governor’s office or

the legislature will affect the result. ATSDR is not immune to these State-based

pressures but they are more distant and ATSDR has a greater chance of independence. I have written about this problem in the past and ask that our paper on the

subject be appended to this testimony.

In summary, I would repeat and add to some of the recommendations we made

in 1991, including:

• an effective arrangement for independent and timely expert peer review of

ATSDR health assessments, consultations and studies.

• an across the board review of the fact sheets and recommendations ATSDR

is giving to communities for relevancy to their concerns. It is not uncommon

for a community to be told by ATSDR there is no hazard and then to be given

advice they should wash their hands and take off their shoes after being in

a contaminated outdoor environment.

• an increase in the breadth of scientific talent recruited by the Agency.

• a re-evaluation of the practice of out-sourcing work to State health departments. Perhaps regional style consultation units, based at universities, would

be useful.

Finally, you have specifically asked me to give my opinion about whether ATSDR

is meeting its mission. Let me try to answer the question by giving you my own

view and the view of most community members I consulted. It is this. The routine

work of ATSDR remains deeply disappointing. ATSDR has acquired, partly on its

own, partly for reasons beyond its control, a reputation with communities it will

have a difficult time remedying. It is not alone in the government in being a deep

disappointment. But it is the disappointment we are here to talk about today.

Disappointment is relative to what one expects. One way to think about this is

on the doctor–patient model. A patient with health concerns or complaints expects

a doctor to listen, to hear and interpret beyond what’s being said, and to be competent—or at least competent enough so the patient will not be able to see obvious

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errors. A patient also expects the doctor to be able to do things that make them

feel more comfortable if not to make them better. The most damaging thing that

can happen to the doctor—patient relationship is loss of trust and faith by the patient. And that is what is at the core of the problem with ATSDR. If a doctor doesn’t

meet basic expectations the patient will look for another doctor. But there is no

other recourse when the patient is a neighborhood and the doctor is ATSDR. This

has produced a self-reinforcing feedback loop where ATSDR frankly admits their reluctance to hold public meetings because of the abuse they receive in these settings,

opting instead for one-on-one encounters. This is seen as a further withdrawal from

the organized community, which responds in kind, increasing the alienation. This is a difficult situation. But I am strongly of the view that it remains vitally important that there continue to be an agency whose job it is to look at community

chemical exposures from the public health point of view. EPA is primarily an environmental regulatory agency, not a public health agency. Public health has the word

‘‘public’’ in it, which implies looking at the situation from the community’s standpoint. ATSDR was supposed to step into the gap. There is no simple technical or legislative fix for what ails ATSDR. The problems are problems of leadership at virtually every level. Presidents from Nixon to Obama

have declared we must make an effort to cure cancer in our lifetime. For those

whose friends, family and indeed themselves are in the cancer years, this appears

to us an important goal. But for my children and grandchildren’s sake, I would have

also liked to hear that we will prevent cancer in our lifetime. ATSDR depends upon

advances in basic science to do its job and the recent stimulus package recognized

the importance of basic health science to our economy and the terrible cost of dread

disease in our communities by injecting badly needed resources into the NIH. Investment in science pays off in many multiples. But left out entirely was money for

the science of preventing cancer and other diseases acquired in the environment and

workplace. NIOSH got nothing, which means it will get less again this year than

last year. The NIH’s program for basic science underlying superfund, the Superfund

Basic Research Program, got nothing, which means it, too will shrink. CDC and its

Center for Environmental Health got nothing. CDC’s only stimulus money is for

bricks and mortar projects. Bricks and mortar don’t prevent cancer. It is a wry

adage in the public health community that no Senator champions an agency because

his wife didn’t get breast cancer or any Congressperson because her child was born

healthy. Much of essential public health and its importance remains invisible to the

public. Until this changes other things that need to change, like ATSDR, won’t. I’m not talking about money here. The amount involved are almost lost in the ac- counting noise among the sums we are talking of these days. This is a question of

leadership. The unglamorous parts of health science, the parts that are true public

health infrastructure and upon which much else depends, like surveillance and vital

records, things ATSDR depends upon, have not had the necessary champions. I include those in the private sector, like myself and in Congress but also the Executive

Branch. Indeed the Agency needs to signal to you in Congress what must be done.

ATSDR is a sister agency of CDC, but the CDC administrator did not visibly, vocally or strenuously fight for it or even her own agency, publicly. Whether she

fought these battles internally I don’t know, but we needed visible and strong public

champions for public health and we didn’t have them. We had a skilled communicator but not a champion. Morale at CDC has dropped precipitously. That’s a leadership question. Similarly, ATSDR needs not only the trust and confidence of the communities it is supposed to serve, but its own leadership needs the trust and confidence of the many dedicated professionals in the Agency itself. That’s not a question for legislation.

In the context of the enormous problems we face in the economy and foreign policy, ATSDR’s problems seem trivial, and in terms of cost they are. But for the affected communities, they are far from trivial. In some cases they are matters of life,

death and happiness. If pressed hard to name the single effect of living in a contaminated community I see most consistently, it would be divorce. In a world where

the stresses on marriage are already large, the additional burden of worrying about

one’s family and what might happen to them or coping with what did happen to

a child, is too much for too many. Chemical contamination doesn’t just take lives,

as terrible as that is. It can also wreck lives.

I thank you for your attention to this urgent matter, of which the problems at

ATSDR are real but only a part.

BIOGRAPHY FOR DAVID OZONOFF

David Ozonoff received his Bachelor’s degree in mathematics from the University

of Wisconsin in 1962 and his MD degree from Cornell University Medical College

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in 1967. In 1968 he received an MPH degree from Johns Hopkins School of Hygiene

and Public Health. He then pursued research work at MIT from 1968 to 1977,

studying, among other things, the psychophysical difficulties of radiologists when

reading chest x-rays. He and his colleagues also published one of the first two-dimensional x-ray reconstructions (CAT scans) in the literature in 1969. He also

served as a consultant to the World Health Organization, assisting WHO in the

preparation and writing of its contribution to the first International Conference on

the Environment which took place in Stockholm in 1972. In 1975 he was a Macy

Fellow in the History of Medicine and the Biological Sciences at Harvard, and in

1976 a Mellon Fellow in the History of Public Health at MIT. In 1977 he moved to the Boston University School of Public Health and in 1983 he became the founding Chair of the Department of Environmental Health, a position he held until 2003 when he became Chair Emeritus He is Professor of Public

Health at Boston University School of Public Health, and Professor of Sociomedical

Sciences and Community Medicine at Boston University School of Medicine. He directs the Superfund Basic Research Program at Boston University, a $17 million

dollar multi-project research effort. He is a Fellow of the Johns Hopkins Society of

Scholars and a Fellow of the Collegium Ramazzini. Dr. Ozonoff’s research has centered on epidemiological studies of populations ex- posed to toxic agents, especially the development of new methods to investigate

small exposed populations. He has studied populations around Superfund sites in

a number of places, most recently case control and cohort studies in the Upper Cape

region of Massachusetts. Dr. Ozonoff frequently serves as advisor or consultant to

local, State and federal agencies on matters of health effects from hazardous wastes

and contaminated drinking water. He chaired the Water Systems Security Committee of the National Research Council/National Academies of Science and has

served on several other NRC panels. He is the author of numerous scientific articles

and is on the editorial boards of the Archives of Environmental Health and the

American Journal of Industrial Medicine and is co-Editor-in-Chief of Environmental

Health, an Open Access international journal.

Chair MILLER. Thank you, Dr. Ozonoff. Dr. Cole, five minutes.

STATEMENT OF DR. HENRY S. COLE, PRESIDENT, HENRY S.

COLE & ASSOCIATES, INC., UPPER MARLBORO, MARYLAND

Dr. COLE. Thank you, Chair Miller and Dr. Broun and Members of the Subcommittee for this very important hearing. I am President of Henry S. Cole & Associates, and it is an environmental consulting firm which, among other things, provides scientific support

to numerous community organizations on environmental issues. I received my Ph.D. in meteorology at the University of Wis- consin in 1969, was an Associate Professor of Environmental

Sciences at UW–Parkside during the 1970’s, and my research into

air pollution meteorology led to my appointment to the Wisconsin

State Air Pollution Council. From 1977 to 1983 I was senior scientist with U.S. EPA’s Office of Air Quality Planning and Standards where my work focused on predicting the impact of source

emissions on ambient air. I am giving you this background because

it qualifies me to talk about the particular case that I am going to

talk about which is Perma-Fix, a facility that processes hazardous

and industrial waste in Dayton, Ohio.

Another thing is that ATSDR retained me as a consultant from

1995 to 2003 to investigate the Agency’s community involvement

practices and to work with the Agency’s Community and Tribal Advisory Committee. The purpose of that work was to help them improve that program.

Since 2004, I have provided technical support to a Dayton, Ohio,

community organization affected by odors and emissions from an

industrial waste processing plant known as Perma-Fix. For years,

residents of surrounding low-income neighborhoods complained of

noxious odors. These complaints were confirmed by the regional air

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pollution control agency which later issued a notice of violations to

Perma-Fix. Residents suspect that many illnesses are related to the

plant’s emissions including nosebleeds, respiratory disease, cardiac

disorders, birth defects, and many other symptoms.

In 2004, ATSDR responded to a community petition and agreed

to do a health consultation on this case. The consultation was

based on a monitoring study of chemicals in community air. The

consultation published in December 2008 found that none of the

chemicals tested were above levels of concern, and that information

on Perma-Fix’s waste and processes did not reveal an obvious

source for the observed odors. I want to emphasize those two findings.

As a scientist with experience in air pollution meteorology, I

found that the limited number of days sampled, only six days sampled, is insufficient to give an accurate representation of long- or

short-term concentrations. The waste process emissions and weather all vary from day to day, requiring a far more robust sampling

plan. In addition, the consultation also failed to consider the additive effects of pollutants and the fact that the area is non-attainment for ozone and inhalable particulates. Moreover, ATSDR failed

to measure or obtain information on the plant’s emission rates or

to conduct air quality monitoring.

It gets worse. In May 2006, the U.S. Government sued PermaFix for its violations of the Clean Air Act. The complaint identifies

Perma-Fix as a major source of hazardous air pollutions and cites

numerous failures to control emission sources. The resulting consent order included a stiff fine and requirements to control emissions. The court docket contains detailed information on the plant’s

emission sources, and ATSDR officials declined to use this data

readily available online despite pleas from the community. They

declined to use government information, detailed information, on

sources in coming to its conclusion. I feel that that is unconscionable. To find no obvious source for the odors, given that kind of

record, is absolutely unconscionable.

The Agency’s sole recommendation asking Perma-Fix to voluntarily control solvent releases could have been made back in 2004

without doing a flawed and predictably inconclusive monitoring

study. It makes me so frustrated I can’t get the word out. Residents were so frustrated that in July 2007 they petitioned the

Agency once again, this time to halt all of its work on Perma-Fix

unless the Agency negotiated a protocol and process acceptable to

the community. They never did that.

Let me just say in concluding that I, too, poll communities that

I have worked with, and this agency has no trust. In fact, if you

look at the agencies that communicate with networks, they advise

communities to be very cautious about cooperating with ATSDR because of these inconclusive studies, and many groups feel that

there is more harm done than good. The reason for that is that if

a conclusion is inconclusive, that quickly gets translated to mean

there is no problem. No evidence is equated with no problem, and

that is used as an excuse for inaction. It may have even damaged

the government’s case. If this health consultation had come out

prior to the consent degree in this case, it may have damaged the

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case. So one has to wonder about an agency and whether they are

fulfilling their mission.

Finally, what has to be done? I think the proverb behind you is

very telling. It says, ‘‘Where there is no vision, the people perish,’’

Proverbs 29:18. This agency has lost its vision, especially in its

dealings with communities, and I think that the first thing that

has to be done is to take a close look at the leadership of the Agency and maybe what is needed is a fresh start. Thank you.

[The prepared statement of Dr. Cole follows:]

PREPARED STATEMENT OF HENRY S. COLE

1.0 Introduction:

First, let me thank Chairman Miller, Ranking Member Broun and the other Members of the Subcommittee for the opportunity to present my views on the future of

ATSDR.

By way of introduction, I am President of Henry S. Cole & Associates, Incorporated, a Washington, DC area-based environmental consulting company now in its

16th year. I received my Ph.D. in atmospheric sciences at the University of Wisconsin in 1969. My career in atmospheric and environmental sciences is approaching

the 40-year mark. During the 1970’s, I served as an Associate Professor of environmental Earth sciences at the University of Wisconsin–Parkside and conducted a research project involving air pollution meteorology. From 1977–1983, I then served

as senior scientist with U.S. EPA’s Office of Air Quality Planning and Standards

and Chief of the Modeling Application Section. This section focused on the relationship between sources, emissions, weather conditions and ambient concentrations.

From 1983–1993, I served as Science Director of the Clean Water Fund.

My consulting firm, founded in 1993, has provided scientific research and technical advice to support the efforts of dozens of community-based organizations to improve the environmental health and sustainability of their communities. A significant portion of my work has been funded by community-based organizations that

receive Superfund Technical Assistant Grants (TAGs) from U.S. EPA. Other clients

have included neighborhood associations, State and national environmental organizations and local governments. ATSDR conducted public health assessments and

consultations in a number of these communities. An additional line of work is scientific support for companies with technologies that are more sustainable than market standards.

From 1994 to 2003, I served as a consultant to the Agency for Toxic Substances

and Disease Registry (ATSDR) in order to help the Agency improve its community

involvement programs and practices. In this capacity I provided advice to former

Administrator Barry Johnson and prepared a report based on case studies of numerous communities where ATSDR provided health assessments or studies. Finally I

served as an advisor to the Agency’s ‘‘Community and Tribal Subcommittee.’’ The

subcommittee included leaders of communities and tribes in which ATSDR had

worked. For additional details see attached CV and www.hcole-environmental.com.

2.0 Is ATSDR Fulfilling It’s Mission?

ATSDR describes it mission in the following way:

ATSDR’s mission is to serve the public by using the best science, taking responsive public health actions, and providing trusted health information to prevent

harmful exposures and disease related exposures to toxic substances.

The Oversight Subcommittee has performed a great service by examining

ATSDR’s handling of the FEMA trailers cased in which hundreds of Katrina victims

were exposed to formaldehyde. The Subcommittee report demonstrates that ATSDR

was negligent in the conduct of its duty. In its efforts to play down the dangers,

the Agency exercised a callous disregard for both science and for the health of those

exposed in the trailers.

In my experience, however, the FEMA trailer case is not an isolated case where the

Agency has failed to live up to its mission. Unfortunately, the Agency’s performance

in a substantial number of communities has undermined its most valuable commodities, the ability to provide ‘‘trusted health information’’ and the ability to ‘‘prevent

harmful exposures’’ and their effects.

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1 Under cooperative agreements, Public Health Assessments are often conducted by State

Health Departments. I recently reviewed the Ohio Department of Health/ATSDR assessment on

the Armco-Hamilton Site in Ohio (former steel mill and coke ovens along the Great Miami

River). In my judgment, this assessment did a reasonably good job in scoping out the information existing and referred to U.S. Geological Survey documents which described the vulnerability

of groundwater to contamination and the close down-gradient vicinity of the Hamilton North

municipal well field. The Health Assessment also recommended that fish be tested for persistent, bio-accumulative contaminants such as PCBs. See: Agency for Toxic Substances and Disease Registry (ATSDR), Public Health Assessment for Armco-Hamilton Plant, 2005. 2For example, ATSDR adopted a number of ideas from its community and tribal advisory

group, including the initiation of health-related Technical Assistance Grants, which allow community organizations to hire independent experts to serve as advisors pertaining to health assessments and health studies. 3 ATSDR, Health Consultation, Exposure Investigation Report, Airborne Exposures to Select

Volatile Organic Compounds, Perma-Fix Of Dayton, Inc., Dec. 15, 2008. 4 According to the Health Consultation, health-related concerns include headaches, nausea,

vomiting, nose bleeds, numbness in legs and hands, heart, gastrointestinal and respiratory disorders, burning eyes, sore throats, unexplained rashes, premature births, and birth defects.

I believe that the Agency has improved the overall quality of its Public Health

Assessments1 and community involvement programs since the early 1990s.2 However, the Agency will have to make some monumental changes in the conduct of

science and in its relationship to communities to warrant its continued use of tax

payer dollars. Such changes will require real leadership and a rededication to

science and public health even when the evidence requires expensive corrective measures and opposition by federal agencies or by business. Moreover, uncertainty is not

an excuse to play down community concerns, but to dig further and to err on the side

of caution.

3.0 ATSDR’s Perma-Fix Health Consultation:

Today, I will focus on a very recent example, of an ATSDR Health Consultation

that has failed the Agency’s mission—a consultation dealing with a Dayton, Ohio

community affected by a plant in their midst that processes industrial and hazardous wastewaters, sludges and oils. The company is Perma-Fix of Dayton (PFD).3

My association with this case included technical consultation to the Dayton Legal

Aid Society in 2004 and pro-bono advice to community leaders.

Let’s imagine for the moment that you live in this community, know as Drexel.

Your homes and those of your neighbors are small. The community has experienced

economic stress for years—not just lately. You have complained to various levels of

government for years about the frequent and sometimes overpowering odors that

occur when Perma-Fix is processing waste. These odors often make doing something

out of doors intolerable and when you get upset enough you call the Regional Air

Pollution Control Agency. Although RAPCA inspectors have confirmed the validity

and intensity of complaints for many, the problem continues unabated. You also suspect that a high incidence of health problems has something to do with emissions

from this plant.4

Then, in 2003, your neighborhood group hears about ATSDR, that it’s a government agency that can help environmentally stressed communities with various studies. Agency officials respond to a call from the group and your visit the community

and appear to be friendly and sympathetic. They tell you how to petition the Agency

and with hopes high your community group does so.

Now lets take a look at what actually happened.

ATSDR accepted the community petition and agreed to do a Health Consultation

in March 2004 based on an Exposure Investigation. The purpose of the investigation

was to determine whether volatile emissions from Perma-Fix (PFD) were exposing

residents to harmful levels of any of 100 chemical species tested. To do this ATSDR

conducted an air monitoring program in the neighborhoods surrounding the plant.

The number of days utilized in the investigation was extremely low; only six days

during the 13-month period from June 2007–June 2008.

More than four years after the petition, ATSDR published its Health Consultation

document just this past December (2008). The principal findings of the Health Consultation on PFD are listed below:

• Although the data only represent ambient air concentrations during the time

of sampling, none of the more than 100 compounds analyzed were detected

over health-based values.

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5 ATSDR, Health Consultation, p. 13. 6The document does not state whether or not the company was notified as to the timing of testing in advance. Prior notification would have allowed the company to take preventive actions

(e.g., not processing certain kinds of wastes) that are not normally employed.

• ‘‘The differences between the average concentrations of volatile organic compounds (VOCs) for downwind and upwind samples were not statistically significant. This lack of difference may be due to the small sample size.’’5

• ATSDR’s review of information on the wastes accepted and the treatment processes used by PFD did not reveal an obvious source for the observed odors in

the neighborhood.

• ATSDR’s outdoor air sampling revealed one compound, ethyl acetate—which

has a low odor threshold and the characteristic odor of fingernail polish remover—may be the source of the reported solvent-like odors. That same odor

was observed by ATSDR staff while touring the PFD facility and was most

noticeable in the filter press room and testing laboratory.

The sole recommendation found in the Health Consultation is as follows:

• ‘‘To reduce solvent-like odors, PFD should determine if there is a source of

ethyl acetate in their waste streams and seek to eliminate or treat it if it is

present.’’

To understand why community members were frustrated and angry we need to

look not only at study’s outcome (after four years) but also at several inter- related

problems including serious deficiencies in the Agency’s science, its failure to utilize

critical information and its flawed community involvement process.

3.1 Inadequacies in the Exposure Investigation’s Monitoring Study

1. The number of sample days (six days over a 13-month period) was woefully inadequate, especially if they are attempting to look at health effects. Both emissions

and weather conditions vary—thus a much larger sample (days and locations) is

needed to capture the worst cases.6

2. The kind of monitoring study conducted by ATSDR should have been supplemented with source testing and air quality modeling. ATSDR officials acknowledged that it did not include source testing. Testing stack and fugitive emissions

could have given the Agency much better information on the chemicals being

emitted from the plant.

3. Air quality modeling can estimate the distribution of concentrations from a

source based on pollutant emission rates and multi-year data sets on weather

conditions. Although modeling has limitations, the combination of monitoring and

modeling provides better information than either alone.

4. Although, the report addresses wind speed and direction, it does not address the

stability of the atmosphere (e.g., the presence or absence of temperature inversions). The combination of stable atmosphere with very slow wind speeds has the

potential for worst case conditions. It is not certain whether ATSDR’s sampling

included such conditions. Moreover, as the Health Consultation acknowledges,

the sample collection length (from two to eleven hours) would not provide information on peak concentrations of relatively short durations.

5. Samples were taken and analyzed on six different days. However, not all of the

contaminants were analyzed for each of the six days. Thus the study may have

failed to detect certain contaminants on some of the days.

3.2 Problems with the Health Consultation Process

1. Despite repeated requests, the protocol was not provided to the community for

review and comment before the study was initiated. The potential deficiencies

could have been discussed in advance of the study had a draft been provided in

advance. This is a key requirement for effective and respectful public involvement. The Health Consultation does not include a response to citizen concerns

and recommendations.

2. ATSDR failed to incorporate substantial information pertaining emissions including those of odors and hazardous air pollutants (HAPs) that were available in

various notices of government violations and suits filed by a resident and regulatory agencies against Perma-Fix (PFD). These include:

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7Documents on the case of Fisher and the United States versus Perma-Fix of Dayton are

available U.S. District Court, Southern District of Ohio (Dayton), CIVIL DOCKET FOR CASE

#: 3:04–cv–00418–MRM. 8Letter from Laura J. Rench to Howard Frumkin, Director National Center for Environmental

Health and ATSDR, July 25, 2007. (Attached) 9Stephen Lester, Center for Health Environment & Justice, Assessing Health Problems in

Local Communities. Updated April 2007.

• In 2002, the Regional Air Pollution Control Agency (RAPCA) issued a Notice

of Violation to Perma-Fix for the company’s failure to comply with RAPCA’s

previous orders pertaining to odor and emissions controls from a number of

sources within the plant.

• In 2005, U.S. EPA filed a ‘‘Finding of Violation’’ in regard to PFD’s failure

to control a variety of hazardous air pollution (HAP) emission sources regulated under the Clean Air Act.

• In May, 2006, the Justice Department in 2006, on behalf of U.S. EPA joined

the suit of a local resident for injunctive relief and civil penalties against

Perma-Fix for similar violations. The complaint again cited numerous failures

to control emissions, e.g., the plant’s bio-plant tanks and wastewater treatment plant and other sources. In addition, the company failed to keep records,

conduct testing, or apply and receive permits as required by regulations. (See

attached copy U.S. Justice Department complaint.)

• In 2007, the parties to the 2006 suit entered into a Consent Decree that imposed a civil penalty of $360,000 and required PDF to (a) identify sources of

emissions and odors (b) measure emissions (c) prevent and control emissions

and odors and (d) obtain a Title V permit from U.S. EPA.

The filings associated with these complaints as well as a variety of documents

(e.g., reports by expert witnesses) were readily available to the Agency online.7 The

information contained in these sources would have been extremely useful to ATSDR

in its design of the monitoring study and in generating a meaningful set of recommendations. For example, one memorandum contained in the docket provides

specific information on waste streams and emission sources. I am also aware that

community leaders made numerous attempts to persuade ATSDR officials to obtain

and use this data. However, to my knowledge the Agency failed to do so; moreover,

the Health Consultation is mum on the Agency violations, the federal and citizen

litigation and the resulting Consent Decree. (See Attached Documents)

Residents were so frustrated with ATSDR’s handling of the study, that in July

2007 they petitioned the Agency once again—this time to ‘‘halt all of its work regarding Perma-Fix until such time as it works out an acceptable protocol and public

involvement process with the affected community.’’ 8 A copy of this letter is attached.

In my judgment, it is unconscionable that the Agency failed to include in its Consultation (2008) the list of uncontrolled emission sources in the record and the extent which Perma-Fix was taking meaningful steps to meet the requirements of the

2007 Consent Decree. Instead, the Consultation’s sole recommendation is of no real

consequence or utility. Moreover, it could have been made back in 2004 without expending funds for a predictably inconclusive monitoring study. Most importantly,

the tepid recommendation coupled with the implied finding that there is ‘‘no evidence for concern’’ can be readily translated to signify, ‘‘no cause for concern.’’ Had

this report been issued earlier, it might have been used to impede the successful

federal and citizen litigation against Perma-Fix and the relief it provides.

Thus, it is not surprising that residents of Drexel have grown frustrated and

angry and have lost the trust they had in ATSDR. There are many similar stories

and word gets around. For example, the Center for Health, Environment and Justice, an organization founded by activist Lois Gibbs, has warned in its publications

that communities may opt to boycott ATSDR (and cooperating State health departments) unless the Agency negotiates with the community in good faith regarding

study protocols and related issues of public concern.9

4.0 Recommendations:

What is needed to create the needed change at ATSDR? First, I would propose

that this subcommittee continue its valuable oversight of ATSDR. Secondly, the

Subcommittee should press ATSDR to adopt the following policies submit legislation

that would mandate the changes if needed.

1. ATSDR should provide draft protocols for all exposure investigations and

health studies for public review and comment. Upon the request of members

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of the public the Agency should be required to subject protocols to independent review.

2. ATSDR should undertake the following measures with regard to all community-related documents, including health assessments, health studies, health

consultations and exposure investigations:

• Provide drafts of the documents for public review with a minimum 40-

day comment period.

• Upon request, subject the draft to peer review by a group of experts free

of ties with ATSDR or facilities which are the subject of the investigation

of concern.

• Upon request, the Agency should hold a public meeting with regard to

the draft document.

• The final document should respond to all community and peer review

comments.

3. In formulating its findings and recommendations, ATSDR should utilize all

pertinent information including federal, State and local agency enforcement

actions and evidence contained therein.

4. In any case where the Agency finds that it has insufficient evidence to support a finding (e.g., health effects), it should include clear language warning

the public or business leaders not to equate the absence of evidence signifies

an absence of effect or concern. ATSDR should monitor press coverage of all

of its community-based documents; where there are indications of confusing

statements or misinterpretations, ATSDR should take immediate and public

measures to correct such statements.

5.0 An integrated approach to community restoration and health.

Environmentally stressed communities approach ATSDR and other health agencies because they have serious concerns and badly need help. Low-income, minority

and tribal communities often are impacted by a multitude of environmental

stresses: e.g., a waste management facility, factory pollution, highly toxic diesel

emissions, and unhealthful levels of inhalable particulates and/or ground level

ozone. Perhaps there are sewerage related problems. There are other stresses as

well—such as unemployment, no access to health care, aging populations, lack of

adequate housing, etc. Health agency actions which focus on a single source are

poorly equipped to deal with this these situations.

Needs vary from one community to another; i.e., the local health clinic may need

expertise to deal with environmental exposures, perhaps a local credit union or pension fund could invest in restoring homes to livability, or perhaps the need is set

up volunteers to visit the homes of elderly neighbors on a continuing basis. Such

efforts will require a different vision and much greater coordination between programs and agencies. However, there are examples of community-based approaches

which attempt to solve problems holistically. For example, in Trenton, a non-profit

organization, Isles, Inc. has set up programs to remove lead from home environments and has trained residents to address these problems and to restore dilapidated buildings. These programs have led to employment and entrepreneurial opportunities. Trenton has the potential to bring in up to $2.4 million for green collar

jobs and career development activities, many of them connected to restoration and

improved environmental health. See http://www.isles.org/

This program is by no means unique. In fact, President Obama’s economic stimulus package contains funding for community-based training and employment in

areas such as weatherization and renewable energy. (See also, The Green Collar

Economy by Van Jones and Ariane Conrad, 2008 for many examples of communitybased initiatives aimed to bring environmental health and economic progress to

communities.)

I believe that public health agencies including ATSDR could play an important

role in fostering the kind of interagency and inter-departmental coordination that

is needed to bring a more holistic and cost-effective approach to community health.

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BIOGRAPHY FOR HENRY S. COLE

Henry S. Cole, Ph.D., the President of Henry S. Cole & Associates, is an environ- mental and atmospheric scientist with broad and in-depth experience on issues involving air pollution, involving facility emissions, air pollution meteorology and

source receptor relationships. His experience includes a wide range of pollutants and

sources including landfills, incinerators, power plants, cement kilns, and industrial

plants. Dr. Cole has a broad and interdisciplinary background in environmental

Earth sciences as well as atmospheric sciences which enables him to provide scientific support and expert opinion on the transport and fate of contaminants in the

environment. Dr. Cole is a professional member of the American Meteorological Association and the American Chemical Society and has won awards from the U.S. Environmental Protection Agency, Sierra Club, and Clean Water Action.

Education

Cole earned his BS with high honors at Rutgers University College of Agriculture (1965) with majors in soil science and meteorology. He obtained his Ph.D. in meteorology at the University of Wisconsin in 1969 and received broad training in atmospheric sciences including dynamics, thermodynamics, climatology, micrometeorology,

and physical meteorology.

Faculty Research and Teaching

As a faculty member of the University of Wisconsin–Parkside (1969–1977) Cole

conducted EPA-sponsored research on the air pollution problems affecting the Chicago-Milwaukee L, Michigan shoreline corridor. He co-authored some of the earliest

and most referenced journal articles on the impact and modeling of shoreline

sources (e.g., power plants, urban emissions). (See Publications List). Cole taught a

variety of courses including meteorology, environmental Earth sciences, and air pollution meteorology. He received tenure and promotion to Associate Professor in

1976. During this period, Cole served as a member of the Wisconsin State Air Pollution Control Council.

U.S. EPA Senior Scientist

During the period 1977–1983, Dr. Cole served as a senior scientist in U.S. EPA’s

Office of Air Quality Planning and Standards (Monitoring, Data and Analysis Division). In this capacity, Cole directed the Modeling Application Section of the Source

Receptor Analysis Branch. This Section used point/stationary source, urban, and reVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00309 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
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gional modeling to develop emission limits and ambient air strategies as part of the

regulatory process. In position as Section Chief, Dr. Cole supervised staff in their

application of numerous point source, urban source, and regional air quality models.

Clean Water Action

From 1983–1993, Cole served as Science Director of Clean Water Fund Action, a

national environmental public interest organization headquartered in Washington,

DC. Cole authored a number of studies on EPA’s Superfund program, the impacts

of municipal waste incinerators and on the Nation’s mercury problem. During this

period Cole frequently provided testimony to Congressional committees on issues

pertaining to Superfund cleanups, mercury emissions, solid waste management policies, and pollution prevention (e.g., alternatives to PCE-based dry cleaning).

DISCUSSION

Chair MILLER. Thank you, Dr. Cole. Mr. Mier testified—you all were all here for the earlier panel. Mr. Mier testified, showed photographs of animals in his community in Midlothian, Texas, and

said ATSDR was not interested in seeing his animals or the pictures of his animals. Dr. Hoffman said that obvious apparent effects on animals would get his attention, and I think if I had noticed that every tadpole near my house had two heads, I would

worry a little bit.

MORE ANIMALS AS SENTINELS OF HUMAN HEALTH

Dr. Ozonoff, what is the value or the reliability of effects on ani- mals in predicting as a sentinel or an indicator of what effects

there may be on human health?

Dr. OZONOFF. Well, there is a long tradition, actually, in epidemi- ology of doing epidemiology on animals as well as doing it on people. There are numerous studies in the literature, for example, of

trapping small rodents called voles and other small animals around

hazardous waste sites, net cropping them to see what the health

effects are. In Vietnam, Agent Orange was looked at because—one

reason it was looked at was because of epidemiology on dogs, the

canine dogs that were in Vietnam. The canary in the coal mine is

another classic example. These are all warning flags. They don’t

give you the answer, but they are like a big sign in the ground that

says dig here.

PEER REVIEW

Chair MILLER. Dr. Ozonoff, you have said you were a part of a panel some time ago that recommended that ATSDR health assessments be subject to independent peer review. What has ATSDR’s

response to that recommendation been?

Dr. OZONOFF. I can’t give you a tally on how many of their assessments are peer reviewed. My impression is very few, but that

some of them are often on the basis of controversy or pressure. One

of the things that we saw in the original GAO panel was that the

squeaky wheel got the grease and that health assessments around

very active community sites that made a lot of noise were more detailed and got more attention than those that didn’t. In fact, some

of them in the original batch of 800-some or 700-some under the

initial mandate were just cut-and-paste jobs of EPA memos, whereas if there was a community, an active community group very concerned about what was going on, they would get more attention.

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Chair MILLER. Dr. Wilson, you were nodding vigorously.

Dr. WILSON. I think that we have enough fingers and toes to calculate the number of health assessments and consultations that

routinely are peer reviewed. I recommended in my Stauffer report

that a new health assessment be conducted and that it be peer reviewed, and that was looked at as way out of proportion for what

could and should be done. I recommend that all of them have the

peer-review process. We are already spending well over 400 days.

If we just speed up a little bit, we will have time to do peer review

within that 400 days and still get a better quality product.

INFORMATION ACCESS

Chair MILLER. Dr. Wilson testified to the unwillingness of

ATSDR to push to get information, to get documents. What would

be the effect of the lack of those documents or what might be the

effect? Dr. Ozonoff, how important is it that they get the information that might be available to other agencies or in the private sector?

Dr. OZONOFF. Well, I think there is an interesting pattern that

emerges when you look at the health assessments. There is a lot

of emphasis on exposure pathways, analyzing exposure, and to

some extent toxicology, and a lot of that is a function of the fact

that those documents are easy to get. The EPA has got a lot of exposure information, so that is available to them. And a lot of

ATSDR health assessors sit actually in EPA regional offices so that

there is not so much independence between those two, and it is one

reason that I think EPA doesn’t find the health assessments very

useful because they are redundant of documents that are with

EPA.

When it comes to documents that are health related, I think

there is just not enough effort expended to get the documentation

both about community concerns—EPA often will be very frank with

both State agencies and communities in saying that they don’t

want to have public meetings with communities because of the

abuse that they suffer when they are at public meetings, so they

meet on them one on one. This is a self-fulfilling prophecy. This is

the Agency withdrawing from the community because of the community’s response, the community then seeing that the Agency is

withdrawing, and it becomes a self-reinforcing cycle. This is no way

to get the kind of information that we are talking about.

DIFFICULTY WITH EPIDEMIOLOGY

Chair MILLER. One more question, although the red light is on.

Dr. Ozonoff, your testimony was probably more critical than my

opening statement, although perhaps more elegantly put than

jackleg science. What is the effect on the health of human beings

from a pattern of inconclusive studies?

Dr. OZONOFF. You are asking me a question that I am very conflicted about because I understand from my own work how difficult

it is to do these studies. One of the things that I have said during

my career that gets quoted most often essentially started out as a

joke, and like a lot of jokes there is a grain of truth to it, which

is that a definition of a public health catastrophe is a health effect

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so powerful that even an epidemiological study can detect it. Epidemiology, you know, is not a very sensitive tool. It is a very blunt

instrument to try and figure out what is going on. But I think that what Dr. Cole said is exactly right. The conten- tion that this is inconclusive or that we don’t see anything or that

there doesn’t appear to be something going on is really interpreted

as a statement that nothing is going on, but the absence of evidence is evidence of absence. And that is particularly harmful to

these communities who then get no follow-up. So I don’t know what we would find if we followed up on these

communities. That is part of the problem which is that it remains

invisible.

Chair MILLER. Dr. Cole, you were raising your hand that you wanted to chime in despite the fact——

Dr. COLE. Yeah, I do want to——

Chair MILLER.—that the red light is on.

Dr. COLE.—chime in because there is a question of what you do when there is scientific uncertainty, when there are a lot of symptoms, when the data is sparse, when the resources don’t produce

the evidence that you are really looking for, yet there is a sense

that there really is a problem. In those instances, I believe that the

public health model, and this is a public health agency, is to err

on the side of caution and to act preventively. We don’t have to

wait, do we, until there are corpses, until there are people and families that are suffering? Let me give you one very specific thing that could have been done at Perma-Fix had there been a different mindset and perhaps

a slightly different mission at ATSDR. Had they looked at all of the

data, they would have found that there were a lot of hazardous

wastes coming into that facility, Perma-Fix, that contained formaldehyde, a probable carcinogen, a very toxic, hazardous air pollution. It is volatile. It escapes. Had they done what I consider to be

their job, they would have found out, where are the sources? Where

is that waste coming from that contains all that formaldehyde?

And then go to those sources and find out what substitutions might

be made or what processes could be added to the facilities that generate that waste that would reduce the amount of formaldehyde.

That is what prevention is, to take a look at the problem, not wait

until there is exact scientific evidence which, as Dr. Ozonoff and

others have said, is often difficult.

Also, we know that prevention oftentimes saves all kinds of

money. It is cost effective because there are many health effects,

both in the workplace and in the environment that could be avoided, and that is a very good way to reduce health care costs, to improve the health of communities, the environmental health of communities, around this country.

Chair MILLER. Thank you, Dr. Cole. There is a college faculty

joke that administrators don’t like to have scientists on their university panels because they know where they stand. When the data

changes, their opinions change. Dr. Broun.

POTENTIAL FIXES

Mr. BROUN. Thank you, Chair. I’ll also start off to ask you all

a question that I asked the first panel, and obviously you all have

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pretty much answered that. If you were a dictator, what would you

do differently to fix the problem, but let me ask Dr. Ozonoff, Doctor, if we could make a change to accomplish the purposes of which

ATSDR is supposed to be doing, with what you are doing and other

entities around the country are doing and even State agencies as

I think you mentioned in your testimony are doing, if we enabled

you or other entities, governmental or private, to be able to do

these studies, wouldn’t we be better off? Why? Why not? Just depending on how you answer the question.

Dr. OZONOFF. I am a scientist, so I am always going to say that

research pays off and it is good to do research, and in fact, that

is exactly what I am going to say. It is very difficult to know in

advance what the benefit of any particular area of basic science research is going to be, except that we know that on average it pays

off. At the risk of special pleading, let me just make an observation

that lots of money was injected into the NIH and the recent stimulus package, but not all of NIH got money. The research program

that provides the basic science for the Superfund program, underlying the basic science that we are talking about, got zero. CDC,

except for bricks and mortar, got zero. NIOSH, which does the

equivalent thing in the workplace, got zero. And part of the reason

is is what Dr. Cole said. There is a vision here that is missing, and

it is just not missing at ATSDR. You know, there is a wry adage

among scientists, or at least cancer scientists, which is that no Senator championed an agency because his wife didn’t get breast cancer or no Congresswoman championed an agency because her children were born healthy. When public health works, nothing happens, right? So therefore we don’t have champions.

I think we are seeing some of the results of that. Public health

agencies are not receiving the kind of moral support and vision,

and they are not being invested from the top down with the kind

of passion for public health that is required. That would make a

huge difference, and of course, I am a scientist. I believe that research is important.

Mr. BROUN. Well, could we do that in the private sector if we just

enable the private sector to do these things? Obviously there are

strong pressures as Dr. Cole, in his testimony, talked about just

from a liability perspective. Couldn’t we do this better in the private sector instead of having one central governmental agency that

is not undergoing peer review and not undergoing the types of investigative work and really is not charged or given the ability to

do so, it seems to me?

Dr. OZONOFF. Well, I am in the private sector, and of course our

research is conducted in the private sector with public monies, but

I am very, as I said in my testimony, very strongly of the opinion

that public health has the word public in it, that it is a public function, that it is a—it carries out a common purpose, all right, and

that common purpose is very important. It needs to be supported.

And ATSDR I think fulfills a role that just has to be fulfilled.

Somebody has to be looking at these communities from the public

health point of view, and that is what ATSDR was tasked with.

Mr. BROUN. Well, Dr. Cole, my time is about out so——

Dr. COLE. I think——

Mr. BROUN.—but you will have to answer quickly, please.

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Dr. COLE.—you touch on something important which you said,

can one agency carry out the mission? And remember, the mission

not only talks about science and determinations of cause and effect,

it also talks about prevention of harm. And I don’t think we can

forget that, and if you look at these communities, you will find that

there are typically many, many health hazards in those communities. Diesel trucks, other plants besides the one that ATSDR or

the landfill that they are investigating. There are multiple environmental stresses, particularly in so-called environmental justice

communities, low-income communities. And these communities not

only have many environmental stresses but economic stresses, nutritional stresses, and many other stresses which complicate the

health effects. So the question is, what is the role of an agency like

ATSDR in those kinds of situations? And this gets to your point

that no one agency can do all of that. You know, there are economic

concerns, there are energy concerns such as the need to weatherize

homes and whatnot, there is lead in homes. Why not train local

people to be a part of the solution to many of those problems? And

there are examples of that. For example, in Trenton, New Jersey,

community members have been trained to clean up the lead in people’s homes. They get a job out of it. That has led to broader restoration efforts. So what can an agency like ATSDR do? Perhaps

it can coordinate—go into a community, work with a community,

find out what the needs are from the community, and then go to

other agencies and the private sector. Maybe there is a plant that

would contribute to taking care of something. Maybe they would

clear a lot for a public park. Everyone can be part of that solution,

but you can’t slice and dice health. Health is a holistic concept. You

have to look at the community and all of the things that are going

on.

And I think the most unfortunate thing is the stove-piping of

government. You have EPA over here, you have the Commerce Department here, you have ATSDR over here, CDC here, and really

it takes, to deal with a community, it takes a village as someone

said. Thanks for your forbearance there.

Mr. BROUN. Thank you, Chair.

Chair MILLER. Thank you, Dr. Broun. Dr. Ozonoff, do you have

an opinion on whether Dr. Broun is a real scientist?

Dr. OZONOFF. As a physician, yes, I do. Yes, he is a real scientist.

Chair MILLER. I want to thank this panel as well, and we will

take another quick break before our last panel. Thank you.

[Recess.]

Panel III:

Chair MILLER. Our final witness is Dr. Howard Frumkin, the Director of ATSDR and the National Center for Environmental

Health. Dr. Frumkin, you will have five minutes to provide a spoken testimony, an oral testimony. Your full written testimony will

be included in the record.

Again, it is the practice of this committee to take testimony

under oath. Do you have any objection to taking an oath?

Dr. FRUMKIN. No, sir.

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Chair MILLER. And you have a right to be represented by counsel. Do you have counsel here today?

Dr. FRUMKIN. No.

Chair MILLER. All right. If you would then stand and raise your

right hand? Do you swear to tell the truth and nothing but the

truth?

Dr. FRUMKIN. I do.

Chair MILLER. Thank you, Dr. Frumkin. You may begin.

STATEMENT OF DR. HOWARD FRUMKIN, DIRECTOR, NATIONAL CENTER FOR ENVIRONMENTAL HEALTH AND AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY (NCEH/

ATSDR)

Dr. FRUMKIN. Chair Miller, Dr. Broun, Representative Broun,

good morning. I am a physician and epidemiologist with 27 years

of experience ranging from primary health care to research to environmental health practice. I have a long and public record to commitment to science, public health advocacy, and community service.

As a scientist, I am deeply committed to using the best science.

As a public health advocate, I am passionate about promoting

health and protecting the public from hazards. As a caregiver, I

know that statistics are only proxies for real people and that when

I serve those people, they deserve all of my skill, compassion, integrity, and courage, and as a public servant, I am accountable for

achieving these results.

I am proud of my agency, of our excellent staff, and of the work

we do in protecting public health. I testified before this subcommittee almost a year ago at a hearing that focused on our response to Hurricane Katrina, including our work specific to formaldehyde in temporary housing units. I testified at that time that

in some respects we could and should have done better. I also

noted that there were key lessons to be learned. During the past

year, we have taken important steps to ensure that our current

and future work builds on those lessons, the point to which I will

return.

Committee staff prepared a lengthy report in advance of today’s

hearing. I respectfully disagree with many of the statements and

conclusions in that report. I would welcome the opportunity to provide a different perspective at an appropriate time. In the meantime, in this brief oral statement, I want to make just three points.

First, protecting the public from toxic exposures is ATSDR’s top

priority, and we adhere scrupulously to good science in doing so.

We work at several hundred sites each year. We identify public

health hazards at a substantial proportion of sites. We offer recommendations to protect the public, and these recommendations

have a strong track record of implementation by appropriate authorities. In some cases, even when exposures appear to be low, we

recommend clean-up activities, adopting the preventive approach

that Dr. Cole just described.

My written testimony includes examples of our successful work

including instances in which we exercised independence and upheld

scientific integrity despite considerable external pressure. Protecting the public on the basis of good science is ATSDR’s top priority.

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Second, we recognize challenges we face and limitations to some

of our work. Some of this is intrinsic to our mission. While communities expect us to provide definitive answers about the links between exposure and illnesses, even the best science sometimes does

not permit firm conclusions. An ailing patient visiting a doctor expects a definite diagnosis, but even the most thorough diagnostic

workup cannot always yield an answer. At other times, the data

needed to assess the health effects of an exposure simply have not

been collected, as if a physician had to attempt a diagnosis without

blood test results. In still other cases, we reach conclusions based

on very sound science, but members of the public differ with our

conclusions. These are all situations in which the communities we

serve feel distressed and disappointed, and so do we.

Another challenge is this. Our staff has declined from about 500

in the early years of this decade to about 300 now. The implications

are obvious.

Let me acknowledge that we are not perfect. As strong and

science-based as our work is, there are things we could do better.

In this morning’s testimony, we heard a number of very sobering

and disturbing perceptions. If we don’t communicate well, if we are

not accountable to communities, if we don’t use available data

fully, if we don’t use the best possible monitoring techniques, if we

don’t correct misrepresentations of our work by other agencies or

individuals, I don’t believe these things happen regularly or often,

but if they do, shame on us and we should do better.

I am firmly committed to representing opportunities for us to do

better and to continuously improving our performance.

This leads to my third point. We are working vigorously to improve our work in four categories: overall mission, science administration, organizational management, and specific procedures.

With regard to overall mission, we are convening a national conversation to examine not only ATSDR’s approaches to protecting

public health, but how our work fits into the broader universe of

agencies and organizations. We believe that some of our core practices now more than two decades old may be ready for renovation,

a perception that some of this morning’s witnesses echoed.

With regard to science administration, the Board of Scientific

Counselors, an independent expert body, conducted a detailed review of our clearance and peer-review procedures at my request.

While the Board found our procedure to be generally sound and effective, it identified several opportunities for improvement which

we are implementing. For example, we have beefed up the staffing

in our Office of Science, clarified clearance requirements to our

staff, and aligned one division which had an independent peer-review process with the centrist peer-review procedures.

With regard to organizational management, CDC brought in an

external firm, PriceWaterhouse, to review our center and to compare it to others at CDC. The focus was on human resource management. Overall, our center’s management was comparable to that

across CDC, a bit better in some respects, a bit worse in others.

Several specific opportunities to improve emerged, and we have

launched a detailed and aggressive management improvement initiative to address them. This includes innovative approaches to hiring new talent, management training, skill building in our staff,

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improved issues tracking, and improved use of performance planning. With regard to specific procedures, we continue to make improve- ments, refining the language we use to communicate our findings

to the public, streamlining the updating of our toxicologic profiles,

replacing the software that tracks our work at sites and more. Mr. Chair, Dr. Broun, other Members of the Committee, on my own behalf and on behalf of enormously dedicated, hard-working

staff, I affirm my commitment to good science, to good science administration, and to public service. In this, I fully agree with this

committee. I am proud of the excellent work we do at hundreds of

sites nationally. I recognize that even excellent work has room for

improvement, and I pledge diligence in identifying and acting on

opportunities to improve. I appreciate the constructive suggestions

this Committee has provided to date, and I look forward to collaborating with this Committee as we move forward. Thank you. [The prepared statement of Dr. Frumkin follows:]

PREPARED STATEMENT OF HOWARD FRUMKIN

Good morning Chairman Miller and other distinguished Members of the Sub- committee. Thank you for the opportunity to be here today. I am Dr. Howard

Frumkin, Director of the Agency for Toxic Substances and Disease Registry

(ATSDR) and the Centers for Disease Control and Prevention’s (CDC’s) National

Center for Environmental Health (NCEH).

I am a physician with 27 years of experience in environmental and occupational medicine and epidemiology. I have been Director of NCEH/ATSDR since September

2005. Previously, I served as Chairman of the Department of Environmental and

Occupational Health at Emory University’s Rollins School of Public Health and Professor of Medicine at Emory Medical School. I am committed to the goal of serving the public by protecting the public’s health, and bringing to bear the best science in doing so. As a public servant, I am accountable for achieving this goal. I am very proud of ATSDR’s overall efforts to protect

the public’s health from chemical exposures.

I testified before this committee on April 1, 2008, at a hearing that focused on the work of ATSDR and NCEH in responding to Hurricane Katrina, including our

work specific to formaldehyde in temporary housing trailers. I testified at that time

that in some respects we could and should have done better. I also noted that there

were key lessons to be learned. During the past year we have taken important steps

to ensure that our current and future work builds on those lessons, which I will address later in this testimony. Today’s testimony will discuss more broadly ATSDR’s scientific and programmatic activities, and will focus on three areas.

• First, I will provide background on ATSDR, including examples of work the

Agency has conducted at specific sites in communities across the United

States.

• Next, I will discuss some of the challenges faced by ATSDR.

• Finally, I will share a vision for ATSDR as we look toward the future, emphasizing our commitment to continuous improvement in four categories: overall

mission, science administration, organizational management, and specific procedures.

The ATSDR Story

ATSDR is the principal non-regulatory federal public health agency responsible

for addressing health effects associated with toxic exposures. The Agency’s mission

is to serve the public by using the best science, taking responsive public health actions, and providing trustworthy health information to prevent harmful exposures

and disease related to exposures to toxic substances.

ATSDR was created by the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, more commonly known as the Superfund

law, and came into existence several years later. CERCLA reflected Congressional

and public concern with toxic chemicals, particularly hazardous waste, in the aftermath of such environmental disasters as Love Canal (New York) in the late 1970s.

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ATSDR was charged with implementing the health-related provisions of CERCLA. The language in CERCLA, and in the subsequent Superfund Amendments and Reauthorization Act of 1986—or SARA—leaves room for interpretation, but in general terms, it assigns ATSDR four responsibilities, each of which is described in more

detail below:

• Protecting the public’s health

• Building the science base on toxic chemicals

• Providing information on toxic chemicals to health professionals and the public

• Establishing and maintaining registries.

ATSDR has pursued each of these responsibilities during the nearly quarter cen- tury since it came into being. Our work is very complex and it has not always been

perfect, as I acknowledged to this committee last year, but overall I am proud of

the wide range of achievements, and proud that we have constantly sought to improve our performance.

Protecting the Public’s Health

A core function of ATSDR is assessing potential health hazards posed by haz- ardous waste sites and making recommendations for protecting public health. This

is a mandated function in the case of Superfund sites, and discretionary in the case

of other hazardous waste sites. Our site-specific work is presented in one of several

forms: Public Health Assessments, Public Health Consultations, Exposure Investigations, and Technical Assists.

A Public Health Assessment, or PHA, is generally conducted when there are mul- tiple contaminants and potential pathways of exposure. In a PHA, ATSDR examines

past, present, and future exposure scenarios to evaluate whether people were, are,

or may in the future be exposed to hazardous substances and, if so, whether that

exposure is harmful, or potentially harmful, and in what ways. ATSDR scientists

generally analyze existing environmental and health data—provided by EPA, other

government agencies, businesses, and the public—and make recommendations. In

some instances ATSDR scientists conduct their own health or exposure investigations. A Health Consultation is similar to a Public Health Assessment in that it

evaluates environmental data and how people might be exposed, but focuses on a

more specific health question and uses a more limited data set. The purpose of an

Exposure Investigation is to fill environmental or biologic knowledge gaps with information needed for our public health work. A Technical Assist is a brief document

that answers a specific, narrow question; because it does not require extensive background research and data analysis, it is generally completed more rapidly than the

more detailed reports.

Recommendations for protecting health and preventing exposures are regular components of these documents. ATSDR is not a regulatory agency; our reports

identify recommended actions that would be appropriate for EPA or other authorities to undertake, but do not compel these actions. Recommendations are directed

to entities responsible for characterizing or mitigating exposures, including State

and local government agencies. Our reports may also recommend that our agency

conduct further work such as health studies, or health professional and community

education. If there is an urgent health threat, ATSDR can issue a public health advisory warning people of the danger. ATSDR can also carry out health education or

pilot studies of health effects, full-scale epidemiological studies, exposure or disease

registries, disease and exposure surveillance activities, or research on specific hazardous substances.

In addition, ATSDR can help protect the public from chemical exposures in settings other than hazardous waste sites, circumstances that are collectively referred

to as ‘‘releases.’’ These releases may range from chemical plant explosions to a spill

of coal combustion products. They can be those identified by government agencies

or by individuals within the community through the petition process.

ATSDR responds to emergencies involving the release of chemicals, most often in

collaboration with the Environmental Protection Agency. ATSDR personnel provide

real-time public health guidance following acute releases of hazardous substances

and health information to the public (for example, helping determine when people

can safely reoccupy their homes and businesses after an evacuation).

Much of this public health protection work is carried out by State health departments, with funding and technical support from ATSDR. Our State cooperative

agreement program functions in 29 states and one tribal government. In many

cases, ATSDR funding provides the only support for these activities at the State

level.

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ATSDR’s work in protecting public health has been highly productive. The Agency issues between 300 and 400 Health Assessments and Health Consultations, and provides more than 1,000 Technical Assists, each year. During the period 1995–2006,

73 percent of our recommendations were implemented by federal, State and local

authorities.

Over the nearly quarter century of our work, we have made important contribu- tions to the way community-based environmental public health is practiced. The required knowledge and skill were hard-won; in the early years growing pains were

common, but over time ATSDR developed considerable expertise in communitybased work. Our staff is committed to working closely with the communities we

serve, to listening to and respecting community concerns, and to incorporating community input into our work plans. ATSDR’s public communications recognize cultural, ethnic, and linguistic diversity. The Agency has helped advance the concept

and practice of Environmental Justice, since many of the communities we serve are

poor and/or members of racial and ethnic minorities.

ATSDR has a strong track record of sticking to the science and advancing public health, even in sometimes controversial, highly charged situations. Several examples are illustrative:

• Montana: Vermiculite mined by the W.R. Grace Company in Libby, Montana, was contaminated with tremolite asbestos. EPA and the Montana Congressional

delegation requested that ATSDR evaluate human health concerns related to asbestos exposure in Libby. ATSDR has conducted a number of activities in the community, including: a screening program to identify people whose health may have

been impacted by exposure to asbestos (revealing that 18 percent of those tested

had abnormalities in the linings of their lungs, as compared to between 0.2 and

2.3 percent of people without asbestos exposure); a mortality review that compared asbestos-associated death rates for residents of the Libby area with those

in Montana and the United States (finding that for the 20-year period examined,

mortality from asbestosis was approximately 40 times higher than the rest of

Montana and 60 times higher than the rest of the United States); and a Tremolite

Asbestos Registry, a listing of individuals with asbestos-related disease or those

at high risk of developing asbestos-related disease because of exposure to asbestos. ATSDR continues to be actively involved with the site and the community,

joining recently with EPA to establish the Libby Health Risk Initiative, a program

to add to the understanding of health effects of exposure to Libby amphibole.

• Ohio: The Brush-Wellman company, in Ottawa County, Ohio, is the major proc- essor of beryllium in the United States. ATSDR completed a Health Consultation

in 2002, and found that emissions at the time did not pose a risk. Past emissions

were known to have exceeded applicable standards, but available data were not

sufficient to permit assessment of the past hazard. Some local officials and the

company strongly objected to follow-up activity, but ATSDR offered clinical testing

for beryllium sensitization to local residents. All concerned individuals were tested; of 18 participants, none tested positive. Based on that finding, ATSDR did not

recommend further testing. We followed up by educating local health care providers to help them identify and test for beryllium exposure and chronic beryllium

disease.

• Minnesota: Excel Dairy is a large dairy farm in Marshall County, Minnesota.

After neighbors complained of odors and respiratory and other symptoms, ATSDR

worked with the Minnesota Department of Health (MDH) to sample for hydrogen

sulfide (H2S) at nearby homes. Data indicated that health based guidelines were

frequently exceeded, often for hours at a time. In 2008 ATSDR recommended that

Excel Dairy take immediate steps to protect health and safety, especially of children, such as by applying permanent covers to the manure lagoons. ATSDR also

recommended that the Minnesota Pollution Control Agency continue to monitor

air emissions of hydrogen sulfide, and that MDH work with local public health

officials to provide people living at the Dairy with appropriate information to protect their health and safety. ATSDR also indicated that if measures to eliminate

exceedances of the state’s standards for H2S were not effective, the Agency would

consider further exposure monitoring in coordination with MDH. In 2008 ATSDR

testified before a House Subcommittee on this matter. EPA is collecting hydrogen

sulfide readings from the facility and will continue to conduct a follow-up assessment.

• New Jersey: The Kiddie Kollege Day Care Center in Franklin Township, New

Jersey, was housed in a former thermometer factory, exposing children and staff

to mercury. In 2007, ATSDR worked with New Jersey health and environmental

officials and staff at the nearby Pediatric Environmental Health Specialty Unit,

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a university-based effort funded partially by ATSDR, to assess the exposures. Initial findings included elevated levels in 31 percent of children and 33 percent of

adults tested, with follow-up testing after exposure had stopped showing a reduction to low levels. New Jersey has since enacted legislation establishing stringent

criteria before building permits can be issued for day care or educational institutions in environmentally high risk sites. ATSDR was directed to prepare a report

on children’s exposure to mercury, which was recently submitted to two Congressional committees.

• North Carolina: During the 1990s, residents of Randolph County, North Carolina, complained of respiratory symptoms that they associated with a nearby polyurethane foam manufacturing plant. ATSDR worked with State authorities to

conduct blood testing and air monitoring. The findings prompted ATSDR to issue

a public health advisory on October 20, 1997, advising local, State, and federal

officials of potential adverse health impacts from hazardous air emissions. Concern focused on toluene diisocyanate, a known trigger of obstructive airway disorders. ATSDR also conducted an asthma investigation of children residing within

a mile radius and found an elevated prevalence of this disease. During the last

three years, ATSDR and the State health department went on to conduct a more

comprehensive study of exposure and health in communities across North Carolina, despite strong industry opposition. Current plans include education for local

physicians on the study results.

• Ohio: City View Center, a shopping center in Cuyahoga County, Ohio, was built

on the site of a former landfill. In 2008, air monitors detected explosive levels of

methane and other combustible gases. Based on the available information,

ATSDR rapidly concluded that an urgent public health hazard was present, and

recommended that immediate action be taken. ATSDR’s finding provided the Ohio

EPA, the Ohio Attorney General, and the U.S. EPA with further grounds for compelling the property owner to install an active vapor extraction system on the

landfill to reduce the migration of gases into the shopping center.

Building the Science Base on Toxic Chemicals

In crafting CERCLA, Congress assigned an applied research role to ATSDR,

which complements the biomedical research role of the National Institute for Environmental Health Sciences (NIEHS). The Agency has combined a program of original research with a longstanding commitment to assembling and making widely

available the results of research across the scientific community.

ATSDR’s applied research includes toxicologic research. In some cases this research is conducted in-house; for example, ATSDR scientists have developed innovative techniques of computational toxicology to help rapidly assess hazards of chemical releases. In other cases, ATSDR identifies critical toxicologic data needs and

works with other federal agencies, as well as State agencies, universities, and volunteer organizations to fill those needs.

A key feature of ATSDR’s scientific research is that it often grows out of site-specific public health activities. For example, as discussed earlier, ATSDR scientists

have conducted a series of epidemiological studies in Libby, Montana, to assess the

health effects of residents’ long-term exposure to asbestos and related minerals.

Still other parts of ATSDR’s research advance the science of exposure assessment.

For example, in evaluating the health effects of past exposures to trichloroethylene

in drinking water at Camp Lejeune, North Carolina, ATSDR scientists confronted

a challenge: how to quantify people’s past exposure to contaminants. Marines and

their families had consumed water over a period of years from a variety of sources

on the base that had varying levels of contamination. It became necessary to reconstruct past exposures based on available records—a complex process requiring historical analysis of contaminated drinking water using innovative ground water modeling and statistical techniques. ATSDR scientists developed and refined the necessary techniques with input from panels of experts and peer reviewers.

ATSDR scientists have compiled data and called attention to the problem of hydrogen sulfide exposure near construction and demolition landfills, a result of the

degradation of gypsum wallboard; and described and quantified the problem of

vapor intrusion, when volatile chemical contaminants in groundwater enter basements.

In addition to original research, ATSDR assembles existing data on toxic chemicals. ATSDR’s Toxicological Profiles are thorough reviews of available toxicological

and epidemiologic information on specific chemicals. They provide screening levels—

called Minimal Risk Levels (MRLs)—that ATSDR health assessors and other responders use to identify contaminants and potential health effects that may be of

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concern at hazardous waste sites. They are widely used references by scientists and

members of the public.

Providing Information on Toxic Chemicals to Health Professionals and the Public

A third function of ATSDR is to provide health professional and community edu- cation through direct service at the community level, and through broader distribution of materials through the Internet and other mechanisms. For example,

ATSDR’s ToxFAQs is a series of summaries of information about hazardous substances. These are user-friendly documents excerpted from Toxicological Profiles and

Public Health Statements. Each ToxFAQ serves as a quick and comprehensible

guide, with answers to the most frequently asked questions about exposure to hazardous substances found around hazardous waste sites and the effects of exposure

on human health.

ATSDR also develops and provides medical education to assist health professionals in diagnosing and treating conditions related to hazardous exposures. An example of this work is ATSDR’s Case Studies in Environmental Medicine, a series

of self-instructional modules that increase clinicians’ knowledge of hazardous substances in the environment and aid in the evaluation of potentially exposed patients. ATSDR has developed other products for the medical community, including

Grand Rounds in Environmental Medicine and Patient Education and Care Instruction Sheets. In addition, ATSDR and EPA established and support university-based Pediatric Environmental Health Specialty Units (PEHSUs) to provide education and

consultation for health professionals, families and others about children’s environmental health.

Establishing and Maintaining Registries

The fourth function assigned to ATSDR is registries—confidential databases de- signed to collect, analyze, and track information about groups of people who share

defined exposures or illnesses. ATSDR also provides information to registrants

about health services and other services available to them through other sources.

Below are examples of registries in which ATSDR currently is actively involved:

• Tremolite Asbestos Registry (TAR). This is a registry of people exposed to tremolite asbestos originating in Libby, Montana. The TAR includes contact,

demographic, exposure, and health outcome information for each registrant.

• World Trade Center (WTC) Health Registry. ATSDR has supported the New

York City Health Department in developing the World Trade Center Health

Registry. The WTC Health Registry is a comprehensive health survey of persons in the lower Manhattan area of New York City who were most directly

exposed to the environmental effects of the events of 9/11/2001.

ATSDR Faces Challenges

While ATSDR has protected public health, advanced science, and provided

science-based information since its inception, the Agency faces ongoing significant

challenges. These are described below.

Science Cannot Answer All the Questions Posed at Sites

When communities are concerned about hazardous exposures, they want clear, definitive answers, much as an ailing patient wants a clear, definitive diagnosis. Communities often expect that an agency such as ATSDR will arrive on the scene, rapidly assess the situation, and reach unequivocal conclusions. Unfortunately, it is not

always possible to reach such conclusions. Among the reasons:

• Accurate exposure data are often unavailable, especially for past exposures.

Without accurate exposure data, it is impossible to correlate exposures with

health outcomes.

• Accurate health data are often unavailable. While registries for certain diseases are sometimes available, such as cancer and birth defects, statistical information is not routinely collected for most health conditions. Without accurate health data, well matched to exposure data by time and place, it is impossible to correlate exposures with health outcomes.

• Some ailments, such as fatigue and headache, are difficult to measure objectively, and therefore difficult to characterize quantitatively.

• Complete information on the toxic effects of many chemicals is lacking, especially for such outcomes as neurobehavioral, developmental, and reproductive

function, and especially following the types of long-term, low-dose exposures

which occur in many communities.

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• Toxicologic data usually refer to one chemical at a time, but in real life, people frequently are exposed to mixtures of chemicals. Scientific data on such

mixed exposures are scanty.

• Many communities have relatively small populations, which are difficult to

study for reasons of statistical power. It is for this reason that important

health findings typically emerge from large studies. The Framingham Heart

Study enrolled nearly 15,000 people over more than 50 years, and the National Children’s Study plans to follow 100,000 children from before birth to

age 21. In a community with a few hundred people, the opportunities for robust research are far more limited.

In summary, definitive answers sometimes do not exist, due to the inherent uncertainties of science, the limits of available data, the limits of small-area epidemiology, and the lack of appropriate public health tools.

Moreover, concerned citizens sometimes have honest disagreements with the results of ATSDR assessments. While ATSDR scientists use standardized methods to

assure objective results, these sometimes yield conclusions that are not expected by

or acceptable to community members. This is understandable. Community members,

who are justifiably concerned about unwarranted exposures from hazardous wastes,

may reject the concept of ‘‘levels of risk’’ when what they want is zero exposure. For

example, in some situations, even where a source of toxic chemicals is identified,

careful measurement may indicate that people absorb little or none of the toxic

chemical. Such findings can be unwelcome to people who desire nothing less than

complete elimination of the contaminant. In some cases, ATSDR and counterpart

State agencies have repeated investigations several times, when negative conclusions were challenged, only to replicate the original findings—and consequently to

face accusations of indifference or worse. Such situations are difficult and frustrating, both for dedicated ATSDR staff and for community residents who earnestly

seek solutions to their problems.

Heavy Emphasis on Hazardous Waste Sites Relative to Other Exposure Routes

In the early 1980s, following the national attention generated by Love Canal,

there was considerable focus on hazardous waste sites. CERCLA (including its public health component, ATSDR) reflected this focus. However, a variety of other

sources, such as food, consumer products, water, and air, are well recognized, and

for many Americans these, not hazardous waste sites, are the predominant pathways of exposure to chemicals.

Workload Challenges

With tens of thousands of hazardous waste sites around the Nation, and with

countless other sources of chemical exposures, ATSDR faces a potential workload

that exceeds its current staffing level. Though ATSDR’s on-board FTE strength has

fallen from 481 in FY 2002 to 306 in FY 2008, without a reduction in workload during that period, we continually strive to meet our mission through increased efficiencies and productivity and the efforts of our dedicated staff.

Limited Research Capacity Relative to Extensive Data Needs

ATSDR has a specific challenge with regard to its research capacity. ATSDR has

carried out a limited program of targeted research, and has worked to identify data

gaps and compile research from industry, academia, and other agencies. However,

with the extensive data needs related to toxic exposures, this remains an ongoing

challenge for the Agency.

Ongoing Efforts to Improve ATSDR

ATSDR is undertaking major efforts to improve its performance and to meet the

challenges outlined above. These efforts range broadly, and can be described in four

categories: review of the overall approach to carrying out our mission, review of

science administration processes, review of management practices, and improvement

of certain other procedures.

Review of the Overall Approach to Carrying Out Our Mission

Careful consideration of ATSDR’s mission has revealed important challenges, as

described above. After almost 25 years of operation with a relatively unchanged

portfolio, these challenges justify re-examination of ATSDR’s approach.

That re-examination is made more compelling by the many changes that have occurred in chemical science and technology during the quarter century of ATSDR’s

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existence. Together these changes have revolutionized the context within which

ATSDR works to protect the public from chemical hazards.

• Analytic chemistry tools now permit measurement of unprecedented low levels

of chemical exposures.

• Biomonitoring, the direct measurement of chemicals in people’s body fluids,

has advanced tremendously, enabling scientists to identify and quantify exposures.

• The genetic revolution and the emergence of the ‘‘omics’’ (genomics,

proteomics, metabolomics) offer the potential to study gene-environment

interactions, and to understand exposures and health effects at an individual

level.

• Toxicologic advances such as computational and in vitro methods offer enormous opportunities for insight into chemical action, more rapidly and at less

expense than ever before.

• Green chemistry represents an innovative approach that seeks to design and

produce environmentally safe chemicals, avoiding the toxic effects on which

ATSDR’s work has focused.

Together, these considerations make clear that a re-evaluation of ATSDR’s approach is timely and appropriate. Moreover, it is clear that ATSDR’s responsibility—

protecting the public from toxic chemicals—does not rest with ATSDR alone. Many

other agencies share in this responsibility, and many other stakeholders—industry,

environmental groups, community groups, professional associations—play essential

roles.

In fact, review of the Nation’s efforts to protect the public from chemical hazards

over the last four decades—an effort that includes ATSDR but extends well beyond—yields compelling conclusions. As a nation we have achieved some notable

successes, but we remain limited in our ability to assemble needed data, draw consistent conclusions, launch protective actions, and inform stakeholders. Various

agencies and organizations—governmental and non-governmental, regulatory and

non-regulatory—carry out public health functions related to chemical exposures.

These functions include exposure and health surveillance, investigation of incidents

and releases, emergency preparedness and response, regulation, research, and education. But improvements can always be made to increase coordination. Some key

responsibilities are not carried out adequately, while others are needlessly redundant. ATSDR’s mission and functions must be considered within this broader context.

In recognition of these realities, ATSDR and its companion Center at the CDC,

the National Center for Environmental Health (NCEH), have initiated the National

Conversation on Public Health and Chemical Exposures. This process will convene

a wide range of stakeholders over one to two years, including community groups,

industry, environmental groups, public health groups, and others. Early responses

from various stakeholder groups has been highly supportive. We expect this effort

to yield an action agenda for revitalizing the public health approach to chemical exposures. Part of this agenda will be direction for ATSDR as it moves into its second

quarter century.

Review of Science Administration Processes

In 2008, this committee raised questions about the adequacy of existing procedures for internal clearance and external peer review of scientific documents at

ATSDR. In response, NCEH/ATSDR asked the Board of Scientific Counselors (BSC),

an external expert group charged with advising the Center on matters of science

and science policy, to assess these procedures and to suggest any needed improvements. The BSC’s overall conclusion was that the existing procedures generally

function well to achieve quality-assurance goals. The BSC report identified and discussed several concerns and recommendations. A draft report was presented at the

November 2008 meeting of the BSC and the BSC approved the final report in early

March 2009. In the meantime, ATSDR has made specific improvements. For example, an independent peer review process maintained in one Division now is subject

to additional oversight consistent with Center-wide procedures; the staff of the

NCEH/ATSDR Office of Science has been enhanced through additional hiring, and

review procedures have been reiterated to supervisors to help assure that all staff

scientists are aware of them.

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Review of Management Practices

In 2008, this committee also raised questions about management practices at

ATSDR. In response, CDC commissioned an independent review of NCEH/ATSDR

management practices. NCEH/ATSDR was compared to two other CDC Centers and

to data from government-wide management-practice surveys, to permit conclusions

about areas of particular need within NCEH/ATSDR.

In general, NCEH/ATSDR management practices were found to be comparable to

those across CDC. Several opportunities for improvement were identified. Examples

include: increasing management awareness of, engagement with, and accountability

to the human capital strategy; improving the use of existing human capital systems

including human resource data systems and processes, performance management,

and recruitment strategies; and improving the Agency capability to constructively

manage conflict and enable better program and scientific results. In addition,

NCEH/ATSDR leadership, in consultation with those in supervisory positions at

CDC’s Coordinating Center for Environmental Health and Injury Prevention (that

NCEH/ATSDR is a part of), identified other opportunities for management improvement. From these, NCEH/ATSDR developed a broad plan for management improvement, and began implementing that plan in late 2008. The plan has five areas of

focus: (1) unifying and revitalizing our mission; (2) human capital strategy; (3)

human capital practices; (4) employee relations; and (5) quality of work life. Below

are some examples of steps being taken to improve management.

• Initiated strategic planning in each Division, as a step in engaging employees

in efforts to achieve shared goals;

• Promote training of managers in team-building, leveraging diversity, complaint and conflict management, alternate dispute resolution, and conduct

and disciplinary actions;

• Adopted Issues Management Tracking software in the NCEH/ATSDR Office

of Policy, Planning, and Evaluation, to track issues and provide a mechanism

for senior management to triage scientific issues to the appropriate office, and

to maintain oversight until project completion;

• Initiated a system of job rotation within NCEH/ATSDR to allow staff to move

to different positions for short periods (one to three months), to enhance staff

skills, facilitate collaboration and innovative partnering within these entities,

and improve morale;

• Initiated several activities to attract new public health professionals into

entry-level positions, to ensure that the needs of the future will be met.

Improvement of Specific Procedures

Finally, NCEH/ATSDR continues to make a wide range of changes in specific procedures, in order to improve performance. Four examples, each specific to ATSDR

and each taken from the last year, are illustrative.

• The wording of Public Health Assessment conclusions: ATSDR has for many

years used five standard categories of conclusions in its Public Health Assessments: ‘‘Urgent Public Health Hazard,’’ ‘‘Public Health Hazard,’’ ‘‘Indeterminate Public Health Hazard,’’ ‘‘No Apparent Public Health Hazard,’’ and ‘‘No

Public Health Hazard.’’ Concerns were raised about this terminology. In particular, the ‘‘No Apparent Public Health Hazard’’ conclusion was seen by some

communities as invalidating their concerns—an understandable reaction,

since it was used in some cases of low but non-zero exposure, where a finding

of zero risk would be hard to support scientifically. ATSDR reviewed these

categories and developed a revised classification that more clearly communicates risk. The new conclusions replace telegraphic phrases with explanatory language, featuring specific information relative to the substance, the

pathway, the time period, and the place. For example:

‘‘ATSDR concludes that touching, breathing, or accidentally eating zinc

found in soil and dust at the XYZ site is not expected to harm people’s

health because zinc levels in soil are below levels of health concern.’’

replaces

‘‘This site posed no apparent public health concern.’’

• Process for updating Toxicologic Profiles. Since its inception ATSDR has produced Toxicologic Profiles by reviewing the accumulated literature at a particular point in time, culminating in publication of a monograph that promptly commenced to go out of date. The Profile would be updated some years

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later with a next edition, which would rather soon become stale. ATSDR is

replacing this ‘‘book publication’’ model with a more contemporary model

based on ongoing, web-based updates of relevant sections as new material becomes available.

• Improved data management: ATSDR requires a sophisticated data manage- ment system to track its large number of sites and activities. A custom-designed system, HazDat, was used for this purpose for years, but became obsolete. In response, ATSDR created Sequoia, a new database system, and

launched it in February 2008. Sequoia is a scientific and administrative database developed to provide access to information on the release of hazardous

substances from Superfund sites or from emergency events and to provide access to information on the effects of hazardous substances on the health of

human populations. Sequoia assembles information on site characteristics;

site activities; site events; contaminants found; contaminant media; basis for

concentration levels, such as maximum, mean, or other descriptor; exposure

pathways; impact on the population; ATSDR public health hazard categorization; ATSDR recommendations; interventions to be taken, as described in the

public health action plan; and a record of intervention effectiveness. Sequoia

should enable better tracking and attainment of performance measures, provide data to support Healthy People objectives, and provide accurate, comprehensive data to support the analysis and identification of site-related

trends and the identification of appropriate public health interventions and

studies.

• Shift in product lines: The standard ATSDR product over the years has been the Public Heath Assessment. These are thoroughly researched documents,

based on extensive data reviews, and often require one to two years to complete—a delay that was unacceptable to some communities. However, community health concerns are often fairly specific. By using a more targeted approach such as a Health Consultation, Exposure Investigation, or Technical

Assist to address those specific concerns, we can respond more rapidly, address public concerns more directly, and conserve scarce resources for instances when a full Public Health Assessment is necessary to address more

complex exposure scenarios.

Conclusion

ATSDR is an agency with a relatively short history, but a history that spans

much of this nation’s response to health concerns resulting from hazardous environmental exposures.

Beginning with enactment of CERCLA legislation, ATSDR scientists have worked

to define a new domain of Environmental Public Health at the community level,

often working beyond the reach of the standard tools of public health. Some challenges were apparent initially: addressing questions for which there were no

straightforward answers, working in charged settings, and working across cultural

and institutional barriers. With time, other challenges have emerged: integration

across multiple chemical exposure pathways; the rapid advance of science, leading

to needed changes in Agency procedures; and allocating resources effectively.

While there have been setbacks along the way, ATSDR has worked diligently to

address the needs and concerns of communities and the people in those communities. Few federal agencies have a stronger track record in working ‘‘on the ground’’

serving local communities. The Agency has developed innovative tools and skill sets

in carrying out its mission. It has assembled a strong record of accomplishment—

protecting health near hazardous waste sites, advancing science, and educating

health professionals and the public.

Nevertheless I recognize the need for ongoing performance evaluation and constant improvement. This committee has pointed out several areas in which improvement may be needed. As described in this testimony, ATSDR is taking aggressive

action to improve in four key domains: review of the overall approach to carrying

out our mission, review of science administration processes, review of management

practices, and improvement of specific procedures.

I am committed to ongoing improvement in every aspect of ATSDR’s work, enabling us to achieve the goals assigned by Congress and deserved by the American

public: protecting public health from dangerous chemical exposures.

BIOGRAPHY FOR HOWARD FRUMKIN

Howard Frumkin is Director of the National Center for Environmental Health at

the U.S. Centers for Disease Control and Prevention, and the Agency for Toxic SubVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00325 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
318

stances and Disease Registry (NCEH/ATSDR). NCEH/ATSDR works to maintain

and improve the health of the American people by promoting a healthy environment

and by preventing premature death and avoidable illness and disability caused by

toxic substances and other environmental hazards.

Dr. Frumkin is an internist, environmental and occupational medicine specialist,

and epidemiologist. Before joining the CDC in September, 2005, he was Professor

and Chair of the Department of Environmental and Occupational Health at Emory

University’s Rollins School of Public Health and Professor of Medicine at Emory

Medical School. He founded and directed Emory’s Environmental and Occupational

Medicine Consultation Clinic and the Southeast Pediatric Environmental Health

Specialty Unit. Dr. Frumkin previously served on the Board of Directors of Physicians for Social Responsibility (PSR), where he co-chaired the Environment Committee; as president

of the Association of Occupational and Environmental Clinics (AOEC); as chair of

the Science Board of the American Public Health Association (APHA), and on the

National Toxicology Program Board of Scientific Counselors. As a member of EPA’s

Children’s Health Protection Advisory Committee, he chaired the Smart Growth and

Climate Change work groups. He currently serves on the Institute of Medicine

Roundtable on Environmental Health Sciences, Research, and Medicine. In Georgia,

he was a member of the state’s Hazardous Waste Management Authority, the Department of Agriculture Pesticide Advisory Committee, and the Pollution Prevention

Assistance Division Partnership Program Advisory Committee, and is a graduate of

the Institute for Georgia Environmental Leadership. In Georgia’s Clean Air Campaign, he served on the Board and chaired the Health/Technical Committee. He was

named Environmental Professional of the Year by the Georgia Environmental Council in 2004. His research interests include public health aspects of urban sprawl and

the built environment; air pollution; metal and PCB toxicity; climate change; health

benefits of contact with nature; and environmental and occupational health policy,

especially regarding minority communities and developing nations. He is the author

or co-author of over 160 scientific journal articles and chapters, and his books include Urban Sprawl and Public Health (Island Press, 2004, co-authored with Larry

Frank and Dick Jackson; named a Top Ten Book of 2005 by Planetizen, the Planning and Development Network), Emerging Illness and Society (Johns Hopkins

Press, 2004, co-edited with Randall Packard, Peter Brown, and Ruth Berkelman),

Environmental Health: From Global to Local (Jossey-Bass, 2005; winner of the Association of American Publishers 2005 Award for Excellence in Professional and Scholarly Publishing in Allied/Health Sciences), Safe and Healthy School Environments

(Oxford University Press, 2006, co-edited with Leslie Rubin and Robert Geller), and

Green Healthcare Institutions: Health, Environment, Economics (National Academies

Press, 2007, co-edited with Christine Coussens).

Dr. Frumkin received his A.B. from Brown University, his M.D. from the University of Pennsylvania, his M.P.H. and Dr.P.H. from Harvard, his Internal Medicine

training at the Hospital of the University of Pennsylvania and Cambridge Hospital,

and his Occupational Medicine training at Harvard. He is Board-certified in both

Internal Medicine and Occupational Medicine, and is a Fellow of the American College of Physicians, the American College of Occupational and Environmental Medicine, and Collegium Ramazzini.

DISCUSSION

MORE ON ANIMALS AS SENTINELS OF HUMAN HEALTH

Chair MILLER. Thank you. Dr. Frumkin, you saw the photographs in Mr. Mier’s testimony, and his testimony was that no one

in Midlothian could get anyone at ATSDR to look at the dogs.

There were a Ms. Markwardt’s dogs, and there were several emails

with ATSDR in which ATSDR on June 23 of this year, so just a

few weeks ago—January 23. I don’t know what I said. ‘‘Again,

ATSDR is sympathetic to the plight of your animals but studies involving animals, even the sentinels for human health issues, are

not activities engaged in or funded by our agency.’’ Before that,

ATSDR had sent an email or someone at ATSDR to Ms.

Markwardt. ‘‘ATSDR is sympathetic to the plight of your animals.

However, veterinarian animal issues are outside of our mandated

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domain.’’ Most recently, January 27, ATSDR wrote Ms. Markwardt

and again said it was beyond the expertise or competence of the

Agency and suggested that she talk to someone at Texas A&M. No

one at Texas A&M has contacted her yet, and it is not clear they

have the funding to pursue any kind of study on the animals.

You have heard the testimony from others about the value of animals as sentinels, as an indicator of something, some kind of exposure that may affect us humans as well, and I am sure you reviewed the report, our staff report, that shows several instances in

which ATSDR did look to effect on animals as an indicator of effect

on humans. Do you stand by those emails? Do you stand by the refusal to look at the dogs in Midlothian or other animals who have

obvious health effects as not reliable or beyond the duties of your

agency?

Dr. FRUMKIN. Mr. Chair, I think this goes back to a point that

Dr. Ozonoff made. The range of expertise needed to serve communities in a comprehensive way is enormous, ranging from veterinary epidemiology to social science to meteorology and so on. We

just don’t have the expertise on board to do good veterinary epidemiology. Given that we have many more requests to do studies

than we have resources to do them, one of the criteria we need to

pay attention to is, do we have the expertise and capacity to do it

well? In a case like this where it is a very, very heartbreaking situation, it certainly bears further looking into. We just don’t have

what it takes to look into it, and we believe we would serve the

public better to be sure that in this case the pet owner is connected

with competent veterinary epidemiologists than to try to take on

something that is outside our lane.

Chair MILLER. But you wouldn’t look at a dog to see if maybe

that might tell you something about the effect there might be on

humans?

Dr. FRUMKIN. It is a very worthwhile place to look. Animals,

when they become sick, can very well be sentinels for environmental exposures. So I don’t discount the importance of looking in

that direction.

Chair MILLER. And you are familiar with the 1991 National

Academies Report, Animals as Sentinels of Environmental Health

Hazards?

Dr. FRUMKIN. Yes, as I just said, animals are very well-recognized valuable sentinels, but a small agency just doesn’t have the

capacity to do everything and that is a particular line of inquiry

that just is outside our skill set.

MORE ON PEER REVIEW

Chair MILLER. Dr. Wilson, you hear the various suggestions that

ATSDR simply does not do peer review or infrequently does, but

Dr. Wilson said that there were fewer peer reviews of ATSDR’s

health assessment than most people had fingers and toes. Apparently Dr. Wilson is trying to protect the possibility he can return

to being a country music disc jockey if need be. And everyone testified that ATSDR’s default is not to seek peer review. It is an extraordinary circumstance when ATSDR does. Everyone seemed to

think the default should be getting peer review.

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Why is it that ATSDR does not fairly routinely have your health assessments, your methodology, your research, your conclusions

peer reviewed?

Dr. FRUMKIN. Let me differentiate between two kinds of products. There are the scientific studies that we produce, and there

are the site-specific reports. On our scientific studies, every one of

them is externally peer reviewed. That is not only a matter of good

practice but it is legislatively required, as I am sure your staff has

alerted you. On the site-specific activities, we are not required to get peer re- view, and so we have an algorithm that we turn to. It balances the

need to get our products out quickly with the need to do rigorous

science. The peer review is very worthwhile in terms of assuring

the quality of science but does slow the process down somewhat.

And so there is discretion on the part of our program managers to

decide whether peer review is needed. Our Office of Science is involved in that decision, and when there is a site-specific report,

that is either in the realm of uncertain science or is liable to be

controversial or is in some other way appears to benefit from greater scrutiny, we do submit that to peer review. Chair MILLER. The assessment by GAO panel, or the opinion of the GAO panel that site-specific studies should routinely be peer

reviewed, you are familiar with that?

Dr. FRUMKIN. Yes, that was well before my time, but I am famil- iar with it.

Chair MILLER. Okay. And I assume that most people have 20 fin- gers and toes combined. Dr. Wilson’s estimate that there were

fewer than 20 that had been peer reviewed, is that correct?

Dr. FRUMKIN. I don’t know what number of our products are peer

reviewed. I would have to get back to you on that. Chair MILLER. Well, in terms of the public feeling some con- fidence in an ATSDR study, wouldn’t peer review add to their confidence?

Dr. FRUMKIN. I think peer review would be very helpful, and we are very, very open to discussing a more comprehensive program

of peer review. We need to be mindful that we have to balance the

need to be expeditious in releasing our products with the need to

do the peer review. We heard the observation earlier that our products take too long to get out the door, and we have been very concerned about that and we have been working hard to accelerate the

production of our reports. And so we would want to balance the two

goods. But I think we are very open to looking further into more

extensive and regular peer review.

Chair MILLER. My time has expired. Dr. Broun.

HINDRANCES TO ATSDR’S PERFORMANCE

Mr. BROUN. Dr. Frumkin, you sat here through this whole morning’s testimony and heard all these charges against your agency

and some against you personally, and kind of going along with

what the Chair started out in the line of questioning, of these

charges against you, how would you answer those—I know there

have been a number of them but the most serious ones are mismanagement and not being scientifically based or honest. Would

you please comment to that and since I just have five minutes, I

321

wanted to ask a second question. You can just probably spend the

next few minutes doing those and my time will be up. What are the greatest hindrances or stumbling blocks for you and your agency to perform the mission that you have been

charged with?

Dr. FRUMKIN. Thank you, Dr. Broun. One challenge in carrying out our mission is that it is intrinsically very difficult mission.

When communities expect us to come in and have firm answers

and when those answers are in many cases elusive, either by their

very nature or because the data we need aren’t available, then we

end up disappointing communities and our people are very disappointed in those situations as well.

So it may be that the very model of work that we use, the very kinds of services we deliver to communities need to be rethought,

and our national conversation aims to do that.

We don’t have the depth of expertise and breadth of expertise

that an agency charged with our mission really ought to have. We

need to have expertise in everything from meteorology to communication sciences to veterinary epidemiology, and we don’t have

that. We are a very small group, and in comparison to the thousands of hazardous waste sites that are out there, the countless

thousands of additional chemical releases, our small agency really

faces a huge challenge quantitatively. I don’t think that we face the challenge of disloyalty to science or unawareness of the best science or of lack of dedication. I think

we have a very dedicated and caring workforce, but in the face of

those challenges, the job is a tough job.

MORE ON POTENTIAL FIXES

Mr. BROUN. What would you do in the way of trying to overcome those stumbling blocks or hindrances to your being able to perform

what the communities expect?

Dr. FRUMKIN. Well, I think the steps that I described earlier that

we are now taking to improve our work very much respond to that

question. So at the very large level of looking at our mission—there

were some comments today about our work plan. Should we delegate more work to the states or less work to the states? Should we

delegate more work to the private sector or less? Those are fair

questions to ask, and we are asking questions at that large scale

in our national conversation.

We do need to be very attentive to good science administration, and we need to look at issues like effective peer review and clearance and be sure that we are doing as well as we can. We have

some suggestions already from this morning’s testimony about

more extensive peer review, and that is the kind of suggestion we

need to take very seriously.

At the level of management within the Agency, we need very

good management. We need skilled management with human resources issues and staff capacity building issues and so on attended

to. We are taking a lot of steps in that direction, so I stand by what

we are doing there. And then there are specific procedures that we

could do better, and we are working hard to do better at them.

So I think that sort of thorough, open look, a willingness to identify places where we could do better and then to take advantage

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of those opportunities really is what we need to have, and I am

proud to say we have that.

Mr. BROUN. Can the private sector handle the functions of doing these studies and producing the scientific products that are necessary?

Dr. FRUMKIN. In some cases we do do that. We have private contractors who handle some of the preparation of our toxicologic profiles. In some cases when we conduct environmental sampling, we

have private contractors who do that. So a certain amount of sharing of this responsibility is very appropriate. I do believe that people expect their government to protect their health, and so I am proud that we have a core government role,

and I think we ought to maintain that role, but I think shared arrangements between the public and private sectors are very, very

practical and we have shown that they can work.

Mr. BROUN. So the answer to that is the State and private sector

can perform these duties if we just enable them to do so?

Dr. FRUMKIN. I think so.

Mr. BROUN. Thank you very much. My time is out and I will yield back, Mr. Chair. Chair MILLER. Thank you, Dr. Broun. Mr. Rothman has joined us. Do you have questions, Mr. Rothman?

Mr. ROTHMAN. I do indeed. Thank you, Mr. Chair. Chair MILLER. You have five minutes.

MORE ON VIEQUES, PUERTO RICO

Mr. ROTHMAN. Thank you. Thank you, Doctor, for your testi- mony. I would like to discuss with you an example of what is a

very disturbing conclusion that ATSDR has apparently rendered

with regards to the public health of the community of Vieques,

Puerto Rico. For over 60 years, roughly 200 days a year the U.S.

Navy used the eastern end of Vieques to practice live ordinance

training exercises. Numerous studies, both academic and scientific,

have confirmed that levels of heavy metals, biotoxins, and carcinogens are sometimes up to 100,000 times higher than the safe levels

in the local ecosystem, and the island suffers a drastically higher

cancer rate than the rest of Puerto Rico.

I have got a lot of questions, Mr. Chair, which I will submit for the record. As many as I can get in, though, in my time I would

be grateful to do. In 2003 following four public health assessments, ATSDR pub- lished a summary of the Agency’s work that included such observations that the residents of Vieques have not been exposed to harmful levels of chemicals resulting from Navy training exercises, that

the bombing of the live impact area has not affected the drinking

water, that levels of chemicals in Vieques’ soil are not of public

health concern, fish and shellfish are safe to eat every day from

Vieques, and other conclusions that seem to be in conflict or contradiction to other independent studies that have found evidence of

potential public health issues that ATSDR was unable to find.

Are you aware, Doctor, that the hair testing of the people of

Vieques, for example, provided to the U.S. Navy showed extremely

high levels of mercury disease, lead disease, cadmium disease, arsenic disease, and aluminum disease? Doctor?

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Dr. FRUMKIN. Mr. Rothman, are you referring to disease or to the levels of exposure to those metals?

Mr. ROTHMAN. Level of exposure to those metals. Let us start

there. If there is evidence of disease, I would like to know if you

found that as well.

Dr. FRUMKIN. I am not familiar in detail with all of the data collected in Vieques over the years. Our agency’s involvement in

Vieques predated my arrival at the Agency. I do know that there

has been sampling conducted by our people, and a lot of sampling

conducted by others and can’t fully explain the results or reconcile

them.

Mr. ROTHMAN. Would you feel comfortable raising your family on Vieques today, Doctor?

Dr. FRUMKIN. I don’t know enough about Vieques to be able to answer that question.

Mr. ROTHMAN. It is my understanding that the U.S. Navy has not been asked by ATSDR to provide the kind of relevant information that I think might clarify some of the conflict in conclusions.

Would you have any objection to requesting from the Navy that

kind of information?

Dr. FRUMKIN. No, sir. I am very happy to pledge to you moving out of this hearing to take a fresh look at the Vieques situation and

to collect any data necessary to clarify the health situation for the

people there.

Mr. ROTHMAN. That is very good news, Doctor. I understand that you don’t have enough information. You have committed to getting

more and being open to reexamining this whole issue anew, is that

a fair summary of your statement?

Dr. FRUMKIN. Yes, sir.

Mr. ROTHMAN. Thank you very much, Doctor. No further ques- tions, Mr. Chair.

Chair MILLER. Thank you. I do recognize myself for an additional round of questions. Dr. Frumkin, when I finished preparing my

opening statement I felt bad. It is hard for a southerner to be that

harsh. We say bless his heart, he means well, instead of the boy

is just dumb as a fencepost. It is hard for us to be that critical. But

the last second two panels made me feel much better about the

tone of my opening statement.

CHANGES IN RESPONSE TO CRITICISM

You have heard a lot of criticisms today, you know of the GAO report that Dr. Ozonoff was part of, in 1992 there was a study

called Inconclusive by Design that makes many of the same criticisms that we have heard today. I know that was before you joined

ATSDR, and certainly the problems with ATSDR predates your

joining the Agency, but can you identify anything that the Agency

did in response to the GAO study or the study Inconclusive by Design that was scathing to respond to those criticisms? Any change

the Agency made?

Dr. FRUMKIN. Mr. Chair, what I can speak to is efforts over the

last three years, and that has been my time at the Agency. We

have recognized the need for a thorough look at the way we do our

business. We have recognized the need to do better in many ways.

Many of the criticisms that were leveled in those reports 20 years

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ago are still leveled now, so we need to take those seriously. That

is exactly the motivator for this national conversation that we are

launching. It is meant to be a multi-stakeholder effort, a very serious and probing effort, to ask over the last 20 years of our work,

what is going well, what hasn’t gone well, and what do we need

to do to do much better moving into the future.

Chair MILLER. Not just still but within the last two hours within

this Committee room. You have said that there are constraints of

budget which I am sure is always true of any Federal Government

agency, and that is some of the reasons that the science isn’t better

than it is or that it is not peer reviewed, that you don’t look at all

the documents, you don’t go look at the dogs. But you have also

heard all the testimony today about the importance of a community

being able to trust ATSDR’s assessment that if there is not something for them to worry about, they need to be able to know that

that ATSDR assessment is something that they can rely upon. And

you have heard that communities can’t rely upon that. Have you

considered whether it would be better to do fewer reports but do

them well? Get them peer reviewed, have something the communities can rely upon but that an assessment that is not reliable, is

not credible, is worse than no assessment at all.

Dr. FRUMKIN. One of the very important possible solutions for us

is to take on fewer projects and to put more resources and time

into each project and do them in more depth, and I think that is

something we need to consider very seriously as we move forward

with our planning. It is also the case that sometimes we do quite

good work, very good work, but our results are simply not welcome

by the community which has other expectations than what we can

deliver, and that is not a matter of malfeasance or inability on the

part of our people. It is a matter that some of the questions that

communities very understandably need to have answered just can’t

be answered. And so we need to be very careful about acknowledging and when we need to do better in order to win the trust of

the community when we simply need to communicate better and be

more accountable, even when we have unwelcome news to deliver.

Chair MILLER. I yield back the balance of my time. Dr. Broun,

do you wish to have a second round of questions?

Mr. BROUN. Mr. Chair, thank you. I have a number of questions

that I am going to submit to the witness, and I appreciate your

offer and I am glad to give you forbearance on time, so we will

work together I think very well.

CLOSING

Chair MILLER. Mr. Rothman has left us. We are now at the end

of our hearing. Thank you, Dr. Frumkin. Under the rules of the

Committee, the record will remain open for two weeks for additional statements from any Member. I think I neglected to mention

that one of the witnesses, Dr. Cole I think, had—we will admit into

the record letters that Dr. Cole made part of his—appended to his

testimony, and there can be submissions of follow-up questions

from the Committee for any witnesses. And all witnesses are now

excused, and the hearing is now adjourned.

[Whereupon, at 12:56 p.m., the Subcommittee was adjourned.]

(325)

Appendix:

ANSWERS TO POST-HEARING QUESTIONS

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ANSWERS TO POST-HEARING QUESTIONS

Responses by Salvador Mier, Local Resident, Midlothian, Texas; Former Director of

Prevention, Centers for Disease Control

I thank you for the opportunity to respond to the following questions and offer

my perception.

As a prelude to my responses, I want to emphasize—public health desperately

needs the mission that gave birth to the ATSDR to be carried out. This mission has never been truly respected or realized. A culture of passive resistance by

internal and external forces was instituted at its inception to keep ATSDR from

completing its mission. This well-engrained culture of passive resistance is still very

much alive and pervasive today.

Although disgraceful, the FEMA trailer fiasco was no different than the egregious

1991 ATSDR political move at reducing pollution control and cleanup costs for industry by minimizing and denying the public health hazard of dioxin. ATSDR denied the science then—and contrary to scientific evidence—trivialized dioxin’s proven and potential impact on public health and attempted to get other agencies to

jump on their bandwagon. The same pattern of trivialization and denial is pervasive

in the majority of ATSDR public health assessments and consultations and in their

Toxicological Profiles upon which their findings are based. The problems identified

by this Subcommittee are only the tip of the iceberg.

One only needs to track forward the culture instilled by Dr. Vernon N. Houk,

former Director, Center for Environmental Health, CDC. In so doing it should be

obvious that in order to evoke the critically needed changes within ATSDR, all direct or indirect proteges of Dr. Houk currently in leadership above and within

ATSDR should be replaced—starting with at a minimum the Director, Coordinating

Center for Environmental Health and Injury Prevention (CCEHIP), down through

at a minimum ATSDR Director, Deputy Director and Director, Division of Health

Assessments and Consultations. Merely tossing a new frog into the swamp as Director is insufficient to bring about the desired consequences.

Questions submitted by Representative Paul C. Broun

Q1. Can the private sector or State agencies perform some or all functions of

ATSDR? Would this be appropriate? What conflict of interests could arise? How

could you protect against this?

A1. Functions inherent to ATSDR’s mission should be the responsibility of a public

agency—and the public rightfully expects this to be a responsibility of a federal

agency. A federal agency such as ATSDR is (or should be) further removed from the

internal State pressures that impair and compromise a state’s ability to make unbiased assessments. Private and State agencies could perform some functions of

ATSDR but there are serious conflict of interest issues (especially for State agencies)

that compromise their ability to conduct fair and objective assessments.

Possible Conflict of Interest—State Agencies

In a statement attached to my written testimony, Dr. Al Armendariz, School of

Engineering at Southern Methodist University (SMU) in Dallas, Texas, made the

following observations to which I concur.

‘‘There is an obvious potential for a conflict of interest when the ATSDR contracts with State regulatory agencies to perform health assessments or to conduct follow-up environmental sampling. [Example] In Texas, the TCEQ is the

State agency that grants permission to facilities in the form of ‘‘permits’’ to emit

pollutants to the atmosphere. In the permit writing process, the State agency

is making a legal statement that a facility will not adversely impact public

health. There is a very obvious potential conflict of interest when the same

agency later goes into the community to do follow-up sampling in response to

an ATSDR investigation. A State agency is essentially examining whether the

facilities to which it granted permission to emit pollutants at an earlier date are

now in fact causing an adverse public health impact. If ATSDR is going to work

with other organizations to conduct assessments or do follow-up sampling,

ATSDR should work with independent third parties with no obvious conflict of

interest, such as State universities or schools of public health, a Federal Government contractor, the American Lung Association, etc.’’

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Possible Conflict of Interest Private Sector

Many universities, schools of public health and other health-based organizations

often depend on grants from private industries to fund many of their research

projects. The threat of losing a grant becomes very real if an organization engages

in activities that may not be advantageous for a contributing entity and presents

a conflict of interest.

It is crucial to build in safeguards that prevent participation if a potential for conflict of interest exists whether it be a State government or an

independent third party.

Problems With State Cooperative Agreements

The degree to which public health issues conflict with industrial prosperity concerns varies greatly from state to state. As an example, in Texas there is considerable political and industry influence (some subliminal and some strongly overt) on

the State environmental agency. This tone of supporting industry at the cost of public health has been clearly set by the State administration and is vigorously advocated and promoted by industry lobbyists and generally has been supported by the

State legislature. It would be irresponsible to pretend this is an exaggerated issue.

It is a pervasive observation expressed by diverse groups of stakeholders and should

not be dismissed. In many states the ability for State agencies to make an objective

assessment of the impact of toxic exposure on the communities’ public health is

greatly compromised. This is why most communities turn to ATSDR—because it is

perceived to be more distant from local political pressures.

Currently, where there is a State cooperative agreement between ATSDR and the

state, ATSDR abdicates the investigative and decision-making responsibility back to

the state—the same institutions that previously failed the community. This is a

costly ‘‘no value realized’’ process—an egregious waste of taxpayer’s money.

It would be naı ̈ve to think that ATSDR can do all of the necessary work independent of the state but ATSDR should assume greater responsibility for many of

the required tasks. Public Health Assessments/Consultations performed under State

Cooperative Agreements should be severely limited—particularly when all avenues

within the state have already been exhausted and a community turns to ATSDR as

the last resort. Resources wasted under these cooperative agreements

should be re-channeled to improve ATSDR’s methodologies used to identify

suspected environmental exposures to hazardous chemicals, conducting

their own assessments/consultation, improving quality control and having

their work peer reviewed by external experts.

Q2. To what extent do you attribute the ATSDR’s problems to leadership?

A2. See my opening statement. There appears to be an entrenched institutionalized

culture that has weakened ATSDR’s commitment to objectively temper and counter

external pressures and has created internal weaknesses that dissuade the Agency

from fulfilling its mission. Changes in this entrenched institutionalized leadership that go deeper and higher than that of the Director’s position are

critical if this culture is to change.

Q3. Do you believe ATSDR attempts to include revolutionary scientific methods and

techniques in their work?

a. If not, how would you propose they better integrate cutting edge science?

b. Is there any risk to getting too far ahead of a technology or method and coming to conclusions that are ultimately proven unfounded?

c. How would you set up policies or procedures to appropriately manage and

unitize these innovations?

A3. I believe that there are internal barriers to and deficiencies in easily accessible

scientific data. This make it difficult for ATSDR public health assessors to readily

access and incorporate the evolving science into their decision-making processes.

It appears ATSDR assessors are almost exclusively dependent on summary statements and obsolete ATSDR toxicology profiles. Based on language and references reflected in their findings, it appears ATSDR assessors do not have access to evolving

science or are not allowed to work ‘‘out of the box established by the ATSDR Toxicological Profiles.’’ Language in these Profiles appears to be the basis for most arrived conclusions in the assessments/consultations.

In his written testimony to Congress Dr. Howard Frumkin states ‘‘Since its inception ATSDR has produced Toxicologic Profiles by reviewing the accumulated literature at a particular point in time [not at the cutting edge], culminating in a publication of a monograph that promptly commenced to go out of date. The Profile

328

would be updated some years later with a next edition, which would rather soon

become stale.’’

Dr. Frumkin stated that ATSDR will be replacing the ‘‘book publication’’ model of the Toxicological Profiles with a more contemporary model based on ongoing, web-based updates of relevant sections as new material becomes available. How cutting edge the science will be depends on the time lapses between the availability

of the data and the update. ATSDR assessors should have immediate easy ac- cess to all cutting edge scientific studies data bases and should be mandated to incorporate the findings into their conclusions. It appears extensive data needs for the Agency have not been met. In his testi- mony, Dr. Frumkin acknowledges, ‘‘ATSDR has a limited research capacity relative

to extensive data needs. Although ATSDR has carried out a limited program of targeted research and has worked to identify data gaps—with the extensive data needs

related to toxic exposures, this remains an ongoing challenge for the Agency.’’ Keeping up with science appears to be a greater problem than ‘‘getting ahead of science.’’ Hence, the question, ‘‘Is there any risk to getting too far ahead of a technology or method and coming to conclusions that are ultimately proven unfounded?’’

is frustrating. Let us pretend for a moment that ATSDR indeed accesses the cutting edge science and this science presents validated information that warns us of the need to incorporate measures to mitigate harm. What is the greater risk—taking preventa- tive measures or ignoring emerging science? Protections that mitigate suspected risks can be relaxed if further scientific findings emerge that more

robustly support an alternative explanation—but damage to human health

cannot be retroactively mitigated and many illnesses and death cannot be

undone.

Resources dedicated to establishing a more proficient science data base and a mandate to incorporate cutting edge science into the public health

assessments is critical.

Q4. How did your experiences with State and local health officials differ from that of ATSDR?

a. Were they better or worse?

b. Do you believe there was enough coordination, too little, or too much?

c. Did you view ATSDR’s work as simply ‘‘rubber-stamping’’ the state’s work, or did they provide value?

A4. Shortly after ATSDR changed Midlothian’s health assessment to a consultation, ATSDR made it clear that they were abdicating all of their responsibilities for making decisions back to the state. ATSDR was to sign off on it. This basically made

it clear that they would simply be ‘‘rubber-stamping’’ the state’s work. We had very little interaction with ATSDR—unless we pursued it and the bulk of the interaction was via e-mail communication. Up until about six to seven months

ago we had frequent communication (both via telephone and e-mail) with several

of the State public health agency staff. We have had almost zero communication (either that we have initiated or they have initiated) since. This July it will be four

years since we petitioned the ATSDR for a Public Health Assessment.

You ask, ‘‘Was the state better or worse than ATSDR. For at least 20 years the

community went to the State agencies asking them for a health assessment because

they were experiencing increasing public health problems. The community found

themselves on a merry-go-round. The health department consistently told them that

the environmental agency says that the toxins to which they and their animals were

exposed was not supposed to make them sick so there was no point in discussing

or looking at their health issues.

In desperation for trusted health information, the community turned to ATSDR.

ATSDR catapulted them right back on the same merry-go-round. The community

ended up back in the same arena—receiving more of the same. Was there a difference? No.

Q5. What was your impression of ATSDR’s coordination with other federal agencies

like EPA?

A5. Since ATSDR was not actively involved with the process, there was no

opportunity to form an impression of ATSDR’s coordination with other federal agencies.

Q6. How does ATSDR’s level of competence compare to other federal and State entities charged with protecting public health?

a. Would you characterize the work ATSDR does as a specialized niche?

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b. Do any other agencies perform this same work?

c. Can you identify any areas of duplication?

A6. Would I characterize the work ATSDR does as a specialized niche? Yes.

ATSDR’s Public Health Assessments/Consultations should be a special niche—

operating independent of external influences. Assessing the impact of toxic exposure on public health is dramatically different from most other public health challenges. First, the science of environmental health

is still evolving and the challenge of attempting to associate environmental toxins

to illness and disease is apparently extremely difficult. Competency or lack of competency is difficult to compare because ATSDR (and other agencies working in the

environmental health arena) appear to have a strong lack of will, interest or courage

to attempt to associate illness and disease that might be associated to industrial

toxins. Thus, in my opinion, it is not so much competency that sets ATSDR and other similar agencies apart from other public health entities but rather the mindset in approaching the public health challenges is drastically different. Efforts to link epidemiological data to toxic emissions from industry evoke a dras- tically different set of dynamics and resistance as compared to linking epidemiological data with a bacteria or virus as sources. This is especially true when the emissions are from industries that are active and remain an integral economic part of

the community. These are very real dynamics that science confronts in this arena

and are extremely difficult to deal with and cannot be dismissed. To dismiss them

is to be naı ̈ve and irresponsible. ATSDR has a tendency to trivialize and deny the existence of epidemiological data. Agencies involved in assessing the public health impact of industrial toxins must make more serious efforts to utilize epidemiology. Although epidemiology is a common public health tool the utilization of this instrument is almost non-existent in

communities impacted by industrial toxins. Time and time again we have been told

by both ATSDR and the State Public Health agency that epidemiology is too expensive, too labor intensive and too difficult in the application to environmental health

issues.

‘‘Do any other agencies perform the same work?’’ Yes, some local and State health departments have environmental health components that can perform some of this

work but the level of expertise and competency varies significantly and with some

it is questionable. Also, see previous comments regarding potential conflict of interest.

Are there areas of duplication? This is a good question. There may be some that involve ATSDR, the National Center for Environmental Health (CDC and under the

same Director) and the National Institute for Environmental Health Sciences. This

should be explored.

Q7. How does ATSDR compare with similar entities in other countries?

a. Do international public heal agencies have similar problems?

b. What do you attribute this to?

A7. I have not studied similar entities outside the U.S. therefore do not feel qualified to answer any part of this question.

However, note the testimony from Dr. Randall Parrish, University of Leicester

(UK). Using a readily available tool, Dr. Parrish was able to pick up where ATSDR

left off and identify depleted uranium in people exposed at Colonie, NY. In this situation I attribute this more to lack of will by ATSDR.

Q8. ATSDR does not do large-scale environmental sampling, and relics upon the

EPA and states to conduct this work.

Q8a. Do you believe ATSDR should also be doing this work?

A8a. ATSDR has the responsibility for scientifically evaluating the adequacy, effectiveness and appropriateness of all data upon which they will

base their decisions—including environmental sampling and monitoring (conducted by a State agency or other entity). This is an important fist step in any analyses they perform. If based on science and logic ATSDR deems there are gaps and

flaws with the adequacy of this data, then EPA, an EPA contractor or the private

sector could assume this responsibility. EPA is the logical federal agency for this

responsibility because of their expertise. I would assume that EPA also has the

budget capacity to consider undertaking some of these sampling activities (since

frankly this is part of their mission).

Although most State environmental agencies have this capacity they are too often

in a compromising and/or conflict of interest position because they issue permits to

industries and legally certify that those industries will not adversely impact the

330

public health of the communities in which they operate. See prior statement regarding potential conflict of interest.

Q8b. How would you suggest we pay for this work?

A8b. Adequate data necessary to arrive at a scientific conclusion is not a luxury

item and should not be considered optional. The primary question should not be how

the work should be financially supported but rather how scientific conclusions can

be made without it. We pay for this work regardless of whether it is done by ATSDR

or another entity. The question should be, ‘‘How can we get the most reliable data?’’

ATSDR resources misdirected towards State Cooperative Agreements could be redirected to pay for this work.

When determining cost you must also factor the increased cost of health care that

would ensue addressing illnesses that stem from our failure to take adequate preventative measures to protect public health.

Q8c. Would this be worth limiting the number of other studies, assessments, or consultations the Agency initiated?

A8c. ATSDR has already instituted a ‘‘shift in product lines’’ downgrading to Health

Consultations, Exposure Investigation, or Technical Assists to as they put it—‘‘respond more rapidly, and address public concerns more directly—and conserve scarce

resources to address more complex exposure scenarios.’’ Perhaps a closer look at

this shift in product lines is necessary to determine whether there was a

value added or lost. Take Midlothian, Texas as an example.

Midlothian, located within the DFW eight-hour Ozone Non-attainment Area, is a

complex scenario with the largest concentration of cement kilns and one of the largest steel mills in the U.S. These processes alone emit a large volume of chemical

and heavy metal toxins. The circumstances are further confounded because these cement kilns are classified as waste recyclers permitted to burn refuse such as tires,

petroleum coke, asphalt roofing, etc. For 20 years the community has been exposed

to hazardous waste incineration—some even before trial testing was completed. TXI

currently is permitted to burn hazardous waste in four outdated wet kilns not designed to burn hazardous waste. These cement kilns are not required to meet the

more stringent MACT standards required for commercial hazardous waste incinerators. Animal and human health issues have been surfacing for almost 20 years.

This is a complex scenario rife with aggregate toxic chemical exposures and multiple

confounding circumstances which logic would tell you would demand a public health

assessment.

Instead of performing a public health assessment ATSDR instituted this ‘‘shift in

product lines’’ and downgraded the assessment to a ‘‘consultation.’’ And as far as

being able to ‘‘respond more rapidly,’’—almost four years later it is still not finalized. And as far as ‘‘address public concerns more directly’’—the document, and the

comments by the six scientists who reviewed the draft do not support that the

public’s concerns were addressed.

The question to ask is, ‘‘To what extent has this ‘‘shift in product lines’’ already

taken place—and has it improved the process and conserved resources?’’

Q9. Please describe the process that you (or your community) went through in petitioning for ATSDR’s help.

Q9a. Was your review ever downgraded to a health assessment or health consultation?

Q9b. Were you consulted in this decision, or were you simply informed by the Agency?

Q9c. Did you have any ability to appeal this decision?

A9a,b,c. The responses to these questions are all in my written and oral testimony.

Q9d. How did this affect your overall impression of the services ATSDR provided?

A9d. My impression was that Midlothian would not be getting a true unbiased public health assessment that would withstand the scrutiny of unbiased scientists. I

knew that Midlothian’s public health assessment would not be subjected to an internal or external peer review. Therefore out of desperation, I appealed to the science

community for help in reviewing the draft consultation published for public comment. Six scientists responded. Their comments will give you insight and answers

to many of the questions you ask herein.

Q10. Please describe your level of communication with ATSDR.

a. Do you feel this was adequate?

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b. What do you think they should have done differently?

A10. Once the ATSDR abdicated their responsibility for assessing Midlothian’s pub- lic health to the state, the bulk of our communication was with the State agency

staff. Basically, we feel ATSDR should have retained the responsibility for making

this assessment.

Q11. Do you believe ATSDR products accurately communicate agency findings?

a. What are some of the problems you have identified in their reports?

b. How can the Agency be more effective in communicating risks?

A11. It is the weakness of and the omissions in their findings more so than ATSDR’s inability to accurately communicate these findings that creates the problem. Communicating a concept or conclusion that does not have a solid sci- entific basis and ignores ‘‘community concerns’’ will always remain difficult.

Dr. Frumkin’s statement that communities expect that ATSDR reach unequivocal conclusions does not accurately represent what communities expect.

Giving reasons such as ‘‘accurate exposure data are often unavailable’’—‘‘accurate health data are often unavailable’’—‘‘complete information on toxic effects of many

chemicals is lacking, especially for such outcomes as neurobehavioral, development,

reproductive function, and especially following the types of long-term, low-dose exposures which occur in many communities’’—‘‘scientific data on mixtures to chemicals

is scanty,’’ Dr. Frumkin further states, ‘‘Unfortunately, it is not always possible to

reach such [unequivocal] conclusions.

Yet in an effort to force conclusions into neat little boxes labeled ‘‘No Apparent

Public Health Hazard’’ or ‘‘Indeterminate Public Health’’ ATSDR reaches ‘‘unequivocal’’ conclusions—ignoring all alleged unknowns as if the lack of data

equated to no harm. Communities expect trusted health information based on

sound science. It is the ‘‘monkey sees no evil’’ game that ATSDR plays that communities find frustrating. These unknowns should be acknowledged and be part of their

conclusions.

The proposed sample wording/rewording, ‘‘ATSDR concludes that touching,

breathing, or accidentally eating zinc found in soil and dust at the XYZ site is not

expected to harm people’s health because zinc levels in soil are below levels of health

concern,’’ given in Dr. Frumkin’s testimony, as is just an example of an extension

of gobbledegook. This exampled phraseology is lacking explanatory information that

the public needs and to a large degree is condescending and insults the community’s

intelligence. It is barren of the scientific basis (expressed in layman’s terms) upon

which conclusions are based that the public seeks and would just exacerbate frustrations that currently exists.

Consider how lead is addressed as an example and suggested clarification when less than a Public Health Hazard is issued.

Even though the preponderance of evidence shows that there is no safe blood-lead

level, ATSDR consistently uses—as a refuge to not assess public health impact

at lower levels—the statement (cut and pasted from their Toxicological Profiles),

‘‘CDC has determined that a blood lead level at or above 10 micrograms per deciliter

(μg/dL) in children indicates excessive lead absorption and is grounds for intervention’’—essentially condoning 10 μg/dL blood-lead level as an acceptable

health risk.

If ATSDR continues to refuses to incorporate accumulated blood-lead levels lower

than 10 μg/dL as a health risk, at a minimum, communities seeking trusted health

information deserve this type of explanation:

All scientific research shows there is no known safe level of lead.

Shortly after lead gets into your body, it travels in the blood to the ‘‘soft tissues’’

and organs (such as the liver, kidneys, lungs, brain, spleen, muscles, and heart).

After several weeks, most of the lead moves into your bones and teeth. In

adults, about 94 percent of the total amount of lead in the body is contained

in the bones and teeth. About 73 percent of the lead in children’s bodies is

stored in their bones. Some of the lead can stay in your bones for decades; however, some lead can leave your bones and re-enter your blood and organs under

certain circumstances (e.g., during pregnancy and periods of breast feeding,

after a bone is broken, and during advancing age).

Lead (from mother’s current exposures, and that leaching from the mothers

bones) interferes with neural development in children and developing fetuses

even at extremely low levels. Even at very low levels, lead is associated with

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negative outcomes in children, including impaired cognitive, motor, behavioral,

and physical abilities. Fetal lead exposure can cause delay in the embryonic development of multiple organ systems, including retardation of cognitive development in early childhood.

Recent science associates very low blood-lead levels in adults with cognitive deficiencies, increased deaths from heart disease and stroke and miscarriages.

Deleterious human health effects at blood-lead levels 10 times lower that 10 μg/ dL have been observed. CDC recommends a blood-lead level at 10 μg/dL as a point of intervention (not as an acceptable level of poisoning or as

an acceptable health risk) because successful chelating treatments below this level have not been identified; therefore, prevention of exposure is essential.

(Statements should be foot-noted with applicable studies/references.)

Q12. Are you aware of ATSDR’s recent efforts to improve its processes and management?

a. Do you believe they will adequately address your concerns?

b. How would you improve tile Agency’s processes and management (or even cul- ture)?

A12. I have read some of the Agency’s proposed efforts. These efforts to date have not been reflected in the quality of the end products—Public Health Assessments/

Consultations.

I have a major concern about the proposed ‘‘National Conversation’’ to determine

the ‘‘public health approach to chemical exposures.’’ It appears to be another form

of ‘‘passive resistance’’ to proactively addressing the issues that are before ATSDR.

Just like public health assessments and consultations are drawn out for years—

keeping the public silenced and at bay, thinking that their guardian agencies are

taking health-protective actions—this ‘‘National Conversation’’ will serve as an infinite diversion—a refuge for inaction.

ATSDR already knows what they have to do and they have the science to back

needed action. Although it is good to keep dialogue open and consistently seek improvement, ATSDR just simply needs to start fulfilling its mission.

Agency processes and management practices are fairly simple to correct and modify. Agency mindset and culture appear to be well engrained and institutionalized

over a long period. Effecting a change in mindset and culture requires concerted

proactive action.

Senior leaders who have maintained their positions in this current environment

are most culpable in setting the existing mindset and culture. To effect desired

changes within the Agency, they need to be replaced. In my opinion, at a minimum,

the Director, Coordinating Center for Environmental Health and Injury Prevention

(CDC), the Director of ATSDR, the Deputy Director and the Director of the Division

of Health Assessments and Consultations must be replaced. There may be a need

to make other personnel changes in this agency but that would require a review by

an outside entity to determine this need.

The new CDC Director must clearly understand the ATSDR mission and the desired mindset and culture necessary in order that ATSDR can carry out its mission.

This understanding is critical to assure that the appropriate replacement staff is appointed and in turn, the new mindset mandate is translated to the Agency staff.

Q13. How can ATSDR do a better job characterizing past exposures given the complexity of the task? Do you have any specific recommendations?

A13. ATSDR needs to scientifically validate the merits of environmental data available. If the system collecting data is suspect, then the data produced are also suspect and should not be used as a basis for ascertaining exposure either past or

present.

ATSDR should review empirical evidence and determine whether this empirical

evidence could be related to exposure. Empirical evidence such as birth defect and

cancer clusters, animal and dog birth defects and other health issues are sometimes

much better monitors of exposure than any mechanical devices. These are red flags

that should warn that something could be awry and further investigation is needed.

If cumulative body burden and past exposures are material to predicted outcomes

of current exposure assessments, ATSDR should not proceed as if they are not material. Lack of data should not be interpreted by ATSDR as an absence of a

negative public health impact.

If past exposures are material to locating people that were in harms way and

needing possible additional medical attention or to assess long-term effect on people

in similar situations, then ATSDR needs to ensure the best tools are used to assess

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these past exposures. See Dr. Randall Parrish’s testimony regarding ATSDR’s failure to use available tools to assess depleted uranium at Colonie, NY.

In some cases, ATSDR should consider implementing CDC’s biomonitoring activities to determine past exposure. This should be given strong consideration in communities where the environmental monitoring system is weak and thus the data

generated cannot be used as a basis to accurately characterize past exposure. This

activity is under the auspices of the National Center for Environmental Health at

CDC and is under the management of the ATSDR Director.

Q14. What roles should ATSDR play in exposure routes not associated with hazardous waste (such as food, consumer products, water, and air)?

a. How should the Agency address these issues?

b. Would there be any overlap with other agencies?

c. What should the Agency do when there is a duplication of effort?

d. Do you believe ATSDR’s current mission is appropriate?

A14. ATSDR is the principal federal public health agency charged with the

responsibility of evaluating the human health effects of exposure to hazardous substances in air, water, and soil and the food chain. Other federal

agencies already have responsibility for assuring the safety, efficacy, and security

of food, drugs and other consumer products. Although their paths may sometimes

cross, the roles and scope of their activities are very different. ATSDR needs to do

a better job with its current responsibilities and not even contemplate the expansion

of their role.

Dr. Frumkin’s expression in his testimony of concern about heavy emphasis on

hazardous waste sites is puzzling since this encompasses the bulk of ATSDR’s responsibilities. The statement, ‘‘However, a variety of other sources, such as food,

consumer products, water, and air are well recognized, and for many Americans

these, not hazardous waste sites, are the predominant pathways of exposure to chemicals,’’ is worrisome. Determining whether the toxins/chemicals from the hazardous

waste sites are contaminating the food, water and air to is within ATSDR’s scope

of responsibility. Furthermore for many Americans living in, near or on hazardous

waste sites—what impacts their health is not an either or situation. Exposure to chemicals and toxins from these hazardous waste sites is a confounding factor on top of the normal body burden of toxins experienced by

the many Americans.

ATSDR’s current mission is extremely appropriate and critical to the

public health of this nation—it just needs to be carried out.

Continued failure to properly assess the impact from toxic exposures or to be clear

about potential health impacts will continue to imperil the Nation’s public health.

It will be a signal to industries and the environmental agencies that the edge has

not yet been reached and activities that produce further increases in toxic emissions

may be possible or that further preventative measures are not necessary.

Those opposed to the success of ATSDR’s mandated mission would realize

a great victory should ATSDR maintain the status quo or be abolished.

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ANSWERS TO POST-HEARING QUESTIONS

Responses by Randall R. Parrish, Head, Natural Environmental Research Council (NERC) Isotope Geosciences Laboratory, British Geological Survey

Answers to questions will refer to the question numbers 1 to 14; several of the

questions refer broadly to interactions witnesses have had with ATSDR; in my particular situation these are not relevant since I have never had any direct or indirect

contact with ATSDR. ATSDR has not contacted me with regards to my work at any

time. I have not attempted to contact ATSDR either. My contribution has mainly

been in evaluating the ATSDR Health Consultation done at Colonie, NY.

Questions submitted by Representative Paul C. Broun

Q1. Can the private sector or State agencies perform some or all of the functions of

ATSDR?

a. Could they do it better?

b. Would this be appropriate?

c. What conflict of interests could arise?

d. How could you protect against this?

A1. As I live in the UK I do not feel I have sufficient knowledge of either State agencies or private sector organizations to address this question.

Q2. To what extent do you attribute the ATSDR’s problems to leadership?

A2. I express my personal view here: I do feel this is in part a leadership issue. In large organizations leadership sets the tone and agenda. I listened to the response of the Director of ATSDR during testimony and generally felt that his comments indicated to me that he had failed to set a clear agenda of priorities for the

Agency, and that he was probably out of his depth, regardless of how good an academic scientist he is or was in his previous role. Weak leadership has undoubtedly

contributed to the acute difficulties the Agency is in now. Poor judgment near or

at the top has led to some of the imprudent actions—especially the formaldehyde

issue.

Q3. Do you believe ATSDR attempts to include revolutionary scientific methods and techniques in their work?

a. If not, how would you propose they better integrate cutting edge science?

b. Is there any risk to getting too far ahead of a technology or method and com- ing to conclusions that are ultimately proven unfounded?

c. How would you set up policies or procedures to appropriately manage and uti- lize these innovations?

A3. In my experience at Colonie, NY, there is little doubt that the Agency failed to take account of and incorporate advances in methods of toxic exposure detection.

The Agency should ask the broad questions—for example—what levels of exposure

might have occurred and can these be documented; can modeling be used to estimate better what inhalation of toxic uranium oxide might have occurred? These

types of questions can be addressed. In my opinion the Agency need not have full

expertise within its own staff to answer all possible technological questions, but they

should have an outward-facing comprehensive knowledge of where to find the experts and how to engage them as consultants, advisors, or as analysts. If they embraced this type of ethos, they could retain the capability of using the best methods

and best science while not being compelled to find this top notch expertise always

within house. I suspect the Agency has the worst of both worlds—neither the experts in house nor the interest to seek outside expertise. This would lead to a highly

insular organization that would, over time, become more and more inadequate given

its remit. I do not have sufficient current knowledge of the organization to comment

much further except to say that what I am suggesting is not rocket science—just

pretty much down to Earth common sense. If they want to get to the bottom of an

issue, you need to seek the best experts and use the most appropriate tools. I would

also say that if the Agency always requires the use of routine methods that are common and well established, and if they require any method to be formally accredited

in a lab, then they will miss major opportunities because the common methods may

not be appropriate for unusual requirements.

Q4. How did your experiences with State and local health officials differ from that

of ATSDR?

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a. Were they better or worse?

b. Do you believe there was enough coordination, too little, or too much?

c. Did you view ATSDR’s work as simply ‘‘rubber-stamping’’ the state’s work, or did they provide value?

A4. I felt that the quality of the ATSDR health consultation at Colonie, NY was fair at best, but to be fair, that of the NY agencies were no better. Neither agency

seemed to feel the need to do any proper study of the situation. Both appeared to

act not in a proactive precautionary way, but almost entirely in a response to public

pressure. In neither case was protecting public health at the top of the agenda. Neither agencies appeared to satisfy the concerns of the public in any substantial way

and this I consider to be a failure of will.

Q5. What was your impression of ATSDR’s coordination with other federal agencies like EPA?

A5. No comment, not enough knowledge.

Q6. How does ATSDR’s level of competence compare to other federal and State entities charged with protecting public health?

a. Would you characterize the work ATSDR does as a specialized niche?

b. Do any other agencies perform this same work?

c. Can you identify any areas of duplication?

A6. No comment, not enough knowledge.

Q7. How does ATSDR compare with similar entities in other countries?

a. Do international public health agencies have similar problems?

b. What do you attribute this to?

A7. Hard to answer. In the UK we have the Health Protection Agency and quite rigorous standards on brownfield or toxic substance sites and there is a much

stronger linkage between governmental levels dealing with these sort of things, unlike the diffuse jurisdictions in the U.S.; of course the UK is much smaller and the

situation is different. I get the impression that there is more proactive precautionary work done in the UK than the U.S. given like for like situations. The

U.S. has a long history of companies with long standing links to the U.S. military

and U.S. DOE being allowed to pollute badly and get away with it, at taxpayers’

expense. In the UK there is a ‘polluter pays’ default policy, which requires costs to

be borne primarily by those that do the polluting. For example in the Colonie, NY

area, the DOE-contracted National Lead Industries did all the polluting and paid

for none of the cleanup, with the government willingly picking up the tab for the

mess ($190M) and still with no agency seemingly interested in evaluating the public

health implications of it all. National Lead has had a habit of abandoning sites and

moving on. The ethos that allows this to continue should be changed—this is long

overdue but unfortunately an entrenched pattern.

Q8. ATSDR does not do large scale environmental sampling, and relies upon the EPA and states to conduct this work.

a. Do you believe ATSDR should also be doing this work?

b. How would you suggest we pay for this work?

c. Would this be worth limiting the number of other studies, assessments, or consultations the Agency initiated?

A8. I think the most effective advice I could give ATSDR is to prioritize its many

projects and for those they commit to, to do them well, rather than cover all of them

poorly. This again, is just common sense. They need to re-establish their credibility

and they have to do excellent and thorough work to achieve this. If their resources

are insufficient to do this at all sites, then they either need additional resources,

or need to do fewer of them. All of this is based on the assumption that they also

need to root out systemic problems within the Agency that prevent them from being

efficient and doing the best science.

Q9. Please describe the process that you (or your community) went through in petitioning for ATSDR’s help.

a. Was your review ever downgraded to a health assessment or health consultation?

b. Were you consulted in this decision, or were you simply informed by the Agency?

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c. Did you have any ability to appeal this decision?

d. How did this affect your overall impression of the services ATSDR provided?

A9. See the preface; I have had no contact either way with the Agency—they have not contacted me nor have I contacted them. They clearly had something to gain

from contacting me, but on the basis of their report, I felt that it was sufficiently

superficial and in part ill-informed that I was unlikely to gain any new knowledge

of the Colonie Site by contacting them.

Q10. Please describe your level of communication with ATSDR.

a. Do you feel this was adequate?

b. What do you think they should have done differently?

A10. See the preface; I have had no contact either way with the Agency—they have not contacted me nor have I contacted them. They clearly had something to gain

from contacting me, but on the basis of their report, I felt that it was sufficiently

superficial and in part ill-informed that I was unlikely to gain any new knowledge

of the Colonie Site by contacting them.

Q11. Do you believe ATSDR products accurately communicate agency findings?

a. What are some of the problems you have identified in their reports?

b. How can the Agency be more effective in communicating risks?

A11. I detailed what I felt were failings in the Colonie Health Consultation in some detail in my original testimony, which is available; I refer the Committee to this.

Q12. Are you aware of ATSDR’s recent efforts to improve its processes and management?

a. Do you believe they will adequately address your concerns?

b. How would you improve the Agency’s processes and management (or even cul- ture)?

A12. No, I am not really aware of what if any progress has been made. Little or none of this was evident during the Committee hearing of 12 March, nor was it convincingly made clear in the written testimony materials. I would not be surprised

if any ‘progress’ was instead relatively superficial. My personal opinion here is that

the Agency is unlikely to recover to an acceptable state without major leadership

change through the fabric of the whole senior leadership layer at ATSDR, but again,

I do not have detailed knowledge.

Q13. How can ATSDR do a better job characterizing past exposures given complexity of the task?

a. Do you have any specific recommendations?

A13. This is a very important question and gets at the heart of the public health issue of sites that have historic rather than active pollution signatures. Many toxic

substances produce health impacts many years after exposure and it is therefore

ESSENTIAL that the best and most innovative methods be used to attempt to assess and detect such exposures and try to quantify them, so that health outcomes

might be evaluated against the exposure data in order test linkages. The Colonie,

NY example is a perfect illustration of the need for ATSDR to do better. If as occurred, the Agency assesses the current information and concludes there was a

major health risk, but then says it can do nothing because it happened 20 years

earlier, well that just isn’t good enough. Our group as you know come along right

afterwards and did the work that the ATSDR should have realized could be done.

Neither ATSDR nor the NY agencies seemed the least inclined to pursue the issue

and instead they appeared to fail to even appreciate that health consequences may

persist. In my opinion (as detailed in my written testimony) they badly misunderstood many aspects of this problem and largely missed the point—a demonstration

of inadequate knowledge of the science and issues. If they need to know what the

past exposure might have been, the Agency could commission the best labs (private

or public sector) to develop such tests when such tests (with their high sensitivity

requirements) are unavailable via routine methods. This is what the UK did in

order to satisfy Gulf War veterans who had persistent concerns about exposure to

depleted uranium munitions. If the methods don’t exist to detect a substance retained in the body from an historic exposure, then talk to the experts and commission new methods to be developed.

Q14. What role should ATSDR play in exposure routes not associated with hazardous waste (such as food, consumer products, water, and air)

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a. How should the Agency address these issues?

b. Would there be any overlap with other agencies?

c. What should the Agency do when there is duplication of effort?

d. Do you believe ATSDR’s current mission is appropriate?

A14. I do not have sufficient knowledge to answer this question.

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ANSWERS TO POST-HEARING QUESTIONS

Responses by Jeffrey C. Camplin, President, Camplin Environmental Services, Inc.

Questions submitted by Representative Paul C. Broun

Q1. Can the private sector or State agencies perform some or all of the functions of

ATSDR?

A1. A major problem with ATSDR research and studies is that private sector and

State agencies perform much of their work in an unsupervised manner. I have identified many reports performed in the Chicago area regarding asbestos where ATSDR

has allowed State agencies to perform incredibly faulty Public Health Assessments.

ATSDR then ‘‘rubber stamps’’ these reports without reviewing their accuracy. In another case, ATSDR funded a study by the University of Illinois at Chicago School

of Public Health that also contained flaws. When I complained to ATSDR about the

poor quality of the study they funded I was told by ATSDR leadership that it was

not their report and they could not require any changes. When I told them that all

ATSDR funded studies must follow their quality guidelines ATSDR stood silent. To

summarize, ATSDR needs to focus on ‘‘accountability’’ of their own staff and those

partners they delegate work to. Without accountability the flawed studies will continue.

Q2. To what extent to you attribute the ATSDR’s problems to Leadership?

A2. Again, the leadership fails to hold their agency accountable for their work products. When I challenged the flawed studies by State agencies ‘‘rubber stamped’’ by

ATSDR in Illinois, my challenges were not addressed. I wrote specifically to ATSDR,

CDC, and HHS leadership and was responded to with form letters that ignored my

challenges. In one case I filed an ethics complaint against ATSDR staff that disturbed asbestos contaminated sand during an exposure study while families were

on the beach. The ATSDR staff had personal protective equipment on while they

exposed families to asbestos fibers. I was told by ATSDR leadership that their staff

was ethical and only perform work in a professional manner. Yet I had video and

photos of the egregious behavior that ATSDR refused to comment on. The leadership is arrogant and complacent. ATSDR will continue to generate flawed work

products as long as the leadership is complacent and does not hold their staff or

partners accountable for their flawed work.

Q3. Do you believe ATSDR attempts to include revolutionary scientific methods and

techniques in their work?

A3. It is the exact opposite: ATSDR uses outdated, flawed, and unscientifically

modified methods to perform their work. All of their asbestos studies contain numerous modifications and limitations which skew and downplay the toxicological

findings of their studies. All of their asbestos pubic health assessments and consultations use a risk model that they admit is inaccurate and outdated. Yet instead

of using more accurate risk models, ATSDR clings to the outdated model. ATSDR

simply adds disclaimers to their report that state the risk from asbestos is significantly underestimated. This is unacceptable. However, ATSDR leadership refuses to

acknowledge the use of better scientific methods. They won’t even run a side by side

comparison of the outdated risk models to more current scientific methods and techniques in their work. This is unacceptable and a major scientific flaw in ATSDR

studies.

Q4. How did your experience with State and local health officials differ from that

of ATSDR?

A4. State and local agency reports were definitely ‘‘rubber stamped’’ by ATSDR.

This is a problem when State and local agencies also participated in studies run by

ATSDR staff. ATSDR, State, and local agencies play off each other when their reports are challenged. ATSDR will say that the state had control, while the state

might say the local agency actually made key decisions, while the local agencies

point the fingers back at the state and ATSDR. Draft documents and e-mail are not

subject to FOIA so it is impossible for the public to determine who actually made

any decisions on studies. ATSDR generally fights all FOIA’s. It would be helpful if

this agency was more transparent. Also, when State or local agencies will not respond to FOIA’s I generally requested the information from ATSDR. ATSDR would

state that they would not give me information from their files from other agencies

and that I would have to get any documents from those agencies. Again, ATSDR

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promotes an atmosphere of secrecy to impede any accountability of responsible parties; particularly of their own staff.

Q5. What was your impression of ATSDR’s coordination with other federal agencies like EPA?

A5. ATSDR and EPA play games with consultations and Public Health Assess- ments. For instance, EPA performed an asbestos study at Illinois Beach State Park

in 2007. ATSDR helped them develop the study, they were present at the site when

the study was performed, and they even participated in the study by disturbing

beach sand and wearing air monitoring equipment. ATSDR Region 5 staff did all

of this. The same staffer from ATSDR Region 5 also helped review the study. Then

EPA asked ATSDR to review the study as though it was the first time ATSDR had

seen the report. Region 5 ATSDR then asked the EPA’s TRW asbestos group to review their risk assessment. However, Region 5 ATSDR staffer who participated in

the testing and who was preparing the risk assessment was also a member of the

EPA’s TRW asbestos group. In the final risk assessment opinion the ATSDR Region

5 staffer documented the process as though he had no involvement other than being

the risk assessor. In reality he had been involved in the entire process from design

to final report to peer review (of his own work). The EPA needed a study that said

the asbestos risks were low because of their involvement with bungling an asbestos

Superfund site that created the contamination. ATSDR played along with EPA the

entire way to make sure the testing was rigged and the risk models were flawed.

The ATSDR staff also made sure he was involved in the peer review so his work

product would not be challenged. This is not transparency or ‘‘independent’’ peer review. This is rigging a study with the EPA to cover-up the mistakes of their past

flawed work product.

Q6. How does ATSDR’s level of competence compare to other federal and State entities charged with protecting public health?

A6. I believe that ATSDR has the potential to generate very competent work. How- ever, the leadership of ATSDR has developed a culture where their work supports

preconceived conclusions by rigging studies and the data. ATSDR is very competent

in arrogantly generating flawed work products. They know that there are not too

many others who have the knowledge to challenge them. When someone does challenge them they arrogantly hide behind the integrity of the Agency and their many

credentials. They cannot handle the truth. ATSDR leadership and staff are very

smart. Unfortunately they do not use their knowledge to promote public health.

They use their expertise to cover-up for errors made by other agencies.

Q7. How does ATSDR compare with entities in other countries?

A7. I am working with the Italian government to write a paper on how asbestos contaminated shorelines have been addressed by the U.S. vs. Italy. The Italian government errs on the side of caution when risks from asbestos are unknown. The

Italian government was shocked to hear how ATSDR was estimating risk from asbestos contamination along the Illinois Lake Michigan shoreline. I have been asked

by the Italian government to participate on their scientific review panel when they

host the World Asbestos Conference later this year in Italy. Many other nations will

be presenting at this conference. Most countries look to the U.S. for leadership on

pubic health and toxicological studies. However, they have become just as disappointed as I have been with the quality of their work. ATSDR does not act in a

precautionary manner unlike most European countries. ATSDR is sliding backwards

as the rest of the world passes them by.

Q8. ATSDR does not do large scale environmental sampling and relies upon the

EPA and states to conduct this work. Do you believe ATSDR should do this

work?

A8. ATSDR actually did some asbestos testing in Illinois. I video taped some of the

testing where ATSDR staff from Region 5 and the Atlanta office exposed the public

during their testing. I filed an ethics complaint against them. ATSDR concluded

their work did not pose a risk to human health. However, when they asked Region

5 EPA to provide comments, EPA found ‘‘extremely high exposures’’ that ATSDR

downplayed. ATSDR published their flawed report anyway stating it was their report and EPA had no jurisdiction. ATSDR should not be doing testing!

Yet there is also a problem with others doing the testing. ATSDR generally takes

the data from their ‘‘partners’’ study at face value. There is no validity or accuracy

checks done on the data. I have found significant problems with data used by

ATSDR in their studies. ATSDR never. seems to review or reject ANY data. They

just take the numbers and plug them into their outdated risk models and conclude

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everything is just fine. The solution is to hold ATSDR accountable for verifying the

integrity of data that they use in their studies. ATSDR must be the Agency that

independently verifies that data used in their risk assessments is accurate. Right

now they do not do this, at least with asbestos studies.

Q9. Please describe the process that you (or your community) went through in petitioning for ATSDR’s help.

a. Was your review ever downgraded to a health assessment or health consultation?

b. Were you consulted in this decision, or were you simply informed by the Agency?

c. Did you have any ability to appeal this decision?

d. How did this affect your overall impression of the services ATSDR provided?

A9. WE DID NOT PETITION FOR ATSDR’s HELP. WE CHALLENGED THEIR

FLAWED DATA AND ASKED FOR BETTER STUDIES AND MORE ACCURATE

RISK ASSESSMENTS. ATSDR REFUSED TO ACKNOWLEDGE THEIR PAST ERRORS AND FLAWS IN THEIR STUDIES. ATSDR CONTINUED TO GENERATE

NEW TESTING FOR THE SOLE PURPOSE OF COVERING UP THEIR FLAWED

STUDIES, NOT TO IMPROVE UPON THEIR FLAWED WORK.

Q10. Please describe your level of communication with ATSDR.

A10. I have challenged their flawed work through their information quality guidelines to no avail. I also appealed their decisions without having my concerns addressed in their responses. All I have ever asked for is ANSWERS to the questions

I posed to them about the quality of their reports and studies. ATSDR (from the

top down) ignores any challenges and provides responses that avoid the actual challenge. There should be an independent review of ATSDR’s responses to information

quality challenges. Right now there is no accountability for their non-responses to

legitimate challenges and concerns.

Q11. Do you believe ATSDR products accurately communicate agency findings?

A11. NO! ATSDR loads up their studies with all kinds of limitations and qualifiers

that significantly impact the accuracy of their findings. Then ATSDR portrays their

findings (with great confidence) that everything is fine. Yet buried in the report are

these significant limitation and qualifiers that indicate how flawed the study actually is. ATSDR needs to communicate just how unreliable their information actually

is. Better yet, they should just do more accurate testing. ATSDR serves the polluter

by generating ‘‘gray area’’ studies that don’t really say one way or the other if a

hazard exists. This is another way ATSDR performs studies that harm public

health.

Q12. Are you aware of ATSDR’s recent efforts to improve its processes and management?

A12. There are no improvements. ATSDR already has good policies and structure.

The leadership is the problem. Since the leadership has not changed I find it hard

to believe anything has improved. What evidence exists that anything has improved? I know in 1991 ATSDR said they were going to improve and they didn’t.

Actions speak louder than words. What has really changed and what is the evidence

that has been verified by an independent agency. I don’t believe Dr. Frumkin’s

empty words that things are changing. According to Dr. Frumkin’s arrogant testimony before the Subcommittee, ‘‘I am proud of the excellent work we do at hundreds of sites nationally. I recognize that even excellent work has room for improvement’’ (line 2229). I do not think that ATSDR was ridiculed back in 1991 or by this

subcommittee for improving upon their ‘‘excellent’’ work. ATSDR continually generates flawed work products that harm public health. Major changes need to take

place. Leadership of ATSDR must be held accountable. If ATSDR leadership is not

held accountable, their complacency will continue.

Q13. How can ATSDR do a better job characterizing past exposures given the complexity of the task?

A13. ATSDR needs to use accurate risk models. For asbestos, ATSDR knowingly

uses outdated risk models to calculate risk. ATSDR needs to make great improvements with how they assess exposures to asbestos.

Q14. What role should ATSDR play in exposure routes not associated with hazardous waste (such as food, consumer products, water, and air)?

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A14. ATSDR needs to take a more holistic approach to public health assessments.

Most times they put blinders on and only look at risks from the perspective of a

certain hazardous waste in a certain location. In reality, the public has multiple exposures from a variety of sources. The risk from one specific site might not be

enough to declare a significant risk. However, when that risk is added to similar

risks in nearby areas or through other pathways the risk rises to a level of concern.

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ANSWERS TO POST-HEARING QUESTIONS

Responses by Ronnie D. Wilson, Associate Professor, Central Michigan University;

Former Ombudsman, Agency for Toxic Substances and Disease Registry

Questions submitted by Representative Paul C. Broun

Q1. Prior to the establishment of ATSDR, how was public health protected?

a. What role did academia play?

b. What role does academia play now?

c. What role does the private sector play?

d. How does this compare to now?

e. Has the role of protecting public health simply shifted from the private sector

to the public sector?

A1. Prior to the creation of ATSDR, little was known about the health effects of

toxic waste exposures. Some research had been conducted by academia (often funded

by or in conjunction with the private sector) and some by EPA. There was a huge

gap in knowledge and there was no regulatory or legislative mandate to fill the void.

Other than academia, little work in the private sector has transpired to protect public health from environmental exposures.

Although academia does play a role, ATSDR has provided funding and oversight

for much of the academic research. ATSDR has also conducted important studies on

the health effects of environmental exposures.

With no regulatory or legislative mandate, outside academia little research has

been conducted by the private sector.

Q2. To what extent do you attribute the ATSDR’s problem to leadership?

A2. Many, both within and outside the Agency, feel that the present leadership is

a major portion of the problem with and within ATSDR. To be fair however, conducting research in environmental health and promoting public health is sometimes

difficult and involves a high degree of complexity. Mistakes can be made with the

best intentions. However, no matter the intent, mistakes have occurred and leadership has known about ATSDR’s deficiencies and has failed to take corrective action.

Further, ATSDR leadership has become a poster child for micro-management,

even to the point of making determinations regarding the exact words are to be used

in health assessments, studies and consultations. While ATSDR’s leadership may be

talented, they are not, and will never be experts in everything, yet no matter what

the issue or the science involved, leadership can, and will, mandate their opinion

over that of those who are indeed experts—often with a bit of world renown. A perfect example is the Katrina Trailers in which management refused to recognize the

dangers and sought to cover up the issue and ultimately forced the removal of a

senior scientist at great expense to the taxpayers.

Q3. Can the private sector or State agencies perform some or all of the functions of

ATSDR?

a. Could they do it better?

b. Would this be appropriate?

c. What conflicts of interests could arise?

d. How could you protect against this?

A3. ATSDR partners with academia and State government to conduct research and

health assessments. Other than academia, the private sector cannot, and will not

do this work to protect public health. If the private sector conducts research at all,

they will do it to protect their interests. ATSDR also does cutting edge research

(e.g., groundwater contaminant fate and transport modeling as is being done at

Camp Lejeune; B-cell work in conjunction with the CDC National Center for Environmental Health lab; polycythemia vera cluster investigation in conjunction with

academia and State government; and the Brick Twp, NJ Autism Cluster investigation, started in 1998 by ATSDR in conjunction with CDC’s Developmental Disabilities division, which provided the first, clinical estimate of autism prevalence in a

U.S. community since the late 1980s and established that autism was sharply increasing.

The key problem with ATSDR is the poor quality of many of the health assessments and health consults. This could be changed by requiring independent peer review and by encouraging ATSDR to involve the community at the planning and

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scoping stage of the health assessment/consult as well as the conduction of the

health assessment/consult.

ATSDR has helped build capacity of State governments. Funding by ATSDR to

several states in the late 1980s was crucial in establishing birth defect registries

in these states as well as crucial to the use of these registries to investigate the

health effects of environmental exposures. ATSDR funded the Woburn study of

childhood leukemia that was conducted by the MADPH. ATSDR funded, provided

oversight, and conducted the water and air modeling for the Dover Twp/Toms River,

NJ childhood cancer study that was conducted by the NJDOH.

ATSDR is a leader in epidemiological research on the health effects of exposures

to toxic waste chemical contaminants in drinking water, having either conducted or

funded the major studies in this field (e.g., four NJ studies, Woburn, Camp Lejeune,

Tucson). ATSDR also funded studies in two states that first documented that exposures to disinfection byproducts (e.g., Trihalomethanes) in drinking water was associated with adverse birth outcomes (low birth weight and specific birth defects).

Q4. Are community complaints about the work of ATSDR new?

A4. Community concerns were the basis for enactment of CERCLA. Therefore, from

the beginning of ATSDR, communities have rightfully looked to ‘‘their agency’’ to

solve health concerns. However, such concerns have often strained at the limits of

environmental science. Working more closely with communities will help, but will

not solve all the communities concerns.

Q4a. Why does this seem to be a perennial problem?

A4a. Although ATSDR is second only to CDC’s STD/HIV in the involvement of communities in its activities, this is not saying much because, other than STD/HIV, the

rest of CDC has a poor record on this as well! It is a problem because ATSDR still

is not fully committed to involving communities at the ground floor of the planning

and scoping of its activities and the conduction of its activities. There are some exceptions, such as the CAPs that have been formed at a few sites.

ATSDR needs to create a mechanism for full community involvement at each site.

Community involvement should be from the moment a site is discovered (or where

a hazardous condition becomes know) until the site clean-up is complete. This may

require a community action group or it may be handled in a simpler fashion. But

some mechanism should be mandated, established, and employed.

The issue continues to arise because of a form of ‘‘ivory tower syndrome,’’ in which

the staff, most often in an assessment or consultation role, does not seek community

input because, ‘‘. . . we are the scientist, what do they know.’’ In such instances,

the failure to include the community not only generates resistance but also serves

to restrict the information flow from the community and to the community.

Q5. Do you believe ATSDR products accurately communicate agency findings?

a. What are some of the problems you have identified in their reports?

b. How can the Agency be more effective in communicating risks?

A5. Toxicological profiles and health assessments are often not reader-friendly. The

health assessments often answer questions that are not of interest to the community

and fail to address adequately questions that are of interest. There is too much

‘‘boiler-plate’’ material that is unnecessary. Public health assessments (PHAs) need

to be tailored to the particular site and the concerns at that site. In addition, PHAs

are uneven in their quality. As for risk communication, holding large ‘‘availability

sessions’’ and public meetings is not usually the best way to communicate risks!

(See answer to #4 on the need for community participation mechanisms).

Profiles, by law, must present the most up-to-date toxicological information. According to some scientific journals, they are the most often cited toxicological resources. ATSDR has provided a public health statement in the front of each toxicological profile that is intended to be understandable to the lay audience, e.g., community groups. More recently, the profiles have added material that is intended to

be helpful to a medical readership. However, if the documents are not meeting the

specific needs of an audience, perhaps the Agency could use focus or other similar

groups as a sounding board for improvement of the final products.

ATSDR should work closely with the concerned community members (e.g., the activists), State and local health agencies and health providers to ensure better health

communications. ATSDR must seek to make sure the questions of concern are addressed, to establish trust, to be fully transparent, to obtain community buy-in to

the approach being undertaken, to make sure the community understands the limitations of the agreed-upon approach, and to establish the best way to communicate

the information/risks.

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PHAs would possess far greater value if mid-level to lower-upper level management was not so concerned with political correctness and ‘‘softening’’ the information. Certain words, like ‘‘carcinogenic’’ cannot be used because the public might become ‘‘alarmed.’’ Yet, the community is asking for the accurate information.

Q6. Are you aware of ATSDR’s recent efforts to improve its processes and management?

a. Do you believe they will adequately address your concerns?

b. How would you improve the Agency’s processes and management (or even culture)?

A6. I see no evidence of any improvement. The initial planning for the so-called

‘‘conversation’’ developed with hardly any staff input. So staff feel the new process

is designed protect (shield) our leadership from Congressional attacks.

Morale is at an all time low throughout CDC as well as ATSDR, primarily because leadership does not respect staff and does not seek staff input at the ground

floor of the planning stage of new initiatives or reorganization, etc. ATSDR and National Center for Environmental Health (NCEH) staff are not collaborating as they

should—a failure of the leadership. There is too much concern about ‘‘turf’’ within

and between ATSDR and NCEH, and there is insufficient commitment to community involvement at ATSDR and NCEH.

Either the existing leadership needs to seriously address these problems or they

need to be replaced with leadership that will address these problems. Likewise, Congress should mandate a formal merger, or separation, of ATSDR and NCEH, so the

staff and the public will have an understanding of to whom they need to speak and

who is responsible for assigned functions.

Q7. What was your impression of ATSDR’s coordination with other federal agencies

like EPA?

A7. It is my experience that ATSDR often does try hard to coordinate and work

with other agencies but gets little response and cooperation from these agencies.

However, one could also assume that some of the failure of other agencies to be cooperative is in part the self infliction of wounds. I have hear high level officials from

four Regions of the EPA indicate that while ATSDR could do good work, they took

so long to do so that others ways of dealing with problems without including ATSDR

had become the norm.

Q8. How does ATSDR’s level of confidence compare to other federal and State entities charged with protecting public health?

A8. I am not sufficiently versed in all the efforts of other agencies, but in general

both federal and State entities have been hamstrung by lack of funding/staff and

the policies. However, I have never seen confidence or talent as a problem at

ATSDR. Rather, I have seen restrictions on the staff by management to ‘‘word

smith’’ documents (assessments and consultation) to avoid ‘‘alarmist’’ issues is more

the problem.

Q9. How does ATSDR compare with similar entities in other countries?

a. Do international public health agencies have similar problems?

b. What do you attribute this?

A9. I have no knowledge of any agency in any other country that is similar to

ATSDR.

Internationally, the Agency is respected, often by countries that have no such public health entity. Having products from ATSDR, like toxicological profiles, serves to

assist other countries.

Q10. ATSDR does not do large scale environmental sampling, and relies upon the

EP and states to conduct this work.

a. Do you believe ATSDR should do this work?

b. How would you suggest we pay for the work?

c. Would this be worth limiting the number of other studies, assessments or consultation the Agency initiated?

A10. Large scale sampling probably should continue to be performed by EPA and

the states, although it would be helpful to involve ATSDR at the ground floor of

the planning, scoping and conduction of sampling at each site. ATSDR should work

more closely with other federal agencies/groups, e.g., the U.S.G.S., in order to gather

current environmental data.

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Sampling should be paid for by the polluters, and most often times is paid via the cost recovery efforts of EPA. During the early days of ATSDR’s existence, there was a serious problem with the number of health assessments that the Agency was required to perform in a short

period of time. This is no longer a major problem. Instead, the major problems for

the PHAs and consults are unevenness and lack of consistency across the PHAs/

consults, failure to address the concerns of the community, and poor scientific quality. Much of this could be resolved by requiring peer review of PHAs and health

consults.

Additionally, the ATSDR Board of Scientific Counselors should monitor the qual- ity of PHAs and set up a task force (within ATSDR or independent of ATSDR) to

deliberate and develop a consensus concerning the risks of specific, controversial

hazardous substances (e.g., TCE, PCE, dioxin, PCBs, perchlorate, and emerging

threats) that would guide ATSDR’s health assessments Finally, full community participation is vital to the success of ATSDR’s work.

Q11. Do you believe ATSDR attempts to include revolutionary methods and tech- niques in their work?

a. If not, how would you propose they better integrate cutting edge science?

b. Is there any risk to getting too far ahead of a technology or method and com- ing to conclusions that are ultimately proven unfounded?

c. How would you set up policies or procedures to appropriately manage and uti- lize these innovations?

A11. ATSDR is at the forefront in historical exposure reconstruction modeling for drinking water. In its effort at Camp Lejeune (working with expert researchers at

GA Tech and expert consultants), it is breaking new ground in the modeling of the

historical groundwater migration of contaminants in order to provide the epidemiological studies at the base with monthly estimates of contamination levels at the

tap decades before testing of the tap water quality were performed (i.e., actual testing for contamination did not begin until 1982 but the water modeling effort was

able to provide scientifically sound estimates of contaminant levels back to the beginning of the water plant’s operation in the early 1950s). No other epidemiological study of drinking water contamination has conducted such an extensive, and cutting-edge, modeling effort. ATSDR also is in the forefront

of disease cluster investigation methods, e.g., its use of molecular testing to confirm

polycythemia vera cases in PA, its use of clinical testing to confirm autism cases

at Brick Township, and its use of water modeling and air modeling at Toms River. ATSDR’s use of immune function tests in communities in proximity to several toxic waste sites identified a pattern of blood cells in certain individuals that resembled a pattern seen in chronic lymphocytic leukemia although these individuals did

not have leukemia. This was the first time this phenomenon was observed. In collaboration with the NCEH lab, ATSDR conducted the first of its kind study to follow-up these individuals with this pattern of blood cells and found that these individuals were at increased risk of eventually having leukemia and that this pattern

of blood cells was associated with living in proximity to hazardous waste sites. ATSDR also provided funding and oversight to academic researchers who con- ducted research focusing on the health effects of exposures to PCBs in the Great

Lakes region and at Anniston AL. ATSDR has state-of-the-art GIS technology and an expert staff on GIS mapping and analysis methods. ATSDR does attempt to include novel, innovative methods in its research. In addition, the protocols of all ATSDR epidemiological studies must undergo peer review

and IRB review before the study is conducted. After the study is conducted, the report of the findings (either a journal article draft or a draft report) must undergo

peer review as well as agency clearance. Even with these reviews, it is possible for

the quality of the study to be substandard scientifically. Therefore, the Board of Scientific Counselors should set up a task force that monitors the quality of the epidemiological research at ATSDR. These review mechanisms should ensure that the

findings and conclusions are not ‘‘unfounded.’’

Q12. How can ATSDR do a better job characterizing past experiences given the com- plexity of the task?

a. Do you have any specific recommendations?

A12. Historical exposure reconstruction is the best way to do this, but it is expensive, time-consuming, and cannot be done at most sites because of lack of sufficient

data. But often the problem is that the public health assessment (PHA) is not focused enough on past exposures. Of course, it is understandable and appropriate for

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a PHA to focus on present exposures if they are occurring. But a strong commitment

to evaluate, as best one can, past exposures is needed as well. Often, this is one

of the major concerns a community has. The PHA should go the extra mile to uncover any information that would help it to characterize past exposures.

Q13. What role should ATSDR play in exposure routes not associated with hazardous waste (such as food, consumer products, water and air)?

a. How should the Agency address these issues?

b. Would there be any overlap with other agencies?

c. What should the Agency do when these is duplication of effort?

d. Do you believe ATSDR’s current mission is appropriate?

A13. ATSDR’s current mission is appropriate. If there are gaps (e.g., disinfection

byproducts in drinking water, other exposures not related to toxic waste substances), then ATSDR should work with NCEH to make sure these gaps are filled.

ATSDR should conduct epidemiological research on the health effects of exposures

to disinfection byproducts and other non-microbial contaminants (CDC focuses on

microbial contaminants) in drinking water, and become the leader in this research,

but the Agency has not moved strongly in this direction. ATSDR may require more

staff and resources, it does have the expertise for water and air modeling and it has

access to the NCEH lab.

Any overlap with EPA could be resolved (e.g., by collaboration!), but in most instances there really is not overlap with EPA (or any other agency) in the research

effort. ATSDR really does fill an important gap in the research on the health effects

of environmental exposures.

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ANSWERS TO POST-HEARING QUESTIONS

Responses by Henry S. Cole, President, Henry S. Cole & Associates, Inc., Upper Marl- boro, Maryland

This report is written in response to a series of questions by Congressman Broun and is based on my experience with ATSDR and a number of affected to communities where ATSDR provided health assessments or consultations. It is also based

on my experience in dozens of communities impacted by hazardous waste sites,

power plants, factory pollution, etc., where State regulatory agencies were involved.

I have not answered several questions, e.g., those involving past exposure methodologies, and cutting edge technologies. Please use other sources of information for

these issues.

Questions submitted by Representative Paul C. Broun

Q1. Big picture: Does ATSDR contribute to the health of environmentally stressed

communities?

A1. In working with environmentally stressed communities, ATSDR has focused largely on determining whether a particular source(s) have the potential to expose

and adversely affect the health of residents. This function is clearly embedded in

the Agency’s mission statement:

ATSDR’s mission is to serve the public by using the best science, taking responsive public health actions, and providing trusted health information to prevent

harmful exposures and disease related exposures to toxic substances.

However, this statement also requires ATSDR to take ‘‘responsive public health

actions’’ and to provide information in a way that would actually prevent harmful exposures and improve community health. In my judgment, ATSDR’s efforts toward

these objectives are lacking. The communities in greatest need of help are most often impacted by a multitude of environmental stresses: e.g., a waste management facility, factory pollution, highly toxic diesel emissions, and unhealthful levels of inhalable particulates and/or

ground level ozone. Perhaps there are sewerage related problems. There are other

stresses as well—such as unemployment, no access to health care, aging populations, lack of adequate housing, etc. Although there is clearly a need to study the

health impacts of various sources and chemicals, studies alone will not bring real

help to communities.

A holistic approach

Needs vary from one community to another; i.e., the local health clinic may need

expertise to deal with environmental exposures, perhaps a local credit union or pension fund could invest in restoring homes to livability, or perhaps the need is set

up volunteers to visit the homes of elderly neighbors on a continuing basis. Such

efforts will require a different vision and much greater coordination between programs and agencies. However, there are examples of community-based approaches

which attempt to solve problems holistically. For example, in Trenton, a non-profit

organization, Isles, Inc. has set up programs to remove lead from home environments and has trained residents to address these problems and to restore dilapidated buildings. These programs have led to employment and entrepreneurial opportunities. Trenton has the potential to bring in up to $2.4 million for green collar

jobs and career development activities, many of them connected to restoration and

improved environmental health. See http://www.isles.org/

This program is by no means unique. In fact, President Obama’s economic stimulus package contains funding for community-based training and employment in

areas such as weatherization and renewable energy. (See also, The Green Collar

Economy by Van Jones and Ariane Conrad, 2008 for many examples of communitybased initiatives aimed to bring environmental health and economic progress to

communities.)

Multi-Agency Approach

Of course, no one agency is equipped to deliver the multi-faceted assistance that

many environmentally stressed communities need for improved health. Given that

the Administration is looking for ways to make government funding work more effectively, Congress and the Administration should consider creating an agency in

the Department of Health and Human Services with a broader mission than

ATSDR. The new agency would focus on the problems and needs of environmentally

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stressed communities. This agency would work closely with communities and local

governments to assess and meet the broad needs of public health. ATSDR would be

replaced by (or ‘‘morphed’’ into) a branch that provides scientific assistance to the

new agency. The new agency would marshal the resources of a broad range of government entities including EPA, the National Institutes of Environmental Health,

Housing and Urban Affairs, the Department of Agriculture, Commerce Department,

etc., to deliver the most needed targeted services (e.g., medical, nutritional, community restoration, educational) etc. The Agency would also attempt to work with local

authorities and industries to seek creative solutions (e.g., a program to retrofit truck

fleets with particulate filters and catalytic converters to curb highly toxic diesel

fumes).

Q2. The role of the private sector.

A2. A number of Congressman Broun’s questions focus on the potential role of the private sector in protecting public health. I have separated private sector into several components:

• Regarding industries (e.g., manufacturing, energy, agribusiness, pharmaceuticals, etc.)—in general they have failed to protect public health (communities and workers) without strong regulation and enforcement by government. A good example is mountain top mining (MTM)—coal companies blast

the tops of mountains to get at coal and dump the overburden into the headwaters of streams. The Bush Administration removed regulatory obstacles to

MTM despite extensive damage to ecosystems and communities in Appalachia.

• Industrial research institutes that address environmental health, in my judgment, often tilt their scientific findings to protect the financial interests of

their corporate members. For example, research funded by the chlorinated

plastic industry attempts to downplay the dangers associated with the life

cycle impacts of vinyl plastics. One exception is the insurance industry, especially those that insure health and environmental damages. Such insurers

have a stake in preventing illness and environmental problems such as toxic

spills and climate change (potential for increased frequency and intensity of

storms and related damage).

• Private research institutes and institutes of higher education have brought

about an enormous increase in our understanding of the relationship between

toxic chemicals and health effects.

• The work of consulting firms often depends on the interests of the client. For

example, consulting firms working for potentially responsible parties at

Superfund sites may conduct field studies and risk assessments that understate the extent of the problem requiring remediation. As a result clients have

lower cleanup costs. However, this is not to say that all consulting firms do

biased research; to the contrary many firms have produced excellent studies

for government, non-governmental organizations, etc.

Q3. The role of State agencies.

A3. In my experiences, State regulatory agencies and State departments of health have been weak in their protection of community health. In some cases this has to

do with insufficient resources. For example, such agencies rely on the regulated industries for information (e.g., stack testing). In other cases there is an extremely

close relationship between agency officials and corporate officials. In many cases, economics, combined with political influence, trumps environmental health. For example, in the Ohio EPA has permitted an energy company to build a large coke oven

battery in Middletown, OH despite the impacts on the local airshed (already a noncompliance zone with regard to ozone and PM2.5); this facility will be located about

0.7 miles upwind of an elementary school.

Q4. ATSDR’s Leadership Problem.

A4. ATSDR’s mission statement is as follows:

ATSDR’s mission is to serve the public by using the best science, taking responsive public health actions, and providing trusted health information to prevent

harmful exposures and disease related exposures to toxic substances.

The Agency’s conduct with regard to formaldehyde exposure in FEMA trailers alone requires that the Agency’s top leadership be replaced. There were at least

three serious problems: (1) bad science (2) failure to protect the health of families

living in the trailers and (3) communicating reassurance rather than accurate information on risk to trailer occupants. The Oversight Subcommittee report (date) demVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00356 Fmt 6601 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
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1Stephen Lester, Center for Health Environment & Justice, Assessing Health Problems in Local Communities. Updated April 2007.

onstrates that the behavior of top ATSDR officials, including its Administrator, not

only failed to carry out the Agency’s mission but destroyed its credibility beyond repair.

In addition, the Agency under current leadership lacks both the vision and cre- ativity that is needed to restore the health of environmentally stressed communities.

Q5. Community Complaints.

A5. As I have stated in my testimony, a large number of communities are frustrated and angered by ATSDR’s work in their communities. For example, a national organization with a large grassroots following has warned in its publications that communities may opt to boycott ATSDR (and cooperating State health departments) unless the Agency negotiates with the community in good faith regarding study protocols and related issues of public concern.1

Witness statements at the March 12, 2009 hearing provide further evidence that the problems at ATSDR are widespread. Secondly, two Congressmen testified at the

hearing about the problems with the Agency’s investigations of the naval bombing

range in Vieques, Puerto Rico. These problems described include: studies that are

shallow and predictably inconclusive from the start, flawed methodologies, over reliance on company or federal agency data (e.g., DOD, DOE), failure to use all available sources of information, failure to effectively involve communities in the design

of studies, and a failure to obtain peer review, especially in controversial cases. Finally, ATSDR’s response to uncertainty is too often to find an ‘‘inconclusive hazard’’

without recommendations for further study or preventive measures. Rather than err

on the side of precaution, ATSDR often issues ‘‘no evidence’’ findings that are quickly translated by sources and enforcement agencies to mean ‘‘no problem.’’ While

there are dedicated scientists and other professionals at ATSDR, the prevailing

leadership has failed to take advantage of a large store of expertise and desire to

help communities. Moreover, the Agency has done little to provide actual relief from or prevention of harm in environmentally stressed communities.

Risk communication:

The quality of risk communication depends upon several factors: (1) the quality of information used as inputs to the assessments (2) the inclusion of all applicable

exposure pathways and routes (3) the confidence that community members have in

those conducting the assessment and reporting the findings. One way to ensure that

all of these conditions are met is to involve the community and their technical advisors from the outset. Programs that give community organizations access to environmental and public health scientists should be expanded. Independent peer review

should be provided when concerned parties request on.

Trends: are the complaints new?

Current efforts: The complaints outlined above are certainly not new. The Agency got off to a very bad start by conducting a large number of congressionally-mandated health assessments at sites on the Superfund National Priorities List (NPL).

These were cursory reports based on EPA and industry data. Residents had little

or no opportunity to provide input or comments. Residents in many ‘‘Superfund

Communities’’ felt that the reports understated their impact and need for protection.

Spurred by widespread and growing criticism in the late 1980’s and early 90’s then

Administrator Dr. Barry Johnson sponsored a series of large meetings that included

grassroots organizations and ATSDR staff. These meetings led to the formation of

an ongoing Community and Tribal Committee and a Community Involvement

Branch (CIB) at the Agency. CIB has formed ongoing community advisory panels

(CAPs) to obtain input and promote dialogue between officials and residents; upfront and continued work of CAPs have helped to improve the responsiveness of

ATSDR to community concerns and the Agency’s trust level. In addition, Dr. Johnson directed the Agency to take decisive action at a number of sites. I believe that

these efforts paid off in terms of what ATSDR was able to deliver and its trust

among affected communities. In my judgment the Agency has lost focus following

Dr. Johnson’s retirement (1998). Dr. Henry Falk had good intentions but lacked the

strong leadership skills needed to guide an Agency with a difficult mission. As stated above, the Agency has suffered irreparable harm under Dr. Frumkin. His recent efforts to establish a national dialogue are simply ‘‘too little and too late’’

to make the kind of changes that are needed.

Q6. ATSDR Products.

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A6. One critical problem with risk communication in ATSDR products is that the

Agency fails to effectively involve communities in the design of studies and in the

wording of reports. In my written testimony (March 12, 2009), I stated that community members should (and their experts) be given an effective opportunities to provide input on protocols for all investigations and on drafts of all reports (including

health consultations) before they are finalized. Community advisory panels that

work with ATSDR over extended periods have been effective in a number of cases;

these help to build confidence in the final ATSDR product.

Moreover, ATSDR products are almost never peer reviewed. ATSDR should provide a peer review process whenever interested parties (e.g., community members)

request one. Affected communities often have a legitimate need for concern and

help; community members are likely to be highly suspicious where ATSDR comes

up with ‘‘no-evidence or no-impact’’ finding—unless they have been involved from

the outset in a meaningful way that develops a strong level of trust.

Q7. ATSDR coordination with other agencies.

A7. ATSDR works very closely with U.S. EPA’s Superfund Office. The coordination

takes place largely at the regional level, with ATSDR regional officials often

headquartered in EPA regional offices. ATSDR also uses data generated by EPA or

by parties liable for cleanups including industries in the private sector and federal

facilities (especially Department of Defense and Department of Energy facilities). In

my judgment, ATSDR often allows these agencies to control the flow of information,

the extent of testing, and even the outcome of studies. Federal agencies including

EPA, DOD, and DOE must often address issues involving cost. For example, given

the absence of the Superfund feedstock tax, EPA has little money to fund cleanups;

thus they are dependent on the industries liable for the cleanup to conduct the remedial work. Negotiations do not always center on protection of health and environment, but on the costs to the company and the agreed upon cleanup may be less

than protective of health and the environment. ATSDR officials who work in close

coordination with EPA officials may in some cases be unwilling to ‘‘rock the boat.’’

I would recommend that agencies conducting health studies be given greater resources to obtain their own data and greater independence from EPA and potentially

liable parties including federal facilities. Potentially responsible parties (PRPs)

should reimburse health-based agencies for the costs of investigations.

ATSDR also has cooperative agreements with State Departments of Health

(DOHs). The DOHs often conduct public health assessments under cooperative

agreement for ATSDR. The DOHs operate under similar restraints with regard to

obtaining information.

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ANSWERS TO POST-HEARING QUESTIONS

Responses by Howard Frumkin, Director, National Center for Environmental Health

and Agency for Toxic Substances and Disease Registry (NCEH/ATSDR)

Questions submitted by Representative Paul C. Broun

Q1. Please explain the difference between a Health Assessment, a Health Consultation, an Exposure Investigation, and a Technical Assist.

A1. A public health assessment is defined as a comprehensive site evaluation of

data and information on the release of hazardous substances into the environment

in order to assess any past, current, or future impact on public health, develop

health advisories or other recommendations, and identify studies or actions needed

to evaluate and mitigate or prevent human health effects (42 Code of Federal Regulations, Part 90, published in 55 Federal Register 5136, February 13, 1990).

A public health consultation is a response to a specific public health issue or

question which requires the analysis of site-specific data, health outcome data or

chemical-specific data. A public health consultation can also serve as a written

record of a verbal response provided when immediate public health input is needed.

Often site-specific data is provided to ATSDR as it becomes available and in order

to provide timely input on public health issues ATSDR will develop multiple public

health consultations. Public health consultations are therefore more limited in the

range of issues addressed. For instance, a public health consultation often includes

the review and analysis of information on a single pathway of exposure whereas a

public health assessment includes the review and analysis of multiple pathways of

exposure.

Public health assessments differ from public health consultations in that they

may consider all pathways at a site, and are released for public comment and include a response to comments.

In an exposure investigation, ATSDR collects and analyzes site-specific information and biological tests (when appropriate) to determine whether people have

been exposed to hazardous substances. Exposure investigations support a site evaluation by conducting targeted sampling to evaluate exposures within a community.

ATSDR documents the findings and analysis of its exposure investigations in the

public health consultation format.

A technical assist is a response to external requests for environmental public

health technical and/or educational information. Such requests may be received via

phone calls, letters, and/or e-mails from external requestors. In general, the technical assist will be used by the requestor to make a more informed decision. Unlike

other ATSDR documents, technical assists do not include a public health hazard category. If a data or information package is submitted for evaluation or a public

health hazard category will be determined, a public health consultation or public

health assessment is the appropriate format to document the analysis and decision

process.

Q1a. How does ATSDR determine which products to provide?

A1a. A preliminary assessment is made of the exposure pathways, the environmental media data, and community concerns to decide what product or products

would provide the most appropriate and timely public health response. In most

cases ATSDR will coordinate with the person requesting our services to discuss the

request and the products and services that are most likely to meet their needs.

Q1b. Does ATSDR consult with the petitioner when it chooses which product to provide?

A1b. When ATSDR receives a petition, a team of environmental scientists, physicians, toxicologists, and other staff members evaluates all site information and decides whether ATSDR will perform a Public Health Assessment or if some other action—such as a Public Health Advisory, Health Consultation, or community environmental health education—would better meet the community’s needs, or if no ATSDR

involvement is needed. As noted above, in most cases ATSDR coordinates with the

petitioner to discuss the request. Petitioners are informed in writing of ATSDR’s decision and the reasons for it. Throughout the Public Health Assessment process,

ATSDR is in regular communication with the petitioner and the community.

Q1c. Does the petitioner have any recourse to appeal ATSDR’s decision?

A1c. The petitioner may request a change in the type of ATSDR product at any

time. However, as a practical matter, few ever do as the ATSDR proposed product

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is tailored to produce the most timely and relevant public health response. Public

health assessments are designed for more complex sites to address multiple human

exposure pathways and many contaminated media whereas health consultations

focus on a single human exposure pathway and media.

Q2. Approximately what percentage of work done by ATSDR is self-initiated, mandated by law, or the result of an outside petition?

A2. Very little of ATSDR’s work at sites is strictly self-initiated. Approximately 35–

45 percent of our current work results from citizen petitions and National Priorities

List (NPL)-mandated work. The majority of the remaining work comes from federal

and State agencies, primarily requests from EPA and State environmental agencies.

Q2a. How many petitions for assistance does ATSDR receive in a year?

A2a. ATSDR has received more than 750 petitions since the Agency first began accepting them in 1987. The average number of petitions each year is approximately

35. (ATSDR received 34 petitions in 2008.)

Q2b. What percentage of petitions are you able to actually assist on?

A2b. While all petition requests are carefully reviewed, approximately 60 percent

have been accepted resulting in the development of a Public Health Assessment or

Health Consultation.

Q2c. How do you prioritize such petitions?

A2c. Petition requests are prioritized using available data based on the likely severity of the environmental and physical hazards, an understanding of the potential

pathways of exposure and the affected population, the availability of data needed

to carry out an assessment, and evidence or suggestions of adverse health outcomes

in the community.

Q3. What options does ATSDR have if sampling data is limited for a particular review?

A3. ATSDR routinely deals with incomplete exposure information. ATSDR’s ability

to draw public health conclusions is sometimes limited by the quantity and/or quality of the exposure information. It is critical that the exposure information used to

evaluate the risk for adverse health effects be complete and accurate. Often situations exist in which either no—or insufficient—data are available or we cannot answer the questions posed by the community due to limitations in science, even when

data are available. However, we do have options for responding to situations in

which there is limited sampling data, as we discuss below.

If exposure data are limited, we can

• search for and retrieve existing data (ATSDR has pioneered methods, and is

very experienced at this task),

• measure past exposures using new and innovative methods (however, even

when we can measure levels in the environment, it is difficult to know if people have actually been exposed),

• model past exposures,

• use biomonitoring techniques (such as those developed by the National Center

for Environmental Health laboratory) when appropriate,

• report that there are limitations when we cannot quantify exposures and say

so, communicating well, or

• recommend that needed sampling be done by agencies such as EPA and State

agencies that are equipped to perform the sampling.

If health outcome data are limited, we can

• use existing health outcome databases (although the United States does not

systematically collect data on many health outcomes, such as asthma,

neurodevelopmental disorders, or immune function disorders) or

• collect data by performing epidemiological studies (such studies are expensive

and time-consuming, and therefore only rarely feasible).

Q3a. Is caveating the limitations in the report your only option?

A3a. No. We have many options, as described above.

In addition, ATSDR works closely with CDC’s National Center for Environmental

Health Environmental Public Health Tracking Program. The Tracking Program

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brings together data on environmental hazards, exposure to environmental hazards,

and health effects potentially related to exposure to environmental hazards.

As a final note, we need to emphasize that caveats are important. The public

needs to know if data is missing and how that may limit what we can do.

Q3b. How challenging is this in terms of communicating results?

A3b. This creates frustration for some members of the public, who expect definitive

answers. For example, at Colonie, New York, we considered an epidemiologic study

of workers exposed to metals. We requested health data for the former workers but

were not able to obtain the data. This important and missing piece of information,

combined with the lack of environmental data for the years of peak activity at the

plant, left a research gap for investigators and frustrated members of the community.

However, we do have options for responding to situations in which there is limited

sampling data, as we discussed above.

Q3c. How do you propose ATSDR address this issue?

A3c. We address the issue of not having enough data by using the best available

data, recommending how data gaps can be filled, and communicating the limitations

of that data to the communities we serve.

ATSDR is striving to expand the use of state-of-the-art exposure assessment strategies, and also to combine the use of sampling and modeling results. For example,

to accurately estimate park visitor exposures to asbestos at the Illinois Beach State

Park site, ATSDR employed activity-based-sampling and used the most current

methods for asbestos analysis, developed by the International Organization for

Standardization.

We also recognize that we must redouble our effort to be clear about the limitations of the data and to work with communities from the beginning of the public

health assessment process, and throughout the process, to ensure that—to the extent possible—expectations are realistic. ATSDR has launched initiatives so that

concerned citizens better understand the complex nature of environmental exposures and will be able to make informed decisions about the exposure to toxic substances and their health.

Q4. In the case of formaldehyde levels in FEMA trailers, EPA conducted sampling

after limited consultation with ATSDR. That sampling was deemed to be insufficient to characterize long-term exposure. How does the Agency now ensure that

it receives appropriate samples to adequately characterize exposure and risk?

A4. In the case of the initial work with the FEMA trailer data, ATSDR’s role was

as a technical assist that primarily involved reviewing EPA sampling data.

In its initial review, ATSDR staff did not consider the implications of chronic exposures. That has been corrected. We corrected the Health Consultation and published a revised document providing background information on exposure to formaldehyde and health effects (including those of long-term exposure), and clarifying

the limitations of the data analysis.

Following the initial assessment, and recognizing that the ATSDR health consultation was not designed to reflect actual conditions of those living in trailers,

CDC’s National Center for Environmental Health undertook—and is continuing to

conduct—extensive activities to assess health risks related to temporary housing

units used after Hurricane Katrina. These activities include: a structural study to

analyze emissions from individual components of trailers and mobiles homes used

as temporary housing, and a study of occupied housing to evaluate levels of formaldehyde under actual living conditions. This effort led to recommendations regarding the use of the trailers as temporary housing and resulted in FEMA removing

people from units with unsafe levels of formaldehyde. NCEH also is undertaking a

comprehensive long-term study of children’s health related to Hurricane Katrina.

Recognizing that this is a broader problem, NCEH and ATSDR convened a group

of agencies to address broadly the health challenges of manufactured structures.

The results of this effort are expected during the coming year.

ATSDR routinely confers with other agencies on sampling methodology. Recent

examples include the coal fly ash spill in Tennessee and concerns over the use of

Chinese drywall in homes. ATSDR brings unique value by adding public health expertise to EPA’s sampling expertise, allowing the methods to consider the ways that

people are actually exposed.

Q5. How can ATSDR do a better job characterizing past exposures given the complexity of the task? Do you have any specific recommendations?

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A5. Reconstructing past exposures is a core challenge in the environmental health field. ATSDR routinely deals with incomplete exposure information. ATSDR has several options for investigating exposures and potential health effects. We can search for and retrieve existing data. ATSDR scientists are skilled at lo- cating data sources and obtaining available data. ATSDR is utilizing new ways to measure past exposures. Using innovative meth- ods, ATSDR scientists are able to measure levels of environmental contaminants in

ways previously unavailable; however, even when we can measure levels in the environment, it is often difficult to know if people have actually been exposed. ATSDR also has developed methods to model past exposures. The Agency uses ex- posure-dose reconstruction as an approach that incorporates computational models

and other approximation techniques to estimate cumulative amounts of hazardous

substances internalized by individuals presumed to be or who are actually at risk

from contact with substances associated with hazardous waste sites. For example,

ATSDR developed techniques for modeling complex water distribution systems to investigate past exposures to TCE and PCE at Camp Lejeune in North Carolina.

ATSDR’s water modeling activities support the Agency’s current epidemiologic study

of childhood birth defects and cancer possibly related to past exposure to contaminated drinking water at the base. We are also exploring the use of modeling in conjunction with sampling data. In addition, we are increasingly using biomonitoring techniques to measure the level of contaminants that are actually in people’s bodies. However, this is only appropriate for past exposures when the chemical persists in the body. Some are

quickly metabolized or expelled and, therefore, do not yield usable biomonitoring results.

Advancing science in the three areas discussed above—1) measuring past expo- sures, 2) modeling, and 3) biomonitoring—would further improve the characterization of past exposures.

Q6. How does ATSDR decide when to partner with State health departments?

A6. ATSDR works closely with State and local health departments whenever pos- sible. In more than half the states, this work is carried out through our cooperative

agreement program using federal funds. Funding is based on a competitive process

to ensure states are qualified to conduct this work. In all the states, we provide

technical assistance as requested by the states.

Q6a. Do these partnerships end up providing states with additional resources from the Federal Government?

A6a. Yes. The cooperative agreement program allows states to build capacity in en- vironmental health. Even though resources are limited, in many cases the only capacity within the state to deal with health impacts of hazardous waste sites comes

from money ATSDR provides.

Q6b. Is this an appropriate function of the Federal Government, or should states be

funding work with their own resources?

A6b. There is a role for both the Federal Government and the State governments

in environmental health. How these roles are balanced is a policy decision.

The Comprehensive Environmental Response, Compensation and Liability Act

(CERCLA), as amended by the Superfund Amendments and Reauthorization Act

(SARA), provides that ‘‘The activities of the Administrator of ATSDR described in

this subsection and section 9611 (c)(4) of this title shall be carried out by the Administrator of ATSDR, either directly or through cooperative agreements with States (or

political subdivisions thereof) which the Administrator of ATSDR determines are capable of carrying out such activities. Such activities shall include provision of consultations on health information, the conduct of health assessments, including those

required under section 3019(b) of the Solid Waste Disposal Act [42 U.S.C. 6939a (b)],

health studies, registries, and health surveillance.’’ See 42 U.S.C. 9604(i)(15).

Q6c. How does ATSDR ensure that conflicts of interest do not arise, or that ATSDR’s

work is simply seen as a ‘‘rubber stamp?’’

A6c. In general, conflicts do not arise in our work activities with State health departments. Our goal is mutual—we want to provide the best public health information for the communities potentially impacted by a toxic exposure. ATSDR interacts

with State Health Departments on a routine basis, in the context of technical assistance; and ATSDR has a more formalized process, the State Cooperative Agreement

Program. There is an inherent sensitivity in working collaboratively with our State

Partners. The states are closer to their community concerns. On the other hand, federal agencies can provide additional resources or certain types of specialized experVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00362 Fmt 6601 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
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tise. ATSDR prides itself on strong working relationships with State Health Departments. In rare cases-say, when the state owns the site of concern—there may be

an appearance of or the potential for a conflict of interest, however, ATSDR minimizes any potential impact and ensures that these sites are addressed with the best

public health approach available. In all cases, ATSDR insists that good science be

used in all products produced by the state with our support. Protecting public health

is our first priority. ATSDR routinely receives requests from State Health Departments for technical assistance. For example, when a coal burning power plant had an accidental release

of fly ash in a Tennessee community, the Tennessee Health Department immediately requested ATSDR technical assistance in responding to community health

concerns. In providing technical assistance ATSDR provides independent review

based on its expertise and experience, and does not simply ‘‘rubber-stamp’’ conclusions or products. In this circumstance, the Tennessee Health Department prepared

a fact sheet to distribute to the local community members to provide information

on their health and this fly ash release. ATSDR reviewed the fact sheet and noted

that the statement related to health concerns was too reassuring to the community,

since it did not consider the longer-term exposure to the fly ash in the sediment.

The Tennessee Health Department agreed with ATSDR to change the fact sheet language. The revised fact sheet in now on their web site and being used for all additional public health meetings.

Q7. How has the Agency evolved in terms of the services it provides?

A7. Initially, most of ATSDR’s work was mandated at Superfund sites, listed on EPA’s National Priorities List. Over the years, the amount of that work has declined, as fewer Superfund sites have been proposed. Technical requests from other

agencies and from State and local health departments have emerged as an increasing force for ATSDR’s environmental health response work. The role of ATSDR is

an important one and despite the modest resources (approximately $74 million), we

make positive contributions to health and safety in many communities.

Q7a. Has the number of health assessment and consultation petitions increased recently?

A7a. Petitions have remained relatively stable through the years, averaging ap- proximately 35 per year. From 1987–2007, ATSDR received more than 750 petitions.

Approximately 60 percent of these were accepted and addressed by ATSDR and its

cooperative agreement partners.

Q7b. Has the Agency begun to investigate additional pathways of exposure?

A7b. Although Love Canal and other hazardous waste sites were the focus when CERCLA was enacted and ATSDR created, ATSDR authority under CERCLA is not

limited to hazardous waste sites—it extends to hazardous substance ‘‘releases.’’ This

can include multiple ways people are exposed to chemicals. Examples of the breadth

of ATSDR’s work include our emergency response program and our work with air

releases from power plants and industrial facilities, such as those at the Mirant and

Rubbertown sites.

Enormous progress has been made in addressing threats from hazardous waste

sites. In addition, emerging science has provided greater insights into how people

are exposed to chemicals and what chemicals are in people’s bodies. It is clear that

many human exposures to chemicals are not from waste sites. As a result, we recognize the importance of investigating sources and pathways of exposure beyond hazardous waste sites.

In evaluating the health impacts of chemical exposures from a broader range of

sources, we are cognizant of the possibility of duplication of effort with other agencies. This is part of the motivation for our National Conversation on Public Health

and Chemical Exposures. Over a year into planning, this process involves a broad

cross-section of stakeholders, including environmental groups, communities, professional groups, public health groups, industry, and other agencies, to assess our work

to date, in the broader context of cross-government efforts to address chemical hazards and to make recommendations for involvement. These may involve substantial

changes in how ATSDR does its work. This effort will identify gaps in, and emerging

priorities for, the public health approach to chemical exposures and identify solutions that strengthen public health.

Q7c. How has this impacted the Agency?

A7c. ATSDR has done limited work with exposures to hazardous substances not related to hazardous waste sites, such as naturally-occurring asbestos, air emissions

from power plants and industrial facilities, and uranium in water. The National

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Conversation on Public Health and Chemical exposures will help inform development of approaches to addressing potential health impacts of other sources and

pathways of exposure.

Q7d. How has the Agency adapted its communications strategy to meet these

changes?

A7d. We have and will continue to communicate effectively with the communities

we serve. Through openness, cultural competency, and careful needs assessment, we

actively engage communities through our site work. Our Community Involvement

Branch includes communication specialists, health educators, and other professionals with extensive experience in this area. These professionals, like others at the

Agency, stay abreast of developments in the field and incorporate them into our

work.

Q8. The ability to determine causation is complex and analysis of health risk levels

vary based on numerous factors.

A8. Communities often expect that an agency such as ATSDR will arrive on the

scene, rapidly assess the situation, and reach unequivocal conclusions. Unfortunately, it is not always possible to reach such conclusions. Definitive answers sometimes do not exist, due to the inherent uncertainties of science. Available data—both

environmental and health outcome data—are often limited. Small area epidemiology

lacks the statistical power to draw definitive conclusions. Finally, the public health

field often lacks the appropriate tools to allow us to establish causation.

Despite limitations, ATSDR has identified a public health hazard in approximately 30 percent of cases. In approximately 40 percent of cases, available data suggest little or no risk, and, in approximately 30 percent of cases, available data do

not permit a conclusion. In addition, our documents include specific recommendations and follow-up actions to be taken by agencies with appropriate jurisdiction.

More than 70 percent of these are implemented.

It is possible to draw certain negative conclusions with confidence. For example,

with sufficient information we may positively conclude that contamination from an

identified source is not reaching a community. However, positive conclusions are

harder to reach. For example, even when we identify a complete pathway and document exposure, we cannot always establish a causal link between the exposure and

disease in the community. In many cases, it is impossible to draw firm conclusions.

Q8a. How does the Agency communicate the limitation of their products and findings?

A8a. ATSDR communicates these limits both in person and in writing. For example,

Community Involvement and Health Education Specialists, through public meetings, public availability/poster sessions and other community meeting formats, communicate with stakeholders throughout the process. Through early and ongoing

communication, ATSDR provides information on public health implications, risk,

and limitations of our work in qualitative terms. The information includes how we

will be:

• reviewing environmental data (to include environmental or health data limitations and data gaps),

• gathering community concerns,

• identifying ways people might come in contact with chemicals,

• determining if people are being exposed,

• determining how that exposure might affect public health,

• providing conclusions and recommendations,

• preparing a public health action plan, and

• communicating community involvement activities.

In summary, we want communities to know what to expect, including the difficulty in coming up with a causal link between exposure and disease. For example,

we communicate ‘‘risks’’ instead of ‘‘cause.’’

In addition, ATSDR has recently revised its public health hazard conclusion categories to more clearly describe, using plain language, the potential risks from eating, touching and breathing unsafe chemicals. Our revised hazard conclusion categories will be placed at the front our documents so that the community is immediately aware of our public health messages and other issues about the site.

Q8b. To what extent do you attribute criticism of agency products to poor communication?

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A8b. We attempt to minimize the potential for poor communication. Communicating information is fundamental to ATSDR’s Public Health Assessment process, and we

work very hard at it. ATSDR has extensive experience and great expertise in communicating with the public. However, we recognize that there are always opportunities to do better.

Sometimes, however, community members, who are justifiably concerned about exposures to hazardous substances, may reject the concept of ‘‘levels of risk’’ when

what they want is zero exposure. Despite our early and active engagement with

communities and our scientific attempts to address their concerns, there will always

be expectations which we cannot meet. In the case of Illinois Beach State Park, several individuals remain convinced that dangerous exposures are occurring, despite

four rounds of extensive air sampling over the last decade using highly reliable

methods that reached the opposite conclusion. In stressful situations, research

shows that many people have difficulty processing information and give greater

weight to negative information. By pulling from this research, we can better guide

our communication efforts.

Q8c. Do you have any suggestions on how to better communicate the limitations?

A8c. As I said in my testimony, even excellent people and organizations can always improve. ATSDR is continuing to take steps to improve our ability to communicate

complex scientific information to communities, including:

• Continue fine-tuning our community involvement process; focusing our site

teams on the skills needed to effectively interact with communities, including

preparing and presenting information to stakeholders, and including them in

the decision-making processes.

• Continue initiating contact before the health assessment process begins and

listen to community concerns, obtain critical information, and assess needs,

and increasing our on-site community-level environmental health literacy

education efforts.

• Continue incorporating community outreach activities as a standard component of the ATSDR Public Health Assessment and Health Studies activities.

• Continue developing and incorporating community health education activities

along with our community outreach activities.

• Implement the new language and format of our public health hazard conclusion categories so that our health messages are clearer and easier to understand.

• Continue to use PHCs, LPHCs, and TAs to respond to stakeholder environmental health concerns in a timely manner.

Our goal is to include the community in the public health activities at the begin- ning and during the health assessment to ensure they are provided current, ongoing, and relevant information throughout the process and have the opportunity to

provide input.

Q9. Do you believe ATSDR attempts to include revolutionary scientific methods and techniques in their work?

A9. ATSDR pays close attention to emerging scientific methods, and uses them when appropriate. We recognize the need to balance the use of new methods with

the use of validated and widely accepted techniques. For example, when we investigated polycythemia vera (PV) in Pennsylvania, as public health scientists, we

knew that most cluster investigations do not identify environmental causes, and are

cautious and deliberate about such investigations. ATSDR focused initially on

verifying and quantifying the excess cases of disease, sought outside hematologic expertise, and remained open minded about a possible environmental etiology. The hematology expert had identified a genetic mutation called JAK2 found to occur in

most PV patients. This revolutionary discovery has now led scientists to search for

the cause of the JAK2 mutation in hopes that this knowledge will help them find

the cause of PV. Using this genetic marker, ATSDR scientists confirmed 38 cases

of PV. ATSDR will further evaluate the spatial distribution of cases and review

available environmental data. ATSDR plans to conduct further scientific research to

determine the cause of the PV.

Ultimately, the decision of when to use new methods is a scientific judgment and a decision best made in consultation with a broad range of scientific experts.

Through expert panels and peer review, ATSDR engages independent scientists and

scientists from other agencies and institutions in its decision-making process.

When ATSDR develops new methods, we report those methods through peer-reviewed, scientific journals.

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Q9a. How can the Agency better integrate cutting-edge science?

A9a. The methods ATSDR uses to integrate new technologies with existing science work very well. For example, we have re-trained scientists to apply new methods.

We have a dedicated GIS unit and a dose reconstruction lab. ATSDR scientists have

developed innovative techniques of computational toxicology to help rapidly assess

hazards of chemical releases. ATSDR also provides training to State and local partners to assist them in incorporating new methods into their health assessment

work.

In addition, ATSDR scientists continuously monitor scientific literature and at- tend professional meetings to increase their awareness of new techniques and how

to apply them to their work at sites. We use peer review to ensure that these methods are the best available for assessing exposures and protecting public health. ATSDR’s external Board of Scientific Counselors evaluated our site assessment

and our peer review procedures. While providing us with a number of constructive

recommendations, their report highlights the soundness of our approach in incorporating both public and expert scientific input. ATSDR also works closely with NIH and other science-based agencies and organi- zations to keep abreast of new and innovative technologies, methods, and techniques.

Q9b. Is there any risk to getting too far ahead of a technology or method and coming to conclusions that are ultimately proven to be unfounded?

A9b. There is a risk to getting too far ahead of a technology or method. However, we do not shy away from using cutting-edge science. Before cutting-edge techniques

or methods are applied to a public health problem, those approaches are peer-reviewed as are the developed products (be they Public Health Assessments, health

studies, toxicological profiles, etc.). Our primary objective is to protect public health

and we maintain that objective throughout the health assessment process.

Q9c. How would you set up policies or procedures to appropriately manage and uti- lize these innovations?

A9c. The decision to use new methods requires scientific judgment. These decisions are best made in consultation with scientific experts, both internally and externally.

Through the use of expert panels and peer reviews, ATSDR calls upon the expertise

of independent scientists and scientists from other agencies to inform our decisionmaking process. When ATSDR develops new methods, we report those methods through peer-re- viewed, scientific journals. We clearly identify limitations in methods, data analyses, and conclusions in our products, as is standard in scientific documents. We have peer review policies and

procedures in place to triage documents when new or controversial science is applied. Additionally, our Board of Scientific Counselors has reviewed clearance procedures and receives programmatic reviews and updates and provides guidance on our

scientific approaches and programs.

Q10. How does ATSDR compare with similar entities in other countries?

A10. Most countries do not have any agency similar to ATSDR, nor do they have

programs as comprehensive as those administered by the Environmental Protection

Agency (EPA) to regulate and remediate chemical releases. Each year ATSDR receives requests from the governments of other countries to send their scientists,

physicians, epidemiologists, and engineers to Atlanta for special training on conducting public health assessments. For example, the French government does not

have an agency comparable to ATSDR;, they have sought ATSDR staff to teach in

French public health agencies, and have sent public health scientists to train with

ATSDR. In addition, the Pan American Health Organization (PAHO) has translated

our public health assessment manual into Spanish for use by public health officials

in Latin America.

Q10a. Do international public health agencies have similar problems?

A10a. The World Health Organization (WHO) has limited capabilities in the core

areas of ATSDR’s work. Addressing health issues related to environmental exposures to hazardous substances often is left to the independent countries to address.

The Basel Convention addressed the trans-boundary shipment of hazardous waste,

but did not include any health-related discussion.

ATSDR is seen as the world leader in addressing public health concerns related

to exposures to hazardous waste.

Q10b. What do you attribute this to?

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A10b. Even though hazardous wastes have been a concern for many years, the investment of resources to address public health issues resulting from these exposures

has been limited. More investment must be made to improve the science and the

methods that public health officials use to evaluate exposures and to educate and

assist communities with environmental health concerns.

Q11. ATSDR does not do large scale environmental sampling, and relies upon the

EPA and states to conduct this work.

Q11a. Do you believe ATSDR should also be doing this work?

A11a. Many times, environmental data already exist, based on regulatory requirements. However, to answer important exposure questions, ATSDR scientists often

need data that do not exist. These are needed to fill gaps between existing sets of

data or to provide site-specific information related to exposures and health.

In limited cases, ATSDR does conduct environmental or biological sampling, although these efforts can be tremendously expensive and time-consuming. ATSDR

can only conduct a few large-scale sampling projects each year. This leaves ATSDR

with the difficult trade-off between conducting more extensive sampling at fewer

sites, and responding to concerns at a greater number of sites.

To make the best use of limited resources, ATSDR generally works in partnership

with other agencies when large scale environmental sampling is needed. These

agencies often have the regulatory authority to conduct environmental monitoring

and sampling, as well as the technical expertise and resources. As noted earlier,

ATSDR often is called on to provide technical assistance in development of sampling

plans to ensure sampling is conducted in a way that maximizes the usefulness of

data for assessing exposures. And, ATSDR often assists in evaluating data, applying

its expertise in the health effects of potential exposures.

There are also creative solutions to this dilemma. For example, environmental

sampling is useful, but, in some cases, it can be replaced by biomonitoring. In the

case of 1,4 Dioxane, ATSDR used existing NCEH biomonitoring data to determine

that there were no detectable levels in the people sampled. This was an economical

solution that allowed us to use our resources to respond to other exposures.

Q11b. How would you suggest we pay for this work?

A11b. ATSDR does not have the resources to conduct large-scale research—either

to develop environmental or biological sampling data to assess exposures or to investigate the toxicological properties of a hazardous substance. The Agency identifies

data needs, seeks out existing data to fill those needs, and works in partnership

with other agencies, at the federal, State, and local levels, as well as with academic

institutions and private entities, to develop data to meet needs where sufficient data

do not currently exist.

Q11c. Would this be worth limiting the number of other studies, assessments, or consultations the Agency initiated?

A11c. Limiting the number of sites in order to free up resources to conduct original

sampling would diminish ATSDR’s capacity for responding to community concerns

and frustrate communities seeking answers to important health concerns. Already

ATSDR does only a small number of health studies, which are far more resource

intensive than other approaches.

Sites under consideration for Public Health Assessments, Health Consultations,

Exposure Investigations and Technical Assists come to ATSDR through the Superfund process, from direct requests from other federal agencies (EPA, DOE, DOD,

etc.), and from requests from concerned community members. ATSDR reviews each

site and prioritizes according to need and available resources; however, we strongly

believe that it is important to remain responsive to communities, to work with them

to address health concerns, and to engage at sites as needed.

Q12. What role should ATSDR play in exposure routes not associated with hazardous wastes (such as food, consumer products, water, and air)?

a. How does the Agency intend to address these issues?

b. Is there any overlap with other agencies?

c. What does the Agency do when there is duplication of effort?

A12. ATSDR helps protect the public from exposures to hazardous substances from

releases at hazardous waste sites and at a variety of other settings. These releases

may range from chemical plant explosions to a spill of coal combustion products.

They can be those identified by government agencies or by individuals within the

community through the petition process.

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A series of environmental laws in the 1970s and 1980s defined the U.S. approach

to chemical exposure risks. A mosaic of agencies and organizations, governmental

and nongovernmental, regulatory and non-regulatory, carry out various public

health functions. As a result, some key responsibilities may not be carried out adequately, and others may be redundant. ATSDR’s mission and functions must be considered within this broader context.

In recognition of these realities, ATSDR and its companion Center at the CDC, the National Center for Environmental Health (NCEH), have initiated the National

Conversation on Public Health and Chemical Exposures. This process is designed to identify gaps in, and emerging priorities for, the public health approach to chemical

exposures and identify science-based solutions that strengthen public health. This

will build on ATSDR’s strong working relationships with a broad range of stakeholders, and further help us to use resources responsibly, avoid redundancy, and

eliminate gaps in public health coverage. Public health functions related to chemical exposures include exposure and health

surveillance, investigation of incidents and releases, emergency preparedness and

response, regulation, research, and education. When our efforts overlap, we work

closely with other agencies by sharing data and expertise to recognize and mitigate

community exposures and protect public health. For example, ATSDR responds to

emergencies involving the release of chemicals, most often in collaboration with the

Environmental Protection Agency. ATSDR personnel provide real-time public health

guidance following acute releases of hazardous substances and health information

to the public (for example, helping determine when people can safely reoccupy their

homes and businesses after an evacuation).

ATSDR also works with other partner agencies to provide advice and guidance on topics such as exposure routes, toxicology, data sampling, data collection, epidemiology, and data analysis. We collaborate with the Food and Drug Administration

and U.S. Department of Agriculture on issues pertaining to food, with the Environmental Protection Agency and U.S. Geological Survey on air and water concerns,

and with the Consumer Product Safety Commission when product safety is in question. We may evaluate data collected by these other agencies for health implications,

while our partner agencies may examine other aspects, such as environmental or

regulatory implications.

Q13. How does ATSDR’s level of competence compare to other federal and State entities charged with protecting public health?

A13. ATSDR is a non-regulatory environmental public health agency. We are com- munity-oriented, working to respond to local concerns. We operate by bridging the

work of other agencies, and between federal agencies and states. We are a specialized agency, and, in the areas in which we specialize, we are very good. However, we are a small agency, lacking the depth and breadth in some areas that would enable us to more fully fulfill our mission. With only 300 employees, we

lack adequate capacity in certain important fields, such as veterinary epidemiology,

industrial hygiene, and air quality modeling. To address these challenges, we work

closely with other federal and State agencies. To help devise a long-term solution,

we have initiated our National Conversation to identify gaps in, and emerging priorities for, the public health approach to chemical exposures, and to identify sciencebased solutions that strengthen public health.

Q13a. Would you characterize the work ATSDR does as a specialized niche?

A13a. Several agencies (including NIH’s National Institute of Environmental

Health Sciences and EPA, in addition to ATSDR) share responsibility for assessing

the human health effects from exposure to environmental contaminants. ATSDR

does have a specialized niche in assessing exposures to hazardous waste. CERCLA

specifically established ATSDR for this purpose. ATSDR has pioneered the public

availability session and remains an authority on public interaction with communities potentially impacted by hazardous waste sites. ATSDR is a world leader in

providing toxicological profiles of specific toxic substances. ATSDR’s toxicological

profiles are frequently used and held in very high regard, domestically as well as

internationally.

Q13b. Do any other agencies perform this same work?

A13b. ATSDR’s work complements that of NIEHS, EPA, the National Toxicology

Program (NTP), NIOSH, OSHA, FDA, and Consumer Product Safety Commission

(CPSC). These agencies, along with other agencies and organizations, governmental

and non-governmental, regulatory and nonregulatory, carry out various public

health functions related to chemical exposures. These functions include exposure

and health surveillance, investigation of incidents and releases, emergency preVerDate 11-MAY-2000 19:54 Dec 21, 2009 Jkt 047718 PO 00000 Frm 00368 Fmt 6601 Sfmt 6621 C:\DWORK\I&O09\031209\47718 SCIENCE1 PsN: SCIENCE1
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paredness and response, research, and education. NCEH/ATSDR plays a significant

role in carrying out several of these key public health functions.

Q14. In your testimony, you describe one of the problems ATSDR faces is the dif- ficulty ATSDR sometimes faces when a community refuses to believe your conclusions. Specifically, you mention that ATSDR and counterpart site agencies

have had to repeat investigations several times at the same location which end

up yielding the same conclusions as the original investigation. This does not

seem like the most efficient use of resources. What can be done to ensure that

communities who have genuine problems have access to the resources ATSDR

can provide?

A14. ATSDR does, from time to time, revisit a site. In some instances this may be considered inefficient, but we consider it to be prudent, as our work is a mixture

of community service and the best science. If new data are available, new scientific

methods emerge, or community concerns persist, this may justify returning to conduct additional work at a site.

For example, in the case of Illinois Beach State Park, continuing questions illus- trated a need for additional information. New sampling techniques provided a greater level of confidence in the results. Even there, a small number of community members were not convinced. However, through the cooperation with other federal and

State agencies, we provided the community with scientifically rigorous health guidance. On the other hand, after careful review of new research related to the Colonie,

New York, site, since the hazard has long ago been removed, among other reasons,

ATSDR concluded that a community study would be unlikely to have scientific yield

or public health benefit.

Q15. In your written statement, you mention the challenges related to the research capacity at ATSDR. Given the workload and the statutory authorities given to

ATSDR, would you consider research to be a primary goal for this organization? Would it not make more sense that you identify gaps in scientific knowledge through your public health assessments and leave it to another, moreequipped agency or organization to undertake the research required to fill those

holes?

A15. ATSDR is charged under CERCLA with expanding the knowledge base about health effects from exposure to hazardous substances.

Research on the human health effects of environmental exposure to hazardous

substances is conducted by a number of federal agencies, including the NIEHS,

NCEH, EPA, and ATSDR. ATSDR carries out its research responsibilities through

a number of mechanisms. The Agency takes steps to initiate needed research. For

example, ATSDR identifies important data gaps and takes steps to fill those gaps,

such as through petitions to the National Toxicology Program to conduct research

on particular exposures (i.e., naturally occurring asbestos). ATSDR also funds a

longstanding program through the Association of Minority Health Professions

Schools (AMHPS) to conduct needed research, while supporting the training of minority professionals in toxicology. ATSDR has a distinct role in applied public health research, arising from the Agency’s site-specific work. Examples of ATSDR’s work in applied public health research include the development of innovative modeling techniques at Camp Lejeune

in North Carolina, investigation of community exposures to TDI (toluene

diisocyanate) in North Carolina, research on a possible environmental component of

polycythemia vera in Pennsylvania, and research into beryllium disease in community settings in Ohio. This research flows from our field work. We definitely have a research role, but we need to be strategic. In some cases, it is better for us to leave research to others;

in other cases, it is important that ATSDR do the research, based on the unique

expertise and experience of its workforce.

Questions submitted by Representative Steve Rothman

Q1. ATSDR seems to say to the people of Vieques Island, ‘‘Nevermind. Nothing to worry about here.’’

A1. This is not an accurate characterization of ATSDR’s approach to the people of

Vieques. Over the last decade ATSDR’s work in Vieques has been extensive, careful,

and responsive. This work included:

• A series of Public Health Assessments (PHAs) to investigate environmental

contamination on the island and possible pathways by which people might be

exposed to those contaminants.

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• Training and materials for health care providers and educators so that accurate environmental health information was available to the community.

• Extensive consultation with the community, before, during, and after its investigations, to hear public concerns and to incorporate them into its work.

ATSDR’s work on the island included four PHAs, each investigating a different potential pathway of exposure to dangerous chemicals: groundwater and drinking

water (2001), soil (2003), fish and shellfish (2003), and air (2003). In addition, we

convened two expert panels, one to evaluate the accuracy and reliability of hair testing, and one to assess environmental risk factors for heart disease. Throughout the course of our work in Vieques, we encouraged community partici- pation, provided educational material, and held meetings to explain both our findings and the methods used to reach our conclusions. We solicited public comments

on each of our Public Health Assessments and addressed those comments in our

final documents. We met with members of the community, both individually and in

public forums, to discuss the findings. We worked through health care providers and

educators on the island to make educational material available to residents. This

is a record of Agency action that reflects sincere concern for, and accountability to,

the people we serve.

ATSDR continues to be dedicated to the health of the people of Vieques. We have

committed to re-engaging in Vieques, to assessing new or persistent health concerns, to analyzing any new data, and to reassessing our conclusions as appropriate.

Q1a. Why is it that independent scientists can find troubling evidence of potential

public health issues that ATSDR is unable to find?

A1a. ATSDR is not aware of any published peer-reviewed scientific studies that

have documented human exposure to hazardous chemicals on Vieques at levels of

health concern.

There is evidence of environmental contamination on Vieques. We are aware of

some credible, though unpublished, measurements of chemicals in grass, in non-edible plant species near the live impact area (LIA) at the eastern end of the island,

and in non-edible animals, as well as studies of how plants may take up metals.

These data suggest that some plants near the LIA and some non-edible marine species contain contaminants—results that correspond to ATSDR’s own findings. However, this contamination was some miles from where people live on the island. Moreover, detailed assessment did not identify specific pathways—say, eating, drinking,

or breathing—by which people might absorb these contaminants. At the time of our

assessments, neither the food people were eating, nor the water they were drinking,

nor the air they were breathing, nor the soil they were touching, contained contaminants at levels associated with health problems. Even if contaminants are present

in the environment, if they do not reach people’s bodies, then human health effects

are not expected.

The Environmental Protection Agency (EPA), National Oceanic and Atmospheric

Administration (NOAA) and others continue to characterize the nature and extent

of the contamination associated with past Department of Defense (DOD) activities

on the island. Based on this work, we are currently considering whether new data

warrant additional activities to assess potential exposures that might impact the

health of the people of Vieques.

Q2. Are you aware of the scientific studies done on the island of Vieques questioning

the ATSDR’s public health assessments?

A2. Through media reports, we are aware of several studies of environmental contamination and health on Vieques. ATSDR has requested the environmental studies

for review, but was informed that they had not been published and were unavailable. ATSDR also followed up on reports of a study of cancer mortality on Vieques;

however, this report has also not yet been published. ATSDR is assessing the quality and availability of cancer registry data in Puerto Rico, including Vieques—previously unsatisfactory but now said to be much improved—to determine if the registry can be used to study cancer rates on Vieques.

Q3. Are you aware of the hair testing of the people of Vieques themselves, provided

to the U.S. Navy, showing extremely high levels of mercury, lead, cadmium, arsenic and aluminum?

A3. ATSDR is aware of the human hair analysis, which indicated elevated levels

of mercury (and antimony in one individual). Hair analysis is a controversial method in environmental health, and one that can be subject to variability and inaccuracy. To assess the Vieques findings, ATSDR convened an independent expert panel

to evaluate the science of hair analysis. This is an example of ATSDR’s willingness

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to carefully evaluate whether emerging or novel scientific methods might assist in

our assessments. In this case the expert panel concluded that the hair analysis was

likely to be unreliable. ATSDR offered to follow up with a broader, biological exposure investigation, of which human hair analysis would be a part, in addition to

other specimens; however, the community opted not to participate at that time. ATSDR was also made aware of results of animal hair testing from the Puerto Rico Department of Agriculture in cooperation with the Farmers Association of

Puerto Rico. These groups concluded that agricultural products from Vieques were

suitable for consumption and did not contain toxic levels of these contaminants.

Q4. How do you evaluate the public health exposures of dangerous contaminants at specific sites?

A4. We assess whether chemicals released into the environment are reaching people by empirically evaluating the specific pathways that might operate: eating, drinking, touching, or inhaling the chemicals. If there is a ‘‘completed pathway’’—evidence that chemicals are reaching people—we then determine quantitatively whether the exposure levels are associated with adverse health effects, by turning to toxicological, epidemiological, and medical studies in the literature.

Q4a. How do you know what to test for?

A4a. Two main sources guided our sampling efforts: in-house expertise related to chemicals present in explosive residue; and Department of Defense (DOD) data regarding the composition of the bombs. The Environmental Protection Agency (EPA)

has an oversight role in working with DOD to determine adequate characterization

of the nature and extent of contaminants. In addition to reviewing sampling data

from other agencies, ATSDR sampled for bomb-related metals and explosive residues.

Q4b. Did the U.S. Navy provide ATSDR with a list of all the chemicals used at its Roosevelt Roads Naval Station on Vieques or found in its munitions which

have leached chemicals onto the island and into the sea as a result of ordnance

exercises at the Vieques Naval Training Range for over 69 years?

A4b. Yes, the Navy provided ATSDR with a list of chemicals found in its munitions; however, we cannot know with certainty whether the list of chemicals provided by

the Navy was complete.

Q4c. Did the U.S. Navy provide information to ATSDR about the amount of depleted uranium, or napalm or Agent Orange or dioxins or other potentially toxic

chemicals it used on Vieques?

A4c. The Navy provided ATSDR with this information. The information the Navy provided indicated that:

• Two Marine aircraft fired 263 rounds of ammunition armed with depleted

uranium (DU) penetrator projectiles on the LIA in February 1999.

• The Nuclear Regulatory Commission (NRC) conducted an environmental survey on Vieques in June 2000.

• More than 70 percent of the DU rounds have been located and the locations

have been marked.

• NRC reported that a recent survey found no additional depleted uranium.

Q4d. Wouldn’t you agree that the party who is in the best position to know exactly what toxics and chemicals were used on Vieques is the U.S. Navy? If so, did

ATSDR ever demand the kind of relevant information I’ve mentioned here, so

that the people of Vieques and those of us who are concerned about their health

might know what they have really been facing in terms of harmful exposure

to all these toxic chemicals?

A4d. The Navy has extensive information on environmental contaminants in Vieques, and ATSDR must rely on the Navy data in its assessments. This not unusual; we often have to rely on data from others. In the case of Vieques, ATSDR

asked for and received data from the Navy. ATSDR has also received information

from NRC on depleted uranium, from the U.S. Fish and Wildlife Service (FWS) and

NOAA on aquatic life, and from EPA on various environmental media.

Q5. Do you stand by your agency’s assessment that Vieques is a perfectly safe environment?

A5. No ATSDR document says that the environmental is perfectly safe. However, each of our Public Health Assessments on specific pathways is based on solid analysis and we stand by these documents. According to the data we have reviewed, as

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long as people do not enter restricted areas, including the LIA and nearby waters,

they are safe from contaminant exposure and from the physical injury risk associated with unexploded ordnance.

Q6. Would you feel comfortable raising your family in a similar environment?

A6. The data we have reviewed have revealed nothing that would prevent me from

raising my family on Vieques. However, I would keep my family out of the restricted, unremediated areas in the LIA.

Q7. What do you think ATSDR could have done differently to improve the public

health assessments performed on Vieques?

A7. Vieques is one of ATSDR’s most comprehensive investigations. It included four

Public Health Assessments, in addition to other work. The Vieques investigation included assessments of the air pathway, soil pathway, water pathway, seafood pathway, hazards associated with vibrations, and numerous review panels to evaluate

unpublished data collected by others. ATSDR provided numerous health education,

physician education, and school-based environmental health education resources

and training to help the community gain the knowledge to identify hazards, protect

themselves from the hazards, and notify authorities about the hazards.

EPA and other agencies are engaged in an environmental clean up and additional

sampling, and ATSDR remains available to review their data as necessary.

As discussed above, ATSDR’s focus was on assessing exposures rather than health

outcomes. Some may suggest that we should have done a health outcome study during our work on Vieques. Typically, ATSDR does not investigate health outcomes

unless exposures are documented. This is to focus ATSDR’s limited resources in

communities where exposures are found.

ATSDR was—and is—interested in learning more about health statistics on

Vieques, especially if there is strong local support for such an inquiry. At the time

of our work on Vieques, cancer registry data were not considered adequate to support rigorous analysis. Since ATSDR’s work, the Puerto Rico cancer registry has

made significant progress. We may consider using these data to address the concern

about the cancer rate on Vieques.

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