[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]


 
                      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



















             ATSDR: PROBLEMS IN THE PAST, POTENTIAL FOR THE FUTURE?

















                      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

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                  COMMITTEE ON SCIENCE AND TECHNOLOGY

                   HON. BART GORDON, Tennessee, Chair
JERRY F. COSTELLO, Illinois          RALPH M. HALL, Texas
EDDIE BERNICE JOHNSON, Texas         F. JAMES SENSENBRENNER JR., 
LYNN C. WOOLSEY, California              Wisconsin
DAVID WU, Oregon                     LAMAR S. SMITH, Texas
BRIAN BAIRD, Washington              DANA ROHRABACHER, California
BRAD MILLER, North Carolina          ROSCOE G. BARTLETT, Maryland
DANIEL LIPINSKI, Illinois            VERNON J. EHLERS, Michigan
GABRIELLE GIFFORDS, Arizona          FRANK D. LUCAS, Oklahoma
DONNA F. EDWARDS, Maryland           JUDY BIGGERT, Illinois
MARCIA L. FUDGE, Ohio                W. TODD AKIN, Missouri
BEN R. LUJAN, New Mexico             RANDY NEUGEBAUER, Texas
PAUL D. TONKO, New York              BOB INGLIS, South Carolina
PARKER GRIFFITH, Alabama             MICHAEL T. MCCAUL, Texas
STEVEN R. ROTHMAN, New Jersey        MARIO DIAZ-BALART, Florida
JIM MATHESON, Utah                   BRIAN P. BILBRAY, California
LINCOLN DAVIS, Tennessee             ADRIAN SMITH, Nebraska
BEN CHANDLER, Kentucky               PAUL C. BROUN, Georgia
RUSS CARNAHAN, Missouri              PETE OLSON, Texas
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
                                 ------                                

              Subcommittee on Investigations and Oversight

                HON. BRAD MILLER, North Carolina, Chair
STEVEN R. ROTHMAN, New Jersey        PAUL C. BROUN, Georgia
LINCOLN DAVIS, Tennessee             BRIAN P. BILBRAY, California
CHARLES A. WILSON, Ohio              VACANCY
KATHY DAHLKEMPER, Pennsylvania         
ALAN GRAYSON, Florida                    
BART GORDON, Tennessee               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



















                            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

                               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


         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.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                            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

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
    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.
    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 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 
uncorrected for so long--keeping the public in harm's way for a year 
longer than necessary--was not an isolated incident.
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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 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.
    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.
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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 consultation 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.
---------------------------------------------------------------------------
    \18\ Amanda Caldwell and Susan Waskey, ``Midlothian Industrial 
Plant: Emission Data,'' Geography Special Problems, University of North 
Texas, July 25, 2008.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \19\ Marvin Legator, et al., ``The Health Effects of Living Near 
Cement Kilns; A Symptom Survey in Midlothian, Texas,'' Toxicology and 
Industrial Health, Vol. 14, No. 6, 1998.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \20\ Marvin S. Legator and Amanda M. Howells-Daniel, ``A Deliberate 
Smokescreen,'' Archives of Environmental Health, Vol. 49 (No. 3), May/
June 1994.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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 problems. 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\
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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 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\
---------------------------------------------------------------------------
    \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
    \24\ ``HEALTH CONSULTATION: Cliff Village Wells Site, City of Cliff 
Village, Newton, Missouri, 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
---------------------------------------------------------------------------
    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 two-mile 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.
---------------------------------------------------------------------------
    \26\ ``Federal Agency Releases Results of Polycythemia Vera 
Investigation,'' ATSDR Media Announcement, Agency for Toxic Substances 
and Disease Registry, October 24, 2007, available here: http://
www.atsdr.cdc.gov/NEWS/schuykillpa102407.html
---------------------------------------------------------------------------
    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 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.
---------------------------------------------------------------------------
    \27\ Mike 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
---------------------------------------------------------------------------
    To his credit, Dr. Hoffman presented his abstract at the American 
Society of Hematology 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\
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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 high-rate 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.''
---------------------------------------------------------------------------
    \29\ Polycythemia Vera Investigation, Agency for Toxic Substances 
and Disease Registry, http://www.atsdr.cdc.gov/sites/
polycythemia-vera/
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    In the wake of internal disagreements between Dr. Hoffman and ATSDR 
regarding the potential link between environmental contamination and 
the PV cluster, Dr. 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.
---------------------------------------------------------------------------
    \31\ Dr. 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/18/2/534

Asbestos Beach--Illinois State Beach Park in Chicago

    Mr. Jeffery Camplin is President of Camplin Environmental Services 
and technical 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 fibers 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\
---------------------------------------------------------------------------
    \32\ ``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
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \33\ See: ``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
---------------------------------------------------------------------------
    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 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\
---------------------------------------------------------------------------
    \35\ Letter 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.
---------------------------------------------------------------------------
    ``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.
---------------------------------------------------------------------------
    \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 Environment, 
September 2007, available here: http://www.albany.edu/news/
pdf-files/Depleted-Uranium-Article.pdf
---------------------------------------------------------------------------
    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 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.
---------------------------------------------------------------------------
    \37\ ``Health Consultation: Colonie Site (Aliases: Colonie Interim 
Storage Site and Formerly National 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
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \38\ ``A Summary of ATSDR's Environmental Health Evaluations for 
the Isla de Vieques Bombing 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
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \39\ See: ``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
    \40\ Dr. 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

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.
---------------------------------------------------------------------------
    \41\ ``Public Health Assessment, Kelly Air Force Base, San Antonio, 
Bexar County, Texas,'' Prepared by Agency for Toxic Substances and 
Disease Registry, September 9, 1999, available here: http://
www.atsdr.cdc.gov/HAC/pha/kelly/kel-toc.html
---------------------------------------------------------------------------
    In a critique of the ATSDR report, Dr. Katherine Squibb, a 
toxicologist at the University 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\
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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

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\
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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. 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.
---------------------------------------------------------------------------
    \47\ ``Consumer Factsheet on: TRICHLOROETHYLENE,'' U.S. 
Environmental Protection Agency, available here: http://www.epa.gov/
OGWDW/dwh/c-voc/trichlor.html
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \48\ ATSDR Lusher Site PHA, p. 12.
    \49\ ``Toxicological Profile for Trichloroethylene,'' U.S. 
Department of Health and Human Services, 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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \52\ ATSDR Lusher Site PHA, pp. 14-15.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \53\ ATSDR TCE Tox Profile, pp. 90-91.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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

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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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 Assistant 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\
---------------------------------------------------------------------------
    \56\ ``Report on a Meeting Between ATSDR and Community 
Representatives,'' Citizen's Clearinghouse for Hazardous Wastes, June 
30, 1990, Washington, D.C.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.

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\
---------------------------------------------------------------------------
    \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
    \60\ For 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
---------------------------------------------------------------------------
    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 referenced material was 
either destroyed or misplaced during an agency physical move this past 
October [2002].'' \63\
---------------------------------------------------------------------------
    \62\ Letter from William A. Pierce, Deputy Assistant Secretary for 
Public Affairs/Media, Department of Health and Human Services to Mr. 
Thomas Townsend, November 25, 2003.
    \63\ Letter from Lynn Armstrong, CDC/ATSDR FOIA Officer, Office of 
Communication, Department of Health and Human Services, Centers for 
Disease Control and Prevention (CDC) to Thomas Townsend, June 2, 2003.
---------------------------------------------------------------------------
    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 real-
world 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\
---------------------------------------------------------------------------
    \64\ Denita L. McCall, Represented by Disabled American Veterans 
before Department of Veterans Affairs, Rating Decision, January 17, 
2007.

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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \66\ E-mail from Dr. Howard Frumkin to Dr. Tom Sinks, Tuesday, 
February 7, 2006 11:15 a.m.
---------------------------------------------------------------------------
    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. Sinks wrote: ``good 
try--no. Let's run the advertisement. It will include machinists and 
they may call us.'' \68\
---------------------------------------------------------------------------
    \67\ E-mail from Dr. Dan Middleton to Dr. Tom Sinks, Subject: 
machine shop workers, Wednesday, June 14, 2006, 4:54 p.m.
    \68\ E-mail from Dr. Tom Sinks to Dr. Dan Middleton, Subject: RE: 
machine shop workers, Thursday, June 15, 2006, 5:02 p.m.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \72\ David 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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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 regarding 
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 public-health 
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\
---------------------------------------------------------------------------
    \75\ Marc 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
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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

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 
Subcommittee 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.
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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. Interviews 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 review, 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 that endeavors to protect 
it. Without a leader able and willing to confront those issues, the 
public's health will continue to be harmed.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    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, 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 
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 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.

                                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.]
    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 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 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. 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 repeatedly 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 declared 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 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-
relevant 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.
    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 Preventive 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 
``Indeterminate'' 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 infrastructure, 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 picture 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 embarked 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 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 Industries 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.

Addendum #1

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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 #3

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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:

    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 down-wind 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 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 during 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 Structure, Be Expected to Have the Potential to Cause Adverse 
Effects through the Ah-r-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 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 large-scale 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 conclusion 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 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 short-term 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 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.

    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 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-[email protected]

Addendum #5

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Addendum #6

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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 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 chemicals 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 analysis. 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 interpretation 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 listings. 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 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:

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    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.
    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.

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;

        (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.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

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 expended 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 metals 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 
location 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 indication 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 further 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 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 disrupting 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 effect 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.

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 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. (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 sample; (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 control 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.

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.
    The concern that we were given conflicting data by TCEQ was not 
unfounded. 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.

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 health-based 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 (benzene; 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 
contaminant-specific 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 
manganese (PM10)] had one or more level above the most 
conservative contaminant-specific 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 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 (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 accurate 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.

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, adjusting 
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.
    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 mm), 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 
mm), 1994 through 2004 (690 results) PM2.5 Fine 
Particulates (0 to 2.5 mm), 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 
mm), 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 
mm), 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)

    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 
        apparently 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 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.

        (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 usually 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 (mg/m3)] 
that would result in a daily exposure dose [expressed as milligrams per 
kilogram 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 person 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 mg/m3 was created for evaluating lead based on a 
long-ago outdated level (quarterly average) 1.5 mg/m to protect a long-
ago outdated once acceptable blood lead level of 30 mg/dl. In addition 
a blood lead level of 10 mg/dl was used as a comparative 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 mg/
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 mg/
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 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/Chaparral 
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. 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 
non-carcinogenic 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.

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 mgL 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.

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.

        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 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 naive 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.

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 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,

NOX--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.
    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 SOX 
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.

5. Specific Plants and Pollutants

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


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 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 chemical released over the 17-year reporting period was Hydrogen 
Chloride (334,655 lbs.) Ash Grove's state Criteria Emissions Releases 
show that Sulfur Dioxide (SOX) and Nitrous Oxides (NOX) 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 SOX, NOX 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 (NOX) 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 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 company-to-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.

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 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.
---------------------------------------------------------------------------
    \1\ Abramson JH, Gahlinger PM. Computer Programs for 
Epidemiologists: PEPI, version 4.0. !Salt Lake City, Utah: Sagebrush 
Press, 2001.

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 epispadias remained 
statistically significantly elevated in Midlothian after adjustment for 
sex, maternal age, and maternal race/ethnicity.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    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.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


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.
    The prevalence of hypospadias or epispadias among male infants was 
also statistically significantly higher in Midlothian than Texas.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


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).

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


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 [email protected], or visit our web site at http://
www.dshs.state.tx.us/birthdefects/

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, non-
Hodgkin'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 expected 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 clusters\1\ 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.
---------------------------------------------------------------------------
    \1\ Guidelines for Investigating Clusters of Health Events, Centers 
for Disease Control and Prevention, MMWR 1990; 39 (RR-11): 1-16.
---------------------------------------------------------------------------
    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 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.

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\
---------------------------------------------------------------------------
    \2\ American Cancer Society website: http://www.cancer.org/docroot/
CRI/content/
CRI-2-4-1x-Who-ge
ts-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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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
    \5\ Doll 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

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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.

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.

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 
[email protected] dshs.state.tx.us

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                      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 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.
    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 questions 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 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 #200M 
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 environmental 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 Industries 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 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:

        (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 deposition were still living in the area; and,

        (5)  it seemed certain that if individuals living there also 
        had aerosol-contaminated 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-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 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 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 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 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.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

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.

        [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
        
                    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 inter-laboratory 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.
    I have led our national facility and worked with its talented staff 
to move the facility 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 adjudication 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 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 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 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 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.

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
                    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 provided 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 populated area not in 
the area of greatest population near Wilkes-Barre.
    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 suggested 
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 presented 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 
state-of-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 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 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 clearly 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 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.
    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 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.
    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 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 
community. 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 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, 
specifically 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, 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. 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 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 
hearing, 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 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.
    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.
    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 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 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 contractors and dictate the 
recovery of the dollars spent for flawed reports.
    This concludes my remarks, and I will be happy to answer 
questions 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 appropriate 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 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.

  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 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 terrible 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, 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 average 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 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 accounting 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 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 exposed 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 
Wisconsin 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 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 Perma-
Fix 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 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.
    I believe that the Agency has improved the overall quality of its 
Public Health Assessments\1\ 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.
---------------------------------------------------------------------------
    \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.
    \2\ For 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.

3.0 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.
---------------------------------------------------------------------------
    \3\ ATSDR, Health Consultation, Exposure Investigation Report, 
Airborne Exposures to Select Volatile Organic Compounds, Perma-Fix Of 
Dayton, Inc., Dec. 15, 2008.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.

          ``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\
---------------------------------------------------------------------------
    \5\ ATSDR, Health Consultation, p. 13.

          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\
---------------------------------------------------------------------------
    \6\ The 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.

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:

          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)
---------------------------------------------------------------------------
    \7\ Documents 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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \8\ Letter from Laura J. Rench to Howard Frumkin, Director National 
Center for Environmental Health and ATSDR, July 25, 2007. (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\
---------------------------------------------------------------------------
    \9\ Stephen Lester, Center for Health Environment & Justice, 
Assessing Health Problems in Local Communities. Updated April 2007.

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 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 community-based 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.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


                      Biography for Henry S. Cole
    Henry S. Cole, Ph.D., the President of Henry S. Cole & Associates, 
is an environmental 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 regional 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 animals 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 
epidemiology 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.
    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 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 
contention 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 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.
    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.
    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.
    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, improved issues 
tracking, and improved use of performance planning.
    With regard to specific procedures, we continue to make 
improvements, 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 
Subcommittee. 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.
    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 century 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 hazardous 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 multiple 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.
    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 
contributions 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 community-based 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 processor 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, 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 
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 education 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 designed 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.

          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 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.

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 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 management 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 Substances 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 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.
    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 review, 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 
familiar with it.
    Chair Miller. Okay. And I assume that most people have 20 
fingers 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 
confidence 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 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 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 
testimony. 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 
published 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?
    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 
questions, 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 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.]
                               Appendix:

                              ----------                              


                   Answers to Post-Hearing Questions




                   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.''

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 naive 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 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 
access 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 testimony, 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 preventative 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?

        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 drastically 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 naive 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 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?

        b.  What do you think they should have done differently?

A10. Once the ATSDR abdicated their responsibility for assessing 
Midlothian's public 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 scientific 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 (mg/dL) in 
children indicates excessive lead absorption and is grounds for 
intervention''--essentially condoning 10 mg/dL blood-lead level as an 
acceptable health risk.
    If ATSDR continues to refuses to incorporate accumulated blood-lead 
levels lower than 10 mg/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 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 mg/dL have been observed. CDC recommends a blood-
        lead level at 10 mg/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 culture)?

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 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.
                   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 coming to conclusions that are ultimately proven 
        unfounded?

        c.  How would you set up policies or procedures to 
        appropriately manage and utilize 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?

        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?

        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 culture)?

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)

        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.
                   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 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 
Assessments. 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. However, 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 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)?

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.
                   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 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.
    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.
    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 quality 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 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 utilize 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 conducted 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 complexity 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 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.
                   Answers to Post-Hearing Questions
Responses by Henry S. Cole, President, Henry S. Cole & Associates, 
        Inc., Upper Marlboro, 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 community-based 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 
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 non-compliance 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) 
demonstrates 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 creativity 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\
---------------------------------------------------------------------------
    \1\ Stephen Lester, Center for Health Environment & Justice, 
Assessing Health Problems in Local Communities. Updated April 2007.
---------------------------------------------------------------------------
    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; 
up-front 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.

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.
                   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 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 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?

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 locating data sources and obtaining available data.
    ATSDR is utilizing new ways to measure past exposures. Using 
innovative methods, 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 exposure-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 exposures, 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 possible. 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 environmental 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 expertise. 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 approximately 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 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?

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 beginning 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.

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 attend 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 organizations 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 utilize 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 decision-making 
process.
    When ATSDR develops new methods, we report those methods through 
peer-reviewed, 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?

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.
    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 community-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 science-based 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 
preparedness 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 difficulty 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 illustrated 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, more-equipped 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.

          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 participation, 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 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 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.