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


 
                  PREVENTING HARM - PROTECTING HEALTH:
                     REFORMING CDC'S ENVIRONMENTAL
                        PUBLIC HEALTH PRACTICES

=======================================================================

                                HEARING

                               BEFORE THE

                   SUBCOMMITTEE ON INVESTIGATIONS AND
                               OVERSIGHT

                  COMMITTEE ON SCIENCE AND TECHNOLOGY
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             SECOND SESSION

                               __________

                              MAY 20, 2010

                               __________

                           Serial No. 111-95

                               __________

     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
STEVEN R. ROTHMAN, New Jersey        MICHAEL T. MCCAUL, Texas
JIM MATHESON, Utah                   MARIO DIAZ-BALART, Florida
LINCOLN DAVIS, Tennessee             BRIAN P. BILBRAY, California
BEN CHANDLER, Kentucky               ADRIAN SMITH, Nebraska
RUSS CARNAHAN, Missouri              PAUL C. BROUN, Georgia
BARON P. HILL, Indiana               PETE OLSON, Texas
HARRY E. MITCHELL, Arizona
CHARLES A. WILSON, Ohio
KATHLEEN DAHLKEMPER, Pennsylvania
ALAN GRAYSON, Florida
SUZANNE M. KOSMAS, Florida
GARY C. PETERS, Michigan
JOHN GARAMENDI, California
VACANCY
                                 ------                                

              Subcommittee on Investigations and Oversight

               HON. BRAD MILLER, North Carolina, Chairman
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


                            C O N T E N T S

                              May 20, 2010

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

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

                           Opening Statements

Statement by Representative Brad Miller, Chairman, Subcommittee 
  on Investigations and Oversight, Committee on Science and 
  Technology, U.S. House of Representatives......................    11
    Written Statement............................................    15

Statement by Representative Paul C. Broun, Ranking Minority 
  Member, Subcommittee on Investigations and Oversight, Committee 
  on Science and Technology, U.S. House of Representatives.......    16
    Written Statement............................................    17

                                Panel I:


Ms. Cynthia A. Bascetta, Director, Health Care, Government 
  Accountability Office (GAO)
    Oral Statement...............................................    19
    Written Statement............................................    20

Mr. Stephen Lester, Science Director, Center for Heath, 
  Environment and Justice (CHEJ)
    Oral Statement...............................................    23
    Written Statement............................................    25

Dr. John P. Wargo, Professor of Environmental Risk Analysis and 
  Policy, Yale University
    Oral Statement...............................................    31
    Written Statement............................................    33

Dr. Marc Edwards, Charles P. Lunsford Professor, Department of 
  Civil and Environmental Engineering, Virginia Polytechnic 
  Institute and State University
    Oral Statement...............................................    41
    Written Statement............................................    42

                               Panel II:

Dr. Robin M. Ikeda, MD, MPH, Deputy Director, Office of 
  Noncommunicable Diseases, Injury and Environmental Health, and 
  Acting Director for the National Center for Injury Prevention 
  and Control (NCIPC), Centers for Disease Control and Prevention 
  (CDC)
    Oral Statement...............................................    81
    Written Statement............................................    83

              Appendix: Additional Material for the Record

A Public Health Tragedy: How Flawed CDC Data and Faulty 
  Assumptions Endangered Children's Health in the Nations's 
  Capital, a Report by the Majority Staff of the Subcommittee on 
  Investigations and Oversight...................................    96


  PREVENTING HARM - PROTECTING HEALTH: REFORMING CDC'S ENVIRONMENTAL 
                        PUBLIC HEALTH PRACTICES

                              ----------                              


                         THURSDAY, MAY 20, 2010

                  House of Representatives,
      Subcommittee on Investigations and Oversight,
                       Committee on Science and Technology,
                                                    Washington, DC.

    The Subcommittee met, pursuant to call, at 9:03 a.m., in 
Room 2318 of the Rayburn House Office Building, Hon. Brad 
Miller [Chairman of the Subcommittee] presiding.


                            hearing charter

                  COMMITTEE ON SCIENCE AND TECHNOLOGY

              SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT

                     U.S. HOUSE OF REPRESENTATIVES

                  Preventing Harm - Protecting Health:

                     Reforming CDC's Environmental

                        Public Health Practices

                         thursday, may 20, 2010
                        9:00 a.m. to 11:00 a.m.
                   2318 rayburn house office building

    The Investigations and Oversight Subcommittee of the House 
Committee on Science and Technology will convene a hearing at 9:00 a.m. 
on Thursday, May 20, 2010, to examine the policies and procedures used 
by the National Center for Environmental Health/Agency for Toxic 
Substances and Disease Registry (NCEH/ATSDR) of the Centers of Disease 
Control (CDC) to assess, validate and release public health documents 
and to detail specific instances where these offices have relied upon 
flawed science and incomplete data to draw critical public health 
conclusions. Resolving these policy and procedural issues within ATSDR 
and ensuring that the CDC's public health documents in general rely 
upon sound scientific data to reach public health conclusions is 
essential to ensuring the health and safety of the public. The purpose 
of this hearing is to help lay down a new road map for CDC in helping 
to reform its environmental public health practices, largely carried 
out by NCEH/ATSDR.
    The Subcommittee plans to release two new reports at this hearing, 
one prepared by the Government Accountability Office (GAO) regarding 
ATSDR's clearance policies and procedures regarding release of its 
public health documents and a Subcommittee staff report on how the CDC 
responded to the District of Columbia's 2003/2004 lead-in-water crisis. 
This will be the Subcommittee's third hearing regarding ATSDR's public 
health practices in the past two years.\1\ The hearing will also 
provide an opportunity for Members to question CDC regarding 
commitments made at the Subcommittee's last hearing to re-examine 
ATSDR's passed public health investigations on the island of Vieques in 
Puerto Rico, for instance, and to re-visit the agency's assessment of 
public health hazards in Midlothian, Texas.
---------------------------------------------------------------------------
    \1\ In April 2008, the Subcommittee held a hearing on a flawed 
public health consultation written by ATSDR for the Federal Emergency 
Management Agency (FEMA) that addressed human health issues regarding 
exposures to formaldehyde in toxic trailers that were provided to 
victims of Hurricanes Katrina and Rita. That hearing also examined 
retaliation by ATSDR's leadership against Dr. Chris De Rosa, then the 
agency's chief toxicologist, for concerns he raised with both the 
quality of this report and public health concerns he had with these 
trailers. Links to witness statements and other material from this 
hearing are available here: http://www.science.house.gov/publications/
hearings-markups-details.aspx?NewsID=2133. Last 
year the Subcommittee held another hearing on specific investigations 
by ATSDR that were criticized by outside scientists and local 
communities they affected as being woefully inadequate, based upon 
faulty scientific data or omitting critical information. Links to this 
hearing's material are available here: http://science.house.gov/
publications/hearings-markups-details.aspx?NewsID
=2376.

GAO Review & Recommendations Regarding ATSDR Clearance Policies

    Ms. Cynthia Bascetta, the Director of Health Care Issues at the GAO 
is responsible for leading reviews of programs designed to protect and 
enhance public health. She will provide testimony regarding the GAO's 
recent investigation of ATSDR's clearance policies. The GAO report 
based on her team's investigation concludes that the policies and 
procedures that ATSDR has established for preparing and releasing its 
public health documents lack ``critical controls to provide reasonable 
assurance of product quality.'' Further, GAO finds that the roles and 
responsibilities of the agency's management regarding the development 
of ATSDR's products, their oversight and eventual clearance are not 
well defined. The agency also lacks a comprehensive risk assessment 
process for evaluating priorities regarding its development, review and 
release of public health documents.
    The lack of policies and procedures guarantees that ATSDR's 
products will be of variable quality. Further, problems with the 
clearance and review of critical public health documents has been 
exacerbated since 2007 when ATSDR took its database tracking system 
called the Hazardous Substance Release and Health Effects Database or 
HazDat off line. According to ATSDR, the database ``contained 
scientific and administrative information on the release of hazardous 
substances from Superfund sites or from emergency events and on the 
effects of hazardous substances on the health of human populations.'' 
\2\ To replace the HazDat database ATSDR designed a database called 
Sequoia intended to track requests, exposure data, work flow for site-
specific products, and to improve the flow of information about newly 
initiated work between management and staff. But ATSDR officials told 
GAO that it is still unclear if the agency will need additional 
database systems to provide them with all the information they need to 
effectively manage the agency's activities.\3\ In addition, the Sequoia 
database is not yet fully operational.
---------------------------------------------------------------------------
    \2\ ``Hazardous Substance Release and Health Effects Database,'' 
Agency for Toxic Substances and Disease Registry, U.S. Department of 
Health and Human Services, available here: www.atsdr.cdc.gov/
hazdat.html.
    \3\ ``Agency for Toxic Substances and Disease Registry: Policies 
and Procedures for Public Health Product Preparation Should Be 
Strengthened,'' Government Accountability Office, GAO-10-449, April 
(ck) 2010.
---------------------------------------------------------------------------
    The result of having unclear policies and procedures combined with 
the lack of an information infrastructure that can help assess critical 
toxic exposure data, track specific public health investigations, or 
coordinate and synchronize management and staff assessments of 
potential human health hazards due to toxic exposures is a haphazard, 
ad hoc review of the agency's public health reports prior to their 
release. In fact, critical determinations regarding whether or not an 
ATSDR public health assessment or health consultation should be 
submitted for external peer review, the GAO found, are left largely to 
the discretion of the agency's management and staff. In addition, 
ATSDR's leadership has repeatedly argued that the vast bulk of the 
agency's products, including public health consultations and public 
health assessments are exempt from peer review.
    The 1986 Superfund Amendments and Reauthorization Act (SARA), which 
amended the Comprehensive Environmental Response, Compensation, and 
Liability Act (CERCLA), did exempt ATSDR's public health assessments 
from mandatory peer review.\4\ Congress has never revised that 
exemption and this language has repeatedly been cited by ATSDR leaders 
as the reason they do not subject their public health assessments to a 
scientifically credible and rigorous peer review process. The SARA 
amendment, however, never forbid or banned ATSDR from conducting peer 
review of its public health assessments. The agency simply chooses not 
to submit the vast majority of its public health documents for any sort 
of external peer review.
---------------------------------------------------------------------------
    \4\ ``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. 
The new law also set an arbitrary deadline of December 1988 for the 
poorly funded and poorly staffed agency to conduct public health 
assessments at an astounding 951 Superfund sites. In order to 
accomplish a quantitative victory by conducting these assessments at so 
many sites in so little time the quality of the reports, exempted from 
peer review, suffered as a result.
---------------------------------------------------------------------------
    ATSDR does claim that its scientific ``studies'' are subjected to 
peer review.\5\ However, the agency argues that public health 
consultations--the main product coming out of the agency--are not 
scientific studies and therefore not required to go through the peer 
review process. As a result of these attitudes by management, GAO found 
a vanishing small number of ATSDR products in 2008 underwent peer 
review. GAO's review shows that only 2 of the 282 public health 
assessments and health consultations ATSDR published in FY2008 
underwent external peer review. In 1991, nearly twenty years ago, GAO 
recommended that at least a sample of future ATSDR public health 
assessments undergo external peer review. However, GAO's most recent 
review in 2010 found that ``ATSDR does not currently have such a policy 
and instead relies on management and staff discretion to determine 
which public health assessments should be submitted for external peer 
review.'' According to GAO, 80-percent of non-management ATSDR staff 
believe that external peer review would be beneficial in ensuring the 
quality of ATSDR public health products.
---------------------------------------------------------------------------
    \5\ See Appendix C, ``ATSDR Peer Review Policy,'' Revised: March 1, 
1996, on pages 22-27 in: ``Public Health Response Plan: Midlothian, 
Texas, Public Comment Release, January 21, 2010, prepared by The Agency 
for Toxic Substances and Disease Registry and the Texas Department of 
State Health Services, available here: www.atsdr.cdc.gov/sites/
midlothian/docs/
Midlothian-Public-Comment%201-25-
10.pdf.

The Subcommittee DC/CDC Lead Staff Report

    These sorts of systemic failures that fail to appropriately design 
public health studies, fail to adequately validate public health data, 
or fail to sufficiently examine public health conclusions can result in 
flawed, incomplete or scientifically unsound public health 
recommendations and conclusions that may result in serious public 
health consequences. A key example of the impact these systemic 
problems can have is documented in a Subcommittee staff report on the 
investigation into how the CDC responded to the Washington, D.C. lead-
in-water crisis in 2004.
    On Saturday, January 31, 2004, The Washington Post published a 
story that informed the public for the first time that water tests 
conducted the previous summer by the D.C. Water and Sewer Authority 
(WASA) showed that thousands of DC homes, two-thirds of those tested, 
had elevated lead levels in their tap water above the Environmental 
Protection Agency's (EPA) limit of 15 parts-per-billion (ppb).\6\
---------------------------------------------------------------------------
    \6\ 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 mid-February 2004 the CDC responded to a request from the 
District of Columbia government to help evaluate potential human health 
affects of elevated lead levels in the city's drinking water. This 
assistance resulted in the publication of a CDC ``Morbidity and 
Mortality Weekly Report'' (MMWR) article, published on an ``emergency 
basis'' on March 30, 2004 that concluded: ``The findings in this report 
indicate that although lead in tap water contributed to a small 
increase in BLLs [blood lead levels] in DC, no children were identified 
with BLLs >10 g/dL [10 micrograms of lead per deciliter of blood], even 
in homes with the highest water lead levels. In addition, the 
longitudinal surveillance data indicate a continued decline in the 
percentage of BLLs >10 g/dL.'' \7\ The paper, and talking points 
prepared by the CDC's primary author of the MMWR, to respond to the 
public, press, congressional and other inquiries regarding the MMWR 
article reassured the public that there was no evidence of human health 
harm due to elevated lead levels in DC's water.
---------------------------------------------------------------------------
    \7\ ``Blood Lead Levels in Residents of Homes with Elevated Lead in 
Tap Water--District of Columbia, 2004,'' Morbidity and Mortality Weekly 
Report (MMWR), MMWR Dispatch, Vol. 53, March 30, 2004, available here: 
http://www.cdc.gov/mmwr/pdf/wk/mm53d330.pdf.
---------------------------------------------------------------------------
    The MMWR included two distinct studies. One looked at 84,929 
historical blood lead level (BLL) test results provided to the District 
of Columbia's Department of Health (DCDOH) between January 1998 and 
December 2003, primarily from commercial laboratories that conducted 
these tests for physicians' offices, health clinics and hospitals. 
According to the MMWR this longitudinal analysis showed that between 
1998 and 2000 the percentage of children with elevated BLLs decreased 
substantially, but that the decline for those living in homes with lead 
service pipes declined less dramatically from 2000 to 2003. This 
leveling off of the decline came just after WASA added chloramines to 
the drinking water supply.\8\
---------------------------------------------------------------------------
    \8\ ``Blood Lead Levels in Residents of Homes with Elevated Lead in 
Tap Water--District of Columbia, 2004,'' Morbidity and Mortality Weekly 
Report (MMWR), MMWR Dispatch, Vol. 53, March 30, 2004, available here: 
http://www.cdc.gov/mmwr/pdf/wk/mm53d330.pdf.
---------------------------------------------------------------------------
    The Subcommittee's investigation, however, found that the number of 
children in the District of Columbia who had elevated blood lead levels 
(BLLs) in 2002 and 2003 is more than three times higher than the CDC 
reported either at the time of the crisis or since. Today, the CDC 
maintains that 315 DC children suffered from elevated blood lead levels 
in 2002 and 2003, yet the laboratories that conducted these tests 
informed the Subcommittee that in reality at least 949 DC children had 
elevated blood lead levels at the time. The DC government's own 
database now show that 963 children suffered from elevated blood lead 
levels in 2002 and 2003. By early 2004, the CDC was aware of critical 
data integrity issues regarding public health surveillance data it had 
on DC blood lead tests yet it failed to clearly address or thoroughly 
investigate these issues even as they relied on that data to construct 
the MMWR article.
    The table below shows the break out of children with elevated lead 
levels as reported by the CDC, the District and through the 
Subcommittee's own efforts to work with health labs that analyzed 
District blood tests in 2002 and 2003.




    \9\ Cities and states that have cooperative agreements with the CDC 
and obtain CDC grant funds for their lead programs are required to 
provide CDC with their raw public health surveillance data regarding 
lead screening tests each year. Since 1992, the District of Columbia 
has received nearly $12 million in CDC lead grant funding. Once the CDC 
receives this raw surveillance data, which is supposed to include all 
blood lead tests performed that year, then CDC publishes a separate 
list based upon the number of children tested, not the number of tests 
conducted, on the CDC lead branch web-site. The incomplete raw 
surveillance data CDC received from DC regarding the city's 2003 blood 
lead tests in early 2004 were provided to the CDC for use in the March 
2004 MMWR report. The numbers posted by CDC on its web-site in March 
2005 regarding the number of individual children who had elevated blood 
lead tests in DC in 2003 was based on this incomplete and flawed data 
and remain there today, available here: www.cdc.gov/nceh/lead/data/
State-Confirmed-byYear-1997-
to-2006.xls.
    \10\ The District of Columbia government's numbers in this chart 
are based upon records provided by the DC government to the 
Subcommittee in summary forms called LeadTrax Management Reports. The 
DC government switched from a CDC developed database that tracked blood 
lead level test results called STELLAR in 2004. This database had many 
technical problems and management issues in the DC lead office 
contributed to a tremendous backlog of test data being entered into 
STELLAR. As a result the 2003 blood lead test data in STELLAR was 
woefully incomplete. When the DC government switched from STELLAR to a 
new database tracking system called LeadTrax that replaced STELLAR in 
April 2004 the DC lead program re-obtained 2002 and 2003 blood lead 
test data from the laboratories and re-loaded it into the new LeadTrax 
database. As a result, DC had much better, more complete and accurate 
`historic' blood lead test data entered into LeadTrax by 2005. Somehow, 
either through miscommunication or misunderstandings between the DC 
lead branch and the CDC lead branch CDC never seems to have realized 
this critical fact and never attempted to obtain this new data to 
revise the original findings of the 2004 MMWR article.
    \11\ The Subcommittee obtained summary data of the number of 
individual children five years old or younger who had elevated blood 
lead levels above the CDC ``level of concern'' of >10 g/dL [10 
micrograms of lead per deciliter of blood] in 2002 and 2003 that were 
reported to the DC Department of Health. The Subcommittee wrote to all 
seven laboratories providing blood lead test data to DC back in 2002 
and 2003, so that we could compare the data CDC posted on its website 
with the data the labs reported to DC. Under the CDC's lead grants to 
the District, copies of the raw public health surveillance data 
regarding blood lead tests provided to the DC government from these 
laboratories was supposed to be provided to the CDC.
    The MMWR report also included a separate study known as the 
``Cross-Sectional Study'' that specifically targeted homes in DC with 
extraordinarily high water lead levels of 300-parts-per-billion (ppb) 
or above, and attempted to correlate those high levels of lead in water 
to the incidence of elevated BLLs among residents in those homes. The 
MMWR found that even in 98 DC homes with the highest levels of lead in 
their drinking water none of the 201 residents from these homes had 
elevated BLLs above the CDC's level of concern.
    The Subcommittee found that many of the study participants did not 
drink the tap water at all therefore eliminating any potential health 
risks resulting from elevated blood lead levels. In fact, the majority 
of the participants in this study reported drinking bottled water, 
according to a spreadsheet containing raw data for this study. But this 
was never mentioned in the MMWR article. In addition, at least one 
child who was found to have an elevated blood lead level in a home with 
drastically elevated water lead levels was inexplicably dropped from 
the study altogether.
    All of the federal and District agencies involved in this study, 
including the DC Department of Health, the CDC and the U.S. Public 
Health Service claim that they have been unable to identify any of the 
raw data, survey questionnaires or other key records which form the 
basis of this Cross-Sectional Study. A single spreadsheet of raw data 
for this study obtained from the DC government via a Freedom of 
Information Act (FOIA) request by water expert Dr. Marc Edwards from 
Virginia Polytechnic Institute and State University in 2006 shows such 
fundamental flaws as individuals with test dates after the study was 
completed. The NCEH study, however, was used to reassure the public 
that there was no evidence of public health harm due to elevated water 
lead levels in the District of Columbia. The Cross Sectional Study was 
widely cited by local public health officials dealing with their own 
elevated water lead issues in Michigan, North Carolina and Washington 
State, for instance, and they used it to publicly discount any 
correlation between their own elevated water lead levels and elevated 
BLLs that could result in public harm. In 2007, Dr. Edwards wrote a 
formal letter to CDC requesting clarification regarding concerns he had 
about the data used in the 2004 MMWR article and the public health 
conclusions reached by the CDC. Dr. Edwards will testify about his 
experience attempting to gain answers to his questions and his own 
independent research on the DC lead-in-water crisis that completely 
contradicts the findings of the MMWR article and the CDC.
    The Subcommittee has found that the 2004 CDC MMWR article was based 
on flawed, misleading and incomplete data. Key problems with the 
underlying scientific integrity of the data used to write the MMWR were 
known to the article's primary author, Dr. Mary Jean Brown, head of the 
CDC's lead program, before the report was published, yet these flaws 
were not shared with co-authors, the publication's editors, CDC's 
leadership or the public. Efforts to resolve critical data integrity 
issues after the report was published were belated, weak and 
ineffective. Despite the clear scientific integrity questions that 
surrounded the CDC's blood lead screening data it obtained from the 
District of Columbia in early 2004, by 2007 scientists at the CDC were 
pushing forward with attempts to publish a peer reviewed journal 
article in the aftermath of the DC lead crisis based on the same faulty 
and incomplete data.
    Remarkably, despite the clear gaps in the data the CDC was using 
for this new study, they reached drastically different conclusions from 
the original 2004 MMWR article. The new study, for instance, concluded 
that children living in homes with partial lead pipe replacements were 
four times more likely to have an elevated blood lead level than 
children living in homes without lead pipes. This issue has national 
implications since many cities have conducted partial lead pipe 
replacements as a means of reducing elevated water lead levels. The 
conclusions reached by CDC clearly have significant public health 
consequences as well.
    Rather than attempting to broadly inform the public about these 
results and local public health officials or water utilities by 
publishing the CDC's findings in the agency's Morbidity and Mortality 
Weekly Report (MMWR) the agency has spent years trying to get their 
findings published in a peer reviewed scientific journal. Early last 
year the report was rejected twice by the CDC's Associate Director for 
Science. In the end, NCEH/ATSDR's Deputy Director, Dr. Tom Sinks, 
became a co-author of this proposed article and the paper was then 
cleared for release. It was rejected by one peer review scientific 
journal and sent to a second. The new CDC Director put a hold on trying 
to publish this article until all of the surveillance data this article 
is based upon could be obtained and reviewed by CDC. That data has now 
been obtained by CDC and they are attempting to publish their new study 
in a peer reviewed scientific journal. This is a welcome step, but it 
has taken the CDC six years to follow through on something that should 
have been done back in 2004. In addition, because this information 
reveals significant public health concerns it would seem more 
appropriate to use the CDC's MMWR to get the information out rapidly 
rather than waiting many more months to get it accepted and published 
in a scientific journal.
    The mission of 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 to 
toxic substances.'' \12\ But, nearly since its inception ATSDR has been 
criticized for not living up to that charge. Stephen Lester, Science 
Director at the Center for Health, Environment and Justice has been one 
of those critics and will testify about his own efforts to help the 
agency reform itself for the past two decades. Lester and others have 
criticized ATSDR for repeatedly failing to adequately investigate 
public health concerns. Last year, at the Subcommittee's ATSDR hearing 
we looked into some of the cases listed below and ATSDR committed to 
re-visiting some of these past investigations as a result.
---------------------------------------------------------------------------
    \12\ ``Statement of Mission,'' Agency for Toxic Substances and 
Disease Registry, undated, available here: http://www.atsdr.cdc.gov/
about/mission.html.

Vieques Island, Puerto Rico

    From 1941 to 2003 the U.S. Navy engaged in live bombing practice 
activities on and off the coast of Vieques Island in Puerto Rico 
spreading munitions containing 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.\13\ Those 
assessments have been widely criticized. One of those critics has been 
Dr. John Wargo, Professor of Environmental Risk Analysis and Policy at 
Yale University, who has investigated the public health consequences of 
toxic contamination on Vieques for the past seven years and will 
testify at Thursday's Subcommittee hearing.
---------------------------------------------------------------------------
    \13\ ``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.
---------------------------------------------------------------------------
    In the wake of last year's Subcommittee hearing, ATSDR management 
engaged in some positive actions regarding Vieques. The former NCEH/
ATSDR director, Dr. Howard Frumkin, visited Vieques and committed to 
re-evaluating ATSDR's past public health assessments of the island. The 
agency held a meeting last year with Puerto Rican scientists and other 
experts in what it described as a ``scientific consultation'' to 
discuss steps ATSDR should take to re-evaluate its past public health 
reports and recommendations regarding future action to evaluate toxic 
contamination on Vieques. Some scientists are frustrated, however, that 
ATSDR has been slow in developing any plans to launch new public health 
evaluations and these scientists are uncertain whether that will ever 
happen. The agency, for instance, never conducted a comprehensive food 
intake survey on the island, a critical step in evaluating potential 
chemical exposures to the island's residents and it is unclear if ATSDR 
plans to conduct one in the future. ATSDR had intended to issue a 
report for public comment in March that details information gaps, 
research needs and recommended actions regarding Vieques. But the 
agency now says that report won't be ready for release until mid-to-
late summer.

Midlothian, Texas

    At our last ATSDR hearing, the former ATSDR director also committed 
to re-focusing the agency's attention on Midlothian, Texas home to 
three cement plants and one steel mill that have released more than one 
billion pounds of toxic chemicals into the local environment since 
1990. In 2005 the agency accepted a public petition to conduct a health 
consultation on the potential health effects of toxic substances 
released from Midlothian's cement kilns. A draft version of the study 
was released in 2007 and received wide-spread criticism from 
independent scientists and local community members. A final version of 
the health consultation has still not been released. In addition, a 
second health consultation which was supposed to address air monitoring 
data of specific toxic chemicals was never initiated.
    In the wake of our hearing ATSDR did get more involved in 
Midlothian, although actual progress has been more difficult to 
measure. The agency held a public meeting, it conducted a survey of the 
local community's public health concerns, it formed a Community 
Assistance Panel (CAP) and it detailed two veterinarians to help 
examine health concerns regarding the town's animal population, 
including dogs, horses and goats that have exhibited what appears to be 
abnormally high numbers of stillbirths, birth defects and deformities.
    Virtually all of these actions, however, have been criticized by 
local community members. It is unclear to them when the veterinarians' 
evaluation will be completed or what to expect from it. One local 
resident says it seems ATSDR is treating the animal investigation as 
simply a veterinarian issue and not an important and urgent indicator 
of potential human health harm from exposure to toxic contamination. 
Local residents also complain that ATSDR's public meetings were not 
well publicized. ATSDR established a local Community Assistance Panel 
(CAP) to reportedly help provide input to ATSDR's activities regarding 
public health evaluations in Midlothian. Yet, the panel formed by ATSDR 
had an overwhelming number of representatives from the very industries 
that have contributed to the toxic contamination in and around 
Midlothian in the first place. There were reportedly six industry 
representatives, one representative from the local school board, one 
from the city and two community representatives. ATSDR apparently hand-
selected the two community representatives that it believed were ``fair 
and balanced'' based on interviews that were conducted with local 
residents last summer.
    The Subcommittee and many others have repeatedly criticized ATSDR 
for paying undue heed to the corporate interests or local politicians 
that have vested interests in concluding that there are no actual or 
potential public health hazards due to toxic exposures in local 
communities. In the Midlothian case, for instance, ATSDR never offered 
a seat on the panel to the agency's most vocal critics from the 
community. But the town's corporate interests that were responsible for 
the pollution were well represented. The perception in Midlothian is 
that ATSDR was attempting to silence its critics once again. In the 
end, ATSDR disbanded the short-lived Community Assistance Panel because 
of these concerns. These sorts of clearly avoidable and continuing 
blunders by the agency do not instill confidence in its ability to 
reform itself.

Polycythemia Vera Cancer Cluster Funding

    In another case, CDC approved $2.5 million in FY2010 funding for 
research into a cluster of rare blood cancers called polycythemia vera 
in eastern Pennsylvania, after our hearing last year. Senator Arlen 
Specter had been pushing for this funding to investigate the potential 
scope and cause of these cancers. Part of the funding was intended to 
fund research efforts that would investigate potential links between 
this cancer cluster and environmental contamination. Again, after our 
hearing drew attention to this issue ATSDR engaged in some positive 
actions. They assisted in forming a Community Action Committee (CAC) 
that would help provide information on the government's research into 
the polycythemia vera cluster to the public and ATSDR secured funding 
to support various research efforts regarding the polycythemia vera 
cluster.
    Yet, a few weeks ago the agency apparently attempted to 
``reprogram'' the $2.5 million in funds for this effort without 
informing Congress or the local affected communities in Pennsylvania. 
Once Senator Specter became aware of this issue and wrote to the 
Department of Health and Human Services the reprogramming effort 
reportedly ceased. The CDC says that it ``considered a number of 
options for reallocating resources. At this point, CDC does plan to 
continue funding the polycythemia vera cancer cluster in FY2010.''

The Value of a National Conversation?

    The recommendations offered by GAO in its new report on ATSDR 
provide a guidepost for essential reform of the agency. None of the 
critical and constructive reforms necessary will occur, however, 
without strong leadership at the top of the agency that recognizes the 
agency's past miscues and missteps and is able and willing to step in a 
new direction. It seems clear to the Subcommittee that the current 
cadre of ATSDR's top management, many of whom have been at the agency 
for decades and have been in positions capable of executing necessary 
changes at the agency, have been unable or unwilling to implement the 
critical reforms necessary to help protect the public's health from 
potentially toxic contamination. They have simply failed to rely on 
sound science and rigorous reviews of the public health documents the 
agency releases to the public.
    Unfortunately, over the past year, for instance, the agency's 
leadership has been focused on what it has described as a ``National 
Conversation on Public Health and Chemical Exposures,'' ``a 2-year 
project to create a national action agenda for strengthening the United 
States' approach to protecting the public from harmful chemical 
exposures.'' The project is being sponsored by both CDC and ATSDR.\14\ 
These extravagant efforts appear to have been a clear and present 
diversion from any real reform efforts at the agency. This process has 
refocused attention inside ATSDR away from rectifying the agency's own 
problems and strengthening its own public health procedures towards a 
broad ranging discussion of environmental contamination and public 
health that appears to overstep the agency's congressional mandate and 
its public health mission. This effort, begun under the agency's former 
director, has diverted attention, financial resources and energy from 
any attempt to quickly and aggressively fix the known and unambiguous 
problems that have hindered the agency's scientific credibility, data 
integrity and public health value since its creation two decades ago.
---------------------------------------------------------------------------
    \14\ See details here: http://www.atsdr.cdc.gov/
nationalconversation/index.html.
---------------------------------------------------------------------------
    The former director of ATSDR was removed from his position late 
last year. The current director of the Centers for Disease Control and 
Prevention (CDC) now has an opportunity to appoint a strong, solid 
director and new management team at ATSDR that is committed to 
inaugurating sound scientific practices that will serve the local 
communities that the agency was established to both advise and help 
protect.
    Dr. Robin M. Ikeda, Deputy Director for the Office of 
Noncommunicable Diseases, Injury and Environmental Health and Acting 
Director for the National Center for Injury Prevention and Control, 
Centers for Disease Control and Prevention (CDC) will be our last 
witness and will respond to Members' questions about CDC's 
environmental public health practices and inform the Subcommittee where 
CDC is on the road to reform at NCEH and ATSDR.

Witnesses:

Panel I

Ms. Cynthia A. Bascetta, Director, Public Health and Medical Services, 
Government Accountability Office (GAO)

Mr. Stephen Lester, Science Director, Center for Health, Environment & 
Justice (CHEJ)

Dr. John P. Wargo, Professor of Environmental Risk Analysis and Policy, 
Yale University

Dr. Marc Edwards, Charles P. Lunsford Professor, Department of Civil 
and Environmental Engineering, Virginia Polytechnic Institute and State 
University, Blacksburg, Virginia

Panel II

Dr. Robin M. Ikeda, MD, MPH, Deputy Director for the Office of 
Noncommunicable Diseases, Injury and Environmental Health and Acting 
Director for the National Center for Injury Prevention and Control, 
Centers for Disease Control and Prevention (CDC)
    Chairman Miller. Good morning. Welcome to this morning's 
hearing: Preventing Harm - Protecting Health: Reforming CDC's 
Environmental Public Health Practices.
    This is the third subcommittee hearing to examine the 
performance of the Agency for Toxic Substances and Disease 
Registry, ATSDR. Today, we will expand our work to examine the 
work of its sister agency, the National Center for 
Environmental Health, NCEH. Together, those offices are the 
Centers for Disease Control's experts in performing 
environmental health evaluations.
    In previous hearings, we documented problems with ATSDR's 
work on formaldehyde and the safety of trailers provided to 
families that survived Hurricane Katrina. We also documented 
problems with ATSDR's environmental assessments at Camp 
LeJeune, Vieques, Puerto Rico, and Midlothian, Texas. Three of 
the four cases mentioned have seen the health evaluations 
withdrawn by ATSDR, and the fourth is under review. They are to 
be commended, we do commend ATSDR for their willingness to 
admit failings, but today we will hear reasons to worry about 
what they are doing to make sure there are not failings in the 
future. We will examine one of these past examples, looking 
into current actions by the CDC to launch a new public health 
evaluation at Vieques, Puerto Rico.
    Additionally, we are releasing a staff report that 
documents serious flaws in an article written by CDC staff in 
2004 to respond to the District's lead-in-water crisis. That 
article--the District of Columbia. That article was built on 
significantly incomplete data for one of the two studies and 
unreliable data in the other study. But the message to District 
residents in the article was very clear: no serious harm 
resulted from the elevated level of lead in their water.
    After that article was published in the Morbidity and 
Mortality Weekly Report, the MMWR, in March 2004, the public 
clamor went away, press coverage died down, and most of the 
federal staff dispatched to assist the city validate the 
message, that there was no crisis by quietly returning to their 
home agencies. The authors knew there were problems with those 
studies, but in their disclosure on the limits of their data, 
they said not a word about missing data or confounding 
variables.
    This subcommittee cannot possibly identify every mistaken 
evaluation, assessment, report or article done by ATSDR or NCEH 
staff. That is not the role of Congressional oversight. We do 
not do peer review. We are not peers. But the CDC must take the 
steps themselves to make sure that these offices get on the 
right path and proceed in a way that avoids those problems in 
the future. And sometimes to get on the right path, you have to 
determine what constitutes the right path and what constitutes 
the wrong path. Our previous hearings and today's testimony 
makes it clear that the wrong path includes or has included in 
the past conducting studies designed to make it impossible to 
find a health problem. It is not the role of the government to 
tell everybody that they have got nothing to worry about.
    Analyzing data that is incomplete, inaccurate, or 
irrelevant to the underlying question without disclosing the 
known limits of the data, responding to critics by attacking 
their knowledge or their motives, failing to have rigorous and 
consistent reviews of study design, data collection and 
quality, analytical methods and conclusions, failing to have 
consistent policies and procedures for conducting public health 
research and interventions and for publications, all of this 
needs to change if ATSDR and NCEH are to succeed.
    We need more honesty and transparency and less attitude. 
When you work at a public health science agency and the words 
that are frequently used to describe your work are 
``haphazard'', ``hit or miss'', ``ad hoc'', maybe you should 
pause and reflect.
    This morning we have a new analysis that reworks part of 
the MMWR article on lead in D.C.'s drinking water, with more 
complete data on blood lead tests for District residents. The 
NCEH staff had more complete data, but they manipulated it, 
scrubbed it in a way that can't be evaluated by experts or by 
the public. They provide no real levels, no real numbers of 
children with elevated blood levels, something that residents 
would understand, and it makes it impossible to compare their 
raw numbers to numbers reported by the District or this 
subcommittee. Most important, the other years in this 
longitudinal study were treated in a different way that makes 
it almost impossible to compare, undermining the validity of 
the entire exercise.
    Undoubtedly, much of ATSDR's and NCEH's problem is a 
failure to communicate, in the words of Cool Hand Luke. But we 
have heard a great deal of evidence that the quality of the 
science is simply not consistently what it should be.
    I congratulate Dr. Frieden for initiating a search for a 
new leader of ATSDR-NCEH. A new team can do much to restore the 
confidence of the staff, to provide guidance about quality and 
procedures, processes, and give this country a function we 
desperately need: a reliable, expert evaluation of 
environmental health dangers.
    There are many talented, committed professionals at ATSDR 
and NCEH. Our criticism of the agency has never been a 
criticism of the professionalism or the commitment of their 
employees. Eighty percent of the staff at ATSDR would like to 
have their work subject to peer review more often. That is 
obvious evidence that the staff is committed to their job and 
want to do the right thing, and the public and the employees of 
ATSDR deserve leadership that matches their own commitment.
    I am attaching to my opening statement a report by the 
majority staff regarding the CDC's response to the lead-in-
water crisis in Washington, D.C., back in 2004, and also 
attaching a statement submitted by the Hon. Pedro Pierluisi, 
the delegate from Puerto Rico and other documents for the 
record.
    [The information follows:]

    
    
    
    
    
    

    [The prepared statement of Mr. Miller follows:]

               Prepared Statement of Chairman Brad Miller

    Good morning. Welcome to the hearing: Preventing Harm, Protecting 
Health: Reforming CDC's Environmental Public Health Practices.
    This is the third Subcommittee hearing to examine the performance 
of the Agency for Toxic Substances and Disease Registry (ATSDR). Today, 
we also examine the work of its sister agency, the National Center for 
Environmental Health (NCEH). Together, these offices are the Centers 
for Disease Control's (CDC) experts in performing environmental health 
evaluations.
    In prior hearings we documented problems with ATSDR's work on 
formaldehyde and the safety of trailers provided to families that 
survived Hurricane Katrina. We also documented problems with ATSDR 
environmental assessments at Camp LeJeune, Vieques, Puerto Rico and 
Midlothian, Texas. Three of the four cases mentioned have seen the 
health evaluations withdrawn by ATSDR, and the fourth case is under 
review. They are to be commended for being willing to admit to 
mistakes--but today we will hear reasons to worry about what they are 
doing to set the record right. We will examine one of these past 
examples, looking into current actions by the CDC to launch a new 
public health evaluation in Vieques Puerto Rico.
    Additionally, we are releasing a staff report that documents 
serious flaws in an article written by CDC staff in 2004 to respond to 
the District's lead-in-water crisis. That article was built on 
significantly incomplete data for one of the two studies and unreliable 
data in the other study. But the message to District residents in the 
article was very clear: no serious harm resulted from the elevated lead 
in water situation. After that article was published in the Morbidity 
and Mortality Weekly Report--the MMWR--in March 2004, the public clamor 
went away, press coverage died down, and most of the Federal staff 
dispatched to assist the City validated the message that there was no 
crisis by quietly returning to their home agencies. The authors knew 
there were problems with their studies, but in their disclosure on the 
limits of their data, they said not one word about missing data or 
confounding variables.
    This Subcommittee cannot possibly identify every mistaken 
evaluation, assessment, report or article done by ATSDR or NCEH staff 
and that is not the role of Congressional oversight. The CDC must take 
all necessary steps to set these offices on the right path. Sometimes 
to get on the right path, we must understand what constitutes the wrong 
path. Between our previous hearings, and today's testimony from the 
Government Accountability Office (GAO) it is clear that the wrong path 
includes:

        1.  Conducting studies designed to make it impossible to find a 
        health problem.

        2.  Analyzing data that is incomplete, inaccurate, or 
        irrelevant to the underlying question without disclosing the 
        known limits of the data.

        3.  Responding to critics by attacking their knowledge or their 
        motives.

        4.  Failing to have rigorous and consistent reviews of study 
        designs, data collection and quality, analytical methods and 
        conclusions.

        5.  Failing to have consistent policies and procedures for 
        conducting public health research and interventions and for 
        publications.

    All of this needs to change if ATSR and NCEH are to succeed.
    We need more honesty and transparency and less attitude from these 
offices. When you work at a public health science agency and the words 
more frequently used to are ``haphazard,'' ``hit-or-miss'' and ``ad 
hoc'', maybe you should pause and reflect.
    This morning we have a new analysis that reworks part of the MMWR 
article on lead in DC's drinking water, with more complete data on 
blood lead tests for District residents. The NCEH staff had more 
complete data, but they scrubbed it in a way that can't be evaluated by 
experts or by the public. They provide no real numbers of children with 
elevated blood lead levels--something that residents would understand--
and make it impossible to compare their raw numbers to numbers reported 
by the District or this Subcommittee. Most important, the other years 
in this longitudinal study were not ``scrubbed'' in the same way the 
newly complete 2003 report was, making the validity of the entire 
exercise questionable.
    Undoubtedly much of ATSDR's and NECH's problem is a failure to 
communicate in the words of Cool Hand Luke. But we have heard a great 
deal of evidence that the quality of the science is simply not 
consistently what it should be.
    I congratulate Dr. Frieden for initiating a search for a new leader 
of ATSDR-NCEH. We need a new team there that can restore staff 
confidence, provide guidance about quality and processes, and give to 
this country a function we so desperately need: reliable, expert 
evaluation of environmental health dangers. There are many talented 
committed professionals at ATSDR and NCEH. The public and those 
professionals deserve that leadership.

    Chairman Miller. I now recognize Dr. Broun for his opening 
statement.
    Mr. Broun. Thank you, Mr. Chairman. Good morning.
    I want to welcome our witnesses here today and thank the 
Chairman for holding this hearing. As a legislator and as a 
physician, I am certainly concerned about environmental public 
health.
    As the chairman noted, the Agency for Toxic Substances and 
Disease Registry and the Centers for Disease Control are no 
strangers 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 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 several internal 
reviews of those efforts and the Committee asked GAO to review 
the agency's processes. Additionally, this Committee held 
another hearing to hear from communities about their 
experiences with ATSDR and spent over a year examining how the 
CDC and the D.C. Department of Health responded to the D.C. 
lead crisis. Throughout these processes, it became abundantly 
clear that the processes by which scientific products are 
tasked, developed, reviewed, distributed and communicated are 
woefully inadequate. GAO's report offers a number of 
recommendations but it will take a concerted and a sustained 
effort to bring about the cultural change needed to ensure 
public trust.
    While the work that the Agency does is critically 
important, it is also very difficult. Determining causation and 
making health determinations is not always black and white. 
Despite the complexity of their work, the public deserves to 
have an agency that they trust, and 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 
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. Chairman, and I yield back the balance of my 
time.
    [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. As a legislator and a physician, 
I am certainly concerned with Environmental Public Health.
    As the Chairman noted, the Agency for Toxic Substances and Disease 
Registry (ATSDR) and the Centers for Disease Control (CDC) are no 
strangers 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 
those efforts and the Committee tasked GAO to review the Agency's 
processes.
    Additionally, this Committee held another hearing to hear from 
communities about their experiences with ATSDR, and spent over a year 
examining how the CDC and DC Department of Health responded to the DC 
lead crisis.
    Throughout this process, it became abundantly clear that the 
processes by which scientific products are tasked, developed, reviewed, 
distributed, and communicated are woefully inadequate. GAO's report 
offers a number of recommendations, but it will take a concerted and 
sustained effort to bring about the cultural change needed to ensure 
public trust.
    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.
    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.

    Chairman Miller. Thank you, Dr. Broun.
    We will include any other opening statements from any 
members in the record.

Panel I
    It is now my pleasure now to introduce our witnesses today. 
Ms. Cynthia Bascetta is currently the Director of Public Health 
and Medical Services at the Government Accountability Office, 
GAO. While at GAO, she has investigated the federal response to 
Hurricane Katrina and the delivery of federal health services 
to responders affected by the terroristic attack on the World 
Trade Center buildings. She holds a master's in public health 
from the University of Michigan. Mr. Stephen Lester is Science 
Director for the Center for Health, Environment and Justice, 
CHEJ. Mr. Lester has a master's degree in toxicology from the 
Harvard University School of Public Health and a master's 
degree in environmental health from the New York University's 
Institute of environmental medicine. He has worked for 20 years 
to help initiate reforms at ATSDR. Dr. John Wargo is Professor 
of Risk Analysis, Environmental Policy and Political Science at 
Yale. It says Yale University. He is the author of several 
books on toxic contamination and the impact on children, and he 
has served as an advisor on child health-related issues to the 
White House, EPA and CDC. He has spent the last seven years 
investigating toxic contamination on the Puerto Rican island of 
Vieques and will discuss his assessment of the CDC's failures 
to evaluate fully the potential human health hazards there. Dr. 
Marc Edwards is currently the Charles Lunsford Professor of 
Civil Engineering at Virginia Tech. He holds an undergraduate 
degree in basic medical sciences and a Ph.D. in environmental 
engineering. In 2007, he won a MacArthur fellowship, commonly 
called a Genius Grant, and he recently won the 2010 Praxis 
Award in professional ethics from Villanova University. His 
paper on the CDC lead-in-water crisis published last year in 
the Journal of Environmental Science and Technology was 
selected as the journal's best paper in the category of 
science, beating out nearly 1,500 other papers. We look forward 
to hearing from him and from all the witnesses today.
    As our witnesses should know, you will each have five 
minutes for your spoken testimony. Your written testimony will 
be included in its entirety in record of the hearing. When you 
have completed your spoken testimony, we will begin with 
questions. Each member will have five minutes to question the 
panel. It is the practice of the Subcommittee, because we are 
an investigations and oversight subcommittee, to receive our 
testimony under oath. Do any of you have any objection to 
taking an oath? Okay. The record should reflect that all the 
witnesses nodded in the negative, that they did not have an 
objection. You also have the right to be represented by 
counsel. Do any of you have counsel with you today? The record 
should reflect that all the witnesses nodded in the negative, 
that they do not have counsel today.
    Please stand and raise your right hand. Do you swear to 
tell the truth and nothing but the truth? The record should 
reflect that all of the witnesses have taken the oath. And now 
that you are at ease, we will start with Ms. Cynthia Bascetta. 
I want to thank you and the GAO for the hard work you have done 
in response to our Subcommittee's request for help with this, 
and your work was certainly thorough and diligent. You are 
recognized for five minutes.

   STATEMENT OF CYNTHIA A. BASCETTA, DIRECTOR, HEALTH CARE, 
             GOVERNMENT ACCOUNTABILITY OFFICE (GAO)

    Ms. Bascetta. Mr. Chairman and members of the Subcommittee, 
thank you very much for inviting me to testify about the need 
for ATSDR to strengthen its policies and procedures for 
preparing public health products. My remarks will highlight the 
findings of our report to the Subcommittee. As you are well 
aware, concerns about the quality of ATSDR's public health 
products are long standing. Prior GAO work, other studies and 
investigative reports by your own staff document products that 
have had serious scientific weaknesses. Our findings focus on 
the organizational climate that contributed to publication of 
these products rather than an assessment of the products 
themselves.
    To do our review, we used the Standards for Internal 
Control in the Federal Government to assess the agency's 
policies and procedures for the three phases of product 
preparation. These are initiating new work, developing a 
product and reviewing and clearing the product for publication. 
For all phases, we documented the lack of some critical 
controls needed to provide a reasonable assurance of product 
quality.
    The first deficiencies we found were during the initiation 
of new work. ATSDR's policies and procedures establish neither 
an adequate assessment of risk nor a clear information flow. 
The agency previously incorporated some of the principles of 
risk assessment when it classified some hazardous chemical 
sites as high priority or focus sites and it required products 
for these sites to undergo a higher level of review and 
clearance. It no longer does this, and instead generally relies 
on various meetings held at different levels to inform 
management and staff about newly initiated work. As a result, 
it cannot ensure that it is managing public health products 
commensurate with their risks.
    For the product development phase, we found that ATSDR's 
policies and procedures neither clearly define management roles 
and responsibilities nor require that management monitor the 
development of key components of public health products such as 
exposure assessments and health effects evaluations. One 
official told us that the agency identified staff with the 
right expertise for assignments. However, we noted in our 
report that this is not a substitute for ongoing monitoring. 
Without monitoring, problems that occur during product 
development may not be identified until review and clearance if 
they are identified at all. This can undercut public confidence 
as well as waste valuable time and resources.
    Finally, review and clearance policies do not reflect 
current practices. For example, the review of products in the 
division of health assessments and consultation usually stops 
with division branch chiefs, even though policy highly 
recommends clearance by the division director or the associate 
division director for science. Moreover, these policies and 
procedures direct management and staff to use discretion to 
identify products that should undergo higher levels of review 
rather than determining this through a comprehensive risk 
assessment process. The agency's criteria for discretionary 
review includes situations in which a document could have a 
high degree of visibility or contains highly sensitive 
information. However, because there is no consistent process, 
ATSDR again cannot ensure that its products receive the 
appropriate level of review and clearance.
    Mr. Chairman, ATSDR has told us that factors such as 
scientific uncertainty and resource limitations affect its 
ability to conduct its mission. We believe that such challenges 
are precisely why the agency must be held accountable for 
strengthening its processes to improve product quality. In its 
current state, management has limited its own ability to 
monitor agency work and ensure that resources are being 
allocated appropriately. The Office of the Director is in a 
reactive rather than a leadership position with respect to the 
divisions and the public health work it manages. In our report, 
we recommend ways for ATSDR to provide reasonable assurance of 
the quality of its public health products.
    This concludes my remarks, and I would be happy to answer 
your questions.
    [Statement of Ms. Bascetta follows:]

               Prepared Statement of Cynthia A. Bascetta

    Mr. Chairman and Members of the Subcommittee:
    I am pleased to be here today to discuss the Agency for Toxic 
Substances and Disease Registry's (ATSDR) policies and procedures for 
product preparation. ATSDR investigates community exposures related to 
chemical sites and releases; works with federal, tribal, state, and 
local agencies to identify potential exposures; assesses associated 
health effects; and recommends actions to stop, prevent, or minimize 
these harmful effects. In conducting these activities, the agency 
publishes many types of public health products, including public health 
assessments, health consultations, health study reports, and exposure 
investigations. Recent reports by the Institute of Medicine\1\ and 
ATSDR's Board of Scientific Counselors\2\ have identified various 
concerns such as the appropriateness and quality of the data used in 
ATSDR's products, the methodology and design of the studies, and 
clearance policies.
---------------------------------------------------------------------------
    \1\ See Institute of Medicine, Review of ATSDR's Great Lakes Report 
Drafts (Letter Report) (Washington, D.C.: National Academies Press, 
2008).
    \2\ ATSDR's Board of Scientific Counselors is an advisory committee 
that provides advice and guidance to the ATSDR Director. At ATSDR's 
request, the Board of Scientific Counselors convened a work group to 
evaluate the agency's peer review processes. The board issued a report 
in March 2009; as of May 11, 2010, the report was not available on 
ATSDR's Web site.
---------------------------------------------------------------------------
    This committee has held two previous hearings that focused on its 
concern about the quality of ATSDR's products. In response, ATSDR has 
noted that multiple factors have posed challenges for the agency, 
including limitations in the ability of available science to answer 
community questions about the effect of chemical exposures, limitations 
in ATSDR's ability to collect data related to exposures, and reductions 
since 2004 in the number of ATSDR staff and resources available to 
conduct the agency's mission. My testimony is based on our April 2010 
report,\3\ which is being publicly released today, and addresses the 
extent to which ATSDR's policies and procedures for product initiation, 
development, and review and clearance provide reasonable assurance of 
public health product quality.
---------------------------------------------------------------------------
    \3\ See GAO, Agency for Toxic Substances and Disease Registry: 
Policies and Procedures for Public Health Product Preparation Should be 
Strengthened, GAO-10-449 (Washington, D.C.: Apr. 30, 2010).
---------------------------------------------------------------------------
    To address this question, we reviewed ATSDR's policies and 
procedures and interviewed officials to identify guidance related to 
the preparation of public health products. We focused our review on 
those policies and procedures related to public health assessments, 
health consultations, exposure investigations, and health study reports 
because these products are considered to be ATSDR's core public health 
products and concerns have been raised about the quality of products 
such as these, in which ATSDR identifies potential exposures to 
hazardous chemicals and assesses associated health effects. We compared 
the policies and procedures ATSDR uses to guide the preparation of its 
public health products to the standards described in the Standards for 
Internal Control in the Federal Government,\4\ \5\ and the related 
Internal Control Management and Evaluation Tool. \6\
---------------------------------------------------------------------------
    \4\ See GAO, Standards for Internal Control in the Federal 
Government, GAO/AIMD-00-21.3.1 (Washington, D.C.: November 1999).
    \5\ See Office of Management and Budget Circular No. A-123, 
(Revised): Management's Responsibility for Internal Control (Dec. 21, 
2004).
    \6\ See GAO, Internal Control Management and Evaluation Tool, GAO-
01-1008G (Washington, D.C.: August 2001).
---------------------------------------------------------------------------
    We also interviewed employees in ATSDR's headquarters, employees in 
3 of ATSDR's 10 regional offices, and employees in 3 of 30 cooperative 
agreement partner offices to gain a better understanding of ATSDR and 
the policies and procedures related to product preparation. Further, we 
conducted interviews with officials, experts, and researchers outside 
ATSDR to gain an understanding of ATSDR's relationship with other 
agencies, to get their perspectives on ATSDR's work, and to learn about 
the policies and procedures used by other prominent scientific research 
organizations. A full description of our scope and methodology is 
included in our report.
    We conducted this performance audit from April 2009 to April 2010, 
in accordance with generally accepted government auditing standards. 
Those standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe that 
the evidence obtained provides a reasonable basis for our findings and 
conclusions based on our audit objectives.
    In brief, we found that the policies and procedures that ATSDR has 
established for public health product preparation lack some of the 
critical controls to provide reasonable assurance of product quality. 
To provide reasonable assurance that agency objectives are being met, 
federal internal control standards call for agencies to establish 
policies and procedures, assess risks associated with achieving agency 
objectives, ensure effective information sharing throughout the 
organization, monitor agency activities, and establish key areas of 
authority and responsibility for management and staff. We found that 
ATSDR's policies and procedures are deficient in the three phases of 
preparation of public health products: (1) initiation, which includes a 
decision by the agency to begin work on a public health product and the 
assignment of staff to prepare the product; (2) development, which 
includes management approval to proceed with the development of a 
product and the actual drafting of the public health product; and (3) 
review and clearance, which is the process by which a product is 
internally or externally reviewed and disseminated as a final public 
health product.

          ATSDR's policies and procedures for work initiation 
        do not establish and describe an adequate assessment of risk or 
        information flow. When work is being initiated, we found that 
        ATSDR lacks comprehensive policies and procedures for assessing 
        and categorizing the risk of that new work. For example, ATSDR 
        previously incorporated some of the principles of risk 
        assessment when the agency officially classified some hazardous 
        chemical sites as ``high-priority'' or ``focus sites,'' and 
        required any products resulting from review of those sites to 
        undergo a higher level of review and clearance. However, it no 
        longer does so. Because ATSDR does not currently have policies 
        and procedures that describe how the agency is to 
        comprehensively assess and categorize the risk of work it 
        initiates to prepare public health products, management cannot 
        ensure that it has consistently managed the risk related to new 
        work. Furthermore, since ATSDR's policies and procedures do not 
        establish how information about newly initiated work should 
        flow between management and staff, ATSDR generally relies on 
        various meetings to inform management and staff about new work. 
        The agency is implementing a new database called Sequoia, which 
        may improve the flow of information. However, officials told us 
        that further evaluation is needed to determine if Sequoia could 
        do everything required by management or if some information 
        will have to be captured in separate databases.

          ATSDR's policies and procedures for product 
        development do not provide for clear management roles and 
        responsibilities or consistent monitoring of product 
        development. During product development, many of ATSDR's 
        policies and procedures do not clearly define management roles 
        and responsibilities and do not consistently require that 
        management monitor the development of key components of these 
        products. For example, the primary document--the Public Health 
        Assessment Guidance Manual--that guides the development of 
        public health assessments and health consultations, which are 
        among the agency's core products, identifies exposure 
        assessment \7\ and health effects evaluation as the two primary 
        technical components of the public health assessment process. 
        However, there is no requirement that staffs work in either of 
        these areas be reviewed and approved by management during the 
        development of a product to ensure its accuracy and 
        appropriateness. Because of these deficiencies, management may 
        be unclear about its responsibilities, and problems that occur 
        during product development may not be identified or addressed 
        until review and clearance, if at all. For example, ATSDR and 
        Institute of Medicine reports show that because scientific 
        concerns were not identified during development of an ATSDR 
        report regarding chemical releases in the Great Lakes region, 
        the document underwent several years of review, and a final 
        report was not issued until more than 4 years after the first 
        draft was written.
---------------------------------------------------------------------------
    \7\ An exposure assessment is the process of finding out how people 
come into contact with a hazardous substance, how much of the substance 
they are in contact with, and where the substance is located. An 
exposure assessment reviews data collected by other federal and state 
government agencies, and differs from an exposure investigation in 
which ATSDR staff collect and analyze site-specific environmental or 
biological samples to determine whether individuals have been exposed 
to hazardous substances.

          ATSDR's review and clearance policies and procedures 
        do not always reflect current practices and do not establish a 
        process for ensuring consistent review of all products. We 
        found that some review and clearance policies do not reflect 
        current practices. For example, ATSDR's Clearance Quick-
        Reference Guide indicates that all public health assessments, 
        health consultations, and exposure investigations must be 
        reviewed and cleared by the division director or the division 
        associate director for science. Yet according to Division of 
        Health Assessment and Consultation (DHAC) management and staff, 
        the review and clearance of DHAC products usually stops after 
        review by branch chiefs within the division.\8\ Furthermore, 
        review and clearance policies and procedures direct management 
        and staff to use discretion to identify products that require 
        higher levels of review, rather than making this determination 
        through a comprehensive risk assessment process. While ATSDR 
        policy sets out criteria for when additional review may occur, 
        such as when a document could have a high degree of visibility, 
        there is no required point during a product's preparation when 
        management and staff collectively determine whether a product 
        meets the criteria, and whether additional review is warranted. 
        Thus, the agency cannot ensure that all products consistently 
        receive the appropriate level of review.
---------------------------------------------------------------------------
    \8\ DHAC is one of four ATSDR divisions.

    In conclusion, while management controls alone cannot guarantee 
product quality, they can help ensure the development of timely and 
credible public health products at ATSDR. But ATSDR lacks some critical 
controls to provide reasonable assurance of product quality, 
particularly for public health assessments, health consultations, and 
exposure investigations. Without assessing the risk of work being 
undertaken by the agency and using those risk assessments to guide 
agency processes for public health product preparation, ATSDR cannot 
provide reasonable assurance that its products have undergone the 
appropriate level of monitoring and review. If established, a risk 
assessment process could be used to determine the proper level of 
scrutiny for the initiation, development, and review and clearance 
phases, thereby ensuring that this determination is made consistently 
across the agency. Additionally, the agency's policies lack guidance 
for management about its role in monitoring product development, and do 
not require management's monitoring and approval of key components of a 
product during its development. Without adequate monitoring by 
management during a product's development, product errors may not be 
caught or significant publication delays may occur during the review 
and clearance phase, potentially undermining public confidence in the 
agency's products.
    Our report recommends that ATSDR develop policies and procedures to 
ensure that an assessment of the risk associated with a product is 
conducted at the time site-specific work is initiated, and that any 
assigned risk level be re-evaluated throughout product preparation to 
ensure that it remains appropriate. Our report also recommends that 
ATSDR revise existing policies and procedures, or develop new guidance, 
to provide documented direction for various levels of management on 
their roles and responsibilities in the monitoring of all products 
prior to review and clearance, such as requirements for management to 
monitor and approve key components of these products.
    In commenting on a draft of the report from which this testimony is 
based, ATSDR neither agreed nor disagreed with our recommendations and 
did not address them directly, but stated that the agency has begun to 
incorporate our recommendations. Although ATSDR did not comment 
directly on our recommendation that the agency conduct a risk 
assessment at the time site-specific work is initiated and reevaluate 
the assessment throughout product preparation, in its comments ATSDR 
stated that senior management was looking into formalizing and unifying 
coordination, triage, and prioritization of all incoming requests 
across the agency. ATSDR also acknowledged a need to make its 
prioritization process more explicit throughout the agency. Related to 
our recommendation that ATSDR revise or develop policies and procedures 
to include direction for management in monitoring products prior to 
review and clearance, ATSDR noted that its process to formalize and 
unify coordination, triage, and prioritization of all incoming requests 
was expected to include the specification of management and staff roles 
and responsibilities from initiation through publication.
    Mr. Chairman, this concludes my statement. I would be pleased to 
respond to any questions you or other Members of the Subcommittee may 
have.

    Chairman Miller. Thank you, Ms. Bascetta.
    Next is Mr. Lester for five minutes.

   STATEMENT OF STEPHEN LESTER, SCIENCE DIRECTOR, CENTER FOR 
             HEATH, ENVIRONMENT AND JUSTICE (CHEJ)

    Mr. Lester. Mr. Chairman, distinguished members of the 
Subcommittee, thank you for this opportunity to testify on the 
policies and procedures used by the Agency for Toxic Substances 
and Disease Registry to evaluate health problems in 
communities. My name is Stephen Lester. I am the Science 
Director with the Center for Health, Environment and Justice. 
CHEJ is a national environmental health organization founded in 
1981 by Love Canal community leader Lois Gibbs. I joined CHEJ 
in 1983, and as Science Director I have easily reviewed many 
hundreds of health studies, health assessments and health 
investigations including many conducted by ATSDR. It is with 
this background and experience that I offer this testimony.
    I would like to begin by stating that under no 
circumstances should the responsibility for evaluating health 
problems in communities be taken away from ATSDR. It is 
critically important that a federal agency be available to 
respond to concerns and questions raised by community 
organizations. While ATSDR has not done this well, the solution 
is not to throw the baby out with the bathwater but fix the 
problem and reform the agency so it does its work well.
    CHEJ spent several years from 1990 to 1992 working closely 
with ATSDR to help reform the agency. We took on this task 
following a meeting with Barry Johnson, then the director of 
the agency. At the time ATSDR was feeling a great deal of 
pressure as the U.S. General Accounting Office at the time had 
begun an investigation into the quality and effectiveness of 
its work. Our organization sponsored two meetings with ATSDR, 
the details of which are described in my written testimony. I 
would summarize this experience by saying that ATSDR learned 
what people wanted and adopted their language in its literature 
but the agency did not change what they had always been doing, 
using inadequate or inappropriate methods to assess health 
problems in communities. Now 20 years later, little has 
changed.
    CHEJ had a similar meeting in January of 2009 with Dr. 
Howard Frumkin, then director of the ATSDR. Dr. Frumkin came to 
our office to seek CHEJ's participation in a national 
conversation that would, among other issues, seek to improve 
the effectiveness of the ATSDR in addressing health problems in 
communities. We shared with Dr. Frumkin our previous experience 
with the agency and suggest that he begin by looking back at 
the recommendations that came out of our earlier work. Those 
recommendations were never acted on and are still applicable 
today. If the agency had implemented these recommendations, it 
is very likely there would be no need for a hearing today.
    ATSDR's inadequate or flawed health studies, health 
assessments and health investigations have had a significant 
impact on communities because decisions are made as a result of 
these studies that affect people's lives and well-being. These 
decisions might include whether to require additional cleanup, 
provide supplemental drinking water, relocate people or take 
other steps to reduce exposures. None of these or similar 
actions were taken when ATSDR's studies find nothing or are 
inconclusive. Such conclusions might be appropriate if the 
study design were capable of providing a reasonably accurate 
evaluation of the potential health problems in a study 
population. Unfortunately, this is not usually the case. 
Instead, studies conducted by ATSDR consistently ask the wrong 
questions, use inappropriate comparison groups, are based on 
incomplete or inadequate information, and use other ill-
conceived scientific methods that lead to irrelevant or 
inconclusive results. Consequently, people who live in 
contaminated communities are not getting the information and 
assistance or the medical treatment they need to protect 
themselves and their children from chemical exposures.
    It is difficult to say why ATSDR has acted as it has over a 
period of more than 20 years. I do feel, however, that much of 
their behavior can be traced to a lack of respect and interest 
in listening to and working with impacted communities. ATSDR 
should seek community involvement and consider the community 
its partner in developing whatever work is done. I also believe 
that the agency has been strapped by legislative language that 
frames its work and restricts its responsibilities and 
authority.
    To address some of these problems, I offer a few 
recommendations. First, ATSDR needs to meet with and include 
the community early on before it decides how to respond to the 
questions and concerns raised by the community. How it responds 
should be tailored to address these concerns and questions.
    Second, ATSDR should be given the legal authority to 
provide financial resources to communities so they can 
participate as partners in the design and development of the 
studies and assessments they do. Perhaps a health assessment 
grant, similar to EPA's technical assistance grant, could be 
made available to these communities.
    Third, ATSDR needs to acknowledge that the scientific 
methods and procedures currently used to respond to questions 
and concerns about increased health problems in a community are 
limited and rarely can provide accurate and useful information 
about these health problems. Research is needed to critique the 
scientific methods and procedures currently used.
    And lastly, ATSDR should be given the authority it needs to 
achieve its mission to take appropriate actions to avoid and 
end public health exposures.
    I have additional recommendations that are included in my 
written testimony. Thank you for your time and the opportunity 
for these comments, and I would be happy to answer questions.
    [Statement of Mr. Lester follows:]

                  Prepared Statement of Stephen Lester

    Mister Chairman, distinguished Members of the Subcommittee, thank 
you for this opportunity to testify on the policies and procedures used 
by the Centers for Disease Control and Prevention and its National 
Center for Environmental Health/Agency for Toxic Substances and Disease 
Registry (ATSDR) to assess, validate and release public health 
documents. My name is Stephen Lester and I am the Science Director for 
the Center for Health, Environment & Justice (CHEJ). CHEJ is a national 
environmental health organization founded in 1981 by Love Canal 
community leader Lois Gibbs. We assist people to fight for justice, 
empower them to protect their communities, and lead national 
environmental health campaigns.
    I would like to address five issues in my testimony.

        1)  I will provide some background on past efforts taken by 
        CHEJ to reform the way ATSDR investigates and responds to 
        potential public health hazards.

        2)  I will provide a brief description of how ATSDR's 
        inadequate or flawed public health investigations have impacted 
        local communities that have been exposed to environmental 
        contamination.

        3)  I will briefly discuss my impression as a participant of 
        the agency's initiative called the National Conversation on 
        Public Health and Chemical Exposures.

        4)  I will provide brief comments on why ATSDR has failed to 
        adequately protect the public in the past and has been unable 
        to address the issues that have led to these failures for the 
        past two decades.

        5)  I will provide specific recommendations that I believe are 
        important to help reform ATSDR and help ensure that its future 
        public health products are based on sound science, address 
        critical aspects of potential human health effects of 
        environmental contamination and assist local communities 
        exposed to toxic substances.

    By way of background, I have master's degrees in toxicology from 
the Harvard University School of Public Health, and in environmental 
health from the New York University Institute of Environmental 
Medicine. I have been involved in evaluating health studies and health 
problems in communities since I was hired in 1978 by the New York State 
Department of Health to be the Science Advisor to the residents at Love 
Canal in Niagara Falls, NY. I joined the Center for Health, Environment 
& Justice in 1983 where I have been the Science Director since. One of 
my main responsibilities has been to provide scientific assistance and 
understanding to grassroots community organizations across the country. 
A key component of this work has been to evaluate both completed and 
proposed health studies conducted by state or federal agencies in 
response to requests from communities to address perceived increases in 
adverse health problems in their community. Over the 27 years that I 
have been doing this work I have easily reviewed many hundreds of 
health studies, health assessments, and health investigations, 
including many conducted by ATSDR. It is with this background and 
experience that I offer this testimony.
    First, I want to make it clear that under no circumstances should 
the responsibility for evaluating health problems in communities be 
taken away from ATSDR. It is critically important that a federal agency 
be available to respond to concerns and questions raised by community 
organizations. While ATSDR has not done this well in the past, the 
solution is not to throw the baby out with the bath water but to fix 
the problem and reform the agency so that it does its work well. I will 
offer several recommendations later on how this may be done.

I. CHEJ's Efforts to Work with ATSDR

    CHEJ (then as the Citizens Clearinghouse for Hazardous Waste or 
CCHW) spent several years, from 1990 to 1992, working closely with 
ATSDR to help reform the agency. We took on this task after Barry 
Johnson who was then the Director of ATSDR came to our office to meet 
with Lois Gibbs, CHEJ's Executive Director, and myself in early 1990. 
This meeting occurred at a time when ATSDR was feeling a great deal of 
pressure about the quality and effectiveness of its work. The U.S. 
General Accounting Office (GAO) had begun an investigation into the 
quality of the Public Health Assessments being conducted by the agency 
and several leading agency officials were called before Congress to 
address these concerns.
    ATSDR was required by the Superfund Amendments and Reauthorization 
Act of 1986 to complete by December 1988 Public Health Assessments at 
all 951 Superfund sites that existed at that time. In response to this 
mandate, ATSDR made a poor decision that Barry Johnson would later 
acknowledge was a major mistake. The agency chose to sacrifice quality 
for quantity. ATSDR also acknowledged at the time that the use of data 
generated by EPA to evaluate the extent of contamination at a Superfund 
site was often inadequate to evaluate the public health risks posed by 
the contamination at a site, but they used it anyway. GAO released its 
final report on the ATSDR's Public Heath Assessments in 1991.
    One had to ask why Barry Johnson came to CHEJ at that time in 1990. 
Was he looking to divert some of the pressure the agency was feeling 
and show that things were different now? In his own words, Barry 
Johnson told Ms. Gibbs and I that the agency was ``turning over a new 
leaf.''
    Recognizing the importance of the work of ATSDR, CHEJ decided to 
work with the agency and we proposed in a letter to Barry Johnson a 
series of workshops involving community leaders from sites where ATSDR 
had conducted either a health study, health assessment, or some health 
investigation, and key agency staff. The initial concerns that CHEJ had 
with ATSDR and the proposed plan to conduct the workshops are described 
in a memo written to Barry Johnson on January 10, 1990. A copy of this 
memo is included as Attachment 1.
    The first meeting was held on June 30, 1990. The purpose of that 
meeting was to provide communities with the opportunity to express 
their needs and concerns directly to ATSDR; to provide the agency with 
the opportunity to explain what the agency does and plans to do in the 
future; to look at how well ATSDR addresses the needs and concerns 
identified by the community representatives; and to look at ways the 
agency and communities can work together to address these needs and 
concerns. A summary of the meeting is included as Attachment 2.
    The participants of this meeting generated a list of concerns/
problems that community representatives had with ATSDR; a list of needs 
identified by the representatives; a list of issues that needed to be 
addressed, and a series of recommendations. The recommendations 
included:

          Change ATSDR's Congressional mandate to better and 
        more directly serve community needs;

          Work with local community groups to help get 
        relocation or medical care for those who need it;

          Increase citizen's role in health studies, health 
        assessments, or health investigations--involve groups from the 
        beginning--set up a process that allows for true public input.

          Consider community needs in establishing programs and 
        setting priorities--meet with people/ask them what their needs 
        are;

          Conduct a health study, health assessment, or health 
        investigation that uses objective measures of health damage--
        stop using risk assessment, especially those that focus on 
        cancer alone;

          Stop doing health assessments that measure only risks 
        based on exposure data; instead conduct studies that answer the 
        question ``Is my health affected?"

          Educate family physicians and health care providers 
        about the consequences of chemical exposures.

    A second meeting was held in May 1991. A larger number of community 
representatives participated in this meeting as well as a number of 
scientists and agency staff. A summary of this meeting is included as 
Attachment 3. Barry Johnson made a number of commitments at this 
meeting, some of which were kept, but others were not. This began the 
deterioration of the working relationship not only between CHEJ and 
ATSDR, but between many community leaders and the agency. Community 
leaders expected to see changes in how a health study, health 
assessment, or health investigation was conducted by ATSDR. Instead, 
they saw few changes. They wanted another meeting, but ATDSR, who had 
paid for the first two meetings, wanted to limit a third meeting to 8 
to10 people and to limit the conversation to the agency's draft public 
participation plan that they were developing. People did not agree with 
this agenda and refused to participate in a third meeting.
    I would summarize this experience this way. ATSDR learned what 
people wanted and adopted the language of the people they had met with. 
They used this language in their literature to make it sound like they 
were doing the right thing while they continued to do what they had 
always been doing--using inadequate or inappropriate methods to assess 
health problems in communities. In my opinion, ATSDR used this 
experience to sharpen its image at the expense of meeting community 
needs. In the words of Dr. Nicholas Ashford, Professor of Technology 
and Policy at the Massachusetts Institute of Technology and a 
participant in the second meeting, ``ATSDR became primarily concerned 
with public relations and not in developing public relationships.''
    Ms. Gibbs and I also had a meeting in January of 2009 with Dr. 
Howard Frumkin, then director of ATSDR that had a very similar feeling 
to the meeting in 1990 with Dr. Barry Johnson. Dr. Frumkin came to our 
office to seek CHEJ's participation in what was described as a National 
Conversation that would among other issues seek to improve the 
effectiveness of ATSDR in addressing health problems in communities. We 
shared with Dr. Frumkin our previous experience with ATSDR and 
suggested that he skip the national conversation and begin by looking 
back at the recommendations that came out of the work we did with ATSDR 
from. 1990 to 1992. Most of those recommendations were never 
implemented by the agency and they are still applicable today. Copies 
of the same materials found in Attachments 1-3 were sent to Howard 
Frumkin following our meeting, but we never heard back from him about 
these recommendations. If the agency had listened to the community 
leaders who attended the two CHEJ meetings back in 1990-91 and had 
implemented the recommendations offered at that time, then it's very 
likely there would be no need for today's hearing.

II. How the Studies, Assessments, and Investigations Conducted by ATSDR 
                    have Impacted Local Communities

    Over the years, we have seen many examples of ATSDR's inadequate or 
flawed health studies, health assessments and health investigations. 
The impact of these studies is quite significant in the communities 
where these studies are conducted. Most importantly, decisions are made 
as a result of these studies that affect people's lives and well being. 
These decisions might include whether to require additional cleanup, 
provide supplemental drinking water, relocate people, or take other 
steps to reduce exposures. None of these or other similar actions are 
taken when an ATSDR health study, health assessment, or health 
investigation finds no relationship between exposure and health 
outcomes, or if it is inconclusive.
    The recent report by the President's Cancer Panel also found that 
``weak, flawed and uncorroborated studies'' are a barrier to taking 
steps to reduce exposures and protect the public. ``Efforts to 
identify, quantify and control environmental exposures that raise 
cancer risk . . . have been complicated by the use of different 
measures, exposure limits, assessment procedures, and classification 
structures across agencies. In addition, efforts have been compromised 
by a lack of effective measurement methods and tools; delay in adopting 
available newer technologies; inadequate computational models; and 
weak, flawed or uncorroborated studies.'' \1\
---------------------------------------------------------------------------
    \1\ Reducing Environmental Cancer Risk What We Can Do Now, 
President's Cancer Panel, 2008-2009 Annual Report, Bethesda, Maryland, 
April 2010, Executive Summary, Page ii.
---------------------------------------------------------------------------
    Negative or inconclusive findings would logically follow if the 
design of a study was capable of providing a reasonably accurate 
evaluation of the potential health risks and health problems occurring 
in the study population. Unfortunately, this is not usually the case. 
Instead, studies conducted by ATSDR have consistently asked the wrong 
questions (Yukon, PA; Pensacola, FL), used inappropriate study design 
(Elmira, NY; Fort Hall, ID), dilute exposed populations with unexposed 
populations (Hopewell Junction, NY), suffered from omissions and 
scientific inaccuracies (Camp Lejeune, NC; Jacksonville, FL), used 
incomplete and or inadequate information (Midlothian, TX, Frederick, 
MD), and used other ill-conceived scientific methods that lead to 
irrelevant or inconclusive results.
    Consequently, there have been hundreds of studies in hundreds of 
communities where the results are inconclusive by design, leading to a 
complete lack of trust and confidence in ATSDR and in government in 
general.\2\ And as result, people who live in these contaminated 
communities are not getting the information and assistance they need to 
protect themselves and their children from the chemical exposures that 
they suffer. They are also are not getting the medical treatment they 
need to address their health problems. ATSDR's conclusions also tend to 
discourage both the individual and the local family physician from 
further evaluating their health problems.
---------------------------------------------------------------------------
    \2\ See Inconclusive by Design, Waste, Fraud, and Abuse in Federal 
Environmental Heath Research, Environmental Health Network, National 
Toxics Campaign, May 1992 and Centers for Disease Control: Cover-up, 
Deceit and Confusion, Citizens Clearinghouse for Hazardous Waste, 1988.

III. The National Conversation

    ATSDR has partnered with the U.S. Environmental Protection Agency 
(EPA) and the National Institute for Environmental Health Sciences 
(NIEHS) to create an initiative called the ``National Conversation on 
Public Health and Chemical Exposures.'' \3\ This project is intended to 
convene a wide range of stakeholders, including community groups, 
industry, environmental groups and public health groups to develop an 
``action agenda for revitalizing the public health approach to chemical 
exposures.''
---------------------------------------------------------------------------
    \3\ See http://www.atsdr.cdc.gov/nationalconversation/index.html.
---------------------------------------------------------------------------
    I am an appointed participant to the Scientific Understand Work 
Group (one of six contributing work groups) of this National 
Conversation. This process began in June of 2009 when Howard Frumkin 
was still director of ATSDR. The project is expected to continue until 
some time in mid 2011. There are some very good people involved in this 
effort (there are more than 180 participants in the 6 work groups plus 
another 30 or so on the leadership council) and at this point it would 
be premature to evaluate the process and its effectiveness. I will say 
however, that since Dr Frumkin left the project, there has been a 
noticeable leadership void for the project (no permanent replacement 
has yet to be named) and many of the participants including myself have 
raised questions about how the work product of the group will be used 
and who is the target audience of the final work product. These and 
related questions are being addressed by the addition of an 
implementation meeting to the end of the project period. This meeting 
was not part of the originally plan and there is concern that there is 
no funding to hold this meeting.
    Another observation about the National Conversation is that we have 
been directed in our work groups to make our recommendations generic 
and not focused on a specific agency such as ATSDR, even though I and 
others have raised specific issues to address weaknesses at ATSDR. If 
this process holds true, I would expect the good work that comes out of 
this process will not be specifically targeted or necessarily taken up 
by ATSDR.

IV. ATSDR's Failure to Adequately Protect the Public and Address the 
                    Issues that have Led to these Failures for the Past 
                    Two Decades.

    It is difficult to say why ATSDR has acted as is has over a period 
of more than 20 years. Obviously some staff will have turned over 
during this time and some staff will have remained. I do feel, however, 
that much of their behavior can be traced to a lack of respect and 
interest in listening to and working with impacted communities. Perhaps 
it is arrogance and disdain for those with less education and perceived 
knowledge as Barry Johnson, Director of ATSDR from 1986 to 1998, warned 
a roomful of his staff and peers, ``We may carry with us the 
presumption of education. It is evident in our language--in phrases 
such as ``self- reported'' or ``anecdotal evidence''--and in our 
dealings with the non-toxicologists, non-physicians, non-
epidemiologists, and non-engineers who live around sites.'' \4\
---------------------------------------------------------------------------
    \4\ Division of Heath Assessments and Consultations (DHAC) and 
Cooperative Agreement States Workshop, San Antonio, Texas, March 7, 
1990.
---------------------------------------------------------------------------
    Johnson closed his presentation by telling the audience that they 
should ``not discount their experience [the community leaders]. They 
are our guides, and we should hear them.'' Good advice. Ironically, 
this is exactly what ATSDR needed to do then and unfortunately, still 
needs to do today. ATDSR needs to recognize that in order to solve 
community health problems caused by exposures to toxic chemicals they 
need to partner with the impacted community, understand its needs and 
concerns, and develop a response that meets those needs. Together with 
the community, ATSDR should define the questions that people want the 
agency to address. In response, the agency needs to be honest and 
straightforward with the community in presenting the limitations of the 
scientific methods available to respond to these concerns and 
questions. Furthermore, the role and availability of resources needs to 
be addressed early in the site assessment process. If the most 
promising study design requires a labor intensive collection of 
information which will cost an inordinate amount of money, then this 
needs to be addressed right up front with the community.
    ATSDR also needs to avoid the cookie-cutter one size fits all 
approach to evaluating health risk at a site that has been so popular 
with agency. This approach is favored because it is safe and helps 
address the many uncertainties inherent in evaluating the health impact 
from exposure to toxic chemicals. These uncertainties include specifics 
about exposure including the level and length of exposure, the 
susceptibility and vulnerability of the individual, cumulative effects 
overtime and due to exposure to multiple chemicals, and the special 
vulnerabilities of children. But these uncertainties should not be used 
to avoid taking action to reduce exposures and protect public health. 
As pointed out by the President's Cancer Panel, despite many 
uncertainties, ``in a great many instances, we know enough to act.'' 
\5\
---------------------------------------------------------------------------
    \5\ Reducing Environmental Cancer Risk What We Can Do Now, 
President's Cancer Panel, 2008-2009 Annual Report, Bethesda, Maryland, 
April 2010, Executive Summary, Page vi.
---------------------------------------------------------------------------
    The agency has also been strapped by legislative language that 
frames its work and restricts its responsibilities and authority. For 
example, Congress said that the agency must conduct a health assessment 
for every Superfund site in the nation. This seems logical at face 
value, but the legislation provided little guidance on what should be 
included in this assessment or how it should be conducted. When most 
community leaders learn that ATSDR is going to do a health assessment, 
they immediately think that the agency is going to evaluate or assess 
some measure of the health of the people who are exposed in the 
impacted community. In most cases, these leaders are shocked to find 
out that this is not what happens. Instead, ATSDR's health assessment 
is little more than an assessment of the risks based on available 
exposure data. Barry Johnson described the health assessment as the 
agency's ``principle statements on health risk'' and that ``health 
assessments are qualitative risk assessments.'' \6\
---------------------------------------------------------------------------
    \6\ Barry Johnson, ``Quantitative Risk Assessment--Experiences and 
Lessons in Effective Risk Communication,'' V.T. Covello et al, Plenum 
Press, 1989, pp. 63-66.
---------------------------------------------------------------------------
    When CHEJ meet with Johnson and asked him to change the term 
``health assessment'' because it was inaccurate and misleading, he 
refused, arguing that he could not change what Congress had mandated 
ATSDR to do. Consequently, the announcement that a health assessment 
will be done in a community immediately raises the expectations, and 
hopes, of the community. When they learn how the health assessment is 
actually conducted, they are disappointed, often angry and frustrated, 
which quickly leads to distrust of the agency and of government in 
general.
    Another statute limitation is that EPA is not required to act on 
the results of an ATSDR health assessment unless the assessment 
concludes that a site poses a ``significant'' risk.\7\ In these 
instances, EPA is legally required to take steps to reduce exposures 
and eliminate or mitigate the risk, though how it does this is not 
defined. In 1991, when GAO first evaluated the effectiveness of ATSDR's 
Health Assessments, they found that only 13 of 951 posed a significant 
risk, a number that is extremely low.\8\ It is unclear what criteria 
ATSDR uses to define this critical legal threshold. It is clear, 
however, that recommendations to take action at sites that do not meet 
this threshold are not likely followed by the agency. This may lead to 
frustration of ATSDR staff and a lack of enthusiasm to research and 
identify ways to reduce or eliminate exposures if the agency does not 
have the authority to carry out its recommendations.
---------------------------------------------------------------------------
    \7\ U.S. General Accounting Office, Superfund Public Health 
Assessments Incomplete and of Questionable Value, GAO/RCED-91-178, 
August, 1991.
    \8\ Ibid.
---------------------------------------------------------------------------
    There is also a lack of leadership at the top of the agency, not 
just because there is no current full-time director, but over the 
years, the agency has lacked a director with vision and a commitment to 
protecting the health of the public. The agency needs a champion who is 
willing to fully accept and carry out its mission to ``serve the public 
by using the best science, taking responsive public health action, and 
providing trusted health information to prevent harmful exposures and 
disease related exposures to toxic substances.''
    To the extent that Congress can take steps to remove barriers to 
carrying out this mission, then I would welcome and encourage these 
changes.

V. Recommendations for Reforming ATSDR

        1)  ATSDR needs to meet with and include the community early on 
        before it decides how to respond to the questions and concerns 
        raised by the community. How it responds should be tailored to 
        address the concerns and questions raised by the community. 
        ATDSR should consider the community its partner and jointly 
        develop the scope of work to be done at the site. A similar 
        recommendation was made in 1990.

           Before beginning any work at a site, ATSDR should include 
        members of the affected community in the design and development 
        of any protocol for conducting a health study, heath assessment 
        or health investigation that the agency is considering in 
        response to a request or concerns raised by a community. This 
        same recommendation was made in 1990.

        2)  ATSDR should consider providing financial resources to 
        communities so that they can participate as partners in the 
        design and development of the study/assessment. Perhaps a 
        Health Assessment Grant, comparable to EPA's Technical 
        Assistance Grant could be made available to community 
        organizations. This same recommendation was made in 1990.

        3)  ATSDR needs to acknowledge that the scientific methods and 
        procedures currently used to respond to questions and concerns 
        about increased health problems in a community are limited and 
        rarely can provided accurate and useful information about the 
        health problems in a community. Research is needed to critique 
        the scientific methods and procedures currently used to respond 
        to questions about increased health problems in a community.

           ATSDR should overhaul its health study, health assessment, 
        and cluster investigation methods and procedures. The 
        fundamental direction of such studies should be to aid local 
        communities in applying precautionary principles to end 
        potentially harmful exposures. The local community should have 
        the right to veto the undertaking of a health evaluation/
        investigation. This right should be codified explicitly in 
        federal legislation. A similar recommendation was made in 1990.

        4)  ATSDR should be given the authority it needs to achieve its 
        mission which is ``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.'' ATSDR should have the 
        authority to order the relocation of residents exposed to 
        levels of toxic chemicals that pose an unacceptable health risk 
        and to take appropriate actions to reduce or avoid public 
        health exposures.

           ATSDR has the authority to declare and respond to urgent 
        public health concerns, and to require EPA to take action on 
        significant risks, but the agency has little if any authority 
        to take action at sites where the risks are not as well 
        characterized or defined, which likely include more that 90% of 
        the sites that ATSDR is involved in. The agency needs to be 
        given the authority to follow through with steps to reduce or 
        eliminate exposures especially in situations where data is 
        lacking or where uncertainty about the risks exists.

        5)  ATSDR should take a precautionary approach to environmental 
        health. The primary role of a federal health agency should be 
        to identify precautionary measures that could be taken to 
        reduce public exposure to toxic substances. Clear thresholds 
        should be established and adhered to that recommend actions 
        such as relocation or providing alternative water supplies.

        6)  ATSDR should have its own budget for testing to collect and 
        analyze environmental samples. The agency is too dependent upon 
        data and information generated by EPA that is collected to 
        define the degree and extent of contamination at a site, not 
        necessarily to evaluate the health risks and health impacts 
        posed by a site. With its own budget for testing, the agency 
        would be able to address data quality concerns and to fill in 
        data gaps and inconsistencies. The agency should also be 
        empowered to challenge EPA when it identifies data of poor 
        quality, data gaps, or data inconsistencies. It may also be 
        helpful if ATSDR got involved earlier in the site investigation 
        process in order to have input into the design of the data 
        collection process as part of the Remedial Investigation/
        Feasibility Study (RI/FS).

        7)  ATSDR should review and perhaps alter its criteria for 
        establishing if a significant risk exists at a site. It 
        currently appears to have an overly stringent requirement for 
        data to prove past or current significant health risks. A 
        different framework is needed to allow ATSDR to use limited and 
        incomplete data, which will always be the case, to reach 
        conclusions on the basis of the weight of the evidence. It 
        needs to focus more on qualitative information rather than on 
        the kinds of data used by EPA in risk assessments.

        8)  In considering options to address the community's concerns 
        and questions, ATSDR should be flexible and more creative and 
        consider alternatives such conducting a pilot study to gather 
        information rather than limit their options to a health 
        assessment or other typical response. A pilot study might 
        include conducting specific medical tests to help determine who 
        has been exposed and how severely, collecting blood from a 
        targeted group of residents, or conducting a disease or symptom 
        prevalence study which could provide valuable information to 
        the community and which could be the basis for further study 
        and action. A similar recommendation was made in 1990.

        9)  There should be independent and timely expert peer review 
        of ATSDR health studies, health assessments, and health 
        investigations. The peer review members should include 
        community representatives as well as scientists.

    Thank you for your time and the opportunity to provide these 
remarks. I will be happy to answer any questions you may have.

    Chairman Miller. Thank you, Mr. Lester.
    Dr. Wargo for five minutes.

  STATEMENT OF JOHN P. WARGO, PROFESSOR OF ENVIRONMENTAL RISK 
              ANALYSIS AND POLICY, YALE UNIVERSITY

    Dr. Wargo. Mr. Chairman and distinguished members of the 
committee, thank you very much for inviting me. I feel honored 
to be here today, and I want to share my thoughts with you 
about the island of Vieques but also the effectiveness of the 
ATSDR and CDC in providing public health assessments. I would 
also like to conclude with some recommendations, some directed 
to reform the science and the quality of analysis done at ATSDR 
but also to suggest several legislative initiatives that I 
think are also necessary.
    My name is John Wargo, and I spent seven years conducting 
research on the island, and my research is more fully presented 
in four chapters in a book just published by Yale Press called 
Green Intelligence.
    The ATSDR concluded in 2003 that contaminants released by 
the United States and allied forces during the latter half of 
the 20th century posed no significant health to those who live 
on or formally lived on the island of Vieques, Puerto Rico. My 
own conclusions, recognizing that more than 100 million pounds 
of munitions had been released on that island over a period of 
nearly 60 years, including nearly 200 different types of 
munitions, have created a toxic soup, a mess that I have never 
seen anything similar to in my experience. My conclusions are 
that the ATSDR's public health assessments, one on fish and 
shellfish, another on air, another on soils and another on 
water, contain serious flaws in scientific methods, analyses 
and interpretations of evidence yet the agency consistently 
concluded that human health risks are not significant.
    In brief, the agency concluded that the absence of evidence 
of contamination is sufficient to conclude that the absence of 
significant health effects occurred on the island. However, the 
poor quality of environmental monitoring and surveillance make 
it impossible to justify the sweeping declarations of safety 
that are made by the ATSDR. One problem with the agency is that 
it rarely has conducted its own research on environmental 
contamination, human exposure, disease prevalence, and these 
flaws are carried through to their analyses and conclusions. 
For example, the ATSDR on Vieques has conducted no human tissue 
testing, so they have no firm evidence of what exposures may 
have occurred and whether or not the body burdens of Vieques 
residents still show evidence of the exposures.
    Finally, I would like to suggest that the agency's public 
health assessments are not peer reviewed, and I would also 
argue from my analyses that they would not stand up to peer 
review. They would not be published in high-quality scientific 
journals.
    Congressman Miller asked me several questions, and I wanted 
to make a couple of comments about the ATSDR's fresh look 
effort. I had the opportunity to go to CDC's headquarters and 
to review with them their progress and interpretations of data 
last fall, roughly six years following the release of their 
public health assessments. I believe that the ATSDR scientists 
and administrators realize that their 2003 public health 
assessments and conclusions of safety were premature and poorly 
supported by available evidence. Is this really a fresh look? 
Well, I am not clear about that, and I think that we need to 
hear directly from them about it. It is certain to me that they 
are analyzing other data that is now available to them but they 
are still not collecting human tissue data. They are still not 
trying to reconstruct human exposure to the chemicals that were 
released on the island. They have not conducted their own 
independent testing of plants, chemicals in plants or in fish 
or in wildlife that can become components of the viequenses' 
food supply.
    I believe there is an underlying cultural problem here that 
was alluded to earlier. The ATSDR I think has misperceived its 
intended mission. The public health assessments demonstrate the 
agency believes that its purpose is to search for conclusive 
evidence that hazardous chemicals have caused health loss. 
Since the data necessary to demonstrate and to prove health 
loss associated with chemical exposures is rarely sufficient, 
the agency almost always concludes no significant threat to 
human health and it declares safety. Yet these conclusions are 
illogical and scientifically flawed. ATSDR may not have 
sufficient evidence to conclude community danger but it 
similarly does not have sufficient evidence to conclude safety.
    So I would like to conclude just by referring to certain 
principles that might help to reform the agency's efforts. One 
is, they need to track the sources of contamination on the 
island. There is still no good accounting for what the Navy 
released, when they released it and where they released it. 
This makes the scientific process of understanding human 
exposure and health risks just about impossible. The agency 
really does need to do human tissue testing. It needs to study 
disease prevalence. We need fundamental epidemiology on the 
island to be able to distinguish health outcomes that the 
population experienced and try to relate those to intensities 
of exposure. They need to express their findings and critique 
their data with analyses of the certainty and quality of each 
component of a risk assessment, and they do not do that.
    So in conclusion, I would just like to suggest that the 
central problem seems to be their predisposition, the need to 
prove danger, and I suggest that the standard be reversed. The 
burden of proof should be on the agency to demonstrate a 
reasonable certainty of no harm. Now, that phrase is taken from 
the Food Quality Protection Act. Switch the burden of proof on 
the agency to demonstrate safety, a reasonable certainty of no 
harm. If they needed to do that, I think we would get a much 
more thorough evaluation of the data, a much more realistic 
assessment of patterns of exposure and ultimate health effects.
    I am going to close with one thought. I went back this 
morning and I reviewed the Superfund law. I looked at title 42, 
chapter 103, subchapter one, section 9604, that describes 
Congress's intent for the ATSDR. If you read that paragraph 
carefully, you will find that the agency is directed to 
understand patterns of exposure, to assess human health risks, 
to conduct tissue testing when necessary, and all of these 
requirements of Congress, had they occurred on Vieques, then I 
don't believe that we would be here today.
    Thank you very much for your attention.
    [Statement of Dr. Wargo follows:]

                  Prepared Statement of John P. Wargo

    My name is John Wargo and I am here this morning to provide 
testimony to evaluate the public health assessments (PHA'S) prepared by 
the Agency for Toxic Substances Disease Registry (ATSDR) concerning 
human health risks on the island of Vieques, Puerto Rico. I also hope 
to provide my thoughts on what might be done to improve the quality of 
the CDC/ATSDR's public health assessments for communities lying near 
Superfund National Priority sites.
    I have been a professor at Yale University for the past 25 years, 
and I specialize in the estimation of human exposure to hazardous 
chemicals with a special focus on children and women's health. I have 
conducted research in Vieques, Puerto Rico during the past 7 years. I 
also have provided advice to several EPA administrators, testified in 
both Senate and House committees, worked with several National Academy 
of Sciences committees, provided advice to the Vice President's office, 
the Food and Drug administration, the World Health Organization, the 
Food and Agriculture Organization, and I have served on EPA's 
Scientific Advisory Panel and Review Board for nearly 5 years.
    My research Vieques is more fully presented in a book titled Green 
Intelligence that includes 4 chapters on the history and toxic 
aftermath of the Navy's actions on the island. This book was peer 
reviewed and published by Yale University Press in late 2009, and I am 
attaching relevant chapters to today's testimony as background for the 
committee to review.

Response to Congressman Miller's Question 2:

    ``Describe your assessment of ATSDR's 2003 environmental health 
evaluations of Vieques which determined that there were no adverse 
human health effects caused by U.S. military bombing operations there 
that have left a legacy of environmental contamination on the island.''

        1.  The ATSDR concluded in 2003 that contaminants released by 
        the U.S. and allied forces during the latter half of the 20th 
        century posed no significant health threat to those who live 
        on, or formerly lived on the island of Vieques, Puerto Rico. My 
        own conclusions are that the ATSDR's public health assessments 
        contain serious flaws in scientific methods, analyses and 
        interpretations of evidence, yet the agency consistently 
        concludes that human health risks are insignificant.

        2.  In brief, the Agency concluded that the absence of evidence 
        of contamination is sufficient to conclude the absence of 
        significant health threat. However, the poor quality of 
        environmental monitoring and surveillance makes it impossible 
        to justify the sweeping declarations of safety made by ATSDR.

        3.  The Agency routinely relied on studies previously prepared 
        or data collected by others rather than designing new studies 
        that are appropriate for local conditions and problems. The 
        Agency did collect fish and examined them to identify the 
        presence of hazardous chemicals, however their sampling designs 
        were inappropriate and insensitive.

        4.  The Agency rarely conducted its own research on 
        environmental contamination, human exposure, and disease 
        prevalence, and flaws in any available studies leads them to 
        conclude there is no credible evidence of a causal relation 
        between hazardous materials and disease within communities that 
        lie adjacent to Superfund sites. ATSDR conducted no human 
        testing on Vieques to determine whether hazardous chemicals 
        released by the Navy were present in the tissues of island 
        residents. Nor did the Agency conduct any original 
        epidemiological studies to understand patterns of disease 
        prevalence on the island. These types of data are fundamentally 
        necessary to understand the relations between hazardous 
        chemicals and human illness.

        5.  I believe the Agency has overlooked the role of food 
        contamination as a source of human exposure in its health 
        assessments on Vieques. Research on food intake in many island 
        communities demonstrates the importance of fish and shellfish 
        as routes of human exposure to methylmercury. The National 
        Academies of Science concluded in 2000 that the most 
        scientifically defensible limit for human intake of 
        methylmercury is 0.1 ug/kg/day. This is also EPA's recommended 
        limit on daily intake. ATSDR throughout most of this final 
        report assumed in 2003 that a level 3 times higher than the NAS 
        and EPA recommendation is the appropriate benchmark.

        6.  A careful review of the ATSDR public health assessments 
        reveals an agency determined to find no causal relation between 
        the Defense Departments 60 year history of dropping nearly 100 
        million pounds of weapons on a small island, and the 
        exceptional incidence of human illness among those that lived 
        through this history.

        7.  Soil Contamination Public Health Assessment: The Navy and 
        ATSDR failed to collect soil contamination data associated with 
        military operations. The absence of these data prevented them 
        and others from understanding when and where soil might pose a 
        public health threat. This could occur from soil particles 
        exploding into the atmosphere, drifting downwind in the 
        atmosphere, eventually settling on plants, soils, and perhaps 
        open cisterns.

        8.  Grazing Animals and their Products: The Navy, EPA, and 
        ATSDR neglected research on grazing activities by cattle, 
        goats, sheep, pigs and chickens. Their importance to the diet 
        of Vieques population is poorly understood, but could 
        potentially have been a significant additional pathway of 
        exposure. The Navy leased lands to those who grazed their 
        stock, some in close proximity to the Live Impact Area.

        9.  The Navy has carefully controlled access to the bombing 
        range in a manner that has precluded the conduct of scientific 
        research by independent scientists such as myself. It is 
        reportedly spending hundreds of millions of dollars in efforts 
        to clear the area of metal wreckage, but little has been spent 
        to understand historical patterns of resident exposure. When 
        the government controls the science, they control the narrative 
        risk to human health. There is a clear need to create an 
        alternative institutional to conduct these health assessments 
        by independent and unbiased scientists.

        10.  Finally the Agency's public health assessments are not 
        peer reviewed. And I believe that given the limitations I have 
        described in my detailed attachments, they would not withstand 
        peer review in top-tier journals such as Environmental Health 
        Perspectives, or the American Journal of Public Health.

Response to Congressman Miller's Question 3:

    ``Given your experience over the past year interacting with ATSDR 
regarding their commitment to take ``a fresh look'' at available data 
regarding potential public health threats from toxic exposures to the 
Vieques residents what lessons do you believe ATSDR has learned, if 
any, from their original environmental health evaluations?''

        1.  Premature Findings of Safety: I believe that ATSDR 
        scientists and administrators now realize that their 2003 
        public health assessments and conclusions of safety were 
        premature, and poorly supported by available evidence.

        2.  Fresh Look? The ATSDR may produce update PHA's based upon 
        additional data collected by other government organizations. It 
        is unclear whether the agency intends to collect original data. 
        During our meeting in the fall of 2009 at CDC headquarters in 
        Atlanta, a group of independent scientists strongly recommended 
        that ATSDR collect original data.

        3.  Underlying Cultural Problem: The ATSDR has, I believe, 
        misperceived its intended mission. The PHA's demonstrate that 
        the agency believes its purpose is to search for conclusive 
        evidence that hazardous chemicals have caused health loss.

           Since data necessary to demonstrate the cause of health loss 
        from rarely exist, the agency normally finds ``no significant 
        threat to human health'', and it declares the safety of 
        surrounding communities. Yet these conclusions are illogical, 
        and scientifically flawed. ATSDR may not have sufficient 
        evidence to conclude community danger, but it similarly does 
        not have sufficient evidence to conclude ``safety''.

        4.  Resource Limitations May be Driving Premature Conclusions: 
        ATSDR has a budget of nearly $15 million per year to spend on 
        PHA's. Consider for example that 150 Superfund sites require 
        investigation to understand community health risks. This would 
        allow the Agency to spend $100,000 per site per year to conduct 
        research. This limited budget would normally preclude the 
        conduct of original research specifically tailored to 
        individual sites. ATSDR appears to have dealt with its resource 
        constraints by developing generic PHA's that rely on data and 
        analysis previously conducted by others.

        5.  Can ATSDR be Expected to Adopt Health Protective 
        Recommendations? I find this to be unlikely unless additional 
        decision protocols are adopted to guide the agency's data 
        collection, analyses, interpretations, and recommendations. My 
        specific recommendations follow in response to question 4.

Response to Congressman Miller's Question 4:

    ``Provide any specific recommendations you may have about how ATSDR 
can help ensure that its future public health products are based on 
sound science and address critical aspects of potential human health 
effects of environmental contamination.''

Principles for Improving ATSDR Public Health Assessments: ATSDR should:

        1.  Track the Sources and Movement of Hazardous Chemicals

        2.  Pay More Attention to Chemical Persistence and Mobility

        3.  Test Appropriate Media for the Presence of Chemical 
        Residues

        4.  Understand the Magnitude and Variability of Human Exposures

        5.  Consider Exposure to Chemical Mixtures

        6.  Consider Variability in Human Susceptibility: Pregnant 
        Women, Children

        7.  Conduct Human Tissue Testing

        8.  Evaluate Disease Prevalence in the Community of Concern

        9.  Explicitly Evaluate the Quality and Uncertainty of Each 
        Data Source

        10.  ATSDR's Burden Should be to Prove Safety, Not Significant 
        Risk

        11.  Establish Rigorous Standards Before Declaring Safety

        12.  Answer the Question: Is there Reasonable Certainty of No 
        Harm?

        13.  Recommend Realistic Guidelines for Exposure Reduction.

    This concludes my testimony, however I am providing a detailed 
critique of the 2003 Vieques Public Health assessments in the following 
four attachments.

Attachment 1: Critique of ``Public Health Assessment: Fish and 
Shellfish Evaluation, Isla de Vieques Bombing Range, Vieques, Puerto 
Rico'', dated June 27, 2003.

        1.  Sampling Design:

                  Insufficient Sample Sizes: The size of 
                samples collected and tested for individual species is 
                insufficient to reach any conclusion about the extent 
                and variability in fish contamination among sites. No 
                more than 5 individuals were tested for each species at 
                each site. This small sample size does not permit 
                statistical comparison among locations. Table 7 
                describes the number of each species collected at each 
                of the 6 sampling sites. For example, only 11 
                yellowtail Snapper were collected, although they are 
                among the most commonly consumed fish by island 
                residents. At two sites, no Yellowtail were collected, 
                only 1 was collected at another, 2 at another, 3 at 
                another and 5 at the last location. This sampling plan 
                is fundamentally flawed to test the hypothesis that 
                higher concentrations would be found in fish in closer 
                proximity to the Live Impact Area. It also does not 
                take into account intensity or direction of currents, 
                or direction of prevailing winds.

                  Areas Commonly Fished? ATSDR did not 
                structure its sampling design based upon knowledge of 
                areas commonly fished by Vieques fishermen and 
                residents, nor did it investigate which species are 
                most likely to be consumed on the Island, compared with 
                those sold off-Island.

                  Testing Fish Purchased At Markets? ATSDR 
                collected fish at the market in Isabel Segunda and 
                tested them for the presence of mercury. Yet the Agency 
                has no knowledge of where these fish were caught. These 
                fish might have originated tens of miles offshore from 
                Vieques.

        2.  Vieques Islanders' Fish Intake: Before any conclusion may 
        be reached about the hazard posed by fish contaminated at 
        different concentrations, patterns of fish intake should have 
        been carefully studied. Understanding the species most often 
        consumed and the amounts consumed are both necessary to 
        estimate exposure and health risk. Also some groups such as 
        commercial fishermen's families and subsistence fishermen are 
        likely to have far higher intake of fish than predicted by a 
        random survey of Vieques residents, or by U.S.D.A. national 
        food intake surveys. This has been well demonstrated for 
        Republic of the Seychelles, and other island communities.

        3.  Mercury:

                a.  There are important conflicts in the analyses that 
                ATSDR presents to justify its conclusions regarding the 
                safety of consuming fish caught near Vieques.

                b.  The key issue is whether mercury exposures exceed 
                the health guidelines recommended by the U.S. National 
                Academy of Sciences (NAS). The NAS concluded in 2000 
                that the most scientifically defensible limit for human 
                intake of methylmercury is 0.1 ug/kg/day. ATSDR 
                throughout most of this final report assumes that a 
                level 3 times higher than the NAS recommendation is the 
                appropriate benchmark. See Tables D3 and D4.

                c.  Using average concentrations of mercury detected in 
                fish collected at 6 locations, all exceeded the NAS 
                recommended limit by 6-11 times for children, and by 3-
                5 times for adults.

                d.  In many instances in the report, ATSDR compares 
                exposure estimates to its recommended limit of 0.3 ug/
                kg/day. If exposures exceed the limit, ATSDR places a 
                star (*) next to the estimate, and the accompanying 
                note states: ``Estimated exposure exceeds health 
                guideline . . .''

                e.  ATSDR presents data on Snapper concentrations 
                (Tables D17 and D18) and in this case only, they have 
                changed their recommended limit to be in accordance 
                with the NAS recommendation (0.1 mg/kg/day).

                f.  Even though both the adult and children's estimated 
                exposure to mercury in snapper is 2-4 times higher than 
                the recommended limit, ATSDR does not highlight the 
                estimate with an asterisk and cautionary language.

                g.  If ATSDR had employed the lower, more health 
                protective limit, the threat to children, even average 
                Snapper intake appears to place them at significant 
                risk.

                h.  Given these problems, how can ATSDR conclude: ``It 
                is safe to eat snapper every day''?

        4.  Cumulative Exposures: The ATSDR does not address the 
        potential for Vieques residents to exceed safe levels of 
        exposure to contaminants such as methylmercury in fish caught 
        nearby in addition to other sources such as canned tuna fish. 
        ATSDR should explain why it believes that pregnant women and 
        children are safe from typically detected levels of 
        methylmercury in tuna, in addition to mercury detected in 
        Vieques fish. Cumulative exposure should be addressed for other 
        contaminants released by the U.S. military on the island.

        5.  Half-life of Methylmercury: ATSDR neglected to consider the 
        extended half-life of methylmercury in the human body; 
        estimates range between 40-180 days. Half life is defined as 
        the amount of time necessary to reduce the body's concentration 
        by 50%. Given this extended period, frequent fish consumption 
        can cause concentrations to build in the body. Vieques 
        fishermen often consume fish 5 or more times per week, yet 
        ATSDR did not study their intake patterns, or their tissue Hg 
        concentrations.

        6.  Uncertainty, Error Estimates, and Statistical Significance: 
        ATSDR does not follow standard scientific practice and report 
        sources and magnitudes of uncertainty--including error--
        surrounding estimates of exposure? Nor does the Agency present 
        quantitative estimates of the statistical significance of their 
        findings. This would be difficult and damaging to their 
        conclusions due to small sample sizes.

        7.  ATSDR Conclusions: Despite limitations in sampling design 
        and sample size, the ATSDR reached three aggressive and 
        unsupportable conclusions:

                  ``It is safe to eat a variety of fish and 
                shellfish every day.''

                  ``It is safe to eat fish and shellfish from 
                any of the locations sampled, including from around the 
                LIA and the two sunken Navy target vessels.''

                  ``It is safe to eat the most commonly 
                consumed species, snapper, every day.'' (ATSDR 2003 pp. 
                2-3).

        8.  Other Foods: ATSDR assumes that fish constitute the only 
        significant food that might carry contaminants of military 
        origin to the dinner table. It is well recognized that the Navy 
        leased rights on the Eastern end of the island to graze cattle. 
        Since cattle grazed for years immediately downwind from the 
        Live Impact Area, it seems prudent to consider the potential 
        for metals, explosives, and other contaminants of military 
        origin to be taken up by plants that are in turn consumed by 
        cattle. Due to the propensity of many of these compounds to 
        persist and bioaccumulate, beef and dairy consumption could 
        have been an additional source of exposure. Similarly, other 
        plants used for food and grown in contaminated soils should be 
        considered potentially important pathways for human exposure. 
        The restriction of ATSDR attention to fish seems convenient 
        rather than scientifically justified.

        9.  Conclusions:

                a.  The Navy admits responsibility for intense release 
                of munitions and other hazardous substances to the 
                Vieques environment--tens of millions of pounds of 
                ordnance--during the last half of the 20th century.

                b.  The ATSDR's conclusions that fish intake by Vieques 
                residents poses no health threat is not supported by 
                the data the Agency relied upon to reach the finding.

                c.  Mercury levels detected in fish sampled by ATSDR 
                may pose a specific threat to fetuses, infants, and 
                children, depending on their bodyweights, fish intake, 
                and fish contamination levels. This threat is well 
                recognized by many scientists. The level deemed safe 
                has varied among government agencies, including FDA, 
                EPA, ATSDR, and the World Health Organization. EPA's 
                standards have been the most rigorous.

                d.  Detected mercury concentrations result in ATSDR's 
                own human exposure estimates that are 2-11 times higher 
                than maximum levels recommended by both the National 
                Academy of Sciences and the Environmental Protection 
                Agency.

                e.  Lead, mercury, cadmium, chromium, arsenic, and 
                uranium have all been released into the Vieques 
                environment by U.S. and allied armed forces. These 
                elements are well recognized to hazardous substances, 
                and they have the potential to be absorbed by plants, 
                wildlife, fish and shellfish.

                f.  The ability of mothers to transfer mercury to 
                unborn fetuses, the low body weight of fetuses and 
                children relative to adults, and the rapid growth and 
                development of fetal and childhood tissues, all combine 
                to make young children especially vulnerable to toxic 
                effects that threaten normal growth and development. 
                Age-related physiological susceptibility is not part of 
                the ATSDR health risk assessment, and it should be 
                fully considered.

Attachment 2: Critique of Vieques ATSDR Water Public Health Assessment

          The Vulnerable Period: The 35 year period between 
        1943 and 1978 (when a public water supply from mainland Puerto 
        Rico was completed) is the most likely time when the island's 
        population might have been exposed to hazardous compounds 
        released to the environment by the Navy via drinking water. Yet 
        this is also a period when government testing of environmental 
        quality on the island was minimal.

          Absence of Water Quality Testing: The poor history 
        and quality of water quality testing make it difficult to 
        reconstruct a history of exposure with precision. Water 
        supplies on Vieques were not tested routinely for chemicals 
        that were intensively released to the environment by the Navy.

          No New Data: ATSDR did not conduct any tests of its 
        own. Instead, the Agency relied on former studies conducted by 
        the Puerto Rican Department of Health (1999, 1995), the USEPA 
        (1999-2000), the U.S. Geological Survey (1996), and a 
        consulting firm hired by the Navy (1999).

          Most Likely Routes of Exposure: The most probable 
        routes of exposure to chemicals released to the Vieques 
        environment by the Navy include 1) contamination of drinking 
        water wells from airborne chemicals that drifted and settled in 
        the watersheds surrounding municipal wells; 2) contamination of 
        cisterns from airborne chemicals that drifted and settled into 
        the tanks; 3) contamination from Naval use of pesticides and 
        herbicides; 4) contamination from fuel releases-both 
        intentional and accidental; and 5) waste disposal practices.

          No Peer Review: The ATSDR studies are not peer 
        reviewed, remain unpublished, and are often based upon sampling 
        designs and exceptionally small sample sizes (ranging between 
        1-12 samples). Degradation products were not tested or 
        reported.

          No Dose Reconstruction: The ATSDR did not attempt to 
        reconstruct possible doses experienced by island residents. 
        This normally should be done in a way that accounts for the 
        special vulnerability of fetuses, infants and small children, 
        who normally consume far higher amounts of water per unit of 
        their bodyweight per day. Given uncertainty, simulation 
        modeling would be the most appropriate analytic method to 
        estimate the range of exposures most likely experienced by the 
        island's population.

          Pesticides and Herbicides Neglected: The EPA studies 
        cited by ATSDR routinely neglected to test for pesticides and 
        herbicides. The Puerto Rico DOH did test for pesticides and 
        herbicides in 1995. However, the Navy has not disclosed its use 
        of pesticides and herbicides, and this could help guide water 
        quality sampling designs.

          Cisterns: ATSDR did not evaluate exposures that may 
        have resulted from contaminated cisterns. It is probable that 
        chemical residues from the explosion of ordnance drifted 
        westerly with prevailing winds over inhabited areas on Vieques. 
        It is also probable that these residues settled down in open 
        cisterns, leading to human exposures via drinking water 
        consumption. Exposures via this route were likely higher prior 
        to the completion of the public water supply pipeline from the 
        main island in 1978. Cisterns are still used when power is 
        interrupted on the island, or when water pressure drops.

          Detections of Explosives: ATSDR also reported the 
        presence of RDX (0.04 ppb) and Tetryl (0.05) in the drinking 
        water supplies of Isabel Segunda (0.5 ppb), and RDX (0.04 ppb) 
        in the drinking water of Esperanza in May of 1978, referencing 
        a Naval Surface Weapons Center report (Hoffsommer and Glover 
        1978; Lai 1978). Neither the Navy nor the ATSDR provide a 
        plausible explanation for these findings, nor did the Navy 
        follow these findings with additional sampling efforts. This 
        same 1978 study reported detection of RDX above the limit of 
        detection in sea water west of the NAF area. This is 
        significant given the enormous dilution potential of the ocean. 
        Higher concentrations of RDX were then reported in a lagoon, to 
        the west of the NAF, and in surface water runoff from the NAF 
        area. These findings--a declining gradient in concentration of 
        RDX from the bombing range to a nearby lagoon, and then to 
        seawater--suggest a logical pathway of chemical movement from 
        the Live Impact Area to coastal waters.

          Sampling Design: The ATSDR conclusion that ``public 
        drinking water supplies pose no health hazard'' is not 
        supported by a statistically valid sampling design, and 
        discounts exposures that most likely occurred (given the Navy's 
        findings of RDX and Tetryl in the community water supply) 
        during the third quarter of the 20th century.

          Nitrate and Nitrite: The ATSDR found several wells on 
        the island had high nitrate and nitrite levels, and attributed 
        contamination to either agricultural activity or septic system 
        leakage. Nitrate and nitrite are also common components of 
        military ordnance, yet this was not considered by the Agency.

          Absence of Risk or Absence of Testing? The studies 
        interpreted by ATSDR do not demonstrate the absence of health 
        threat associated with Naval activities. Instead, they 
        demonstrate the absence of the Navy's testing of the 
        community's drinking water supplies.

Attachment 3: Critique of Vieques Air Pathway Evaluation Public Health 
Assessment

        1.  Failure to Collect and Manage Air Pollution Data: On 
        numerous occasions, the ATSDR concluded that air pollution data 
        was mismanaged by the Navy and therefore provides unreliable 
        information regarding the magnitude and distribution of air 
        contaminants during high activity training periods on the Live 
        Impact Area.

           The following excerpts from the ATSDR Soil PSA demonstrate 
        this problem:

                a)  ``Over the last 2 years, ATSDR has identified two 
                documents indicating that PREQB conducted air sampling 
                on Vieques in 1972 (Cruz Perez 2000; TAMS 1979), but 
                original documentation for this sampling effort 
                apparently cannot be located.''

                b)  ``ATSDR has identified two references suggesting 
                that another air sampling project took place on Vieques 
                in 1978, starting on May 16 and continuing through July 
                (Cruz Perez 2000; EPA 1999). However, original 
                documentation of this sampling project has not been 
                located.''

                c)  ``The Navy's 1979 Environmental Impact Statement 
                (EIS) for continued use of the bombing range documents 
                results from a 2-month air sampling program (TAMS 
                1979). . . . No information is provided on the sampling 
                methods used or on data quality . . . . ATSDR finds 
                that the measured concentrations from this sampling 
                effort are of an unknown quality, because no 
                documentation can be found describing the sampling 
                methods used or the quality assurance measures taken.''

                d)  ``ATSDR has identified two accounts of an EPA air 
                sampling project that reportedly took place on Vieques 
                in the 1970s (ViequesLibre 2001, ViequesWar 2001). 
                Neither account cites an EPA document where these 
                findings are published or provides critical information 
                ATSDR would need to interpret this sampling project, 
                such as the number and locations of sampling stations, 
                the sampling methods, and the measured air 
                concentrations.''

                e)  ``Based on the best information available, ATSDR 
                has reason to believe that EPA never sampled air on 
                Vieques in the 1970s. Because valid sampling data form 
                the best basis for evaluating the public health 
                implications of exposure to air pollution, ATSDR 
                encourages any individuals with detailed information on 
                past sampling projects to submit them to the agency for 
                review.''

                f)  ``Because no sampling programs extensively 
                characterized air quality on Vieques during live 
                bombing exercises, ATSDR relied entirely on a modeling 
                study to evaluate this exposure scenario.''

                   Why would ATSDR and EPA fail to collect data during 
                live fire exercises, especially given the intensity of 
                litigation and criticism of these activities by island 
                residents?

        2.  Exposures to Releases from Military Training Exercises 
        Using ``Live'' Bombs

                a)  Averaging Periods: The ATSDR has averaged pollution 
                levels over two periods, one year and 24 hours. This 
                may be relevant for chronic respiratory disease 
                prevalence, however it neglects the potential for short 
                term bursts of pollution to exacerbate existing 
                respiratory problems such as asthma, allergies, and 
                chronic bronchitis. Averaging pollution over 24 hours 
                could make short term high intensity releases caused by 
                explosions disappear. However, these episodes may be 
                quite relevant to estimating respiratory distress among 
                the sensitive. This is especially problematic for young 
                children who have immature and narrower airways than 
                adults.

                b)  Particle Size: As mentioned above, low diameter 
                particles (less than 2.5 microns in size) were not 
                measured. These fine and ultrafine particles stay 
                suspended for longer periods of time, move longer 
                distances, and may become more deeply embedded in the 
                lungs of young children, or others with restricted 
                airway diseases. These finer particles were not 
                measured by ATSDR, the Navy, or EPA. These particles 
                may also act as nuclei for other hazardous VOC's.

        3.  Wind Blown Dust: ``ATSDR concludes that wind-blown dust 
        from the LIA on days when bombing did not take place is not a 
        health hazard.'' Wind blown dust near the LIA is likely to have 
        contained fine diameter particles that are likely to have 
        become airborne under dry and windy conditions. This could have 
        led to range worker exposures to mixtures of chemicals released 
        when weapons exploded and settled to the ground.

        4.  Chaff: ``ATSDR can only conclude that the previous chaff 
        usage at Vieques was not greater than 133 tons per year.'' 
        ATSDR notes that no one has quantified the fate of chaff 
        released above Vieques. Chaff is dropped from aircraft to 
        confuse radar and disguise airborne military operations. 
        ``Chaff fibers typically are 25 microns ( m) thick and between 
        1 and 2 centimeters long''. Chaff fibers are visible to the 
        human eye and have the appearance of short, very fine, hair-
        like fibers. (Naval Research Laboratory 1999).''

                a.  Each year ATSDR estimates that 266,000 pounds of 
                chaff may have been deliberately dropped over or near 
                Vieques.

                b.  Ground level concentrations of chaff were never 
                monitored by the Navy or other government authorities.

        5.  African Dust Storms:

                a)  The Navy suggested that the source of metals and 
                other contaminants on Vieques could have been Sub 
                Saharan dust storms thousands of miles away.

                b)  It is difficult to understand why this hypothesis 
                generated more credibility with the Navy than a more 
                plausible hypothesis, namely that airborne chemicals 
                released to the atmosphere could move with prevailing 
                winds to reach island villages, only 6-9 miles away.

Attachment 4: Critique of Vieques Soil Pathway Evaluation Public Health 
Assessment

        1.  Failure to Collect and Manage Soil Contamination Data: The 
        Navy consistently failed to collect soil contamination data 
        associated with training operations. The absence of these data 
        prevented them and others from understanding when and where 
        soil might pose a public health threat. This could occur from 
        soil particles exploding into the atmosphere, drifting downwind 
        in the atmosphere, eventually settling on plants, soils, and 
        perhaps open cisterns.

        2.  Grazing Animals and their Products: The Navy, EPA, and 
        ATSDR neglected research on grazing activities by cattle, 
        goats, sheep, pigs and chickens. Their importance to the diet 
        of Vieques population is poorly understood, but could 
        potentially have been a significant additional pathway of 
        exposure.

                 ``Community members expressed concern over the 
                possibility that livestock are accumulating heavy 
                metals by grazing on contaminated plants . . . . To 
                date, ATSDR has not been able to obtain the original 
                data or report that support these findings.''

        3.  Plant Contamination: ``ATSDR could not quantify exposures 
        from these reports nor draw any health conclusions about 
        whether consuming plants grown in Vieques would result in 
        harmful health effects.''

                 Why would ATSDR not test soil, edible plant tissues, 
                and edible animal products for hazardous compounds 
                released to the environment by Navy activities?

    Chairman Miller. Thank you, Dr. Wargo.
    Dr. Edwards for five minutes.

   STATEMENT OF MARC EDWARDS, CHARLES P. LUNSFORD PROFESSOR, 
  DEPARTMENT OF CIVIL AND ENVIRONMENTAL ENGINEERING, VIRGINIA 
           POLYTECHNIC INSTITUTE AND STATE UNIVERSITY

    Dr. Edwards. Yes, and thank you for cuing up the PowerPoint 
I will use to support my experiences and observations related 
to the 2001-2004 D.C. lead-in-water crisis.
    The D.C. lead crisis was a historic violation of the public 
trust by government. Lead in D.C.'s drinking water was very 
high from 2001 to 2004 due to corrosion of plumbing materials 
in tens of thousands of homes, apartments, buildings, schools, 
even the U.S. Congress was impacted. The levels of lead were 
very high, some of which exceeded hazardous waste levels, and 
this danger was hidden from the public for nearly three years. 
When this was revealed in a January 31, 2004, front page 
Washington Post article, there was understandably public 
concern and outrage because lead is perhaps the best-known 
neurotoxin. It affects every vital system in the body. The 
damage is irreversible, and infants and developing fetuses are 
most vulnerable.
    The publication of the Washington Post article set in 
motion five different Congressional hearings, an investigation 
led by current U.S. Attorney General Eric Holder, lawsuits and 
an investigation by the GAO, all of which were to be derailed 
by the CDC.
    In early April 2004, the CDC published what they purported 
was their assessment of the impacts of the high lead in blood 
on residents of Washington, D.C., and their conclusion was very 
clear and unambiguous. They stated that although lead in tap 
water contributed to a small increase in blood leads, no 
children were identified with blood lead levels above the 10-
microgram-per-deciliter CDC level of concern, even in the homes 
with the highest water lead of greater than 300 parts per 
billion. In other words, according to the CDC, all health 
impacts were below their level of concern by definition.
    This publication was little more than a cheap publicity 
stunt. What the CDC did not reveal was that they had data in 
their possession that 75 percent of the consumers whose blood 
lead they tested had been drinking bottled water for weeks, 
months or even a year before their blood lead had been tested, 
removing all evidence of harm that would have been done. CDC 
knew about potential forgery in the blood lead data and that 
thousands of children's blood lead records had gone missing and 
they further skewed their data analysis, deleted other critical 
information that could have put their conclusions into some 
kind of context.
    For years, the CDC refused to correct the scientific 
record, and what is more, they actively blocked any of my 
attempts to try to figure out what occurred. They did not 
release data, records or follow FOIA law. They would not 
investigate obvious data irregularities and other credible 
questions I raised, and they did nothing or even encouraged the 
spread of their misguided conclusions, creating untold harm. So 
when their report hit the press, the news story about the D.C. 
lead crisis was it was much to do about nothing and that the 
real problem was public hysteria because CDC had proved there 
were no health effects. In Seattle, the CDC study was cited as 
reason why parents should not be the slightest bit concerned 
about high level in Seattle schools' drinking water because of 
the great work CDC had done in Washington, D.C. And I attended 
workshops and conferences in Europe, Australia and Canada where 
the CDC work was cited as definitive proof that high lead in 
water did not cause harm to humans.
    Fed up with this stonewalling by the CDC for over two 
years, I collaborated with Children's National Medical Center, 
Dr. Dana Best and a Ph.D. in my research group, and we 
reevaluated using Children's National Medical Center data the 
effects of elevated blood lead on young children, and what we 
discovered was that the high lead in D.C. water caused a 240 
percent increase in lead poisoning for kids less than 30 months 
of age in neighborhoods that had the highest lead in water and 
a greater than 900 percent increase in lead poisoning for 
infants less than 15 months of age, many of whom were drinking 
formula made from reconstituted tap water.
    So in conclusion, we determined that high lead in water is 
a public health concern, and this was known 2,000 years ago, 
and this is the knowledge that CDC's publicity stunt erased 
from the public consciousness. I have also concluded that there 
is a culture of scientific corruption in branches of this 
important agency, and there is no evidence it has the 
capability for self-correction.
    [Statement of Dr. Edwards follows:]

                   Prepared Statement of Marc Edwards

EXPERIENCES AND OBSERVATIONS FROM THE 2001-2004 ``DC LEAD CRISIS''

INTRODUCTION

    I am the Charles Lunsford Professor of Civil and Environmental 
Engineering at Virginia Tech, where I conduct research at the interface 
of basic science, public health, corrosion control and environmental 
engineering. I have published over 100 peer-reviewed journal articles, 
made hundreds of technical presentations, and have been recognized with 
numerous awards including a Presidential Faculty Fellowship from the 
White House/National Science Foundation (1996) and a MacArthur 
Fellowship (2008). Time magazine named me amongst the 4 most important 
``Innovators'' in water from around the world (2004) and just this year 
Villanova University awarded me the Praxis Award in Professional 
Ethics.
    My undergraduate training in the basic/medical sciences (BS in Bio-
Physics), my graduate degree in Environmental Engineering (MS/PhD), and 
my experiences with the Centers for Disease Control and Prevention 
(CDC) from 2005 to the present make me highly qualified to discuss key 
aspects of the agency's public health practices. I have worked on the 
issue of elevated lead in Washington DC drinking water from 2001-2004, 
an event widely referred to as the ``DC Lead Crisis,'' since I was 
hired by the United States Environmental Protection Agency (US EPA) in 
2003 to evaluate causes of the contamination. I testified on this issue 
before the US House Government Reform Committee in March 2004 and have 
worked on the issue as a volunteer ever since.
    Before relating my experiences and observations, I disclose my 
position on certain matters discussed in this testimony. I believe that 
in some instances, elevated lead in US potable water is a public health 
concern. Other countries have studied this issue, determined that lead 
in water is a major correlate to elevated levels of lead in children's 
blood, but have rationally weighed the different needs and decided that 
other problems are more deserving of public funding.1 I 
respect, appreciate and can support such honest and open assessments. I 
also believe that lead paint and dust hazards pose a serious health 
threat, and I support all rational efforts to address them. I also 
believe that the vast majority of scientists and public health 
officials in the water industry, US EPA, local Departments of Health, 
and the CDC are conscientious and uphold very high ethical and 
scientific standards. I believe in the CDC's mission. I also believe it 
is critically important that the CDC retain the public's trust. My 
testimony today should not be construed contrary to the above 
statements. Indeed, I offer today's testimony in hopes of saving the 
CDC from itself.
    My experiences and knowledge are primarily related to a publication 
entitled Blood Lead Levels in Residents of Homes with Elevated Lead in 
Tap Water--District of Columbia, 2004.2 This paper was 
coordinated, prepared, and published by the CDC in their March 30, 2004 
Morbidity and Mortality Weekly Report (MMWR) series. The MMWR series is 
often called ``the voice of CDC'' and ``is the agency's primary vehicle 
for scientific publication of timely, reliable, authoritative, 
accurate, objective. and useful public health information and 
recommendations.'' 3 This particular paper is henceforth 
referred to as the ``CDC MMWR.'' The paper had 21 coauthors, actions of 
three of whom are discussed in this testimony:

        1)  Mary Jean Brown, ScD, RN, Chief of the Lead Poisoning 
        Prevention Branch at the National Center for Environmental 
        Health (NCEH), CDC. Dr. Brown prepared the paper.

        2)  Lynette Stokes, PhD, MPH, who at the time of the paper's 
        writing was overseeing the blood lead testing program at the 
        Washington DC Department of Health (DC DOH). Dr. Stokes was 
        previously employed by CDC's sister agency. the Agency for 
        Toxic Substances and Disease Registry (ATSDR). Dr. Stokes is 
        listed as 1st author of the paper.

        3)  Daniel R. Lucey, MD, MPH, interim head of the DC DOH. Dr. 
        Lucey was involved in the DC Lead Crisis for just a few weeks 
        before publication of the CDC MMWR. In his public statements, 
        Dr. Lucey made it clear that he did not have experience on lead 
        health issues, and that his actions and responses relied on the 
        expertise of Dr. Brown and Dr. Stokes.

    According to the CDC, contributions to the MMWR series ``must 
contain new or original information or guidelines/recommendations that 
substantially increase understanding of a public health problem.'' 
3
    My testimony begins with a review of what was known about 
lead in drinking water prior to publication of the CDC MMWR and then 
gives a brief overview of the DC Lead Crisis. After describing how the 
destructive impacts of the CDC MMWR were amplified by reckless 
omissions destined to mislead readers, it briefly discusses some of the 
intermediate and longer-term repercussions of the publication. 
Speculation as to the CDC's possible motivation to mislead readers and 
the public at large, and failure to clearly correct their misleading 
conclusions for years after being made well-aware of serious problems 
with them, set the stage for highlighting some of my own experiences 
with the CDC. The testimony provides substantive insights to 
deficiencies in the agency's environmental public health practices.

HEALTH EFFECTS OF LEAD IN WATER: BEFORE THE CDC MMWR

    Knowledge that elevated lead in water poses a public health concern 
dates back more than 2,400 years. In 312 BC, Vitruvius noted that ``. . 
. water ought by no means to be conducted in lead pipes, if we want to 
have it wholesome.'' 4 Later work on the subject was 
succinctly summarized on March 5, 2004 in the Congressional testimony 
of MacArthur Fellow and Johns Hopkins University Professor Ellen 
Silbergeld, PhD: 5

         `` . . . lead exposure via drinking water alone can by 
        itself be sufficient to induce toxicity, especially in young 
        infants. In a landmark paper in 1967, Sir Abraham Goldberg and 
        his colleagues traced the etiology of a cluster of mentally 
        retarded children in Glasgow to the storage of drinking water 
        in lead lined tanks (Gibson et al 1967). Shannon and Graef 
        (1989) reported the case of an infant poisoned by drinking 
        water with a lead concentration of 130 ppb. EPA considers that 
        `lead at concentrations of 40 ppb or higher poses an imminent 
        and substantial endangerment to the health of children and 
        pregnant women' '' (bold italic emphases in original).

    Dr. Silbergeld's written testimony was accompanied by an extensive 
list of peer-reviewed scientific papers that linked elevated lead in 
drinking water to lead in blood, and by extension to adverse human 
health effects.
    Additional research is noteworthy. For instance, to examine the 
role of (then legal) lead solder as a potential hazard, Ryu et al. 
(1983) tracked a group of 7 infants fed formula contaminated with 70 
parts per billion (ppb) lead and another group of infants formula 
containing 10 ppb lead.6 The blood lead of the infants 
exposed to the lower level of lead increased by 1.1 ug/dL, whereas that 
of infants exposed to the higher level of lead rose by 8.3 ug/dL 
(Figure 1). A blood lead level of 10 ug/dL or higher is termed ``a 
level of concern'' by the CDC for children less than 6 years of age. 
Blood lead levels exceeding the CDC level of concern are also commonly 
referred to as ``elevated'' or ``lead poisoning'' in different 
localities. The blood lead of infants consuming formula with 70 ppb 
lead rose above the CDC 10 ug/dL level of concern after about 1 month 
of exposure (Figure 1).




Figure 1. Effects of infant formula contaminated with lead on blood 
lead of infants (data from Ryu et al., 1983).6

    Numerous other peer-reviewed research publications were 
consistent with the Ryu et al. results, including one co-authored by 
CDC's Dr. Brown entitled ``Childhood lead poisoning: Case study traces 
source to drinking water.'' 7 8 In that study, an 
infant whose blood lead rose to 42 ug/dL had no other lead source in 
the home but contaminated drinking water, and the flushed water 
contained just 20-80 ppb lead. These publications served as the basis 
for the US EPA Lead and Copper Rule (US EPA, 1991), the nation's only 
federal regulation designed to protect consumers from exposure to 
elevated levels of lead in their drinking water.9
    In early March 2004, after public disclosure of DC's serious 
lead in water contamination problems, and several weeks before the CDC 
MMWR's publication, researchers at the US EPA National Center for 
Environmental Risk Assessment used projections based on human health 
data to predict the likelihood of lead poisoning for DC infants 
consuming reconstituted infant formula for one year. I obtained copies 
of this work via the Freedom of Information Act (FOIA).10 
The US EPA determined that if lead in DC tap water exceeded about 200 
ppb, it was a virtual certainty that a DC infant's blood lead would 
rise above the CDC's 10 ug/dL level of concern (Figure 2). Even if the 
drinking water contained just 50 ppb lead, the agency calculated, blood 
lead levels of nearly 1 out of every 2 infants (i.e., 50% probability 
of elevated blood lead) would rise above CDC's level of concern. 
According to an inter-agency e-mail, the US EPA sent Dr. Stokes memos 
and results summarizing their work as part of an on-going conversation 
between the US EPA and DC DOH.




Figure 2. Data from US EPA projections made early March 2004, 
indicating the likelihood of elevated blood lead in DC infants as a 
function of water lead level. Infants were assumed to consume 
reconstituted formula for 1 year of exposure.

    As a further point of reference, on February 2, 2005, the US 
Consumer Product Safety Commission (CPSC) was to classify a lead dose 
of 175 ug as an ``acute health risk'' to children: 11

         ``To avoid exceeding the 10  g/dL level of concern from 
        acute exposure, CPSC staff recommends that children not ingest 
        more than 175  g of accessible lead in a short period'' (red 
        underlined emphasis in original).

    The new CPSC standard was used as a trigger for recalling millions 
of products. If this standard, which was applied to jewelry and toys 
(products not intended for human consumption), were applied to lead in 
water (a product intended for human consumption), the one-time 
ingestion of 1 liter of water at 175 ppb lead would also be classified 
as an ``acute health risk'' due to concerns related to elevated blood 
lead.
    In conclusion, prior to publication of the ``new information'' in 
the CDC MMWR on March 30, 2004, there was extensive knowledge in the US 
public health community that water lead levels in the range of 20-70 
ppb would constitute a serious public health concern (Table 1). Canada 
and the World Health Organization (WHO) also have health-based 
guidelines of 10 ppb for drinking water.12 13

Table 1. Relevant lead in water standards and associated public 
health guidance as of early March 2004; the key conclusion of the CDC 
MMWR, published on March 30, 2004; and the CPSC acute health risk 
criteria of early 2005, as applied to drinking water.




THE DC LEAD CRISIS AND THE CDC MMWR

    The lead levels in DC drinking water from 2001-2004 were 
unprecedented in modern history. Some samples exceeded ``hazardous 
waste'' criteria (>5,000 ppb) and the contaminated water was present in 
tens of thousands of DC buildings including homes, apartments, offices, 
schools, daycare facilities and even the US Congress. From 2001-2004 
the extent of the problem was hidden from the public by illegal 
actions, unethical behavior and bungling of numerous government 
agencies as detailed in investigations led by current US Attorney 
General Eric H. Holder, the US Government Accountability Office (GAO), 
hearings before five Congressional Committees, and hundreds of articles 
in the Washington Post and elsewhere.14-20 Some findings 
from these investigations and the role of each agency are briefly 
summarized in Table 2.
    Due to the actions and inactions of these government agencies, 
consumers of DC tap water including pregnant women and their fetuses, 
children attending schools and daycare centers, commuters, tourists and 
even members of the US Congress were at relatively high risk of 
exposure to lead in water hazards from 2001-2004. The public was for 
the most part entirely unaware of the contamination, and for almost 
three years did not receive adequate warnings to use simple actions 
that would reduce or eliminate the hazard (e.g.. use of filters, 
bottled water or flushing).

Table 2. Key agency involvement in the DC Lead Crisis. For details see 
references.14-20




    When the extent of the lead in water problem was first 
revealed in the Washington Post on January 31, 2004,21 the 
public was fearful of the harm done to DC's children, and outraged at 
the responsible agencies' multi-year and gross negligence. Lead, which 
is perhaps the best-known environmental neurotoxin, affects adversely 
and irreversibly every major organ system in the human body. Developing 
fetuses and infants are most vulnerable to harm from exposure.
    On March 8, 2004, the international law firm Paul Hastings filed a 
class action lawsuit against DC WASA and DC City Government, and gave 
formal notice to the US EPA, and the Army Corps of Engineers of a 
potential lawsuit. The press release stated that the lawsuit was 
brought on behalf of two young children with lead in water levels of 
435 and 310 ppb, and that potentially tens of thousands of ``. . . DC 
residents have been unwittingly exposed to lead, a serious toxin.'' 
22
    A few weeks later the CDC released the CDC MMWR. purportedly 
investigating the impacts of the high lead in water on the blood lead 
of DC residents. Contrary to reasonable expectations based on prior 
research (Table 1), the CDC paper concluded that no children had 
experienced elevations to blood lead levels that exceeded CDC's level 
of concern as a result of the DC Lead Crisis:

         ``. . . although lead in tap water contributed to a small 
        increase in BLLs in DC, no children were identified with BLLs 
        >10  g/dL, even in homes with the highest water lead levels. . 
        . . Water was collected from homes with a high probability of 
        having lead service pipes; the March 2004 BLL screening program 
        was limited to families living in homes with the highest water 
        lead levels, and the routine blood lead surveillance program 
        focused on identifying children at highest risk for lead 
        exposure. For these reasons, the percentages of BLLs >5  g/dL 
        or >10  g/dL reported probably are higher than those found in 
        the general population.''

    In conjunction with the release of the CDC MMWR, CDC also prepared 
an internal agency ``Talking Points'' memo produced to me via FO1A 
(Figure 3). The memo's ``main message'' was that ``There is no 
indication that DC residents have blood lead levels above the CDC 
levels of concern . . . as a result of lead in water.''




Figure 3. CDC MMWR ``Talking Points'' Main Message.

    The CDC's reassuring conclusion brought a collective sigh of relief 
from government officials and anxious parents. Reinforced at numerous 
press conferences and in sworn testimony by the paper's DC DOH co-
authors, including Dr. Lucey and Dr. Stokes, it rapidly fostered a 
new--albeit false--understanding regarding one of the best-understood 
and widely studied environmental health hazards. The ``no significant 
harm'' echo chamber reverberated with statements such as the following:

         ``Overall, what we have been finding, and again this is 
        primarily from the CDC publication that just came out this week 
        . . . we have not found evidence that lead in the water has 
        increased the percent of elevated blood lead levels in young 
        children, so that is very, very good and important 
        information.''

    Sworn Testimony of Dr. Lucey to the DC Council, April 1, 2004

         ``. . . that's good news, that's good news . . . . the homes 
        we went to with the public health service, that had the highest 
        levels of lead in the water, greater than 300 ppb and this was 
        published last week March 30 in the Morbidity and Mortality 
        Weekly Report. 201 people who live in those homes with the 
        highest levels of lead in the water. Zero. None. Zero out of 
        201 had elevated blood lead levels . . . .''

    Dr. Lucey at the Mayor's Press Conference, April 7, 2004

         ``None of the 201 persons we tested who live in homes with the 
        highest measured levels of lead in the drinking water (i.e. > 
        300 parts per billion (ppb)) had elevated blood lead levels.''

    Written Testimony of Dr. Lucey, US Senate Oversight Hearing of 
Drinking Water in the District of Columbia, April 7, 2004

    Not to be outdone in exploiting the public relations opportunity 
that the CDC MMWR created, DC WASA hired a consultant. Tee L. Guidotti, 
MD, MPH, via a contract with George Washington University, who was to 
meet regularly with the CDC and DC WASA on DC lead in water issues 
through at least late 2007. In the immediate aftermath of the CDC MMWR 
publication, Dr. Guidotti made numerous public statements about the 
insignificance of very high lead in water levels (>300 ppb):

         ``Dr. Tee Guidotti . . . has advised the Water and Sewer 
        Authority . . . that: A discernable effect on BPb  
        of children requires at least sustained levels of 300 ppb.''

    Jerry N. Johnson, former General Manager, DC WASA, Testimony to US 
Senate Committee on Environment and Public Works, April 7, 2004.

         ``Drinking water is at most a minor source of lead for 
        children. Drinking water may contribute a small amount if 
        sustained exposure.''

    Tee L. Guidotti report to DC WASA, see also May 6, 2005; Washington 
Post, May 9, 2005.

CRITICAL INFORMATION OMITTED FROM THE CDC MMWR

    The public, and apparently some of the agencies themselves, had 
been successfully duped. The CDC MMWR may have been authoritative but 
it was not trustworthy--the paper's conclusions were skewed by omission 
of several critical facts. Just how skewed, was not to be revealed, 
until my colleagues and I published a peer reviewed journal article in 
2009 that proved hundreds (and in all likelihood thousands) of children 
had their blood lead elevated above the CDC level of concern as a 
result of exposure to DC's contaminated drinking water from 2001-
2004.23 Our paper was recently acknowledged with an award 
for Best Science paper appearing in the prestigious journal 
Environmental Science and Technology during 2009.
    Details of my initial concerns regarding omission of critical data 
in the CDC MMWR were provided in two letters to the CDC Office of 
Scientific starting in 2007. Both of my letters are currently available 
on-line.24 I await, and defer to, two forthcoming 
investigative reports by the US House Committee on Science and 
Technology and the Washington DC Office of Inspector General for 
additional information about actions of the CDC and DC DOH co-authors. 
In this section, I mention 4 representative omissions (which are not 
necessarily the worst ones) so that the remainder of my testimony can 
be placed into context. Thereafter, I reveal what I currently know 
about the authors' knowledge and rationale for each of these omissions.
    First, the portion of the CDC MMWR that was to be most cited in 
testimony and press coverage, involved blood lead testing for a group 
of 201 DC residents who lived in homes with over 300 ppb lead in their 
flushed tap water. These residents had volunteered for a special water 
lead sampling event conducted by DC WASA in 2003, and had been informed 
that their tap water was severely contaminated (>20 times the 15 ppb US 
EPA lead action limit) several months to a year before DC DOH began 
testing residents' blood. By the time their blood lead was collected 
for the CDC MMWR study in March 2004, the residents had been taking 
measures to protect themselves from the high lead in water for an 
extended period of time. Given that the half-life of lead in blood is 
on the order of 28-36 days,25 by the time these residents'' 
blood was drawn for analysis, the evidence of harm would have largely 
disappeared from their blood. Ironically, in contrast to statements in 
the CDC MMWR and associated sworn testimony suggesting that the ``worst 
case'' of lead exposure had been captured in this study, this 
particular group of 201 residents tested, were actually amongst the 
least likely groups in the city to show evidence of harm from high lead 
in water. The CDC's discovery that none of these residents had elevated 
blood lead, therefore, provided little or no insight into what their 
blood lead had been months to a year before taking actions to protect 
themselves.23
    Second, the CDC MMWR authors did not reveal detailed 
knowledge, in their possession, proving that virtually all of the 201 
residents targeted for their study were taking active protective 
measures, as anyone would if told months to a year previously that 
their drinking water was contaminated with astronomical levels of lead. 
Specifically, a spreadsheet I obtained from the DC DOH via FOIA 
revealed that for residents who answered a DC DOH questionnaire and had 
an indicated blood lead collection date, all but 6 (of the 201) were 
using bottled water or a filter. Of 174 residents who answered a 
question about bottled water use, 130 indicated ``Y'' and 44 indicated 
``N.'' Assuming that Y meant ``yes'' (i.e., consistent with the symbols 
used for lead filter use in the paper and in the spreadsheet), then 75% 
of the residents who responded to the questionnaire were using bottled 
water. Moreover. none of the 6 residents who were potentially drinking 
tap water (without use of filters or bottled water) were children. The 
only statement appearing in the CDC MMWR that even alludes to some of 
these critically important facts, was a confusing single sentence that 
made no mention whatsoever of bottled water use:

         ``Of the 201 residents, a total of 153 (76%) reported drinking 
        tap water, and 52 households (53%) reported using a water 
        filter.''

    Sworn verbal testimony by Dr. Lucey, sometimes mentioned the use of 
water filters but repeatedly emphasized that the researchers had 
determined that a majority of residents in their study ``were drinking 
tap water.'' The precise question in the DC DOH questionnaire asking 
residents about their consumption of tap water is important, and has 
never been produced to me. For example, the residents may have been 
asked ``how much tap water do you generally consume,'' which might have 
caused residents to provide answers based on their experiences in the 
months to a year before they had been told their flushed water was 
contaminated with more than 300 ppb lead. If that were the case, the 
answer might not have any relevance to their water consumption in the 
weeks, months or year before their blood lead was finally analyzed in 
March 2004. To my knowledge. Drs. Lucey, Stokes and Brown never once 
publicly mentioned that their data demonstrated that 75% of their 
supposedly ``worst case'' DC residents were drinking bottled water.
    Third, at no point did the CDC MMWR authors discuss, acknowledge, 
or cite a single reference to decades of prior scientific research that 
unambiguously linked elevated lead in water to elevated lead in blood, 
and which could have put their novel MMWR conclusions into context. The 
impact of this omission was amplified by the authors' repeated 
statements in public press conferences and under oath that virtually 
nothing had been known about links between lead in water and lead in 
blood prior to conducting the CDC MMWR study. For example, responding 
to DC City Council Members' questions about the health effects of lead-
contaminated drinking water and with Dr. Stokes at his side, Dr. Lucey 
asserted that:

         ``. . . What we have been doing here in the District of 
        Columbia for about the last 5 weeks, that is, we are trying to 
        generate scientific data to answer that question because the 
        answer doesn't exist in the medical literature . . . we 
        published this article in the CDC MMWR . . . trying to answer 
        the question . . . . What is the correlation between the EPA 
        action level of 15 ppb, or really any concentration of lead in 
        the water, and the effect on health, even as assessed though 
        blood lead levels? It seemed to me the best way to try to 
        answer this question, after not finding the answer in the 
        medical literature, after not finding the answer by talking to 
        lead experts within at the Department of Health or at the 
        Centers for Disease Control that's my answer, to generate the 
        data.''

    Testimony of Dr. Lucey, DC Council Hearing, April 1, 2004

    Indeed, the first lawmaker exposed fully to the picture portrayed 
by the CDC MMWR enthusiastically asserted that when it came to links 
between lead in water and lead in blood:

         ``. . . . there is no real data out there to see the 
        correlation. So we really do believe, by the enormous amounts 
        of blood testing that we are doing related on this lead in the 
        water issue, we are doing a public service not only for the 
        District of Columbia, but for the United States of America and 
        probably even the World on this issue . . . .''

    DC Council Member Carol Schwartz, Mayor's Press Conference, April 7 
2004

    Taking on the role of medical pioneers, the CDC MMWR authors even 
spoke about speculative bio-mechanistic theories, which are flatly 
contradicted in the scientific literature, to support the astounding 
CDC MMWR ``no significant harm'' discovery:

         `` may not get into the bloodstream as 
        readily as potentially, inhaling dust, or eating a chip which 
        has large concentrations of lead . . . we're learning that, and 
        we really did not know what we'd see.''

    Lynette Stokes, Your Health Matters, aired May 2004

    Fourth, the CDC MMWR omitted knowledge about the high degree of 
uncertainty, as to which DC residents had what type of service line 
pipe. The CDC knew that DC WASA's database regarding service line 
material occurrence was little more than a guesstimate, because the 
data sent to CDC was grouped into three categories: 1) homes with lead 
service lines, 2) homes without lead service lines, and 3) homes 
suspected to have lead service lines. Even these categories grossly 
misrepresented the utility's knowledge, because DC WASA later revealed 
that there were thousands of more lead service lines in DC than they 
initially suspected. DC WASA's underestimation of homes with lead 
service lines was important because it confounded the CDC's analysis, 
and also, because residents known to be living in homes with lead 
service lines have historically been targeted for specialized public 
health protection by DC WASA and DC DOH. Some of the strongest evidence 
of childhood elevated blood lead from water, was later linked to homes 
in which DC WASA had only suspected had a lead service line.26
    For the CDC MMWR, the actual blood lead data for residents 
living in homes with suspected lead service lines were analyzed, but no 
mention of this analysis, or even an acknowledgement that the data 
existed, was to appear in the published paper. The analysis indicated 
that of 144 DC residents tested in homes with suspected lead service 
lines in 2000 (before lead in water was high), only 12 (or 11.5% of the 
total) had blood lead > 10 ug/dL. But for 141 residents tested in 2001 
(when lead in water was high) 18 (or 18.4% of the total) had blood lead 
> 10 ug/dL. A similar increase occurred in 2003 versus 2000. The trend 
in this dataset showing increased incidence of elevated blood lead for 
these residents, after the lead in water had increased, was 
contradictory to the conclusions eventually published in the CDC MMWR.
    According to the Federal Register (2000), scientific misconduct via 
falsification refers to ``. . . changing or omitting data or results . 
. .'' so that the overall presentation is inaccurate.27 
Further, ``A finding of research misconduct requires that (a) There be 
a significant departure from accepted practices of the relevant 
research community; and (b) The misconduct be committed intentionally, 
knowingly, or recklessly; and (c) The allegation be proven by a 
preponderance of the evidence.'' In response to the question ``Aren't 
there circumstances when omission of data or results is appropriate?,'' 
the Federal Register states that:

         `` . . . . omission of data is considered falsification when 
        it misleads the reader about the results of the research.''

    Internal agency documents provided to me via FOIA in late 2009 shed 
light on important aspects of the authors' knowledge about the omission 
of data. Although the record is incomplete, it strongly suggests that 
several CDC MMWR co-authors did not see a draft copy of the paper 
before a ``nearly final'' version was distributed by Dr. Brown on March 
23, 2004--seven days before the paper was published. Two days before 
the distribution of the ``nearly final draft,'' one co-author wrote a 
comment about the study of the 201 residents with > 300 ppb lead in 
their flushed water. He asked about the government employees who 
questioned the residents:

         ``Did they ask about bottled water.''

    On March 23, 2004 at 12:04 pm, Dr. Brown e-mailed a copy of the 
``nearly final draft'' to several potential co-authors, with a message 
that included the following statement:

         ``By COB today I need every officer who believes he/she 
        contributed sufficiently to merit authorship to forward an e-
        mail to Dr. Mary Jean Brown at  which states that 
        you've read the final draft, concur with the results, and your 
        involvement is sufficient to merit authorship.''

    Dr. Brown's e-mail message did not solicit her co-authors' feedback 
on the content of the nearly final draft. It just gave the recipients 
slightly less than five hours on a workday, to decide whether or not 
they wanted to be listed as co-authors. Again, the record in my 
possession suggests that many of the recipients had never seen the 
paper prior to this time. Despite these constraints, a few recipients 
responded with questions and comments, gently revealing concern about 
some of the key omissions in the draft they had received. Specifically:
    One co-author, responding at 1:17 am on March 24, 2004--already 
well after Dr. Brown's ambitious deadline of ``COB''--sent an e-mail 
response that included several co-authors. asking:

         ``Do we want to mention that many of DC residents (couldn't 
        give you #'s though) have been drinking bottled water before 
        any of this went public? Or does that just confound the data 
        some more?''

    An e-mail from another co-author, date deleted, but presumably 
written after the previous comment, stated:

         ``I am not sure if the bottled water consumption would skew 
        the data, but it does present another piece that might confuse 
        the reader.''

    Still another e-mail, date deleted, but written in response to Dr. 
Brown's March 23 e-mail, revealed that some of the co-authors clearly 
knew about the long time that had elapsed between the water testing the 
previous year (i.e., 2003) and the blood lead testing during the month 
of the paper's writing (i.e., March 2004). It also indicated how the 
disclosure of this gap in the paper would be important to help the CDC 
MMWR readers understand ``why currently no persons have blood lead 
levels above the levels of concern'':

         ``Do you want to point out that the water samples that were 
        tested in many of the homes were done last year, but the blood 
        lead measures were determined this month? Between those two 
        time periods, some people stopped drinking water supplied by 
        WASA; some people starting using filters, and some people had 
        the lead supply lines to their home replaced before blood lead 
        levels were measured. The point is that this may help to 
        explain why currently no persons have blood lead levels above 
        the levels of concern'' (bold emphasis added).

    The fact that the above remarks were unsolicited suggests that the 
co-authors who took the initiative to write them may have felt 
especially uncomfortable with the omissions. Moreover, it may explain 
their rather passive tone and unassertive suggestions for changes. It 
may also be the case that other co-authors had similar concerns, or 
even other concerns, but Dr. Brown's e-mail indicated that there was no 
time or even the opportunity to raise them. I have no evidence that Dr. 
Brown ever responded to any of the above co-authors. However, in the 
end, Dr. Brown did not reveal the important facts the authors 
possessed, and which are clearly mentioned in the above e-mails, in the 
published CDC MMWR. Instead, she proceeded to publication with a 
version of events, that was, at a minimum, a reckless presentation of 
what the blood lead level data meant.
    In relation to her decision not to make any mention of bottled 
water use. in 2009 Dr. Brown shared her rationale via e-mail to a 
reporter, who forwarded the answer to me for comment:

         ``This was not included in the report because CMDR Tim Cote, 
        US Public Health Service, a partner in the investigation. had 
        reported that he found on average only a 1  g/dL difference in 
        the average BLL comparing those who did drink water with lead 
        levels greater than 300 ppb to those who did not (4.6 compared 
        to 3.6), making the information about use of bottled water 
        incidental to the overall findings. CMDR Cote planned to 
        publish these data himself . . .'' (bold emphasis added).

    Neither of Dr. Brown's reasons for omitting this critical 
information are sound, either ethically or scientifically. Certainly, 
the fact that 75% of the residents in her study were using bottled 
water is not ``incidental'' to the results of the research, and the 
revelation that the authors were entitled to withhold this critical 
information from the current paper for a possible later publication is 
outrageous.
    Other critical omissions occurred not by failing to put important 
information into the paper, but by actually editing important 
information out. For example, before the ``nearly final draft,'' a 
version of the CDC MMWR featured the following conclusion about blood 
lead levels for residents in homes with ``suspected lead service line'' 
before and after lead in the city's drinking water spiked:

         ``In addresses with suspected lead service lines, the percent 
        of test results > 10 ug/dL showed an increase, however, there 
        were fewer than 50 test results available for these addresses 
        between 2001 and 2003 . . .''

    This version of the paper also included a graph that illustrated 
the incidence of elevated blood lead for residents living in 
``suspected lead service line'' homes increasing from 11.5% in 2000 
(when lead in water was low) to 18.4% for 2001 (when lead in water was 
high). The incidence of blood lead > 10 ug/dL was also much higher in 
homes with suspected lead service lines, versus lead service lines, 
which might also be important, given that homes with lead service lines 
had obtained more public health interventions not offered to homes with 
suspected lead service lines. Sometime before the ``nearly final 
draft,'' the above facts and associated text were deleted. Again, all 
mention of ``suspected lead service lines'' was deleted from the CDC 
MMWR.
    Three more important editorial changes even occurred after the 3/
23/2004 ``nearly final draft'' had been signed off on by the CDC MMWR 
co-authors. Such changes clearly violate CDC policies for clearance of 
publications. For example, the ``nearly final draft'' featured the 
sentence:

         ``Elevated levels of lead in the water are a public health 
        concern.''

    This key sentence was completely deleted from the CDC MMWR.
    The ``nearly final draft'' version of the paper had also qualified 
the conclusion about the lack of elevations in blood lead levels above 
10 ug/dL:

         ``However, neither longitudinal surveillance data nor BLL 
        testing in addresses with the highest water lead levels 
        indicate that exposure to lead in tap water in Washington, DC 
        resulted in blood levels above 10 ug/dL, although this cannot 
        be completely ruled out'' (bold emphasis added).

    In the published paper, the same conclusion appeared without the 
qualifier, and with a change of words that created a major shift in 
perception and certainty:

         ``The findings in this report indicate that although lead in 
        tap water contributed to a small increase in BLLs in DC, no 
        children were identified with BLLs >10  g/dL, even in homes 
        with the highest water lead levels.''

    Replacement of ``although this cannot be completely ruled out,'' 
with ``even in homes with the highest water lead levels.'' was a 
regrettable shift in emphasis.
    The ``nearly final draft'' version of the paper, also had at least 
one clear reference to a citation about prior research linking lead in 
water to lead in blood, which stated:

         ``Consistent with previous work . . .  levels 
        well above the EPA action level of 15 ppb may result in an 
        increase in the percent of blood lead levels > 5 ug/dL.5 
        ''

    Although none of the documents in my possession allow me to see 
what reference ``5'' is, this statement and citation to prior research 
were also completely deleted from the published CDC MMWR. The deletion 
supported later public presentations that virtually nothing had been 
previously known about links between lead in water and increased blood 
lead.
    Ultimately, others will have to pass judgment on actions of the CDC 
MMWR authors in relation to these and other omissions of data, and 
other critical information from the CDC MMWR. But the record is clear, 
that at the height of a historic public health crisis, the CDC crafted 
an account of the public health impact that was destined to mislead not 
only the public, but also the public health and scientific communities 
nationally and internationally about the lessons learned from the DC 
Lead Crisis. The CDC not only deleted the statement that ``Elevated 
levels of lead in the water are a public health concern'' from the 
wording and skewed presentation of research results in the research 
paper, but in the process, deleted this fact from the public 
consciousness. Even more egregious than possible falsification and 
scientific misconduct, is CDC's repeated refusal to correct the 
scientific record, or highly misleading statements made about the work 
(as will be revealed in the sections that follow), because their 
inaction magnified and perpetuated the CDC MMWR's harmful 
repercussions.

IMMEDIATE REPERCUSSIONS OF THE CDC MMWR CONCLUSION

    The damaging repercussions of the CDC MMWR conclusion and the 
associated public relations campaign (including the CDC ``Talking 
Points'' memo) cannot be understated. Some of the impacts were realized 
even before the paper was published. Specifically, on March 18, 2004, 
Dr. Brown sent a draft copy of the CDC MMWR to her US EPA R3 contact 
with the subject line ``Re: EPA cite for 40 ppb.'' Shortly after Dr. 
Silbergeld's testimony on March 5, 2004, Dr. Brown had queried US EPA 
about their unambiguous health warning concerning the dangers of 
elevated lead in water, which was featured prominently on the agency's 
website in 2 locations:

         ``. . . lead at concentrations of 40 ppb or higher poses an 
        imminent and substantial endangerment to the health of children 
        and pregnant women.''

    By transmitting the draft CDC MMWR, Dr. Brown communicated to US 
EPA the obvious: that the forthcoming CDC publication would find no 
evidence for elevated blood lead in DC children who had been exposed to 
water lead levels far above the US EPA's 40 ppb threshold. Days later, 
on March 26, 2004, US EPA R3 and US EPA HQ, who were under intense 
criticism for their own role in the DC Lead Crisis, and all too willing 
for an excuse to hide their true understanding of health impacts of 
elevated water lead on children, removed all versions of the 40 ppb 
warning from their websites without any announcement or explanation. 
Earlier that week, responding to concerns of a US EPA scientist about 
the dubiousness of certain statements relating to the plumbing sources 
of lead in DC water, a US EPA R3 manager frankly revealed the agency's 
vulnerable state of mind at the time:

         ``. . . this is being driven as much by public relations and 
        politicians as what makes sense most other ways.''

    Rick Rogers, Chief of the Drinking Water Branch, US EPA R3, March 
23, 2004

    At around that same time, US EPA R3 posted confusing and ambiguous 
information about the health effects of 15 ppb lead, on a special web 
page that the agency designed for DC residents:

         ``The Action Level for lead is 0.015 milligrams per liter (mg/
        1) which is equivalent to 15 parts per billion (ppb). For 
        copper, the Action Level is 1.3 mg/1 or 1,300 ppb. This Action 
        Level was not designed to measure health risks from water 
        represented by individual samples. Rather, it is a statistical 
        trigger value that, if exceeded, requires more treatment, 
        public education and possibly lead service line replacement'' 
        (http://www.epa.cov/dclead/oversight.htm).

    The US EPA R3 statement that the 15 ppb lead action limit ``was not 
designed to measure health risks from water represented by individual 
samples'' was then cited repeatedly by the CDC MMWR authors in sworn 
written/oral testimony under oath starting April 1, 2004. The fact that 
this new ``public health message'' had been specially crafted for DC 
and, to my knowledge, was not replicated on any other US EPA web pages, 
was never revealed to the public. Upon hearing Dr. Lucey read US EPA's 
confusing message in the immediate aftermath of the CDC MMWR 
publication, one reporter wrote in amazement:

         ``This incredible information was offered by the city's 
        interim medical director, Dr. Daniel Lucey just hours before a 
        U.S. Senate committee held public hearings on the issue of the 
        city's drinking water. Lucey seemed as baffled by the website 
        admission as TBR. If the EPA standards don't measure the health 
        risk, why have them? How can there be an action level, 
        triggering specific action by state and local officials, when 
        the health risk level hasn't been determined? Is the EPA 
        engaging in CYA (cover your @#$) or does it really not know 
        what level of lead contamination constitutes a risk for 
        individuals? . . . The EPA's admission that it is completely 
        ignorant is unconscionable.''

    The Barras Report (TBR), April 10 2004

    The combination of: 1) the CDC MMWR's skewed ``main message'' that 
exposure to more than 300 ppb did not elevate residents' blood lead 
above levels of concern, 2) the authors' failure to cite, discuss or 
acknowledge prior contradictory human health research in the CDC MMWR 
or in public testimony, and 3) the US EPA's removal of the agency's 40 
ppb health warning and dissemination of confusing new language, created 
a public relations coup that protected the agencies' interests at the 
expense of public health.
    The CDC MMWR was immediately cited by revisionists, who defended 
the agencies responsible for the DC Lead Crisis, and concluded that the 
real problem was the public's uninformed ``hysteria'':

         ``The ongoing hysteria about lead in D.C.'s drinking water is 
        much ado about nothing, according to a new report from the 
        Centers for Disease Control and Prevention . . . Despite this 
        three-ringed media-lawyer-government circus, there is no actual 
        ``problem.'' No health effects whatsoever have been attributed 
        to the lead in D.C.'s water . . . the EPA can reasonably claim 
        ``no harm, no foul'' with respect to the unintended 
        consequences of its actions this time.'' (http://
        www.washingtontimes.com/commentary/20040405-095052-3607r.htm)

    This ``no harm'' message was delivered brazenly to the US Congress 
in May 2004, when an invited witness used the CDC MMWR to assert that 
while DC did not do the best job of informing the public about the 
2001-2004 contamination, the agencies involved had been proven correct 
in trying to prevent citywide panic by downplaying the dangers of the 
unprecedented lead in water elevations and by hiding information from 
the public:

         ``The notification provisions of the Safe Drinking Water Act 
        are also too inflexible. Every community must notify the public 
        when violations occur. . . . the problem is that these 
        notifications are not educating people. Instead, they are being 
        used to trigger alarm scenarios that are amplified by the 
        media. The resulting crisis mentality is not educating the 
        public, it's scaring them needlessly . . . . I am not saying 
        they did the greatest job on earth . . . It is worth noting 
        that D.C. was correct in its assessment that the lead issue 
        didn't warrant a panicked response. The science and the history 
        related to lead exposure strongly indicates that lead in 
        drinking water--even at levels that are multiple times higher 
        than federal standards--does not warrant the frenzied reaction 
        we've seen in D.C. A recently released Centers for Disease 
        Control and Prevention (CDC) study reinforces these findings. 
        It found that the elevated lead levels in D.C. water did not 
        raise the level of lead in anyone's blood to a level of 
        concern.''

    Statement of Angela Logomasini, Competitive Enterprise Institute, 
Testimony to US House Government Reform Committee, May 21, 2004

    The CDC MMWR was also prominently cited in, and clearly tempered, 
all subsequent investigations into the DC Lead Crisis in Congressional 
Hearings, the GAO investigation, and newspapers.16-20 
Afterall, if the CDC had proven that under the worst case in Washington 
DC no one experienced blood lead elevations above their level of 
concern, then the potential health implications of the DC Lead Crisis 
were also ``below concern'' by definition. What little debate there was 
about health effects, was relegated to nebulous discussions about ``how 
safe is safe,'' and the possible impacts of lead on health if blood 
lead had been only ``slightly'' elevated (but well below the CDC level 
of concern).

LONGER TERM REPERCUSSIONS OF THE CDC MMWR

    The CDC MMWR was intended to influence decision makers. The CDC 
itself notes that the MMWR readership ``. . . consists of physicians, 
nurses, public health practitioners, epidemiologists and other 
scientists, researchers, educators. . .,'' 3 and as was 
emphasized in the CDC MMWR ``Talking Points'' memo:

         ``The use of complementary data, in this case existing 
        childhood blood lead surveillance data combined with current 
        BLLs in residents of homes with the highest water lead levels, 
        provided important information for decision makers. Such data 
        are essential to identifying and responding to populations at 
        risk.''

    Dr. Brown herself provides a first-hand illustration in how the 
``important information for decision makers'' was to be applied 
henceforth in the public health community. On July 16, 2004, when lead 
in DC water was still astronomically high but the CDC MMWR had been 
solidly embraced and had gone unchallenged for over three months, Dr. 
Brown e-mailed CDC MMWR co-author Dr. Stokes to affirm that the DC Lead 
Crisis was effectively over. The first sentence of her e-mail read:

         ``Now that there is a better understanding of the public 
        health impact of lead in the drinking water in the District, I 
        hope we will be able to focus on the issue of lead-based paint 
        hazards.''

    In the aftermath of the CDC MMWR, Dr. Brown also applied her wisdom 
to edit a memo entitled ``LEAD, WATER, PAINT AND CHILDREN.'' Excerpts 
of the memo read:

         ``Childhood lead poisoning is making headlines once again, 
        this time because of the drinking water scandal in Washington, 
        DC. . . . At the same time, policy makers and parents alike 
        must keep in mind that drinking water is only one way that 
        children are exposed to lead. Lead-based paint and dust hazards 
        in children's homes pose far greater risks to children than 
        lead in drinking water . . . . The higher lead levels in the 
        District's water over the past three years have undoubtedly 
        raised children's lead levels, probably by an average of one or 
        two micrograms per deciliter. Of course, children who drank 
        water with lead levels many times the EPA action level may have 
        experienced greater elevations'' (bold emphasis added).

    Dr. Brown's written editorial comment regarding the bold sentence 
above? ``I guess I wouldn't say this.''
    After the CDC MMWR had eliminated lead in water as a public health 
concern, the possibility that ``decision makers'' would learn anything 
useful from the DC Lead Crisis relative to mitigating lead in water 
hazards vanished. Investigative reporting by the Washington Post in 
late 2004, demonstrating that numerous water utilities from around the 
US were conducting misleading testing of lead in water, created 
relatively little impact locally and nationally.28 The Lead 
Free Drinking Water Act,29 a Congressional bill that had 
gained momentum in the early days of the DC Lead Crisis to fill obvious 
gaps in the US EPA Lead and Copper Rule, failed on three separate 
occasions (2004, 2005, 2007). The Paul Hastings lawsuit was dropped. 
And Washington DC's first ever lead poisoning prevention bill was 
passed in 2008, only after the DC City Council eliminated all 
references to drinking water that had been recommended by key members 
of the District's lead poisoning prevention community.
    The US EPA, relieved by the CDC findings and by the determination 
that they could reasonably claim ``no harm, no foul,'' cited the 
research repeatedly. Eager for even broader coverage of the CDC MMWR 
conclusions, a US EPA R3 employee wrote to the CDC:

         ``One story that should be told to a larger audience is the 
        results of the historic blood lead level analysis . . . I 
        thought a good way to do that would be the development of a 
        short paper summary of those results either as a joint EPA/CDC 
        paper or just CDC or CDC and DC DOH.''

    E-mail from Rick Rogers, Chief of the Drinking Water Branch, US EPA 
R3, January 7, 2005

    US EPA R3 even offered to hire sub-contractors to assist with the 
writing of this paper. When CDC did not take up the offer, US EPA R3 
went ahead on their own, and paid for the creation and distribution of 
blood lead fact sheets and other materials re-hashing the results of 
the CDC MMWR and other misleading information, at least some of which 
was later proved false. CDC reviewed and approved these materials, 
which featured the following conclusion:

         ``Residents with high lead levels in their tap water did not 
        have elevated blood lead levels. DC DOH also tested people who 
        live in homes with elevated lead in their tap water (over 300 
        ppb). Of the 201 residents from 98 homes with elevated lead in 
        their water, no children aged 6 months to 15 years had blood 
        lead levels over 10 mg/dL.''

    Revised version of blood lead fact sheet accessed May 10, 2006 at 
http://www.epa.gov/dclead/
BloodLevelsFactSheetlO-06-rev.pdf

    Most personnel at the responsible agencies were not held 
accountable for their role in the crisis, and some who were partly 
responsible for its precipitation and handling, were even rewarded. In 
March 2005 the US EPA R3 ``Lead Response Team'' received the highest 
recognition the agency offers for outstanding employee performance, as 
announced in an e-mail from the Director of the US EPA R3 Water 
Protection Division:

         ``I am very pleased to report that . . . members of the DC 
        Lead Response Team . . . took the Gold!!! . . . The Gold Medal 
        is the highest Honor Award granted by the Agency. It is . . . 
        for distinguished service of major significance to 
        environmental improvement and to public service.''

    Jon Capacasa, US EPA Region III, March 22, 2005

    More than matching US EPA's eagerness to celebrate the landmark 
discoveries in the CDC MMWR, DC WASA gave its own regurgitation of the 
``no significant harm'' conclusion:

         ``The results of the tests confirmed that there was no 
        identifiable public health impact from elevated lead levels in 
        drinking water.'' . . . .``It is important for customers to 
        understand that although environmental lead exposure can be 
        very hazardous over a long period of time, large numbers of 
        tests conducted by the D.C. Department of Health in 2004 have 
        detected no measurable health effects from potential exposure 
        to lead in drinking water in the District of Columbia.'' (bold 
        emphasis added)

    DC WASA Web page and Mailing to Consumers, January 10, 2006

    To further enhance the visibility and scientific credibility of the 
CDC MMWR's ``historic blood lead level analysis,'' starting in 2005 DC 
WASA funded Dr. Guidotti to re-package the CDC MMWR data and other 
misleading information into a peer-reviewed publication. Fortified with 
an erroneous timeline and numerous additional inaccuracies and 
omissions, the Guidotti paper--published in 2007--effectively re-wrote 
history and portrayed DC WASA's and DC DOH's management of the DC Lead 
Crisis as a model public health response. Following in the pioneering 
footsteps of the CDC MMWR, Dr. Guidotti's main conclusion was that 
``There appears to have been no identifiable public health impact from 
the elevation of lead in drinking water in Washington, DC.''
    The Guidotti paper came under fire in 2009. In response to press 
coverage that raised serious questions about the integrity of the work, 
Dr. Guidotti himself e-mailed a ``Dear Colleague'' defense, which 
stated that his paper's conclusions had received the CDC's stamp of 
approval:

         ``The data are valid and the conclusions were agreed upon by 
        the Department of Health, EPA, and CDC.''

    Tee L. Guidotti, e-mail communication to ``Clean Water Network,'' 
Feb. 2, 2009

    At the request of an Independent Review Panel that examined only 
two of numerous concerns about the integrity of the Guidotti paper, the 
``no identifiable public health impact'' conclusion was eventually 
removed, and Dr. Guidotti himself apologized for writing the unfounded 
statement. Remaining allegations about the Guidotti paper have not been 
addressed (for the complete list of allegations, see letter to the 
journal Environmental Health Perspectives): 24
    The dangerous ``lesson'' of the DC Lead Crisis as packaged in 
the CDC MMWR began to achieve its goal of influencing decision makers 
and policy, and spread quickly to cities across the US and even 
internationally (Figure 4). A pattern formed. Whenever a significant 
problem with elevated lead in potable drinking water of homes, schools 
or other buildings was discovered, local public health officials and 
reputable scientists referenced the conclusions of the CDC MMWR as the 
most authoritative and--in the understanding of many--``only'' reliable 
information on the subject. Again and again, consumers that had just 
learned about risks of lead contaminated water in their community, were 
assured that consumption of over 300 ppb lead in Washington DC had not 
caused an increase in blood lead of concern.
    Clearly, the main message and unambiguous conclusions of CDC's 
Chief of Lead Poisoning Prevention, Dr. Brown, had been transmitted 
down through the chain of command of the public health community. The 
fact that individuals with expertise in science and public health 
accepted the preposterous absurdity that consumption of lead in water 
over 300 ppb did not elevate the blood lead of even a single child over 
the CDC's level of concern, despite the scientific understanding that 
existed prior to 2004 (Table 1 and associated discussion), is testament 
to the enormous persuasive power that the CDC wields over the public 
and the public health community. When the CDC's research is based on 
sound scientific reasoning and reliable data, this power can be wielded 
to great benefit. But when it is based on faulty reasoning and 
misleading data it can create untold harm. This was the case with the 
CDC MMWR.




Figure 4. Representative quotes of those applying the CDC MMWR to 
public policy and health messaging.

SPECULATION REGARDING CDC's MOTIVATION

    Dr. Brown's actions, and those of the CDC, to allow such an 
egregious and historic violation of basic scientific principles, and to 
jeopardize the public's health and trust, are mystifying. In this 
section I highlight information that might help shed light on some of 
the reasons behind the unfortunate decisions that were made.
    The dramatic reduction of blood lead levels in children over the 
last few decades is a public health triumph. Phase-outs of lead in 
gasoline, lead solder in canned food tins, lead paint, and reduced 
levels of lead in drinking water due to the Lead and Copper Rule 
created landmark improvements in public health. I would be the first to 
acknowledge Dr. Brown's contributions to this spectacular success 
story. However, childhood lead poisoning has still not been eliminated 
and further work is clearly needed.
    One would assume that the CDC Lead Poisoning Prevention Branch 
would exert leadership to ensure that all lead health threats are 
acknowledged properly and addressed as best as possible within existing 
financial and regulatory constraints, but I do not believe that this is 
how the CDC is approaching childhood lead poisoning prevention today, 
or did so in the past. For example, historical accounts of US EPA's 
efforts in the early 1990s to regulate lead in drinking water reveal 
that the then CDC director of the former Center for Environmental 
Health ``. . . railed against doing much in drinking water because he 
did not want to disarm lead in paint.'' 30 The same 
viewpoint, that health concerns related to lead in water somehow 
compete with and threaten the CDC's efforts to address lead in paint, 
seem to persist at the CDC to this day.
    Almost a decade after the passage of the US EPA Lead and Copper 
Rule of 1991, a President's Task Force adopted a strategy to eliminate 
childhood lead poisoning by 2010. The focus was the elimination of lead 
paint hazards. Underlying the narrowness of the Task Force's approach 
was the assumption that ``The U.S. Environmental Protection Agency 
(EPA) has . . . placed strict limits on the amount of lead in drinking 
water . . . ,'' and thus that lead at the tap was already being 
addressed.31 Such misunderstandings of the scope and 
effectiveness of the US EPA Lead and Copper Rule also permeate the 
CDC's literature. In reality, the US EPA Lead and Copper Rule does not 
put any limit whatsoever on the allowable lead in residential tap water 
(9% of collected samples can be any value whatsoever), and the 
regulation does not address the vast majority of child care centers and 
schools. Indeed, a recent 2009 Associated Press article demonstrated 
that lead levels in thousands of schools nationwide have problems with 
elevated lead in water,32 and many schools have some taps 
dispensing water lead concentrations well over the CPSC acute health 
threshold or even hazardous waste levels.33
    Maintaining a strict focus on lead paint as the primary cause 
of childhood lead poisoning, even at the expense of potentially serious 
non-paint lead sources, seems to guide much of the CDC's and Dr. 
Brown's work and reasoning. Characteristically, a few years ago, the 
Chief of the CDC's Lead Poisoning Prevention Branch responded to a 
peer-reviewed article about the relationship between lead in blood 
(BPb) and lead in contaminated soil by castigating the researchers for, 
amongst other things, not placing adequate emphasis on lead paint. In 
her critique, Dr. Brown mentioned the article's failure to cite ``. . . 
the compelling body of scientific evidence demonstrating that 
deteriorated lead-based paint and the contaminated dust and soil it 
generates is highly correlated with BPb levels in children.'' 34
    The perplexed authors responded that the subject of their 
paper was lead in soil, not lead in paint, and that: 35

         ``We are concerned that people working at agencies that 
        should champion the reduction of lead exposure do not 
        appreciate the fact that multiple sources of lead have 
        accumulated in urban environments and that all major sources 
        and reservoirs need full attention if we expect to meet the 
        goals of Healthy People 2010 (2005) [the national program that 
        aimed to eliminate childhood lead poisoning by 2010].''

    Why, when writing about the worst lead in water contamination event 
in modern history, would Dr. Brown in her CDC MMWR paper, commit a much 
more serious scientific omission, and not cite the compelling body of 
scientific studies demonstrating that lead in drinking water can be 
highly correlated to blood lead? A clue to Dr. Brown's tunnel-vision 
mindset can be found in a quote in the New York Times, which appeared 
on September 30, 2003, just months before the Washington Post broke the 
story on the DC Lead Crisis:

         ``Lead paint remains the most concentrated and readily 
        accessible source, and nothing should detract from our interest 
        in eliminating it,'' said Dr. Mary Jean Brown, chief of the 
        lead poisoning prevention branch at the Federal Centers for 
        Disease Control and Prevention in Atlanta.'' 36

    Indeed, from the earliest phases of the lead crisis and well 
in advance of data collection for the CDC MMWR, a key concern expressed 
amongst the public health community that follows Dr. Brown's 
leadership, was that the unprecedented media attention focused on DC's 
lead in water problems would draw attention and funding away from 
efforts to control lead paint.37 The handling of the DC Lead 
Crisis, and omission of critical data and deletion of key words and 
phrases from the CDC MMWR, suggests that Dr. Brown may have been 
blinded by her commitment to bolster her crusade against lead paint, 
and illustrates exactly how far she was willing to go in preventing a 
non-paint lead source from detracting focus from it.
    In 2005 when I first began to suspect serious problems with the CDC 
MMWR, one of Dr. Brown's colleagues told me confidentially that no 
matter how distorted the CDC MMWR proved to be or how serious the 
wrong-doing, Dr. Brown would never willingly correct the public health 
misconceptions her work had created. At first I was in disbelief But 
more than 6 years after the publication of the CDC MMWR, and more than 
4 years since Dr. Brown was clearly made aware of serious problems with 
the CDC MMWR's main message, Dr. Brown has doggedly failed to clear the 
scientific record of the misunderstanding that she herself created and 
promoted. In the end, unfortunately, one has to wonder if the 
repercussions of the CDC MMWR were exactly as Dr. Brown intended.
    One final example gives insight not only to Dr. Brown's motivation, 
but also to her temperament, which tragically feeds her conduct. In 
early 2009 when some lead poisoning prevention advocates from the 
Alliance for Healthy Homes, Clean Water Action and Parents for Nontoxic 
Alternatives in Washington DC began to try and correct the record, and 
to start promulgating more accurate public health messages and policies 
about lead in drinking water, Dr. Brown reacted with outright hostility 
and began to spread the word to lead poisoning prevention officials and 
advocates across the country that she was being unfairly attacked by an 
``unholy alliance'' seeking to get her fired.37 This was not 
true, the groups' longstanding work on the issue had in fact never 
focused on Dr. Brown, and what they were actually doing was directing 
efforts to persuade the CDC to correct the takeaway message of the CDC 
MMWR. But as a major funder of the nation's lead poisoning prevention 
community, Dr. Brown's power would have been sufficient to deter many 
stakeholders from joining the call for CDC's accountability. In fact, 
Dr. Brown succeeded in intimidating some Alliance for Healthy Homes 
board members into restraining the staffs advocacy, because they 
worried she might damage the organization's reputation and jeopardize 
its funding. Ultimately, in late 2009, one Alliance for Healthy Homes 
employee who led the organization's work on the issue was not offered 
employment when his organization merged with another national healthy 
housing nonprofit that receives significant CDC funding. This employee, 
who has offered decades of laudatory service to the goal of childhood 
lead poisoning prevention, was explicitly told that he would be a 
financial liability to the organization because his advocacy work on 
the CDC MMWR had upset Dr. Brown.37
    In the end, I have come to suspect that the CDC and Dr. Brown 
were driven, at least in large part, by an over-zealous, misguided, and 
unscientific compulsion to exclusively focus attention and funding on 
the lead source they consider most important. Their ``mission'' may 
have even contributed to ``missing'' hundreds (and quite possibly 
thousands) of cases of elevated blood lead in Washington DC children 
due to contaminated water from 2001-2004,23 and twisting the 
DC Lead Crisis into a public relations coup for lead paint, rather than 
acknowledging it for the environmental health tragedy it was.
    For those interested in further elaboration on CDC and Dr. Brown's 
motivation, see Appendix 1.

MOTIVATION FOR MY OWN JOURNEY WITH THE CDC

    The first time I read the CDC MMWR, based on my knowledge of prior 
research, I knew its conclusions were a scientific impossibility. On 
the other hand, I also knew that the neurological harm to DC children 
could not be undone, steps were seemingly underway to partly mitigate 
the worst of DC's lead in water contamination, and if lessons could be 
learned from the DC Lead Crisis that could prevent future harm, perhaps 
a ``cover-up'' of the public health impact was not the worst thing that 
could have happened. I expected that the responsible agencies would 
work hard to redeem themselves and once again make themselves worthy of 
the public trust. Moreover, while I had suspicions and concerns about 
the CDC MMWR from the start, I did not know, with certainty, the true 
extent of the falsification that had occurred until late 2009. Early 
on, I simply assumed that the authors had tried to faithfully present 
the data and their methods, and perhaps, something along the way 
unintentionally went awry.
    For a while I flirted with theories that the accepted laws of 
chemistry, biology and physics did not apply to Washington DC children, 
and that the lead in DC's water was somehow not harmful. A colleague, 
research chemist Michael Schock at the US EPA, had discovered that DC's 
lead problem was linked to formation of Pb(IV) rust on the lead pipes, 
as opposed to Pb(II) rust per prior conventional wisdom. Devising and 
conducting experiments throughout 2004 to test the hypothesis that 
Pb(IV) in water might not be harmful if ingested by DC consumers, I 
eventually proved to myself that there was no scientific support for 
such an explanation. The accepted laws of nature would apply. By late 
2005, alarmed by the growing influence of the CDC MMWR, concerned about 
its implications for public health not only in DC but also nationally 
and internationally, curious about the quality of the science and data 
the CDC had used to arrive at its conclusions, and confused about how 
two millennia of human experience with harmful effects from lead in 
water could be rendered irrelevant almost overnight--I resolved to 
pursue this issue via investigative science.
    Additional factors gave me resolve to begin this particular 
journey. I had heard engineers at water utilities cite the CDC MMWR as 
justification to ``game'' the Lead and Copper Rule sampling 
requirement, by conducting water monitoring for lead in ways that 
almost guarantee compliance with the standard, even when serious lead 
in water contamination was present. I began to cringe at public health 
meetings in the US and Canada when officials inevitably laid the CDC 
MMWR on the table, and stated that it was their duty to publicly 
downplay the adverse impacts of water to avoid needlessly alarming the 
public. Indeed, wasn't that the takeaway lesson from the DC Lead Crisis 
and applied by Dr. Brown herself? Of course, unfortunately, their 
reassuring public health messages would make it far less likely that 
precautionary measures would be taken seriously by the public, and that 
children and developing fetuses would be protected from harm. This 
highlights the impacts on the public of misconduct in public health 
research, via distortion and misinformation, ``which ripples from the 
large scale of federal organizations to the personal level of 
individuals.'' 38
    I was appalled at the actions of US EPA R3 and US EPA HQ, who 
in late March/early April 2004, selfishly and cowardly gutted the 
health basis for their own lead in water regulation, by replacing clear 
and understandable warnings with misleading gibberish. The US EPA even 
stood silent. in April 2004, when they were publicly ridiculed in DC 
for arriving at their 15 ppb lead in water action limit by ``pulling a 
number out of a hat.''
    Lead in DC Public Schools. I was also particularly disturbed by 
behavior of DC WASA and US EPA R3 employees. To this day, for example, 
I believe that the 2004 sampling at DC Public Schools was devised to 
hide problems with elevated lead in water. When the testing was 
complete, DC WASA trumpeted the ``good news'' about the relatively low 
incidence of lead in water hazards, reassuring DC residents that all 
was well, without revealing the flawed water collection methods that 
could have missed serious lead problems. Some of the methods used were 
later effectively banned by the US EPA for that very this reason. As a 
result, I believe, DC WASA ensured future needless harm to DC 
schoolchildren, in partnership with US EPA R3, which backed the water 
utility up on their claims. It took me 3 years to confirm and expose 
the fact that there were very serious problems with lead in much of the 
DC school system, with some taps dispensing lead concentrations over 
hazardous waste levels (>5,000 ppb).33 Still, the CDC MMWR 
conclusions seemingly rendered the health implications of that work 
insignificant.
    Partial Lead Service Line Replacements. My worry was reinforced 
when, in 2008, in partnership with a coalition of public health 
advocates in DC, we discovered that DC WASA's 5-year and $100 million 
``accelerated'' lead in water ``remediation'' program was not nearly 
the success that DC WASA and US EPA R3 had claimed. Thousands of lead 
water pipes were dug up and replaced with copper pipe, but only the 
publicly owned portion of the old lead pipe was replaced. The privately 
owned portion was left in the ground. This program of partial lead 
service line replacement-worsened lead in water levels in many homes 
for an undetermined duration. For years the agencies repeatedly claimed 
in public and in written scientific reports (again contradicting 
decades of prior experience and research), that partial replacements in 
DC were not causing lead to spike:

         ``. . . there was no immediate change, or immediate increase 
        in lead levels in the tap water'' . . . ``there is no evidence 
        that the lead levels increase'' . . . ``remove half the lead . 
        . . you have a lot less lead in your tap water as a result.''

    Rick Rogers EPA R3, Interview on WAMU Radio, May 2004

    In 2004, I had testified to the US Congress that partial lead 
service line replacements were a waste of money and that my research 
had shown the procedure could increase residents' risk for lead 
exposure. After years of denial and false statements by DC WASA and US 
EPA R3, I eventually proved that the two agencies had themselves 
collected hundreds of data points showing severe problems with DC 
residents' exposure to high lead in water, following DC WASA's partial 
lead service line replacement ``remedy'' at their homes.
    But the public health implications of our work were to be 
neutralized by what was becoming a well-oiled tag team effort by Dr. 
Guidotti and the CDC. Dr. Guidotti provided testimony and ``public 
education'' at community meetings, asserting that even the highest 
levels of lead in DC's water after partial lead service line 
replacement (sometimes exceeding 100,000 ppb) probably did not pose a 
health risk. Dr. Guidotti wrote:

         ``It has been alleged that spiking lead levels after partial 
        lead service line replacements present a health risk. This is 
        probably not correct.''

    Testimony of Dr. Guidotti, March 10, 2008

    The CDC attended two of several DC WASA public meetings on this 
issue, and consistently supported Dr. Guidotti with silent 
acquiescence, no matter how outrageous the George Washington University 
professor's proclamations. The CDC repeatedly refused to answer direct 
questions from DC residents, that could have put Dr. Guidotti's 
testimony into some context. At these meetings, DC WASA distributed 
written ``public education'' materials embellishing on the already 
ludicrous CDC MMWR conclusion. For instance, the water utility's fact 
sheet stated that:

         ``In 2004, the CDC analyzed results from a District Department 
        of Health examination of blood lead levels among children 
        during the period of elevated lead levels in tap water at many 
        homes. 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.''

    Even ignoring the already distorted analysis of the 201 residents 
portrayed in the original CDC MMWR, clearly, the CDC MMWR never looked 
at 201 children. The CDC MMWR itself stated that only 17 of the 201 
targeted ``worst-case'' residents were under the age of 6. Moreover, 
the CDC MMWR study involved no environmental risk assessments at the 
homes of DC children with elevated blood lead levels. Finally, although 
the CDC MMWR implied that virtually all detected blood lead elevations 
in DC were due to lead paint, it never stated this.
    When two DC public health advocates called on the CDC to demand 
that DC WASA correct the misleading presentation of the CDC's own 
research results, the CDC failed to do so. A CDC employee who claimed 
to have consulted a CDC lawyer, claimed that there was nothing CDC 
could do to redress the inaccuracies in already distributed versions of 
DC WASA's fact sheet. However, the official assured the two advocates 
that he would request all future versions of the DC WASA fact sheet 
prior to dissemination in order to correct any misleading statements. 
Despite that assurance, the fact sheet was once again distributed on 
May 1, 2008 with the same misleading language in place.
    As perplexing as CDC's behavior was in relation to the above 
incident, what was going on behind the scenes was even worse. 
Unbeknownst to either myself or the DC residents who were pleading with 
the CDC in 2008 to correct Dr. Guidotti's and DC WASA's assertions that 
lead-contaminated drinking water does not pose a significant public 
health concern, the CDC had been researching the impacts of partial 
lead pipe replacements on blood lead levels of DC children probably 
since at least 2005.39 Based on accounts of individuals who 
attended a November 2007 meeting between EPA, CDC, DC DOH and Dr. 
Guidotti, and as substantiated in later e-mails in my possession, the 
CDC actually had data in late 2007 that indicated public health risks 
from DC's partial lead service line replacements. It was not until 
February 2009, long after the time when disclosure of their results 
could have been used to prevent more needless harm to DC children, and 
to properly guide public debate, that CDC eventually issued online an 
``important update'' based on their research in DC:

         ``CDC's Healthy Homes and Lead Poisoning Prevention Branch has 
        conducted an epidemiological study of the relationship between 
        children's blood levels and lead water service lines. Our 
        preliminary results suggest that when lead service lines are 
        partially replaced, that is the public portion of the line from 
        the the main to the meter is replaced, children are more likely 
        to have blood lead levels greater than or equal to 10  g/dL, 
        compared to children living in housing with either undisturbed 
        lead service lines or service lines that are not made of lead'' 
        (bold emphasis added).

    The ethics of how CDC conducted its ``research work'' given 
extensive prior knowledge about lead spikes after partial pipe 
replacement, their duplicity in covering up what was actually occurring 
to children in these homes, and their failure to inform the public 
about their knowledge of the potential harm throughout the numerous 
public meetings on this subject in 2008, strikes me as highly unethical 
and deserving of future scrutiny. Yet it is also completely consistent 
with CDC's past actions, to withhold and control any information that 
may cast doubt on their message that lead in water is not a significant 
public health concern.
    DC WASA Sampling Inconsistent with Intent of LCR. The coalition of 
concerned DC residents also discovered that since 2005 DC WASA, again 
with the full knowledge and
    approval of US EPA R3, had achieved compliance with the Lead and 
Copper Rule by monitoring DC's water via the use of a sampling protocol 
that required flushing taps for 10 minutes the night before sampling. 
In the water industry, pre-flushing is understood as a well-known 
method to game the US EPA lead standard, by temporarily reducing lead 
concentrations at the tap. After reviewing the coalition's appeal of DC 
WASA's protocol, Cynthia Dougherty, the Director of US EPA HQ Office of 
Ground Water and Drinking Water, determined in a letter to the 
coalition that flushing on the eve of compliance sampling was 
inconsistent with the intent of the Lead and Copper Rule:

         ``We believe that [requesting flushing only in the households 
        participating in the sampling] goes against the intent of the 
        monitoring protocol, since it changes the normal water use of 
        the homeowners in the sample.''

    However, without acknowledging or giving any consideration to the 
potential ramifications of DC WASA's 4-year-long reliance on the flawed 
flushing practice--in terms of reported compliance with the Lead and 
Copper Rule and associated potential health impacts on DC residents--
Ms. Dougherty closed her letter by reinforcing the CDC's lead source 
hierarchy:

         ``Thank you for bringing this matter to our attention. 
        However, we hope that this new issue does not deflect from the 
        importance of addressing more serious sources of lead in 
        housing that your association has highlighted in the past. The 
        nation has a goal of eliminating childhood lead poisoning by 
        2010 and, while our program is focused on reducing exposure 
        from drinking water, it is critical for us to not lose sight of 
        the importance of directing resources and attention at more 
        serious sources'' (bold emphases added).

    With this letter, US EPA shamelessly abdicated all responsibility 
for having allowed DC WASA to achieve compliance with federal lead 
standards via the use of a sampling protocol that violated the intent 
of the Lead and Copper Rule, and that may have hid years of problems 
with lead in water contamination. Moreover, it forcefully downplayed 
the health risks from lead-contaminated drinking water, knowing full 
well that the community it was addressing had just recently experienced 
the most severe lead in water crisis recorded in US history, and that 
the preponderance of scientific evidence--including work by US EPA's 
own scientists--had predicted that serious public health harm should 
have occurred.
    In short, I began this journey with the CDC, and have been able to 
sustain it in the face of repeated agency backstabbing and personal 
attacks, because I was convinced that lead in water does sometimes pose 
a serious public health concern, and that innocent children in DC, all 
over the US, and around the world have been put in harms way by the 
deception of the CDC MMWR.

TRYING TO GET THE FACTS FROM THE CDC

    I started my investigation into the CDC MMWR via a FOIA request to 
DC DOH on October 23, 2005. In this FOIA, I asked for all information 
related to the ``300 ppb'' study in the CDC MMWR and certain e-mails 
written by Dr. Stokes, who was the listed 1st author of the report. I 
followed up with dozens of phone calls and e-mails through February 
2006. The DC DOH FOIA Office did not return a single phone call, e-
mail, or otherwise acknowledge that I existed. I submitted a FOIA 
appeal in early February 2006, which resulted in the DC Mayor's Office 
ordering DC DOH to produce the information I had requested within 20 
days. The 20 days came and went without DC DOH even acknowledging the 
Mayor's order. The Mayor's Office then threatened to report the DC DOH 
FO1A officer for misconduct. On April 27, 2006, the DC DOH FOIA officer 
informed me that Dr. Stokes had left DC DOH shortly after I had 
submitted my FOIA for information about the CDC MMWR, and that her e-
mails had been destroyed. He refused to tell me exactly when she left. 
DC DOH repeated this maneuver in early 2008, when I submitted a similar 
request for e-mails of CDC MMWR co-author and DC DOH employee, 
Christine Onwuche. Within weeks after submission of my FOIA, Ms. 
Onwuche too had left DC DOH, and the e-mail records I had requested had 
been destroyed. The maneuver is illegal, because from the moment a FOIA 
request is received, the FOIA Office is supposed to protect the 
integrity of the requested documents.
    A couple of months into my phone call and e-mail marathon trying to 
reach DC DOH in relation to my October 23, 2005 FOIA, I realized that 
DC DOH was going to stonewall my access to any information about the 
CDC MMWR, and I began making dozens of attempts to contact the editor 
of the CDC MMWR series for a few simple answers to my questions. The 
editor did not return my phone calls, e-mails or letters. I then 
decided to submit my first FOIA to the CDC on December 27, 2005, with a 
request for e-mails between DC DOH and CDC related to the preparation 
of the CDC MMWR. On May 17, 2006 I submitted to the CDC a second FOIA 
for the data used in the ``300 ppb'' study. To date, I have submitted 
more than 10 FOIA requests to the CDC, any one of which makes for a 
compelling story of governmental abuse of the public and credible 
scientists, but I will limit my testimony to these two CDC FOIAs as 
examples.
    Playing the CDC Shell Game. Sharing of data amongst scientists, and 
responding to straightforward questions about research methods, is 
central to the conduct of good science. These concepts seem to be 
foreign to the DC DOH and CDC. Given the 1) ``historic'' nature of the 
CDC MMWR findings concerning DC residents who were supposedly consuming 
water with over 300 ppb lead, 2) numerous associated sworn testimonies 
about the 300 ppb study to the DC City Council and the US Congress, and 
3) the CDC's stated desire to have the CDC MMWR impact policy and 
having great success in doing so (Figure 4), I assumed I would receive 
the data behind this study within weeks after requesting it from DC DOH 
on October 23, 2005 and then again from the CDC on May 17, 2006. 
Instead, the two agencies played what I consider to be an irresponsible 
and unethical shell game, implying that the data existed, but appearing 
to act as if they could not figure out whose responsibility it was to 
produce them.
    On April 13, 2006, the DC DOH FOIA officer informed me that the 
data for the CDC MMWR were housed at the CDC. He also stated that he 
had been in contact with the CDC about my request, but that I would 
have to submit another FOIA directly to the CDC. I did so on May 17, 
2006. On May 31, 2006, I received a spreadsheet via e-mail from DC DOH, 
without any written explanation. This spreadsheet obviously included 
some data related to the 300 ppb study, parts of which I cited earlier 
in connection to DC residents' bottled water use. But the spreadsheet 
raised dozens of questions and in many ways was completely inconsistent 
with the information presented in the CDC MMWR. Eight months later, on 
January 23, 2007, the CDC informed me that that the 300 ppb data was 
``housed at the FDA.''
    In summary, more than 4.5 years after first requesting the 300 ppb 
data, nothing that could possibly be the blood lead data behind this 
historic analysis in the CDC MMWR has been produced to me. In fact, I 
am highly doubtful that the blood lead data portrayed in the CDC MMWR 
ever existed, and have come to suspect that at least some of that data 
is a complete fabrication.
    Pages from the CDC's FOIA Playbook. A chronology of my first FOIA 
to the CDC, submitted on December 27, 2005, highlights the abusive 
practices of the CDC FO1A Office in relation to those seeking critical 
information about the agency's environmental public health practices. 
After following up my FOIA request with 5 e-mails and voice messages 
that were never answered, on April 16, 20061 decided to file an appeal 
concerning the CDC's delay in responding to my request.
    Over 7 months later, on November 3, 2006, I received a phone call 
from the CDC FOIA Office. They stated that my documents had been ready 
to mail for 4 or 5 months, but that because I had filed an appeal, the 
release of the documents had been placed on hold. If I wanted to 
receive the documents I had been waiting for, I first had to withdraw 
my appeal. I immediately memorialized this bizarre ``Catch-22'' 
conversation in an e-mail to the FOIA officer, and withdrew my appeal. 
Later that day, the CDC FOIA Office mailed me a letter that did not 
contain the documents I had just been promised. Rather, the letter 
stated that the agency was withholding the documents, and if 1 did not 
agree with their action, to submit an appeal. The appeal clock would 
have to be restarted. Dismayed at CDC's childish antics and mind games 
(i.e., Sike!), I promptly resubmitted an appeal on the FOIA, to replace 
the appeal CDC had just duped me into withdrawing--not that it mattered 
because FOIA appeals were ignored at CDC as well. More than 2 years 
went by without a response of any sort.
    In a letter dated January 21, 2009, a day after the Obama 
administration took office, my hopes were raised when I received a 
letter from the CDC stating in part:

         ``This letter is a response to your November 2006 Freedom of 
        Information Act (FOIA) Appeal for specific documents between 
        CDC and the D.C. Department of Health during the 2004 lead 
        crisis. I apologize for the delay in responding to your 
        request. This office has experienced a significant turnover in 
        staff, and we are working through our backlog of requests. . . 
        . If you are still interested in receiving the requested 
        information, please contact  . . . If you are no longer 
        interested in the information, you need to do nothing.''

    I immediately responded that I was still interested in receiving 
the documents.
    When the US House Committee on Science and Technology began 
investigating the CDC MMWR in March 2009, I had still not received the 
documents I had requested, and I made the Committee aware of CDC's FOIA 
abuses. Perhaps because of that, in early November 2009, I received a 
phone call from a CDC FOIA officer, asking me yet again, whether I 
still wanted the documents from my 2005 FOIA. I said that I did.
    Finally, in a package dated November 20, 2009, nearly 4 years after 
my initial FOIA request, the CDC released to me 108 pages of documents. 
While I am grateful for finally getting a partial response, numerous 
pages are clearly missing for reasons that I do not understand. For 
example, only every other page of the CDC MMWR drafts was included 
(i.e., page 1, 3 and 5), so it is possible that I was given a single-
copied version of double sided originals. This week I reinitiated 
efforts to get a full response to my 2005 request.
    I close by noting that in the past 4-plus years I have experienced 
numerous other abuses by the CDC, but will mention one last one that 
strikes me as especially flagrant. I am pursuing my investigation as a 
volunteer, and as such I routinely submit requests for a fee waiver. 
The CDC has repeatedly denied my requests, on the grounds that my FOIA 
will not ``advance the understanding of the general public as 
distinguished from a narrow segment of interested persons,'' and that 
the ``public's understanding of the government'' will not be 
``substantially greater as a result of the disclosure.'' I mention this 
because I have had to pay the CDC several thousand dollars. much of it 
toward CDC employees' salary, for the privilege of being abused by 
their FOIA system. I also freely disclose to anyone who reads this 
document--the CDC has determined that my research and testimony does 
not enhance the general public's understanding of government 
operations.

CDC REFUSED TO CORRECT THE SCIENTIFIC RECORD

    When I began this journey 5 years ago, the last thing I ever wanted 
was an exhausting, voluntary ordeal, that would ultimately cost me tens 
of thousands of dollars in FOIA charges alone to the agencies, and 
which would lead to the unpleasant experiences which culminate in 
today's testimony. The record shows I did everything in my power to 
avoid this from happening. However, that was not the path that fate, or 
Dr. Brown or CDC's actions, would choose for me.
    Through my FOIAs of CDC and DC DOH, Dr. Brown was well aware of my 
serious concerns about the CDC MMWR since at least late 2005. Safely 
ensconced behind the twin parapets of an abusive FOIA Office and a 
Science Office that would spare no effort to avoid upholding accepted 
standards of scientific integrity (see later section), Dr. Brown must 
have felt empowered to ignore me. Reporters who raised substantive 
questions about the CDC MMWR based on facts I provided them, were 
rebuffed by the CDC press office, with statements that either 
questioned my integrity, intellect and intentions. I was once told they 
stated:

         ``No one has a problem with our paper except an Engineer with 
        no formal training in, or appreciation of, public health.''

    Despite my dismay at CDC's arrogance, misconduct, and growing 
concern about serious problems with the CDC MMWR, I did my very best to 
work within the system and to stop the harm it was creating. After more 
than a year and just a few weeks after discovering Dr. Brown had 
actually authored the paper (she is listed as the 18th author), I wrote 
an e-mail that was both a plea for correcting the record, and an 
ultimatum (Figure 5). At that point, January 11, 2007, Dr. Brown could 
have avoided all of the revelations presented in this testimony, the US 
House Investigation into the CDC, and exposure of her actions skewing 
the data and analysis of the CDC MMWR, which she clearly knew about. To 
repeat this point for emphasis, had Dr. Brown corrected the CDC MMWR's 
public health message in early 2007, and stopped the harm it was (and 
would continue) to perpetuate, I would have dropped the matter. Her 
supreme arrogance and unfortunate temperament would not allow herself 
to do so.




Figure 5. Text of 1/11/07 e-mail to CDC's Dr. Brown and CDC MMWR Editor 
Shaw.

CDC OFFICE OF SCIENCE RIDES TO THE RESCUE . . . OF DR. BROWN

    When Dr. Brown refused to correct the scientific record, my 
personal ethics and that of other engineers to ``hold paramount the 
safety, health and welfare of the public,'' dictated that I take my 
concerns to the appropriate authorities. In this case, that was the CDC 
Office of Science. At first I was hopeful. In the beginning, they at 
least responded to my e-mails. But thereafter, their treatment of me 
fell into the routine of abuse with which I had become so familiar via 
the CDC FOIA office. I will not force the reader to relive my ordeal 
here and now, nor do I wish to do so myself. Suffice it to say that my 
unsuccessful communications with the CDC Office of Science via e-mail, 
letter and phone numbered in the hundreds.
    The bottom line is that, according to my perception and experience, 
the CDC Office of Science worked very hard trying to justify why it was 
their duty to do absolutely nothing to address my concerns. Ignoring 
their own written procedures, they played childish word games, trying 
to make me give up and go away. To this day I doubt that they 
investigated my allegations. But if they did, and they found no 
evidence of the problems outlined herein, they are even more ethically 
challenged than I believe to be the case as I compose this testimony.
    One lowlight of the experience was when the CDC Office of Science 
was used, as a cheap public relations ploy, to further sustain the 
illusion of Dr. Brown's trustworthiness and that of the CDC MMWR. In an 
April 11, 2009 press release that the office of CDC's media relations 
issued to respond to a negative media article about the CDC MMWR, the 
CDC claimed the following:

         ``Scientific integrity is CDC's hallmark . . . . CDC's Office 
        of Science takes any such allegation very seriously; it 
        thoroughly investigated this complaint and found no evidence of 
        scientific misconduct.''

    I eagerly await the report of the US House Committee to see just 
how serious, and how thorough this ``investigation'' of my allegations 
actually was.

WHAT REALLY HAPPENED TO DC's CHILDREN DURING THE DC LEAD CRISIS

    After exhausting all hopes that anyone at the CDC would demonstrate 
a shred of scientific integrity or backbone in acknowledging problems 
with Dr. Brown's behavior, or even express the slightest concern about 
children who were still being left unprotected from elevated lead in 
water due to the CDC MMWR's flawed message. I gave up trying to resolve 
my concerns through CDC's broken system.
    In early 2008, I collaborated with Dana Best, MD, MPH at Children's 
National Medical Center (CNMC) in Washington DC, which is a hospital 
with a reliable and robust database on blood lead levels of DC 
children. Along with Virginia Tech graduate student Simoni 
Triantafyllidou, we conducted a very simple and straightforward 
analysis which was eventually written into the paper ``Elevated Blood 
Lead in Washington D.C. Children from Lead Contaminated Drinking Water: 
2001-2004'' and published in the peer-reviewed journal Environmental 
Science and Technology.23
    Given the authority of the CDC and Dr. Brown on the subject 
of lead health effects, and presumptions of most scientists about high 
standards of scientific integrity at the CDC, getting our paper through 
the scientific review process was difficult. One reviewer had concerns 
about publishing our paper, because it cited some data collected via 
FOIA, and was disturbed that this information would give readers the 
impression that CDC and other agencies did not supply their data 
willingly. Another reviewer stated that the paper should not be 
accepted because it ``relies on a lot of data the authors did not 
collect, were apparently not involved in the original studies, and with 
which they do not provide sufficient information concerning the 
conditions and methodology under which the data were collected.'' In 
other words, because the CDC and Dr. Brown would not follow established 
principles of scientific conduct and share information/data with us, 
reviewers were reluctant to approve publication of our own paper. In 
writing the final draft, I therefore had to create an imaginary world, 
in which the CDC's actions were interpreted in an unreasonably positive 
light. I even wrote the following in reference to the CDC MMWR:

         ``Differences in conclusions between this work and the earlier 
        CDC study are mostly attributed to the type of analysis and 
        interpretation . . .''

    This statement should not be construed as support for Dr. Brown's 
analysis in the CDC MMWR. Our research determined that the decades of 
prior peer-reviewed literature, demonstrating that lead in water can be 
a serious public health concern, were correct. It further demonstrated 
very strong links between elevated lead in water and lead in blood for 
the most vulnerable children in DC from 2001-2004. Our work directly 
refuted the CDC MMWR ``main message'' that there ``is no indication 
that DC residents have blood lead levels above the CDC levels of 
concern . . . as a result of lead in water.'' It also exposed the 
misleading work of the CDC's close collaborator in DC, Dr. Guidotti and 
his DC DOH co-authors, who published a misleading paper which concluded 
that ``There appears to have been no identifiable public health impact 
f from the elevation of lead in drinking water in Washington, DC.'' 
Based on our analysis, hundreds, and in all likelihood thousands, of DC 
children had their blood lead elevated above the CDC level of concern 
as a result of elevated lead in water from 2001-2004.

EPILOGUE

    Since publication of our paper, the CDC has doggedly defended the 
CDC MMWR against all criticism. The paper stands on the agency's 
website to this day, unscathed; a monumental public health fiasco, 
where it continues to mislead and place children all over the world in 
harm's way. Contradicting 2000 years of human knowledge and experiences 
related to adverse health effects from lead in drinking water, for a 
contaminant that is perhaps the best-known environmental neurotoxin--
how can anyone trust CDC's integrity on more controversial subjects?
    Some have said that my experiences and testimony prove that 
``science works,'' and that falsification by scientists will always get 
exposed. That is simply not the case. Science is no match whatsoever 
for the bullying, abuse of authority and lack of integrity of powerful 
government agencies. Had I not volunteered nearly 10,000 hours of my 
time to expose wrongdoing by these agencies, spent tens of thousands of 
dollars of my family's funds, sacrificed my personal life and career. 
and endured years of back-stabbing and personal attacks by the CDC and 
other agencies, I am doubtful that lead in water would ever again have 
been seriously considered a public health concern. Indeed, as I write 
this testimony, I am still uncertain that this will occur.
    I also thank all those who volunteered to work with me on this 
effort. I am humbled by, and stand in awe of, the sacrifice of 
scientists, victims and activists who stand against agency misconduct, 
many of whom end up destroyed or disillusioned in the process. Although 
no one emerges from these experiences unscathed, collectively, our 
actions do make a difference.

CONCLUSIONS

    As long as the CDC continues to defend the CDC MMWR, the agency 
will not have a shred of scientific credibility. As I first stated 
publicly in May 2006, the CDC MMWR has to be retracted.
    To the extent that my experiences with individuals in the CDC Lead 
Poisoning Prevention Branch and the CDC Office of Science are any 
indication, there is a culture of scientific corruption in branches of 
this important agency, and there is no evidence that it has the 
capability for self-correction. I know highly ethical and outstanding 
scientists in other parts of the CDC, and I sincerely hope that they 
too, will not face insurmountable obstacles in achieving the public 
good.

REFERENCES

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2. CDC MMWR (2004). Blood Lead Levels in Residents of Homes with 
        Elevated Lead in Tap Water--District of Columbia, 2004. L 
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        Calhoun, MD, AC Glymph, MPH, ME Knuckles, PhD, D Lucey, MD, 
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4. Hodge, A.T. (1981) Vitruvius, Lead Pipes and Lead Poisoning. 
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5. Silbergeld, E. (2004). Lead Contamination in the District of 
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6. Ryu, J. E.; Ziegler, E. E.; Nelson, S. E.; Fomon, S. J. (1983). 
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7. Cosgrove, E.V., M. J. Brown, P. Madigan, P. McNulty, L. Okonski and 
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        346-349.

8. Lacey, R., Moore, M., Richards, W. (1985). Lead in water, infant 
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9. EPA (1991). Safe Drinking Water Act Lead and Copper Rule (LCR). In 
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10. EPA (2004). National Center for Environmental Risk Assessment. 
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11. USCPSC, Office of Information and Public Affairs. CPSC Announces 
        New Policy Addressing Lead in Children's Metal Jewelry. (2005) 
        Quote accessed http://www.cpsc.gov/businfo/pbjewelgd.pdf.

12. Health Canada (2003). Illustrative standard accessed at http://
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13. WHO, Geneva (1993). Guidelines for Drinking-Water Quality, 2nd 
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14. Holder, E. (2004). Summary of Investigation Reported to the Board 
        of Directors of the District of Columbia Water and Sewer 
        Authority. http://www.washingtonpost.com/wp-srv/metro/specials/
        water/wasa071604.pdf (accessed Aug. 2, 2004).

15. House Government Reform Committee. ``Public Confidence, Down the 
        Drain: The Federal Role in Ensuring Safe Drinking Water in the 
        District of Columbia.'' Hearing March 5, 2004.

16. Fisheries, Wildlife and Water Subcommittee of Environment and 
        Public Works. Oversight of Drinking Water in the District of 
        Columbia. Hearing April 7, 2004.

17. House Government Reform. DC Lead Crisis. Hearing May 21, 2004.

18. Energy and Commerce Committee Subcommittee on Environment and 
        Hazardous Materials U.S. House of Representatives. Lead in DC 
        Water. Hearing. July 22, 2004.

19. House Government Reform. Oversight of DC Lead in Water. Hearing. 
        March 11, 2005.

20. Government Accountability Office (2006). Report to Congressional 
        Requesters. EPA Should Strengthen Ongoing Efforts to Ensure 
        That Consumers Are Protected from Lead Contamination. GAO-06-
        148

21. Nakamura, D. Water in D.C. Exceeds EPA Lead Limit Random Tests Last 
        Summer Found High Levels in 4,000 Homes Throughout City. 
        Saturday, January 31, 2004; Page A01

22. Hastings, 2004. Paul Hastings Files Class Action Lawsuit on Behalf 
        of DC Residents Exposed to High Lead Levels in Water: WASA, DC 
        City Government, EPA, Army Corps of Engineers Targets of 2 
        Legal Actions by Firm. Accessed May 10, 2010 at http://
        www.dcwatch.com/wasa/040308.htm.

23. Edwards, M., Triantafyllidou, S., and D. Best. Elevated Blood Lead 
        in Washington D.C. Children from Lead Contaminated Drinking 
        Water: 2001-2004. Environmental Science and Technology. 43, 5 
        1618-1623 (2009).

24. Information and letters which are currently available online at the 
        following location. http://www.dcwasawatch.blouspot.com/2010/
        05/may-20-congressional-hearing-will.html

25. Rabinowitz, M. B.; Wetherill, G. W.; Kopple, J. D. Kinetic analysis 
        of lead metabolism in healthy humans. J. Clin. Invest. 1976, 58 
        (2), 260-270.

26. Renner, R. (2006). Lead on Tap. An alarming return of lead in 
        drinking water is being ignored by the EPA and municipal 
        officials. Salon. November 27, 2006. Accessed May 9th at http:/
        /www.salon.com/news/feature/2006/11/27/lead.

27. Federal Register: December 6, 2000. Volume 65, Number 235. Page 
        76260-76264. Accessed May 10. 2010 http://ori.dhhs.gov/
        policies/fed-research-misconduct.shtml

28. Leonnig, C.L., Becker, J. and D. Nakamura. Lead Levels in Water 
        Misrepresented Across U.S. Utilities Manipulate or Withhold 
        Test Results to Ward Off Regulators. Washington Post. October 
        5, 2004; Page A01

29. H.R. 4268: Lead-Free Drinking Water Act of 2004. Accessed at http:/
        /www.govtrack.us/congress/bill.xpd?bill=h108-
        4268&tab=committees

30. Powell, M., 1997. The 1991 Lead/Copper Drinking Water Rule & the 
        1995 Decision Not to Revise the Arsenic Drinking Water Rule: 
        Two Case Studies in EPA's Use of Science. Discussion Paper 97-
        05. March 1997 (Revised) Science at EPA: Information in the 
        Regulatory Process. Accessed at http://www.rff.org/documents/
        RFF-DP-97-05.pdf.

31. President's Task Force on Environmental Health Risks and Safety 
        Risks to Children (2000). Eliminating Childhood Lead Poisoning: 
        A Federal Strategy Targeting Lead Paint Hazards, February 2000.

32. Burke, G. AP Impact. Drinking Water at Thousands of Schools 
        Contains Unsafe Lead, Other Toxins. Associated Press. September 
        25, 2009.

33. Lambrinidou, Y., Triantafyllidou, S., Edwards, M. Failing Our 
        Children: Lead in US School Drinking Water. New Solutions 2010. 
        V. 20(1):25-47.

34. Brown, M.J., and D.E. Jacobs. Sources of Blood Lead in Children. 
        Environ Health Perspect. 2006 January; 114(1): A18-A19.

35. Laidlaw MAS, Mielke HW, Gonzalez CR, Filippelli GM, Johnson DL 
        2006. Blood Lead in Children: Laidlaw et al. Respond. Environ 
        Health Perspect 1 14:A19-A19. doi:10.1289/ehp.114-aI9a. January 
        2006. Environ Health Perspect. 2006 January; 114(1): A19.

36. Johnson, K. (2003). For a Changing City, New Pieces in a Lead-
        Poisoning Puzzle. New York Times

37. Scott, R. Personal communication May 11, 2010.

38. Plionis. E. (2007). It's All the Little Things: How Misdemeanors in 
        Scientific Misconduct are as Bad as Fabrication and 
        Falsification. Accessed May 10,2010 at http://
        serendip.brynmawr.edu/exchange/node/1636.

39. Onwuche, C. Pdf of powerpoint presentation in my possession. The 
        CDC has not produced documents on this ``research'' that I have 
        requested via FOIA.

40. Leonnig, C.D. and D. Nakamura. D.C. Knew Of Lead Problems In 2002 
        Timing of E-Mails Contradicts Claims. Washington Post Staff 
        Writers Monday, March 29, 2004; Page A01.

41. Miller, B. (2009). Letter to Kathleen Sebillius.

42. Rabin, R. The Rhode Island Lead Paint Lawsuit: Where do we go from 
        here? New Solutions, Vol. 16(4) 353-363. 2006

43. Mealey's Litigation Report. Lead. Volume 16, Issue #8 Brown Not 
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44. Campbell, A.C. Society Suffers Cost of Lead Poisoning. Harvard 
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45. Renner, R. Exposure on Tap: Drinking Water as an Overlooked Source 
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46. Goldstein, A. Bush Budget Would Cut Lead Prevention Funds. 
        Washington Post. April 11, 2004

APPENDIX 1: ADDITIONAL SPECULATION ABOUT CDC MOTIVATION

    In retrospect, when the DC Lead Crisis became front-page news on 
January 31, 2004, it presented both problems and opportunities for the 
CDC and their DC DOH colleagues. Both agencies had been almost 
exclusively focused on and trained to address lead paint hazards, and 
this ``worldview'' would have been undermined by finding significant 
adverse health impacts from the crisis. On the other hand, if it were 
found that lead-contaminated water could not be linked to a single DC 
child with a blood lead elevated above the CDC level of concern, the 
problems would be eliminated and the agencies' approach would be 
vindicated.
    The problems were multi-fold. First, from the earliest phases of 
the crisis, the public health community worried that the unprecedented 
media attention to lead in drinking water could divert public attention 
and funding away from addressing lead paint.37
    Second, in the weeks just before the publication of the CDC 
MMWR, media attention was shifting to DC DOH's ignorance about, and 
mismanagement of, DC's lead in water issues.40 Contrary to 
initial claims that DC DOH first learned about problems with high lead 
in water in January 2004, the Washington Post was on the verge of 
informing the public that DC DOH's knowledge went back to October of 
2002. In particular, former ASTDR employee and CDC MMWR co-author Dr. 
Stokes was in the cross-hairs, because in October 2002 she (together 
with other DC DOH officials) ``ignored the mounting health threat and 
failed to issue clear instructions to residents about how to reduce 
their risk of lead poisoning.'' 40 Although obviously 
responsible for her actions, Dr. Stokes' inattention to the water 
problem fully conformed with the CDC's ``lead-paint-centric'' approach 
to childhood lead poisoning prevention, so any further press coverage 
of Dr. Stokes' lapses would also risk drawing attention to deficiencies 
in CDC policies. The CDC MMWR, rushed to publication just one day after 
this Washington Post article, effectively immunized both Dr. Stokes and 
the CDC from further criticism.
    Third, any serious investigation of who knew what and when at DC 
DOH, would have led to public revelations about agency bungling that 
went far beyond anything that had ever been previously revealed in the 
press. Specifically, on September 26, 2001, a DC WASA employee called 
the DC OIG hotline and reported that DC WASA had ``intentionally'' 
hidden many lead in water test results from early 2001 that ``exceeded 
the EPA action limit.'' 14 Also, later research would 
demonstrate that at this exact time frame, DC WASA was collecting data 
showing that DC's water lead levels were spiking to dangerous levels 
and that hundreds of DC's children had elevated blood lead levels due 
to exposure to the high lead in water.23 It is now 
undisputed that DC WASA and US EPA R3 knew that the US EPA water lead 
action standard would likely be exceeded by July 19, 2002, and had 
certainly knowledge of some problems as far back as August 2001.14
    My FOIA request of US EPA reveals that on June 21, 2002, a DC 
DOH water quality division employee wrote a letter to US EPA R3 
requesting funding for ``a lead service line replacement program.'' It 
seems likely the employee knew something was amiss relative to lead in 
water and its health impacts for DC residents, because the employee 
later indicated to US EPA R3 that during April 2002, she had tried to 
get geographic data on elevated blood lead levels of children from the 
CDC-funded DC Lead Poisoning Prevention Program staff, and link it to 
information on the location of lead pipe. In response to her June 21, 
2002 request for action, on July 24, 2002, US EPA R3 and DC WASA 
disingenuously stated that ``testing has shown lead levels to be below 
Federal action levels'' and ``water quality testing . . . has 
consistently supported the position that our . . . lead and copper 
levels are below the action level.'' This, despite the now undisputed 
fact that both agencies knew about the forthcoming lead action level 
exceedance at least 5 days earlier (if not months and months earlier).
    In the July 24th, 2002 response, US EPA R3 told the DC DOH water 
quality division that DC WASA had addressed ``your concerns about the 
health effects of lead levels in the District's drinking water 
supplies.'' Clearly, the episode represents a lost opportunity by the 
agencies to address substantive lead in water health effects for DC 
children, nearly 20 months before the frenzied activities by the CDC 
and DC DOH in response to the Washington Post story in early 2004. It 
is quite likely that the DC DOH water quality division employee did not 
get cooperation from the CDC-funded childhood lead program in early 
2002 when she tried to draw links between elevated blood lead in DC and 
occurrence of lead service lines. At a minimum, in early 2002, the 
efforts of the DC DOH water quality employee represented a chance for 
the agencies to ``connect the dots'' and address the spike in childhood 
lead poisoning that was occurring throughout DC due to contaminated 
water at that time.14 23
    Fourth, public testimony and the CDC's ``Talking Points'' 
memo that accompanied the release of the CDC MMWR, stated clearly that 
the CDC became involved in the DC Lead Crisis on February 16, 2004. In 
fact, three questions in the CDC ``Talking Points'' memo, directly or 
indirectly, addressed the question of when CDC first became involved in 
the DC Lead Issue, and why the CDC was not doing more. The facts 
indicate that the CDC's statement was not completely accurate. Putting 
aside the likelihood that some CDC staff and DC DOH Lead Poisoning 
Prevention program knew about possible water-lead problems in April 
2002, the CDC had also funded the DC DOH's grossly dysfunctional DC 
Lead Poisoning Prevention Program for years, and was acutely aware of 
serious shortcomings in the DC DOH's management of data and its poor 
record keeping. For example, a few months after the publication of the 
CDC MMWR, some CDC employees were alerted to forgery of blood lead 
records at the DC DOH, and to the fact that thousands of blood lead 
test data from 2003 were missing.41 Perhaps because of the enormous 
public health implications of the news for DC residents, as well as 
serious questions that would be raised about the integrity of the CDC 
MMWR that relied on this incomplete data, the CDC did not report the 
information about the data forgery and the missing blood lead data to 
appropriate authorities.41 The agency's inaction suggests 
both complicity with DC DOH and duplicity in the CDC's actual 
commitment to protecting public health. Once again, had the CDC MMWR 
acknowledged even a single case of childhood lead poisoning from water, 
it is reasonable to assume that an investigation into DC DOH's failing 
lead poisoning prevention program would have revealed serious 
deficiencies under CDC's oversight.
    Fifth, if the CDC's DC investigation had concluded that lead 
contaminated water could cause childhood lead poisoning, this could 
potentially interfere with a game-changing legal case of national 
importance that offered the possibility of billions of dollars from 
former lead-pigment makers for lead paint remediation. A landmark 
lawsuit against lead paint companies, initiated in Rhode Island in 
1999, seemed to be heading towards a historic settlement which could 
require the defendants to pay billions in funds to rid Rhode Island 
homes of lead paint hazards and ultimately might create similar 
programs nationwide.42 To date, the CDC has not produced 
documents that I have requested about Dr. Brown's involvement in this 
lawsuit; however, in 2007 Rhode Island apparently did consider that Dr. 
Brown serve as a ``Special Master'' to oversee spending the funds from 
the lawsuit, a proposal which the defendants protested.43
    Indeed, an October 2002 article about Dr. Brown's recent 
research on lead in Rhode Island, stated that ``She  added that 
the study may aid plaintiffs waging legal battles against lead paint 
manufacturers, mentioning one case in Rhode Island that recently 
resulted in a hung jury.'' 44
    To my knowledge, lead in water was never raised as a 
potential lead source in the Rhode Island lawsuit. However, if the DC 
Lead Crisis were shown to have caused demonstrable harm, it could have 
provided another significant argument for the former lead paint 
defendants, weakened the Rhode Island lawsuit, and jeopardized the 
potential procurement of billions of dollars nationally for lead paint 
remediation. Indeed, Lead and Copper Rule monitoring results and a 
recent article in the journal Environmental Health Perspectives (EHP) 
have revealed chronic problems with lead in the tap water of 
Providence, Rhode Island, and I am aware of relatively high lead in 
water of other Rhode Island cities.45
    As for opportunities, they were also significant, for those 
interested in generating new funding sources to mitigate lead paint. 
First, any public relations coup about the supposed lack of harm from 
water, provided a high profile platform that CDC could (and did) use to 
drive home its belief that even in the midst of the largest lead in 
water contamination event in modern history, the only significant 
health concern in DC was lead paint. Two events, removal of the 
language from the US EPA website about the dangers of 40 ppb lead in 
water, and Dr. Brown's removal of the statement ``Elevated levels of 
lead in the water are a public health concern'' from the CDC MMWR, were 
separated at most by 3 days in late March 2004.
    Secondly, the CDC's handling of the DC Lead Crisis not only 
protected lead paint advocates' drive for a Rhode Island legal 
settlement, but it was also used to create new opportunities for 
funding for lead paint from the water industry. For starters, the DC 
DOH lead program obtained millions of dollars of funding from DC WASA 
in early 2004 for blood lead tests, environmental assessments and 
software to track lead poisoning. National funding aspirations were 
also significant and could be cultivated. As revealed in a recent EHP 
article, one of Dr. Guidotti's colleagues and 2007 paper co-authors 
made a presentation at the 2009 American Public Health Association 
conference, about a Portland, Oregon program, in which water utilities 
could pay for lead paint remediation, in exchange for not having to 
fully optimize corrosion control to minimize lead in water 
concentrations according to federal regulations. The EHP article 
stated: 45

         ``Portland instead spends $500,000 annually on a public 
        education campaign and lead paint abatement program. `This 
        approach was a win-win for community public health, reducing 
        lead exposure across the community and across media of 
        exposure, especially for children,' says David Leland, manager 
        of the Oregon Department of Human Services Drinking Water 
        Program . . . . `Look at the hierarchy of concern for lead,' 
        says Leland. `Number one was the lead from gasoline in the air, 
        before it was banned. Now it's paint,' he says.''

         ``. . . Jim Elder, who headed the EPA drinking water program 
        from 1991 to 1995  `Portland's choice between optimum 
        corrosion control and public education is a ``covert form of 
        cap and trade' . . .''

    Finally, funding for lead paint programs were to be cut by 25% in 
draft federal budgets, as revealed in a Washington Post article just 
days after the MMWR was released.46 A few weeks later, on 
April 29, 2004, the CDC MMWR was used to update the President of the 
United States on what the CDC had done lately in relation to 
``Protecting Health Care Consumers,'' and also provided an opportunity 
to reiterate the high exposure risk from lead paint relative to lead in 
water. An ATSDR and CDC e-mail with the subject ``CDC Topics for 
Secretary Thompson to Discuss with President Bush,'' mentioned that in 
relation to the DC Lead Crisis, CDC had helped:

         ``. . . address pressing consumer questions about the lead 
        exposure. Scientists found that . . . there was no evidence 
        that it caused an increase in the number of children in the 
        District with blood lead levels >= 10 ug/dL (our level of 
        concern for individual children). Support to the district 
        continues with development of a comprehensive assessment of 
        lead sources in children's environments, including lead paint 
        and leaded house dust.''

    Chairman Miller. Thank you, Dr. Edwards.
    We will now begin our first round of questions. I now 
recognize myself for five minutes.
    I am struck by how many people seem not to understand that 
there is a reason that parents tell their children the story of 
the little boy who called wolf. There really is a point to the 
story. It is important to protect your credibility because the 
day may come when you need to be believed. This seems to be the 
little agency that cried that there was no public health 
concern, and there is a time that we need to reassure the 
public, to tell the public that there is nothing to worry 
about, to damp down hysteria, to use a word from the Washington 
Times story six years ago, but if the agencies responsible for 
determining public health do not have credibility, they will 
not be able to do that credibly.
    This subcommittee before Dr. Broun's service studied the 
preparations for a dirty bomb attack a couple of years ago. And 
one of the things that we needed to be prepared to do in the 
case of a dirty bomb was to tell the public not just what they 
had to worry about but what they didn't have to worry about, 
that their children were okay, that they could occupy certain 
areas within our largest cities, and they needed to be able to 
do that credibly. The public needed to believe them, and we 
need to protect the credibility of our government agencies 
responsible for determining if there is an environmental health 
hazard if they are to play that important role of damping down 
hysteria when the time comes when there may be panic and there 
may be hysteria.
    Dr. Edwards, CDC has I think just today issued a new 
report, analysis, study in the MMWR looking again at the 2004, 
2003 data. Have you had a chance to look at that?
    Dr. Edwards. Yes, I have been sent a copy of that.
    Chairman Miller. And do you have--what is your reaction to 
that? I am tempted to say do you have an opinion satisfactory 
to yourself, but I am not a lawyer anymore.
    Dr. Edwards. Deception, smoke-and-mirror gimmicks, 
perverted science, this is what the CDC embraces. There is 
nothing in that report that clearly indicates the harm that was 
done to D.C.'s children, as CDC knows, as it sits there today 
occurred, and the new report shows absolutely nothing of 
relevance other than the sorry set of data that they used for 
their assessment, and by correcting a single year of data, 
2003, and leaving all the other years uncorrected, comes up 
with a comparison that is completely irrelevant. It took them 
eight months of effort to correct the data they relied on for 
2003 alone. It would take therefore probably another 24 months 
of attempts to get good data for the earlier years which they 
need for their comparison.
    Chairman Miller. Ms. Bascetta, the GAO study appears pretty 
damning, the policies and procedures that ATSDR and NCEH, their 
procedures for initiating, developing, reviewing and clearing 
their public health products. How does ATSDR and CDC begin? 
Where do they start to fix this problem? They have new 
leadership at that agency. They will shortly have--at CDC in 
Dr. Frieden. They will shortly have new leadership at NCEH and 
ATSDR. Where do they begin to fix things?
    Ms. Bascetta. Obviously the concern today about the MMWR in 
particular which has always been viewed as an authoritative 
source of public health information is something that they must 
fix. We made two recommendations to ATSDR to develop a risk 
assessment process to better manage their public health 
products, and a second recommendation to revise their existing 
policies and procedures or to develop new guidance to provide 
documented direction for various levels of management, and 
roles and responsibilities in monitoring. One of the things we 
believe very strongly is that this has to happen at the 
initiation of work and throughout the process, that it is too 
late to wait for review and clearance, that they need to bring 
the resources and the expertise to bear early in the process 
and that they need to manage their workload so that they can 
detect any problems early and correct them.
    Chairman Miller. Thank you.
    My time is expired. I now recognize Dr. Broun for five 
minutes.
    Mr. Broun. Thank you, Mr. Chairman, and to the whole panel, 
the President's cancer panel recently released a report on the 
cancer risk for chemicals and other environmental hazards that 
was roundly criticized by the American Cancer Society for 
overestimating these threats. In a critique of the paper, Dr. 
Michael J. Thun, vice president emeritus, epidemiology and 
surveillance research at ACS stated, ``Unfortunately, the 
perspective of the report is unbalanced by its implications 
that pollution is the major cause of cancer,'' and by its 
dismissal of cancer prevention efforts aimed at the major known 
causes of cancer--tobacco, obesity, alcohol, infections, 
hormones, sunlight as ``focused narrowly.'' Then it went on to 
state, ``That report is more provocative when it restates 
hypotheses as if they are facts, for example, its conclusion 
that the true burden of environmentally, i.e., pollution-
induced cancer has been grossly underestimated does not 
represent scientific consensus. Rather it reflects one side of 
a scientific debate that has continued for almost 30 years.''
    Before we get into other matters, and since we have such an 
esteemed panel here today, would you please briefly comment on 
how the President's panel addressed the risk of environmental 
cancer versus other causes? The whole panel. Who wants to take 
it first? Mr. Lester, I see you reaching for the button.
    Mr. Lester. Well, I don't think the report says that the 
environment is the major source of cancer. What I think it says 
is that while there are many uncertainties about what we know 
and don't know about various exposures and various causes, we 
have a great deal of information about the relationship between 
these exposures and the toxicity of these chemicals and the 
susceptibility of the population, and I think the report says 
that we should take action and we should take steps to reduce 
exposures to the extent that we can, that we are not doing 
enough of that. I think Dr. Wargo mentioned that there seems to 
be this burden of having to rely on certainty that a chemical 
is causing a particular health problem and that if we do that 
we are just continuing to allow the population to be exposed 
and for the varying rates of different kinds of health problems 
to continue to rise as we are seeing in the last five to 10 
years.
    So I think that the message from that report is really that 
we should take steps that we can to reduce exposures because 
there is a lot that we can do along those lines.
    Mr. Broun. Anyone else? Dr. Wargo.
    Dr. Wargo. Yes, I have had a chance to explore that 
question in a number of different contexts. One was in my 
experiences on a VA case where a very complicated mixture of 
chemicals was released and dozens of those compounds are 
recognized to be carcinogens. Also, I worked with several 
National Academy of Science panels that looked at this question 
with respect to pesticides, and you probably know that there 
are a number of pesticides, the last I looked, more than 100, 
that are allowed to be used that are carcinogenic in laboratory 
studies. There are obvious problems in relying on animal 
studies alone but given the long latency period between 
exposure and the onset of many kinds of tumors, it makes it 
extremely difficult to prove that a chemical or a mixture 
induced cancer.
    Now, I approach this question in a different way, and I 
think that the President's panel was suggesting a similar 
route, that it makes good sense to be precautionary and 
preventative where you can. It makes common sense to figure out 
where your exposure to carcinogens in the environment are most 
extreme and to reduce those. And in fact, when I think about 
how my wife and I raised my family, we couldn't prove that any 
chemicals that were positive in carcinogenicity tests were 
threatening our children but it was just prudent to avoid 
exposure. So I really agree with the panel's recommendations 
and I think that much more attention needs to be focused on 
managing environmental contamination as a way of reducing our 
burden of exposure to carcinogens.
    Mr. Broun. While I agree more research should be done to 
better understand environmental causes of cancer, I hope that 
it will not be a distraction from greater causes. Dr. Graham 
Colditz of Washington University School of Medicine St. Louis 
said, ``The report's overemphasis on environmental toxins could 
actually cause more harm than good when it comes to the fight 
against cancer. Maybe up to four percent of cancers in the 
Western world are caused by contaminants and pollution yet we 
are chasing new unknown causes rather than focusing on acting 
on what we know.'' Things like this report are making it harder 
to move the Nation to a healthier lifestyle and I am very 
concerned about that as a physician.
    My time is up, and I yield back.
    Chairman Miller. It is.
    Mrs. Dahlkemper for five minutes.
    Mrs. Dahlkemper. Thank you, Mr. Chairman, and thank the 
witnesses here today.
    Dr. Edwards, the main message from the 2004 MMWR and the 
statements made by federal and city officials was that since 
blood levels above 10 micrograms per deciliter for children 
under six didn't show elevated numbers, everything was fine. My 
understanding is that blood levels between five and 10 
micrograms per deciliter can have serious health and 
developmental effects and consequences for young children. So 
do you know why this message wasn't more clearly delivered in 
the District, and can you just comment on that?
    Dr. Edwards. Actually that message was delivered in the CDC 
MMWR, that there is no safe level of lead and that there was a 
small increase, or there might have been a small increase in 
blood lead that was observed, but unfortunately, the way it was 
interpreted by the coauthors of the CDC MMWR who testified to 
Congress and the D.C. council and in the press was that because 
the increase was below the level of concern, that by definition 
the health effects were also below the level of concern. So it 
is unfortunate their subsequent sworn testimony did not look at 
that issue in more detail but the reality is, as we showed in 
our paper, that the blood level of hundreds, if not thousands 
of D.C. children was raised above levels of concern, was raised 
above levels that constitute lead poisoning.
    Mrs. Dahlkemper. What was the sampling number on that?
    Dr. Edwards. It depends on which part of the study. There 
was one part of the study which was of 201 residents supposedly 
from the worst case homes, the homes where it wasn't revealed 
that 75 percent of the people had been drinking bottled water 
for weeks to months to a year beforehand. That only had perhaps 
a dozen children of whom none were drinking the tap water. 
There was another study where there were tens of thousands of 
data collected under the routine surveillance program and that 
was subject to a lot of flaws that are detailed in my testimony 
and in the House report.
    Mrs. Dahlkemper. Thank you.
    Mr. Lester, can you tell me, you have been working with 
ATSDR-related issues for two decades now, how have you found 
ATSDR reacting to your criticism and what has been your 
experience over those two decades you have worked with them?
    Mr. Lester. Well, when we first started they came to us 
seeking a route to reach the communities that they work with 
and to try to find a way to solve the concerns and the issues 
that had been raised. So for a year or so they were very 
responsive and conscientious and caring about how they could 
better work and involve communities in their work. But as 
things went on, as time went on, it became clear that they 
could not continue to develop those relationships. I think a 
lot of it goes back to the fact that they just don't value what 
community people know. I think that there are problems with the 
way they perceive information that people provide to them, and 
so they do not continue--they did not continue to work with 
communities or to listen to communities or pay attention to 
what communities want.
    Mrs. Dahlkemper. Have there been any recent examples of 
this in the last two, three years?
    Mr. Lester. Yes, yes. I mean, over the years I think I 
mentioned in my testimony they became very slick at changing 
the language and adopting the language of what people want and 
appearing to respond to what people are concerned about, but 
they actually didn't--nothing has changed over the 20 years, in 
short. I mean, they are just doing many of the same things 
today that they did 20 years ago and it is very frustrating to 
continue to raise these issues with them and them to continue 
to do what they do.
    Mrs. Dahlkemper. Ms. Bascetta, without policies and 
procedures in place, can we have faith in the quality of the 
work being done by the ATSDR?
    Ms. Bascetta. It certainly lowers our comfort level without 
those policies and procedures. The flip side is that having 
those policies and procedures is necessary but not sufficient 
to guarantee high product quality, uniform and consistent 
product quality because other factors, you know, could come 
into play. But certainly having policies and procedures is a 
necessary first step.
    Mrs. Dahlkemper. Thank you. My time is just about up. I 
yield back.
    Chairman Miller. Thank you.
    Mr. Rothman for five minutes.
    Mr. Rothman. Thank you, Mr. Chairman.
    I am going to focus most of my questions, if not all of 
them, on Dr. Wargo with regards to the island of Vieques in 
Puerto Rico. Firstly, thank you for your work all these years 
in identifying and highlighting the significant and very 
disturbing health issues of the people of Vieques. I am told 
that in your book you refer approvingly or accept the Puerto 
Rican health officials' statements that residents of Vieques 
have a 25 percent higher infant mortality rate, 30 percent 
higher rate of cancer, 95 percent higher rate of cirrhosis of 
the liver, and a 381 percent higher rate of hypertension as 
well as a 41 percent higher rate of diabetes than those on the 
main island of Puerto Rico just eight miles away. And yet ATSDR 
saw no connection between those anomalies, if you will, and the 
dropping of 100 million pounds of explosives and contaminants 
including TNT, lead, mercury, PCBs and other pretty horrific 
poisons.
    As you know, based on the prompting of many people 
including myself, in May of 2009 ATSDR's Dr. Frumkin was before 
us and agreed in response to a question of mine to officially 
for the first time, as far as I know, reopen the investigation 
on the health consequences of all those 50-plus years of 
bombing the island of Vieques. They say they put together an 
independent peer-review panel. I submitted two names 
recommended by the mayor of Vieques, two scientists. They just 
announced, they sent me a letter that I just received that they 
are going to put one of them on the panel but that all of the 
others still have no connection to ATSDR.
    There is also--and I am sorry we only have five minutes for 
this. There was a heart disease study done back in 1999, I 
think, so that of course would be a peer review and a tissue 
sample study, would it not? In any event, do you think that 
from what you know, and I know you were out there in October at 
the CDC, do you think that this new panel will give a 
satisfactory review and determination about the connection, if 
any, between these health anomalies of the residents of Vieques 
and the 52 years of bombing on that island?
    Dr. Wargo. No. I think that there are some serious 
fundamental deficits in the science and the quality of data 
that is available to the agency, and I also think that in 
fairness to the agency, if you took their total budget that is 
allocated toward public health assessments per year, and out of 
a budget of roughly $75 million per year, probably $10 million 
of that is allocated to public health assessments. So, say you 
are running ATSDR and you are responsible for doing health 
assessments or additional cleanup assessments on hundreds of 
different Superfund sites, that translates into tens of 
thousands of dollars only per year, to conduct an 
epidemiological study, to understand the cardiovascular 
effects----
    Mr. Rothman. Forgive me, Doctor. I have 58 seconds left. 
Can you provide me, would you be willing to provide me with a 
list of recommendations on what this new panel needs to do so I 
can submit it to ATSDR and request/demand that they adopt your 
recommendations so that you can be confident and I can be 
confident and the people of Vieques can be confident that this 
new review will be worth the paper is written on?
    Dr. Wargo. Absolutely. I would be delighted to do that, and 
I just want to say one other thing about the islanders, 9,300 
people that live there and suffered through 60 years of 
military activity and bombing, it is incredibly important to 
think of this group of people as a highly stressed people. When 
the Navy went in and took their land away, they basically 
destroyed their jobs, they moved them from their houses. This 
has been an island under serious social and economic stress for 
a long time, and we all know that under those conditions you 
have background medical problems and illnesses that the 
exposures are sitting on top of. So I think that much more 
attention by the ATSDR has to be placed on the idea of 
susceptibility, you know, who are the susceptible people on 
that island. They are the young, they are the youngest. They 
are the fetuses in pregnant women. They are also the elderly. 
These are the population subgroups that I think deserve the 
greatest degree of attention, and those with other background 
illnesses that the chemical exposures are piling on top of.
    Mr. Rothman. May I have--I will wait for the second round 
unless the chairman----
    Chairman Miller. We do have time for a second round.
    Mr. Rothman. Very good. Thank you, Chairman.
    Chairman Miller. Because every member kind of stuck to the 
five minutes, we do have time for a second round.
    Dr. Edwards, the MMWR is not peer reviewed, and in 
fairness, not everything can be peer reviewed. I think even the 
critics who have suggested there should be further peer reviews 
that there is a sampling at least, not that everything be peer 
reviewed, but you certainly qualify as a peer and have looked 
more closely at the MMWR analysis than just about anybody, and 
you were also very critical of today's publication. Have you 
compared the fundamental findings of that 2004 MMWR to the 
publication today and particularly the reliance on the cross-
sectional study that found no correlation between the highest, 
the elevated water lead levels and blood lead levels?
    Dr. Edwards. Well, the thing I most remember about the new 
publication, and I have just seen it, you know, this morning, 
is that they are now claiming that their conclusion all along 
was that children living in homes with lead pipes had much 
higher blood lead than children living in homes without lead 
pipe, and implying that the public's conclusions were the 
results of misreading the earlier publication, and that is 
absolutely false. If you look at their quote where they talk 
about that in the new publication, it leaves out a sentence 
before it in the original MMWR that specifically says that the 
children living in the homes with lead pipes have high blood 
lead because of lead paint and other sources, not water. So 
they left that out. They are trying to rewrite history in the 
most blatant way I can imagine.
    Chairman Miller. And with respect--I know you have already 
touched on this, well, more than touched on it, you discussed 
it at some length, but again, what flaws did you see in the 
cross-sectional study for the 2004?
    Dr. Edwards. You mean the study of the----
    Chairman Miller. Comparison of water lead level and blood 
lead level.
    Dr. Edwards. Within the 300 PPB study?
    Chairman Miller. Right.
    Dr. Edwards. Oh. Well, first and foremost, not mentioning 
the water filter use, even though the authors discussed that 
they should put that in the publication and they purposely 
decided not to mention it, the fact that there was this 
sampling gap and that those residents were not the worst case 
in the city but in fact was the group of residents in the city 
least likely to show harm from the high lead in water. So it 
was completely mischaracterizing what they did.
    Chairman Miller. Ms. Bascetta, the GAO report did 
emphasize, I just touched on, peer review. Do you know how 
often ATSDR now does conduct peer review and how often do you 
think it should conduct peer review?
    Ms. Bascetta. For their largest category of studies, out of 
282 they only chose to do peer review twice. All of their 
health studies, but that is a very small proportion of their 
work, are peer reviewed. And as for what our suggestion would 
be, it is hard to answer that question without knowing more 
about the specific circumstances in which the peer review might 
be warranted but they do have criteria for where they think 
that a higher level of review is warranted, either from 
internal peer review or externally, and I would suggest that 
they take a look at those criteria and try to figure out in 
what percentage of cases they need to apply that more 
consistently across all their products.
    Chairman Miller. Dr. Edwards, back to the D.C. water, there 
was one child who did have elevated blood lead levels and they 
decided to exclude him from the study because they thought he 
had not been living there long enough. Do you have a sense of 
how long it takes exposure to affect the blood lead level and 
was it scientifically valid to exclude that child and do you 
have any information that they excluded children from the study 
who had not lived there long but--did not live in that house 
for very long but did not have high blood level either--blood 
lead level?
    Dr. Edwards. Yes. At the levels of lead and water, the 
highest lead in water levels in D.C. at that time, 24,000, 
48,000 parts per billion lead in water. These are nine times 
hazardous waste levels of lead in the water. Drinking a single 
glass of water at that level could elevate your blood lead over 
CDC's level of concern and cause lead poisoning. There is no 
doubt about it. So drinking a single glass of D.C. tap water at 
that time, if you were one of the unlucky ones to get that 
very, very high does of lead, that is all it would have 
required, one glass of water.
    Chairman Miller. So if the child had been living in a house 
for a couple months, they should not have been excluded from 
the study. That seems a fairly obvious----
    Dr. Edwards. That was part of my allegations to CDC, why is 
it you are deleting from your study your known evidence about 
children that did have high blood lead, and the reason is, is 
because they could not allow it to be perceived that even a 
single child had been harmed, not one.
    Chairman Miller. I know that I praised everyone on the 
Committee for sticking to the five minutes and now I have 
exceeded slightly myself.
    Dr. Edwards, none of us particularly like criticism but you 
have been very critical of NCEH and ATSDR's work in this area, 
CDC's work in this area. How have they taken your criticism? 
Have they regarded it as helpful and constructive or perhaps 
less welcoming of it?
    Dr. Edwards. Well, they have been very unwelcoming, to say 
the least, but worse than what is constituted the scientific 
misconduct, possible scientific misconduct in the CDC and MMWR 
is that they refused for years to correct the public record. 
They saw this being misused not only in D.C. but all around the 
country and around the world and they refused to correct the 
record.
    Chairman Miller. Thank you.
    Dr. Broun is now recognized for six minutes and 25 seconds.
    Mr. Broun. Thank you, Mr. Chairman.
    After hearing you all's testimony, I think that the 
American public should be very concerned about any product that 
ATSDR puts out. Under the Superfund Amendments and 
Reauthorization Act, it exempted ATSDR from peer review. Can 
you tell me why we should not repeal that exemption? I see no 
reason that they should be exempted from peer review, just as 
Dr. Edwards was just talking about, these exemptions, exempting 
folks from the study and how the study was done. I am a medical 
doctor, a practicing physician, and some members of this 
committee who are more true research scientists, don't call me 
scientific but I am an applied scientist and I am just appalled 
at the products that ATSDR is putting out, frankly. Why 
shouldn't we--is there any reason to not remove this exemption 
on peer review? Let us start with Dr. Edwards and then Dr. 
Wargo.
    Dr. Edwards. Well, I can't really speak authoritatively to 
that issue. What I can say in the case of the CDC MMWR, that 
the lead author from the CDC gave all her coauthors less than 
three hours to review the publication and determine whether 
they wanted to be coauthor or not. So not only is it not being 
peer reviewed in some cases, the coauthors are not even being 
given a chance to give input to the publication, and when they 
gave input, in many instances it was ignored, and I also showed 
that CDC violated its own clearance policies time and time 
again related to this publication. So it would be helpful if 
they started following their own rules to guard against release 
of misguided information before we started talking about 
additional rules which might very well be useful.
    Mr. Broun. So your answer is you think that we should 
remove the exemption from peer review there?
    Dr. Edwards. I don't feel I can answer the question.
    Dr. Wargo. I couldn't agree with you more. I think that 
that exemption has created very serious problems of credibility 
for the agency and I have also participated in panels working 
with the Environmental Protection Agency on their science 
advisory panel and their science review board and I know that 
those reviews can be conducted in an open, a transparent and a 
highly scientific and highly critical forum efficiently, and 
that is the key. You don't want to have the public health 
assessments held up for six months or a year to go through a 
peer review process. But if you have a standing group of 
experts in an area that know the literature, that are 
recognized to be the best in their field, this can happen quite 
efficiently. I see no reason to maintain that exemption.
    Mr. Broun. Dr. Wargo, do you think this can be done in an 
expeditious manner or, as Dr. Edwards was talking about, the 
coauthors offered just hours but that seems to be a bit hasty 
to me, but can we do this expeditiously and still have peer 
review?
    Dr. Wargo. I believe you can. I believe you can, and I 
think that having, say, standing panels of experts that are on 
call to conduct peer reviews in ways that would not prolong the 
agency's deliberations before they release a document, 
especially when you have a community that might be being 
exposed and at risk, you want that opportunity to intervene 
quickly. So I see it happen in the scientific community all the 
time.
    Mr. Broun. Thank you very much. I am not going to use my 
whole six minutes and 28 seconds, so I yield back.
    Chairman Miller. I think Dr. Broun is just trying to make 
the chairman look bad.
    Mr. Rothman for five minutes.
    Mr. Rothman. That would be impossible, Mr. Chairman.
    Dr. Wargo, we received--my office received after a request, 
some written assurances from ATSDR that they were aware of the 
limitations of health care access on Vieques as they were aware 
of the many health problems of the people of Vieques, and they 
said that, paraphrasing, while they could not provide the care 
themselves, they have committed to work with public health and 
health care partners to seek improvement and access to health 
care. Do you know of any evidence of their activities in that 
regard?
    Dr. Wargo. No, I do not, and I fully agree that there are 
problems with providing medical care to the islanders. To get 
on and off that island commonly takes either a plane ticket, 
which is expensive, to get to San Juan or most of the islanders 
will get to the main island by taking a two-hour ferry. So if 
you have an emergency situation, it is just not sustainable.
    Mr. Rothman. And I don't believe there is a hospital on the 
island. I am not even sure, is there a clinic on the island?
    Dr. Wargo. There is a clinic on the island.
    Mr. Rothman. Okay.
    Dr. Wargo. But that community needs its own state-of-the-
art hospital.
    Mr. Rothman. One would imagine that the moral 
responsibility of the people of the United States who were the 
beneficiaries of the 50-plus years of research, the bombing and 
use of our weaponry to protect our country, one would argue, I 
argue, that we have a moral responsibility to take care of the 
residents of that island, the 10,000 or less who suffered the 
consequences of in essence protecting us by allowing us to test 
our munitions.
    Vieques was designated a federal Superfund site. Am I 
correct, Dr. Wargo?
    Dr. Wargo. Yes, that is correct.
    Mr. Rothman. Is it ATSDR's role to say in its report that 
even if they don't find a connection between the poisons 
dropped or contaminants dropped on their island over 52 years 
and these health care--health status anomalies, that is the 
right way to describe these higher rates of diseases and bad 
physical conditions, even if they don't find a connection, is 
it their job to recommend that these people be taken care of or 
is that by the U.S. government in some way or must that come 
from someplace else?
    Dr. Wargo. Well, I read the provision in the statute that I 
cited earlier, and it is very clearing that provision that they 
do have a responsibility, that they have a responsibility to 
suggest opportunities for exposure reduction, and if they 
understand that there are adverse health outcomes, they have an 
obligation as well to consider what might be done in order to 
treat illnesses.
    Mr. Rothman. Is that only if the illnesses were related to 
exposure?
    Dr. Wargo. Well, that is not clear in the code, and it 
strikes me that again if you have got a population that is 
stressed, that has a high background incidence of the illnesses 
that you just reviewed, and they are being exposed to chemicals 
that are well known----
    Mr. Rothman. But they would have to come to that--they 
would have to make that finding. They would have to make that 
connection.
    Dr. Wargo. They would but, you know, knowing what I know 
about that island, you would be pretty hard pressed to reach a 
conclusion that those islanders were not exposed to those 
chemicals.
    Mr. Rothman. I agree with you, and ATSDR in a recent letter 
to us said that they believe that further investigation is 
warranted and that they will support Puerto Rican health 
officials and public health agencies to pursue that further 
investigation. Again, I would ask kindly and respectfully if 
you could provide my office as soon as possible with your list 
of recommendations that we will pass on immediately to ATSDR so 
that we can get a fair and medically credible, scientifically 
credible conclusion or examination completed as soon as 
possible by ATSDR.
    Dr. Wargo. May I respond just very briefly?
    Mr. Rothman. Yes.
    Dr. Wargo. It strikes me that the agency should be thinking 
about the problem in a very different way. They should be 
thinking about it as an opportunity to understand how to reduce 
exposures, not six months down the road, not five years down 
the road, but tomorrow, and there are opportunities to do that.
    Mr. Rothman. To reduce exposure on Vieques or in other 
places?
    Dr. Wargo. On Vieques, but the same principle I think 
should apply to all Superfund sites and all communities that 
live adjacent to them.
    Mr. Rothman. Would you include that in your list of 
recommendations?
    Dr. Wargo. Absolutely.
    Mr. Rothman. I thank the chairman.
    Chairman Miller. Thank you, and the Chair thanks Mr. 
Rothman for exceeding his time.
    Mr. Rothman. You are welcome.
    Chairman Miller. And we will include in the record Dr. 
Wargo's response.
    We will now take a short break between panels. I thank all 
of you for appearing today and we will be back in a minute with 
Dr. Ikeda.
    [Recess.]

Panel II
    Chairman Miller. I will introduce our second panel, which 
consists of one witness, Dr. Robin Ikeda. Dr. Ikeda serves as 
the Deputy Director for the Office of Noncommunicable Diseases, 
Injury and Environmental Health, and as the Acting Director for 
the National Center for Injury Prevention and Control at CDC. 
She has an undergraduate degree from Stanford, an MD from 
Cornell and an MPH, master of public health, degree from Emery. 
As our witness should know from having been here earlier, you 
will have five minutes for your spoken testimony. Your written 
testimony will be included in its entirety in the record for 
the hearing. When you have completed your spoken testimony, we 
will begin with questions and each member will have five 
minutes, and likely we will only have one round. I am sure you 
are disappointed.
    It is the practice of the Subcommittee to take testimony 
under oath, as you saw earlier. Do you have any objection to 
taking an oath? The witness spoke the word ``no.'' You also 
have the right to be represented by counsel. Do you have 
personal counsel here? Okay. If you will now please stand and 
raise your right hand? Do you swear to tell the truth and 
nothing but the truth? Okay. Dr. Ikeda has taken the oath. Dr. 
Ikeda, you are now recognized for five minutes for your spoken 
testimony.

 STATEMENT OF ROBIN M. IKEDA, MD, MPH, DEPUTY DIRECTOR, OFFICE 
 OF NONCOMMUNICABLE DISEASES, INJURY AND ENVIRONMENTAL HEALTH, 
    AND ACTING DIRECTOR FOR THE NATIONAL CENTER FOR INJURY 
PREVENTION AND CONTROL (NCIPC), CENTERS FOR DISEASE CONTROL AND 
                        PREVENTION (CDC)

    Dr. Ikeda. Good morning, Chairman Miller, Ranking Member 
Broun and other distinguished members of the Subcommittee. On 
behalf of Dr. Thomas Frieden, Director of the Centers for 
Disease Control and Prevention, CDC, and Administrator of the 
Agency for Toxic Substances and Disease Registry, ATSDR, I 
would like to thank you for the opportunity to present this 
testimony.
    I am Captain Robin Ikeda, a physician and a member of the 
United States Public Health Service Commission Corps. Since 
February 2010, I have served as the CDC Deputy Director for 
Noncommunicable Disease. In this position, I provide guidance 
and leadership to the four noncommunicable disease centers at 
CDC including the National Center for Environmental Health and 
ATSDR. I have worked at CDC for nearly two decades and have 
served as Associate Director for Science at both the 
Epidemiology Program Office and at the National Center for 
Injury Prevention and Control.
    Today I will focus on several areas of interest to the 
Subcommittee: improvements underway within NCEH and ATSDR, the 
National Conversation, CDC's work on elevated lead in 
Washington, D.C., drinking water, and the fresh look that ATSDR 
is taking on the island of Vieques in the Commonwealth of 
Puerto Rico.
    CDC/ATSDR's senior leadership understands the need to 
improve ATSDR's ability to address concerns of communities 
related to potential exposures to hazardous substances. A team 
from the Government Accountability Office, GAO, recently 
reviewed ATSDR's processes related to preparation and review of 
scientific manuscripts. We appreciate the GAO recommendations 
to improve ATSDR's procedures. In particular, ATSDR is working 
to strengthen both our priority setting and project management 
to make them more explicit and consistent across the agency. 
Staff roles and responsibilities from project inception to 
publication of findings must also be clearly defined and 
understood.
    On a larger scale, NCEH, ATSDR along with many others 
launched the National Conversation in June 2009. Individuals 
from dozens of organizations are represented on the National 
Conversation six work groups. This two-year project will 
identify strategies to better protect the public from harmful 
chemical exposures. The National Conversation is currently at 
the midpoint in the process. Recommendations from the project's 
leadership council are expected this winter.
    Moving to more specific areas, I will touch on our efforts 
to address lead in the District of Columbia drinking water. As 
you have heard, between 2000 and 2003, the District of Columbia 
detected a very high lead concentration in its drinking water. 
Available surveillance data were analyzed and in April 2004 CDC 
reported that lead in tap water contributed to a small increase 
in blood lead levels in D.C. among those living in homes with 
lead service lines. Several concerns have been raised about 
this report. A critical issue has been the missing blood lead 
data from 2003 and whether this compromised our analysis. Given 
these concerns, we took steps to obtain the data that we should 
have had for the 2003 analysis. We conducted a complete 
reanalysis and invited outside experts to review our work. 
Today I can report to you that our more comprehensive analysis 
did not fundamentally change our findings from 2004. These 
results were released on our website yesterday and will be 
announced in CDC's MMWR--that's the Morbidity and Mortality 
Weekly Report--today.
    My final topic is ATSDR's work on the island of Vieques. 
Between 1999 and 2006, ATSDR evaluated the extent of exposures 
to hazardous substances and potential health effects. As part 
of this work, ATSDR used available data collected from a 
variety of sources. In general, these reports found that 
residents of Vieques had likely been exposed to contaminants. 
However, the levels of exposure were sufficiently low that the 
available scientific methods at that time could not establish a 
link to negative health effects.
    In 2009, ATSDR pledged to take a fresh look at the island 
of Vieques. This has involved both a thorough review of its 
previous work on the island and any new scientific data. In 
August 2009, ATSDR leadership and staff visited the island, and 
during November convened a face-to-face consultation with 
independent scientists including individuals from Puerto Rico 
and from academic institutions on the mainland. ATSDR is in the 
final stages of completing a draft report. This document will 
be externally peer reviewed and then shared with this Committee 
and the public for comment.
    NCEH/ATSDR works to address environmental public health 
concerns including those raised by communities. Although we 
have assembled a strong record of accomplishment, we 
continually seek to strengthen our ability to prevent harmful 
exposures and to protect the public. I am committed to applying 
my 19 years of experience at CDC, particularly my service as 
Associate Director for Science, to guide this ongoing 
improvement in our work. I look forward to working with the new 
Director of NCEH/ATSDR and Dr. Frieden to protect the public 
from dangerous environmental exposures.
    Thank you, Mr. Chairman and members of the Subcommittee, 
for this opportunity to testify before you today.
    [Statement of Dr. Ikeda follows:]
                  Prepared Statement of Robin M. Ikeda

Introduction

    Good morning Chairman Miller, Ranking Member Broun, and other 
distinguished members of the Subcommittee.
    On behalf of Dr. Thomas Frieden, Director of the Centers for 
Disease Control and Prevention (CDC) and Administrator of the Agency 
for Toxic Substances and Disease Registry (ATSDR), I would like to 
thank you for the opportunity to present this testimony.
    I am Captain Robin Ikeda, a physician board-certified in both 
internal medicine and preventive medicine, as well as a member of the 
U.S. Public Health Service Commissioned Corps. Since February 2010, I 
have served as CDC Deputy Director for Noncommunicable Diseases, 
Injury, and Environmental Health. I am responsible for providing 
guidance and leadership to the four noncommunicable disease centers at 
CDC, including the National Center for Environmental Health (NCEH) and 
ATSDR. I have had the privilege of serving at CDC for nearly two 
decades, during which I have held key leadership positions including as 
Associate Director for Science in CDC's Epidemiology Program Office, 
and later in the same role at the National Center for Injury Prevention 
and Control. I began my CDC career as a member of the Epidemic 
Intelligence Service, assigned to the New York State Department of 
Health.
    This experience provides a solid foundation for the 
responsibilities I have in my current position, particularly during 
this important time for ATSDR and NCEH, when we are actively searching 
for a new director to lead our environmental health programs. We are 
committed to finding a director who will assure and facilitate 
excellence at NCEH/ATSDR in achieving our mission.
    Today I will focus my remarks on several areas in which the 
Subcommittee has expressed interest: changes underway within NCEH and 
ATSDR to improve the ways in which we protect the health of the public; 
CDC's work related to lead poisoning prevention, including that related 
to elevated lead in Washington, D.C. drinking water; and the fresh look 
that ATSDR is taking to evaluate potential health effects of exposures 
to hazardous substances on the Island of Vieques in the Commonwealth of 
Puerto Rico.

ATSDR Improvements

    ATSDR is a small agency with a large mission. CDC/ATSDR's senior 
leadership, and Dr. Frieden in particular, understand the need to 
improve ATSDR's ability to address concerns of communities related to 
potential exposures to hazardous substances.
    Recently, a team from the Government Accountability Office (GAO) 
completed a review of ATSDR's management processes related to 
preparation of scientific documents, and provided us with a draft 
report, Agency for Toxic Substances and Disease Registry: Policies and 
Procedures for Public Health Product Preparation Should be Strengthened 
(GAO-10-449). We appreciate GAO drawing attention to areas where ATSDR 
can improve the documentation and functioning of our processes and 
controls. ATSDR has undertaken several efforts to formalize and improve 
its processes in fulfilling its public health mission. Several 
improvements are underway. Some of these changes are in response to the 
report, and others were initiated prior to our receipt of the draft 
report.

          ATSDR is working to ensure that scientific principles 
        and approaches are consistently applied across all of our 
        divisions--and that all documents that are prepared for public 
        dissemination receive an appropriate level of review and 
        clearance.

          ATSDR has moved away from paper-based tracking and 
        record keeping systems to computer or electronic based systems. 
        This ensures review and clearance by the appropriate chain-of-
        command, and precise documentation of the process. ATSDR is 
        working to greatly improve project tracking, to ensure projects 
        stay on track, are completed in a timely fashion, and receive 
        scientific and management review and input on a consistent 
        basis.

          As recommended by GAO, ATSDR is working to strengthen 
        its project management and priority-setting processes, to make 
        them more explicit and consistent across the Agency. It is 
        important, given the scope of ATSDR's mission, that we have a 
        sound system for handling and triaging requests and that 
        management and staff roles and responsibilities are clearly 
        defined and understood from project inception to publication of 
        findings.

    In addition to these improvements in processes for preparation of 
scientific documents, ATSDR is actively reviewing other ways to further 
strengthen its scientific approach. These include:

          Reviewing areas where ATSDR work has been 
        particularly effective, and the needs of federal, state, and 
        community partners, in order to identify a clear set of 
        priorities that emphasize the activities that are achievable 
        and best meet the needs of our partners.

          Adjusting the scope or volume of ATSDR's scientific 
        activities to ensure consistently high quality.

          Leveraging both NCEH and ATSDR programmatic and 
        scientific strengths to improve environmental public health 
        practice.

National Conversation on Public Health and Chemical Exposures

    Many agencies and organizations--governmental and nongovernmental, 
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.
    In June of 2009, with the collaboration of ATSDR and NCEH, other 
government agencies, national experts and members of the public, the 
National Conversation on Public Health and Chemical Exposures was 
launched.\1\ The National Conversation is a two year project that aims 
to identify strategies that many stakeholders, including ATSDR, can 
take to better protect the public from harmful chemical exposures. The 
National Conversation currently is at the mid-point in the process.
---------------------------------------------------------------------------
    \1\ www.atsdr.cdc.gov/nationalconversation
---------------------------------------------------------------------------
    Through the National Conversation, public health professionals and 
others who contribute the experience and perspectives of government, 
communities, business, NGOs, and academic institutions, are engaging in 
a collaborative effort to recommend measures based on consideration of 
the broad range of related programs and activities. Many knowledgeable 
individuals from dozens of organizations are represented on one of the 
National Conversation's six work groups or Leadership Council. The work 
groups are organized around key components of public health action on 
chemical exposures, including Monitoring, Scientific Understanding, 
Policies and Practices, Chemical Emergencies, Serving Communities, and 
Education and Communication, and each group is currently developing a 
report of prioritized recommendations. We anticipate that these 
recommendations will be provided to the project's Leadership Council 
within the next year.
    Among the issues currently being discussed as part of the National 
Conversation are several that relate directly to current CDC/ATSDR 
programs and activities, including:

          Building state biomonitoring capacity;

          Enhancing ATSDR's community-based environmental 
        health activities; and

          Advancing ATSDR's efforts to characterize risks from 
        exposure to multiple chemicals.

NCEH Work Related to Lead Poisoning Prevention, Lead in Washington, 
                    D.C., Drinking Water.

    Substantial improvements have been made in reducing lead in the 
environment: during 1999-2004, 1.4% of children in the United States 
aged 1-5 years had blood lead levels above 10 ug/dL, compared with 8.6% 
of children during 1988-1991.\2\ These improvements are the result of 
population-wide prevention strategies to reduce the incidence of lead 
poisoning. Collaborative public health efforts by CDC, the 
Environmental Protection Agency, the Department of Housing and Urban 
Development and others contributed to this dramatic reduction.
---------------------------------------------------------------------------
    \2\ Jones, Robert L., David M. Homa, Pamela A. Meyer, Debra J. 
Brody, Kathleen L. Caldwell, James L. Pirkle, and Mary Jean Brown. 
Trends in Blood Lead Levels and Blood Lead Testing Among U.S. Children 
Aged 1 to 5 Years, 1988-2004: Pediatrics, March 2, 2009, 123(3); e376-
385. http://pediatrics.aappublications.org/cgi/content/abstract/123/3/
e376
---------------------------------------------------------------------------
    However, lead paint hazards in residences and public buildings, and 
lead in water, consumer products, and as a result of take-home exposure 
by parents who work with lead, continue to contribute to children's 
blood lead levels.
    Since 1990 CDC has designed and implemented programs that identify 
the children most likely to have elevated blood lead levels and helped 
ensure that they receive timely and appropriate care; identify the 
houses most likely to have lead hazards and ensure that the lead 
hazards are controlled or eliminated before more children are exposed; 
provide information to health care providers, educators, and advocates 
to support lead poisoning prevention; and provide information to 
parents to empower them to protect their children from lead exposure. 
CDC also supports 40 state and local health departments through funding 
and technical assistance to eliminate elevated blood lead levels in 
children.
    Between 2000 and 2003, the District of Columbia (D.C.) detected 
very high lead concentrations in its drinking water. Upon learning of 
this in February, 2004, CDC immediately began working with the D.C. 
Department of Health to ensure that the public was alerted to this 
exposure and that alternative sources of drinking water were made 
available. Within six weeks, CDC analyzed all available surveillance 
data, and, in April 2004, reported in the CDC publication, the 
Morbidity and Mortality Weekly Report (MMWR) \3\, that between 2000 and 
2003, lead in tap water contributed to a small increase in blood lead 
(BPb) levels in D.C. among those living in homes with lead water 
service lines. The report also advised that there is no safe level of 
exposure to lead and all sources of lead exposure should be eliminated.
---------------------------------------------------------------------------
    \3\ Stokes L, Onwuche NC, Thomas P, et al., Blood Lead Levels in 
Residents of Homes with Elevated Lead in Tap Water--District of 
Columbia, 2004; MMWR Weekly, April 2, 2004, 53(12); 268-270.
---------------------------------------------------------------------------
    Concerns have been raised over whether the MMWR report accurately 
characterized the impact of lead in water on blood lead levels. We take 
those concerns seriously. Over the past 8 months, we have taken a 
number of additional steps to improve our understanding of the impact 
of elevated lead levels in tap water on the levels of lead in the blood 
of D.C. residents. Today I can report to you that, as a result of a 
more comprehensive analysis, we have concluded that CDC's initial 
reports did not understate the magnitude of the problem.\4\
---------------------------------------------------------------------------
    \4\ CDC's reanalysis is available at: http://www.cdc.gov/nceh/lead/
leadinwater/
---------------------------------------------------------------------------
    Since the initial analyses attracted much interest, I would like to 
provide a little more detail about our reanalysis here. CDC conducted a 
more intensive data recovery and reanalysis because data reported in 
the 2004 MMWR did not include a substantial number of test results from 
blood specimens collected in 2003. Scientists outside CDC, lead 
poisoning prevention advocates, and Members of Congress have raised 
concerns that the missing test results might have resulted in an 
underestimation of the effect that elevated drinking water lead levels 
had on blood lead levels. To evaluate this potential bias, CDC recently 
collected all known 2003 blood lead test results and compared them to 
the subset of tests included in the MMWR article. This reanalysis was 
peer reviewed by experts from outside of CDC.
    CDC received 2003 blood lead test results from D.C. on three 
occasions. In March 2004, CDC received 9,765 test results from 
surveillance data and included these in the analysis for the MMWR 
article. An additional 1,753 tests from 2003 surveillance data (that 
had not been received previously) were reported by July 2006. In the 
fall of 2009, CDC received 21,324 test results reported by the 
laboratories that ran tests for D.C. children. Of these tests, 7,701 
had been reported previously as surveillance data, while 12,168 tests 
had not been previously reported to CDC. Of these, 1,455 were not 
included in analyses because they were either duplicates, not from 
2003, or not from a D.C. address.
    CDC found that the percent of 2003 blood lead tests that were 
elevated were actually lower when using all known 2003 blood lead tests 
compared to the subset of tests used previously in the 2004 MMWR 
article. The only variable that systemically predicted whether or not a 
test had been reported as part of the DC surveillance datasets was the 
reporting laboratory processing the test. Previously missing but now-
available 2003 data did not cause an underestimation for 2003 of the 
association between elevated blood lead levels and lead water service 
lines.
    Nonetheless, CDC recognizes the importance of better understanding 
the contribution of lead in water to blood lead in children. CDC 
recently completed an epidemiological study, and the preliminary 
results suggest a relationship between partial replacement of lead 
water service lines and elevated blood lead levels in children. That 
is, when public water service lines are replaced but the portion of the 
service lines belonging to the homeowner are not, the preliminary 
results suggest that blood lead levels increase, at least for some 
period of time. Due to the significance of the preliminary findings, 
even though publication of the study results was still pending, on 
January 5, 2010, CDC sent letters to lead program grantees (state and 
local departments of health) and water departments across the Country, 
and posted this information on our website.\5\
---------------------------------------------------------------------------
    \5\ http://www.cdc.gov/nceh/lead/waterlines.htm
---------------------------------------------------------------------------
    In the wake of the MMWR article we have learned a great deal about 
how we work with state and local governments to gather surveillance 
data, how we communicate our findings, and how we ensure appropriate 
response when questions are raised about the quality of our science. We 
are applying these lessons to our ongoing work in NCEH and ATSDR, and 
we have new organizational structures and leadership in place across 
CDC to help ensure that appropriate steps are taken.

ATSDR Evaluation of Potential Human Health Hazards on Vieques

    In 1999 ATSDR received a petition from a resident of Vieques, who 
was concerned about potential health effects related to the Navy 
bombing range and other military training activities. ATSDR has worked 
extensively on the island to evaluate the extent of exposures to 
hazardous substances, and potential health effects. As part of this 
work, ATSDR used available data collected from the Commonwealth of 
Puerto Rico, the U.S. Environmental Protection Agency, the U.S. Navy, 
and published scientific reports, as well as gathering additional data 
to supplement areas where needed. ATSDR also convened expert scientific 
panels to gather more information on specific areas. From 2001 to 2006, 
ATSDR published four public health assessments, as well as reports on 
several specific topics of health concern to the community. In general, 
these reports found that residents of Vieques had likely been exposed 
to contaminants. However, the levels of exposure were sufficiently low 
that the available scientific methods could not establish a link to 
negative health effects. Notwithstanding, ATSDR could not say with 
certainty that the low level of exposure did not cause harmful effects 
in some people.
    In 2009, ATSDR pledged to take a fresh look at the island of 
Vieques in response to members of Congress, who expressed concerns 
voiced by the community. ATSDR outlined an aggressive course of action 
to thoroughly review its previous work on the island and to gather any 
new scientific data that has become available. In August 2009, ATSDR 
leadership and staff visited the island and met with representatives of 
EPA, the Puerto Rico Environmental Quality Board, the Puerto Rico 
Department of Health, and the Puerto Rico Cancer Registry to determine 
what additional information was available. We also met with elected 
officials, health officials, and members of the community on Vieques to 
better understand community concerns related to health and the 
environment.
    Since then, ATSDR has convened a face-to-face scientific 
consultation with independent scientists who have conducted research 
work related to health and environmental issues on Vieques. The 
consultation included scientists from Puerto Rico as well as from 
academic institutions on the mainland, and focused on the strengths and 
weaknesses of many environmental health studies conducted in Vieques. 
ATSDR is currently in the final stages of completing a draft report--A 
Fresh Look at Environmental, Biological, and Health Data from the 
Island of Vieques, Puerto Rico--which will be submitted for external 
peer review. Once the peer review and clearance processes have been 
completed, ATSDR will release the document for public comment.

Conclusion

    NCEH and ATSDR work to address environmental public health 
concerns, including the needs and concerns raised by communities. 
Although we have assembled a strong record of accomplishment--
protecting health near hazardous waste sites, advancing science through 
our health studies and the work of the environmental health laboratory, 
and educating health professionals and the public--NCEH and ATSDR 
constantly seek to strengthen our ability to prevent harmful exposures 
and protect the public.
    For example, ATSDR reviews and updates health assessments based 
upon significant additional data that it obtains, and based on 
advancements in scientific knowledge. At Camp Lejeune, North Carolina, 
ATSDR has been gathering data, refining methods, and amending findings 
as additional information has come to light. I appreciate the Committee 
Members' interest in ATSDR's work at Camp Lejeune, and support in 
responding to the concerns of the service men and women who served 
there. We look forward to working with you in the future as ATSDR 
continues to work at Camp Lejeune and at other sites across the 
Country.
    ATSDR also seeks to maximize the effectiveness of our internal 
processes and appreciate the recommendations from GAO for improving 
processes at ATSDR.
    I am committed to applying my 19 years of experience at CDC, and in 
particular my service as Associate Director for Science in different 
parts of the Agency, to guide and contribute to this ongoing 
improvement in our work, and look forward to working with the new 
Director of NCEH/ATSDR to achieve the goal of protecting the public 
from dangerous environmental chemical exposures.
    Thank you Mr. Chairman and Members of the Subcommittee for the 
opportunity to testify before you today.

    Chairman Miller. Thank you, Dr. Ikeda. We will now have a 
round of questioning, and the Chair recognizes himself for five 
minutes.
    Dr. Ikeda, there has been some assertion that the MMWR from 
2004 was misinterpreted, was widely misinterpreted as saying 
that there really was not a public health concern. That was not 
the intent, it shouldn't have been read that way. But it does 
appear to have been widely reported in the press that that was 
the takeaway, the lesson, and it appears that that was in fact 
from the documents that you all had provided or that we have 
obtained that seems to be the intended message. That there was 
a talking point, talking points for Dr. Brown, main message, 
there is no indication that D.C. residents have blood lead 
levels above the CDC levels of concern of 10 micrograms per 
deciliter for children six months to 15 years old and 25 
micrograms per deciliter for adults as a result of lead in the 
water. There was an e-mail exchange between Dr. Falk, who was 
then the head of ATSDR/NCEH, and Dr. Brown referring to the 
MMWR. Dr. Falk said, ``Have you had many calls? How is it 
going?'' She wrote back, ``Today has been the first day in over 
a month that there wasn't a story on lead in water in the 
Washington Post and also the first that I haven't been 
interviewed by at least one news outlet. I guess that means it 
worked.''
    What steps should ATSDR and NCEH and CDC take in the 
future, or do you think it was incumbent upon those agencies to 
correct this impression? Did they do as they should have, and 
how do you go forward from here?
    Dr. Ikeda. One of the reasons that we published the MMWR 
today, this is a notice to readers that points people in the 
direction of the reanalysis, was to correct the record, was to 
let people know that we understood that our comments in the 
MMWR from 2004 were ambiguous and open to interpretation, so we 
wanted to make sure that people understood the principal 
message that we intended from 2004. Certainly we know that no 
lead level is safe and that we are very concerned about 
addressing and preventing, controlling, and eliminating lead 
exposure from any source.
    In terms of I think the larger question that you were 
asking about how ATSDR can move forward from here, we have 
heard a number of comments today about the concerns raised 
about scientific quality at ATSDR, procedural issues at ATSDR, 
and we are working to correct those. There are a number of 
improvements that are in place already and others that we are 
contemplating and thinking about in terms of moving forward. 
Dr. Frieden is very committed to ensuring the highest quality 
of science at ATSDR. I know that you and he have had 
conversations about that. And it is my responsibility as Deputy 
Director to make sure that that commitment is carried through. 
So I look forward to working with him and our new director to 
ensure that we improve the overall processes, procedures and 
scientific quality at ATSDR.
    Chairman Miller. With respect to the D.C. lead issue and 
the 2004 MMWR, what is published today does not specifically 
retract or correct the weaknesses of the cross-sectional study, 
which was the most single cited part of the study. You heard 
Dr. Edwards' testimony today that it had a very fundamental 
flaw, that it is hard to imagine it was not intentional, that 
it left the impression that children drinking the water did not 
have elevated blood lead levels--that is not easy to say--when 
in fact they weren't, the vast majority of the children, 
perhaps all the children weren't drinking the water at all. 
Have you corrected that part of the record?
    Dr. Ikeda. And again, we hope that our statement today and 
that the notice to readers in the MMWR will indicate to folks 
that we realize that statements in that original MMWR were 
ambiguous and open to interpretation. The cross-sectional study 
has not been repeated so I can't speak to whether there is any 
ability to redo that study or not. Certainly that study had 
limitations as well. We heard already today about the limited 
numbers, the possibility of other confounding factors 
influencing the results, etc.
    Chairman Miller. My time is expired. Dr. Broun for five 
minutes.
    Mr. Broun. Thank you, Mr. Chairman.
    Dr. Ikeda, in the case of formaldehyde levels in FEMA 
trailers, EPA conducted sampling after limited consultation 
with ATSDR. The sampling was deemed to be insufficient to 
characterize long-term exposure. In the case of D.C. lead in 
water, the agency received insufficient data from the D.C. 
health department, Department of Health, that was also 
counterintuitive. How does the Agency now ensure that it 
receives appropriate samples and the data to adequately 
characterize exposure and risk?
    Dr. Ikeda. In addition to the improvements that I mentioned 
earlier that are specific to ATSDR, there are a number of 
organizational CDC improvements that are also ongoing. 
Certainly our efforts to build state and local capacity and to 
strengthen our relationships and how we work with state and 
local health departments and labs would assist in this effort. 
You may know that CDC underwent an organizational improvement 
over the past several months and we now have a new office for 
state, local, tribal, and territorial support which is designed 
to help us strengthen those relationships and make sure that we 
provide the appropriate levels of technical assistance to 
states and locals and laboratories and also to address some of 
the accountability issues that have been a problem in the past.
    Mr. Broun. Doctor, what does ATSDR have if sampling data is 
limited for particular review? How challenging is this in terms 
of communicating results and how do you propose ATSDR address 
this issue?
    Dr. Ikeda. I think there are a couple different things in 
that question. Often in science we have limited information 
and, you know, we joke in science that more studies are needed 
because that is always true. We always feel like we need more 
information. We never have perfect understanding. And science 
is very dynamic, that it is always changing, there is always 
new information. So there is that part of it. We can always try 
and get more information, more samples. But the other piece of 
it is the communication piece, so how do we, when we have 
limited information, how do we share findings and 
recommendations, how do we even craft findings and 
recommendations when the data are limited, and that really is 
an art and we have to make sure that our communication messages 
are clear and that we document and let folks know that it is 
limited in whatever way.
    Mr. Broun. Doctor, is caveating the limitations in reports 
your only option that you have on sampling data?
    Dr. Ikeda. I am sorry. I am not sure I----
    Mr. Broun. Is caveating the limitations in the report of 
the sampling data, is that your only option of trying to make 
sure that the particular review is appropriate?
    Dr. Ikeda. I am sorry if I am not answering the question. 
Forgive me. I think we would try and make efforts to achieve 
the appropriate samples or the full sample size that we would 
want. I guess I am assuming that we are talking in a world 
where these samples don't exist, that we don't have more of 
them. And there are other communication venues that we could 
use to make sure that people understand that we are making 
these recommendations based on limited information.
    Mr. Broun. I want to go back to the previous panel where we 
were talking about the exemption for peer review as well as not 
only the methodology but the results of the reviews. Would CDC 
welcome a peer review process that is mandated and not exempted 
as it is today, and would you welcome a review of the findings 
beyond the methodology, just what the conclusions would be from 
that peer review as well as a review of the findings from the 
data samples that you get?
    Dr. Ikeda. Peer review is a pillar of good science and 
certainly we welcome peer review in many different forms at 
CDC. As someone who oversaw peer review for other centers at 
CDC, I recognize the value of transparent peer review. I think 
you heard some of the concerns raised about peer review here, 
that again we need to balance the rigor of peer review and the 
time that it takes to conduct good peer review with the need to 
get information out quickly, particularly in emergent settings. 
So yes, in general peer review is--we support peer review 
wholeheartedly. I think it is just trying to balance when it is 
appropriate, whether it is for all documents, and the 
timeliness with which we can then move out with 
recommendations.
    Mr. Broun. Thank you, Doctor. If I may take my extra 
minute, Mr. Chairman, I have got one more quick question.
    As a physician, and I know that you are a physician also, 
we look at data, we look at results, and what I was taught in 
medical school five years later was--what I was taught in 
medical school as being absolute fact, five years later we were 
being taught exactly the opposite. When you have this 
expeditious process, do you all have any kind of process in 
place or mechanism in place to come back and re-review what was 
done in such a hurried-up manner so that the appropriate 
findings, if they were indeed found in the original review, are 
still valid or if there is another set of conclusions that may 
be kind of contradictory to the original findings? Is there a 
process or is there not one to go back and do that?
    Dr. Ikeda. I think it depends on the type of product. 
Certainly things that CDC puts out that are listed as interim 
recommendations, for example, in an H1N1-type situation where 
again they are trying to get recommendations out in an 
expeditious way and yet they realize that the science on which 
it is based may not be complete. So for things like that, it is 
clearly labeled, you know, this is interim with the 
understanding that this is preliminary based on the best 
information that we have now but we know we need to get it out 
quickly. For those types of documents, there is a process 
because it is labeled interim to begin with and so there is a 
process by which it is reviewed if and when other additional 
data become available. For other documents, I think it is less 
clear. It is part of the general scientific process as you were 
describing where information is always changing, new 
information is always at hand, and the findings and conclusions 
and results and recommendations may change over time.
    Mr. Broun. Thank you, Doctor, and I appreciate your letting 
me have a few extra minutes, Mr. Chairman. Thank you, and I 
yield back.
    Chairman Miller. And the Chair thanks Dr. Broun for 
exceeding his time, although he didn't exceed it quite that 
much.
    The Chair now recognizes Mr. Rothman.
    Mr. Rothman. I thank the chairman, and let me--I was remiss 
in not thanking you earlier, Mr. Chairman, for holding this 
hearing. It is extremely important.
    Dr. Ikeda, thank you for being here. I have a lot of 
questions. I am going to try to ask them quickly and I hope you 
can give me as concise answers as possible. Do you know--I got 
a letter from Dr. Frieden saying that he had pursuant to my 
request and the mayor of Vieques's request decided to accept at 
least one of the two scientists that the mayor of Vieques had 
requested be a part of the study, although he did say that they 
have already established or identified their peer review panel 
and this scientist would be an adjunct reviewer of the report 
whose comments would be carefully considered. Do you know the 
name of the scientist that was chosen?
    Dr. Ikeda. No.
    Mr. Rothman. Okay. If you can get that to us as soon as 
possible, that would be great.
    You said in your testimony that the draft was expected, I 
am paraphrasing, soon, reasonably shortly. Do you have some 
kind of a better date estimate than that?
    Dr. Ikeda. I don't have a specific date estimate. I do know 
that the draft report is being prepared now to be delivered to 
the peer reviewers, so the panel of seven peer reviewers will 
then review, provide their comments, come back to CDC to 
incorporate those comments, consider those comments, so those 
are the steps that will be taking place.
    Mr. Rothman. Thank you. I mentioned earlier, I don't know 
if you were here, that I thought that the United States had a 
moral obligation to the people of Vieques to take care of them 
because it seems obvious that there is a connection between the 
dropping of several hundred million pounds of contaminants on 
that island over 52 years has caused health problems to these 
people, and the people are suffering as a result. If one is to 
believe the findings of the Puerto Rican health authorities, 
there are unusually high levels of infant mortality, cancer, 
cirrhosis of the liver, hypertension and diabetes amongst other 
things going on. I sit on another committee in addition to this 
one called the Appropriations Committee and I am on the 
Defense, among others, subcommittee of Appropriations. Could 
you make sure or do I need to put this in writing that we get a 
recommendation whether there is a causal connection 
acknowledged in the final report between these high rates of 
illnesses in the people of Vieques and the dropping of these--
and the creation of this federal Superfund site by the dropping 
of these poisons on the island for 52 years, whether or not 
they make a connection? Could you tell us how much it would 
cost to establish a sufficient medical facility on that island 
to take care of these people and how much it would cost? Let me 
just finish. And perhaps wearing that other hat of mine, I can 
then try to get the resources to establish that appropriate 
facility to take care of these people.
    Dr. Ikeda. I don't know how much it would cost but I can 
certainly consult with colleagues and we can do our best to 
provide an estimate, but----
    Mr. Rothman. Can we make it a part of the report, though?
    Dr. Ikeda. From the consultation in November, there was 
clear discussion about CDC's role in terms of assisting Puerto 
Rico health officials to make sure that clinical care was 
received by folks, and again----
    Mr. Rothman. In light of that--I have 27 seconds. Sorry. In 
light of that acknowledgment by CDC that you wanted to help the 
Puerto Rican health care officials, I am requesting that you 
put a dollar amount on what help is necessary to completely 
address the health care issues that are being suffered by the 
people of Vieques.
    Dr. Ikeda. Thank you for the suggestion.
    Mr. Rothman. Thank you.
    Chairman Miller. Thank you.
    We have been joined by the delegate from the District of 
Columbia, Eleanor Holmes Norton. I ask unanimous consent that 
Ms. Norton join the panel. Without objection.
    And the Chair now recognizes Ms. Norton for five minutes.
    Ms. Norton. Chairman Miller, I certainly can't thank you 
enough, and I thank you and the ranking member for allowing me 
to question this witness and to join the panel, but I want to 
thank you, Mr. Chairman, especially for the enormously 
important follow-through you have done here with this 
investigation.
    This matter was a matter of national concern. So what you 
do here, you do not only for the residents of the District of 
Columbia but for all of those who were roused by the notion 
that in all places, the Nation's capital, there was lead in the 
water. Some of these families of course came to see me in the 
Government Oversight and Reform Committee, which has 
jurisdiction over District of Columbia matters. There were a 
number of hearings in which we also were told that there was 
nothing to fear but fear itself. Those hearings were in 2004. 
There was panic, particularly among young women with children 
and some of those who came to see me were pregnant, were told 
not to worry.
    Therefore, Dr. Ikeda, I have got to be concerned now. That 
was then, this is now. In light of what we know now about what 
CDC reported to them, my concern is with the families that have 
now been identified. We know who has experienced lead in the 
water of five to 10 milligrams above what it should have been. 
We know that those who rushed to change their pipes, part of 
the pipes now have worse conditions involving that. What can 
CDC do now for these now-identified families? What specifically 
can you do? Do you intend to notify them? Do you intend to be 
in touch with them to and to examine them and their children 
for the health effects of this misinformation?
    Dr. Ikeda. CDC works with local and state health department 
lead programs who in turn then work directly with families who 
have been exposed or who have been discovered to have high 
levels of lead and there are--the programs that are in place 
include contact with the individuals----
    Ms. Norton. Dr. Ikeda, I am going to have to ask you very 
specifically. I am not asking you about the CDC's programs. I 
am well aware of them. I am asking you whether in preparing 
your testimony now that you know what has occurred, what 
specific initiative you believe CDC should take in this 
situation now with respect to whatever it is you can do, what 
services you can provide, not what services are generally 
available. What is it that CDC can do? What will you be asking 
CDC staff to do, if anything?
    Dr. Ikeda. I am sorry if I am misunderstanding your 
question. I would say that we work through the lead prevention 
programs to make sure that children and families are 
appropriately taken care of.
    Ms. Norton. You have been in touch with the District of 
Columbia?
    Dr. Ikeda. Yes, our lead programming folks.
    Ms. Norton. Regarding this new information?
    Dr. Ikeda. I don't know about regarding the new 
information. I do know that we posted and shared letter to--a 
dear-colleague-type letter letting them know that this 
information had been released on our website yesterday and that 
the MMWR notice to readers was being published today.
    Ms. Norton. Do you intend to meet with the mayor or with 
health officials in the District of Columbia?
    Dr. Ikeda. I don't know.
    Mr. Norton. You don't know whether you intend to meet or 
have CDC staff meet with health officials or the mayor of the 
District of Columbia? You don't know that?
    Dr. Ikeda. Offhand----
    Ms. Norton. You can't testify that you will do that?
    Dr. Ikeda. No, I was responding to the question that I 
don't know, but I can certainly take the suggestion back to 
our----
    Ms. Norton. I wish you would take the suggestion. It seems 
to me all but obvious that CDC be in touch immediately with 
health officials in the District of Columbia to offer specific 
services to them and to the identified families. I would very 
much appreciate that.
    Dr. Ikeda. I will.
    Ms. Norton. Thank you, Dr. Ikeda, and thank you very much, 
Mr. Chairman.
    Chairman Miller. Thank you.
    We are at the end of our time. The President of Mexico is 
speaking to a joint session in just a short while. There is 
certainly--there has certainly been a problem with paralysis, 
intentional paralysis by analysis on environmental issues. This 
subcommittee, I have been very critical in the last Congress 
and the last Administration for the work at OIRA in insisting 
upon studies of studies before finding anything to present a 
public health risk, formaldehyde being perhaps the best 
example.
    Mr. Rothman. May I have 20 seconds, Mr. Chairman?
    Chairman Miller. Mr. Rothman is recognized for 20 seconds.
    Mr. Rothman. I wanted to clarify one thing, Dr. Ikeda. I 
believe that there is a connection between the bad health 
situation of the people of Vieques and what we did to the 
island, the United States did, for 52 years, and I believe that 
the proper study should reveal that, so I don't want my 
comments that there should be a health clinic regardless of the 
findings to be misinterpreted otherwise. I believe there is a 
connection. I believe a fair and scientifically valid study 
will prove that, and I hope that with the new procedures it 
will.
    Thank you, Mr. Chairman.
    Chairman Miller. Thank you.
    Formaldehyde, there were studies upon studies upon studies, 
studies of studies. All of that seemed to be urged by the 
Administration, by the formaldehyde industry and by allies in 
Congress. Our former colleague, Mark Souder, was best known in 
Congress for two positions. One was that sex was bad for you 
and the other was that formaldehyde was good for you. He 
apparently changed his position on sex but maybe not on 
formaldehyde. We don't want to get that point. We don't want to 
have paralysis by analysis but we do want to have sound science 
that has credibility, that does reach a conclusion but one that 
can be taken seriously.
    I do hope that the new--I have, as you have pointed out, 
spoken to Dr. Frieden, and I trust that we will again. I hope 
that there is an effort to make this an agency that the 
professionals who work there can be proud of the work they do 
and that the Nation can rely upon the work they do. We need 
that.
    So I want to thank all of our witnesses for testifying. The 
record will remain open for a couple of weeks, for two weeks 
for any additional statements from members. I know that Dr. 
Wargo was going to provide a response to a question from Mr. 
Rothman.
    With that, the witnesses are now excused and the hearing is 
adjourned.
    [Whereupon, at 10:56 a.m., the Subcommittee was adjourned.]


                               Appendix:

                              ----------                              


                   Additional Material for the Record



  A Public Health Tragedy: How Flawed CDC Data and Faulty Assumptions 
Endangered Children's Health in the Nations's Capital, a Report by the 
   Majority Staff of the Subcommittee on Investigations and Oversight




























































































































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