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

[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

______

U.S. GOVERNMENT PRINTING OFFICE
57-173 WASHINGTON : 2010
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing Office,
http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center, U.S. Government Printing Office. Phone 202�09512�091800, or 866�09512�091800 (toll-free). E-mail, [email protected].

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.''
³My 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).⁶Numerous 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.⁹In 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.^14-20When 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.''
²²A 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.²³Second, 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.²⁶For 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): ²⁴The 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.³³Maintaining 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.'' ³⁴The 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.'' ³⁶Indeed, 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.³⁷In 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.'' ³⁸I 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.²³Given 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

1. Watt, G.C.M., Gilmour, W.H., Moore, M.R., et al. (1996). Is lead in
tap water still a public health problem? An observational study
in Glasgow. British Medical Journal 313, 979-981.

2. CDC MMWR (2004). Blood Lead Levels in Residents of Homes with
Elevated Lead in Tap Water--District of Columbia, 2004. L
Stokes, PhD, NC Onwuche, P Thomas, PhD, JO Davies-Cole, PhD, T
Calhoun, MD, AC Glymph, MPH, ME Knuckles, PhD, D Lucey, MD,
District of Columbia Dept of Health. T Cote, MD, G Audain-
Norwood, MA, M Britt, PhD, ML Lowe, MCRP, MA Malek, MD, A
Szeto, MPH, RL Tan, DVM, C Yu, M Eberhart, MD, MJ Brown, ScD, C
Blanton, MS, GB Curtis and DM Homa, PhD. Accessed May 10, 2004
at http://www.cdc.aov/mmwr/preview/mmwrhtml/mm53d330al.htm.

3. CDC (2010). Quotes accessed May 9, 2010 at http://www.cdc.aov/mmwr/
about.html.

4. Hodge, A.T. (1981) Vitruvius, Lead Pipes and Lead Poisoning.
American Journal of Archaeology, 85(4) 486-491.

5. Silbergeld, E. (2004). Lead Contamination in the District of
Columbia Water Supply Oversight Hearing by the Committee of
Government Reform, March 5, 2004. Accessed May 10, 2004 at
http://www.dcwatch.com/wasa/040305g.htm.

6. Ryu, J. E.; Ziegler, E. E.; Nelson, S. E.; Fomon, S. J. (1983).
Dietary intake of lead and blood lead concentration in early
infancy. Am. J. Dis. Child. 137, 886-891.

7. Cosgrove, E.V., M. J. Brown, P. Madigan, P. McNulty, L. Okonski and
J. Schmidt, Childhood lead poisoning: Case study traces source
to drinking water. (1989). J. Environ. Health 52 (1989), pp.
346-349.

8. Lacey, R., Moore, M., Richards, W. (1985). Lead in water, infant
diet and blood: The Glasgow duplicate diet study 1979-1980,
Sci. Total. Environ. 41. 235-257.

9. EPA (1991). Safe Drinking Water Act Lead and Copper Rule (LCR). In
Federal Register, Vol. 56, pp 26460-26564.

10. EPA (2004). National Center for Environmental Risk Assessment.
Risks of elevated blood lead for infants drinking formula
prepared with tap water. Documents produced in response to EPA
FOIA #HQ-RIN-00337-06.

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://
www.ene.gov.on.ca/envision/gp/4449e.htm

13. WHO, Geneva (1993). Guidelines for Drinking-Water Quality, 2nd
edition.

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
Neutral, Should Not Be Special Master.

44. Campbell, A.C. Society Suffers Cost of Lead Poisoning. Harvard
Crimson. November 2002.

45. Renner, R. Exposure on Tap: Drinking Water as an Overlooked Source
of Lead. Environ Health Perspect 118:a68-a72. doi:10.1289/
ehp.118-a68 Published: 01 February 201

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.³⁷Second, 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 2001.¹⁴My 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.⁴³Indeed, 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.'' ⁴⁴To 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.⁴⁵As 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