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57–173PDF 2010

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 
(II)

COMMITTEE ON SCIENCE AND TECHNOLOGY 

HON. BART GORDON, Tennessee, Chair 

JERRY F. COSTELLO, Illinois 

EDDIE BERNICE JOHNSON, Texas 

LYNN C. WOOLSEY, California 

DAVID WU, Oregon 

BRIAN BAIRD, Washington 

BRAD MILLER, North Carolina 

DANIEL LIPINSKI, Illinois 

GABRIELLE GIFFORDS, Arizona 

DONNA F. EDWARDS, Maryland 

MARCIA L. FUDGE, Ohio 

BEN R. LUJA ́ N, New Mexico 

PAUL D. TONKO, New York 

STEVEN R. ROTHMAN, New Jersey 

JIM MATHESON, Utah 

LINCOLN DAVIS, Tennessee 

BEN CHANDLER, Kentucky 

RUSS CARNAHAN, Missouri 

BARON P. HILL, Indiana 

HARRY E. MITCHELL, Arizona 

CHARLES A. WILSON, Ohio 

KATHLEEN DAHLKEMPER, Pennsylvania 

ALAN GRAYSON, Florida 

SUZANNE M. KOSMAS, Florida 

GARY C. PETERS, Michigan 

JOHN GARAMENDI, California 

VACANCY 

RALPH M. HALL, Texas 

F. JAMES SENSENBRENNER JR., 

Wisconsin 

LAMAR S. SMITH, Texas 

DANA ROHRABACHER, California 

ROSCOE G. BARTLETT, Maryland 

VERNON J. EHLERS, Michigan 

FRANK D. LUCAS, Oklahoma 

JUDY BIGGERT, Illinois 

W. TODD AKIN, Missouri 

RANDY NEUGEBAUER, Texas 

BOB INGLIS, South Carolina 

MICHAEL T. MCCAUL, Texas 

MARIO DIAZ-BALART, Florida 

BRIAN P. BILBRAY, California 

ADRIAN SMITH, Nebraska 

PAUL C. BROUN, Georgia 

PETE OLSON, Texas 

SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT

HON. BRAD MILLER, North Carolina, Chairman 

STEVEN R. ROTHMAN, New Jersey 

LINCOLN DAVIS, Tennessee 

CHARLES A. WILSON, Ohio 

KATHY DAHLKEMPER, Pennsylvania 

ALAN GRAYSON, Florida 

BART GORDON, Tennessee 

PAUL C. BROUN, Georgia 

BRIAN P. BILBRAY, California 

VACANCY 

RALPH M. HALL, Texas 

DAN PEARSON Subcommittee Staff Director 

EDITH HOLLEMAN Subcommittee Counsel 

JAMES PAUL Democratic Professional Staff Member 

DOUGLAS S. PASTERNAK Democratic Professional Staff Member 

KEN JACOBSON Democratic Professional Staff Member 

TOM HAMMOND Republican Professional Staff Member 
(III)

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

(1)

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.
2
3

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.

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. 

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 com-
4

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. 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. 5See 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.

prehensive 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. 

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. 

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

6David 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. 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. 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 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

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 >10μg/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 >10μg/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. 

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

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.
6

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. 10The 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. 11The 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 >10μg/

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.
7

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 coauthor 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. 
8

12 ‘‘Statement of Mission,’’ Agency for Toxic Substances and Disease Registry, undated, available here: http://www.atsdr.cdc.gov/about/mission.html. 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 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. 

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. 

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, 
9

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 
10

14See details here: http://www.atsdr.cdc.gov/nationalconversation/index.html. 

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. 

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)
11

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 
12

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:]
13
14
15

[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. 
16

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. 
17

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. 
18

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 blackand-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 jour-
19

nal’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 
20

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 
21

1See 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. 3See 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). 4See GAO, Standards for Internal Control in the Federal Government, GAO/AIMD–00–21.3.1 

(Washington, D.C.: November 1999). 5See Office of Management and Budget Circular No. A–123, (Revised): Management’s Responsibility for Internal Control (Dec. 21, 2004). 6See GAO, Internal Control Management and Evaluation Tool, GAO–01–1008G (Washington, 

D.C.: August 2001). 

of Medicine1 and ATSDR’s Board of Scientific Counselors2 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. 

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. 

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

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 
22

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. 8DHAC is one of four ATSDR divisions.

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 ‘‘highpriority’’ 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. 

• 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 
23

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. 

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 con-
24

ducted 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. 
25

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 
26

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:
27

• 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. 
28

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. 2See 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. 3See http://www.atsdr.cdc.gov/nationalconversation/index.html. 

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

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. 

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.’’

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.
29

4Division of Heath Assessments and Consultations (DHAC) and Cooperative Agreement 

States Workshop, San Antonio, Texas, March 7, 1990. 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. 6 Barry Johnson, ‘‘Quantitative Risk Assessment—Experiences and Lessons in Effective Risk 

Communication,’’ V.T. Covello et al, Plenum Press, 1989, pp. 63–66. 

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, nonepidemiologists, and non-engineers who live around sites.’’ 4

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

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

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 ‘‘sig-
30

7 U.S. General Accounting Office, Superfund Public Health Assessments Incomplete and of 

Questionable Value, GAO/RCED–91–178, August, 1991. 8 Ibid. 

nificant’’ 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. 

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 
31

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 
32

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 
33

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.
34

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.
35

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?
36

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.
37

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 halflife 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.
38

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 addi-
39

tional 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?
40

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 (μm) 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.’’
41

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 
42

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 
43

in US potable water is a public health concern. Other countries have studied this 

issue, determined that lead in water is a major correlate to elevated levels of lead 

in children’s blood, but have rationally weighed the different needs and decided that 

other problems are more deserving of public funding.1 I respect, appreciate and can 

support such honest and open assessments. I also believe that lead paint and dust 

hazards pose a serious health threat, and I support all rational efforts to address 

them. I also believe that the vast majority of scientists and public health officials 

in the water industry, US EPA, local Departments of Health, and the CDC are conscientious and uphold very high ethical and scientific standards. I believe in the 

CDC’s mission. I also believe it is critically important that the CDC retain the 

public’s trust. My testimony today should not be construed contrary to the above 

statements. Indeed, I offer today’s testimony in hopes of saving the CDC from itself. 

My experiences and knowledge are primarily related to a publication entitled 

Blood Lead Levels in Residents of Homes with Elevated Lead in Tap 

Water—District of Columbia, 2004.2 This paper was coordinated, prepared, and 

published by the CDC in their March 30, 2004 Morbidity and Mortality Weekly Report (MMWR) series. The MMWR series is often called ‘‘the voice of CDC’’ and ‘‘is 

the agency’s primary vehicle for scientific publication of timely, reliable, authoritative, accurate, objective. and useful public health information and recommendations.’’ 3 This particular paper is henceforth referred to as the ‘‘CDC MMWR.’’ The 

paper had 21 coauthors, actions of three of whom are discussed in this testimony:

1) Mary Jean Brown, ScD, RN, Chief of the Lead Poisoning Prevention Branch 

at the National Center for Environmental Health (NCEH), CDC. Dr. Brown 

prepared the paper.

2) Lynette Stokes, PhD, MPH, who at the time of the paper’s writing was overseeing the blood lead testing program at the Washington DC Department of 

Health (DC DOH). Dr. Stokes was previously employed by CDC’s sister 

agency. the Agency for Toxic Substances and Disease Registry (ATSDR). Dr. 

Stokes is listed as 1st author of the paper.

3) Daniel R. Lucey, MD, MPH, interim head of the DC DOH. Dr. Lucey was 

involved in the DC Lead Crisis for just a few weeks before publication of the 

CDC MMWR. In his public statements, Dr. Lucey made it clear that he did 

not have experience on lead health issues, and that his actions and responses relied on the expertise of Dr. Brown and Dr. Stokes.

According to the CDC, contributions to the MMWR series ‘‘must contain new or 

original information or guidelines/recommendations that substantially increase understanding of a public health problem.’’ 3

My testimony begins with a review of what was known about lead in drinking 

water prior to publication of the CDC MMWR and then gives a brief overview of 

the DC Lead Crisis. After describing how the destructive impacts of the CDC 

MMWR were amplified by reckless omissions destined to mislead readers, it briefly 

discusses some of the intermediate and longer-term repercussions of the publication. 

Speculation as to the CDC’s possible motivation to mislead readers and the public 

at large, and failure to clearly correct their misleading conclusions for years after 

being made well-aware of serious problems with them, set the stage for highlighting 

some of my own experiences with the CDC. The testimony provides substantive insights to deficiencies in the agency’s environmental public health practices.

HEALTH EFFECTS OF LEAD IN WATER: BEFORE THE CDC MMWR 

Knowledge that elevated lead in water poses a public health concern dates back 

more than 2,400 years. In 312 BC, Vitruvius noted that ‘‘. . . water ought by no 

means to be conducted in lead pipes, if we want to have it wholesome.’’ 4 Later work 

on the subject was succinctly summarized on March 5, 2004 in the Congressional 

testimony of MacArthur Fellow and Johns Hopkins University Professor Ellen 

Silbergeld, PhD: 5

‘‘ . . . lead exposure via drinking water alone can by itself be sufficient 

to induce toxicity, especially in young infants. In a landmark paper in 

1967, Sir Abraham Goldberg and his colleagues traced the etiology of a cluster 

of mentally retarded children in Glasgow to the storage of drinking water in 

lead lined tanks (Gibson et al 1967). Shannon and Graef (1989) reported the 

case of an infant poisoned by drinking water with a lead concentration of 130 

ppb. EPA considers that ‘lead at concentrations of 40 ppb or higher poses 

an imminent and substantial endangerment to the health of children 

and pregnant women’ ’’ (bold italic emphases in original).
44

Dr. Silbergeld’s written testimony was accompanied by an extensive list of peerreviewed scientific papers that linked elevated lead in drinking water to lead in 

blood, and by extension to adverse human health effects. 

Additional research is noteworthy. For instance, to examine the role of (then 

legal) lead solder as a potential hazard, Ryu et al. (1983) tracked a group of 7 infants fed formula contaminated with 70 parts per billion (ppb) lead and another 

group of infants formula containing 10 ppb lead.6 The blood lead of the infants exposed to the lower level of lead increased by 1.1 ug/dL, whereas that of infants exposed to the higher level of lead rose by 8.3 ug/dL (Figure 1). A blood lead level 

of 10 ug/dL or higher is termed ‘‘a level of concern’’ by the CDC for children less 

than 6 years of age. Blood lead levels exceeding the CDC level of concern are also 

commonly referred to as ‘‘elevated’’ or ‘‘lead poisoning’’ in different localities. The 

blood lead of infants consuming formula with 70 ppb lead rose above the CDC 10 

ug/dL level of concern after about 1 month of exposure (Figure 1).

Figure 1. Effects of infant formula contaminated with lead on blood lead of infants 

(data from Ryu et al., 1983).6

Numerous other peer-reviewed research publications were consistent with the Ryu 

et al. results, including one co-authored by CDC’s Dr. Brown entitled ‘‘Childhood 

lead poisoning: Case study traces source to drinking water.’’ 7 8 In that study, an infant whose blood lead rose to 42 ug/dL had no other lead source in the home but 

contaminated drinking water, and the flushed water contained just 20–80 ppb lead. 

These publications served as the basis for the US EPA Lead and Copper Rule (US 

EPA, 1991), the nation’s only federal regulation designed to protect consumers from 

exposure to elevated levels of lead in their drinking water.9

In early March 2004, after public disclosure of DC’s serious lead in water contamination problems, and several weeks before the CDC MMWR’s publication, researchers at the US EPA National Center for Environmental Risk Assessment used projections based on human health data to predict the likelihood of lead poisoning for DC 

infants consuming reconstituted infant formula for one year. I obtained copies of 

this work via the Freedom of Information Act (FOIA).10 The US EPA determined 

that if lead in DC tap water exceeded about 200 ppb, it was a virtual certainty that 

a DC infant’s blood lead would rise above the CDC’s 10 ug/dL level of concern (Figure 2). Even if the drinking water contained just 50 ppb lead, the agency calculated, 

blood lead levels of nearly 1 out of every 2 infants (i.e., 50% probability of elevated 

blood lead) would rise above CDC’s level of concern. According to an inter-agency 

e-mail, the US EPA sent Dr. Stokes memos and results summarizing their work as 

part of an on-going conversation between the US EPA and DC DOH.
45

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 μg/dL level of concern from acute exposure, CPSC 

staff recommends that children not ingest more than 175 μg 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.
46

THE DC LEAD CRISIS AND THE CDC MMWR 

The lead levels in DC drinking water from 2001–2004 were unprecedented in 

modern history. Some samples exceeded ‘‘hazardous waste’’ criteria (>5,000 ppb) and 

the contaminated water was present in tens of thousands of DC buildings including 

homes, apartments, offices, schools, daycare facilities and even the US Congress. 

From 2001–2004 the extent of the problem was hidden from the public by illegal 

actions, unethical behavior and bungling of numerous government agencies as detailed in investigations led by current US Attorney General Eric H. Holder, the US 

Government Accountability Office (GAO), hearings before five Congressional Committees, and hundreds of articles in the Washington Post and elsewhere.14–20 Some 

findings from these investigations and the role of each agency are briefly summarized in Table 2. 

Due to the actions and inactions of these government agencies, consumers of DC 

tap water including pregnant women and their fetuses, children attending schools 

and daycare centers, commuters, tourists and even members of the US Congress 

were at relatively high risk of exposure to lead in water hazards from 2001–2004. 

The public was for the most part entirely unaware of the contamination, and for 

almost three years did not receive adequate warnings to use simple actions that 

would reduce or eliminate the hazard (e.g.. use of filters, bottled water or flushing).

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

When the extent of the lead in water problem was first revealed in the Washington Post on January 31, 2004,21 the public was fearful of the harm done to DC’s 

children, and outraged at the responsible agencies’ multi-year and gross negligence. 

Lead, which is perhaps the best-known environmental neurotoxin, affects adversely 

and irreversibly every major organ system in the human body. Developing fetuses 

and infants are most vulnerable to harm from exposure. 

On March 8, 2004, the international law firm Paul Hastings filed a class action 

lawsuit against DC WASA and DC City Government, and gave formal notice to the 

US EPA, and the Army Corps of Engineers of a potential lawsuit. The press release 

stated that the lawsuit was brought on behalf of two young children with lead in 
47

water levels of 435 and 310 ppb, and that potentially tens of thousands of ‘‘. . . DC 

residents have been unwittingly exposed to lead, a serious toxin.’’ 22

A few weeks later the CDC released the CDC MMWR. purportedly investigating 

the impacts of the high lead in water on the blood lead of DC residents. Contrary 

to reasonable expectations based on prior research (Table 1), the CDC paper concluded that no children had experienced elevations to blood lead levels that exceeded 

CDC’s level of concern as a result of the DC Lead Crisis:

‘‘. . . although lead in tap water contributed to a small increase in BLLs in DC, 

no children were identified with BLLs >10 μg/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 μg/

dL or >10 μg/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):
48

‘‘Dr. Tee Guidotti . . . has advised the Water and Sewer Authority . . . that: 

A discernable effect on BPb <blood lead> of children requires at least sustained 

levels of 300 ppb.’’

Jerry N. Johnson, former General Manager, DC WASA, Testimony to US Senate 

Committee on Environment and Public Works, April 7, 2004.

‘‘Drinking water is at most a minor source of lead for children. Drinking water 

may contribute a small amount if sustained exposure.’’

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

9, 2005.

CRITICAL INFORMATION OMITTED FROM THE CDC MMWR 

The public, and apparently some of the agencies themselves, had been successfully 

duped. The CDC MMWR may have been authoritative but it was not trustworthy—

the paper’s conclusions were skewed by omission of several critical facts. Just how 

skewed, was not to be revealed, until my colleagues and I published a peer reviewed 

journal article in 2009 that proved hundreds (and in all likelihood thousands) of 

children had their blood lead elevated above the CDC level of concern as a result 

of exposure to DC’s contaminated drinking water from 2001–2004.23 Our paper was 

recently acknowledged with an award for Best Science paper appearing in the prestigious journal Environmental Science and Technology during 2009. 

Details of my initial concerns regarding omission of critical data in the CDC 

MMWR were provided in two letters to the CDC Office of Scientific starting in 2007. 

Both of my letters are currently available on-line.24 I await, and defer to, two forthcoming investigative reports by the US House Committee on Science and Technology 

and the Washington DC Office of Inspector General for additional information about 

actions of the CDC and DC DOH co-authors. In this section, I mention 4 representative omissions (which are not necessarily the worst ones) so that the remainder of 

my testimony can be placed into context. Thereafter, I reveal what I currently know 

about the authors’ knowledge and rationale for each of these omissions. 

First, the portion of the CDC MMWR that was to be most cited in testimony and 

press coverage, involved blood lead testing for a group of 201 DC residents who lived 

in homes with over 300 ppb lead in their flushed tap water. These residents had 

volunteered for a special water lead sampling event conducted by DC WASA in 

2003, and had been informed that their tap water was severely contaminated (>20 

times the 15 ppb US EPA lead action limit) several months to a year before DC 

DOH began testing residents’ blood. By the time their blood lead was collected for 

the CDC MMWR study in March 2004, the residents had been taking measures to 

protect themselves from the high lead in water for an extended period of time. 

Given that the half-life of lead in blood is on the order of 28–36 days,25 by the time 

these residents’’ blood was drawn for analysis, the evidence of harm would have 

largely disappeared from their blood. Ironically, in contrast to statements in the 

CDC MMWR and associated sworn testimony suggesting that the ‘‘worst case’’ of 

lead exposure had been captured in this study, this particular group of 201 residents tested, were actually amongst the least likely groups in the city to show evidence of harm from high lead in water. The CDC’s discovery that none of these residents had elevated blood lead, therefore, provided little or no insight into what their 

blood lead had been months to a year before taking actions to protect themselves.23

Second, the CDC MMWR authors did not reveal detailed knowledge, in their possession, proving that virtually all of the 201 residents targeted for their study were 

taking active protective measures, as anyone would if told months to a year previously that their drinking water was contaminated with astronomical levels of lead. 

Specifically, a spreadsheet I obtained from the DC DOH via FOIA revealed that for 

residents who answered a DC DOH questionnaire and had an indicated blood lead 

collection date, all but 6 (of the 201) were using bottled water or a filter. Of 174 

residents who answered a question about bottled water use, 130 indicated ‘‘Y’’ and 

44 indicated ‘‘N.’’ Assuming that Y meant ‘‘yes’’ (i.e., consistent with the symbols 

used for lead filter use in the paper and in the spreadsheet), then 75% of the residents who responded to the questionnaire were using bottled water. Moreover. none 

of the 6 residents who were potentially drinking tap water (without use of filters 

or bottled water) were children. The only statement appearing in the CDC MMWR 

that even alludes to some of these critically important facts, was a confusing single 

sentence that made no mention whatsoever of bottled water use:

‘‘Of the 201 residents, a total of 153 (76%) reported drinking tap water, and 52 

households (53%) reported using a water filter.’’
49

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:

‘‘<Lead from water> 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 
50

childhood elevated blood lead from water, was later linked to homes in which DC 

WASA had only suspected had a lead service line.26

For the CDC MMWR, the actual blood lead data for residents living in homes 

with suspected lead service lines were analyzed, but no mention of this analysis, or 

even an acknowledgement that the data existed, was to appear in the published 

paper. The analysis indicated that of 144 DC residents tested in homes with suspected lead service lines in 2000 (before lead in water was high), only 12 (or 11.5% 

of the total) had blood lead > 10 ug/dL. But for 141 residents tested in 2001 (when 

lead in water was high) 18 (or 18.4% of the total) had blood lead > 10 ug/dL. A similar increase occurred in 2003 versus 2000. The trend in this dataset showing increased incidence of elevated blood lead for these residents, after the lead in water 

had increased, was contradictory to the conclusions eventually published in the CDC 

MMWR. 

According to the Federal Register (2000), scientific misconduct via falsification re- fers 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 <e-mail> 

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’’:
51

‘‘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 μg/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).
52

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 

μg/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 . . . <water lead > 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 
53

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 
54

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
55

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 measur- able 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 peerreviewed publication. Fortified with an erroneous timeline and numerous additional 

inaccuracies and omissions, the Guidotti paper—published in 2007—effectively rewrote 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 emailed a ‘‘Dear Colleague’’ defense, which stated that his paper’s conclusions had 

received the CDC’s stamp of approval:

‘‘The data are valid and the conclusions were agreed upon by the Department 

of Health, EPA, and CDC.’’

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

At the request of an Independent Review Panel that examined only two of numerous concerns about the integrity of the Guidotti paper, the ‘‘no identifiable public 

health impact’’ conclusion was eventually removed, and Dr. Guidotti himself apologized for writing the unfounded statement. Remaining allegations about the 

Guidotti paper have not been addressed (for the complete list of allegations, see letter to the journal Environmental Health Perspectives): 24

The dangerous ‘‘lesson’’ of the DC Lead Crisis as packaged in the CDC MMWR 

began to achieve its goal of influencing decision makers and policy, and spread 

quickly to cities across the US and even internationally (Figure 4). A pattern 

formed. Whenever a significant problem with elevated lead in potable drinking 
56

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.
57

SPECULATION REGARDING CDC’s MOTIVATION 

Dr. Brown’s actions, and those of the CDC, to allow such an egregious and historic 

violation of basic scientific principles, and to jeopardize the public’s health and 

trust, are mystifying. In this section I highlight information that might help shed 

light on some of the reasons behind the unfortunate decisions that were made. 

The dramatic reduction of blood lead levels in children over the last few decades 

is a public health triumph. Phase-outs of lead in gasoline, lead solder in canned food 

tins, lead paint, and reduced levels of lead in drinking water due to the Lead and 

Copper Rule created landmark improvements in public health. I would be the first 

to acknowledge Dr. Brown’s contributions to this spectacular success story. However, childhood lead poisoning has still not been eliminated and further work is 

clearly needed. 

One would assume that the CDC Lead Poisoning Prevention Branch would exert 

leadership to ensure that all lead health threats are acknowledged properly and addressed as best as possible within existing financial and regulatory constraints, but 

I do not believe that this is how the CDC is approaching childhood lead poisoning 

prevention today, or did so in the past. For example, historical accounts of US EPA’s 

efforts in the early 1990s to regulate lead in drinking water reveal that the then 

CDC director of the former Center for Environmental Health ‘‘. . . railed against 

doing much in drinking water because he did not want to disarm lead in paint.’’ 30

The same viewpoint, that health concerns related to lead in water somehow compete 

with and threaten the CDC’s efforts to address lead in paint, seem to persist at the 

CDC to this day. 

Almost a decade after the passage of the US EPA Lead and Copper Rule of 1991, 

a President’s Task Force adopted a strategy to eliminate childhood lead poisoning 

by 2010. The focus was the elimination of lead paint hazards. Underlying the narrowness of the Task Force’s approach was the assumption that ‘‘The U.S. Environmental Protection Agency (EPA) has . . . placed strict limits on the amount of lead 

in drinking water . . . ,’’ and thus that lead at the tap was already being addressed.31 Such misunderstandings of the scope and effectiveness of the US EPA 

Lead and Copper Rule also permeate the CDC’s literature. In reality, the US EPA 

Lead and Copper Rule does not put any limit whatsoever on the allowable lead in 

residential tap water (9% of collected samples can be any value whatsoever), and 

the regulation does not address the vast majority of child care centers and schools. 

Indeed, a recent 2009 Associated Press article demonstrated that lead levels in thousands of schools nationwide have problems with elevated lead in water,32 and many 

schools have some taps dispensing water lead concentrations well over the CPSC 

acute health threshold or even hazardous waste levels.33

Maintaining a strict focus on lead paint as the primary cause of childhood lead 

poisoning, even at the expense of potentially serious non-paint lead sources, seems 

to guide much of the CDC’s and Dr. Brown’s work and reasoning. Characteristically, 

a few years ago, the Chief of the CDC’s Lead Poisoning Prevention Branch responded to a peer-reviewed article about the relationship between lead in blood 

(BPb) and lead in contaminated soil by castigating the researchers for, amongst 

other things, not placing adequate emphasis on lead paint. In her critique, Dr. 

Brown mentioned the article’s failure to cite ‘‘. . . the compelling body of scientific 

evidence demonstrating that deteriorated lead-based paint and the contaminated 

dust and soil it generates is highly correlated with BPb levels in children.’’ 34

The perplexed authors responded that the subject of their paper was lead in soil, 

not lead in paint, and that: 35

‘‘We are concerned that people working at agencies that should champion the 

reduction of lead exposure do not appreciate the fact that multiple sources of 

lead have accumulated in urban environments and that all major sources and 

reservoirs need full attention if we expect to meet the goals of Healthy People 

2010 (2005) [the national program that aimed to eliminate childhood lead poisoning by 2010].’’

Why, when writing about the worst lead in water contamination event in modern 

history, would Dr. Brown in her CDC MMWR paper, commit a much more serious 

scientific omission, and not cite the compelling body of scientific studies demonstrating that lead in drinking water can be highly correlated to blood lead? A clue 

to Dr. Brown’s tunnel-vision mindset can be found in a quote in the New York 

Times, which appeared on September 30, 2003, just months before the Washington 

Post broke the story on the DC Lead Crisis:

‘‘Lead paint remains the most concentrated and readily accessible source, and 

nothing should detract from our interest in eliminating it,’’ said Dr. Mary Jean 
58

Brown, chief of the lead poisoning prevention branch at the Federal Centers for 

Disease Control and Prevention in Atlanta.’’ 36

Indeed, from the earliest phases of the lead crisis and well in advance of data collection for the CDC MMWR, a key concern expressed amongst the public health 

community that follows Dr. Brown’s leadership, was that the unprecedented media 

attention focused on DC’s lead in water problems would draw attention and funding 

away from efforts to control lead paint.37 The handling of the DC Lead Crisis, and 

omission of critical data and deletion of key words and phrases from the CDC 

MMWR, suggests that Dr. Brown may have been blinded by her commitment to bolster her crusade against lead paint, and illustrates exactly how far she was willing 

to go in preventing a non-paint lead source from detracting focus from it. 

In 2005 when I first began to suspect serious problems with the CDC MMWR, 

one of Dr. Brown’s colleagues told me confidentially that no matter how distorted 

the CDC MMWR proved to be or how serious the wrong-doing, Dr. Brown would 

never willingly correct the public health misconceptions her work had created. At 

first I was in disbelief But more than 6 years after the publication of the CDC 

MMWR, and more than 4 years since Dr. Brown was clearly made aware of serious 

problems with the CDC MMWR’s main message, Dr. Brown has doggedly failed to 

clear the scientific record of the misunderstanding that she herself created and promoted. In the end, unfortunately, one has to wonder if the repercussions of the CDC 

MMWR were exactly as Dr. Brown intended. 

One final example gives insight not only to Dr. Brown’s motivation, but also to 

her temperament, which tragically feeds her conduct. In early 2009 when some lead 

poisoning prevention advocates from the Alliance for Healthy Homes, Clean Water 

Action and Parents for Nontoxic Alternatives in Washington DC began to try and 

correct the record, and to start promulgating more accurate public health messages 

and policies about lead in drinking water, Dr. Brown reacted with outright hostility 

and began to spread the word to lead poisoning prevention officials and advocates 

across the country that she was being unfairly attacked by an ‘‘unholy alliance’’ 

seeking to get her fired.37 This was not true, the groups’ longstanding work on the 

issue had in fact never focused on Dr. Brown, and what they were actually doing 

was directing efforts to persuade the CDC to correct the takeaway message of the 

CDC MMWR. But as a major funder of the nation’s lead poisoning prevention community, Dr. Brown’s power would have been sufficient to deter many stakeholders 

from joining the call for CDC’s accountability. In fact, Dr. Brown succeeded in intimidating some Alliance for Healthy Homes board members into restraining the 

staffs advocacy, because they worried she might damage the organization’s reputation and jeopardize its funding. Ultimately, in late 2009, one Alliance for Healthy 

Homes employee who led the organization’s work on the issue was not offered employment when his organization merged with another national healthy housing nonprofit that receives significant CDC funding. This employee, who has offered decades of laudatory service to the goal of childhood lead poisoning prevention, was explicitly told that he would be a financial liability to the organization because his advocacy work on the CDC MMWR had upset Dr. Brown.37

In the end, I have come to suspect that the CDC and Dr. Brown were driven, at 

least in large part, by an over-zealous, misguided, and unscientific compulsion to exclusively focus attention and funding on the lead source they consider most important. Their ‘‘mission’’ may have even contributed to ‘‘missing’’ hundreds (and quite 

possibly thousands) of cases of elevated blood lead in Washington DC children due 

to contaminated water from 2001–2004,23 and twisting the DC Lead Crisis into a 

public relations coup for lead paint, rather than acknowledging it for the environmental health tragedy it was. 

For those interested in further elaboration on CDC and Dr. Brown’s motivation, 

see Appendix 1.

MOTIVATION FOR MY OWN JOURNEY WITH THE CDC 

The first time I read the CDC MMWR, based on my knowledge of prior research, 

I knew its conclusions were a scientific impossibility. On the other hand, I also knew 

that the neurological harm to DC children could not be undone, steps were seemingly underway to partly mitigate the worst of DC’s lead in water contamination, 

and if lessons could be learned from the DC Lead Crisis that could prevent future 

harm, perhaps a ‘‘cover-up’’ of the public health impact was not the worst thing that 

could have happened. I expected that the responsible agencies would work hard to 

redeem themselves and once again make themselves worthy of the public trust. 

Moreover, while I had suspicions and concerns about the CDC MMWR from the 

start, I did not know, with certainty, the true extent of the falsification that had 

occurred until late 2009. Early on, I simply assumed that the authors had tried to 
59

faithfully present the data and their methods, and perhaps, something along the 

way unintentionally went awry. 

For a while I flirted with theories that the accepted laws of chemistry, biology and 

physics did not apply to Washington DC children, and that the lead in DC’s water 

was somehow not harmful. A colleague, research chemist Michael Schock at the US 

EPA, had discovered that DC’s lead problem was linked to formation of Pb(IV) rust 

on the lead pipes, as opposed to Pb(II) rust per prior conventional wisdom. Devising 

and conducting experiments throughout 2004 to test the hypothesis that Pb(IV) in 

water might not be harmful if ingested by DC consumers, I eventually proved to 

myself that there was no scientific support for such an explanation. The accepted 

laws of nature would apply. By late 2005, alarmed by the growing influence of the 

CDC MMWR, concerned about its implications for public health not only in DC but 

also nationally and internationally, curious about the quality of the science and data 

the CDC had used to arrive at its conclusions, and confused about how two millennia of human experience with harmful effects from lead in water could be rendered irrelevant almost overnight—I resolved to pursue this issue via investigative 

science. 

Additional factors gave me resolve to begin this particular journey. I had heard 

engineers at water utilities cite the CDC MMWR as justification to ‘‘game’’ the Lead 

and Copper Rule sampling requirement, by conducting water monitoring for lead in 

ways that almost guarantee compliance with the standard, even when serious lead 

in water contamination was present. I began to cringe at public health meetings in 

the US and Canada when officials inevitably laid the CDC MMWR on the table, and 

stated that it was their duty to publicly downplay the adverse impacts of water to 

avoid needlessly alarming the public. Indeed, wasn’t that the takeaway lesson from 

the DC Lead Crisis and applied by Dr. Brown herself? Of course, unfortunately, 

their reassuring public health messages would make it far less likely that precautionary measures would be taken seriously by the public, and that children and 

developing fetuses would be protected from harm. This highlights the impacts on 

the public of misconduct in public health research, via distortion and misinformation, ‘‘which ripples from the large scale of federal organizations to the personal 

level of individuals.’’ 38

I was appalled at the actions of US EPA R3 and US EPA HQ, who in late March/

early April 2004, selfishly and cowardly gutted the health basis for their own lead 

in water regulation, by replacing clear and understandable warnings with misleading gibberish. The US EPA even stood silent. in April 2004, when they were 

publicly ridiculed in DC for arriving at their 15 ppb lead in water action limit by 

‘‘pulling a number out of a hat.’’

Lead in DC Public Schools. I was also particularly disturbed by behavior of DC 

WASA and US EPA R3 employees. To this day, for example, I believe that the 2004 

sampling at DC Public Schools was devised to hide problems with elevated lead in 

water. When the testing was complete, DC WASA trumpeted the ‘‘good news’’ about 

the relatively low incidence of lead in water hazards, reassuring DC residents that 

all was well, without revealing the flawed water collection methods that could have 

missed serious lead problems. Some of the methods used were later effectively 

banned by the US EPA for that very this reason. As a result, I believe, DC WASA 

ensured future needless harm to DC schoolchildren, in partnership with US EPA 

R3, which backed the water utility up on their claims. It took me 3 years to confirm 

and expose the fact that there were very serious problems with lead in much of the 

DC school system, with some taps dispensing lead concentrations over hazardous 

waste levels (>5,000 ppb).33 Still, the CDC MMWR conclusions seemingly rendered 

the health implications of that work insignificant. 

Partial Lead Service Line Replacements. My worry was reinforced when, in 

2008, in partnership with a coalition of public health advocates in DC, we discovered that DC WASA’s 5-year and $100 million ‘‘accelerated’’ lead in water ‘‘remediation’’ program was not nearly the success that DC WASA and US EPA R3 had 

claimed. Thousands of lead water pipes were dug up and replaced with copper pipe, 

but only the publicly owned portion of the old lead pipe was replaced. The privately 

owned portion was left in the ground. This program of partial lead service line replacement-worsened lead in water levels in many homes for an undetermined duration. For years the agencies repeatedly claimed in public and in written scientific 

reports (again contradicting decades of prior experience and research), that partial 

replacements in DC were not causing lead to spike:

‘‘. . . there was no immediate change, or immediate increase in lead levels in 

the tap water’’ . . . ‘‘there is no evidence that the lead levels increase’’ . . . ‘‘remove half the lead . . . you have a lot less lead in your tap water as a result.’’

Rick Rogers EPA R3, Interview on WAMU Radio, May 2004
60

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 emails 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 μg/dL, compared to 
61

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 emails 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 
62

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 emails 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 ‘‘Catch22’’ 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. 
63

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 <name> . . . 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.
64

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 trust-
65

worthiness and that of the CDC MMWR. In an April 11, 2009 press release that 

the office of CDC’s media relations issued to respond to a negative media article 

about the CDC MMWR, the CDC claimed the following:

‘‘Scientific integrity is CDC’s hallmark . . . . CDC’s Office of Science takes any 

such allegation very seriously; it thoroughly investigated this complaint and 

found no evidence of scientific misconduct.’’

I eagerly await the report of the US House Committee to see just how serious, 

and how thorough this ‘‘investigation’’ of my allegations actually was.

WHAT REALLY HAPPENED TO DC’s CHILDREN DURING THE DC LEAD 

CRISIS 

After exhausting all hopes that anyone at the CDC would demonstrate a shred 

of scientific integrity or backbone in acknowledging problems with Dr. Brown’s behavior, or even express the slightest concern about children who were still being left 

unprotected from elevated lead in water due to the CDC MMWR’s flawed message. 

I gave up trying to resolve my concerns through CDC’s broken system. 

In early 2008, I collaborated with Dana Best, MD, MPH at Children’s National 

Medical Center (CNMC) in Washington DC, which is a hospital with a reliable and 

robust database on blood lead levels of DC children. Along with Virginia Tech graduate student Simoni Triantafyllidou, we conducted a very simple and straightforward analysis which was eventually written into the paper ‘‘Elevated Blood Lead 

in Washington D.C. Children from Lead Contaminated Drinking Water: 2001–2004’’ 

and published in the peer-reviewed journal Environmental Science and Technology.23

Given the authority of the CDC and Dr. Brown on the subject of lead health effects, and presumptions of most scientists about high standards of scientific integrity at the CDC, getting our paper through the scientific review process was difficult. One reviewer had concerns about publishing our paper, because it cited some 

data collected via FOIA, and was disturbed that this information would give readers 

the impression that CDC and other agencies did not supply their data willingly. Another reviewer stated that the paper should not be accepted because it ‘‘relies on 

a lot of data the authors did not collect, were apparently not involved in the original 

studies, and with which they do not provide sufficient information concerning the 

conditions and methodology under which the data were collected.’’ In other words, 

because the CDC and Dr. Brown would not follow established principles of scientific 

conduct and share information/data with us, reviewers were reluctant to approve 

publication of our own paper. In writing the final draft, I therefore had to create 

an imaginary world, in which the CDC’s actions were interpreted in an unreasonably positive light. I even wrote the following in reference to the CDC MMWR:

‘‘Differences in conclusions between this work and the earlier CDC study are 

mostly attributed to the type of analysis and interpretation . . .’’

This statement should not be construed as support for Dr. Brown’s analysis in the 

CDC MMWR. Our research determined that the decades of prior peer-reviewed literature, demonstrating that lead in water can be a serious public health concern, 

were correct. It further demonstrated very strong links between elevated lead in 

water and lead in blood for the most vulnerable children in DC from 2001–2004. 

Our work directly refuted the CDC MMWR ‘‘main message’’ that there ‘‘is no indication that DC residents have blood lead levels above the CDC levels of concern . . . 

as a result of lead in water.’’ It also exposed the misleading work of the CDC’s close 

collaborator in DC, Dr. Guidotti and his DC DOH co-authors, who published a misleading paper which concluded that ‘‘There appears to have been no identifiable public health impact f from the elevation of lead in drinking water in Washington, DC.’’ 

Based on our analysis, hundreds, and in all likelihood thousands, of DC children 

had their blood lead elevated above the CDC level of concern as a result of elevated 

lead in water from 2001–2004.

EPILOGUE 

Since publication of our paper, the CDC has doggedly defended the CDC MMWR 

against all criticism. The paper stands on the agency’s website to this day, unscathed; a monumental public health fiasco, where it continues to mislead and place 

children all over the world in harm’s way. Contradicting 2000 years of human 

knowledge and experiences related to adverse health effects from lead in drinking 

water, for a contaminant that is perhaps the best-known environmental 

neurotoxin—how can anyone trust CDC’s integrity on more controversial subjects? 
66

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
67

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-congressionalhearing-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–
68

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.37

Second, in the weeks just before the publication of the CDC MMWR, media attention was shifting to DC DOH’s ignorance about, and mismanagement of, DC’s lead 

in water issues.40 Contrary to initial claims that DC DOH first learned about problems with high lead in water in January 2004, the Washington Post was on the 

verge of informing the public that DC DOH’s knowledge went back to October of 

2002. In particular, former ASTDR employee and CDC MMWR co-author Dr. Stokes 

was in the cross-hairs, because in October 2002 she (together with other DC DOH 

officials) ‘‘ignored the mounting health threat and failed to issue clear instructions 

to residents about how to reduce their risk of lead poisoning.’’ 40 Although obviously 

responsible for her actions, Dr. Stokes’ inattention to the water problem fully conformed with the CDC’s ‘‘lead-paint-centric’’ approach to childhood lead poisoning 

prevention, so any further press coverage of Dr. Stokes’ lapses would also risk drawing attention to deficiencies in CDC policies. The CDC MMWR, rushed to publication just one day after this Washington Post article, effectively immunized both Dr. 

Stokes and the CDC from further criticism. 

Third, any serious investigation of who knew what and when at DC DOH, would 

have led to public revelations about agency bungling that went far beyond anything 

that had ever been previously revealed in the press. Specifically, on September 26, 

2001, a DC WASA employee called the DC OIG hotline and reported that DC WASA 

had ‘‘intentionally’’ hidden many lead in water test results from early 2001 that ‘‘exceeded the EPA action limit.’’ 14 Also, later research would demonstrate that at this 

exact time frame, DC WASA was collecting data showing that DC’s water lead levels were spiking to dangerous levels and that hundreds of DC’s children had elevated blood lead levels due to exposure to the high lead in water.23 It is now undisputed that DC WASA and US EPA R3 knew that the US EPA water lead action 
69

standard would likely be exceeded by July 19, 2002, and had certainly knowledge 

of some problems as far back as August 2001.14

My FOIA request of US EPA reveals that on June 21, 2002, a DC DOH water 

quality division employee wrote a letter to US EPA R3 requesting funding for ‘‘a 

lead service line replacement program.’’ It seems likely the employee knew something was amiss relative to lead in water and its health impacts for DC residents, 

because the employee later indicated to US EPA R3 that during April 2002, she had 

tried to get geographic data on elevated blood lead levels of children from the CDCfunded 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 CDCfunded 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 gamechanging legal case of national importance that offered the possibility of billions of 

dollars from former lead-pigment makers for lead paint remediation. A landmark 

lawsuit against lead paint companies, initiated in Rhode Island in 1999, seemed to 

be heading towards a historic settlement which could require the defendants to pay 

billions in funds to rid Rhode Island homes of lead paint hazards and ultimately 

might create similar programs nationwide.42 To date, the CDC has not produced 

documents that I have requested about Dr. Brown’s involvement in this lawsuit; 

however, in 2007 Rhode Island apparently did consider that Dr. Brown serve as a 

‘‘Special Master’’ to oversee spending the funds from the lawsuit, a proposal which 

the defendants protested.43

Indeed, an October 2002 article about Dr. Brown’s recent research on lead in 

Rhode Island, stated that ‘‘She <Brown> added that the study may aid plaintiffs 

waging legal battles against lead paint manufacturers, mentioning one case in 

Rhode Island that recently resulted in a hung jury.’’ 44
70

To my knowledge, lead in water was never raised as a potential lead source in 

the Rhode Island lawsuit. However, if the DC Lead Crisis were shown to have 

caused demonstrable harm, it could have provided another significant argument for 

the former lead paint defendants, weakened the Rhode Island lawsuit, and jeopardized the potential procurement of billions of dollars nationally for lead paint remediation. Indeed, Lead and Copper Rule monitoring results and a recent article in the 

journal Environmental Health Perspectives (EHP) have revealed chronic problems 

with lead in the tap water of Providence, Rhode Island, and I am aware of relatively 

high lead in water of other Rhode Island cities.45

As for opportunities, they were also significant, for those interested in generating 

new funding sources to mitigate lead paint. First, any public relations coup about 

the supposed lack of harm from water, provided a high profile platform that CDC 

could (and did) use to drive home its belief that even in the midst of the largest 

lead in water contamination event in modern history, the only significant health 

concern in DC was lead paint. Two events, removal of the language from the US 

EPA website about the dangers of 40 ppb lead in water, and Dr. Brown’s removal 

of the statement ‘‘Elevated levels of lead in the water are a public health concern’’ 

from the CDC MMWR, were separated at most by 3 days in late March 2004. 

Secondly, the CDC’s handling of the DC Lead Crisis not only protected lead paint 

advocates’ drive for a Rhode Island legal settlement, but it was also used to create 

new opportunities for funding for lead paint from the water industry. For starters, 

the DC DOH lead program obtained millions of dollars of funding from DC WASA 

in early 2004 for blood lead tests, environmental assessments and software to track 

lead poisoning. National funding aspirations were also significant and could be cultivated. As revealed in a recent EHP article, one of Dr. Guidotti’s colleagues and 

2007 paper co-authors made a presentation at the 2009 American Public Health Association conference, about a Portland, Oregon program, in which water utilities 

could pay for lead paint remediation, in exchange for not having to fully optimize 

corrosion control to minimize lead in water concentrations according to federal regulations. The EHP article stated: 45

‘‘Portland instead spends $500,000 annually on a public education campaign 

and lead paint abatement program. ‘This approach was a win-win for community public health, reducing lead exposure across the community and across 

media of exposure, especially for children,’ says David Leland, manager of the 

Oregon Department of Human Services Drinking Water Program . . . . ‘Look 

at the hierarchy of concern for lead,’ says Leland. ‘Number one was the lead 

from gasoline in the air, before it was banned. Now it’s paint,’ he says.’’

‘‘. . . Jim Elder, who headed the EPA drinking water program from 1991 to 

1995 <stated> ‘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 
71

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 
72

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 
73

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 
74

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 ATSDRrelated 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. 
75

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? 
76

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. 
77

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. 
78

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 
79

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 
80

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.]
81

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 
82

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 experi-
83

ence 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 
84

1www.atsdr.cdc.gov/nationalconversation

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

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. 

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 re-
85

3Stokes 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. 4 CDC’s reanalysis is available at: http://www.cdc.gov/nceh/lead/leadinwater/

duce 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. 

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. 

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

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 
86

5http://www.cdc.gov/nceh/lead/waterlines.htm

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

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 
87

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 
88

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 longterm 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, 
89

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 conclu-
90

sions 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 
91

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 followthrough 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 
92

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. 
93

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.] 

(95)

Appendix: 

ADDITIONAL MATERIAL FOR THE RECORD
96

A PUBLIC HEALTH TRAGEDY: HOW FLAWED CDC DATA AND FAULTY ASSUMPTIONS

ENDANGERED CHILDREN’S HEALTH IN THE NATIONS’S CAPITAL, A REPORT BY THE

MAJORITY STAFF OF THE SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT
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