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Before the Subcommittee on Investigations and Oversight, Committee on 
Science and Technology, House of Representatives: 

United States Government Accountability Office: GAO: 

For Release on Delivery: 
Expected at 9:00 a.m. EDT:
Thursday, May 20, 2010: 

Agency for Toxic Substances and Disease Registry: 

Policies and Procedures for Preparing Public Health Products Should Be 

Statement of Cynthia A. Bascetta:
Director, Health Care: 


[End of section] 

Mr. Chairman and Members of the Subcommittee: 

I am pleased to be here today to discuss the Agency for Toxic 
Substances and Disease Registry's (ATSDR) policies and procedures for 
product preparation. ATSDR investigates community exposures related to 
chemical sites and releases; works with federal, tribal, state, and 
local agencies to identify potential exposures; assesses associated 
health effects; and recommends actions to stop, prevent, or minimize 
these harmful effects. In conducting these activities, the agency 
publishes many types of public health products, including public 
health assessments, health consultations, health study reports, and 
exposure investigations. Recent reports by the Institute of Medicine 
[Footnote 1] and ATSDR's Board of Scientific Counselors[Footnote 2] 
have identified various concerns such as the appropriateness and 
quality of the data used in ATSDR's products, the methodology and 
design of the studies, and clearance policies. 

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,[Footnote 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 

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, 
[Footnote 4],[Footnote 5] and the related Internal Control Management 
and Evaluation Tool.[Footnote 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 which a product is 
internally or externally reviewed and disseminated as a final public 
health product. 

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

* ATSDR's policies and procedures for product development do not 
provide for clear management roles and responsibilities or consistent 
monitoring of product development. During product development, many of 
ATSDR's policies and procedures do not clearly define management roles 
and responsibilities and do not consistently require that management 
monitor the development of key components of these products. For 
example, the primary document--the Public Health Assessment Guidance 
Manual--that guides the development of public health assessments and 
health consultations, which are among the agency's core products, 
identifies exposure assessment[Footnote 7] and health effects 
evaluation as the two primary technical components of the public 
health assessment process. However, there is no requirement that 
staff's 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.[Footnote 8] Furthermore, review and 
clearance policies and procedures direct management and staff to use 
discretion to identify products that require higher levels of review, 
rather than making this determination through a comprehensive risk 
assessment process. While ATSDR policy sets out criteria for when 
additional review may occur, such as when a document could have a high 
degree of visibility, there is no required point during a product's 
preparation when management and staff collectively determine whether a 
product meets the criteria, and whether additional review is 
warranted. Thus, the agency cannot ensure that all products 
consistently receive the appropriate level of review. 

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 

For questions about this testimony, please contact Cynthia A. Bascetta 
at (202) 512-7114 or Contact points for our Offices 
of Congressional Relations and Public Affairs may be found on the last 
page of this testimony. Individuals who made key contributions to this 
testimony include Karen Doran, Assistant Director; George Bogart; 
Roseanne Price; Mario D. Ramsey; Christina Ritchie; and Carla Willis. 

[End of section] 


[1] See Institute of Medicine, Review of ATSDR's Great Lakes Report 
Drafts (Letter Report) (Washington, D.C.: National Academies Press, 

[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. 

[3] See GAO, Agency for Toxic Substances and Disease Registry: 
Policies and Procedures for Public Health Product Preparation Should 
be Strengthened, [hyperlink,] 
(Washington, D.C.: Apr. 30, 2010). 

[4] See GAO, Standards for Internal Control in the Federal Government, 
(Washington, D.C.: November 1999). 

[5] See Office of Management and Budget Circular No. A-123, (Revised): 
Management's Responsibility for Internal Control (Dec. 21, 2004). 

[6] See GAO, Internal Control Management and Evaluation Tool, 
[hyperlink,] (Washington, 
D.C.: August 2001). 

[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. 

[8] DHAC is one of four ATSDR divisions. 

[End of section] 

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