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Agency for Toxic Substances and Disease Registry: Policies and Procedures for Public Health Product Preparation Should Be Strengthened

GAO-10-449 Published: Apr 30, 2010. Publicly Released: May 20, 2010.
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Highlights

The Agency for Toxic Substances and Disease Registry (ATSDR) has faced concerns related to the quality of some of the public health products it publishes. ATSDR investigates community exposures related to certain hazardous chemical sites and releases; assesses associated health effects; and recommends actions to stop, prevent, or minimize harmful effects. ATSDR publishes many types of products, including public health assessments, health consultations, exposure investigations, and health study reports. GAO was asked to examine the extent to which ATSDR's policies and procedures for product preparation, including work initiation, product development, and review and clearance, provide reasonable assurance of product quality. GAO reviewed ATSDR policies and procedures and interviewed agency officials and employees.

Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Agency for Toxic Substances and Disease Registry To strengthen the ATSDR's policies and procedures, and ensure that they provide reasonable assurance of public health product quality, the director of ATSDR should develop policies and procedures to ensure that a risk assessment is conducted at the time site-specific work is initiated, and that any assigned risk level be reevaluated throughout product preparation to ensure that it remains appropriate.
Closed – Implemented
In response to our recommendation, ATSDR finalized and implemented the "ATSDR Policies and Procedures" document on March 22, 2011 in order to update selected internal controls (e.g. prioritization of site work and management controls) to help the agency focus resources on mission-related public health problems that can be effectively managed. By finalizing and implementing this document, ATSDR can provide reasonable assurance that its products have undergone the appropriate level of monitoring and review. Specifically, ATSDR can use this document to determine the proper level of scrutiny throughout the initiation, development, and review and clearance phases, including whether or not a product should undergo external peer review, thereby ensuring that this determination is made consistently across the agency.
Agency for Toxic Substances and Disease Registry To strengthen ATSDR's policies and procedures, and ensure that they provide reasonable assurance of public health product quality, the director of ATSDR should 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 monitoring and approval of key components of these products.
Closed – Implemented
In response to our recommendation, as of March 2011, ATSDR had included revisions to its policy for the clearance of products for public use to include documented direction for various levels of management on their roles and responsibilities in the monitoring of all products prior to review and clearance. Additionally, ATSDR created a policies and procedures manual that details management controls of the agency's work. By revising its policy for the clearance of products for public use and creating a policy that addresses management controls, ATSDR has a reasonable assurance that its management has a clear understanding of the role they are supposed to play in supervising a product?s preparation, and that product errors are caught and significant publication delays do not occur during the review and clearance phase.

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Topics

Agency evaluationData collectionData integrityDatabasesGovernment information disseminationHazardous substancesHealth hazardsInformation managementInformation resources managementInternal controlsInvestigations by federal agenciesInvestigations into federal agenciesMonitoringProduct evaluationPublic healthQuality assuranceRisk assessmentRisk managementStandardsToxic substances and disease registryInformation sharingPolicies and procedures