	Background

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, among other  things. Internal control includes activities such as establishing  policies and procedures, assessing risks associated with achieving agen objectives, ensuring effective information sharing throughout the  organization, conducting ongoing monitoring of agency activities, and  establishing key areas of authority and responsibility for agency  management and staff. Therefore, once in place, internal control  provides reasonable assurance, not absolute assurance, that an agency’s  objectives are being achieved. ATSDR’s Policies and Procedures for P Health Product Preparation Lack Some Critical Controls to P Reasonable Assurance of Quality

The policies and procedures that ATSDR has established for public health product preparation lack some of the critical controls to provide  ot been  reasonable assurance of product quality. Moreover, although policies and procedures include some routine oversight of product  development, they do not consistently require that management monitor  the development of key components of these products. Although ATSDR has not established policies or procedures that establish  and describe information flow within the agency, it is implementing a new  agencywide system called Sequoia, which may improve the flow of  information about newly initiated work between management and staff. ATSDR also lacks comprehensive policies and procedures for assessing  and categorizing the risk of work being initiated at the agency. If a site was classified as a focus  site, which typically occurred as work was being initiated, any public  health products resulting from that site were required to undergo a higher  level of review during review and clearance. 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 all new work, or  established product preparation procedures commensurate with the risk. However, these meetings rely on division management to  bring problems or concerns regarding product development to the  attention of the OD, and according to ATSDR officials, Issues Management  meetings focus only on “sites of interest.” Thus, while products related to  “sites of interest” may be discussed at these meetings, current ATSDR  procedures do not ensure the discussion of key components of products  for ATSDR sites not identified as “sites of interest.” Additionally, items on  the agenda of the Issues Management meeting are not prioritized to ensure  that the most significant problems associated with the development of a  public health assessment or health consultation are promptly addressed. Due to scientific concerns identified in the  document once review and clearance began, the document underwent  several years of reviews and revisions, and a final report was not issued  until December 2008. 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

While ATSDR has implemented policies and procedures governing the  review and clearance of its public health products, some sections of  ATSDR’s review and clearance policies and procedures do not reflect  current practices. The agency’s clearance policy and procedures generally direct  management and staff to use discretion to identify products that warrant a  higher level of review, rather than determining review and clearance levels  through a risk assessment process. However, even  though ATSDR and DHAC have established criteria, there is no required  point during a product’s preparation where management and staff  collectively determine whether a product meets the criteria, and if  additional review is warranted. Because ATSDR does not conduct a  comprehensive risk assessment of its products or sites, and its policies  and procedures instead rely on management and staff discretion to make  these determinations, the agency cannot ensure its products consistently  receive the appropriate level of review and clearance.
Why GAO Did This Study

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.

What GAO Found

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. While ATSDR has established some policies and procedures to guide the preparation of its public health products, the policies and procedures do not establish how information is to flow between management and staff during initiation. Absent such policies and procedures, ATSDR generally relies on various meetings to inform management and staff about new work. The agency is also implementing a new database, which may improve information flow. Furthermore, ATSDR does not comprehensively evaluate and categorize the risk of work being initiated. While the agency used to officially classify some hazardous chemical sites as "high-priority" or "focus sites," and require any products resulting from those sites to undergo a higher level of review and clearance, it no longer does so. Because ATSDR does not comprehensively assess and categorize the risk of work being initiated at the agency, management cannot ensure that they have consistently managed the risk related to new work. Additionally, many of ATSDR's policies and procedures that guide product development do not clearly define management roles and responsibilities and do not consistently require that management monitor the development of key components of these products. These deficiencies may lead management to be unclear about their responsibilities, and may result in problems that occur during product development not being 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. Moreover, because some review and clearance policies do not reflect current practices, ATSDR staff cannot rely on these policies to accurately or consistently determine review and clearance procedures. 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.