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®: CRE Regulatory Action of the Week

IQA Can Be Used to Challenge EPA's EDSP Disseminations
On September 26, 2011, the U.S. Environmental Protection Agency published Federal Register notice of EPA's final guidance document titled, "Weight-of-Evidence: Evaluating Results of EDSP Tier 1 Screening to Identify the Need for Tier 2 Testing.'' According to EPA's notice, this guidance document for the Endocrine Disruptor Screening Program

    "provides basic principles and criteria for application of a WoE approach to evaluate results from the battery of Tier 1 screening assays along with other scientific and technical information relevant to Tier 1 screening to determine whether or not a chemical has the potential to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal pathways of the endocrine system. The combined results and information will also be used to identify which tests and information may be needed for Tier 2 testing."
EPA's "WoE approach" relies heavily on the Agency Information Quality Act Guidelines in determining whether Tier 2 testing is needed. For example, the WoE guidance states:
    "Information that is submitted voluntarily and is applicable to support or clarify an EPA action is generally referred to as -- other scientifically relevant information. Sources of relevant scientific and technical information may include results from EPA or OECD equivalent test guideline studies and information from published or publically available peer-reviewed studies. Regardless of the source, the information is evaluated for quality and relevance, taking into account the Agency's Information Quality Guidelines (USEPA, 2002b) before use in an EPA action."


    "In general, published or publically available peer-reviewed studies are conducted in accord with standard scientific methods that include hypothesis development and testing through observation, experimentation, and verification. However, unlike test guideline studies, published studies in the open literature (i.e., non-guideline) do not typically adhere to GLP. Thus, for non-guideline, as well as guideline studies, to be considered as primary or secondary sources of information in a WoE evaluation with Tier 1 screening results, EPA would generally evaluate the quality and relevance of the information indicated in EPA Information Quality Guidelines (USEPA, 2002b)."


    "Evaluation of the quality of scientific and technical information contained in test guideline, as well as non-guideline studies, is fundamental for consideration of that information in a WoE analysis that would support a regulatory decision. Developed in response to the Office of Management and Budget (OMB, 2002), the Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental Protection Agency (USEPA, 2002b) contain EPA's policy and procedural guidance for ensuring and maximizing the quality of information. This and other guidance documents relevant to evaluation of the quality of scientific and technical information can be found at the EPA website."
The WOE guidance document also contains a lengthy, detailed discussion of the IQA standards and their application. EPA's express and heavy reliance on the IQA emphasizes the fact that EPA's EDSP information disseminations, and EPA's WoE guidance document itself, can be challenged under the DQA.
  • Click here to read read EPA's Federal Register notice of its WoE guidance document
  • Click here to read EPA's WoE guidance document