EPA Requests National Academy of Sciences Input on Consideration of Certain Human Toxicity Studies; Announces Interim Policy
Agency Requests National Academy of Sciences Input on Consideration of Certain Human Toxicity Studies; Announces Interim Policy
In a letter, the Environmental Protection Agency is requesting that the National Academy of Sciences conduct an expeditious review of the complex scientific and ethical issues posed by EPA's possible use of third-party studies which intentionally dose human subjects with toxicants to identify or quantify their effects.
EPA will ask the Academy to furnish recommendations regarding the particular factors and criteria EPA should consider to determine the potential acceptability of such third-party studies. Recently, most submissions to the Agency have concerned toxicity testing of pesticides, such as studies used to establish a No Observed Adverse Effect Level or No Observed Effect Level for systemic toxicity of pesticides. The Academy is also being asked to provide recommendations on whether internationally accepted protocols or the Protection of Human Subjects Rule ("the Common Rule," which details the protection of human subjects of EPA-conducted or supported research) could be applied to develop the scientific and ethical criteria for EPA to evaluate such studies. These third-party studies that will be the focus of the Academy review are those that have not been conducted or funded by a federal agency in compliance with EPA's Common Rule, or its equivalent.
"Our paramount concern in developing our policy on these studies must be protection of human health and adhere to the most rigorous ethical and scientific standards," said EPA Administrator Christie Whitman. "Formulating a policy that appropriately reflects our competing concerns in this matter will not be easy, and I thank the National Academy of Sciences for agreeing to assist EPA in evaluating these complex issues. The one thing that all parties agree upon is the need for EPA to formulate a formal policy on the use of human testing data, and we will do so in a transparent and responsible manner."
The Agency will ask that the Academy incorporate early in its review an open, public and participatory process through which all interested parties may raise their concerns and ideas for consideration. Following the Academy's review, EPA will engage in an open and participatory process involving federal partners, interested parties and the public during its policy development and/or rule making regarding future acceptance, consideration or regulatory reliance on such human studies.
During the Academy's consideration of the issues and until a policy is in place, the Agency will not consider or rely on any such human studies in its regulatory decision making, whether previously or newly submitted. Should EPA be legally required to consider or rely on any such human study during this interim period, the Agency will assemble a Science Advisory Board subpanel to review and comment on scientific appropriateness and ethical acceptability of the study in question, and the Agency will provide an opportunity for public involvement. This external review would occur prior to consideration of the study and would allow the Science Advisory Board to review all available information on the study.
Notwithstanding the interim policy, existing provisions of the Federal Insecticide, Fungicide, and Rodenticide Act and the Toxic Substances Control Act, continue to require industry to report any adverse effects information from such studies. In any instance where third-party human testing data suggests a public health concern, the Agency would promptly consider that information.If you would like to be included in our mailing list for continuing information on pesticides, Email Us. with "subscribe" in the subject line.