Submission of Exposure Information

Those sponsors who choose to submit exposure information to the HPV Challenge Program are encouraged to follow the steps outlined below. Companies are discouraged from including risk characterizations in their submissions.

Sponsors should develop information that identifies chemical uses, releases to the environment and exposed populations, including the extent, duration and frequency of such exposures. Three important elements should be considered when submitting this information:

  monitoring data of known quality that are representative of the exposed population are preferred over estimated exposure values calculated using such techniques as modeling and should be submitted when available;

  limitations in the information provided should be transparent and well documented. Further, they should be presented in such a way that the sponsor conveys an understanding of the "completeness" of the information provided, describing which exposure scenarios are covered/not covered in the submission and the fraction of the total nationally aggregated production volume which is represented by the exposure information submitted;

  exposure information should be set apart from the hazard information and presented in a separate section of the submission.

Numerous resources are available for developing exposure information, including EPA's Exposure Assessment Tools and Models website http://www.epa.gov/opptintr/exposure/ and the Alliance for Chemical Awareness website http://www.chemicalawareness.org

. In addition, the Organization for Economic Cooperation and Development (OECD) exposure guidance is under development and is expected to be available in the Spring of 2003. It will be referenced on this website at that time.

Submission of Exposure Information

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