Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated.

WORKGROUP #1 COMMENTS ON

EPA'S RISK ASSESSMENT PROCESS FOR TOLERANCE REASSESSMENT

The workgroup provided a variety of comments and raised several issues related to the staff paper, EPA's Risk Assessment Process for Tolerance Reassessment." These and additional written comments received following the June 22-23 TRAC meeting will be considered in producing the next version of this paper.

Questions and Comments

• Can new information come in during exposure assessment, before the hazard identification process?
  
• Discuss how EPA will deal with variations in quality of residue data in decisionmaking
  
• Include information on assumptions, to provide clarity on degree of conservatism of the analysis
  
• Clarify what is included in the "residential" category, since exposures in school settings or due to spray drift do not appear to be covered.
  
• Does EPA consider %crop treated in acute dietary assessments? (Clarify)
  
• Need a better definition of acceptable data quality and discussion of whether the concept of "acceptable" varies at different points in the process
  
• Clarify the discussion of Q₁*.
  
• Number the boxes in the flowchart, to indicate how they related to the other charts.
  

Issues

• What happens when the risk cup is full? What is the risk mitigation process?
  
• What would the "perfect" database be? (At the plate, single serving, over time, to allow for both acute and chronic exposure assessment.)
  
• Can Part 158 adequately produce information on the effects on children?
  
• Does the statute allow for consideration of %crop treated in acute risk assessment?
  
• Should OPP be using NOEL or NOAEL?

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updated April 13, 1999