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 Although the information provided here was accurate and current when first created, it is now outdated.

Staff Paper #22
TRAC 7/21/98
Issues and Decision Points for OP Tolerance Reassessment Proccess

Discussion points pertaining to the Tolerance Reassessment Proccess that are being presented for discussion by the TRAC Workgroup #2 on 7/27/98.

1. Mitigation of Individual OP Risk Endpoints

• How much mitigation of individual OP risk concerns is appropriate before the EPA begins the cumulative risk assessment? -- Should all risk concerns be fully mitigated on an individual OP basis before proceeding with the cumulative assessment?

-- Should individual risk mitigation begin and continue parallel to cumulative assessment and related risk management -- Should only risks of greatest concern be fully mitigated first? -- Should risks only be mitigated to the point where a cumulative risk assessment methodology and technical capability are available?

2. Cumulative Risk Assessment

• When is it appropriate or desirable for the EPA to conduct a full cumulative risk assessment that includes food, water, and residential contributions to dietary risk?
• Should the full cumulative risk assessment be reached though a tiered process, beginning with a food only cumulative risk assessment?

3. Data Refinement

• At what point(s) in the process should the Agency allow for additional data/information generation or data submission?
• What data are appropriate to generate or submit in light of the FQPA timeframes, current risk assessment methodologies and evaluation tools?

4. Tolerance Reassessment

• Can some tolerances be determined acceptable at an early stage based on a very small contribution to risk plus high value

-- Should it be a factor if the individual related OP has been managed to an acceptable risk level

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updated July 24, 1998