Tolerance Reassessment Advisory Committee

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 Although the information provided here was accurate and current when first created, it is now outdated.

TRAC 5/28-29/98

Staff Paper # 1

AT A GLANCE -- Evolution of FQPA Implementation

Interim Decision Logic

(described to FSAC¹ in Dec.'96 and published in PR Notice 97-1)

Consultation Opportunities²

Current operating policy

Aggregate Exposure.

Estimate exposure components (dietary, drinking water, residential) and risk, allocate portions of total aggregate risk to drinking water, residential, remainder to dietary exposure

SAP³ December 10-11, 1997

SAP March 24-25, 1998

SAP May 5-6, 1998

ILSI⁴ November 1997

ILSI February 1998

Current approach still adds exposure from the three components. Tools/methods for estimating exposure are evolving and improving.

Risk Cup.

5% - 20% of risk cup reserved non-dietary exposure pathways (e.g., 10% for drinking water)

SAP December 10-11, 1997

ILSI November 1997

ILSI February 1998

No longer reserving a percentage of the risk cup. For drinking water and residential (indoor and outdoor), using available data, and scientific methods and models.

Common Mechanism of Toxicity.

Assume common mechanism exists if a pesticide shares a toxicological endpoint and structural similarity with other substances. Any approvals will be time-limited or conditional.

SAP December 10-11, 1997

SAP March 24-25, 1998

ILSI September 1998

Still largely applying interim logic, since in most cases there is still no "available information" concerning common mechanism that can be applied rationally to science decisions.

OPs have been determined to share a common mechanism of toxicity. Need to develop a cumulative risk assessment methodology for considering all aggregate OP risks.

Regulatory Decisions.

Apply interim decision logic when data lacking to estimate specific exposures. If data available, it would be used to estimate exposure more precisely. Decision logic will be revised and updated once interim decisions revisited.

SAP December 10-11, 1997

FSAC¹ December 1996

Interim decision logic has evolved. Better exposure data and estimating techniques being incorporated into decisions.

FQPA Safety Factor (10X).

Retention, reduction or removal of the safety factor based primarily on completeness of the database as well as type and severity of the observed effect(s).

SAP September 9-10, 1997

SAP March 24-25, 1998

SAP July 1998

SAB⁵ Fall 1998

PPDC⁶ April 16-17, 1998

Safety factor decisions are made considering all aspects of the pesticide's risk characterization, i.e., in addition to data, use and exposure are considered.

Probabilistic risk assessments/Monte Carlo/99.9%.

SAP September 9-10, 1997

SAP March 24-25, 1998

Agency is accepting Monte Carlos submitted by registrants according to draft guidance. Evaluating which percentile(s) (e.g., 99.9%) is the most appropriate for decision-making.

Food Safety Advisory Committee (FSAC).
Attached is a list of materials and guidance documents that EPA presented to the SAP, ILSI, and PPDC.
Scientific Advisory Panel (SAP).
International Life Sciences Institute (ILSI).
Scientific Advisory Board (SAB).
Pesticide Program Dialogue Committee (PPDC).