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Cumulative Risk Assessment: Developing the Methods - Available Papers and Where They May be Located
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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 Although the information provided here was accurate and current when first created, it is now outdated. |
February 27, 2002
THE BEGINNING
The Food Quality Protection Act (FQPA), which became law in August 1996, requires EPA to consider the cumulative effects to human health that can result from pesticides and other substances that have a common mechanism of toxicity. Through cumulative risk assessment EPA will be able to determine if the risks posed by a group of pesticides that act in the same way in the body meet the current safety standard.
HOW HAS THE CUMULATIVE RISK ASSESSMENT PROCESS COME ABOUT?
The Office of Pesticide Programs has developed a framework for conducting cumulative risk assessments on pesticides. Achieving this framework has required the development of new methods and tools. EPA began with consideration of what constitutes common mechanism of toxicity, then moved on to methods for conducting aggregate exposure and risk assessments, and finally to the cumulative risk assessment process.
A common mechanism of toxicity group consists of chemicals for which scientifically reliable data demonstrate that the same toxic effect occurs in or at the same organ or tissue by essentially the same sequence of major biochemical events.
- EPA participated in a workgroup by the International Life Sciences Institute (ILSI) to discuss issues surrounding common mechanism as it applies to the organophosphate pesticides. The ILSI workgroup recommended that the organophosphates be classified as a common mechanism group. EPA accepted that recommendation. (Common Mechanism of Toxicity: A Case Study of Organophosphorus Pesticides, Toxicological Sciences, 41:8-20 (1998))
- EPA published draft guidance on common mechanism of toxicity for comment on August 6, 1998.
- The revised guidance was published February 5, 1999 (64 FR 5795) A Guidance for Identifying Pesticide Chemicals and Other Substances That Have a Common Mechanism of Toxicity.*
- EPA has consulted the FIFRA Scientific Advisory Panel regarding various aspects of the Agency's approach to common mechanism of toxicity**
- March 19-20, 1997 Common Mechanism of Toxicity: The Grouping of a Series of Chloroacetanilide Pesticides Based on a Common Mechanism of Toxicity
- March 24-25, 1998 Common Mechanism of Action of Organophosphates
- March 24-25, 1998 Suggested Probabilistic Risk Assessment Methodology for Evaluating Pesticides that Exhibit a Common Mechanism of Action
- September 21-24, 1999 The Carbamate Pesticides and the Grouping of Carbamates with the Organophosphate Pesticides
- September 7, 2001 Common Mechanism of Action of Thiocarbamates and Dithiocarbamates
As part of the individual chemical risk assessment, EPA performs an aggregate risk assessment. The aggregate risk assessment includes consideration of exposures to the pesticide from food, drinking water, and residual/non-occupational sources.
- International Life Sciences Institute (ILSI) has held workshops with presentations and panel discussions by EPA and other scientists
on topics related to aggregate exposure. Publications include:***
- Assessment of Methods to Estimate Pesticides in Drinking Water (1998)
- Aggregate Exposure Assessment Workshop Report (1998)
- A Framework for Estimating Pesticide Concentrations in Drinking
Water for Aggregate Exposure Assessments (1999)
- Aggregate Exposure Assessment: Model Evaluation and Refinement Workshop (2001)
- EPA has published guidance on aggregate risk assessment.
- EPA published draft guidance for comment on November 10, 1999.
- The revised guidance was published on November 28, 2001: General Principles for Performing Aggregate Exposure and Risk Assessment (66 Federal Register 59428). *
- EPA has published several guidance documents related to drinking
water exposure assessment:*
Estimating the Drinking Water Component of a Dietary Exposure Assessment was published for comment on January 4, 1999. The revised version was published on November 10, 1999.
- Standard Operating Procedure for Incorporating Screening-Level
Estimates of Drinking Water Exposure in Aggregate Risk Assessments
was published for comment October 11, 2000.
- Drinking Water Screening-Level Assessments, Part A Guidance for Use of the Index Reservoir in Drinking Water Exposure Assessments was published for comment October 11, 2000.
- Water Treatment Effects on Pesticide Removal and Transformation, published for comment November 21, 2001 (66 Federal Register 58485).
- Standard Operating Procedure for Incorporating Screening-Level
Estimates of Drinking Water Exposure in Aggregate Risk Assessments
was published for comment October 11, 2000.
- EPA has published guidance on conducting residential exposure
assessments:*
- Standard Operating Procedures for Residential Exposure Assessment
was published for comment January 4, 1999.
- Framework for Assessing Non-occupational/Non-dietary Exposure to Pesticides was published for comment January 4, 1999.
- Standard Operating Procedures for Residential Exposure Assessment
was published for comment January 4, 1999.
- EPA has consulted the FIFRA Scientific Advisory Panel regarding
various aspects of the Agency's approach to aggregate risk assessment**
- March 19-20, 1997 Aggregate Exposure Assessment as Required by
FQPA Iterim Approach
- September 9-10, 1997 Standard Operating Procedures (SOPs) for
Residential Exposure Assessments
- December 10-11, 1997 Estimated Drinking Water Exposure as a Component
of the Dietary Risk Assessment
- October 14-15, 1998 Proposed Methods for Basin-Scale Estimation
of Pesticide Concentrations in Flowing Water and Reservoirs for
Tolerance Reassessment
- March 24-25, 1998 Policy of Monte Carlo Analyses for Dietary and
Residential Exposure Scenarios
- February 23-24, 1999 Guidance for Performing Aggregate Exposure
and Risk Assessments; Questions on the Development of Aggregate
Exposure and Risk Assessment Guidance
- May 25-27, 1999 Proposed Methods for Determining Watershed-Derived
Percent Crop Areas and Considerations for Applying Crop Are Adjustments
to Surface Water Screening Models
- September 21-24, 1999 Overview of Issues Related to the Standard
Operating Procedures for Residential Exposure Assessment
- September 21-24, 1999 The LifeLine(TM) Project to Model Aggregate
Exposures to Pesticides (Hampshire Research Institute)****
- February 29-March 3, 2000 Dietary Exposure Evaluation Model (DEEMTM)
and DEEM(TM) Decompositing Procedure and Soft (Novigen Sciences,
Inc.)****
- February 29-March 3, 2000 Development and Use of Distributions
of Pesticide Concentrations in Drinking Water for FQPA Exposure
Assessments: A Consultation
- September 26-29, 2000 Assessing Aggregate and Cumulative Risk
Using LifeLine(TM) (Hampshire Research Institute)****
- June 6-9, 2000 Monitoring Strategies for Pesticides in Surface-Derived
Drinking Water
- September 26-29, 2000 CALENDEX(TM) Calendar-Based Dietary and
Non-dietary Aggregate and Cumulative Exposure Software System (Novigen
Sciences, Inc.)****
- September 26-29, 2000 Models Residentail Exposure REX Model (Infosciences)****
- September 26-29, 2000 Progress Report on Estimating Pesticide concentrations in Drinking Water
- March 19-20, 1997 Aggregate Exposure Assessment as Required by
FQPA Iterim Approach
- Assessing Cumulative Risk
Assessing cumulative risk involves developing ways to combine exposures to different substances that may have differing degrees of toxicity and be used in various ways at various times of the year. EPA's guidance has to address how these factors will be handled. EPA has pursued an open, peer-reviewed process to develop cumulative risk assessment methods and approaches.
- International Life Sciences Institute (ILSI) has held workshops with presentations and panel discussions by EPA and other scientists
on topics related to cumulative risk assessment.
Publications include:***
- A Framework for Cumulative Risk Assessment Workshop Report (1999)
- EPA has held a series of technical briefings to help explain
the methods and issues addressed in the guidance.
- July 2000 - Technical briefing on the draft cumulative risk assessment guidance.
- August 22, 2001 - Technical briefing on background and hazard methodology - revised relative potency factor (RPF) paper. *****
- October 3, 2001 - Technical briefing on background, methods, and data proposed for use in the OP pesticide cumulative exposure assessment for drinking water. *****
- November 15, 2001 - Technical briefing on food and residential exposure methodologies and approaches to integration of multiple pathways of exposure. *****
- January 15, 2002 - Technical briefing on the preliminary cumulative risk assessment. *****
- EPA has consulted the FIFRA Scientific Advisory Panel regarding various
aspects of the Agency's approach to cumulative risk assessment **
- December 8-9, 1999 Issues Pertaining to Exposure Assessment and
Estimating Cumulative Risk
- December 8-9, 1999 Chapter 4 Exposure Assessment and Characterization;
Chapter 6 Estimation and Characterization of Cumulative Risk
- September 21-24, 1999 Proposed Guidance on Cumulative Risk Assessment
of Pesticide Chemicals that have a Common Mechanism of Toxicity
- September 21-24, 1999 Issues Pertaining to Hazard and Dose-Response
Assessment
- September 26-29, 2000 Endpoint Selection and Determination of
Relative Potency in Cumulative Hazard Assessment: A Pilot Study
of Organophosphate Pesticide Chemicals
- September 26-29, 2000 Assessing Aggregate and Cumulative Risk
Using LifeLine(TM) (Hampshire Research Institute)*
- September 26-29, 2000 CALENDEX(TM) Calendar-Based Dietary and
Non-dietary Aggregate and Cumulative Exposure Software System (Novigen
Sciences, Inc.)****
- December 7-8, 2000 Case Study of the Cumulative Risk of 24 Organophosphate Pesticides; Cumulative Risk Assessment Method for Dietary (Food) Exposure; Cumulative Risk Assessment for Residential Exposure; Cumulative Risk Assessment for Drinking Water; Integrated Cumulative Risk Assessment
- March 28, 2001 LifeLine™ system operation review and users manual. **
- September 5-6, 2001, Preliminary Cumulative Hazard and Dose-Response Assessment for Organophosphorus Pesticides; Determination of Relative Potency and Points of Departure for Cholinesterase Inhibition **
- February 5-8, 2002, Organophosphate Pesticides: Preliminary Cumulative Risk Assessment **
- December 8-9, 1999 Issues Pertaining to Exposure Assessment and
Estimating Cumulative Risk
** Background documents and reports from the FIFRRA SAP
*** Information on reports by the International Life Sciences Institute 
**** Model presented by the company developing, not by EPA