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Phase II: Evaluation of ECOFRAM Results and Development of Implementation Options
Initiative to Revise EPA's Pesticide Ecological Assessment Process
U.S. Environmental Protection Agency, Washington, D.C.
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Implementation Team
Once ECOFRAM has completed their final reports, EFED will form an Implementation Team. This team will be composed of a cross-section of EFED scientists experienced in the environmental risk assessments of pesticides. Other OPP divisions will also be asked to participate.
They will be responsible for:
Preparing a technical report summarizing their evaluation and review of the ECOFRAM reports;
Developing options for implementing probabilistic tools and methods based on their conclusions;
Identifying and coordinating additional developmental work, research, and validation;
Organizing peer reviews,
Training, and
Continuing outreach activities.
Technical Report
The Implementation Team will be responsible for OPP's internal technical review of the ECOFRAM reports. This review should include the following:
Comparison and evaluation of ECOFRAM's proposed aquatic and terrestrial assessment methods;
Comparison with the current assessment process;
Summary of proposed changes that can be implemented rapidly, require further development, and are not feasible or appropriate;
Discussion of additional developmental, research, and validation needs; and
Discussion of changes and/or additions to guidelines, standard evaluation procedures, and data requirements.
Implementation Options
Based on the conclusions of their technical review, the Implementation Team will develop implementation options. These will:
Consider how to integrate probabilistic approaches into OPP's current ecological assessment processes;
Describe options to phase-in the new processes;
Discuss mechanisms to encourage additional developmental work, answer research questions, and validate new processes;
Identify the steps and processes to change data requirements guidelines, etc.;
Outline proposals for peer review, training, and outreach; and
Propose a timeline for implementation.
Developmental Work, Research, and Validation
The Implementation Team will need to discuss and consider the following:
Additional developmental work, such as further model development and case studies to test concepts and identify strengths and weaknesses of proposed methods and techniques;
Research needs for evaluating terrestrial risk, such as better defining the distribution of variables, including environmental residues, decline curves, food ingestion rates, and pesticide elimination rates; describing the functional relationship between laboratory and field effects; dose/response reproductive tests; and others;
Research needs for aquatic risk, such as models of tissue residue concentration and effects, guidelines for laboratory toxicity tests with time- varying exposures, general principles for evaluating time-varying exposure- response, and others; and
Validation work, such as evaluating the various functions identified in the model to see if they represent actual field responses and if model predictions are in reasonable agreement with observed field effects.
Peer Review
Potential revisions to the assessment process must receive the appropriate level of critical peer review. The Implementation Team will need to consider at what stage(s) peer review would be appropriate and the best peer review approach. For example, they may consider:
Letter reviews of the Technical Report and Implementation Plan, possibly before an SAP review;
SAP meeting, possibly organized as a joint SAP/Scientific Advisory Board meeting, to discuss the Technical Report and Implementation Plan; and/or
Other options, such as a peer review workshop.
Training
Various levels of training will need to be developed once decisions have been made regarding changes to the assessment process. The Implementation Team will need to discuss the best approach for training various groups, such as risk assessors, risk managers, and stakeholders.
Risk assessors will need training on all aspects of the new processes.
Risk managers will need some technical training, especially on the interpretation of assessment results, assumptions, limitations, and level of certainty. The Implementation Team will need to work closely with risk managers to devise the best training program to suit their needs.
Stakeholders may also be interested in training, and the Team will need to consider the best approach to use for stakeholders, such as a public workshop, short courses during professional meetings, or other approaches.
Outreach
To maintain an open and transparent process, EFED plans to keep the public and the scientific community informed on the progress of the Implementation Team. Several options are available to achieve this.
The public --
Continued updates to the PPDC and SFIREG
Opportunity for public comment on proposed implementation plan
Scientific community --
Continued participation in nationally and internationally recognized meetings
All --
Maintaining the home page
Holding workshops
Acknowledgements
We would like to thank ECOFRAM participants, who have volunteered their time and scientific expertise for their support in this initiative. We would also like to thank the members of EFED, who have reviewed and provided thoughtful comments on the documents from which this presentation was derived. Finally, we would like to acknowledge Jim Cowles, EFED, for his technical assistance and kind support in developing this poster presentation.