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Background Information
Evaluating Ecological Risk: Developing FIFRA Probabilistic Tools and Processes May 22, 1997
Process for Developing Probabilistic Tools and Methodologies for Ecological Assessments
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Attachments
- Workshop Organizing Committee Members
- Vision Statement
- Problem Statement
- Charge to the Terrestrial and Aquatic Workgroups
- Timeline
Background
The FIFRA Scientific Advisory Panel (SAP) met for three days, May 29-31, 1996, to address several scientific issues regarding the Office of Pesticide Programs' (OPP) ecological risk assessments and guidelines. One of the major topics explored with the Panel was OPP's ecological risk assessment methods and procedures. OPP requested the Panel to review and comment on how this office could improve these methods and procedures.
While recognizing and generally reaffirming the utility of the current assessment process and methods, the Panel indicated that OPP has relied on deterministic methods of assessing the effects of pesticides to non-target organisms, rather than providing probabilistic assessments for the chemicals of concern. The Panel strongly encouraged OPP to develop and validate tools and methodologies to conduct probabilistic assessments of ecological risk.
The recommendation of the SAP reaffirms the Environmental Fate and Effects Division's (EFED) dedication to improving ecological assessments. Since the establishment of EFED in 1988, the Division has reviewed its risk assessment methodologies with the help of outside groups. Two of these groups included the Aquatic Dialogue Group and the Avian Effects Dialogue Group. These groups were facilitated through the Conservation Foundation (later named RESOLVE) and provided feedback on OPP's aquatic (Aquatic Effects Dialogue Group,1992) and terrestrial (Avian Effects Dialogue Group, 1989 and 1994) risk assessments. They also recognized the need for probabilistic tools and methods. More recently, EFED, in cooperation with the Society of Environmental Toxicology and Chemistry (SETAC), convened the Aquatic Risk Assessment and Mitigation Dialogue Group (Aquatic Risk Assessment and Mitigation Dialogue Group, 1994). This dialogue group addressed the issue of probabilistic assessments on the aquatic side and provi
Following the recommendations of the SAP and building on the work of the above mentioned projects, EFED is now beginning a new initiative to develop and validate tools and methodologies to conduct probabilistic assessments to address terrestrial and aquatic risk. The purpose of this initiative is to redesign the ecological assessment process by developing and validating probabilistic assessment tools and methodologies. These methodologies are intended for use by EFED for evaluating effects of pesticides to terrestrial and aquatic species and will be developed within the context of the FIFRA regulatory framework. They must also consider OPP resource and time constraints.
Recognizing the importance of involving stakeholders in redesigning its ecological risk assessment process, OPP initiated several channels for external involvement in this initiative. In September and October 1996, EFED met with representatives of the American Crop Protection Association (ACPA) and solicited ACPA's technical cooperation in this initiative. These meetings led to OPP and ACPA forming a joint planning committee (Workshop Organizing Committee or WOK, Attachment 1).
In November 1996 and in March 1997, EFED representatives met with the Pesticide Program Dialogue Committee (PPDC) to inform them of OPP's plans for addressing the ecological risk assessment issues raised by the SAP and to invite PPDC participation in OPP's efforts in this area. (The PPDC is EPA's formally chartered external advisory committee for pesticide program implementation.) A subcommittee of the PPDC is being formed that will address ecological assessment standards and will be consulted as the workshop development process continues.
EFED has also contacted representatives of environmental groups, such as the World Wildlife Fund, National Fish and Wildlife Foundation, Environmental Working Group, and Citizen Action to inform them of the workshop planning process and solicit their involvement. In addition, EFED is contacting other potential participants recommended by these organizations.
Basic Process
The WOK has designed a basic process to develop and validate probabilistic assessment tools and methodologies. This process includes The Ecological Committee on FIFRA Risk Assessment Methods (ECOFRAM), which will conduct the primary review and development of tools and methodologies. It also includes two workshops and public outreach and presentations. This short summary provides a review of the general process.
The ECOFRAM
The ECOFRAM will be responsible for identifying and developing probabilistic tools and methodologies. The ECOFRAM will be divided into two workgroups: one for terrestrial assessment and one for aquatic. These workgroups will be further divided into exposure and effects sub-groups.
ECOFRAM members will be experts drawn from government agencies, academia, environmental groups, industry, and other stakeholders and were identified on the basis of nominations from the WOK. Participants were selected based on expertise, affiliation, availability and other relevant information to ensure that the appropriate disciplines are represented along with a cross-section of affiliations.
The Aquatic and Terrestrial Workgroups will each have approximately 20 members. They are expected to meet 6 to 10 times during their tenure of 6 to 8 months and a substantial time commitment will be required between meetings.
In addition to identifying and developing probabilistic tools and methodologies, the ECOFRAM will identify developmental information and validation needs to ensure that the assessment process supports environmental decisions that are scientifically defensible.
Workshops
Two workshops will be held during the process. The first workshop, Evaluating Ecological Risk: Developing FIFRA Probabilistic Tools and Processes, is scheduled for June 23. This will be an open meeting with various stakeholders and technical experts to discuss the history and scope of the project, the current ecological risk assessment process, and the need for probabilistic assessments. A panel discussion with risk managers is planned as well.
Following the workshop, there will be closed technical meetings involving the Aquatic and Terrestrial Workgroups (ECOFRAM). These meetings will provide the foundation for their efforts and will include general discussions regarding vision, problem statement and charge to workgroups (Attachments 2 , 3, and 4). In addition, the Workgroups will outline their work plans for identifying and developing tools and methodologies for probabilistic assessments.
The second workshop will be held during the Spring of 1998. The purpose of this workshop will be for the Workgroups to share their results and to merge the work from the two workgroups.
SAP
EFED plans to request a consultation with the SAP during the meeting scheduled for September of this year. The focus of this consultation is to apprise the SAP of the status of EFED's initiative to address their comments and obtain recommendations from the SAP on the approach being followed.
In addition, EFED plans to return to the SAP after the process has been completed. The purpose of this meeting will be for the SAP to review and comment on the proposed tools and methods that have been identified and developed for ecological risk assessment.
Outreach
A key component of this process is outreach. To ensure maximum scientific exchange and discussion, the workgroups will participate in nationally recognized professional meetings beginning this Fall. These include such groups as SETAC and American Chemical Society. Although the Workgroups will not have completed their tasks by Fall, they will have met for approximately half of their tenure and should present papers and participate in symposia outlining their progress. Presentations will continue throughout the entire process.
In addition, OPP would like to ensure an open process for those that may be less technically oriented. As a result, the WOK plans to have sessions at both workshops that are suitable for both technical and non-technical participants. Additional outreach efforts such as presentations at the Pesticide Program Dialogue Committee and State FIFRA Issues Research and Evaluation Group are planned as well.
Timeframe
Although the process is still being developed, a general timeline has been outlined (Attachment 5). The WOK anticipates completing the process some time during the Fall of 1998.
References
Aquatic Effects Dialogue Group (1992) Improving Aquatic Risk Assessment Under FIFRA. Report of the Aquatic Effects Dialogue Group. RESOLVE, An Independent Program of World Wildlife Fund.
Aquatic Risk Assessment and Mitigation Dialogue Group (1994) FINAL REPORT. Society of Environmental Toxicology and Chemistry (SETAC) and SETAC Foundation for Environmental Education.
Avian Effects Dialogue Group (1989) Pesticides and Birds: Improving Impact Assessment. Report of the Avian Effects Dialogue Group, July 1989. Prepared by The Conservation Foundation.
Avian Effects Dialogue Group (1994) Assessing Pesticide Impacts on Birds. Final Report of the Avian Effects Dialogue Group, 1988 - 1993. RESOLVE, Center for Environmental Dispute Resolution.
Attachment 1
Workshop Organizing Committee Members
Edward Fite
Environmental Fate and Effects Division
Office of Pesticide Programs
Paul Mastradone
Registration Division
Office of Pesticide Programs
Ron Parker
Environmental Fate and Effects Division
Office of Pesticide Programs
Dana Spatz
Environmental Fate and Effects Division
Office of Pesticide Programs
Ann Stavola
Environmental Fate and Effects Division
Office of Pesticide Programs
Ingrid Sunzenauer
Environmental Fate and Effects Division
Office of Pesticide Programs
Jim Wolf
Environmental Fate and Effects Division
Office of Pesticide Programs
Dave Fischer
Bayer Corporation
Jim Gagne
American Cyanamid Company
Dennis Laskowski
Dow Elanco
Ray McAllister
American Crop Protection Association
Kevin Reinert
Rohm and Haas Company
Rick Stanton
Facilitator, Valent USA
Attachment 2
Vision Statement
The Office of Pesticide Programs accepts and adopts a new conceptual paradigm for ecological risk assessment. Based upon this, the workgroup will develop validated, flexible, probabilistic tools and processes for aquatic and terrestrial risk assessment and characterization for use by the Environmental Protection Agency (EPA) under the FIFRA regulatory framework. Tools and processes developed will incorporate recent advances in the science of risk assessment through an inclusive, participatory approach guided by the EPA Framework for Ecological Risk Assessment. Industry, government, and private resources will be intensively focused to develop and present a widely accepted process for formal approval by EPA at the earliest possible date.
Attachment 3
Problem Statement
In May of 1996 the Office of Pesticide Programs (OPP) presented two ecological risk assessment case studies to the FIFRA Scientific Advisory Panel (SAP) for comment on the methodologies used. The SAP offered a number of suggestions for improving the OPP ecological risk assessment process. Foremost among the suggestions was that OPP move beyond the present single point deterministic process of risk assessment and develop the tools and methodologies necessary to do a probabilistic assessment that addresses the magnitude of the expected impact as well as the uncertainty and variation involved in the provided estimates.
Attachment 4
Charge to the Terrestrial and Aquatic Workgroups
May 6, 1997
The ultimate goal of this initiative is to develop and validate risk assessment tools and processes that address increasing levels of biological organization (e.g., individuals, populations,communities, ecosystems), accounting for direct and indirect effects that pesticides may cause. Achieving this goal may require more that the limited resources and time available for the initial effort. Therefore, work groups will first address direct acute and chronic effects of pesticides on individuals and populations of high-risk species. The species considered first will be terrestrial vertebrates and aquatic vertebrates and invertebrates. Terrestrial invertebrates and terrestrial and aquatic plant species will be addressed subsequently, as resources permit.
Work groups are charged with developing a process and tools for predicting the magnitude and probabilities of adverse effects to nontarget aquatic and terrestrial species resulting from the introduction of pesticides into their environment. Th
The tools that are developed need to have reasonable scientific certainty and be capable of acceptable validation within a reasonable time frame. Nevertheless, model development, as a primary tool, may be limited by a less-than-complete understanding of ecological systems and by the ways that various direct and indirect effects of pesticides may be expressed at higher levels of biological organization. Probabilistic techniques developed should use existing fate and effects data where possible. However, in developing new methodologies and improving risk estimates, it may be necessary to modify or discontinue current tests or to develop new ones.
Methods developed for risk estimates should reflect a solid foundation in environmental toxicology and account for species sensitivity, environmental fate (including the transport,degradation, and accumulation of pesticides in the environment), and other variables. The type of pesticide formulation, application techniques, habitat types (e.g., estuary, pond, stream, field,forest), and species associated with these habitats need to be considered. The translation of residue estimates into exposure estimates and routes of exposure should be incorporated into the methodology.
Methods should be specific enough to allow different risk assessors supplied with the same information to estimate similar values of risk. The rationale for the choice of scenarios needs to be clearly stated. Assumptions and extrapolations need to be specified and explained so the significance of the ecological risk estimates provided by the methods is easily understood.
Finally, the workgroups are asked to define any additional developmental or validation efforts that are needed for the probabilistic methods developed. This will provide a firm scientific basis for use of the risk estimates by environmental decision makers.
A glossary of terms and definitions is attached as a common reference point for workgroup participants. While recognizing that varying opinions of terminology exist, for the purpose of this project, the attached terms and definitions are adopted.
References
U.S. Environmental Protection Agency. 1992. Framework for Ecological Risk Assessment. Office of Research and Development. EPA/630/R-92/001.
Attachment 5
Timeline
| Event | Date |
|---|---|
| Scientific Advisory Panel Meeting | May 29-31, 1996 |
| Briefing for Office Director | August 22, 1996 |
| SAP Issues Compared with ACPA Program Issues - Discussion Meeting with ACPA | September, 1996 |
| Initial Contact with ACPA Environmental Working Committee | October, 1996 |
| Presentation to the Pesticide Program Dialogue Committee | November, 1996 |
| Workgroup Organizing Committee Established | December, 1996 |
| Workgroup Organizing Committee Meeting with Senior Managers | February, 1997 |
| Presentation to the Pesticide Program Dialogue Committee | March, 1997 |
| Bi-Weekly Workgroup Organizing Committee Meetings | December, 1996 - April/May, 1997 |
| Evaluating Ecological Risk: Developing FIFRA Probabilistic Tools and Processes | June 23, 1997 |
| ECOFRAM Meetings | June 24-25, 1997 - January, 1998 |
| Consultation with the Scientific Advisory Panel | September, 1997 |
| Presentations During Professional Meetings | Fall/Winter, 1997 |
| Final Workshop | Spring 1998 |
| Scientific Advisory Panel Review of Proposed Tools and Processes for Ecological Risk Assessment | Summer, 1998 |
| OPP Implements Use of New Tools and Processes | Fall 1998 |
Incremental changes to current tools and processes may be adopted and implemented by OPP throughout the workgroup activities.