Process for Improving FIFRA Tools and Methodologies for Evaluating Ecological Risk
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 for screening, the Panel indicated that OPP's methods were deterministic for assessing the effects of pesticides to non-target organisms and suggested moving to 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 Panel also identified several areas in the assessments that could be expanded to present a more complete perspective or characterization of the potential environmental risk for the pesticides examined. They asked OPP to examine the steps in the risk assessment process that include extrapolation and to consider reinstating field testing. They strongly encouraged field research to validate any models used in the assessment process and to support any new models or methodologies that are developed.
The recommendations of the SAP reaffirm OPP's dedication to improving its ecological assessments. Since 1988, OPP has reviewed its ecological 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 identified and considered many of the areas identified by the SAP, including the need for probabilistic tools and methods, the uncertainties associated with extrapolation, improved risk characterization, the need for field testing and validation.
More recently, OPP, 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 provided several recommendations.
Following the recommendations of the SAP and building on the work of the above mentioned projects, OPP has begun 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 stremgthen the core elements of the ecological assessment process, including those addressed by the SAP, by developing and validating probabilistic assessment tools and methodologies. These methodologies are intended for use by OPP for evaluating effects of pesticides to terrestrial and aquatic species and will be developed within the context of the FIFRA regulatory framework, including 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, OPP 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, OPP 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 has been formed that will address ecological issues and will be involved as the initiative develops. In addition, OPP has made a presentation to the State FIFRA Issues Research and Evaluation Group and circulated related documents for their information.
OPP has also contacted representatives of environmental groups, such as the World Wildlife Fund, National Fish and Wildlife Foundation, Environmental Working Group, Citizen Action, and others to inform them of this initiative and solicit their involvement. In addition, OPP has contacted other potential participants recommended by these organizations.
II. Basic Process
The basic process that will address the SAP's comments includes the Ecological Committee on FIFRA Risk Assessment Methods (ECOFRAM), workshops, outreach, and additional consultations with the SAP. This short summary provides a review of the basic process.
A. The ECOFRAM
The ECOFRAM is responsible for conducting the primary review of the current assessment process and developing new tools and methodologies. In addition, the ECOFRAM will identify additional methods, development and validation needs to ensure that the assessment process supports environmental decisions that are scientifically defensible.
The ECOFRAM is divided into two workgroups: one for terrestrial assessment and one for aquatic. These workgroups are further divided into exposure and effects sub-groups. The Aquatic and Terrestrial Workgroups have approximately 20 members each. They are expected to meet 6 to 10 times during their tenure of 9 to 12 months and a substantial time commitment will be required between meetings.
The ECOFRAM members are experts drawn from government agencies, academia, environmental groups, industry, and other stakeholders. 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.
On June 24 - 25, the first meeting of ECOFRAM took place. This meeting provided the foundation for their efforts and included general discussions regarding vision, problem statement and charge to workgroups (Attachments 2, 3, and 4). A session on problem formulation was held as well. The meeting concluded with the Workgroups beginning to develop their plans for identifying and developing tools and methodologies for probabilistic assessments.
Three workshops will be held during the process. The first workshop, Evaluating Ecological Risk: Developing FIFRA Probabilistic Tools and Processes, was held on June 23. This was 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 was held as well. The purpose of this discussion was to outline the types of questions risk managers pose when making a regulatory decision involving ecological risk and to discuss how improved methods could address these questions.
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 obtain an objective, critical peer review of the results by scientific and technical participants. Following this meeting, the ECOFRAM will consider the peer review comments made and revise their results, as appropriate.
The third workshop will occur some time during the Summer of 1998. This will be an open meeting similar to the first workshop that was held. The purpose will be for the ECOFRAM to share the results of their efforts and present their recommendations. A panel discussion with risk managers is envisioned, in which risk managers will discuss their thoughts on the improved risk characterizations and how these characterizations will improve the decision-making process.
OPP will consult with the SAP during the meeting scheduled for September 1997. The focus of this consultation is to apprise the SAP of the status of OPP's initiative to address their comments and to obtain recommendations from the SAP on the process being followed.
In addition, OPP plans to return to the SAP after the initial effort 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.
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 in the Fall of 1997. These include such groups as the Society for Environmental Toxicology and Chemistry and American Chemical Society. Although the Workgroups will not have completed their tasks by Fall, they will have initiated their efforts and should present papers and participate in symposia outlining their progress and plans. Presentations will continue throughout the entire process.
In addition, OPP plans to continue presentations to the Pesticide Program Dialogue Committee and the State FIFRA Issues Research and Evaluation Group.
A general timeline is outlined in Attachment 5. OPP anticipates completing the process during the Winter of 1998 and implementing the use of new tools and processes in the Spring of 1999.
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
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
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.
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.
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. The methods developed should consist of standardized procedures that integrate estimates of pesticide exposure with knowledge about the potential adverse effects. The methods should account for sources of uncertainty. In addition, the methods must be developed within the context of the FIFRA regulatory perspective and following the outline provided by the Framework for Ecological Risk Assessment (U.S. EPA, 1992).
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 work group participants. While recognizing that varying opinions of terminology exist, for the purpose of this project, the attached terms and definitions are adopted.
U.S. Environmental Protection Agency. 1992. Framework for Ecological Risk Assessment. Office of Research and Development. EPA/630/R-92/001.
|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 24-50, 1997 - January, 1998|
|Consultation with the Scientific Advisory Panel||September, 1997|
|Presentations During Professional Meetings||Fall/Winter, 1997|
|Peer Review Workshop||Summer, 1998|
|Outreach Workshop||Fall, 1998|
|SAP Review of Proposed Ecological Risk Assessment Improvements||Winter, 1998|
|OPP Implements Use of New Tools and Processes*||Spring, 1999|