Clomazone and Fomesafen Registration Review; Draft Ecological Risk Assessments

August 13, 2009 Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P) Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC 20460-001 Re: Docket # EPA-HQ-OPP-2006-0239 The National Potato Council (NPC) respectfully submits comments on the proposal for the herbicide fomesafen as well as the overall Registration Review process. The NPC represents more than 95 percent of the potato growers in the 34 states in the United States that produce commercial quantities of potatoes. The value of potato production in the United States exceeds $3.5 billion annually and that economic value is greatly increased as a result of further processing, packing, handling and retailing. Due to the diversity of pests and diseases that can reduce potato yield and quality, farmers must use a variety of management regimes to produce a marketable crop. The selection of management techniques relies on integrated pest management and treatment options. NPC is active in the Environmental Protection Agency's (EPA or Agency) Pesticide Environmental Stewardship Program (PESP) and yearly presents the NPC Environmental Stewardship Award to two growers who demonstrate exceptional success in reducing the risks to people, the land and non target plants and animals associated with crop protection activities. The Food Quality Protection Act (FQPA) requires the EPA to conduct a Registration Review of all pesticides registered for use in the United States on a rolling 15 year cycle. It is clear that the Registration Review process will focus on evaluating the risks from pesticide use on endangered species and their habitat. This evaluation will be difficult and require the development and refinement of risk assessment tools that scientifically identify the probability of adverse impacts on individual species and particular habitats. In many, if not all cases the deterministic Tier 1 risk assessment tools being employed do not incorporate methodologies with the necessary levels of sophistication. EPA needs to be cognoscente of the limitations of surrogate data when using that data to make assumptions on the possible impact of pesticide applications on species of plants and animals where those possible impacts may vary markedly from those on the species tested in a laboratory. Where data is insufficient or not sufficiently predictive of the possible impacts for the species in the field of particular concern, EPA should allow the registrants latitude to conduct additional reviews or studies and provide extended review timetables to acquire data that closely mirrors real world outcomes. EPA should strongly consider the use of Scientific Advisory Panels (SAP) to provide input on risk assessment methodologies, species impacts and appropriate mitigation techniques. The scientific questions that will be raised during the Registration Review process will be many and complex. Use of the SAP process in developing the methodology and structure for risk assessment and risk mitigation of the Registration Review process as it relates to species impacts allows broad scientific and stakeholder input. The Federal Insecticide, Fungicide & Rodenticide Act (FIFRA) requires a balancing of risks and benefits to determine the eligibility of a compound for registration where human health concerns are not the deciding factor. The consideration of benefits requires meaningful outreach to the agriculture community. The outreach process should be related both to deliberations on individual products and to discussions of the overall process and methodologies for determining risk and mitigation measures for all products subject to Registration Review. Currently, the Agency is required to go beyond the normal FIFRA requirements to evaluate environmental impacts and to ensure that decisions on pesticide registrations protect endangered species. The Endangered Species Act (ESA) requires EPA to consult with the National Marine Fisheries Service and the Fish and…

August 13, 2009 Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P) Environmental Protection Agency 1200 Pennsylvania Avenue, NW Washington, DC 20460-001 Re: Docket # EPA-HQ-OPP-2006-0239 The National Potato Council (NPC) respectfully submits comments on the proposal for the herbicide fomesafen as well as the overall Registration Review process. The NPC represents more than 95 percent of the potato growers in the 34 states in the United States that produce commercial quantities of potatoes. The value of potato production in the United States exceeds $3.5 billion annually and that economic value is greatly increased as a result of further processing, packing, handling and retailing. Due to the diversity of pests and diseases that can reduce potato yield and quality, farmers must use a variety of management regimes to produce a marketable crop. The selection of management techniques relies on integrated pest management and treatment options. NPC is active in the Environmental Protection Agency's (EPA or Agency) Pesticide Environmental Stewardship Program (PESP) and yearly presents the NPC Environmental Stewardship Award to two growers who demonstrate exceptional success in reducing the risks to people, the land and non target plants and animals associated with crop protection activities. The Food Quality Protection Act (FQPA) requires the EPA to conduct a Registration Review of all pesticides registered for use in the United States on a rolling 15 year cycle. It is clear that the Registration Review process will focus on evaluating the risks from pesticide use on endangered species and their habitat. This evaluation will be difficult and require the development and refinement of risk assessment tools that scientifically identify the probability of adverse impacts on individual species and particular habitats. In many, if not all cases the deterministic Tier 1 risk assessment tools being employed do not incorporate methodologies with the necessary levels of sophistication. EPA needs to be cognoscente of the limitations of surrogate data when using that data to make assumptions on the possible impact of pesticide applications on species of plants and animals where those possible impacts may vary markedly from those on the species tested in a laboratory. Where data is insufficient or not sufficiently predictive of the possible impacts for the species in the field of particular concern, EPA should allow the registrants latitude to conduct additional reviews or studies and provide extended review timetables to acquire data that closely mirrors real world outcomes. EPA should strongly consider the use of Scientific Advisory Panels (SAP) to provide input on risk assessment methodologies, species impacts and appropriate mitigation techniques. The scientific questions that will be raised during the Registration Review process will be many and complex. Use of the SAP process in developing the methodology and structure for risk assessment and risk mitigation of the Registration Review process as it relates to species impacts allows broad scientific and stakeholder input. The Federal Insecticide, Fungicide & Rodenticide Act (FIFRA) requires a balancing of risks and benefits to determine the eligibility of a compound for registration where human health concerns are not the deciding factor. The consideration of benefits requires meaningful outreach to the agriculture community. The outreach process should be related both to deliberations on individual products and to discussions of the overall process and methodologies for determining risk and mitigation measures for all products subject to Registration Review. Currently, the Agency is required to go beyond the normal FIFRA requirements to evaluate environmental impacts and to ensure that decisions on pesticide registrations protect endangered species. The Endangered Species Act (ESA) requires EPA to consult with the National Marine Fisheries Service and the Fish and…