Bifenthrin Registration Review

Filed on regulations.gov — full text not in the inline record.

The following comments are offered on behalf of the potato growers represented by the National Potato Council (NPC). NPC's members produce more than 90% of the potatoes harvested in the U.S. every year with a farm gate value of more than $ 4 billion.That value is greatly increased through processing and other value-added activities. Potatoes have high production costs and are susceptible to yield losses from a variety of pests and diseases. Depending on the region of the country, per-acre production costs range from $3500 to over $4000. Thus, managing pest and disease risks including insect damage is a critical component of successfully producing a crop.The pyrethroid family of pesticides is essential for potato growers' pest management programs.. Potato growers utilize Integrated Pest Management (IPM) to identify economic treatment thresholds and rotate chemistries to extend the effective life of pesticides. The use of pyrethroids as a part of a comprehensive IPM program is critical to economically and effectively managing insect pests. Pyrethroids are relatively inexpensive and offer a broad-spectrum alternative to other insecticides.The targeted use of pyrethroids as a part of an IPM program can effectively reduce the pressure for resistance development. Pyrethroids are used on more than 14 million acres of crop land in the U.S. annually and more than sixty per cent of the potato acres receive one or more applications of a pyrethroid. The economic impact of the loss of the pyrethroids would be significant to potato producers. An analysis conducted by Aginfomatics estimates that the economic benefits from pyrethroid use on potatoes is $377 per treated acre. Currently one in five acres of potatoes are exported. Export markets are a key component of the overall economic wellbeing of the potato industry. Pyrethroids have a well-established set of Maximum Residue Limits (MRL) in all the key foreign markets. Continued use of the pyrethroid products will maintain competitiveness for growers focused on export market growth. Based on a review of the draft risk assessments it appears that the EPA analysis significantly over estimates the risk from the use of the pyrethroids and fails to utilize the best available science. We are aware of additional studies and more sophisticated modeling made available to the Agency by the Pyrethroid Working Group that is not incorporated into the draft risk assessment documents. We urge the Agency to incorporate those studies into the final risk assessment document. The EPA estimation of the risks associated with the use of pyrethroids on aquatic systems is a particularly relevant example of the consequences of failing to incorporate the best available science. The Agency's conclusions that there is a significant risk to aquatic systems is not justified by science or field observations. This is significant since the EPA-estimated risk to aquatic systems seems to be the rationale for potential restrictions on the use of pyrethroids beyond the current label requirements. We urge the EPA to revisit the analysis of the aquatic system risk by considering the following enhancements that are currently absent from the initial review: The Agency needs to incorporate the basic behavior of pyrethroid chemistry with water and with organic material into the risk analysis. Pyrethroids are hydrophobic and readily bond with organic material. The equilibrium status for pyrethroids is to have a very small fraction of its molecules freely dissolved in water and the clear majority of its molecules bonded to organic matter. Very little freely dissolved pyrethroids are available to aquatic organisms through the water. Equally important the ingestion of organic material by aquatic organisms is not a meaningful source of exposure. In the limited cases where aquatic organisms can absorb particles bound to organic material, the pyrethroids are metabolized and excreted quickly. Any concentrations in animal tissue w…

Filed on regulations.gov — full text not in the inline record.

The following comments are offered on behalf of the National Potato Council (NPC). The NPC represents ninety-five percent of the potato growers in the U.S. who collectively produce a potato crop valued at nearly $4 billion a year at the farm gate. The ability to protect their investment in that crop and to supply a safe high quality product to consumers is dependent on the ability to manage phytosanitary threats. In particular, potato growers have a very significant interest in the registration review being conducted by EPA for Cymoxanil and Mefenoxam fungicides. In general, the comment period was inadequate to fully address the complex issues surrounding these vital crop protection tools. We would hope that the agency would extend the comment period to allow stakeholders to comprehensively comment on this important information. The risk assessment submitted for comment by EPA is a screening level evaluation and fails to capture the complexities of actual use in the field and the impacts of mitigation measures being utilized on farms. It is our understanding that the various registrants of Pyrethroid insecticides have conducted additional studies and refinements to the current model that have not been utilized by EPA. In addition we question whether the current EPA modeling captures the positive effects of the current label requirements to reduce any negative impacts on aquatic and other species. A more refined model based on assumptions more closely matching real world application conditions and requirements would improve the accuracy of and confidence in regulatory decisions. Cymoxanil is used almost exclusively for late blight, the most devastating disease of potatoes in the U.S. It is one of the few fungicides registered on potatoes that can control established late blight infections. Most fungicides act preventatively and are effective only when applied before an outbreak occurs, so once an infection occurs, growers have few options for control of this widespread disease. However, cymoxanil works very quickly and its combination of curative ability and fast activity means it can control established late infections. Mefenoxam is a very important active ingredient for control of Pythium and pink rot. It is considered to be the most effective product for pink rot and is the standard for control of this widespread and devastating disease. There are not many alternative options for these diseases. Therefore, the use of mefenoxam is critical. The alternatives to mefenoxam (phosphoric acid-based fungicides) require multiple applications but are still less effective than a single application of mefenoxam. The industry has directed significant resources towards mefenoxam resistance management in order to retain the effectiveness of the product. Currently, mefenoxam is the only group 4 fungicide registered on potatoes. The National Potato Council looks forward to working with the Agency in the future in order to provide the most comprehensive and transparent review of these products.