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Bt Plant-Incorporated Protectants October 15, 2001 Biopesticides Registration Action Document

a comprehensive assessment of whether all relevant data support such regulatory action, as part of a larger requirement that would also likely involve alternative host plants.

In addition, the Agency is mandating additional improvements to the current IRM programs that will require: 1) anyone purchasing Bt cotton to sign a grower agreement which contractually binds the grower to comply with the IRM program and that there will be a mechanism by the year 2003 by which every grower affirms their contractual obligations to comply with the IRM program, 2) an ongoing IRM education program, 3) an ongoing IRM compliance monitoring program including a third party compliance survey and mechanisms to address non-compliance, 4) and ongoing insect resistance monitoring program for each target insect pest, 5) remedial action plans to be implemented if resistance does develop, and 6) annual reporting of the IRM (and other) activities. No other pesticide products than the Bt crop products have such extensive IRM requirements.

4. Benefits

EPA believes that significant benefits accrue to growers, the public, and the environment from the availability and use of certain Bt plant-incorporated protectants. This section outlines how those benefits are defined and evaluated. Specific information on grower cost savings, increased yields, reduced conventional pesticide use, benefits to wildlife, etc. is presented by product. Direct benefits

to growers for all Bt products is estimated to be less than $350 million in 2000.

Major

environmental benefits occur through less insecticide use and improved product quality.

a. Bt Corn

In addition to assessing the risks from the use of Cry1Ab and Cry1F expressed in corn, EPA has evaluated the benefits from the use of these products. Direct grower benefits include improved yield and profitability, improved crop management effectiveness, reduction in farming risk, and improved opportunity to grow field corn in case of severe pest infestation. Total annual monetary grower benefits from the use of Bt field corn are less than $219 million annually. The magnitude of benefits for any year is largely a function of the level of lepidopteran insect pressure in that year. That is, other things being equal, the higher the insect pressure, the higher the benefits. The major environmental benefit is potential reduction in mycotoxins. EPA believes that use of Bt sweet corn would result in significant reductions in the use of chemical pesticides. However, the current use of Bt sweet corn is very low.

b. Bt Cotton

In addition to assessing the risks from the use of Cry1Ac expressed in cotton, EPA has evaluated the benefits from the use of this product. Direct grower benefits include reduced pesticide use, improved crop management effectiveness, reduced production costs, improved yield and profitability, reduction in farming risk, and improved opportunity to grow cotton in areas of severe pest infestation. Total monetary grower benefits from the use of Bt cotton are between $60 million

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