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Croplife files petition on EPA screening program

CropLife America (CLA), the nation's largest trade organization for promoting the safe and responsible use of crop protection products and its industry, has filed a formal petition with the Environmental Protection Industry (EPA) requesting further examination and explanation of the agency's soon to be implemented Endocrine Disruptor Screening Program (EDSP) and its processes.

CLA is filing this petition to help keep the EDSP on schedule and ensure that EPA takes into consideration the unique aspects of conventional pesticide regulatory requirements as they intersect with the endocrine screening regulatory process.

"It's paramount that EPA's endocrine program is scientifically sound," said Jay Vroom, CLA president and CEO. "We have been closely involved with the EPA's endocrine screening science and policy development for a dozen years, and fundamentally believe that EPA is very much on the right track with the EDSP. However, as key EPA decision deadlines approach in August, we wanted to be absolutely clear about a number of unique aspects of pesticides regulatory data already in EPA's possession that, if correctly considered, will help keep the EDSP on schedule and advancing the overall goals of protection of public health and the environment."

Congress has mandated that EPA's endocrine screening program base its findings on "appropriate validated test systems and other scientifically relevant information" and "minimize duplicative testing."

CropLife emphasizes the need for EPA to demonstrate why existing and substantial data on the toxicity of pesticides, including data on reproductive and developmental toxicity, are not sufficient to meet the program's requirements and allow EPA to avoid the time consuming effort of examining more rudimentary tier one test data on pesticides.

The petition in part requests that EPA perform the necessary economic analyses that would highlight the cost to industry and inform the public of the program's current direction.

CLA advocates that prior to initiation of the EDSP, EPA carry out the following recommendations to ensure best practices are put in place:

• Comply with the congressional mandate to minimize unnecessary and redundant testing by reviewing data already submitted by pesticide registrants through established scientific practices using a flexible, case-by- case approach before issuing test orders or else fully explain why those existing data are inadequate.

• Fully validate both individual assays and assay batteries required under the program, including greater efforts to minimize false results.

• Develop protocols for interpreting, evaluating and prioritizing screening data to determine whether additional testing would be required.

• Finalize how any additional testing will be conducted and how those data are to be interpreted.

• Prepare a regulatory flexibility analysis and develop alternative procedures to reduce the Program's burden on small businesses.

• Prepare a regulatory impact analysis to ensure the program is implemented in the most cost-effective and least burdensome manner.

"We ask that EPA detail how the EDSP will be implemented well in advance of test orders so that stakeholders, including the pesticide and the rest of the chemical industries, food and agricultural sectors, and the nation as a whole, have a clear understanding of the process," said Vroom.

"We believe that EPA already has the data they need to successfully implement this program for pesticides and that the current proposal could place unnecessary financial, time, and resource burdens on our industry, EPA, and society," added Vroom. "We think the answers to our petition issues will head-off such possibilities, and keep the program on track and on schedule."

Established in 1933, CropLife America ( represents the developers, manufacturers, formulators and distributors of plant science solutions for agriculture and pest management in the United States. CropLife America's member companies produce, sell and distribute virtually all the crop protection and biotechnology products used by American farmers.

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