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Pesticide Registration

Determining the Number of Field Trials Required to Register Seed-Treatment Uses

Gathering data is necessary in order to support seed-treatment pesticide registrations. However, certain registration cases may require different amounts and types of data. This page has the guidance memo, decision trees and additional reference documents to help a manufacturer determine how many field trials are necessary to register seed-treatment uses.

On this page:

Reduced Residue Chemistry Data Requirements for Seed-Treatment Uses Memo

This memo describes the tiered approach and guidance EPA has developed for determining when the number of required field trials can be reduced to register seed-treatment uses.

In this effort to streamline manufacturer and agency resources, EPA, in collaboration with the Health Canada Pest Management Regulatory Agency (PMRA), analyzed seed-treatment residue data that have been submitted to EPA and PMRA.

This analysis showed that the amount of data required to support registration could be substantially reduced and still be protective of human health.

The outlined procedure and memo document supersedes EPA’s previous guidance  ("Classification of Seed Treatments as Food or Nonfood Uses," dated Oct. 28, 1999).

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Decision Trees

To help manufacturers understand the seed-treatment residue chemistry data requirements under the new guidance, EPA created two decision trees detailing the processes: one for potato seed treatments only and one for all remaining crops. A case study supporting the reduction in field trials was also conducted to demonstrate how the seed-treatment decision trees would affect the ultimate number of field trials required.

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Reference Documents

These documents include past EPA memos, previous guidance, and items referenced in the new guidance memo.

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