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.

• Reduced Residue Chemistry Data Requirements for Seed-Treatment Uses Memo
• Decision Trees
• Reference Documents

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Reduced Residue Chemistry Data Requirements for Seed-Treatment Uses Memo

• 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).

Decision Trees

• Potato Seed Treatment Decision Tree 
• All Other Remaining Crops Decision Tree

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.

Reference Documents

• "OECD Guidelines for the Testing of Chemicals: Crop Field Trial" 
• “Guidelines for Reduced Residue Field Trial Requirements to Support Joint Projects Between Canada and the United States”

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

• Reduced Residue Chemistry Data Requirements for Seed-Treatment Uses Memo (pdf) (578.4 KB, January 26, 2018)
• Potato Seed Treatment Decision Tree (pdf) (469.82 KB, January 26, 2018)
• All Other Remaining Crops Decision Tree (pdf) (367.56 KB, January 26, 2018)
• Classification of Seed Treatments as Food or Nonfood Uses (pdf) (62.69 KB, October 28, 1999)
• Acres Planted per Day and Seeding Rates of Crops Grown in the United States (pdf) (2.15 MB, November 10, 2010)