The purpose of the modification is to extend the response date until July 8th, and change the classification to Full and Open. All other terms and conditions
remain the same
USDA-APHIS-WS requires a set of product chemistry registration studies (following EPA’s study guideline
OPPTS 830.1700 [1]) to be completed on a manufacturing source of an active ingredient (sodium nitrite)
in accordance with Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Good Laboratory
Practices (GLPs) [2]. This study must characterize the active ingredient sodium nitrite, the major impurity
sodium nitrate, and loss on drying in each of the 5 batches.
As part of this contract, we will need the contract laboratory to produce GLP-compliant Certificates of
Analysis (CoA) for the two reference standards, sodium nitrite and sodium nitrate, that will be used in
the subsequent preliminary (5-batch) analysis study.