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IR-4 Advisory #2003-03 April 25, 2003

Title: Conflicting Chemistries in IR-4 Studies

Issue/Question: Can IR-4 formalize a system to inform Field Research Directors (FRD) what chemistries might conflict with test substances used in IR-4 residue studies?

Background: IR-4 has not had a system by which FRD can be consistently, and in a timely manner, informed about conflicting chemistries for specific test substances; this issue comes up every year. Study Directors (SD) do not have any kind of master list of chemistries that conflict with test substances we use. For certain chemistries, the registrant provides the SD with specific materials that should not be used in a residue study with that test substance, and the SD specifies this requirement in the protocol. Other times, the registrant may require that plots to be treated with a particular test substance should be located in the field where this or similar compounds have not been applied for at least one year or more - this fact is also specified as a requirement in the protocol. Some within IR-4 have suggested that SD provide lists of conflicting chemistries along with protocols for each study.

Resolution: The most efficient means by which potential conflicting chemistry issues can be resolved, if not specifically addressed in a study protocol, is for FRD to provide to the SD the name(s) of specific maintenance products they need to use during their trial, and the SD can confirm acceptability. This way, the SD only needs to address the conflicting chemistry question on a case-by-case basis. If an FRD needs to make a quick decision about using a certain maintenance product (due to sudden appearance of a pest which needs to be controlled) and can't reach the SD, alternative contacts should be the Laboratory Research Director for the study, the chemistry coordinator at IR-4 headquarters, or the registrant contact identified in the protocol.

(This advisory re-emphasizes the response to this question in Item 67 in the San Antonio Results Document, dated 9/27/02.)

If you have any questions, please contact your Regional/ARS Field Coordinator or the appropriate Study Director for further guidance.


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