Email Correspondence between Robert Mitkus, Toxicologist, HED and Dana
Vogel, Branch Chief RAB1/HED, in Regard to Acute and Subchronic
Neurotoxicity and Functional Immunotoxicity Testing Data Gaps:

From:	Robert Mitkus/DC/USEPA/US

To:	Dana Vogel/DC/USEPA/US@EPA

Date:	03/03/2009 12:28 PM

Subject:	Re: Fw: immunotoxicity and neurotoxicity studies and FR Notices




Hi Dana, I've gone through the etoxazole database and modified the
language for the FR.

Rob

a. EPA began requiring functional immunotoxicity testing of all food and
non-food use pesticides on December 26, 2007.  Since this requirement
went into effect after the tolerance petition was submitted, these
studies are not yet available for etoxazole.  In the absence of specific
immunotoxicity studies, EPA has evaluated the available etoxazole
toxicity database to determine whether an additional database
uncertainty factor is needed to account for potential immunotoxicity. 
No evidence of immunotoxicity was found.  Due to the lack of evidence of
immunotoxicity for etoxazole, EPA does not believe that conducting
immunotoxicity testing will result in a NOAEL less than the cRfD NOAEL
of 4.62 mg/kg bw/day already established for etoxazole, and an
additional factor (UFDB ) for database uncertainties is not needed to
account for potential immunotoxicity. 

b. Acute and subchronic neurotoxicity testing is also required as a
result of changes made to the pesticide data requirements in December of
2007.  Although neurotoxicity studies have not yet been submitted, there
is no evidence of neurotoxicity in any study in the toxicity database
for etoxazole.  Therefore, EPA has concluded that an additional
uncertainty factor is not needed to account for the lack of these data.

