BIT Cancer Study Data Waiver Request Meeting Minutes

July 16, 2008

Room S-8100

2:00 – 3:30 PM

See sign-in sheet for attendees

Representatives from Rohm & Haas and Arch Chemicals requested a meeting
with the Agency to discuss a proposed data waiver request for the
benzylisothiazolone (BIT) chronic cancer study that the Agency has asked
for via the Data Call-In (DCI) process.  The DCI for BIT was issued in
March 2008.

Rohm & Haas and Arch Chemicals would like to use a weight-of-evidence
approach similar to what was submitted for
4,5-Dichloro-2-n-octyl-3(2H)-isothiazolone (DCOIT) when used as a wood
preservative with BIT when used in metal working fluids. 

Arch Chemicals has submitted toxicology studies on other isothiazolones
(ITAs) to the Agency. The other ITAs include chloromethylisothiazolone
(CMIT), methylisothiazolone (MIT), and octylisothiazolone (OIT). 

The Agency asked that the registrants submit their data waiver request
for the BIT chronic cancer study with their 90-day response to the DCI. 
The BIT data waiver request will be evaluated by the Agency and a
response will be issued.  

The registrants asked to meet again with the Agency in October 2008
after their formal data waiver request is submitted.

