Meeting Summary

EPA/Osmose Inc.

October 13, 2010, 11:00 AM to 12:00 PM

Room S-8721, 2777 S. Crystal Drive, Arlington, VA 22202

Participants

Osmose Inc.: Teri Muchow, John Butala

EPA: Nader Elkassabany, Tim Leighton, Mark Hartman, Tim McMahon,
Jonathan Chen, Lance Wormell, Jessica Ryman, Rebecca von dem Hagen

Summary

On Wednesday, October 13, 2010 AD hosted a meeting with sodium fluoride
registrant Osmose Inc.  Osmose Inc. requested this meeting to discuss
the 90-day dermal toxicity data requirement issued in the February 2010
post-RED DCI.  During the meeting, Osmose presented an overview of the
dermal risk assessment performed for the 2007 RED and proposed that a
dermal absorption study be performed and used in conjunction with the
existing oral toxicity study in place of the 90-day dermal toxicity
study currently required.  Osmose believes a dermal absorption study
would be appropriate in lieu of a 90-day dermal toxicity study because
the dermal absorption study would have the ability to address the
absorbed dose via the appropriate route of exposure while also using
fewer animals and saving resources.  After additional discussion on the
risk picture, the Agency suggested that the registrant first determine
the level of worker exposure based on the required label mitigation.  If
it is determined that label mitigation sufficiently reduces worker
exposure, then the Agency may determine that refining the existing 100%
dermal absorption rate is not necessary.

Next Steps

Osmose will work with EPA to develop an observational worker exposure
monitoring study.  Based on the outcome of the worker exposure study,
the Agency will determine if the 100% dermal absorption rate needs to be
refined by either a dermal absorption or a 90-day dermal toxicity study.

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