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FOOD AND DRUG ADMINISTRATION - page 110 / 263

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DR. KIBBE:  Thank you.

DR. HAUCK:  If acceptable, I wanted to go back briefly to the question raised about the empty canister and the zero tolerance criterion.

DR. KIBBE:  Sure.  Enjoy yourself.

DR. HAUCK:  The problem with the zero tolerance criterion in the FDA draft proposal is it really impinges on normal variability.  That's what makes it sort of a guaranteed to fail sort of thing eventually.  You can imagine setting -- I should put a different name on it.  You can imagine setting some sort of, say, clinically acceptable limits or some much wider than that, saying if there really was a canister that had 10 percent in it or 300 percent in it, that we don't want that to be in a consumer's hands, and if by some stroke of luck that should show up in a sample, that would be a problem.  It would be a much wider type of zero tolerance and that sort of thing would probably not impinge on the producer risk in terms of normal variability.

DR. KIBBE:  Anybody else?  Gary?

DR. HOLLENBECK:  Is there a concern when the distribution is not normal?  Whoever would like to respond.

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