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August 2005



At the time the documents for the preliminary cumulative risk assessment for the N-methyl carbamate pesticides were developed for the August 23 - 26, 2005 , Scientific Advisory Panel (SAP) meeting, the Agency was planning to hold a separate SAP meeting in September 2005 to discuss various issues regarding human studies. On August 2, 2005, the Appropriations Act covering EPA for FY 2006 was enacted which directed the Agency not to 'accept, consider, or rely on third-party intentional dosing human toxicity studies for pesticides, . . . until the Administrator issues a final rulemaking on this subject.' This law also calls for an accelerated schedule for rulemaking, to be completed within 180 days.

To focus on implementing this legislation, the Agency has decided not to hold the Scientific Advisory Panel (SAP) meeting that was tentatively scheduled for September 19-23. This meeting had been planned to obtain input on weight of evidence determinations for certain pesticides (mainly organophosphates and carbamates), including seeking input on both technical and ethical questions regarding third-party human toxicity studies. EPA has determined that this meeting is not necessary at this time since recent legislation restricts the Agency's consideration or use of data from human toxicity studies until rulemaking in this area is finalized. Consequently, any reference made in the N-methyl carbamate documents regarding the September SAP meeting should be disregarded.

Additionally, although the preliminary cumulative risk assessment for the N-methyl carbamate pesticides does not rely on, use or discuss data from human studies, human study data are contained in files for two of the pesticides (oxamyl and methomyl). This information should be disregarded as it has no relevance to the assessment.

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