To direct the Administrator of the Environmental Protection Agency to conduct a review of all third party intentional human dosing studies to identify or quantify toxic effects.

SA 1068. Mr. BURNS (for himself, Mr. Chambliss, Mr. Inhofe, and Mr.
Brownback) proposed an amendment to the bill H.R. 2361, making
appropriations for the Department of the Interior, environment, and
related agencies for the fiscal year ending September 30, 2006, and for
other purposes; as follows:

On page 200, after line 2, add the following:
Sec.  . (a) The Administrator of the Environmental
Protection Agency shall conduct a thorough review of all
third-party intentional human dosing studies to identify or
quantify toxic effects currently submitted to the Agency
under FIFRA to ensure that they:
(1) address a clearly defined regulatory objective;
(2) address a critical regulatory endpoint by enhancing the
Agency's scientific data bases;
(3) were designed and being conducted in a manner that
ensured the study was adequate scientifically to answer the
question and ensured the safety of volunteers;
(4) was designed to produce societal benefits that outweigh
any anticipated risks to participants;
(5) adhered to all recognized ethical standards and
procedures in place at the time the study was conducted; and
(6) are consistent with section 12(a)(2)(P) of the Federal
Insecticide, Fungicide, and Rodenticide Act and all other
applicable laws.
(b) The Administrator shall, within 60 days of the
enactment of this Act, report to the House and Senate
Committees on Appropriations; the Senate Committee on
Agriculture, Nutrition and Forestry; and the House Committee
on Agriculture on the results of the review required under
subsection (a) and any actions taken pursuant to the review.
(c) Within 180 days of the enactment of this Act, the
Administrator shall issue a final rule that addresses
applying ethical standards to third party studies involving
intentional human dosing to identify or quantify toxic
effects.
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