EPA rule for human testing is criticized

EPA is for the first time establishing criteria under which it will allow human subjects to be used for pesticide exposure tests. The rule, to be issued by Jan. 29, was leaked to several legislators by a concerned government official, according to Sen. Barbara Boxer (D-Calif.), who received a prepublication copy. The major criticism of the regulation is that it would permit pesticide testing on pregnant women, infants, and children. For example, the rule apparently allows pesticide makers to use pregnant women and children in exposure studies if the tests are not intended to be submitted under one of the two pesticide laws. Also, pregnant women and children can be dosed with pesticides on foods up to the tolerance level for those foods, which may be far above the background level to which the general population is exposed. The rule requires that a Human Studies Review Board be set up to review study protocols, as recommended by the National Research Council, but the board would serve an advisory role only and have no power to veto studies or require changes. In August 2005, Congress passed a ban on accepting human pesticide tests until EPA enacted strict ethical standards. Boxer and the other members of Congress who saw the rule have called on EPA Administrator Stephen L. Johnson to "fix" the regulation.