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News Releases issued by the Office of Chemical Safety and Pollution Prevention

 

Bans on Human Studies Extended to Nursing Women

Release Date: 06/23/2006
Contact Information: Enesta Jones, (202) 564-4355 / jones.enesta@epa.gov

(Washington, D.C. - Friday, June 23, 2006) EPA is issuing a direct final rule that bans using nursing women in intentional dosing research for pesticides. The final rule guarantees nursing women are not involved in human studies and provides protection to nursing infants who may also be exposed. EPA will not rely on data from previous studies that included nursing women. The new restrictions mirror the protections explicitly provided for studies involving pregnant women and children in the final rule issued by EPA in January 2006. This final rule banned all third-party intentional dosing research involving children and pregnant women intended for submission to EPA under the pesticide laws. More information on the regulation of human studies, the direct final rule and a parallel notice of proposed rulemaking are available at http://www.epa.gov/oppfead1/guidance/human-test.htm