Evaluate BPA in rodent models to address data gaps related to potential low dose effects that have been identified by FDA/CFSAN and NTP. This analysis will help FDA assess the toxicities associated with exposure to BPA, a component in baby bottles and formula and food/water containers, and determine the appropriate safety levels for humans. This study is supported by an interagency agreement between NIEHS/NTP and FDA to support studies of mutual benefit to FDA and NIEHS/NIH.BPA is primarily used to make plastic bottles and metal-based food and beverage cans and is an endocrine disruptor which can mimic the body’s own hormones and may lead to negative health effects. Safety levels for humans are currently under review. It appears that greatest sensitivity to BPA is in early development. A reevaluation of the safety of BPA in light of recent research (which suggests adverse effects at lower levels than previously indicated) will contribute to the development and initiation of approved protocols.These data will address current controversies in the risk assessment of BPA. A major goal of the study is to provide a basis to initiate interaction among FDA, NTP, and academic scientists in a follow-up 2 year study to incorporate endpoints that may improve future evaluations of endocrine active agents.ON TRACKON TRACKmain1. Protocol concept reviewed by the TSSRC11/1/2009Completed11/1/2009main2. Develop protocol and complete the peer review (1)3/1/2010Completed3/1/2010main3. Obtain NCTR approval on the protocol6/1/2010Completed6/1/2010main4. Begin research6/1/2010Completed6/1/2010main5. Complete the assessment of research findings10/1/2011<i>(TBD)</i>On Trackmain6. Develop draft technical report, manuscript, and/or publication (2)12/1/2011<i>(TBD)</i>On Trackmain7. Complete the peer review (NCTR and other FDA researchers) of draft technical report, manuscript, and/or publication1/1/2012<i>(TBD)</i>On Trackmain8. Submit the draft technical report, manuscript, and/or publication to the document tracking system for NCTR Center Director approval3/1/2012<i>(TBD)</i>Not Yet Startedmain9. Obtain final approval of the technical report, manuscript, and/or publicationTBDNot Yet Startedmain10. Submit final technical report, manuscript, and/or publication to a scientific journal6/1/2012<i>(TBD)</i>Not Yet Startedmain11. Publish final technical report, manuscript, and/or publication10/1/2012<i>(TBD)</i>Not Yet Started(1) This protocol will evaluate a broad range of BPA doses in rodents treated orally during pregnancy followed by direct oral dosing of pups until they are young adults (90 days of age). The results of the study will be used to select doses for a long-term study (chronic study) that will evaluate effects into old age. In the current study, a variety of endpoints related to reproductive development, control of energy utilization (that is fat deposition), and general toxicity are being evaluated. The subsequent chronic study will involve collaboration with academic laboratories.(2) Manuscripts published to date: (1) Doerge, D.R., Twaddle, N.C., Vanlandingham, M., and Fisher, J.W. Pharmacokinetics of bisphenol A in adult and neonatal Sprague-Dawley rats. Toxicol. Appl. Pharmacol. 247, 158-165 (2010).; (2) Doerge, D.R., Twaddle, N.C., Vanlandingham, M., and Fisher, J.W. Pharmacokinetics of bisphenol A in adult and neonatal rhesus monkeys. Toxicol. Appl. Pharmacol. 248, 1-11 (2010).; (3) Twaddle, N.C., Churchwell, M.I., Vanlandingham, M., and Doerge, D.R. Quantification of deuterated bisphenol A in serum, tissues, and excreta from adult Sprague-Dawley rats using liquid chromatography with tandem mass spectrometry. Rapid Commun. Mass Spectrom. 24, 3011-3020 (2010).; (4) Doerge, D.R., Vanlandingham, M., Twaddle, N.C., and Delclos, K.B. Lactational transfer of bisphenol A in Sprague-Dawley rats. Repro. Toxicol. 199, 372-376 (2010).BPABisphenol ACFSANCenter for Food Safety and NutritionNTPNational Toxicology ProgramNIEHSNational Institute of Environmental Health SciencesNIHNational Institute of HealthTSSRCToxicology Study Selection and Review Committeehttp://www.fda.gov/AboutFDA/Transparency/track/ucm203296.htmFDA-TRACK NCTR Dashboardhttp://www.fda.gov/AboutFDA/Transparency/track/ucm252974.htmFDA-TRACK Research Glossary਍††਍਍਍਍਍਍਍