FIFRA Scientific Advisory Panel Minutes No. 21015-04. A set of scientific issues being considered by the Environmental Protection Agency regarding integrated endocrine bioactivity and exposure-based prioritization & screening

Authors: JENKINS, FRED - Environmental Protection Agency (EPA); BARR, DANA - Emory University; BERROCAL, VERONICA - University Of Michigan; BROWN, TERRY - Johns Hopkins University; DELCLOS, KENNETH - Us Food & Drug Administration (FDA); DENVER, ROBERT - University Of Michigan; DOERGE, DANIEL - Us Food & Drug Administration (FDA); JETT, DAVID - National Institute Of Health (INSA); MCMANAMAN, JAMES - University Of Colorado; PERKINS, EDWARD - Us Army Corp Of Engineers (USACE); Potter, Thomas; PROPPER, CATHERINE - Northern Arizona University; SCHLENCK, DANIEL - University Of California; WELLER, GRANT - Savvysherpa, Inc

Submitted to: Government Publication/Report
Publication Type: Government Publication
Publication Acceptance Date: 3/3/2015
Publication Date: 3/3/2015
Citation: Jenkins, F., Barr, D.B., Berrocal, V., Brown, T., Delclos, K., Denver, R., Doerge, D., Jett, D., Mcmanaman, J., Perkins, E., Potter, T.L., Propper, C., Schlenck, D., Weller, G. 2015. FIFRA Scientific Advisory Panel Minutes No. 21015-04. A set of scientific issues being considered by the Environmental Protection Agency regarding integrated endocrine bioactivity and exposure-based prioritization & screening. Government Publication/Report. http://www.epa.gov/scipoly/sap/meetings/2014/120214meeting.html#minutes.

Interpretive Summary: USEPA convened a panel of fourteen experts to evaluate the strengths and weaknesses of their proposed approach to use “Integrated Endocrine Bioactivity and Exposure-Based Prioritization and Screening” methods that can assist the agency in identifying and prioritizing chemicals for testing under the agency’s Endocrine Disruptor Screening Program (EDSP). The agency’s high throughput testing framework and approaches assessing potential exposures was described. It is anticipated that the methods will be used to prioritize chemicals for testing under the EDSP. This report summarizes the panel’s evaluation of the agency’s methodology and provides recommendations identifying both strengths and limitations. The agency will use the report to guide further refinement of the proposed framework and in development of new regulations and procedures to evaluate chemical exposure risks.

Technical Abstract: On December 2-4, 2014, the US Environmental Protection Agency convened a public meeting of the FIFRA Scientific Advisory Panel (SAP) to address scientific issues associated with the agency’s “Integrated Endocrine Bioactivity and Exposure-Based Prioritization and Screening” methods. EPA is proposing to use these methods to identify pesticides and other chemicals that may require further testing to determine their potential to cause endocrine disruption. The Panel provided recommendations to EPA though responses to charge questions in 3 topic areas: 1) estrogen bioactivity, 2) androgen bioactivity, and 3) Integrated Bioactivity Exposure Ranking (IBER). There was consensus among Panelists that the agency’s methods were well founded and scientifically sound. However the Panel was concerned about the potential effects of weighting (or the lack of it) on the integration of different assay results in estrogen and androgen activity testing programs. The need for evaluating error propagation in assessing uncertainties in computations was also identified. In the case of exposure assessments, there was concern about the model’s failure to specifically address workplace environments and impacts on highly sensitive groups such as pregnant and lactating women and infants. Further clarification and additional development in these and other topic areas were recommended prior to use of these methods for their identified purpose.