The following committee members were present at
the closed sessions of the event
Jonathan Samet (chair), Melvin Andersen, Jon Arnot, George Daston, David Dunson, Nigel Greene, Heather Patisaul, Kristi Pullen, Beate Ritz, Ivan Rusyn, Robert Tanguay, Justin Teeguarden, James Tiedje, Paolo Vineis, Michelle Williams, Fred Wright, and Lauren Zeise
The following materials (written documents) were
made available to the committee in the closed
sessions:
1. Food and Drug Administration. 2014. Toxicological Principles for the Safety Assessment of Food Ingredients; Public Meeting on Updates and Safety and Risk Assessment Considerations (Docket No. FDA-2014-N-1497). Federal Register 79(210):64603-64604.
2. Osterman, R. 2014. Food Safety Requirements: Applicable Legal Principles. Presentation at the Food Advisory Committee Risk assessments and susceptible life stages and populations, on December 16, 2014.
3. Mega, J. et al. 2014. Population and Personalized Medicine in the Modern Era. JAMA 312(19):1969-1970.
4. Ioannidis, J. et al. 2009. Researching Genetic Versus Nongenetic Determinants of Disease: A Comparison and Proposed Unification. Sci. Transl. Med. 1(7): 1-8.
5. Patel, C. and Ioannidis, J. 2014. Studying the Elusive Environment in Large Scale. JAMA 311(21):2173-2174.
6. Casey, W. 2015. A New Path Forward: The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and National Toxicology Program’s Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM). Journal of the American Association for Laboratory Animal Science. 54(2): 170-172.
7. Joint Research Center. 2014. EURL ECVAM Status Report on the Development, Validation and Regulatory Acceptance of Alternative Methods and Approaches (2013- April 2014) (Report EUR 26702 EN). Luxembourg: Publications Office of the European Union.
8. Patlewicz, G. 2015. Building scientific confidences in the development and evaluation of read-across. Regulatory Toxicology and Pharmacology 72: 117-133. Submitted to the committee by Tina Bahadori on May 28, 2015.
9. Balshaw, D. 2015. NIEHS: Transforming Exposure Science. Presentation to the Committee on Incorporating 21st Century Science into Risk-Based Evaluations, on June 4, 2015, in Washington, DC.
10. Patel, C. 2015. Integrating clinical, environmental, and genomic data streams for precision medicine. Presentation to the Committee on Incorporating 21st Century Science into Risk-Based Evaluations, on June 4, 2015, in Washington, DC.
11. Casey, W. 2015. Validation of Next-Generation Alternative (Non-Animal) Toxicity Approaches. Presentation to the Committee on Incorporating 21st Century Science into Risk-Based Evaluations, on June 4, 2015, in Washington, DC.
12. Becker, R. 2015. Developing Scientific Confidence in 21C Risk Assessment Approaches. Presentation to the Committee on Incorporating 21st Century Science into Risk-Based Evaluations, on June 4, 2015, in Washington, DC.
13. Patlewicz, G. et al. 2015. Proposing a scientific confidence framework to help support the application of adverse outcome pathways for regulatory purposes. Regulatory Toxicology and Pharmacology 71: 463-477. Submitted to the committee by Richard Becker on June 4, 2015.