Improving Risk Analysis Approaches Used By the U.S. EPA

Closed

7th Meeting of the Committee on Improving Risk Analysis Approaches Used by the US EPA

September 27 - 28, 2007

Past

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Thomas A. Burke chair
A. John Bailer
John M. Balbus
Joshua T. Cohen
Adam M. Finkel
Gary Ginsberg
Bruce K. Hope
Jonathan I. Levy
Thomas E. McKone
Gregory M. Paoli
Dorothy E. Patton
Joseph V. Rodricks
Bailus Walker
Lauren Zeise

The following topics were discussed in the closed sessions:

1. Draft report chapters
2. Draft report findings and recommendations
3. Report timeline

The following materials (written documents) were made available to the committee in the closed sessions:

1. Rhomberg, L.R. 2007. Hypothesis-based weight of evidence: An approach to hazard identification and to uncertainty analysis for quantitative risk assessment. Submitted to the National Research Council Committee on Improving Risk Analysis Approaches Used by the US EPA. Aerospace Industries Association Pp. 1-23.

Date of posting of Closed Session Summary:

October 02, 2007

Contact

Morgan Motto

202-334-2818
mmotto@nas.edu

Location

Keck Center

500 5th St NW

Washington DC 20001, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Closed

6th Meeting of the Committee on Improving Risk Analysis Approaches Used by the US EPA

July 16 - 17, 2007

Past

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Thomas A. Burkechair
A. John Bailer
John M. Balbus
Joshua T. Cohen
Roger M. Cookevia telephone
Adam M. Finkel
Gary Ginsberg
Bruce K. Hope
Jonathan I. Levy
Thomas E. McKone
Gregory M. Paoli
Dorothy E. Patton
Joseph V. Rodricks
Terry F. Yosie
Lauren Zeise

The following topics were discussed in the closed sessions:

1. Draft report chapters
2. Draft report findings and recommendations
3. Report timeline

The following materials (written documents) were made available to the committee in the closed sessions:

1. Crawford-Brown, D.J. and K.G. Brown. 1992. Hazard Identification In Carcinogen Risk Analysis: An Integrative Approach. U.S. Environmental Protection Agency. October 1992, Pp. 1-225. Rhomberg, L. 2007. Handout Presentation Slides. Hypothesis Based Weight of Evidence and its Bearing on Uncertainty Analysis in Risk Assessment. June 12, 2007.

2. Crawford-Brown, D.J., J.R. Arnold, and K.G. Brown. 1994. Hazard Identification In Carcinogen Risk Analysis: An Integrative Approach, Part III An Application of the Methodology: Formaldehyde In Air. U.S. Environmental Protection Agency. April 1994, Pp. i-262.

Date of posting of Closed Session Summary:

July 25, 2007

Contact

Morgan Motto

202-334-2818
mmotto@nas.edu

Location

J. Erik Jonsson Woods Hole Center

314 Quissett Avenue

Woods Hole MA 02543, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Closed

5th Meeting of the Committee on Improving Risk Analysis Approaches Used by the US EPA

June 11 - 12, 2007

Past

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Thomas A. Burke chair
A. John Bailer
John M. Balbus
Joshua T. Cohen
Roger M. Cooke via telephone
Adam M. Finkel
Gary Ginsberg
Bruce K. Hope
Jonathan I. Levy
Thomas E. McKone
Gregory M. Paoli
Dorothy E. Patton
Joseph V. Rodricks
Terry F. Yosie
Lauren Zeise

The following topics were discussed in the closed sessions:

1. Draft report chapters
2. Draft report findings and recommendations
3. Report timeline

The following materials (written documents) were made available to the committee in the closed sessions:

1. Visual aids used for the following presentations 06-11-2007:
     a. Rhomberg, L. 2007. Handout Presentation Slides. Hypothesis Based Weight of Evidence and its Bearing on Uncertainty      Analysis in Risk Assessment. June 12, 2007.
     b. Silkworth, J.B. 2007. Handout Presentation Slides. USEPA Reducing the Uncertainties of Interspecies Extrapolation. June 12,      2007.
     c. Sass, J. 2007. Handout Presentation Slides. Improving Risk Analysis Approaches Used By the U.S. EPA: An NGO      Perspective. June 12, 2007.
     d. Fenner-Crisp, P. 2007. Handout Presentation Slides. Determining the Human Relevance of Modes of Action in Other)      Animals. June 12, 2007.

2. Krewski, D., K. Bakshi, R. Garrett, E. Falke, G. Rusch, and D. Gaylor. 2004. Development of acute exposure guideline levels for airborne exposures to hazardous substances. Regul Toxicol Pharmacol. 39:184–201

Date of posting of Closed Session Summary:

June 25, 2007

Contact

Morgan Motto

202-334-2818
mmotto@nas.edu

Location

Keck Center

500 5th St NW

Washington DC 20001, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Closed

4th Meeting of the Committee on Improving Risk Analysis Approaches Used by the US EPA

April 17 - 18, 2007

Past

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Thomas A. Burke,chair
A. John Bailer
John M. Balbus
Joshua T. Cohen
Adam M. Finkel
Gary Ginsberg
Bruce K. Hope
Jonathan I. Levy
Thomas E. McKone
Gregory M. Paoli
Dorothy E. Patton
Charles Poole
Joseph V. Rodricks
Terry F. Yosie
Lauren Zeise

The following topics were discussed in the closed sessions:

1. The committee’s statement of task, report topics, and plan of action
2. Draft report chapters
3. Draft report findings
4. Report timeline

The following materials (written documents) were made available to the committee in the closed sessions:

1. Koch, L. and N.A. Ashford. 2006. Rethinking the role of information in chemicals policy: Implications for TSCA and REACH. Journal of Cleaner Production 14:31-46.

2. Ashford, N.A. 2005. Implementing the precautionary principle: Incorporating science, technology, fairness and accountability in environmental, health and safety decisions. Int. J. Risk Assessment and Management 5:112-124.

3. Visual aids used for the following presentation 02-26-2007:
        a. Brenner, R. 2007. Handout Presentation. Presentation by Rob Brenner to the national academy of sciences on improving risk analysis
        approaches used by the U.S. environmental protection agency. February 26, 2007.

4. EPA (U.S. Environmental Protection Agency). 2007. Follow-up information on expert elicitation: Response to question raised by the NAS Committee on Improving Risk Analysis Approaches Used by the US EPA. Office of Air Quality Planning and Standards Air Benefits and Cost Group. Submitted to the Committee on Improving Risk Analysisi Approaches Used by the US EPA, March 26, 2007.

5. EPA (U.S. Environmental Protection Agency). 2006. Expanded expert judgment assessment of the concentration-response relationship between PM2.5 exposure and mortality. Final Report. Office of Air Quality Planning and Standards. Pp. 109. September 21, 2006

6. EPA (U.S. Environmental Protection Agency). 2006. Expanded expert judgment assessment of the concentration-response relationship between PM2.5 exposure and mortality. Appendices. Office of Air Quality Planning and Standards. Pp. 113. September 21, 2006.

7. RTI International. 2006. Peer Review of Expert Elicitation. Pp.56. September 29, 2006.

8. EPA (U.S. Environmental Protection Agency). Chapter 5: Benefit analysis and results. In PMNAAQS. Pp. 114.

9. Conner, L. 2006. Comparison of study designs for USEPA and Harvard/Kuwait PM2.5 expert elicitation studies for the U.S. population. Memo. U.S. Environmental Protection Agency. June 12, 2006.

10. Walker, K. Handout Presentation Slides. Primer on Expert Judgment. Submitted to the Committee on Improving Risk Analysis Approaches Used by the US EPA, March 26, 2007.

11. Crump, K.S. 2003. Cancer and non-cancer risk assessment should be harmonized. BELLE Newsletter 5:2-4.

12. Parkin, R.T. 2007. Foundations and frameworks for microbial risk assessment (Draft). Center for Risk Risk Science and Public Health, School of Public Health and Health Services, George Washington Univeristy. Submitted to U.S. Environmental Protection Agency. Washington, DC: March 2007.

13. EPA (U.S. Environmental Protection Agency). 1999. Residual Risk Report to Congress. Office of Air and Radiation and Office Of Air Quality Planning and Standards. U.S. Environmental Protection Agency. EPA-453/R-99-001. March 1999.

14. Visual aids used for the following presentations 04-17-2007:
        a. Hattis, D. 2007. Handout Presentation Slides. Risk Analysis--New Visions for the Future. April 17, 2007.
        b. Parkin, R. 2007. Handout Presentation Slides. Foundations and Frameworks for Microbial Risk Assessment. April 17, 2007.
        i. Parkin, R. 2007. Handout. Table 3. Categories of microbial risk assessment frameworks with MRA examples. April 17, 2007.
        c. Crump, K. 2007. Presentation to Committee on Improving Risk Analysis Approaches Used by the US EPA. April 17, 2007.
        d. Kyle, A.D. 2007. Handout Presentation Slides. Community needs for assessment of environmental problems. April 17, 2007.
        i. Kyle, A.D. 2007. Handout. References for Presentation. April 17, 2007.
        e. Ashford, N.A. 2007. Handout Presentation Slides. Integrating Science and Technology in Chemicals Policy. April 17, 2007.

Date of posting of Closed Session Summary:

April 30, 2007

Contact

Morgan Motto

202-334-2818
mmmotto@nas.edu

Location

National Academy of Sciences Building

2101 Constitution Ave NW

Washington DC 20418, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Closed

3rd Meeting of the Committee on Improving Risk Analysis Approaches Used by the US EPA

February 26 - 27, 2007

Past

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Thomas A. Burke chair
A. John Bailer
John M. Balbus
Joshua T. Cohen
Roger M. Cooke
Adam M. Finkel
Gary Ginsberg
Bruce K. Hope
Jonathan I. Levy
Thomas E. McKone
Gregory M. Paoli
Dorothy E. Patton
Charles Poole
Joseph V. Rodricks
Terry F. Yosie
Lauren Zeise via teleconference

The following topics were discussed in the closed sessions:

1. The committee’s statement of task, report topics, and plan of action
2. Draft report chapters
3. Topics and presenters for future committee meetings
4. Report timeline

The following materials (written documents) were made available to the committee in the closed sessions:

1. EPA (U.S. Environmental Protection Agency). 2007. NAS/NRC Committee on Improving Risk Analysis Approaches Used By the U.S. EPA Responses. Office of Prevention, Pesticides and Toxic Substances. Submitted to the Committee on Improving Risk Analysis Approaches Used by the US EPA, February 12, 2007.

2. EPA (U.S. Environmental Protection Agency). 2007. NAS/NRC Committee on Improving Risk Analysis Approaches Used By the U.S. EPA. Office of Air and Radiation. Submitted to the Committee on Improving Risk Analysis Approaches Used by the US EPA, February 08, 2007.

3. EPA (U.S. Environmental Protection Agency). 2007. EPA Region 2 and the Office of Solid Waste and Emergency Response. Region 2 and the Office of Solid Waste and Emergency Response. Submitted to the Committee on Improving Risk Analysis Approaches Used by the US EPA, February 05, 2007.

4. EPA (U.S. Environmental Protection Agency). 2007. NAS/NRC Committee on Improving Risk Analysis Approaches Used By the U.S. EPA. Office of Water. Submitted to the Committee on Improving Risk Analysis Approaches Used by the US EPA, February 07, 2007.

5. Visual aids used for the following presentations:
       a. Preuss, P. 2007. Handout Presentation Slides. Human health risk assessment used to accomplish EPA's mission. February 26, 2007.
       b. Shapiro, M. 2007. Handout Presentation Slides. Improving risk assessment in EPA: Office of water. February 26, 2007.
       c. Jones, J. 2007. Handout Presentation Slides. Office of prevention, pesticides, and toxic substances: Improving human health risk assessment. February 26, 2007.
       d. McGartland, A. 2007. Handout Presentation Slides. Moving risk assessment forward: Better information for decision-making. February 26, 2007.
       e. Callahan, M. 2007. Handout Presentation Slides. Improving risk assessment: A regional perspective. February 26, 2007.
       f. Sinks, T. 2007. Handout Presentation Slides. Risk analysis and public health practice. February 26, 2007.
       g. Fava, J.A. 2007. Handout Presentation Slides. Role of life cycle approaches. February 26, 2007.

6. Five Winds International. 2000. Emmitsburg plan for fostering the rational integration of human and environmental considerations into public and private decision-making processes. Prepared for the American Chemistry Council. November 2000.

Date of posting of Closed Session Summary:

March 05, 2007

Contact

Morgan Motto

202-334-2818
mmotto@nas.edu

Location

National Academy of Sciences Building

2101 Constitution Ave NW

Washington DC 20418, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Closed

2nd Meeting of the Committee on Improving Risk Analysis Approaches Used by the US EPA

December 19 - 20, 2006

Past

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Thomas A. Burkechair
Melvin E. Andersen
A. John Bailer
John M. Balbus
Joshua T. Cohen
Adam M. Finkel
Gary Ginsberg
Bruce K. Hope
Jonathan I. Levy
Thomas E. McKone
Gregory M. Paoli
Dorothy E. Patton
Charles Poole
Joseph V. Rodricks
Bailus Walker
Terry F. Yosie
Lauren Zeise

The following topics were discussed in the closed sessions:

1. NRC policies and procedures on potential sources of conflict of interest and bias
2. Committee composition and expertise
3. The committee’s statement of task, report topics, and plan of action
4. Topics and presenters for future committee meetings
5. Report timeline

The following materials (written documents) were made available to the committee in the closed sessions:

1. De Rosa, C. 2006. Public health practice and contemporary issues in risk assessment. Presented at the Second Meeting on Improving Risk Analysis Approaches Used by the US EPA, December 19-20, 2006, Washington, DC.

2. Donkers, R. 2006. Chemical control measures: comparison of the approaches in the EU and the U.S. at Federal and State level.

3. Finkel, A.M. 1990. Confronting uncertainty in risk management: A guide for decision-makers. Center for Risk Management. Resources for the Future. January 1990.

4. NIEHS. 2006. 2006-2011 Strategic Plan: New Frontiers in Environmental Sciences and Human Health.

5. NTP. 2004. A National Toxicology Program for the 21st Century. A Roadmap for the Future.

6. Suter, G.W., T. Vermeire, W.R. Munns, and J. Sekizawa. 2003. Framework for the Integration of Health and Ecological Risk Assessment. Human and Ecological Risk Assessment. 9(1):281-301.

7. Documents submitted by NASA (National Aeronautics and Space Administration):
a. NASA (National Aeronautics and Space Administration). 2006. NASA Comments to the NAS Committee on Improving Risk Analysis Approaches Used by the US EPA. Presented at the Second Meeting on Improving Risk Analysis Approaches Used by the US EPA, December 19-20, 2006, Washington, DC.
b. NASA (National Aeronautics and Space Administration). 2006. NASA general safety program requirements. Office of Safety and Mission Assurance. Submitted at the Second Meeting on Improving Risk Analysis Approaches Used by the US EPA, December 19-20, 2006, Washington, DC.
c. Stamatelatos, M., H. Dezfuli, and G. Apostolakis. 2006. A proposed risk-informed decision-making framework for NASA. National Aeronautics and Space Administration. Submitted at the Second Meeting on Improving Risk Analysis Approaches Used by the US EPA, December 19-20, 2006, Washington, DC.

8. Visual aids used for the following presentations:
a. Donkers, R. 2006. Handout Presentation Slides. REACH and how it compares to the U.S. system. December 20, 2006.
b. Portier, C.J. 2006. Handout Presentation Slides. Emerging technologies and their applications in risk assessment. December 20, 2006.
c. Suter, G. 2006. Handout Presentation Slides. Lessons for health risk assessment from ecological risk assessment. December 20, 2006.

9. Walker, Y.P. 2006. DoD Comments to NRC Committee on Improvements to EPA Risk Analysis. Presented at the Second Meeting on Improving Risk Analysis Approaches Used by the US EPA, December 19-20, 2006, Washington, DC.

Date of posting of Closed Session Summary:

December 27, 2006

Contact

Morgan Motto

202-334-2818
mmotto@nas.edu

Location

National Academy of Sciences Building

2101 Constitution Ave NW

Washington DC 20418, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Closed

1st Meeting of the Committee on Improving Risk Analysis Approaches Used by the US EPA

November 20 - 21, 2006

Past

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Thomas A. Burke (chair); A. John Bailer; John M. Balbus; Joshua T. Cohen; Roger Cooke (via telephone); Adam M. Finkel; Gary Ginsberg;
Bruce K. Hope; Jonathan I. Levy; Thomas E. McKone; Gregory M. Paoli; Dorothy E. Patton; Charles Poole; Joseph V. Rodricks; Bailus Walker; Terry F. Yosie; Lauren Zeise

The following topics were discussed in the closed sessions:

1. NRC policies and procedures on potential sources of conflict of interest and bias
2. Committee composition and expertise
3. Committee’s statement of task, report topics, and plan of action
4. Topics and presenters for future committee meetings
5. Report timeline

The following materials (written documents) were made available to the committee in the closed sessions:

1. Visual aids used for the following presentations:
a. Preuss, P. 2006. Handout Presentation Slides. Human Health Risk Assessment at EPA: Background, Current Practice, Future Directions. November 20, 2006.
b. Zenick, H. 2006. Handout Presentation Slides. Maturation of Risk Assessment: Attributable Risk as a More Holistic Approach. November 20, 2006.
c. Kavlock, R. 2006. Handout Presentation Slides. Computational Toxicology: New Approaches to Improve Environmental Health Protection. November 20, 2006.
d. Farland, W. 2006. Handout Presentation Slides. Improving Risk Analysis: Issues for Consideration. November 20, 2006.
e. Crawford-Brown, D. 2006. Handout Presentation Slides. Revising the Intellectual and Methodological Framework for Risk Assessment. November 20, 2006.

2. Documents submitted by the General Electric Company:
a. General Electric Company. 2004. Comments of the General Electric Company on the USEPA Staff Report Titled “An Examination of EPA Risk Assessment Principles and Practices." Presented at the First Meeting on Improving Risk Analysis Approaches Used by the US EPA, November 20-21, 2006, Washington, DC.
b. General Electric Company. 2004. Exhibits to Accompany: Comments of the General Electric Company on the USEPA Staff Report Titled “An Examination of EPA Risk Assessment Principles and Practices." Presented at the First Meeting on Improving Risk Analysis Approaches Used by the US EPA, November 20-21, 2006, Washington, DC.
c. General Electric Company. 2004. GE's Redline to the USEPA Staff Report Titled "An Examination of EPA Risk Assessment Principles and Practices". Presented by the General Electric Company at the First Meeting on Improving Risk Analysis Approaches Used by the US EPA, November 20-21, 2006, Washington, DC.

3. AIA (Aerospace Industries Association). 2006. AIA AERO Testimony at the Meeting of the National Research Council Committee on Improving Risk Analysis Approaches Used by the US EPA. Presented at the First Meeting on Improving Risk Analysis Approaches Used by the US EPA, November 20-21, 2006, Washington, DC.

4. Gardenier, J.S. 2006. Elephants in the Room: A Public Comment by John S. Gardenier to the National Research Council Committee on Improving Risk Analysis Approaches Used by the US EPA. Presented at the First Meeting on Improving Risk Analysis Approaches Used by the US EPA, November 20-21, 2006, Washington, DC.

Date of posting of Closed Session Summary:

November 29, 2006

Contact

Morgan Motto

202-334-2818
mmotto@nas.edu

Location

Keck Center

500 5th St NW

Washington DC 20001, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

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Improving Risk Analysis Approaches Used By the U.S. EPA

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7th Meeting of the Committee on Improving Risk Analysis Approaches Used by the US EPA

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