Public Forum on OMB's Proposed Risk Assessment Bulletin: Implications for Practice Inside and Outside Government

Location

Washington, DC

Event Dates

Tuesday, 23 May 2006 to Wednesday, 24 May 2006

A two-day public forum featuring the most thoughtful and well-known experts from the profession of risk analysis, including a lecture by Dr. John Graham, former director of OMB's Office of Information and Regulatory Affairs.

Overview

The United States U.S. Office of Management and Budget (OMB) has recently proposed language in a risk assessment bulletin that will, if adopted, become or influence federal guidance for conducting risk assessments. OMB has requested public comments on the bulletin by 15 June 2006.

The Society for Risk Analysis is organizing a public forum to allow experts, practitioners, and all interested parties to share information and insights regarding the proposed risk assessment bulletin. The discussion will be useful to individuals in preparing comments they may anticipate submitting to OMB. The goals of the forum are to

  • identify the implications of the bulletin for the practice of risk assessment at federal agencies,
  • compare the principles expressed or implied in the proposed bulletin with broad opinion about how risk assessment is, should, or can be performed in both typical and ideal practice,
  • consider what the implications of the bulletin might be for risk assessment methodology and practice beyond federal agencies and beyond the United States, and
  • discuss the proposed bulletin not only with respect to its intended scope of technical aspects of risk assessment, but also within a broader context that includes risk management and risk communication.

The forum will be comprised of talks by invited speakers and panel sessions that will include both open and moderated discussion. The meeting is intended to allow for airing of diverse views and is not intended necessarily to build consensus among participants.

The Society for Risk Analysis believes it has a responsibility to provide an open forum for discussion of scientific and policy questions related to, and informed by, risk analysis. The positions taken by the participants in conferences and workshops hosted or co-sponsored by the Society are those of the participants themselves, and are not necessarily those of the Society.

Who should attend

The audience for the forum includes anyone interested in understanding the likely implications for the practice of risk assessment, within the U.S. federal government and outside it, following the guidance recently issued by the Office of Information and Regulatory Assessment of the Office of Management and Budget. Anyone contemplating sending comments on the guidance to OMB would also benefit by attending the forum.

Confirmed panelists

Nancy Beck, Office of Management and Budget (http://www.whitehouse.gov/omb)

Rick Becker, American Chemistry Council (http://www.americanchemistry.com/s_acc/index.asp)

Michael Belzer, Wayne State University and University of Michigan (http://www.is.wayne.edu/mbelzer/)

Richard B. Belzer, Regulatory Checkbook and Neutral Source (http://neutralsource.org/)

Tom Billy, former administrator, USDA's Food Safety and Inspection Service, and former chair, Codex Alimentarius

Robin Cantor, Managing Director, Navigant Consulting, and past president of SRA

Tim Carpenter, University of California (http://www.epi.ucdavis.edu/F-carpentert.htm)

Louis Anthony Cox, Jr., (http://cafescicolorado.org/Cox.htm and http://www.cox-associates.com/tonybio.htm)

Caroline Smith DeWaal, Center for Science in the Public Interest (http://www.wkconline.org/index.php/seminars/speakerpage/?sid=923 and http://www.seafoodandhealth.org/documents/CarolineSmithDeWaal.PDF)

E. Donald Elliott, Willkie Farr and Gallagher, Yale University Law School, and formerly General Counsel to the U.S. Environmental Protection Agency (http://www.law.yale.edu/outside/html/faculty/ede2/profile.htm and http://www.epa.gov/history/admin/ogc/elliott.htm)

Susan Ferenc, Chemical Producers and Distributors Association, and formerly Safrisk (http://www.safrisk.com)

Scott Farrow, University of Maryland, Baltimore County, and formerly Government Accountability Office (http://www.umbc.edu/economics/)

H. Christopher Frey, president, Society for Risk Analysis, and North Carolina State University (http://www4.ncsu.edu/~frey/)

John D. Graham, RAND Graduate School, former administrator of OMB's Office of Information and Regulatory Affairs (http://www.prgs.edu/dean.html,

http://www.hcra.harvard.edu/nomination/index.html, http://www.whitehouse.gov/omb/inforeg/bio.html and http://www.hcra.harvard.edu/nomination/bio.html)

Mark Greenwood, Ropes & Grey, and former director, EPA Office of Pollution Prevention and Toxics (http://www.ropesgray.com/bios/bio_detail.aspx?SectionID=2&AttorneyID=000110710003)

Yacov Haimes, Founding Director, Center for Risk Management of Engineering Systems, University of Virginia, and past president of SRA (http://www.virginia.edu/crmes)

Jefferson B. Hill, Jacobs & Associates, and former senior advisor to the administrator, Office of Information and Regulatory Affairs, Office of Management and Budget (www.regulatoryreform.com)

John Keller, Professional Consulting Services

James H. Lambert, Associate Director, Center for Risk Management of Engineering Systems, University of Virginia (http://www.virginia.edu/crmes)

Stanley H. Levinson, AREVA NP Inc. (www.areva.com)

Steven C. Lewis, Integrative Policy and Science (http://www.integrativepolicyandscience.com/)

Igor Linkov, Cambridge Environmental

Charlie Menzie, Menzie-Cura Associates (http://www.menziecura.com)

Arthur Miller, Exponent

Paul Noe, OMB Office of Information and Regulatory Affairs

Warner North, NorthWorks Consulting (http://www.northworks.net/w_main.htm)

Robert O'Connor, National Science Foundation

Jacqueline Patterson, TERA (http://www.tera.org)

Jennifer Sass, Natural Resources Defense Council (http://www.nrdc.org/health/science/ijsscience.asp)

Stuart Shapiro, Edward J. Bloustein School of Planning and Public Policy, Rutgers University (http://policy.rutgers.edu/faculty/shapiro/)

Mitchell Small, Carnegie Mellon University (http://www.ce.cmu.edu/~ms35/)

Cathy St. Hillaire, Center for Health Risk Analysis, Life Sciences Research Office

James Valverde, Insurance Information Institute (http://www.iii.org/media/photos/jamesv/)

Vern Walker, Hofstra University School of Law (http://www.hofstra.edu/Academics/Law/law_media_walker.cfm)

Pamela Williams, Chemrisk, Inc. (http://www.chemrisk.com)

Charlie Yoe, College of Notre Dame of Maryland (http://www.ndm.edu/gateways/faculty-and-staff/faculty-experts/)

Agenda (tentative)

Tuesday, 23 May 2006

8:30-8:45 Welcome by the Society for Risk Analysis

8:45-10 Session 1
Introduction to OMB's Risk Assessment Bulletin

(a) Information quality guidelines (IQG)

  • What are the IQG?
  • How does risk assessment fit into the IQG?
  • Why risk assessment is an IQ problem

(b) Proposed risk assessment bulletin

  • Scope, scale, coverage, exemptions
  • General provisions
  • "Special Standards for Influential Risk Assessments”

10:00-10:30 Break

10:30-12:15 Session 2
Introduction to Risk Assessment and Its Many Uses

(a) Risk assessment methods

  • Types (qualitative, quantitative, probabilistic, etc.)
  • Safety assessment v. risk assessment
  • Assumptions, data, and models
  • Comparative risk assessment

(b) Uses of risk assessment

  • Priority setting
  • Description, classification, and characterization
  • Regulatory analysis (including benefit-cost analysis and decision analysis)
  • Risk management

12:15-1:45 Luncheon address by John D. Graham

2:00-3:30 Session 3
Impacts Beyong the Scope of the Bulletin

(a) Other areas of risk analysis

  • Risk communication
  • Decision analysis
  • Risk management

(b) Other domains

  • States, other national governments, and international institutions
  • Stakeholders in risk analysis (e.g., regulated entities, NGOs)
  • Tort

3:30-3:45 Break

3:45-5:00 Session 4
How the Bulletin Affects Risk Assessments Used for Regulatory Purposes

  • Data collection (e.g., test guidelines, PRA [for human data], exposure assessment, economic impacts)
  • Regulatory impact analysis (e.g., baseline, identification of alternatives, benefit-cost analysis of alternatives)
  • Interagency review (i.e., competing agency agendas, views, analyses)
  • Administrative law (e.g., public comment)

6:00-7:30 Reception

Wednesday, 24 May 2006

8:30-10:00 Session 5A
Current State of Practice and Impacts on Practice by Application Area

  • Agriculture (e.g., import/export)
  • Food (e.g., food additives, pathogens)
  • Chemicals (e.g., environmental, occupational; carcinogens, non-carcinogens)
  • Communicable disease (e.g., , avian flu)

10:00-10:30 Break

10:30-12:15 Session 5B
Current State of Practice and Impacts on Practice by Application Area (continued)

  • Engineering safety (e.g., fixed facilities)
  • Transportation (e.g., highways, air/land/sea vehicles)
  • Ecosystems (e.g., ESA)
  • Global climate change
  • Terrorism (e.g., fixed facilities, ports)

12:00-1:30 Lunch

1:30-3:00 Session 6A
How the Bulletin Affects Influential Risk Assessments

  • Basic science (e.g., research priorities, objectives, and techniques)
  • Data collection (e.g., test guidelines, PRA [for human data], exposure assessment)
  • Pre-dissemination review of information quality (required by OMB IQ Guidelines)
  • Risk assessment, modeling (e.g., DR, F&T, etc.)
  • Risk characterization

3:00-3:30 Break

3:30-5:00 Session 6B
How the Bulletin Affects Influential Risk Assessments (continued)

  • Variability analysis
  • Uncertainty analysis
  • Peer review (cf. OMB Bulletin on Peer Review)

5:00 Adjourn

Posters

Participants in this public forum are invited and encouraged to present posters during the event. The posters will be displayed throughout the forum. The dimensions of the poster space are 3 feet by 3 feet. Posters can be assembled any time after 7:30 am on 23 May. If you would like to present a poster, please reserve a space by emailing the SRA Secretariat liaison David Drupa at ddrupa@burkinc.com no later than 19 May.

Registration

The registration fee is $400. You can register on site, but to assure yourself a space, register as soon as possible with
Registration form
Secretariat sra@burkinc.com
Society for Risk Analysis www.sra.org
1313 Dolley Madison Boulevard, Suite 402
McLean, Virginia 22101 USA
1-703-790-1745, fax 1-703-790-2672

Venue

The event will be held 8:30am - 5pm on Tuesday and Wednesday, 23-24 May 2006, at the Cafritz Conference Center, which is located on the third floor of the Marvin Center at The George Washington University in Washington, DC. The main entrance of the Marvin Center is located on 21st Street between H and I Streets. The address is
Cafritz Conference Center
The George Washington University
800 21st Street, NW, Suite 204
Washington, DC 20052
Phone: 1-202-994-9222
Fax: 1-202-994-7442
Email: cafritz@gwu.edu
Directions to the conference center

Parking

The rate is $13 per day. A university parking garage is located on the bottom five levels of the Marvin Center and can be accessed on H Street, between 21st and 22nd Streets. This parking garage is open from 7am until midnight. The Cafritz Conference Center does not have reserved parking for people attending events in the building. In addition to the Marvin Center garage, the visitor's parking garage can be accessed on I Street between 23rd and 22nd Streets. This parking garage is open 24 hours. For more information on arranging parking, please contact the Parking Office at 1-202-994-7275.

Nearby hotels

Located in the heart of Washington, DC, in the Foggy Bottom district, there are several hotels within one block of the Cafritz Conference Center.

Sponsoring organizations

Society for Risk Analysis
Society of Environmental Toxicology and Chemistry in North America
Society of Toxicology
International Society of Regulatory Toxicology and Pharmacology

Organizing committee

Rick Becker, Richard Belzer, Ann Bradley, Scott Ferson, Jack Fowle Chris Frey, John Keller, Steven Lewis, Igor Linkov, Kara Morgan, Resha Putzrath, Mark Powell, Cristina McLaughlin, Margaret MacDonell, Greg Paoli, Kim Thompson, Pamela Williams, and James Wilson.

References and links

Registration form http://www.sra.org/docs/OMB_Registration.pdf

OMB's proposed guidance http://www.whitehouse.gov/sites/default/files/omb/assets/omb/inforeg/proposed_risk_assessment_bulletin_010906.pdf

OMB request for peer review of the proposed guidance http://www.whitehouse.gov/sites/default/files/omb/assets/omb/pubpress/2006/2006-01.pdf

List of OMB's government-wide initiatives on information quality http://www.whitehouse.gov/omb/inforeg/infopoltech.html#iq

Society for Risk Analysis http://www.sra.org

Other conferences and workshops sponsored or cosponsored by the Society for Risk Analysis http://www.sra.org/events.php

Society for Environmental Toxicology and Chemistry North America http://www.setac.org/

Society of Toxicology http://www.toxicology.org/

International Society of Regulatory Toxicology and Pharmacology http://www.isrtp.org/

More information

More information can be obtained from Greg Paoli (1-613-260-1424, fax -1443) or Jim Wilson (1-314-569-2615).