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RASS Annual Business Meeting & Reception Monday, March 7, 2005 6:00 p.m. – 7:30 p.m. New Orleans Convention Center Room 229 Laissez Le Bon Temps Rouler!

RASS Annual Business Meeting & Reception Monday, March 7, 2005 6:00 p.m. – 7:30 p.m. New Orleans Convention Center Room 229 Laissez Le Bon Temps Rouler!

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RASS Annual Business Meeting &

Reception

Monday, March 7, 2005

6:00 p.m. – 7:30 p.m.

New Orleans Convention Center Room 229

Laissez Le Bon Temps Rouler!

Agenda

Accomplishments for 2004-2005 (A. Jarabek) Status of RASS Introduction of new officers

RASS Best Abstract Award (M. Gargas) RASS Best Student Abstract Award (M. Gargas) RASS Best Manuscript Awards (K. Krishnan)

Advancing Risk Assessment Demonstrating Risk Assessment Application

Web page revisions and logo contest (D. Proctor) Next Year: Programs and Activities (K. Krishnan) Open Session for Membership Input

Ideas to better serve RASS membership 2004 nomination of symposia workshops, continuing education, etc.

Concluding comments by Incoming President (K. Krishnan) Panel Discussion: Dose-dependent Transitions in Mechanisms of

Toxicity

Status of RASS: 2005 Annual Meeting

How many members belong: 384 (↑ of 100) Budget (December 2004): $11,645 Members registered to attend meeting as of March 1: ??

Additional revenue: $4,900 (estimate) Annual meeting expenditure: $2000 (estimate)

Sponsored CE Courses: 6 Sponsored Symposia: 6 Secondary endorsements: 26 Precedent set with historical highlight: Vinyl Chloride

RASS 2004-2005 Accomplishments Emphasize the role of specialty sections Monthly Telecon Series – the State of our Science

November: NAS report on use of human studies December: Dose-response assessment: Past & Present

Rory Conolly, CIIT Centers for Health Research January: Dose-response assessment: Future

Rory Conolly and Rusty Thomas, CIIT CHR February: HESI Panel on Dose-dependent transition Coming yet this Spring:

April 13: Bruce Hope, OR DEP on bioterrorism risk assessment May 11: Michael Liebman, Windber Institute: Discovery and

Data mining in health care June 8: Woodrow Setzer, US EPA, NHEERL: OP modeling

Special thanks to Merck for generous offer of telecon system

RASS 2004-2005 Accomplishments

Updated RASS home page User friendly Information sharing Event broadcasting Logo contest

Student membership and SAC liaison Letter soliciting student volunteer sent out Student to be determined ASAP for 2006

Consider a Contemporary Concepts in Toxicology (CCT) workshop

RASS 2005 CCT Workshop

Probabilistic Risk Assessment (PRA) —Bridging Components Along the Exposure-Dose-Response Continuum

Deadline for poster submission is May 12, 2005For more information visit www.toxicology.org

July 25 ─ 27, 2005Omni Shoreham HotelWashington DC

2005-2006 RASS Officers

President Kannan Krishnan Vice President Mike Gargas Vice President-Elect Jennifer Orme-Zavaleta Secretary/Treasurer Lynne Haber Councilor (2 year) Teresa Leavens Councilor (1 year) Deborah Proctor Past President Annie Jarabek

Outgoing Officersto Whom We Owe

Many Thanks…

Councilor Lorenz Rhomberg Secretary/Treasurer Steve DiZio Past President Ed Sargent

Other Grande Gratitude to Jeanne Galbo

CIIT Centers for Health Research

RASS Best Abstract Competition 276 Abstracts with keyword “risk assessment”

reviewed by chair of committee 137 Vetted by Awards Committee

Scored based on criteria: Originality Quality / Clarity Relevance to the risk assessor

No vote for member with conflict of interest on any abstract

RASS 2005 Best AbstractAwards Committee

Mike Gargas, The Sapphire Group, Inc. (Chair) John Christopher, Cal EPA Michael Dourson, TERA, Inc. Annie Jarabek, CIIT CHR / US EPA

RASS 2005Best Abstract“Top Ten” Blue Ribbon Winners 377. A Framework/Approach for Incorporating PBPK Modeling into

Cumulative Risk Assessment of Chemical Mixtures. R. Yang; J. Dennison; J. Lipscomb

381. Risk Assessment in Nephrotoxicology Sensitivity of Renal Tests. P. Potnis; A. Maier; T. Guidotti

402. Incorporation of Trichloroacetic Acid Plasma Binding in Human and Mouse in Trichloroethylene Risk Assessment. D. Keys; M. Lumpkin; J. Bruckner; J. Fisher

404. Monte Carlo Analysis of Sources of Variability in Chloroform‑induced Hepatic Cytolethality and Regenerative Proliferation in B6c3f1 Mice. Y. Tan; R. Conolly

349. An integrated QSAR‑PBPK model for simulating pharmacokinetics of chemicals in mixtures. K. Price; K. Krishnan

847. A Harmonized PBPK Model for Trichloroethylene Risk Assessment. T. Covington; H. Clewell; J. Fisher; D. Keys; C. Hack; J. Zhao

RASS 2005Best Abstract“Top Ten” Blue Ribbon Winners

866. Validation of a Human Physiologically‑Based Pharmacokinetic Model for Vinyl Acetate Against Human Nasal Dosimetry Data. P. Hinderliter; K. Thrall; R. Corley; L. Bloemen; B. Matthew

1096. Assessment of neurotoxicity using zebrafish as a model organism. N. Roy; C. Ton; Y. Lin; C. Parng

1304. A Mechanistic Model of Lifetime Cancer Risk for Inhalation Exposures to Reactive Gases. J. Kimbell; D. Kalisak; R. Conolly; F. Miller; A. Jarabek

1934. Evaluation of Systemic Toxicity in Mixtures of Trichloroethylene (TCE), Heptachlor (HEPT), and Di(2‑ethylhexyl)phthalate (DEHP) Assessed in a 5x5x5 Design. J. Simmons; S. Yeatts; J. Zhao; C. Gennings; A. McDonald; R. MacPhail

2110. Improved Dosimetric Adjustment Factors for Interspecies Extrapolation of Inhaled, Poorly Soluble Particles. B. Asgharian; O. Price; A. Jarabek; F. Miller

RASS 2005Best Abstract Award Winner

Abstract 2110. (Thursday March 10)

Improved Dosimetric Adjustment Factors for Interspecies Extrapolation of Inhaled, Poorly Soluble Particles. B. Asgharian, O. Price, A.M. Jarabek

and F.J. Miller. CIIT Centers for Health Research

RASS 2005 Best Student AbstractCompetition

Submission process Student submits abstract and extended abstract (up to 5

pages) Advisor provides letter of recommendation

Review process – vetted by Award Committee based on criteria:

Originality Clarity Role of Student

Special thanks to Taylor and Francis Burdock Group, Inc.

RASS 2005 Best Student AbstractNominees

62. Decreased Acetaminophen and Bromobenzene-induced Hepatotoxicity and Lethality in Type 2 Diabetic Mice.   M. Mitra; S. Sawant; A. Dnyanmote; J. Latendresse; A. Warbritton; H. Mehendale, University of Louisiana.

197. Rat Kidney injury molecule-1 (rKim-1) ELISA: A sensitive assay for early detection of kidney tubular injury in preclinical toxicity studies.   V. Vaidya; T. Ichimura; J. Bonventre , Harvard Medical School, Brigham and Women’s Hospital.

259. PBPK modeling of inter-child differences in pharmacokinetics on the basis of subject-specific data on hepatic CYP2E1 levels.   A. Nong; D. McCarver; R. Hines; K. Krishnan, University of Montreal.

731. Role of Toxicokinetics in the Bioactivation-mediated Liver Injury of Thioacetamide in Ad Libitum Fed and Diet Restricted Rats.   J. Chilakapati; M. Korrapati; H. Mehendale, University of Louisiana.

2095. Characterization of Deltamethrin (Dlt) Metabolism in Adult Male Sprague-dawley Rats.  S. Anand; W. Haines; J. Bruckner; J. Fisher; S. Muralidhara; D. Hunter; S. Padilla, University of Georgia.

RASS 2005 Best Student AbstractAward Committee

Mike Gargas, The Sapphire Group, Inc. (Chair) Lisa Sweeney, The Sapphire Group, Inc. Jim McDougal, Wright State University James Holder, US EPA NCEA

RASS 2005 Best Student AbstractWinner

Abstract 197.

Rat Kidney injury molecule‑1 (rKim‑1) ELISA: A sensitive assay for early detection of kidney tubular injury in preclinical toxicity studies. V. Vaidya, T. Ichimura, and J. Bonventre Harvard Medical School, Brigham and Women’s Hospital.

RASS Annual Best Manuscript Competition Nominations by membership Review of relevant journals published in past year

Toxicological Sciences Toxicology & Applied Pharmacology Human & Ecological Risk Assessment Regulatory Toxicology & Pharmacology Risk Analysis

Chosen by Vice-President & Awards Committee “Top ten” fully vetted Scoring criteria: merit, clarity, and impact

No vote on manuscript for committee member if any conflict of interest

RASS 2005 AwardBest Manuscript Advancing Risk Assessment Science

Kannan Krishnan, Univ. Montreal (Chair) Mel Andersen, CIIT CHR Marcy Banton, Lyondell Mike Gargas, The Sapphire Group, Inc. Annie Jarabek, CIIT CHR / US EPA William Slikker, NCTR

Awards Committee

2005 RASS “Top Ten” Papers ADVANCING SCIENCE OF RISK ASSESSMENT

1. Ashani Y and Pistinner S. (2004). Estimation of the upper limit of human butrylchloinesterase dose required for protection against organophosphates toxicity: a mathematically based toxicokinetic model. Toxicological Sciences 77: 358-367.

2. Conolly RB and Lutz WK. (2004). Nonmonotonic dose response relationships: mechanics basis, kinetic modeling and implications for risk assessment. Toxicological Sciences 77: 153-157.

3. Dorne JL, Walton K, Renwick AG. (2004). Human variability in the renal elimination of foreign compounds and renal excretion-related uncertainty factors for risk assessment. Food Chem. Toxicol. 42(23): 275-98.

4. Englehardt JD (2004) Predictive Bayesian dose-response assessment for appraising absolute health risk from available information. Human and Ecological Risk Assessment 10: 69-78.

5. Gaylor DW and Aylward LL. (2004). An evaluation of benchmark dose methodology for noncancer continuous data health effects in animals due to exposed to dioxin. Regulatory Toxicology and Pharmacology 40: 9-17.

2005 RASS “Top Ten” Papers ADVANCING SCIENCE OF RISK ASSESSMENT

6. Gaylor DW, Lutz WK and Conolly RB. (2004). Statistical analysis of nonmonotonic dose-response relationships: research design and analysis of nasal cell proliferation in rats exposed to formaldehyde. Toxicological Sciences 77: 158-164.

7. Toyoshiba H, Yamanaka T, Sone H, Parham FM, Walker NJ, Martinez J, Portier CJ. (2004). Gene interaction network suggests dioxin induces a significant linkage between aryl hydrocarbon receptor and retinoic acid receptor beta. Environ. Health Perspect. 112(12): 1217-24.

8. Razzaghi M and Kodell R. (2004) Quantitative risk assessment for developmental neurotoxic effects. Risk Analysis 24: 1673.

9. Clark LH, Setzer RW and Barton HA. (2004) Framework for evaluation of physiologically-based pharmacokinetic models for use in safety or risk assessment. Risk Analysis 24: 1697.

10. Calabrese EJ (2004). Hormesis: from marginalization to mainstream: a case for hormesis as the defaul dose-response model in risk assessment. Toxicol. Appl. Pharmacol. 197: 125-136.

Risk Assessment Specialty Section 2005

Best Paper Advancing the

Science of

Risk Assessment

Toyoshiba H, Yamanaka T, Sone H, Parham FM, Walker NJ, Martinez J, Portier CJ. (2004). Gene interaction network suggests dioxin induces a significant linkage between aryl hydrocarbon receptor and retinoic acid receptor beta. Environ. Health Perspect. 112(12): 1217-24.

RASS 2005 AwardBest manuscript demonstrating application of risk assessment

Kannan Krishnan, Univ. Montreal (Chair) Steve DiZio, Cal EPA Lynne Haber, TERA Deborah Proctor, Exponent Resha Putzrath, EPA Forum Ed Sargent, Merck

Awards Committee

2005 RASS “Top Ten” Papers APPLICATION OF RISK ASSESSMENT

1. Babich MA, Chen SB, Greene MA, Kiss CT, Porter WK, Smith TP, Wind ML, Zamula WW. (2004). Risk assessment of oral exposure to diisononyl phthalate from children’s products. Regul. Toxicol. Pharmacol. 40(2): 151-67.

2. Booze TF, Reinhardt TE, Quiring SJ and Ottmar RD. (2004). A screening level assessment of the health risks of chronic smoke exposure for wildland firefighters. Journal of Occupational and Environmental Hygiene 1: 296-305.

3. Conolly RB, Kimbell JS, Janszen D, Schlosser PM, Kalisak D, Preston J and Miller FJ. (2004). Human respiratory tract cancer risks of inhaled formaldehyde: dose response predictions from biologically-motivated computational modeling of as combined rodent and human dataset. Toxicological Sciences 82: 279-296.

4. Farrrow S. (2004). Using risk assessment, benefit-cost analysis, and real options to implement a precautionary principle. Risk Anal. 24(3): 727-35.

5. Himmelstein MW, Carpenter SC, Evans MV, Hinderliter PM, Kenyon EM. (2004). Kinetic modeling of beta-chloroprene metabolism: II. The application of physiologically based modeling for cancer dose response analysis. Toxicol. Sci. 79(1): 28-37.

2005 RASS “Top Ten” Papers APPLICATION OF RISK ASSESSMENT

6. Kirman CR,, Sweeney LM, Teta MJ, Sielken RL, Valdez-Flores C, Albertini RJ and Gargas ML. (2004). Addressing nonlinearity in the exposure-response relationship for a genotoxic carcinogen: cancer potency estimates for ethylene oxide. Risk Analysis 24: 1165.

7. Renwick AG. (2004). Establishing the upper end of the range of adequate and safe intakes for amino acids: a toxicologist’s viewpoint. J. Nutr. 134(6 Suppl): 1617S-1624S.

8. Schoen A, Beck B, Sharma R and Dubé E. (2004) Arsenic toxicity at low doses: epidemiological and model of action considerations. Toxicology and Applied Pharmacology 198: 253-267.

9. Sweeney LM, Andersen ME and Gargas ML. (2004). Ethyl acrylate risk assessment with a hybrid computational fluid dynamics and physiologically-based nasal dosimetry model. Toxicological Sciences 79: 394-403.

10. Tsuji JS, Benson Rj, Schoof RA, Hook GC. (2004). Health effect levels for risk assessment of childhood exposure to arsenic. Regul. Toxicol. Pharmacol. 39(2): 99-110.

Risk Assessment Specialty Section 2005

Best Paper Demonstrating the

Application of

Risk Assessment

Kirman CR,, Sweeney LM, Teta MJ, Sielken RL, Valdez-Flores C, Albertini RJ and Gargas ML. (2004). Addressing nonlinearity in the exposure-response relationship for a genotoxic carcinogen: cancer potency estimates for ethylene oxide. Risk Analysis 24: 1165.

RASS Web Page Update

RASS Description, Goals and Activities Links

Monthly Telecons Dates and Downloads

History of RASS Current and Previous Officers and all Presidents Annual Meeting

Best Abstract Awards Best Student Abstracts RASS Endorsed Symposia, etc.

RASS Web Page Update (continued)

Links Annual Meeting

Information regarding reception Information regarding Panel Discussion Tonight

Best Manuscript Awards from 2004 and 2005 Upcoming Events

CCT on Probabilistic Risk Assessment Links to other sites and meetings of interest

Just Getting Started

Seeking Your Input

Logo Contest History of RASS Feedback on

Web Page Pictures Graphics Send to [email protected]

Logo Contest

First Entry

Logo Contest

Second Entry

Logo Contest

Third Entry

Logo Contest

Extended for 1 week after SOT (3/17/05) Email Your Entries to Deb Proctor

([email protected]) Computer and drawing skills are not required Prepares will be Anonymous RASS Membership will vote by email Winner by End of March

Proof that Ability to Draw is Not a Requirement

RASS 2005/06 Program & Activities Submission of symposia and continuing education proposals

Need your input & ideas Evaluate venue attributes that best suit topic:

Symposium Workshop Continuing Education

Provide endorsements: Four primary endorsements Help fully develop proposals

Follow-up Contemporary Concepts in Toxicology (CCT) program PRA proposal Program development and funding formula

RASS 2005/06 Program & Activities (cont.) Post-doc and graduate student memberships in RASS

Risk assessment programs Institutional contacts Enrolment

RASS Newsletter Bi-monthly, electronic Update on activities, hot issues, announcements, opportunities,

… Membership participation

Teleconference presentations Risk assessment tools Topics TBD by YOU — please let us know!

RASS 2005 ReceptionConclusion

Open Forum Panel Discussion: Dose-dependent

transitions in mechanisms of toxicity William Slikker, US FDA NCTR Ray David, Eastman Kodak Rory Conolly, CIIT Centers for Health Research Dale Hattis, Clark University William Farland, US EPA ORD David Jacobson-Kram, US FDA CDER