Final Program - Society for Risk Analysis

explosion of a bomb in a building, train, subway, or highway. Respondents rated thePerceived Riskiness and WTP for dealing with each threat. Demographic, attitudinal,and party affiliation data were collected. Psychometric variables were far strongerpredictors of both Perceived Riskiness and WTP than were demographic ones. ForPerceived Riskiness, the adjusted R-squared for regression models using demographicvariables as predictors ranged from .06 to .11. For each threat, White Male status wasa significant negative predictor; Evangelical status was a significant positive predictor.The adjusted R-squared values for models with psychometric predictor variables -Severity, Understood, Number Affected, and Likelihood -ranged from .49 to .61. Allfour predictors were significant for each threat, with one exception. For WTP, theadjusted R-squared using demographic variables ranged from .02 to .07. White Malestatus was a significant negative predictor and Evangelical status was a significantpositive predictor for each threat; Education Level was a significant negative predictorfor three threats. The adjusted R-squared for models using psychometric predictorswere higher, ranging from .29 to .41. All four psychometric variables were significantpredictors for each threat. A model predicting WTP as a simple function of PerceivedRiskiness was statistically significant, ranging from .22 to .34 across threats. Amodel that combined Perceived Riskiness and the four psychometric variables furtherimproved the ability to predict WTP. Adding the demographic variables did not appreciablyimprove prediction.P.96 Murphy MM, Rahaman F, Claycamp HG; meghan.murphy@fda.hhs.govUS Food and Drug Adminstration (FDA)MULTI-ATTRIBUTE ASSESSMENT METHOD FOR PHARMACYCOMPOUNDINGPharmacy Compounding (PC) is the combining, mixing or altering of a drug bya pharmacist, based on a prescription, to create a new drug that meets a medical needfor a patient. PC serves patients by allowing those with allergies to drug ingredients orother medical needs to take medications that they would otherwise be unable to use.Producing a drug outside of a pharmaceutical manufacturing facility can introduceuncertainties in the quality of the product. A portion of the uncertainty is likely dueto variability in both the level of training of pharmacists and the adequacy of the facilitiesused to produce compounded drugs. The variabilities among pharmacists andfacilities can make compounded drugs susceptible to quality issues such as incorrectpotency, lack of content uniformity, or contamination with bacteria or endotoxin.FDA’s mission includes protection of the public by minimizing consumer exposureto unsafe, ineffective, and poor quality compounded drugs. To this end, FDA is developingrisk management strategies for allocating program resources to compoundingpractices that entail the greatest risks to the patient. To provide a uniform frameworkfor prioritizing compounding issues, a multi-attribute assessment method wasdeveloped through the elicitation of PC experts within the U. S. Food and Drug Administration.The Pharmacy Compounding Assessment Model (PCAM) is a multiattributemethod that integrates expert judgment to prioritize incoming pharmacycompounding cases based upon the scoring of several attributes perceived by PCexperts to be indicative of potential risk within a pharmacy compounding scenario.The utilization of PCAM will aid pharmacy compounding regulators by providinga consistent and objective methodology to better inform resource allocation, whichwill improve the ability to protect public health. Disclaimer: This paper reflects theviews of the author and should not be construed to represent FDA’s views or policies.T4-F.4 Merad M, Marcel F; myriam.merad@ineris.frINERISDECISION AID PROCESS IN RISK MANAGEMENT - FROM THECONDUCT OF THE EXPERTISE PROCESS TO ITS GOVERNANCEThe analysis and management of risks in the field of safety, security and environmentare complex issues on which the conduct of public expertise is subjectto strong stakes. This paper addresses the issues of the understanding, the supportand the governance of public expertise process and public decision-making processthrough research done on risk prevention of major technological accidents. Ouronboard research approach has allowed us to see what decision support tools couldaccompany the expertise process and, thus, the decision-making process. We haveshown what it necessary, in areas with strong issues such as risks management, to disposeof methodological approaches to better understand the conditions of expertiseand the emergence of recommendations. Opening expertise process to society alsoallowed us to explore the different modes of participatory governance and proposesteps for the design of participatory structures. Different case study (e.g. Seveso highthreshold plants, nanotechnologies,...) have enabled us to highlight the different tensions,constraints and biases to which the conduct of expertise is subject.W4-B.4 Nachman K, Fain K, Shah S, Fox M; mfox@jhsph.eduJohns Hopkins UniversityCOMPARABILITY OF TOXICOLOGICAL EVALUATION FRAME-WORKS FOR VETERINARY AND HUMAN PHARMACEUTICALS ANDENVIRONMENTAL CHEMICALS FOR FOUR FEDERAL PROGRAMSThe US population is routinely exposed to numerous naturally-occurring andanthropogenic compounds, often as a result of their uses in industry and agriculture.These compounds, which include commercial chemicals, pesticides, veterinary drugsand other substances, are regulated by different offices of the Food and Drug Administration(FDA) and the Environmental Protection Agency (EPA) under differentlegal authorities. As a result, differing approaches for toxicity evaluation employed bythe varying programs may lead to inconsistencies in levels of public health protectionacross types of chemicals. The purpose of this project is to characterize and contrast149