Final Program - Society for Risk Analysis

tize information needs. A meta-analysis of published occurrence data and publicallyavailable data on production and use is underway. As part of the assessment, OSThas been developing an inclusive “universe” of active pharmaceutical ingredients(APIs), registered pharmaceuticals, as well as collecting, publically available marketingresearch, and published occurrence data. This effort produced a list of about 3,000drugs - prescription and over the counter drugs, human and animal drugs, and selectelicit drugs. However, this includes many redundant variants (e.g., salts) of the sameprime API. OST removed these redundancies because analytical methods target theprime organic-chemical component. This refinement reduced the universe to a listof about 1,800 prime APIs. Linking the universe with the occurrence data showsthat only about 10% of all prime APIs have been identified as target analytes (eitherdirectly or through a degradation product) in water, waste waters, or biosolids. Onlyabout 20% of the “top drugs” (from commercial prescriptions or sales over a 3 yearperiod) have been targeted. Many occurrence studies were driven more by analyticalmethods than risk characterization. The pharmaceuticals on the OST list are beinglinked to WHO Anatomical Therapeutic Categories (ATCs) to assess which therapeutic/mode-of-actionclasses have/have NOT yet been included in analytical studies ofoccurrence. The ATC information will be related to toxicological data to help identifyresearch needs and develop an informed approach for assessing human health risksof pharmaceuticals in water. This presentation is based on the views and opinions ofthe authors and does not necessarily reflect EPA policy.W4-B.2 Conerly O, Gebhart AM, Fitzpatrick S, Bloom R; conerly.octavia@epa.govUS Environmental Protection Agency, Toxservices, US Food and Drug AdministrationPHARMACEUTICALS IN THE ENVIRONMENT: HEALTH EFFECTSSCREENINGPharmaceuticals have been detected in water at very low levels. Pharmaceuticalshave robust datasets that characterize pharmacological and toxicological attributesat and above clinically relevant dose levels, but data gaps exist that affect possibleextrapolation to health risks at low levels of exposure. Pharmaceuticals are designedfor use in specific subpopulations under controlled exposures, and consideration ofchronic, low-level exposures among the general population is not part of the drug approvalprocess. Therefore, health risks, if any, from such exposures remain uncharacterized.Significant challenges exist related to estimating human health risks associatedwith pharmaceutical occurrence in drinking water. A pilot study between EPA andFDA is underway that utilizes publicly available therapeutic information to conductan initial screening assessment. Data sharing between agencies is key to this screeningapproach. Drug-specific NOAELs and LOAELs were identified based on data frompre-clinical studies for four classes of drugs. Screening-RfD (S-RfD) and ScreeningMaximum Recommended Safe Dose (S-MRSD) values were derived based on EPA80and FDA guidance, respectively, for each drug. The S-RfD and S-MRSD values forthe same drug were similar, within an order of magnitude in most cases, as long asboth points of departure were based on a NOAEL or both were based on a LOAEL.Environmental occurrence data also are being reviewed to evaluate useful ways toscreen and prioritize classes of drugs for risk assessment. Many occurrence studiesare driven more by analytical methods than risk characterization. The results of thisrisk characterization process will be compared with clinical data and this comparisonused to develop an informed, long term strategy for assessing human health risks oflow level pharmaceuticals in water. This presentation is based on the views and opinionsof the authors and does not necessarily reflect EPA or FDA policy.T4-A.3 Connor M, Siegrist M; melanie.connor@usi.chUSITHE STABILITY OF RISK AND BENEFIT PERCEPTIONS: A LONGI-TUDINAL STUDY ASSESSING THE PERCEPTION OF TECHNOLOG-ICAL RISKIn recent years there has been an increased interest in involving the public indecision-making processes about science and technology. In Switzerland, such a decision-makingprocess was the endorsement of the biotechnology moratorium in 2005.Thus, the commercial cultivation of genetically modified crops (GM) and growth ofGM animals is prohibited until 2013. However, only if public attitudes and perceptionsremain constant over time will policy makers be able to take public preferencesinto account to make sound policy decisions. To date there are no longitudinal studiesdirectly assessing changes in people’s perception of risk regarding technologicalhazards. We investigated, therefore, the stability of people’s risk and benefit perceptionsof biotechnology over a period of two years. The same sample of participantsfilled out an identical questionnaire in spring 2008 and in spring 2010. Results wereanalyzed using structural equation modeling and revealed that risk and benefit perceptionof biotechnology are stable (r = 0.5-0.7). The results of the present studyshow that for a well-known and well-established technology such as biotechnology,people’s perceptions are stable; we would also expect similar results for e.g. nuclearpower since people became familiar with the technology and formed their opinionsover time. In this case, it can be assumed that preferences are not arbitrarily constructedwhen responding to questionnaire questions. In contrast, for novel technologiessuch as nanotechnology, risk and benefit perception might be less stable and it islikely that people construct their opinions at the time of responding to questionnaires.Therefore, risk research should regularly examine people’s risk perceptions in orderto gain a clearer picture of the dynamics of their perception and preferences so thatpolicy makers and risk communication scholars have a clearer picture of the trends inpeople’s perceptions.