complexity of the problem <strong>for</strong>mulation. This open process encouraged interactionamong all workshop participants, which was critical <strong>for</strong> in<strong>for</strong>mation sharing amongthe participants and remarkably successful. It was clear that moving towards a moredata-in<strong>for</strong>med risk assessment process and early incorporation of mode of action(MOA) as a centrality <strong>for</strong> risk assessment were generally viewed as key improvements,when directed by the particular problem <strong>for</strong>mulation. In addition, as MOA becomesmore predictive, it will help drive appropriate data collection and identify key issuesin problem <strong>for</strong>mulations. A publicly available compendium of the acceptable doseresponseassessment methodologies will represent a key work product of these workshops.M3-E.1 Pouillot R; Regis.Pouillot@fda.hhs.govFood and Drug AdministrationLOTS OF BACTERIA - FEW CASES: REOPENING THE LISTERIADOSE-RESPONSE MODEL BLACK-BOXListeriosis is a rare disease with regard to its relatively high frequency of isolationin food. The two major dose-response models scaled on epidemiological data <strong>for</strong>Listeria monocytogenes were developed by FDA/FSIS/CDC in 2003 and by FAO/WHO in 2004. Since then, knowledge on the bacteria, the host and their interactionhas increased, notably concerning the physiopathology of the infection, the virulenceof the strains and/or the susceptibility of individuals. New data from experimentalinfections on animal models are also available. Be<strong>for</strong>e developing new dose-responsemodels, it is necessary to better understand how the previous ones were developed:the FDA/FSIS/CDC model uses a dose-response shape from a mouse model. It thenconsiders a very large variability in strain virulence and in host susceptibility. A scalingfactor of ca. 10 log10 is eventually needed to reconcile the model with epidemiologicaldata; the FAO/WHO model is a simpler exponential model scaled on epidemiologicaland exposure data. It does not consider other variability component than theone of a classical exponential model. With the current knowledge, the way to reconcileexposure and epidemiological data in risk assessment models is to consider thatthe average probability of illness <strong>for</strong> a random individual exposed to a given dose ofuncharacterized Listeria monocytogenes is extremely low. The dose-response modelsissued from animal models cannot be used directly <strong>for</strong> risk assessment without largelyoverestimating the number of cases. Obviously, some combinations of high strainvirulence, high individual susceptibilities and other factors in the interaction Listeriahostlead to some occurrences of higher probabilities of illness <strong>for</strong> a given dose.These factors should be better characterized to better evaluate these risks of illness.160W4-E.4 Powell M; mpowell@oce.usda.govUS Department of AgricultureHOW DO YOU MODEL A “NEGLIGIBLE” PROBABILITY UNDERTHE WTO SANITARY AND PHYTOSANITARY AGREEMENT?Since the 1997 EC - Hormones decision, World Trade Organization (WTO)Dispute Settlement Panels have wrestled with the slippery question of what constitutesa negligible risk under the Sanitary and Phytosanitary (SPS) Agreement. Recently,the 2010 Australia - Apples decision focused considerable attention on theappropriate quantitative model <strong>for</strong> a “negligible” probability statement in a risk assessment.Responding to previous criticism in the 2000 WTO Australia - Salmon case<strong>for</strong> using narrative terms such as “negligible,” “extremely low,” and “very low” toqualitatively describe likelihoods, the 2006 Australian Import <strong>Risk</strong> <strong>Analysis</strong> <strong>for</strong> Applesfrom New Zealand used quantitative ranges <strong>for</strong> such terms. The uncertainty abouta negligible probability was characterized as a uni<strong>for</strong>m distribution with a minimumvalue of zero and a maximum value of one in one million. Based on considerationof expert testimony, the 2010 WTO Panel in Australia - Apples found that the use ofthis uni<strong>for</strong>m distribution would tend to overestimate the likelihood of “negligible”events and suggested that a triangular distribution with a most probable value ofzero and a maximum value of one in one million would correct the bias. The Panelobserved that the midpoint of the uni<strong>for</strong>m distribution is 5 in 10 million, but it didnot consider that the triangular distribution has an expected value of 3.3 in 10 million(with a midpoint of 2.9 in 10 million). There<strong>for</strong>e, if using the triangular distribution isthe appropriate correction, the magnitude of the purported bias appears modest. ThePanel’s detailed critique of the Australia - Apples risk assessment, and the conclusionsof the WTO Appellate Body (which hears appeals from reports issued by Panels)about the materiality of faults with the risk assessment found by the Panel, may haveimportant implications <strong>for</strong> the standard of review <strong>for</strong> risk assessments under theWTO SPS Agreement.M4-G.4 Powers C, Gillespie P, Davis JM; davis.jmichael@epa.govNational Center <strong>for</strong> Environmental Assessment, US Environmental Protection AgencyLIFE-CYCLE BASED APPROACHES FOR EVALUATING CARBONNANOMATERIALSLife-cycle based approaches <strong>for</strong> holistically evaluating the environmental implicationsof emerging nanotechnologies have become generally recognized as important.Although several life-cycle assessments (LCAs) of carbon-based nanomaterialsin recent years have offered valuable insights <strong>for</strong> the sustainable developmentof carbon-based nanotechnologies, LCAs typically have limitations in design and inimplementation that can omit important factors from consideration. In this presentationwe highlight various LCAs of carbon nanomaterials and compare them to an alternativelife-cycle based approach known as Comprehensive Environmental Assess-
ment (CEA), which provides both a framework <strong>for</strong> systematically organizing complexqualitative/quantitative in<strong>for</strong>mation and a process to evaluate such in<strong>for</strong>mation usingcollective judgment. The CEA framework encompasses the inception of the materialor product, environmental fate (transport/trans<strong>for</strong>mation) of releases during theproduct life cycle/value chain, exposure-dose of biotic and abiotic receptors, and impactsof both primary materials and secondary by-products. The CEA process buildson the in<strong>for</strong>mation compiled in the framework and uses collective judgment methodsincorporating diverse technical and stakeholder perspectives to evaluate the implicationsof complex and incomplete in<strong>for</strong>mation. Although CEA can be applied <strong>for</strong>both research planning and risk management purposes, in this presentation we primarilyfocus on how CEA differs from LCA as an assessment approach <strong>for</strong> evaluatingthe environmental implications of carbon nanomaterials. Disclaimer: This abstractdoes not necessarily represent the views or policies of the U.S. EPA.M4-J.5 Pradhan AK, Latorre AA, Van Kessel JS, Karns JS, Schukken YH; akp@umd.eduUniversity of Maryland, University of Concepcion-Chile, USDA/ARS-Beltsville, Cornell UniversityQUANTITATIVE RISK ASSESSMENT OF LISTERIOSIS DUE TO CON-SUMPTION OF RAW MILKThe objectives of this study were to estimate the risk of illness due to L. monocytogenesin raw milk sold by permitted dealers, and the risk <strong>for</strong> people on farms whoconsume raw milk. Three scenarios were evaluated <strong>for</strong> raw milk sold by dealers: rawmilk purchased directly from bulk tanks, from on-farm stores, and from retail. To assessthe effect of mandatory testing of raw milk by regulatory agencies, the numberof listeriosis cases per year were compared where (i) no raw milk testing was done,(ii) only a screening test to issue a permit was conducted, and (iii) routine testing wasconducted and milk was recalled if it was L. monocytogenes positive. A greater riskof listeriosis was associated with consumption of raw milk obtained from retail andfarm stores as compared with milk obtained from bulk tanks. This was likely due toadditional time-temperature combination steps in the retail and farm store models,which increased the chances <strong>for</strong> growth of L. monocytogenes in raw milk. A closerelationship between prevalence of L. monocytogenes in raw milk and the values ofdisease incidence was observed. Hence, a reduction in the number of cases per year inall populations was observed when a raw milk-testing program was in place, especiallywhen routine testing and recalling of milk was conducted.T4-C.2 Price PS, Juberg DR; pprice@dow.comThe Dow Chemical CompanyAPPLICATION OF A SOURCE-TO-OUTCOME MODEL TO QUANTI-TATIVELY ASSESS VARIABILITY IN DOSE AND SENSITIVITY IN HU-MANSA source-to-outcome model was created <strong>for</strong> dietary exposures of chlorpyrifosby linking probabilistic dietary exposure models with a PBPK/PD model of an earlykey event in the toxicity pathway <strong>for</strong> the cholinergic effects of the compound. Thismodeling addresses several concerns raised in Chapter 5 of the NAS report “Scienceand Decisions”. First, the modeling goes beyond the margin-of-exposure or hazardindex approaches used in traditional non-cancer risk assessments and provides in<strong>for</strong>mationon the fraction of the population affected by a given dose (i.e., exposure). Second,the model allows the quantitative investigation of inter-individual variations inboth exposure and response (variation in sensitivity) <strong>for</strong> different age groups (adults,children, and infants). Third, by focusing the modeling on an obligatory change thatoccurs early in the toxicity pathway, the model avoids the complexities and uncertaintiesin modeling the occurrence of apical effects. One important finding from theproject is that while there are background rates of some apical effects of chlorpyrifos,current dietary exposures to humans are not predicted to cause any change in the frequencyof these apical effects in marginal populations. This suggests that a low-dosenonlinear individual and population dose-response model is most appropriate <strong>for</strong> thiscompound.M4-D.4 Rak A; andrew.rak@noblis.orgNoblisNAPHTHALENE DOSIMETER FOR ASSESSMENT OF EXPOSUREFOR FUEL HANDLERS: A CASE STUDYThe identification of an emerging chemical is only the first step in a multi-stepsequence used by the Department of Defense (DoD) to manage risks from emergingcontaminants. Once a chemical is identified, the time and resources required to identifyand implement solutions to address potential risks can be significant. The case ofnaphthalene demonstrates the long lead time required to identify and implement riskmanagement actions (RMAs) to address those risks presented by the changing regulatorylandscape. Naphthalene was one of the first emerging contaminants to be identifiedby the DoD’s scan-watch-action process and it remains on the DoD’s Action Listof high priority emerging contaminants. The potential change in the regulatory categorizationfrom a “possible” to a “likely” human carcinogen could have a substantialimpact on how DoD manages occupational exposure to fuel. Jet fuel (JP8), which isa universal fuel <strong>for</strong> most military equipment, contains 1-3% naphthalene by weight.According to the National Academy of Sciences, fuel is the single largest source ofchemical exposure to DoD personnel. At the same time that regulators are evaluat-161
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