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Advisers theNation Sdence, to on Engineering, Medicine ond April 29, 2008 EliasZerhouni, MD Director NationalInstitutes Health of Building 1 9000 Rockville Pike Bethesda,Maryland 20892 DearDr. Zerhouni, At your request,the National Research Council! reconvenedits Committeeon Technical Input on the NIH's Draft Supplementary Risk Assessment and Site Suitability Analyses [DSRASSA]2 to provide you and your blue ribbon panel with further technical input on the scopeand designof any additional studiesthat may be neededto assess risk associated with the siting and operationof the National Emerging Infectious Diseases Laboratory (NEIDL) at Boston University. This new committee is referredto as the Committee on Technical Input on Any Additional Studiesto AssessRisk Associatedwith Operationof the National Emerging Infectious Diseases Laboratory, Boston University. In particular, you askedthe committeeto preparea brief letter report summarizing its views on the scope(e.g., worst casescenarios, alternative sites,biosafety level-3 and- 4 facilities, and selectionof agents)and methodologicalapproaches be taken to to improve any additional risk assessment studiesthat NIH prepares. The committee's full statementof task, as developedwith your office, is provided in the main body of the report. To clarify, in responding to this charge from NIH, the committee did not review the content of previous documents (such as the original environmental impact statement or environmental impact report) or the scopeof what has already been done to address risk and community concerns. This committee restricted its comments to suggestionsbased only on its review of the DSRASSA and on improving the risk assessments presented therein as input to any additional studies that may be neededto assess risk associatedwith the siting and operation of the NEmL. The committeehas largely refrained from prescribing specific methodsand other details, electing insteadto structureits suggestions the blue ribbon panel arounda for lThe principal operating arm of the National Academy of Sciencesand the National Academy of Engineering. 2 list of committee membersand their biographies is included as Attachment A. A

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small number of overarchingquestionsaboutthe risks associated with operatingthe NEillL: What could go wrong? That is, what might be the sequence eventsthat could of causean infectious agentto escape laboratory, set up a chain of transmission, the and causeinfectious diseasein the surroundingcommunity? What are the probabilities of sucha sequence events? of What would be the consequences sucha sequence events? of of The committeebriefly summarizesits advice on thesequestionsbelow. More detailed discussionsare provided in the main body of this report, starting on page6. What Could Go Wrong? Scenarios of Releaseof an Infectious Agent. The committee suggests two-phaseanalysis.The first phaseis risk assessment a basedon a variety of plausible scenariosdesignedto allow a realistic assessment risks associated of with the NEIDL in generaland to illuminate the comparativerisks to the communitiesat the three sites evaluatedin the DSRASSA. In a secondphase,a highly unlikely but still credible high-consequence event could be analyzed.In addition, the committee recommends that discussionsof potential agentreleaseinclude proceduralor work- practice failures, including thosewhich leadto worker exposures and infections; biocontainment-system equipmentfailures; and an appropriatearray of malevolent and actions. What Could Go Wrong? Agents to Consider for Risk Assessment.The committee recommends that for any future assessments NIH selecta variety of agents with appropriatelydiversetransmissioncharacteristics(bloodborne,transmittedon fomites, spreadby aerosol,and/or requiring vectors and the potential for maintenance in existing reservoir species).In addition to portal of entry into the host, suchaspectsof transmissionas high or low Ro,latency, and incubationperiods should be thoroughly addressed. The committeealso believesthat it may be helpful for NIH to clarify for the public and the courts what agentsand forms of agentswill not be researched the at NEillL for reasonsthat are likely to apply in the future. Examplesmay include the virus that causessmallpox and dry, powderedagentsthat are more easily spreadin the air. What Are the Probabilities? The committeerecommends that discussionsof potential agentreleaseinclude probabilistic statements regardingthe three categoriesof releasementionedabove.NIH could updatepreviously generated quantitative measurements safety recordsfor its own and other contemporaryBSL-3 and BSL-4 of laboratoriesover the last 20 years,including considerationof recentaccidentsand exposures, inform the process. to An infectious agent releasecould have a variety of consequences, an and assessment should accountfor them. The committeehas describedfour possiblescenarios that are points along the continuum of possibleconsequences: subsequent no transmission,following a small initial pool of infection; little or no subsequent transmission,following multiple exposures; limited transmissionthat is containedby public health measures; amplified transmission.A basic risk assessment and should begin 2

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with thesefour possibleoutcomes and assess how the characteristics agents of that might be studiedin the NEIDL influencethe likelihood of eachoutcomein the eventof a release.Evena qualitativeanalysisof potentialoutcomeshouldconsiderimpact of the local characteristics example,populationdensity,vector availability, andpublic (for heahhinfrastructure)on the probability of the variousoutcomes. What Would Be the Consequences? IfNIH decidesthat thereis a compelling rationalefor the useof mathematical modelingin any future risk assessments, the modelingmust be donecredibly, transparently, to professional and standards an by experienced teamof epidemiologicalmodelersandmicrobial risk assessors. results The shouldbe interpretedin light of the strengthof the datausedto developthem. Independently the type of approach of used,the model-buildingprocedureandthe procedurefor assigning valuesto parameters needto be clearly laid out andjustified. For example,which parameter valuesare supported the literature,which are estimated by from empirical data,andhow estimates were derivedneedto be transparent clearly and presented. The level of detail in a model shouldbe defended with appropriate empirical data andreference appropriate to scientific literature,andany modelingexerciseshould be accompanied thoroughuncertaintyand sensitivity analyses. by Finally, the committeerecommends NIH usethe accumulated that wisdom in the publishedliteratureon how to achieveeffectiverisk communication. This report reflectsthe consensus the committeeandhasbeenreviewedin of accordance with standard National Research Council procedures (seeAttachmentB). The work was supported staff of the National Research by Council's Boardon Life Sciences: Marilee Shelton-Davenport (studydirector) andFrances Sharples (director, Boardon Life Sciences). The committeethanksthe NIH for seekingits input asthe NIH works to develop resources advancing nationalcapacityto protectandimproveheahh.The for the committeehopesthat its suggestions be useful in this regard.We look forwardto will discussingthis report with you andthe blue ribbon panelon May 2. ~.,J\..,~-- Jo[' Aheame ~~ Committeeon TechnicalInput on Any Additional Studiesto AssessRisk Associatedwith Operationof the National EmergingInfectiousDiseases Laboratory, BostonUniversity