Table Of Content

r' - I sics safety Objectives • Review regulations and biosafety levels • JSC Biosafety Facilities • Biosafety cabinet usage and maintenance • Exposure and Spill Clean-up • Training requirements Slide 2 of 65 . - ;' Biosafety Regulations • NASA Procedural Requirements (NPR) 1800: NASA Occupational Health Program Procedures, Section 4. 1.1 Biosafety - mandates compliance with CDC BMBL, ICAO, IATA Acronym IABSA—American Biological Safety Association CDC- Centers for Disease Control IBMBL — Biosafety in Microbiological and Biomedical Laboratories GAO — Government Accountability Office CAO — International Civil Aviation Organization HHS — Health and Human Services IATA- International Air Transport Association NIH — National Institutes for Health USDA— United States Department of Agriculture i WHO — World Health Organization Slide 3 of 65 . - ;I, National Actions Subcommittee on Oversight and Investigations October, 2007 q American Society for Microbiology: q Need to ensure adequate biosafety training q Strict Compliance with NIH Guidelines and BMBL (CDC/NIH) GAO report called for: q Train lab staff in general biosafety q NIH and CDC Testimony: q Establishment of a Trans-Federal Task Force on Optimizing Biosafety Oversight, consisting of representatives of a broad range of Federal agencies concerned with biosafety risks q Biosafety Curriculum Development and Biosafety Training q Individuals with Certification r q Institutions with Accreditation . - ;I, Biosafety Regulations • CDC/NIH Biosafety in Microbiological and Biomedical Laboratories • NIH Guidelines for Research Involving Recombinant DNA Molecules • OSHA Bloodborne Pathogen Standard • ICAO/IATA/DOT Transportation of Hazardous Materials Slide 5 of 65 .- ;I, Select Agent Regulations • Since September 11, 2001, two major pieces of legislation, the USA PATRIOT Act of 2001 and the "Public Health Security and Bioterrorism Preparedness Act of 2002" have changed the law governing the possession, use, and transport of etiologic agents. • A current list of select agents and other updates may be found at the CDC Office of the Director Select Agent Program website, http://www.cdc.gov/od/sap/index.htm. • Civil penalties for violating the regulations may amount to $250,000 for an individual. • Criminal penalties include a fine or imprisonment up to five years for possession without registration or transfer of a select agent to an unregistered individual. ^J Slide 6 of 65 . - ;' Select Agent Regulations Select Agents - Microorganisms and toxins that have the potential to pose a severe threat to public health (humans, animals, and plants) and safety. - The use and transfer of select agents is regulated by HHS and USDA. 1) HHS SELECT AGENTS AND TOXINS - Yersinia pestis, Ricin 2) USDA SELECT AGENTS AND TOXINS - Foot-and-mouth disease virus 3) USDA PLANT PROTECTION AND QUARANTINE SELECT AGENTS AND TOXINS Slide 7 of 65 . - ;I, Genetically Modified Materials • NIH Guidelines for Research Involving Recombinant DNA Molecules • JSC Biosafety Review Board Form 644 Slide 8 of 65 . - ;' More Information on Regulations Area Specific Plans - OMOHC Tuberculosis exposure control plan, Wyle BBP Program and Wyle Chemical Hygiene Plan For links to the national and international guidelines and regulations - http://www.absa.org Under resources and tools - Key topics and links ^J Slide 9 of 65 ^. - (I• How Does Biosafety Impact Us? Career -Suspension of Work - Texas A&M Incident M tdt Yavt fmrorax rmlt Nib Gpogit ){Gr - ee ••^ 8 - 4 aw,,.,i,- ,^e•ea:I.a •'=owdr- - blaww,. ^:w,aw- d Js.rvm- >^ dY p►cewe»mcrnrpemt wakdk rexx aeH wedef... — — rl p^ •;;}.er•=;y radr- ^^w CIDRAP . CE5C suspends work at Texas ARM bic,diafznse fah 1Dd2 (1..IDRAP Newa) - Thw u, C.— r.4 rnr nwnaee C.nn , andPrevnn Nan (---) on fun .. —11-a bod-1— re rrh labnra tnry a1 T.— ARM Ilnwonuy 1,,—P ae wndc nn xwlnct agantx and toxrnF whae mw CDC. ,nvev t,R,a tec reportx of lab workarF mr.e tea wpm m. catecory R biotartnr a2anta Rnr^n !!a and Coxrafla lwrneth. The allepetl lab acctdenta, abng with related alleged —1.bone of federal law,w endy reported by the S—hlne Prolec t, an A—tr,, Texas, rwnpraht croup ma tm onitors b,adefense fesearch safety. The croup used Tesae freedom or mloimaVOn requests to obtainedocuments ab-1, the lab mclden Le. In April, the Pr uN,L rapor Led that a Texas AlW re Ich., had been iii lec Led w,m grusvMa otter a re bl.ary 2006 a oxd chmarer mruhap and V,.L the scho.1 did not ncdratdy rmbly Llrc CDC es rcpwrcd by lecic,al few. F., days ag, the wal^l,dog y,.uy repo. [cd that the xp-- 0 th— .tiro lr-- A&M w.,kars to C butdctb, wl—l. causes Q lever, wee c.nlrmed n Apnl 2006 but also was not reported Lo the CDC. I In Sunvhinu Pr-ject s.d itc rival —th or I.— A6M coon ubuut througA itv royiow of s.l.dl-ugmt l^bc lhut uro vying la host lho fvd—i goyernmcn t': plunn d new national biod.for— r-01it y, ccardi.rg t. a hn 2 s rap., t er mL —N,,raur. iriy rww-. the laboratory is affiliated with die Foreign A mat and —tic u, Defence Center, a,Dopaortnmt of womoland s W (D—)) c of excellence Mat fecucec an the study of foo Cand-mouth di to-e. avian in Ruanxa, and rl," Valley (aver , according to the canter: Web :ita, the —1.1 is funded by an Ste -N. DNS grant, according to an Associated IYaa,t report yos today. AccnrAvrg to the Lnshinr; rr.j—t. T.... —M nntifid me eW .rib.- thr- Arx,rlMb nfection m Apnl 2001, a yc,r off— thewnA.r'., ill.:., woo rre,firmnd. SMrdy aNar hTo.v ,aa AAM reportrl ma Rnr.v!!a iMwchon, raprocen to hve< fmm the fllf'c SW." Agents anA Tnnna DiyrFinn n.pec teA m1a -11-—1—yaynd, n a 1n 1. mn n, rrb[aneA anA rWoacod by r,nchino oro)er. r, rxderod rho lair to crop ire wnrk m all colacr agonrc and tasvrc ,nril fiemwr nedce. Van Roebuck, a CDC Spokesman, told CIDRAP News that the agency has never Issued such a broad suspension order to a lao oelnre. 419 said me Sun 3e order applies to every agent the lib works with. The list or ahecled aoents Is not public Information because of security concerns, Roebuck Said, In Uri )u„ 00 MLter. the CDC ..Haled !Incwtcerns iL hea about Lln lob, .1—h mclude LP-ode RU of biosale Ly dads. security of the lacity Iran —.U--d —&642, .eeupabanal safely protocols, 0 --U— f.rn tho Co 1. work w,th u—L... agents, rid c mpkence wrU. Iede,al select agent r Ld b.— thr buck 111d CDC .Ifrciuls will v liL mu xus labu,.,[wy .ryuirrim, dro nuxt row --kc m gutlwr „n.r .,r—n—, A— iu, procodurr- and proc—I, -Tenn rho ugcnuy vial novo forward with any reu.mmulWaVana Lo get u—, und- compi—ce; Ito -W. !n --e—en; sent to Y..;rt Agora faculty arc ¢"ff Y,—dl', Cho t4h.d'c incnim Procidont. kddo J. Vavit. taid aha lab—p,, cid— did nor pafc a rhreur Lo unyorn on or .fr Slide 10 of 65