Mount Sinai Lab Accident Report to NIH

DEPARTMENT OF HEALTH 8r HUMAN SERVICES Public Health Senrice Office of Biotechnology Activdie~ National Institutes of Health 6705 Rockledge Drive Suite 750, MSC 7985 Bethesda, MD 20892-7985 (301) 496-9838 (Phone) (301) 496-9839 (Fax) httplloba od nih govloba (it ‘4k, September 2 1,20 1 1 M.S., CIH, CBSP Institutional Biosafety Officer Mount Sinai School of Medicine One Gustave L. Levy Place Box 1155 Atran-Berg Building B2 Room 56D New York. NY 10029 Dear Mr. : Thank you for your September 2,201 1, correspondence to the National Institutes of Health (NIH) Office of Biotechnology Activities (OBA) describing a September 2,201 1, incident in which a researcher at the Mount Sinai School of Medicine was bitten by a ferret that had been previously inoculated with a recombinant form of 191 8 influenza vi&. The inoculation occurred approximately three days prior to this incident. According to your report, the researcher immediately washed the wound with 70-percent alcohol, showered out of the facility, and contacted the biological safety officer. The researcher was examined by the occupational health physician and was administered the 201 1 batch of the Valence influenza vaccine and prescribed a course of Tamiflu. As per Mount Sinai protocol, the researcher was quarantined at home for seven days following the exposure. According to your report, it was verified that the researcher lived alone before being discharged to home-quarantine. The researcher was also instructed to use an N95 respirator if, during the home-quarantine, he needed outside medical assistance. The researcher was also instructed to take his temperature in the morning and evening and report the results, via telephone, to the occupational health physician. The likelihood of illness from th~s exposuie was judged to be remote, but the researcher was monitored until the incubation period for disease had passed. The researcher subsequently showed no symptoms of illness and returned to work on September 9,201 1. The actions taken in response to this incident by Mount Sinai Medical Center appear appropriate. No further information is required at this time. Please contact OBA staff by email at oba@od.nih.gov or by telephone at (301) 496-9838 if you have any questions. Sincerely, ce of Biote,chnology Actiiities Name Name

M.S., CIH, CBSP September 21,201 1 Page 2 cc: M.D., Ph.D., Assistant Professor of Medicine, Mount Sinai School of Medicine Senior Director, Environmental Health and Safety, Mount Sinai School of Medicine Amy P. Patterson, M.D., Associate Director for Science Policy, NIH Allan C. Shipp, Director of Outreach, Office of Biotechnology Activities, NIH Ryan Bayha, Outreach and Education Analyst, Office of Biotechnology Activities, NIH Kathryn Hams, Ph.D., RBP, Senior Outreach and Education Specialist (contractor), Office of Biotechnology Activities, NIH Name Name Name

SeD. 2. 2011 4:3iPM No. 0123 P. 1 DATE - September 2,201 1 TO Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Suite 750, MSC 7985, Bethesda, 0’7-496-9838, 301-496-9839 (fax). MD 20892-7985 (20817 for non-USPS mail), 3 FAX# 301- 496-9839 (fax). SUBJ: Mount Sinai School of Medicine /SA&T Renewal NO. OF PAGES + COVER-I+I COMMENTS: See Attached Letter for information regarding Ferret bite with Modified GMO 1918 Influenza; CDC has also been notified through the Select Agent Program: Expanded contact Info at bottom of letter MS, CIH, CBSP. SM(NRM) Institutional Biosafety Officer Mount Sinai School of Medicine One Gustave L. Levy Place Box 1162 Atran Berg B2-56D New York, New York 10029 2122415169phone 212241 6695Fax Name

Sep. 2. 2011 4:37PId No. 0123 ?, 2 MOUM SINAI SCHOOL I% MEDICINE Institutional Biosafety Program September 2,2011 National Institutes of Health I Office of Biotechnology Greetings: I received a call at @14 58 hrs from stating that he had been bitten by a Ferret, 3 days post- inoculation with a mutant form of the 1918 (Spanish) Influenza. At present he is waiting to be seen by Dr. the Alternate Responsible Official, BSL-3 Director and ID Physician in order to be evaluated. is up to date on his flu shot, and noted that the ferret's incisor barely broke the skin of his left thumb (hands were double-gloved), He immediately washed the slte wlth 70% alcohol, showered out of the facllity as per standard protocol and contacted me. I in turn notified Dr. who will relay back to me his findings. Since this is a genetlcaliy modified Influenza, I have to notify the NIH Office of Biotechnology Activities as well as the Centers for Disease Control. Reallstlcaily, If we were to see an infection it would take two-four days incubation time. Bite-wound inoculation is not a standard exposure route, and stated that the ferret was not morlbund, but to the contrary was energetic and health (not displaying any signs of illness). We will instirute the standard operating procedure of checklng daily for elevated temperature 1 fever, sore throat and the usual flu-like symptoms. wIIl also have to begin taklng Tamiflu prophylactically. Dr. Oaefler stated to me he is on call all weekend as part OF hls rotation in Infectious Disease, and would be able to monitor closely over the weekend if any illness develops. The likelihood is eKtremely remote, but we will not be sure until is past the incubation period without any sequelae. I will keep you updated with regard to any further developments. At present, I will relay exactly what I reported to you to the two agencies. MS, MSHS, CIH, CBSP, SM(NRM) Institutional Biosafety Officer Environmental Health and Safety Tel: 212 241 5169 Pager: Fax: 212 241 6695 6B: 1 Name Name Name Name Name Name Name Name Name Personal Info Personal Info Name

Sep. 8. 2011 ii:43Alvl No. 0137 P. I/? MOUNT SINAI SCHOOL OF MEDICINE FAX DATE September 8,201 1 TO - Ryan T. Bayha outreach and Educatlon Analyst Offlce of Elotechnology Actlvltles Offlce of Sclence Pollcy Natlonal lnstltutes of Health 8706 Rockledge Drlve, Sulte 750 Eethesda, Maryland 20892-7985 (301) 496-9939 (phone) (301) 496-9839 (fax) FAX# -(301) 496-9839 SUBJ: RE, Form 3 Report - -Ferret Bite-9/2/2011 NO. OF PAGES + COVER COMMENTS: Select Agent Form 3 Completed for the incident reported by Fax-and phone. 1+2=3 MS, CIH, CBSP, SM(NRCM) Institutional Eiosafety Officer Mount Sinai School of Medicine One Gustave L. Levy Place Box 11 62 Atran Berg B246D New York, New York 10029 212241 5169phone Name Name

Sep. 8. 2011 11:43AM I. Enliwname: Mwm Slnal School of Medldne No. 0l3i P. 2/3 2. Enlily regblrah number (if appticable): COCO50563 REPORT OF THEFT, LOSS, OR RELEASE OF SELECT (APHISKDC FORM 3) FORN WPAOVEO OWRNO.O6?Q0213 EYP DATE 12Rlmil OME NO- ma578 USDA AGENTS AND TOXINS 3. EnMy address (NOT a posldfce address): One Guslave L. Levy Plate Read all Instrucllons carefully before completing the report. Answer all items completely and type or print In Ink. The reporl must be signed and subrnltted lo elther APHIS or CDC wilhln 7 days of Ihe theft loss or release: 4. Mly: 5. Slale: 6. zipcode: New Yorlr Cily NY 1029 Animal and Plant HealVl InspecUon Sewlce Agncultural Seled Agenl Program 4700 River Road Unit 2 Mailsm 22. Cubicle 1A07 LIST OF SELECT AGENTS AND TOXINS LOST, STOLEN OR RELEASED 20. Wed wls and/or loxjns: 21. Charxle&am 01 egenc A Remshcled 1918 iniluenutvlrus 3dzys poPt lnaulalbn lferrel E Cenlen Iui Disease Conlrol and Prevention Dlvision of Select Agenls and Toxins 1500 CliRon Road NE. MailstOD A-46 latlach additional sheets if riecessaw) n n. Form 24. VdurneorM Numbec (pderAiquidl dvid rmlmls o( wak slant): leg., mL, mg rq) 0 0.00 I Fimt ' M L&L 12122415189 P FAX# 1 10. E-mail address: I 0 25. Dele and Ume Or inddenl; 26. Dale of 1891 invenlory: 19/02/2011 Fbl: Adollo MI: Lasl: Gerda-Saslre 27. Named prindpal inwkalor msponside lor labalmy wiul seled agenfs am5 lodd~s: 30. Bmaleiylevel dlaboraloty urhereirrideflt ~WZJlred:AtlSL3 ~2.Pr~eadelaAedsumm~~eevenlsindudingaLi~neofevenlsamlnameandldaphonenumbetso(agendesno(ified. Thesummaryshouldalso dude dssuiphn olmlainsrs (ag.. she. calor, ~yp. brsnd, and any symbb or mwgs), suppbd'ng dcwmenlaIion (eg., accsfs and inventory ecads). identified weaknesses. wd any COrrBcliw adMm laken (eflsoh addillma1 she& 1 nmrl): recelved a call at @I4 68 hrs Imm staUng !ha1 he had been blllen on Ihe Ish thumb (@ 13 30 hrs by a twrel. which was 3 jays PI- lnoculallon n4lh e mulml form 01 Ihe lala (Spenish) Inhenza. me inu-sarbmke lhrouflh !he double set of flloves and smred !he kin 9nol a deep punclure wound). He provided llrsl ald by expresslnfl he wound and washlw n4th 70% SIhaMI, and showered ouI 01 Ihe EPF adllly as per pmloml. He was seen by Dr. Ihe Allemale Respanslble OMcial. BSLJ Direclor and IO Physician who starled Dr. on Tsmlllu and admlnlslered he newly remked InIluenza vacdne (2011 valsnce) that Is belng admblslered 10 h8alIh care providers. receNed Ihe mandalory Ilu wdne In Oclober. 20101. As of today ( 9l712011) there have been IM sequelae. howevsr he is in luaranllne unlll9f7C2011 and repwung hls health slalus Woe per dlsm lo Df. Shn Daener Name Name Name Name Name Name Name Name

Sep. 8. 2011 li:44Alrl No. 0137 P. 3/3 I SECTION 3-IF THE INCIDENT OCCURRED DURING TRANSFER PROVIDE THE FOLLOWING INFORMATION AND 1 INCLUDE A COPY OFTHE RELEVANT APHISICDC FORM z 33. Transfer aulhomallon nu& lrom PSHIYCM: Form '2 ] 34. Daleshipped I I .. SEGTlON 4 -TO BE COMPLETED ONLY FOR RELEASE OF SELECT , . .AGENTS AND TOXINS ' ' .. 42. Hazards pas& by release: ONo Yes (IIYes, explain. Nikh addilional sbk ilnecesswy.) PMenllal lor lnledlon vllh 1916 Innuma; mule of exposure and load oipolenUal1918 lnflusnza vlrus has Illlk, polenllal Io came an ache inklion. Nonelheless. lhia inddenl Is balng [racked as a SlgnlRcanl exposure unUl Ihe full 7 days 16 reached. 43. Exp~ures: )J No One tndlvldusl wa6 bilh by an inwlaled ferrel, Mays posl lnoculaUon. kYes (If Yes. podde numbetd pwons. animals. and plwls expmsd. AI& addihal she& if neeessay) 44.Areawasdmlaminat~&~No IndMdual probided Immsdlsle wound deanlng end enliaepsls, fdkwed by mandatory 8hwer.wt deeaniarnlnaUan. W Yes (If Yes, explain. All& sddilhal 5heels if necappq.) 45. hWimlVsshmenlwprovided-UNo WYes (Ifyes. e*plain.Al(achad&alsheeisifnecess;uy.) TamlRu reglman pIm Inowlallon rvNl2011 Vslence InRuenra Vawine. I hereby carlify lhal he inbmwMn mlained on his lorn is we md ~ecl Io he kld my hauledge. I underslmd ihal if I kwngiy poMe a fake siakmmian any par( of lhis rmmenL I hurlher undersland Ulat riolh of 7 CFR 331.9 CFR 121, and 42CFR73 Signalure of R~spomlenl: TNs: 0lasefely ohioer and RO Typedoc plnied nmeolRespondenl: MS. MSHS. CBSP, SM[NRCM) Dale: 0910712011 Publk reportlng burden: PuMic reponing burden d voMrm~ lhls InlocrnaGon Is eslimMed la awqe 1 hour per rplponsa, iMding Ihe Lime for renw inSkuAbi~? searchha exisling dala SWOBS. galhering aod mainlairing Ule dala needed. and mmpleling and rebieuing he mlledicn dinfmaiion. An agen~maynoimnd~ar5ponsoc,andapersoni3~requiredloregpondtoacd~ofinfarma~uvnlessild~playza~~en~v~M~Beoolrd number. Send mffUnBnlS regarding vlls burden eslimme OT any her aspld lhis mledan of infarmaha induding suggesbons IofreducinQ lhls burden io CDUATSDR Reports Clearanra offlcec 1WXI c61lon Road NE. MS D-74, Mania, Gqia W; ATTN PRA (09200576). APH~FORM3(12nlR(lll) Name Name