Kennesaw State University Biological Safety Manual

Transcription

1 Envirnmental Health & Safety Bisafety Manual EOSMS 203 Effective Date: REV: 1.0 Page 1 f 64 Kennesaw State University Bilgical Safety Manual Wrking with Bilgically Hazardus Materials in the Lab

2 Cmmn Acrnyms Used A. KSU Kennesaw State University B. USG University System f Gergia C. IBC Institutinal Bisafety Cmmittee D. IACUC Institutinal Animal Care and Use Cmmittee E. EHS Department f Envirnmental Health and Safety F. BSO Bisafety Officer G. PI Principal Investigatr H. NIH Natinal Institutes f Health I. OBA NIH Office f Bitechnlgy Activities J. ABSA American Bilgical Safety Assciatin K. NASBB Natinal Advisry Bard n Bisecurity L. DURC Dual Use Research f Cncern M. OSHA Occupatinal Safety and Health Administratin N. OCGA Official Cde f Gergia O. GAEPD Gergia Envirnmental Prtectin Divisin P. EPA Envirnmental Prtectin Agency Q. USDA United States Department f Agriculture R. APHIS Animal and Plant Health Inspectin Service S. CFR Cde f Federal Regulatins T. CDC Centers fr Disease Cntrl U. BMBL Bisafety in Medical and Bimedical Labratries V. RG Risk Grup W. BSL Bisafety Level X. ABSL Animal Bisafety Level Y. BBP Bldbrne Pathgens Z. OPIM Other Ptentially Infectius Materials AA. LAI Labratry Acquired Illness BB. BSC Bisafety Cabinet CC. SOP Standard Operating Prcedure DD. IPM Integrated Pest Management EOSMS-203 KSU Bisafety Manual Page 2

3 Kennesaw State University (KSU) is cmmitted t prviding and maintaining a safe teaching, learning, living, and wrking envirnment fr all members f its cmmunity. Labratries are unique wrk envirnments that entail a variety f peratins and activities, invlving wrking with hazardus materials. Labratry persnnel, therefre, are at risk f expsure t varius types f hazards, including chemical, bilgical, physical and radilgical. Hwever, with prudent labratry practices, apprpriate equipment, prper facilities and awareness, all labratry peratins can be handled safely, withut undue risk t KSU s emplyees, students, prperties r the envirnment. The respnsibility f ensuring a safe labratry envirnment at KSU is a shared respnsibility between labratry persnnel, administratrs and Envirnmental Health and Safety (EHS) persnnel. Nevertheless, labratry supervisrs, principal investigatrs (PIs) and managers have the primary respnsibility fr safety in labratries under their supervisin, and fr ensuring cmpliance with the applicable health, safety and envirnmental regulatins and plicies with their labs. The KSU Bisafety Manual is intended t prvide guidance t all faculty, labratry persnnel and students n hw t minimize r eliminate the ptential fr expsure t bilgical hazards while wrking in the labratry. The infrmatin presented here als reflects the requirements and guidelines prescribed by the federal gvernment and the state. It is intended that the PI and supervisry persnnel will supplement this infrmatin with instructin and guidance regarding specific practices and prcedures unique t the wrk being dne in their labratries. This manual will be reviewed, and revised as necessary and at least annually. EOSMS-203 KSU Bisafety Manual Page 3

4 Cntact Infrmatin Envirnmental Health & Safety (EHS) Tel: (470) Fax: (470) ehs.kennesaw.edu Web: Bisafety Officer (BSO) Rdrick Esaw, MPH, ASP (470) Institutinal Bisafety Cmmittee (IBC) Bihazard infrmatin; Labratry spills r accidents invlving bilgical agents; Bilgical safety cabinets; Recmbinant DNA guidelines; labratry spills r accidents invlving chemicals; Chemical hygiene plan; Permits Hazardus waste dispsal (chemical, txic, animal); Shipping Requirements; Ventilatin (HVAC) prblems; Fume hd peratin; Labratry safety design Research animal use Bldbrne pathgens training and infrmatin Public Safety, Security and Emergency Management (KSU Plice) resaw@kennesaw.edu Dr. Charles Amlaner VP f Research Tel:(470) Fax: (470) camlaner@kennesaw.edu Web: Rdrick Esaw, MPH, ASP Labratry Safety Manager and Bisafety Officer (470) Vanessa Biggers Chemical Safety Manager Tel: (470) vbigger1@kennesaw.edu Plant Operatins/HVAC Shp Tel: (470) Web: web.kennesaw.edu/plantps/ Dr. Jared Taglialatela, Chair, IACUC (470) Web: dex.html#sectin-4 Rdrick Esaw, MPH, ASP Labratry Safety Manager and Bisafety Officer (470) Public Safety Department Emergency: (470) Nn-Emergency: (470) *Fr the mst current cntact infrmatin, access the EHS website at EOSMS-203 KSU Bisafety Manual Page 4

5 Table f Cntents 1. Purpse and Scpe... 9 A. Purpse...9 B. Scpe Respnsibilities... 9 A. The University...9 B. Deans C. Department/Schl Chairpersns D. Institutinal Bisafety Cmmittee (IBC) E. Envirnmental Health & Safety (EHS)/Bisafety Officer (BSO) F. Principal Investigatrs (PIs) G. Labratry Managers/Labratry Supervisrs H. Emplyees Wrking in the Lab Regulatry Requirements Dual Use Research Risk Management A. Risk Management Steps B. Risk Grups Risk Grup Risk Grup Risk Grup Risk Grup Rutes f Infectin and Expsure Surces EOSMS-203 KSU Bisafety Manual Page 5

6 A. Clinical and Pathlgical Specimens B. Cultures C. Animals D. Latex Glves and Related Allergies Labratry Expsure Ptential A. Teaching Labratries B. Research Labratries C. Clinical Labratries Bisafety Levels and Labratry Practices A. Bisafety Levels Prcedure fr Laundering Labratry Prtective Clthing B. Bisafety Cabinets C. Centrifuge Operatin D. Wrking with Sharps Sharps Safety Waste Handling and Dispsal Prcedures E. Cllectin f Bilgical/Bihazard Waste F. Decntaminatin and Dispsal f Bihazard Waste G. Autclave Use General Autclave Operatin Rules H. Autclave Validatin Odr Cntrl Training EOSMS-203 KSU Bisafety Manual Page 6

7 Recrd Keeping INFORMATION AND TRAINING A. EHS Required Training B. Additinal Training Requirements Incident/Emergency Respnse A. Emergency Prcedures B. Reprting f Incidents/Emergencies C. Pst-Expsure Evaluatin and Fllw-Up Decntaminatin f Bilgical Spills A. Spills in the Bisafety Cabinet B. Spills in Incubatrs C. Spills in Centrifuges D. Spills Outside f the BSC Medical Surveillance Prgram A. Health Status B. Medical Surveillance C. Immunizatins D. Medical Restrictins Pregnancy Other Restrictins Labratry Design Equipment Repairs/Service Animal Bisafety EOSMS-203 KSU Bisafety Manual Page 7

8 16. Plant Bisafety Pest Cntrl Appendices EOSMS-203 KSU Bisafety Manual Page 8

9 1. PURPOSE AND SCOPE A. Purpse This dcument will fcus n the regulatry requirements and best practices fr the safe handling and manipulatin f bilgical hazards encuntered when wrking in research labratries in KSU facilities. The infrmatin prvided is based upn the Natinal Institutes f Health (NIH) Guidelines fr Research with Recmbinant DNA Mlecules, the Occupatinal Health and Safety Administratin (OSHA) Bldbrne Pathgen Standard (BBP) (29 CFR ), and the best practices fund in the Centers fr Disease Cntrl s Bisafety in Medical and Bimedical Labratries, 5th Editin (BMBL). B. Scpe The KSU Bisafety Manual is applicable t activities in all facilities wned, leased r perated by KSU, where KSU emplyees and students wrk with bilgical r bihazardus agents and/r their derivatives. These agents include, but are nt limited t: Bacterial, fungal, and/r parasitic agents Viral agents/viral vectrs Recmbinant DNA (rdna) Materials f human rigin (including bld, bld cmpnents, cells, cell lines, DNA, bdily fluids, and tissues) Bilgical txins The manual applies t all faculty, staff, students, cntractrs and ther persnnel at KSU r under the management r cntrl f KSU. 2. RESPONSIBILITIES A. The University KSU has an bligatin t prvide a wrkplace fr its emplyees that is reasnably safe frm all recgnized hazards, including bilgical hazards that culd cause illness in expsed individuals. Therefre, KSU has instituted a bisafety prgram fr all persnnel wh may be expsed t bilgical hazards (bihazards) during the perfrmance f their duties. Under the bisafety prgram, the University assumes the fllwing respnsibilities: Appinting a Bilgical Safety Officer (BSO) fr the institutin. Ensuring apprpriate training is prvided t persnnel cnducting research with bilgical/bihazardus agents (e.g. bldbrne pathgens, bacteria, viruses/viral vectrs, rdna). Ensuring that research is cnducted in accrdance with the NIH Guidelines, Center fr Disease the BMBL, the OSHA BBP Standard, and all Gergia State laws. EOSMS-203 KSU Bisafety Manual Page 9

10 Establishing an Institutinal Bisafety Cmmittee (IBC) and an Institutinal Animal Care and Use Cmmittee (IACUC) with apprpriate expertise and training. Establishing and implementing plicies fr safe cnduct during research activities invlving bihazards and recmbinant DNA. Prviding adequately designed facilities and cntainment devices fr wrk with bilgical agents. Prviding apprpriate persnal prtective equipment (PPE) fr emplyees. Making the necessary vaccinatins available (thse which prtect the emplyee frm wrk related illness) at n cst t all emplyees. Establishing and maintaining a health surveillance prgram fr persnnel. Reprting any significant prblems, vilatins, r significant research-related accidents r illnesses t the NIH Office f Bitechnlgy Activities (OBA) within 30 days. B. Deans Creating visin, enfrcing plicy, setting perfrmance expectatins, and ensuring timely availability f resurces that supprt bisafety at KSU. Prviding leadership t ensure effective implementatin f the bisafety prgram and ensuring the Cllege s cmpliance with gverning laws, regulatins, and plicies. T this end, Deans may designate a safety fficer(s) within the Cllege/Schl. Reviewing labratry and safety-related assessment reprts as a mean t assess and direct actins necessary t cntinually imprve bisafety at the Cllege/Schl. *Nte: This applies nly t Deans that versee clleges and departments where bihazards are used in teaching and research. C. Department/Schl Chairpersns Setting perfrmance expectatins, managing bisafety risks, and ensuring the Department s cmpliance with this prgram and ther Envirnmental and Occupatinal Safety (EOS) gverning laws, regulatin and plicies. Effectively implementing KSU s bisafety prgram and its requirements within their respective units and labratries. As apprpriate, incrprating the bisafety prgram requirements and respnsibilities int emplyee jb descriptins and address perfrmance related t the same. Ensuring that individuals under their supervisin, including but nt limited t supervisrs, regular and temprary emplyees, cntractrs, and ther affected persnnel, btain required bisafety training. Develping a prcess t maintain incident/illness preventin and envirnmental prtectin prgrams within the department. EOSMS-203 KSU Bisafety Manual Page 10

11 Ensuring prmpt reprting and apprpriate investigatins f incidents/accidents within the unit, in accrdance with the University s Incident Reprting and Investigatin requirements (EOSMS-108). Ensuring develpment and implementatin f a prcess fr cnducting hazard/risk assessments within their respective unit r labratry inclusive f peridic safety inspectins f wrk areas and/r facilities and ensuring nn-cmpliance items are crrected with fllw-up and clsure. Ensuring assessment f the envirnmental and ccupatinal safety impact f bilgical agents and/r bihazards, prcesses and equipment, and incrprate apprpriate cntrls. D. Institutinal Bisafety Cmmittee (IBC) In accrdance with NIH Guidelines, The IBC shall be established as fllws: It shall be cnstituted f a minimum f five (5) vting members; Cllectively, the membership shall have experience and expertise in bihazardus materials and recmbinant DNA technlgy; and The membership shall have the capability t assess the safety f bihazardus and recmbinant DNA research and identify any ptential risks t public health r the envirnment. The IBC shall include at least ne individual with expertise in micrbial pathgens and rdna cntainment principles. The IBC shall have at least tw members unaffiliated with the institutin (apart frm their membership n the cmmittee) and they shall represent the interest f the surrunding cmmunity with respect t public health and prtectin f the envirnment. All appintments t the cmmittee shall be fr three-year terms. Members shall be appinted, r reappinted, by the Vice President f Research r designee. The cmmittee s current membership may be btained by cntacting the Office f Research at (470) Additinal duties regarding the IBC are utlined in the IBC Charter and Prcedures Manual. Under the KSU Bisafety Prgram, the IBC is respnsible fr: Lcal versight and review f activities that use the fllwing ptentially bihazardus materials r prcedures: Recmbinant r synthetic nucleic acid mlecules (rdna/rna) Select agents and txins, as determined by the Federal Select Agent Prgram (apprval f research invlving these activities is cntingent upn their apprval and registratin with the Federal select agent prgram see Other Regulatry Requirements ) Bilgical agents that require Bisafety Level 2 cntainment r higher, including agents in Risk Grup 2, 3, and 4 EOSMS-203 KSU Bisafety Manual Page 11

12 Bld brne pathgens (frm human and nn human primates) All ther bilgical agents that can cause disease in humans Stem cell research Bilgical Nantechnlgy (e.g., drug delivery via nanparticles, etc.) Imprting/Exprting f etilgic agents (which require BSL 2 and r BSL 3 cntainment) int/ut f the campus Xentransplantatin Recmmending r prescribing, and publishing fr the KSU cmmunity, the apprpriate requirements, cnditins, and restrictins necessary (e.g. training, vaccinatins, wrk practices, cntrl measures, PPE, etc.) accrding t NIH guidelines; federal, state, and lcal laws and regulatins; and University System f Gergia (USG) Plicies. Certifying and assigning investigatrs/teachers/wrkers, their labratries r ther wrkspaces, and/r their practices fr wrk, at apprpriate bilgical safety levels prescribed in the latest editin f the BMBL. Activities identified as Bisafety Level 2 (BSL-2) and greater may nt prceed withut the written cnsent f the IBC prir t initiatin f wrk. Reviewing and apprving prtcls/prpsals fr research invlving bilgically hazardus agents. Ntifying each applicant f the IBC s decisin regarding his/her prtcl(s)/prpsal(s) Cnducting annual reviews f prtcls/prpsals and recertificatin every three years fr activities listed in sectin IIB t ensure cmpliance with NIH guidelines and all federal, state, and lcal regulatins and USG plicies. Keeping the KSU cmmunity aware f any changes/updates in the NIH guidelines, laws, plicies, and regulatins assciated with bisafety. Reviewing reprts frm the Bisafety Officer cncerning instances f urgent issues, including persnnel expsure, lss/theft f bilgical agents, breaches in bisafety cntainment, and accidental spills invlving rdna, synthetic nucleic acids, and ther bihazards; reprting such instances t the NIH and regulatry agencies as necessary. *Reprtable incidents must be reprted t NIH/Office f Bitechnlgy Activities within 30 days Overseeing the mnitring fllw up f thse persns testing psitive fr identified pathgens resulting frm cnfirmed labratry acquired infectins. Implementing crrective actins when KSU plicies, NIH Guidelines, federal, state, and/r lcal regulatins are nt fllwed. These actins may include (nt limited t): Terminating f authrizatins Restricting the receipt f bilgical agents Ordering the remval f bilgical agents frm labratries Terminating f access t labratries and/r ther facilities EOSMS-203 KSU Bisafety Manual Page 12

13 *The IBC may chse t reverse these penalties after a thrugh review finds that all peratins are in cmpliance with NIH Guidelines, and all applicable plicies and regulatins. Maintaining recrds f all IBC meeting minutes, prtcl reviews, and any ther dcuments assciated with the IBC r the use f bilgical agents at KSU. Peridically reviewing IBC plicies and prcedures. E. Envirnmental Health & Safety (EHS)/Bisafety Officer (BSO) The respnsibilities f EHS and the BSO include, but are nt limited t, the fllwing: Develping, implementing, and maintaining the University s Bisafety Prgram. Develping prtcls and prcedures t address bisafety issues. Develping, implementing, and maintaining the University s prgram fr select agents and txins. Develping and maintaining the KSU Bldbrne Pathgens Expsure Cntrl Prgram (ECP) Prviding training in the safe use and practices fr thse wrking with ptentially bihazardus materials (e.g. - bldbrne pathgens, viruses/viral vectrs, recmbinant DNA, etc.). Prviding technical advice t PIs, the IACUC, and the IBC n research safety prcedures. Cnsulting with researchers n issues f animal care, bisafety, and the safe use f bilgical materials in the labratry. Perfrming peridic inspectins t ensure that standard perating prcedures (SOPs) are being fllwed and regulatry requirements are being met. Prviding guidance t researchers n labratry security. Prviding guidance t researchers n prper waste dispsal methds in accrdance with federal and state regulatins. Assisting in the develpment f emergency plans fr handling accidental spills and persnnel cntaminatin. Investigating labratry accidents invlving bihazardus materials and rdna research. Prviding guidance with regard t labratry design in accrdance with USG labratry design guidelines. Reprting t the IBC and the institutin any significant prblems, vilatins f the NIH Guidelines, and/r any significant research-related accidents r illnesses f which the BSO becmes aware unless the BSO determines that a reprt has already been filed by the PI. Serving as a member f the IBC and IACUC. Wrking in cnjunctin with the IBC t review all registratin frms fr research prpsals submitted by PIs. EOSMS-203 KSU Bisafety Manual Page 13

14 F. Principal Investigatrs (PIs) PIs are respnsible fr cnducting diagnstic and/r research activities in a manner which minimizes the risk in the labratry envirnment. These respnsibilities include, but are nt limited t: Obtaining the required apprval frm the IBC fr new research prpsals as well as amended existing prpsals (i.e. additin f new agents, animals, etc.) prir t the cmmencement f such wrk labratry envirnment. Cmpleting and dcumenting risk assessments cnducted fr the purpse f determining level f risk and/r lwering the level f risk. Ensuring that lab emplyees and supprt persnnel wh will wrk with bihazards are: (prir t wrking in the labratry): Prperly trained and shw prficiency in standard micrbilgical practices at the apprpriate bisafety level(s). Aware f bihazards and precautins t be taken in cnducting research activities. Advised f the nature recgnized and ptential hazards. Infrmed f the indicatrs f accidental infectins. Cmpleting (PI) all required training fr wrking with bihazards. In cllabratin with the BSO, ensuring that the apprpriate immunizatins, serlgic mnitring, pst expsure prphylaxis, and ther medical mnitring are prvided t persnnel shuld the handling f the infectius agents require such precautins. In cllabratin with EHS and the BSO, develping prcedures fr dealing with accidental spills and accidental expsures amng persnnel. Reprting t the BSO and/r EHS issues pertaining t: All accidents/incidents within the lab that may pse a risk. Expsure f persnnel t bilgical/bihazardus agents. Cmprmise f bilgical r physical barriers. Majr equipment failure which culd cmprmise safe peratins in the labratry. In cnjunctin with the BSO, crrecting prcedures, which may result in hazardus incidents r emplyee expsures. G. Labratry Managers/Labratry Supervisrs Labratry Managers /Supervisrs are respnsible fr supervising the day-t-day peratins lab envirnment. Their respnsibilities include but are nt limited t: Overseeing the activities f labratry emplyees and students engaged in research invlving bilgical/bihazardus agents. In cllabratin with the PI and BSO, ensuring that new staff and/r visiting scientists (e.g. vlunteer wrkers, high schl students, etc.) are prperly trained fr their assigned tasks. Ensuring that lab persnnel demnstrate prficiency in standard and special micrbilgical practices befre wrking with bihazardus agents. EOSMS-203 KSU Bisafety Manual Page 14

15 In cnjunctin with the BSO, ensuring that physical cntainment systems, supprt equipment, waste dispsal and peratin f lab are in accrdance with the design and safety guidelines f the BSL-2 facility. Perfrming regular checks/assessments f cntainment devices, equipment, and PPE. Ntifying the BSO and/r EHS f any incident r prblem that cmprmises the safety f the staff r the integrity f the lab. H. Emplyees Wrking in the Lab All labratry persnnel wh engage in research activities have a shared respnsibility fr ensuring their wn safety while wrking in the lab. Respnsibilities fr all labratry persnnel include, but are nt limited t: Cmpleting all assigned EHS and lab specific training t wrk prficiently and independently in the labratry. Cnducting all research activities in accrdance with University s plicies, prcedures and guidelines, including the standards in this Bilgical Safety Manual. Being familiar with the standard perating prcedures fr labratry activities, the ptential hazards f the infectius agents in use, and emergency prcedures. Emplying gd husekeeping practices t help maintain the labratry in gd wrking cnditin. Cmpleting all medical surveillance requirements. Reprting any medical restrictins, reprtable illnesses, and any event that may be the result f an expsure t the PI and Lab Manager/Supervisr. Reprting irregular labratry cnditins r accidents t the PI and EHS immediately. Perfrming all duties as assigned in a prudent manner. I. Students in the Labratry Students wh are participating in labratry activities fr undergraduate academic credit r vlunteer credit must be supervised by a PI, lab manager, r teaching assistant while in the lab, especially when wrking with bihazards. Student activities invlving hazardus materials, equipment, and/r prcesses shuld be limited at the discretin f the PI/Lab Manager. Students have a shared respnsibility fr ensuring their wn safety while participating in lab activities. These respnsibilities include, but are nt limited t: Cmpleting and submitting the Kennesaw State University Vlunteer Prgram frm prir t beginning labratry activities (See Appendix A). EOSMS-203 KSU Bisafety Manual Page 15

16 Nte: Minrs must have a parent cmplete and sign the Waiver and Release Agreement regarding the use f Kennesaw State University Science labs (See Appendix B). Cmpleting all assigned EHS, departmental, and lab specific training. Cnducting all labratry activities (under the supervisin f a PI r Lab Manager) in accrdance with University s plicies, prcedures and guidelines, including the standards in this Bilgical Safety Manual. Being familiar with the SOPs fr labratry activities, the ptential hazards f the materials in use, and emergency prcedures. Emplying gd husekeeping practices t help maintain the labratry in gd wrking cnditin. Reprting any injuries, reprtable illnesses, and any event that may be the result f an expsure t the PI and Lab Manager/Supervisr. Reprting irregular labratry cnditins r accidents t the PI and EHS immediately. Perfrming all duties as assigned in a prudent manner. 3. REGULATORY REQUIREMENTS The bisafety practices utlined in this manual are based n the NIH Guidelines and the best practices fund in the BMBL. There are additinal guidance dcuments and regulatins impsed by varius funding agencies that individual PIs must be aware f and incrprate int their lab-specific Bisafety Manuals. Bisafety requirements must be fllwed t ensure the cntinuatin f grant funding frm federal agencies and fr health and safety purpses. NIH Guidelines The NIH Guidelines detail prcedures and practices fr the cntainment and safe cnduct f varius frms f recmbinant DNA research, including research invlving genetically mdified plants and animals, as well as human gene transfer. The NIH Guidelines require: The establishment f an IBC fr the review and versight f bilgical research. The appintment f a Bilgical Safety Officer. The establishment f practices, prcedures, and cnditins under which recmbinant DNA activities must be cnducted. All institutins, including KSU, receiving NIH funding fr recmbinant DNA activities must cmply with the NIH Guidelines. Researchers at institutins that are subject t the NIH Guidelines must cmply with the requirements even if NIH des nt fund their individual prjects. Nn-cmpliance EOSMS-203 KSU Bisafety Manual Page 16

17 with the NIH Guidelines may result in suspensin, limitatin, r terminatin f financial assistance fr the research prject and f NIH funds fr ther recmbinant DNA activities at KSU r the requirement fr prir NIH apprval f any and/r all recmbinant DNA prjects at KSU. Center fr Disease Cntrl Best Practices The BMBL, describes the apprpriate measures and facilities fr wrk with all micrbial agents, including bacterial, viral, fungal, parasitic, rickettsial, and prin agents as well as txins f bilgical rigin. The BMBL als addresses the apprpriate measures and facilities fr wrk with vertebrate animals and sets frth bisafety level criteria that are detailed in this dcument. OSHA Bldbrne Pathgens Standard The requirements described in the OSHA BBP Standard (29 CFR ) and the O.C.G.A. (Official Cde f Gergia_ 31-12) apply t wrk with materials f human rigin, including human bld, tissue, rgans, bdy fluids, cells, and DNA. The BBP Standard is a prgram utlines requirements includes training, medical surveillance, prcedures, and equipment that must be in place fr prtectin against bldbrne pathgens. Althugh bldbrne pathgens are included in bisafety, the mre specific requirements fr wrking with BBPs are explained in detail in the KSU BBP Expsure Cntrl Plan. Other Regulatry Requirements Currently, select agents and bilgical txins are nt used in research labratries at KSU. Hwever, in the event that any select agent r bilgical txin is apprved fr use in research, they are subject t federal regulatins and must be registered with the Federal Select Agent Prgram. The Select Agent and Txin rules, which implement prvisins f the Public Health Security and Biterrrism Preparedness and Respnse Act f 2002 may be fund in Department f Health and Human Services (HHS) Standard, Pssessin, Use, and Transfer f Select Agents and Txins; Interim Final Rule (42 CFR 73) and the Department f Agriculture (USDA) Standard, Agricultural Biterrrism Prtectin Act f 2002; Pssessin, Use, and Transfer f Select Agents and Txins; Interim Final Rule (7 CFR 331 and 9 CFR 121). A list f Select Agents and Txins can be fund at the Federal Select Agent Prgram website. Handling and dispsal f bihazardus waste is regulated by OSHA under the BBP Standard and by Gergia State Rule : Slid Waste Management, specifically, : Bimedical Waste. The prcedures fr bihazardus waste handling are highlighted in the waste dispsal sectin f this dcument. The requirements fr packaging and shipment f bihazardus materials are prvided in the Department f Transprtatin s hazardus materials regulatin 49 CFR, Parts Fr mre infrmatin n shipping prcedures at KSU that cmply with these regulatins, refer t the Shipping and Transprtatin Guidelines n the EHS website. EOSMS-203 KSU Bisafety Manual Page 17

18 In additin, permits may be required t ship bilgical materials. Please refer t the CDC Etilgical Agent Imprt Permit Prgram and the Animal and Plant Health Inspectin Service (APHIS) permit prgram. Dual Use Research Dual use (as bradly defined), refers t the malevlent misapplicatin f technlgy r infrmatin initially develped fr benevlent purpses. In life sciences, dual use refers t the ptential misuse f micrrganisms, txins, recmbinant/synthetic nucleic acid technlgy, r research results t threaten public health r natinal security. Dual Use Research f Cncern, referred t as DURC, is research that has a ptential t be DIRECTLY misapplied. The Natinal Science Advisry Bard n Bisecurity (NSABB) is an advisry bard t the U.S. Gvernment n issues f bisecurity. The NSABB is administered thrugh the NIH Office f Bitechnlgy Activities (NIH-OBA), which publishes the mst recent NSABB discussins and NSABB reprts n issues invlving Dual Use Research. A vide prepared by the NSABB is available n the NIH-OBA website, which can be accessed here: If yu think smene may be misusing bilgical agents r data in a manner that may be harmful t public health r natinal security r wish t learn mre abut DURC, please cntact the Bisafety Officer by phne , r visit the KSU Envirnmental Health and Safety main ffice at 1200 Chastain Rd NW, Suite 201. Yur identity will be kept cnfidential. 4. RISK MANAGEMENT A. Risk Management Steps Risk management encmpasses three main cncepts, which include risk characterizatin, assessment/evaluatin f the risk, and management f the risk. An effective risk management prcess includes the fllwing steps: Identifying the hazard What hazardus materials are we dealing with? Assessing the hazard What culd ptentially g wrng frm wrking with these hazardus materials? Determining the risks What risks are acceptable, if any? Determining apprpriate cntrls measures - What can be used/dne t minimize r remve this hazard? Implementing the apprpriate cntrl measures Put develped cntrl measures int practice. Evaluating After an evaluatin perid, review the cntrl(s) implemented t determine their effectiveness, r if additinal cntrl(s) are warranted. Risk characterizatin is a prcess used t identify the hazardus characteristics f a knwn infectius/ptentially infectius agent r bihazardus material, the activities that can result in an EOSMS-203 KSU Bisafety Manual Page 18

19 individual s expsure t an agent, the likelihd that such expsure will cause a Labratry- Acquired Illness (LAI), and the prbable cnsequences f such an infectin. Risk assessment is an imprtant respnsibility fr individuals wh manage micrbilgical and bimedical labratries (e.g. principal investigatrs, labratry supervisrs, etc.). This respnsibility must be shared by varius grups (and individuals) thrughut the University. Hwever, there are specific University persnnel that have respnsibilities fr ensuring apprpriate risk assessments are cnducted. At KSU, the respnsibility f cnducting risk assessments rests primarily n the BSO/EHS and PIs, in cnsultatin with IBC. The infrmatin identified by a risk characterizatin, risk assessment, and ther imprtant factrs will help guide the management f risk thrugh the selectin f apprpriate cntainment levels, micrbilgical practices, safety equipment, and facility safeguards that can prevent LAIs r ther impacts. Other imprtant factrs include the nature and risk grup f the bilgical agent, hst susceptibility, ptential rutes f expsure, and methds t inactivate the agent. B. Risk Grups Bilgical agents have been classified int risk grups (RG) based n the transmissibility, invasiveness, virulence r disease causing capability, lethality f the specific pathgen, and the availability f vaccines r therapeutic interventins. The list f pathgenic micrrganisms includes bacteria, viruses, fungi, parasites, and ther infectius agents. The scheme ascends in rder f increasing hazard frm Risk Grup 1 (RG1) agents, which d nt cause disease in healthy human adults, t Risk Grup 4 (RG4) agents, which cause lethal disease in healthy human adults, and fr which preventative r therapeutic measures are nt available. The American Bilgical Safety Assciatin als prvides a cmprehensive risk grup listing, which references glbal agencies. This list is accessible at Anther reliable surce f infrmatin abut human pathgens is the Pathgen Safety Data Sheets and Risk Assessment (PSDS) published by Health Canada: The descriptins f the fur risk grups are as fllws: Risk Grup 1 Agents are nt assciated with disease in healthy adult humans. Examples: E. cli K-12, Saccharmyces cerevisiae. Risk Grup 2 Agents are assciated with human disease that is rarely serius, and fr which preventive r therapeutic interventins are ften available. Examples: E. cli O157:H7, Salmnella typhimurium, and Cryptspridium parvum. EOSMS-203 KSU Bisafety Manual Page 19

20 Risk Grup 3 Agents are assciated with serius r lethal human disease fr which preventive r therapeutic interventins may be available (high individual risk but lw cmmunity risk). Examples: Yersinia pestis, Brucella abrtus, Mycbacterium tuberculsis. Risk Grup 4 Agents are likely t cause serius r lethal human disease fr which preventive r therapeutic interventins are nt usually available (high individual risk and high cmmunity risk). Examples: Ebla virus, Macacine herpesvirus (frmerly Cercpithecine herpesvirus 1, als called Herpes B r Mnkey B virus). Micrrganisms that are RG1 require standard labratry facilities and micrbilgical practices, whereas thse in RG4 require maximum cntainment facilities. Many f the agents likely t be handled experimentally at KSU are RG1, RG2 r RG3 pathgens (lw, mderate and high hazard, respectively). RG3 agents typically require mre sphisticated engineering cntrls than standard labratries, as well as special handling and decntaminatin prcedures. Micrrganisms classified as RG2 r higher have been reprted t cause infectin and disease in therwise healthy adults. Many have been assciated with labratry-acquired infectins. The prgressin frm expsure, t infectin, t disease fllwing cntact with an infectius agent depends upn the rute f transmissin, inculum, characteristics f the agent, and resistance f the persn expsed, whether innate r acquired. Nt all expsures result in infectin, and even fewer develp int clinical disease. Hwever, it is prudent t handle such agents at the prescribed bisafety level. 5. ROUTES OF INFECTION AND EXPOSURE SOURCES Depending n the rganism in questin, pathgens can be transmitted via fur ptential rutes f expsure. The mst cmmn rutes f expsure are: Inhalatin breathing in airbrne materials such as infectius aersls r dusts) Absrptin (expsure f mucus membranes t infectius drplets) Ingestin (frm cntaminated hands r utensils) Percutaneus inculatin (injectin, incisin, r animal bite). Apprpriate precautins can be implemented t reduce the risk f such expsures. A. Clinical and Pathlgical Specimens Specimens frm human patients r animals may cntain infectius agents. Specimens mst likely t harbr such micrrganisms include bld, semen, vaginal secretins, cerebrspinal fluid, synvial fluid, pleural fluid, pericardial fluid, peritneal fluid, amnitic fluid, and tissues. There are ther EOSMS-203 KSU Bisafety Manual Page 20

21 ptentially infectius materials (OPIM) that are nt usually cnsidered infectius unless they cntain bld. These materials include sputum, nasal secretins, urine, vmit, and feces. When bld is visible in these materials, they shuld be treated as infectius. Persnnel in labratries and clinical areas handling human bld, bdy fluids, nn-human primate material, human cell lines, r ther ptentially infectius materials shuld practice general universal precautins an apprach t infectin cntrl wherein all human bld and certain human bdy fluids are treated as if knwn t be infectius fr Human Immundeficiency Virus (HIV), Hepatitis B virus (HBV), Hepatitis C (HCV) and ther bldbrne pathgens. Such persnnel are required by law (OSHA 29 CFR ) t underg BBP training. At KSU, this training requirement can be satisfied either nline r by attending a classrm training sessin. Fr infrmatin n btaining this training, access the EHS Website. Sme animals, r animal tissues, may harbr endgenus pathgens that cause disease in humans. It is prudent fr persnnel handling these animals r their tissues/bdy fluids t treat their bld and bdy fluids as if they are infectius. B. Cultures Accidental spilling f liquid infectius cultures is an bvius hazard due t the generatin f aersls and/r small drplets. The fllwing rutine manipulatins f cultures may release micrrganisms via aersl frmatin: Ppping stppers frm culture vessels Opening clsed vessels after vigrus shaking Spattering frm flame-sterilized utensils Expelling the final drp frm a pipette Spinning micrfuge tubes in a standard micrfuge Aersls generated immediately fllwing vrtexing When preparing aliquts f infectius material fr lng-term strage, cnsider that lyphilizatin f viable cultures may release high cncentratins f dispersed particles if ampules are nt prperly sealed. Breakage f ampules in liquid nitrgen freezers may als present hazards because f survival f pathgens in the liquid phase. Equipment used fr manipulatins f infectius materials, such as cell srters and autmated harvesting equipment, must be evaluated t determine the need fr secndary cntainment and t cnsider decntaminatin issues. Cstly equipment f this type is ften perated at multi-user r cre facilities; the inherent variability in risk frm ne prject t anther makes it imperative that peratrs and users f these facilities understand risks and methds fr risk mitigatin. Use f human r animal cell cultures in labratries requires special cnsideratin. Cell r tissue cultures in general present few bihazards, as evidenced by their extensive use and lack f infectin transmitted t labratry persnnel. Clearly, when a cell culture is inculated with (r knwn t cntain) an etilgic agent, it shuld be classified and handled at the same bisafety level as the agent. EOSMS-203 KSU Bisafety Manual Page 21

22 C. Animals Exercise care and thughtfulness when using animals t islate and prpagate micrrganisms, study pathlgy, r prduce antibdies. Labratry animals may harbr micrrganisms that can prduce human diseases fllwing bites, scratches, r expsure t excreted material. In the prcess f inculating animals, an investigatr can be expsed t infectius material by accidental selfinculatin r inhalatin f infectius aersls. During surgical prcedures, necrpsies, and prcessing f tissues, aersls can be prduced unintentinally, r the peratr can inflict self-injury with cntaminated instruments. Since animal excreta can als be a surce f infectius micrrganisms, investigatrs shuld take precautins t minimize aersls and dust when changing bedding and cleaning cages. Online training is available thrugh the Cllabrative Institutinal Training Initiative (CITI) webbased training prgram. Please cnsult with the IACUC administratr fr mre infrmatin n the apprpriate training mdules fr a specific research r teaching prgram. Infrmatin n hw t register fr the training is available here. The certificatin must be renewed every three years. D. Latex Glves and Related Allergies Allergic reactins t natural rubber latex have been increasing since 1987, when the Centers fr Disease Cntrl recmmended the use f universal precautins t prtect against ptentially infectius materials, bldbrne pathgens, and HIV. Increased glve demand als resulted in higher levels f allergens due t changes in the manufacturing prcess. In additinal t skin cntact with the latex allergens, inhalatin is anther ptential rute f expsure. Latex prteins may be released int the air alng with the pwders used t lubricate the interir f the glve. NIOSH studies indicate that 8-12% f healthcare wrkers regularly expsed t latex are sensitized, cmpared t 1-6% f the general ppulatin. Latex expsure symptms include skin rash and inflammatin, respiratry irritatin, asthma, and shck. The amunt f expsure needed t sensitize an individual t natural rubber latex is nt knwn, but when expsures are reduced, sensitizatin decreases. NIOSH recmmends the fllwing actins t reduce expsure t latex: a) If latex glves must be used, chse reduced-prtein, pwder-free latex glves. b) Whenever pssible, substitute anther glve material. c) Wash hands with mild sap and water after remving latex glves When using antibitic materials, prcedures shuld be adpted that minimize release f airbrne materials and skin cntaminatin. Of particular cncern are releases f penicillin-type (r ther) antibitics during syringe-lading frm multi-dse vials. Persns wh have had previus expsures and have develped sensitivity can quickly g int anaphylactic shck after inhaling a mist f antibitic material. Be sure t handle these materials with cautin and accrding t use directins. Use and cautin inserts fr each antibitic are prvided in the prduct packaging and shuld be read and understd prir t use. Investigatrs inexperienced in cnducting these types f EOSMS-203 KSU Bisafety Manual Page 22

23 experiments shuld seek help in designing their experiments frm individuals wh are experienced in this special wrk. 6. LABORATORY EXPOSURE POTENTIAL A. Teaching Labratries Whenever pssible, we recmmend the use f avirulent strains f infectius micrrganisms in teaching labratries. Hwever, even attenuated micrbes shuld be handled with care. Students shuld be cautined against and trained t prevent unnecessary expsure, as expsure t avirulent strains may be prblematic in immuncmprmised individuals. Establishment f safety cnsciusness is integral t the cnduct f gd science. B. Research Labratries The risk f expsure increases with experiments in research labratries using high cncentratins r large quantities f pathgens. The use f animals in research n infectius diseases als presents greater pprtunities fr expsure. C. Clinical Labratries Persnnel in labratries perfrming diagnstic wrk-up f clinical specimens frm human r animal patients are ften at risk f expsure t infectius agents. The absence f an infectius disease diagnsis des nt preclude the presence f pathgens. This is especially true f materials frm patients wh have received immunsuppressive therapy since such treatment may activate latent infectins r make hsts mre likely t harbr infectius agents. 7. BIOSAFETY LEVELS AND LABORATORY PRACTICES A. Bisafety Levels Bisafety Levels cnsist f cmbinatins f labratry practices and prcedures, safety equipment, and labratry facility design features apprpriate fr the peratins t be perfrmed within the lab, and are based n the ptential hazards impsed by the agents used and fr the specific lab activity. It is the cmbinatin f practice, equipment, and facility that frm the basis fr physical cntainment strategies fr infectius agents. There are fur bisafety levels, with Bisafety Level 1 (BSL1) being the least stringent and Bisafety Level 4 (BSL4) being the mst stringent. Labratry wrk with bilgical materials at KSU generally falls under the requirements f BSL1 r BSL2. The requirements fr these tw bicntainment levels are explained further in the fllwing paragraphs. Bisafety Level 1 (BSL-1) When wrking with bilgical agents that are nt knwn t cnsistently cause illness r disease in healthy adult humans, BSL-1 is the apprpriate level f cntainment, unless therwise indicated EOSMS-203 KSU Bisafety Manual Page 23

24 thrugh a thrugh risk assessment. BSL-1 wrk areas are nt required t be separated frm nrmal labratry wrk areas r activities. Special practices r special equipment (e.g. bisafety cabinets) is nt usually required. Experiments being cnducted at BSL-1 are usually cnducted n pen bench tps; hwever, standard micrbilgical practices and prudent practices must be emplyed. Lab persnnel wh cnduct labratry wrk at BSL-1 must be trained in standard micrbilgical practices. All KSU lab persnnel wrking at BSL-1 must adhere t the fllwing requirements: Standard Micrbilgical Practices Wash hands using sap and water immediately after wrking with bilgical materials, after remving PPE, and prir t leaving the labratry. D nt eat, drink, smke, instill cntact lenses, r apply csmetics in the labratry area. Keep all f these materials and their cntainers utside f labratry wrk areas. Never pipette materials by muth; use mechanical pipetting devices. Cnduct all prcedures in a way that minimizes the creatin f splashes and/r aersls. Decntaminate all wrk surfaces after cmpletin f wrk, and especially after spilling r splashing f ptentially infectius materials. Use an apprpriate disinfectant t decntaminate surfaces (e.g. 10% bleach slutin, 70% ethanl, etc.) Decntaminate all cultures, slutins, and waste materials prir t dispsal using an apprpriate methd (e.g. autclaving, chemical deactivatin, etc.) Handle all cntaminated sharps apprpriately t prevent accidental percutaneus expsures Ensure that all areas where bilgical/bi-hazardus agents are used have apprpriate signage, marked with the universal bihazard symbl and the crrect Bisafety Level. The sign may als include ther infrmatin, including the agent(s) in use and cntact infrmatin fr respnsible persnnel. Ensure the wrk area is free f pests. General Safety Practices Wear apprpriate attire, such as lng pants, dresses, r skirts that are ankle length. Avid wearing shrts, dresses r skirts that leave skin expsed. Always wear ftwear that cmpletely cvers the ft. Avid sandals, pen ted, pen heeled, r high-heeled shes. Apprpriate glves are recmmended t be used when handling bilgical materials. Inspect all glves fr hles and defects befre using. EOSMS-203 KSU Bisafety Manual Page 24

25 Change glves when they becme cntaminated, trn, r therwise cmprmised. Avid washing and/r reusing dispsable glves. Once glves are remved frm hands, a new pair shuld be dnned. Dispse f used glves as bihazard waste. Glves are nt t be dispsed f in the general waste stream. Wearing f an apprpriate labratry cat r aprn while wrking in the labratry is recmmended. Replace it immediately if it becmes cntaminated r siled. Wearing f apprpriate eye prtectin is recmmended. Minimally, safety glasses with side shields shuld be wrn; hwever, in the event that aersls and/r splashes are pssible, splash prf gggles shuld be wrn fr better prtectin. Nte: While wearing eye prtectin, glves, and lab cat are recmmended fr wrking at BSL- 1, they are required fr wrking with chemical hazards in the labratry. D nt wear lab cats, glves, r ther PPE utside f the labratry area (labratry plus adjacent hallways/stairways/elevatrs between labratries, cld rms, animal facilities, etc.). Remve all PPE prir t leaving the lab area t prevent cntaminatin f public areas (e.g. break rms, rest rms, etc.). When wearing glves between labratries, bserve the ne glve rule. Glved hands must nt tuch dr knbs, light switches, r elevatr buttns. BSL-1 Facility Requirements A BSL-1 facility must have the fllwing safeguards in place: Drs t cntrl access Sink(s) fr hand washing Surfaces that are easy t decntaminate using an apprpriate disinfectant N carpet r Rugs Bench tps must be impervius t water and resistant t heat and chemical hazards (e.g. slvents, acids, bases, etc.) Chairs/stls must be impervius t water and easy t decntaminate using an apprpriate disinfectant Furniture must be capable f supprting anticipated lads and uses. Spaces between benches, cabinets, and equipment shuld be accessible fr cleaning. EOSMS-203 KSU Bisafety Manual Page 25

26 Bisafety Level 2 (BSL-2) When wrking with bilgical agents that pse mderate hazards, and have the ptential t cause illness r disease in healthy adult humans, BSL-2 is the apprpriate level f cntainment, unless therwise indicated thrugh a thrugh risk assessment. KSU Persnnel wrking at BSL-2 cntainment must adhere t the requirements f BSL-1 cntainment (see previus sectin), and the fllwing requirements (as prescribed by the BMBL): Lab persnnel must have specific training fr handling f pathgenic agents and must be supervised by scientists wh are cmpetent in handling infectius agents and assciated prcedures. Access t the labratry must be restricted when vacant and when wrk is being cnducted. All prcedures in which aersls and/r splashes may be created (e.g. mixing, pipetting, vrtexing, etc.) must be cnducted in a bisafety cabinet (BSC) r ther physical cntainment device. Training Labratry persnnel must receive the apprpriate training regarding their duties, expsure preventin, and expsure evaluatin prcedures. Persnnel must receive annual updates r additinal training when there are changes in plicies r prcedures. All labratry persnnel, particularly wmen f childbearing age must be educated n immune cmpetence and cnditins that may predispse them t infectin. Wmen f childbearing age r expectant mthers shuld cnsult their healthcare prvider t receive cunseling and/r guidance. Special Practices All persnnel wh wrk in the lab must be advised f the ptential hazards and must adhere t specific entry/exit requirements. All persnnel seeking t wrk with BSL-2 agents must demnstrate prficiency in standard and special micrbilgical practices prir t beginning wrk with thse agents. All persnnel must be prvided with medical surveillance as needed. The cllectin and strage f serum samples frm at-risk persnnel shuld be cnsidered. All persnnel must be ffered (at n cst) the available immunizatins fr agents that are handled r are ptentially present in the wrk envirnment. EOSMS-203 KSU Bisafety Manual Page 26

27 The KSU bisafety manual must be available and accessible t all labratry emplyees. A lab specific bisafety manual, r at minimum, bisafety SOPs shuld be prepared and available t all emplyees. Ptentially infectius materials must be placed in durable, leak-prf cntainers when cllecting, handling, prcessing, string, r transprting them within a facility. Lab equipment must be decntaminated by prperly trained persnnel using an apprpriate disinfectant bth regularly and after all ptential cntaminatin. All equipment used with infectius materials must be decntaminated prir t repair, maintenance, r remval frm the labratry. Safety Equipment and PPE Bisafety cabinets, PPE, r ther physical cntainment devices must be used as fllws: Anytime prcedures are cnducted that have the ptential fr creating infectius aersls r splashes (e.g. pipetting, centrifuging, grinding, blending, mixing, shaking, r snicating pen cntainers f infectius materials) When inculating certain animals intranasally When harvesting infected tissues frm animals r eggs When high cncentratins r large vlumes f infectius agents are used. These materials can als be centrifuged in the pen labratry as lng as sealed rtrs r centrifuged safety cups are used. Lab cats, gwns, r ther labratry unifrms must be wrn when wrking with bihazardus materials. When infectius/bi-hazardus materials are handled utside f the BSC, eye and face prtectin must be used. Minimally, safety glasses with side shields must be wrn; hwever, in the event that aersls and/r splashes are pssible, splash prf gggles must be wrn fr better prtectin. Nte: T transprt ptentially infectius material in the labratry area between labratry rms, first lad the material int durable, leak prf secndary cntainment (e.g., trays, Styrfam clers with ice, plastic beakers with ice), then remve glves and wash hands thrughly prir t leaving the labratry. Cntinue t wear eye prtectin and labratry cat while transprting. As always, if the labratry cat becmes cntaminated, remve the cat and replace with a clean ne. After arrival t the destinatin, wear new glves. When transprting ptentially infectius materials between labratry rms, the use f a wheeled EOSMS-203 KSU Bisafety Manual Page 27