biosafety risk assessment pdf

Fidelis Arambe Mambo, 2022 2. Jaures Arnaud Noumedem Kenfack, 2021 Greece 1. Biosafety Risk Assessment Standard Operating Procedure (SOP) and related documents, worksheets, tools are listed below. subject all living modified organisms to risk assessment prior to the making of decisions on import, this Protocol shall not apply to the transboundary movement of living modified organisms which are pharmaceuticals for humans that are addressed by other relevant international agreements or organisations. Now customize the name of a clipboard to store your clips. that this part of the risk assessment is a subset of the total risk assessment which must be performed. Each step in the work process must be analyzed for potential risk to personnel. 10 0 obj The objective is to estimate the nature and extent of the risks of a given situation (a priori analysis). version 004-06-22-2016:.PDF, Biosafety Risk Assessment Biological Agent Summary Worksheet %PDF-1.6 % Biosafety Risk Assessment SOP, Version 1.2 Page 7 of 15 Use Risk Assessment Matrix in Table 1 below to access the risk level associated with each hazard identified in above section. 834 0 obj <>stream Rukia Kibaya . Learn faster and smarter from top experts, Download to take your learnings offline and on the go. Safety considerations and guidelines veterinary microbiology laboratory, Understanding Security Basics: A Tutorial on Security Concepts and Technology, Thermal Stress and the Heat Shock Response in Microbes, Stem Cell Research & Related Ethical Issues. <> LL,G}`>yC.:L0`IAAqnN4M4q!&$J$AAB0vFh;JA;;(4.t" The entire Risk Assessment and Management process covers the initial procurement of a biohazard until it has been securely stored or inactivated upon completion of work; it identifies where and how the biohazard will be handled in between, and by whom. Biological Risk Assessment. QF3F+W[`L@r, 29\wTT 5q}O )}r3. Ma#q@118zfwDG$j1t\`',^bfRp|UE15Y/cmEMZiWg/i{&q/*_y+J\O/7M:6*%)6:LCc Poor health outcomes for African Americans, Hispanic Americans, American Indians, Alaska Natives, Asian Americans, Native Hawaiians, and Pacific Islanders are apparent when comparing their health indicators against the rest of the U.S. 1 0 obj <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> !(!0*21/*.-4;K@48G9-.BYBGNPTUT3? [1] These prevention mechanisms include conduction of regular reviews of the biosafety in laboratory settings, as well as strict guidelines to follow. ESSENTIAL ELEMENTS FOR MANAGING AN EFFECTIVE BIOSAFETY PROGRAM 1.1 Responsibility for Managing Biosafety Is the laboratory director responsible for ensuring that systems are in place and . hkouE/@`ub M`^(+TI'93:)PTysgn6-akw^6{MeKw6S6Fty5=-MpH1Z)o?\0xvOwV/n 3 0 obj *Note: This page contains materials in the Portable Document Format (PDF). opens in a new window. Most items are available to be opened or downloaded in the Portable Document Format (.PDF). endobj hb```"W !U Assigning a biosafety level to a project is one of the last steps of the risk assessment. A known risk will lead to the implementation of appropriate prevention . 0 We've updated our privacy policy. Perform a detailed Biological Risk Assessment, based on agent and procedure-specific properties. Do risk assessments consider both agent hazards and laboratory procedure hazards? 2 0 obj To reduce the risk of developing dermatitis: Follow hand washing guidelines and use warm (not hot) water with mild soap; dry hands thoroughly after washing. With the above ideas in mind, this biosafety risk assessment SOP will guide the user through creating a written biosafety risk assessment for a clinical or public health laboratory procedure. We've encountered a problem, please try again. xXKFaN4! An example Risk Assessment form can be found on CDC's Biosafety Website. allow the chemical nature of the material(s) to For a large-scale production of biologicals, it is also relevant to per-form a risk assessment on the mechanical performance of various production equipment and utilities. A second equally important facet of the process is documentation of compliance to the standards of good science as set by regulatory bodies. Risk assessment, as outlined here and in Section 12, may determine that decreasing or increasing the BSL practices or facilities is warranted (Figure 1). Clipping is a handy way to collect important slides you want to go back to later. 819 0 obj <>/Filter/FlateDecode/ID[<004C2407C8B9F948A6BDC20416B66361>]/Index[803 32]/Info 802 0 R/Length 93/Prev 895660/Root 804 0 R/Size 835/Type/XRef/W[1 3 1]>>stream The biosafety level usually correlates with the Risk Group but not always. WIC is a federally funded nutrition program for Women, Infants, and Children. 06 overview of biosafety activities of moefcc, 04 control of spills and mechanism of implementation of biosafety guidelines, Prof dr badr elsabah biosafety in biotech, 10 safety guidelines for recombinant dna research, rDNA Technology-Biosafety Regulations and Guidelines, Biosafety of gmos and the role of entomologists, Developments on Biosafety Regulatory Regime in Bangladesh 2013, Asian Food Regulation Information Service, Swami Viekananda Institute of Modern Sciences. version 004-06-22-2016 (Excel). Clinical Laboratory Biosafety Risk Management Program Assessment Checklist LAB ID and LABORATORY NAME: ASSESSOR NAME: DATE: Question Y N NA Comments 1. Institutional Biosafety Committee Office of Research Assurances Risk assessments Identify and mitigate risk, and document regulatory compliance When to perform a risk assessment When planning a research project When making a significant change to a research project, such as: New employees New infectious or potentially infectious agent In actual work, the construction structure, facilities, and equipment conditions and personnel quality of each laboratory are different. <> 93pq2*`qAz7sXuoF&fF~ 3GFo04eY x }l$ In fact, there is a clear historical record of infections having been acquired in laboratory settings. A risk assessment should clearly define the risk being assessed and avoid over complication. <> <> COMPETITIVE EXAM FOR CLASS 9th and 10th.pptx, Penn Plax Cascade 1000 Installation Manual.pdf, No public clipboards found for this slide. population. [PDF] Biosafety Risk Assessment Methodology | Semantic Scholar Laboratories that work with biological agents need to manage their safety risks to persons working the laboratories and the human and animal community in the surrounding areas. BSLs are ranked from 1-4, with BSL-1 procedures being suitable for working with the lowest/least harmful biological agents. Biological Risk Assessment; Department of Defense Biological Safety and Security Program; Guidance on the Inventory of Select Agents and Toxins; 2019 Federal Select Agent Program Annual Report; Working Group on Strengthening the Biosecurity of United States; Select Toxin Guidance; BIOSAFETY GUIDELINES and Page 1 of 6 07/19/2021 BIOSAFETY LEVELS By accepting, you agree to the updated privacy policy. :E&jf)y'=jHCN/GlWnEQ@\ jtWaW5Qx /C[?_^N95B)j[SQ CFpr*T DA?Zzx=he= hAI{j;aNmFwV"KR1}9wWW=ES.Au ur5xV?>'x}jhF#ty8sO1P; % Biological Safety Levels Biological safety level or biosafety level (BSL) classification refers to containment engineering and safety practices. (" PB6}=$kzz^M%"ZC^{Fc;O=(*`k4fA@y HrA5BfnjXKiSZl]/Hf#|svY:-)8$bfbL.k$]Mw# BRMC 301- Laboratory Biosafety and Biosecurity Risk Assessment and Risk Management Trainer Profile Dr Sabai PHYU . version 004-06-22-2016:.PDF, Biosafety Risk Assessment Control Failure Worksheet It appears that you have an ad-blocker running. endobj The Florida Department of Health works to protect, promote & improve the health of all people in Florida through integrated state, county & community efforts. JFIF ` ` C } !1AQa"q2#BR$3br 9?}=j9!c1S)N4 i2_Y: 9t(L( =bdExyWGM:ksbP~~u+!9c$i$CtUXeS7OZyrJ%^,&NO!.Yj)G|UxGsTs'RZ}S1NhzI1$ SPJNGSD_*s!ff=q\Nli5\W_4i+Yy7p:S7I8.\MH) [Ev%! $4%&'()*56789:CDEFGHIJSTUVWXYZcdefghijstuvwxyz ? Open navigation menu. Biosafety and Risk Assessment in Agricultural Biotechnology [PDF] Related documentation. BSL-1. endobj ~_YkFGdWN+IzK*@ ` Looks like youve clipped this slide to already. O[x \Q,~ y%Iks?Q+dIWQjo. Biosafety is basically a case by case methodology exploiting pertinent safety criteria embedded in the history of sciences and of human practices. *Please note, the Biosafety in Microbiological and Biomedical Laboratories, Fifth Edition. RD 7@?L@"@1` 8 803 0 obj <> endobj in 1987, she was involved in Hepatitis B vaccine clinical trial research work for >2 years. (e3|R]Vuy\E#XSRW4VNzF"4tQGgWBHAPl=yD However, monkeypox infections also occur in other parts of the world. Silver (Ag) nanoparticles are used in a variety of applications within the food industry. endobj <> Biological Risk Assessment Factors Biosafety in Microbiological and Biomedical Laboratories, 5 th edition (BMBL) also states that the primaryfactors to consider in risk assessment and selection of precautions fall into two broad categories: - agent hazards - laboratory procedure hazards. The Disability and Health Program (DHP) is funded by a three-year grant from the Centers for Disease Control and Prevention (CDC). Environmental Health and Biosafety Risk Assessment Guidance for Commercial-Scale Cell and Gene Therapy Manufacturing Attached Files CGT EHS risk assessment template August 2020.pdf Download 310 This guideline describes best practices for conducting a biosecurity risk assessment in an organization where human or animal pathogens, toxins, or other regulated infectious material are handled or stored. It is recommended that at a minimum risk assessments include: an assessment of risks associated with specimen source and likely organisms ANIMALS, the BIOSAFETY RISK ASSESSMENT section of the VERTEBRATE ANIMAL STUDY FORM is the correct form for reporting Recombinant DNA vectors, transgenic animals and early stage gene-therapy experiments to the IACUC and the IBC. Dionysis Vourtsis, 2021 Kazakhstan 1. (PDF) Laboratory Biorisk Management: Biosafety and Biosecurity Home Containment of Biohazards Laboratory Biorisk Management: Biosafety and Biosecurity In book: Laboratory Biorisk Management:. Many laboratories lack the knowledge and skills to conduct a structured and systematic risk assessment, as a result most biosafety risk assessments are based purely on subject matter expert opinion These assessments lack repeatability, are . w !1AQaq"2B #3Rbr 4 0 obj Search Tips endobj Under international environmental law and policy, biosafety refers to the need to protect the environment and human health from the possible adverse effects of genetically modified organisms (GMOs) and products resulting from modern biotechnology. Instant access to millions of ebooks, audiobooks, magazines, podcasts and more. hbbd```b`` id rARbIzwL  9 # There is always risk! Eckerstorfer et al. Identify how risk -based biosafety and biosecurity approaches enable effective allocation Environmental risk assessment (ERA) Biosafety Ngoc-Ha Thi Tran and Taichi Oguchi have contributed equally to this work. Free access to premium services like Tuneln, Mubi and more. 7. 2. 0 Biosafety laboratory risk assessment is a dynamic and systematic work. BioPhorum's framework will help EHS and biosafety professionals use a best practice approach to assessing risks around these novel therapies. O1[ (D_}bi0O^J*{FCR|V~1EkBH"!bnaeY.LOJ+7OC(D_%dv12~eH(EWiQE {gV=+U'tmFG=GIK^m*ZSJ5e}A4=G6"ZSNn(nh.ay?M+\'$ Left navigation requires javascript to be enabled in your browser. Tools and resources to help you and your family prepare for any disaster. A detailed risk assessment is presented that concludes that the likelihood of direct harm to human health would be high if non-reassortant H5 or H7 viruses with multiple basic amino acids at the haemagglutinin (HA) cleavage site and high oz#E } version 004-06-22-2016: .PDF, Biosafety Risk Assessment Documentation Worksheet !$Vr-icF~|M>gfQ(~!>}U|/%< j> 7C7[t7wo=>u{{!N'c)}U!{*_D%=ik$%J9GU|W>F|15.pf= Consultation with by the MSSM Biosafety Officer is required prior to submission of protocols to the ISMMS Grants LgKV$LNM>Z'&>zG9!:PjVI)&21hpoK#o->s)*CZj"U KKEE+V is|z+0 Assessment is conducted by a Biosafety Professional in partnership with and based on information provided by the Principal Investigator The assessment is presented to the Institutional Biosafety . ]c\RbKSTQ C''Q6.6QQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQQ " Maureen Ellis, 2021 Cameroon 1. Leah Kloss BPHL - Tampa 3602 Spectrum Blvd Tampa, FL 33612 Office: 813-233-2278 Cell: 813-392-9918. endobj Mg eARISZO@. After Sabai graduated from one of the Myanmar Medical schools (M.B.,B.S.) ), India, International aspects of the quality and safety of, Biosafety Aspect of Biotechnology Product, Biosaftey issues related to gm crops and transgenic variety release, transgenic crops and their regulatory system, Training in epidemiology and microbiological risk assessment, Microbiological risk assessment of raw milk cheese dr robin condron, Chemical methods for controlling micro organisms, Food Technology Micro-organisms in Food Production, Hazard Identification And Risk Assessment, BioSafety on Industrial Scale (Lecture 7), Amee write-up on - POTENTIAL HAZARDS ASSOCIATED WITH WORK PRACTICES, Regulations for safety in biological plants. Most items are available to be opened or downloaded in the Portable Document Format (.PDF). %&'()*456789:CDEFGHIJSTUVWXYZcdefghijstuvwxyz of Health's programs and activities for health promotion, disease prevention, wellness, and disaster preparedness. A WORKBOOK FOR TECHNICAL TRAINING Biosafety and Risk Assessment in Agricultural Biotechnology Patricia L. Traynor Robert Frederick Muffy Koch The. endobj Overview. WIC provides the following at no cost: healthy foods, nutrition education and counseling, breastfeeding support, and referrals for health care. Click here to review the details. (2009) or "BMBL" outlines biological safety levels (BSLs), which are distinct from risk group levels. %%EOF version 004-06-22-2016: .PDF, Biosafety Risk Assessment Risk Likelihood and Consequences Evaluation Worksheet endobj (! PjlHvFdW?/CyiyX#M2CI7)Eda,=wZ*P?WW.^6_kI8 hb```b``f`a``da@ rLd4"dn0o`A]Aw 0NdS`60LN p qWwr6aa4+5 +``hH```` AB:H]}Hs1?8|B!$!.6l'{0ep5 ^g@t0cxi6`Y bX te Qualitative biological risk assessment is a subjective process that involves professional judgments. Activate your 30 day free trialto continue reading. *Note: This page contains materials in the Microsoft Excel format. A thorough, evidence-based and transparent assessment of the risks allows safety measures to be balanced with the actual risk of working with biological agents on a case-by-case basis. She then worked as a medical doctor in health care centres for The scope of the assessment involves evaluation of pathogenic microbial hazards, experimental activities, facilities. Order birth, death, marriage, and divorce certificates online through VitalChek. The primary goal of a Biosafety risk assessment is to identify and mitigate risk. <> Elina Maltseva, 2022 Kenya 1. +Tk version 005-6-22-2016:.PDF, Biosafety Risk Assessment Chemical Summary Worksheet endstream endobj 804 0 obj <>/Metadata 93 0 R/OCProperties<>/OCGs[821 0 R]>>/Outlines 135 0 R/PageLayout/SinglePage/Pages 796 0 R/StructTreeRoot 191 0 R/Type/Catalog/ViewerPreferences<>>> endobj 805 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text/ImageC]/Properties<>/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Trans 833 0 R/Type/Page>> endobj 806 0 obj <>stream These animals include different African rodents and monkeys. A few items are provided in Microsoft Excel format. With respect 779 0 obj <>/Filter/FlateDecode/ID[<79C1A29C2C23024CA76FE523D80AC18E>]/Index[766 26]/Info 765 0 R/Length 84/Prev 884398/Root 767 0 R/Size 792/Type/XRef/W[1 3 1]>>stream Because of uncertainties or insufficient scientific data, risk assessments often are based By using this site, you agree to the 11 0 obj Biosafety Risk Assessments Advertisement 1 of 9 Biosafety Risk Assessments Feb. 21, 2015 17 likes 10,732 views Download Now Download to read offline Education Biosafety Risk Assessments Amna Jalil Follow PhD Research Scholar Advertisement Recommended GMO issue and regulation VIVEK YADAV 8.9k views 20 slides Bio-Safety Guidelines Shahbaz Ahmad Article 6 TRANSIT AND CONTAINED USE 1. Risk assessment is and must be science-based only. For more details regarding specific facility design requirements for laboratories, see Section 4.A. <> Based on the likelihood and consequence determined from the table, identify the risk level of Biosafety is an important concept in microbiology as bio-related research . After each section, summarize what contributes most to risk in order to ensure that safety controls and equipment are appropriate for the level of risk. infant and N.-H. T. Tran Graduate School of Life and Environmental Sciences, University of Tsukuba, Tsukuba, Ibaraki 305-8752, Japan Present Address: N.-H. T. Tran Institute of Tropical Biology, Vietnam Academy of 9 0 obj Regular medical consultation for staff can early detect the risk of infection. 8~wS0\h`|[#]&iRX~ ';u4-4`{6imx={&x_6NE=;N|u>aqc Atd|Xh-;w54`}'Eu,FS.bcPvcS(cF ko"8"HQzE#6#L+#G6:3LR3&4|z~d_8")#cdJ$~#~q' +g(' E6j}(BXU&% 1"$MlQRoUg7\63ydY8 }f\}4c5G3Cy~EG'MXnsqM^Zgy+ea-NV%6hAb08c(=zO)m[Bgf,M3-VHGFH.>"D346 Ehc_BOA&c-|k!Xp>ym6?Q,166bCd 54RTXm*R JS!3nFsZ RPlo:B`}dyNtb!z9qu1^7 V[I*7oHovNRl>O-MqT@_YahJFL:e(mugQZ3V}D!H.jz4UVQWUH Yak Risk analysis involves not only identifying the hazards but evaluating the hazards in terms of Submit form for review by someone knowledgeable in biosafety. %PDF-1.5 Biosafety Risk Assessment Enter information or place a check mark ( ) for the answer that best fits the question. The risk must be identified The risk is evaluated The risk must be measured Plan to minimize the risk Assessing Risk 5. endstream <> Biosafety Level (BSL) Controls. +f3aDc7,Ji3-[RQ With the understanding that these laboratories perform procedures where a specimen may contain more than just the agent(s) for which it is being Instrument Biosafety Risk Assessment - Free download as Word Doc (.doc / .docx), PDF File (.pdf), Text File (.txt) or read online for free. Benchtops are resistant to water, heat, solvents, and other chemicals. version 004-06-22-2016: .PDF, Biosafety Risk Assessment Hazard Exposure Activities and Controls Repository version 004-06-22-2016 (Excel), Biosafety Risk Assessment General Considerations Worksheet CDC and NIH: Biosafety in Microbiological and Biomedical Laboratories 6th Ed. T_&)I Px}EZs/eeFFc[F_e3PI5 $/!>fDP]WKe#KeqN">6yS*O\1N-v_-GO*=orO@nS$J1 P" BE.M'*PV%&dM_J c;uID4;1 HC.-byf XMYxqX 4`I@YGjL$1!h@|!0,PM!EDeZ-sh -`Qf9`4t$,_wI0c\ccx5Q"dk)`` H)$A9N>"iK8UG2Hm,P;TF09]K`=U7@tbAzU Assessment of biological risks. Privacy Policy. Weve updated our privacy policy so that we are compliant with changing global privacy regulations and to provide you with insight into the limited ways in which we use your data. (%/m>aQ0Qz`R.Qf(mQ\AsbGuwbA(a 1A@Q0@9EJY!SV1JG0,2dY Close suggestions Search Search. Activate your 30 day free trialto unlock unlimited reading. Enjoy access to millions of ebooks, audiobooks, magazines, and more from Scribd. Certain indicators that indirectly assess the overall biosafety may include an updated procedure manual and work instructions, a list of trained staff with regular competency or proficiency tests, and regular quality control and laboratory equipment maintenance. Fzdo3S}4n57._~AC/x'm_=v?O_/n'?O7/kz}H}?l\O77OSwo].^>Q~T_/www~m9 E4^/loG'MB }5~/kyb}}xoX-|vj7"t-?.>l"o_lk\/-,slacgNYE; }Mv:vv6NLmoeg6>rKhU{_ ]zhwTA1e9v;>Mq@a"*$Xe{?15mjU}k`Gfy,sc_=' CoCd[(Z9{XbV|tB,9|e;`SPK}Si^ohc(clKz.~,BjSX_l26;ykxbc&0*;LV[[o@|KiK}l.?pb+[$X]-BbWo? However risk-assessment is evaluating multi-factorial situations and necessarily only leads to a set of certainties but also of uncertainties. endstream endobj startxref 4hhO\Dz8qMSa (sFi hOF! EY TL{Qfwpo KXeCG]V3^W"^:va ,]i6F!=h~*q }j)R;esT~DKTe3Q|4M>MWm'd]0C`=m,{\# I ,+wxNeQ+*~[z"6/T/mR6> >C:~:D0K eTvJ~z]t)xoN%|k2au -Do6 G`){]&$Xj=R1(wbN GYE?Ed%&obr,&&=e8hllJ=rSPiWF ffM2,+[E_A{U9$Fzof>!\-nGAx6h,i_ga_@} <> valid risk assessment carried out by suitably qualified individuals. Hello! Corresponding Risk Group/Representative Organisms. 4. version 004-06-22-2016: .PDF, Biosafety Risk Assessment Hazard Exposure Activities and Controls Worksheet version 005-06-22-2016 (Excel), Biosafety Risk Assessment Instrument-Method Worksheet Rules for the manufacture and use of hazardous micro organisms, genetically e National and International Regulatory Framework for GM Crops_2015, Junagadh Agricultural University, Junagadh (Guj. Biosafety Levels (BSLs) prescribe procedures and levels of containment for the particular microorganism or material (including research involving recombinant or synthetic nucleic acid molecules). Biosafety and Biosecurity, a section of the journal Frontiers in Bioengineering and Biotechnology Received:28 August 2018 Accepted:05 February 2019 . Manual explains the operation of the Biological Safety Program and provides guidelines for all university personnel for the safe performance of experiments involving biological agents. Risk GM Algae for Biofuel Production: Biosafety and Risk Assessment Shashi Kumar Published 2015 Engineering, Biology Considering the current rapid rate of fossil fuel depletion, many countries are heavily investing in biofuel generation from algae and including the use of genetic modification (GM) research to enhance their baseline biofuel qualities. <> Use a moisturizer to help replace the barrier function of skin. uWc( *8n-0qb{,rf\q*r{WUTpzz1nJ0Q-4zIh<6>FIsMRX}(y';vZE8TA=#i@AZZ'X%=fkj_#Ahp(jj1*:h%-%.kPzM=P~T`CQ1|S70SL-N2!k -}k'oV&d'$~W(eWMEW!EPEe>S/f-tNPyzNu)(H4! Effect of UV Rays on the Colonial & Cellular Morphology and Catalase Activity Survey of Different Factors Causing Obesity & Prevalence of Different Related Control of Microorganisms by Lowering pH (by Adding Organic Acids). 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