Regulatory Aspects, Standards,and Guidelines EMD 545b Lecture #4

Regulatory Regulatory Aspects, Aspects,

Standards,and Standards,and GuidelinesGuidelines

EMD 545bEMD 545b

Lecture #4Lecture #4

OSHA Law, OSHA Law, Standards, and Standards, and

DirectivesDirectivesRelated to BiohazardsRelated to Biohazards

OSHA Act of 1970OSHA Act of 1970

Section 1, An ActSection 1, An Act To assure safe/healthful working To assure safe/healthful working

conditionsconditions Section 2, Congressional Section 2, Congressional

Findings/PurposeFindings/Purpose ……to assure so far as to assure so far as

possible…safe/healthful working possible…safe/healthful working conditions and to preserve our human conditions and to preserve our human resourcesresources

Section 5 DutiesSection 5 Duties“General Duty Clause”“General Duty Clause”

(5)(A)(1)Each Employer shall (5)(A)(1)Each Employer shall furnish:furnish: employmentemployment workplace free from recognized hazards workplace free from recognized hazards

that are causing death or serious that are causing death or serious physical harmphysical harm

(5)(A)(2) Each Employer shall (5)(A)(2) Each Employer shall comply with OSHA Standardscomply with OSHA Standards

General Duty ClauseGeneral Duty Clause

Applicability to Biohazards:Applicability to Biohazards: recognized hazard exists (substantial recognized hazard exists (substantial

probability that death or serious harm probability that death or serious harm could occur)could occur) Risk Group 3/4 Agents Risk Group 3/4 Agents Some Risk Group 2 AgentsSome Risk Group 2 Agents

existing measure of abatementexisting measure of abatement economically/technologically feasible economically/technologically feasible

(BMBL, etc) (BMBL, etc)

Section 17 PenaltiesSection 17 Penalties

A) willful or repeat violation (5,000 A) willful or repeat violation (5,000 << x x << 70,000) 70,000)

B) serious violation (up to 7,000 each)B) serious violation (up to 7,000 each) C) less than serious (up to 7,000 each)C) less than serious (up to 7,000 each) D) extending beyond period of D) extending beyond period of

correction (up to 7,000 each day)correction (up to 7,000 each day) Employer pays (who is your employer?)Employer pays (who is your employer?)

Section 17 PenaltiesSection 17 Penalties

E) willful resulting in death (10,000 E) willful resulting in death (10,000 and 6 months jail). and 6 months jail).

repeat of E): 20,000 and 1 year jailrepeat of E): 20,000 and 1 year jail knowingly provide false info (10,000 knowingly provide false info (10,000

and 6 months jail)and 6 months jail) violations of posting requirements violations of posting requirements

(7,000)(7,000) killing an OSHA Inspector - life in killing an OSHA Inspector - life in

prisonprison

OSHA BBP Standard OSHA BBP Standard 1910.10301910.1030 Applicable to all occupational Applicable to all occupational

exposure to blood or other exposure to blood or other potentially infectious materials.potentially infectious materials.

Bloodborne Pathogens:Bloodborne Pathogens: Pathogenic microbes present in blood Pathogenic microbes present in blood

which can cause disease in humans which can cause disease in humans (include, but not limited to HIV, HBV, (include, but not limited to HIV, HBV, and HCV).and HCV).

““OPIM”OPIM”

Other Potentially Infectious MaterialsOther Potentially Infectious Materials human body fluidshuman body fluids

amniotic, cerebrospinal, pericardial, amniotic, cerebrospinal, pericardial, peritoneal, pleural, semen, synovial, vaginal peritoneal, pleural, semen, synovial, vaginal secretions, saliva in dental settings, unknown secretions, saliva in dental settings, unknown fluids, any body fluid visibly contaminated fluids, any body fluid visibly contaminated with blood.with blood.

unfixed human tissues or organs (except unfixed human tissues or organs (except skin)skin)

cell cultures/animal tissues containing cell cultures/animal tissues containing BBP’sBBP’s

Exposure Control PlanExposure Control Plan

Written document, updated and Written document, updated and reviewed annuallyreviewed annually

Identifies occupationally exposed Identifies occupationally exposed employeesemployees

Outlines procedures to protect themOutlines procedures to protect them Documents ongoing consideration of Documents ongoing consideration of

new engineering controlsnew engineering controls

Exposure DeterminationExposure Determination

Evaluate new employees at time or Evaluate new employees at time or hirehire

Evaluate existing employees who Evaluate existing employees who change jobschange jobs

List of jobs where all employees have List of jobs where all employees have exposureexposure

List of jobs where some have exposureList of jobs where some have exposure detailed list of tasks that include detailed list of tasks that include

exposureexposure

Exposure Control PlanExposure Control Plan

Hepatitis B Vaccine OfferHepatitis B Vaccine Offer free, 3 shot vaccinationfree, 3 shot vaccination offer w/in 10 days of hireoffer w/in 10 days of hire signed declination statementsigned declination statement

TrainingTraining at time of hire, before work involving at time of hire, before work involving

exposureexposure retraining each year w/in 365 daysretraining each year w/in 365 days

Methods of ComplianceMethods of Compliance

Universal PrecautionsUniversal Precautions Infection control concept where all Infection control concept where all

human blood and certain body fluids are human blood and certain body fluids are treated as if known to be infectious for treated as if known to be infectious for HIV or HBV.HIV or HBV.

Sharps PrecautionsSharps Precautions Sharps w/ Engineered Sharps Injury Sharps w/ Engineered Sharps Injury

Protections (SESIP): non-needle sharp Protections (SESIP): non-needle sharp or needle device or other sharp with or needle device or other sharp with built-in safety feature or mechanism built-in safety feature or mechanism that effectively reduces risk of exposure.that effectively reduces risk of exposure.

Methods of ComplianceMethods of Compliance

Sharps precautions, sharps containersSharps precautions, sharps containers Good work practicesGood work practices Leakproof containers for transport, Leakproof containers for transport,

storagestorage Labels, signsLabels, signs DecontaminationDecontamination Personal Protective EquipmentPersonal Protective Equipment

free, all sizes, appropriate for task, free, all sizes, appropriate for task, replacement supplies, laundered by replacement supplies, laundered by employeremployer

RecordsRecords

Medical (duration of work + 30 years)Medical (duration of work + 30 years) post-exposure evaluation and follow-uppost-exposure evaluation and follow-up

Training (maintained 3 years)Training (maintained 3 years) Sharps Injury LogSharps Injury Log

type, brand of sharptype, brand of sharp Dept., work area of incidentDept., work area of incident incident descriptionincident description SESIP evaluation applicable?SESIP evaluation applicable?

Scenario #1Scenario #1

New employee with occupational New employee with occupational exposure to human blood and other exposure to human blood and other potentially infectious materials has potentially infectious materials has just been hired by your institution.just been hired by your institution.

Outline OSHA BBP Standard Outline OSHA BBP Standard requirements for this employeerequirements for this employee

Scenario #1 - New Scenario #1 - New EmployeeEmployee

Written exposure determination (yes/no)Written exposure determination (yes/no) If yes, add to database (active w/exposure)If yes, add to database (active w/exposure) Job title/classification (all/some exposed?)Job title/classification (all/some exposed?) Tasks/procedures (update ECP if needed)Tasks/procedures (update ECP if needed) Site specific BBP training before workingSite specific BBP training before working HBV vaccine offer w/in 10 days of hire (yes-3 HBV vaccine offer w/in 10 days of hire (yes-3

shot series, no-sign declaration)shot series, no-sign declaration)

Scenario #1- New Scenario #1- New EmployeeEmployee

Healthcare professional’s written Healthcare professional’s written evaluation for HBV vaccineevaluation for HBV vaccine

Offer retraining every 365 days, Offer retraining every 365 days, updates as necessaryupdates as necessary

Evaluate prior work experience of Evaluate prior work experience of employeeemployee

Audit procedures, facility, Audit procedures, facility, supervisionsupervision

Scenario #2-HIV Scenario #2-HIV ExperimentExperiment

An existing employee from your An existing employee from your bloodborne pathogen program bloodborne pathogen program submits a request to work with HIV submits a request to work with HIV in cell culture.in cell culture.

What is the appropriate Institutional What is the appropriate Institutional response?response?

Scenario #2-HIV WorkScenario #2-HIV Work

Document prior work experienceDocument prior work experience Demonstrated proficiency with Demonstrated proficiency with

techniques, safety techniques, safety practices,equipment and operationspractices,equipment and operations

Adequate trained supervisionAdequate trained supervision Appropriate facility (lab inspection)Appropriate facility (lab inspection) Medical Surveillance (serum Medical Surveillance (serum

storage, post-exposure prophylaxisstorage, post-exposure prophylaxis

Scenario #3 - Exposure Scenario #3 - Exposure ResponseResponse

An employee at your institution has An employee at your institution has just experienced an exposure to just experienced an exposure to human blood.human blood.

What should happen next?What should happen next?


Treat exposed area immediately-Treat exposed area immediately-wash/flushwash/flush

Promptly seek medical evaluation (1-Promptly seek medical evaluation (1-2 hr): confidential and follow-up2 hr): confidential and follow-up

Document the route of exposure and Document the route of exposure and circumstancescircumstances

Attempt to ID source individual Attempt to ID source individual (HIV/HBV/HCV)(HIV/HBV/HCV)


Collect exposed worker’s blood with Collect exposed worker’s blood with consent (test baseline, 6, 12 and 36 consent (test baseline, 6, 12 and 36 weeks)weeks)

Hold blood sample for at least 90 daysHold blood sample for at least 90 days HIV HBIG post exposure prophylaxis is HIV HBIG post exposure prophylaxis is

availableavailable Counseling offeredCounseling offered Worker aware of signs/symptoms of Worker aware of signs/symptoms of

AgentsAgents


Healthcare provider must receiveHealthcare provider must receive copy of regulationcopy of regulation description of job duties description of job duties documentation of exposure routesdocumentation of exposure routes results of source individuals blood testsresults of source individuals blood tests all relevant medical recordsall relevant medical records


Health care professional’s written Health care professional’s written opinionopinion to employee w/in 15 days of completionto employee w/in 15 days of completion employee instructed on conditions that employee instructed on conditions that

may require further evaluationmay require further evaluation All other findings/diagnoses All other findings/diagnoses

CONFIDENTIALCONFIDENTIAL

Biowarfare/Biowarfare/BioterrorismBioterrorism Geneva Protocol (1925)Geneva Protocol (1925) Biological Weapons Convention Biological Weapons Convention

(1972)(1972) Biological Weapons Act (1989)Biological Weapons Act (1989)

Public Law 101-298Public Law 101-298 Chemical and Biological Weapons Chemical and Biological Weapons

Control and Warfare Elimination Act Control and Warfare Elimination Act of 1991of 1991 Public Law 102-182Public Law 102-182

Anthrax Letters - Fall Anthrax Letters - Fall 20012001

5 deaths (FL, NJ, 5 deaths (FL, NJ, NY, CT)NY, CT)

22 total infections22 total infections Mass terrorMass terror

White powder White powder fever!fever!

Unsolved crimeUnsolved crime

Other “bioterror” Other “bioterror” eventsevents

Salmonella in salad Salmonella in salad barsbars

Shigella in pastriesShigella in pastries 125-I Saxitoxin in 125-I Saxitoxin in

take-out foodtake-out food Ricin at IRS building Ricin at IRS building

-thwarted before -thwarted before useuse

UCONN anthraxUCONN anthrax Texas TechTexas Tech

lost Yersinia sampleslost Yersinia samples HoaxesHoaxes

Select Biological Select Biological Agents/ToxinsAgents/Toxins

Anti-terrorism and Effective Death Anti-terrorism and Effective Death Penalty Act of 1996 (Public Law 104-Penalty Act of 1996 (Public Law 104-132)132) Additional Requirements for Facilities Additional Requirements for Facilities

Transferring or Receiving Select Agents Transferring or Receiving Select Agents 42 CFR Part 72.6 (Select Agent 42 CFR Part 72.6 (Select Agent Rule)Rule)

USA Patriot Act (Public Law 107-56USA Patriot Act (Public Law 107-56 Uniting and Strengthening America by Uniting and Strengthening America by

Providing Appropriate Tools Required to Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of Intercept and Obstruct Terrorism Act of 20012001

Possession now addressedPossession now addressed

DHHS-CDC, USDA-APHISDHHS-CDC, USDA-APHIS Public Health Security and Public Health Security and

Bioterrorism Preparedness Bioterrorism Preparedness Response Act of 2002Response Act of 2002 Public Law 107-188Public Law 107-188

42 CFR Part 73, 9 CFR Part 121, 7 42 CFR Part 73, 9 CFR Part 121, 7 CFR Part 331CFR Part 331

Regulatory language for USA Regulatory language for USA PATRIOT ACTPATRIOT ACT Lists of Select AgentsLists of Select Agents

Select Agent List DHHS-Select Agent List DHHS-CDCCDC

Crimean Congo haemorrhagic fever virusCrimean Congo haemorrhagic fever virus Coccidiodiodes posadasiiCoccidiodiodes posadasii Ebola virusesEbola viruses Cercopithecine herpesvirus 1 Cercopithecine herpesvirus 1

(Herpes B virus)(Herpes B virus) Lassa fever virusLassa fever virus Marburg virusMarburg virus Monkeypox virusMonkeypox virus Rickettsia prowazekiiRickettsia prowazekii Rickettsia rickettsiiRickettsia rickettsii South American haemorrhagic fever virusesSouth American haemorrhagic fever viruses

Junin, Machupo, Sabia, Flexal, GuanaritoJunin, Machupo, Sabia, Flexal, Guanarito


Tick-borne encephalitis complex (flavi) Tick-borne encephalitis complex (flavi) virusesviruses

Central European tick-borne encephalitisCentral European tick-borne encephalitis Far Eastern tick-borne encephalitisFar Eastern tick-borne encephalitis Russian spring and summer encephalitisRussian spring and summer encephalitis Kyasanur forest diseaseKyasanur forest disease Omsk hemorrhagic feverOmsk hemorrhagic fever

Variola major virus (Smallpox virus)Variola major virus (Smallpox virus) Variola minor virus (Alastrim)Variola minor virus (Alastrim) Yersinia pestisYersinia pestis


AbrinAbrin ConotoxinsConotoxins DiacetoxyscirpenolDiacetoxyscirpenol RicinRicin SaxitoxinSaxitoxin Shiga-like ribosome inactivating Shiga-like ribosome inactivating

proteinsproteins TetrodotoxinTetrodotoxin

DHHS-CDC USDA Overlap DHHS-CDC USDA Overlap AgentsAgents

Bacillus anthracisBacillus anthracis Brucella abortus, B. melitensis, B. suisBrucella abortus, B. melitensis, B. suis Burkholderia mallei, B. pseudomalleiBurkholderia mallei, B. pseudomallei Botulinum neurotoxin producing species Botulinum neurotoxin producing species

of Clostridiumof Clostridium Coccidioides immitisCoccidioides immitis Coxiella burnetiiCoxiella burnetii Eastern equine encephalitis virusEastern equine encephalitis virus Hendra virusHendra virus Francisella tularensisFrancisella tularensis Nipah virusNipah virus

DHHS-CDC USDA Overlap DHHS-CDC USDA Overlap AgentsAgents

Rift Valley fever virusRift Valley fever virus Venezuelen equine encephalitis virusVenezuelen equine encephalitis virus Botulinum neurotoxinBotulinum neurotoxin Clostridium perfringens epsilon toxinClostridium perfringens epsilon toxin ShigatoxinShigatoxin Staphylococcal enterotoxinsStaphylococcal enterotoxins T-2 ToxinT-2 Toxin

Select Agent List Select Agent List USDAUSDA

Akabane virusAkabane virus African swine fever virusAfrican swine fever virus African horse sickness virusAfrican horse sickness virus Avian influenza virus (highly pathogenic)Avian influenza virus (highly pathogenic) Blue tongue virus (Exotic)Blue tongue virus (Exotic) Bovine spongiform encephalopathy agentBovine spongiform encephalopathy agent Camel pox virusCamel pox virus Classical swine fever virusClassical swine fever virus Cowdria ruminantium (Heartwater)Cowdria ruminantium (Heartwater) Foot and mouth disease virusFoot and mouth disease virus Goat pox virusGoat pox virus

Select Agent List Select Agent List USDAUSDA

Lumpy skin disease virusLumpy skin disease virus Japanese encephalitis virusJapanese encephalitis virus Malignant catarrhal fever virus (exotic)Malignant catarrhal fever virus (exotic) Menangle virusMenangle virus Mycoplasma capricolum/M.F38/M. Mycoplasma capricolum/M.F38/M.

mycoides caprimycoides capri Mycoplasma mycoides mycoidesMycoplasma mycoides mycoides Newcastle disease virus (velogenic)Newcastle disease virus (velogenic) Peste Des Petits Ruminants virusPeste Des Petits Ruminants virus Rinderpest virusRinderpest virus Sheep pox virusSheep pox virus Swine vesicular disease virusSwine vesicular disease virus Vesicular stomatis virus (exotic)Vesicular stomatis virus (exotic)

Select Agent List APHISSelect Agent List APHIS Candidatus Liberobacter africanusCandidatus Liberobacter africanus Candidatus Liberobacter asiaticusCandidatus Liberobacter asiaticus Peronosclerospora philipinensisPeronosclerospora philipinensis Ralstonia solanacearum race 3, biovar 2Ralstonia solanacearum race 3, biovar 2 Schlerophthora rayssiae var zeaeSchlerophthora rayssiae var zeae Synchytrium endobioticumSynchytrium endobioticum Xanthomonas oryzae pv. oryzicolaXanthomonas oryzae pv. oryzicola Xylella fastidiosa (citrus variegated Xylella fastidiosa (citrus variegated

chlorosis strain)chlorosis strain)

USA PATRIOT ACTUSA PATRIOT ACT

Restricted person (can’t possess, Restricted person (can’t possess, receive, transport) receive, transport)

under indictment for a crime punishable by under indictment for a crime punishable by imprisonment for a term > 1 yearimprisonment for a term > 1 year

has been convicted of crime punishable by has been convicted of crime punishable by imprisonment > 1 yearimprisonment > 1 year

fugitive from justicefugitive from justice unlawful user of a controlled substanceunlawful user of a controlled substance illegal alien illegal alien adjudicated as a mental defectiveadjudicated as a mental defective dishonorable discharge from US Armed dishonorable discharge from US Armed

ServicesServices

Restricted PersonRestricted Person Is an alien who is a national from a Is an alien who is a national from a

country that has history of country that has history of supporting terrorism:supporting terrorism: SyriaSyria SudanSudan LybiaLybia CubaCuba IranIran IraqIraq North KoreaNorth Korea

Components of Bioterrorism Components of Bioterrorism LawLaw Registration of individuals (possess, Registration of individuals (possess,

access)access) Registration of agents, locationRegistration of agents, location Description of storage and security Description of storage and security

requirementsrequirements Pre-authorization of transfersPre-authorization of transfers Select Agent InventorySelect Agent Inventory

Components of Bioterrorism Components of Bioterrorism LawLaw Restricted AccessRestricted Access

Facility Facility fences, guards, video monitorfences, guards, video monitor

BuildingBuilding locked access (key, keycard, guard, video)locked access (key, keycard, guard, video) floors (keycard access, alarms, labels)floors (keycard access, alarms, labels) LabLab

locked, lockboxes, away from office and traffic locked, lockboxes, away from office and traffic areasareas

Security Training/Manuals/InspectionsSecurity Training/Manuals/Inspections

Components of Bioterrorism Components of Bioterrorism LawLaw Security PlanSecurity Plan

procedures for reporting loss of keys, procedures for reporting loss of keys, passwordpassword

reporting suspicious people/packagesreporting suspicious people/packages removal of unauthorized personnelremoval of unauthorized personnel

reporting release, loss, or theftreporting release, loss, or theft Access controlAccess control Emergency response plansEmergency response plans Inventory tracking quantities of SA’sInventory tracking quantities of SA’s

NIH Guidelines NIH Guidelines for Research for Research

Involving rDNA Involving rDNA Molecules (April, Molecules (April,

2002)2002)

NIH Guidelines - April NIH Guidelines - April 20022002

NIH - OBA (Office of Biotechnology NIH - OBA (Office of Biotechnology Activities)Activities)

Outline scope of regulated rDNA Outline scope of regulated rDNA work and required containment levels work and required containment levels (changes approved by NIH-OBA)(changes approved by NIH-OBA)

ApplicabilityApplicability NIH Sponsored InstitutionsNIH Sponsored Institutions NIH Supported projects (US & Abroad)NIH Supported projects (US & Abroad)

Responsibilities: Responsibilities: InstitutionInstitution

Ensure full conformity with GuidelinesEnsure full conformity with Guidelines Establish an IBCEstablish an IBC Appoint a BSO (if necessary)Appoint a BSO (if necessary) Ensure adequate expertise for Ensure adequate expertise for

protocol review (plant, animal, human protocol review (plant, animal, human gene transfer)gene transfer)

Training (IBC/BSO/PI’s/Lab staff)Training (IBC/BSO/PI’s/Lab staff) Health Surveillance (BL3/Large scale)Health Surveillance (BL3/Large scale)

Responsibilities - IBCResponsibilities - IBC

5 members (2 from community)5 members (2 from community) Expertise (rDNA, biosafety, Expertise (rDNA, biosafety,

containment, legal)containment, legal) Annual report to NIH-OBA (roster/CV’s)Annual report to NIH-OBA (roster/CV’s) AssessAssess

Containment level, facilities, proceduresContainment level, facilities, procedures Develop emergency plans, report violationsDevelop emergency plans, report violations

Responsibilities: Responsibilities: Biosafety OfficerBiosafety Officer

IBC MemberIBC Member InspectionsInspections Report problems to IBCReport problems to IBC Develop emergency plansDevelop emergency plans Advise on lab securityAdvise on lab security

Responsibilities: Responsibilities: Principal InvestigatorPrincipal Investigator

Full compliance with GuidelinesFull compliance with Guidelines Can’t start/modify non-exempt work Can’t start/modify non-exempt work

w/out approvalw/out approval Report violations w/in 30 daysReport violations w/in 30 days Make initial determination of Make initial determination of

containmentcontainment Instruct/train lab staffInstruct/train lab staff Supervise safety performanceSupervise safety performance

Section III: Experiments Section III: Experiments covered by the NIH covered by the NIH

GuidelinesGuidelines Require approval before initiationRequire approval before initiation

III-A: Transfer significant drug-resistant III-A: Transfer significant drug-resistant trait (IBC/RAC review/NIH Director)trait (IBC/RAC review/NIH Director)

III-B: Cloning toxins (IBC/NIH-OBA)III-B: Cloning toxins (IBC/NIH-OBA) III-C: Human gene transfer III-C: Human gene transfer

(IBC/IRB/FDA NIH-OBA registration)(IBC/IRB/FDA NIH-OBA registration) III-D: Risk group 2-4 & restricted, III-D: Risk group 2-4 & restricted,

defective virus in cell culture, animals, defective virus in cell culture, animals, plants, large scale plants, large scale

Section III: Experiments Section III: Experiments Covered by the Covered by the

GuidelinesGuidelines IBC Notice at time of initiationIBC Notice at time of initiation

III-E-1: < 2/3 viral genomeIII-E-1: < 2/3 viral genome III-E-3 Production of transgenic III-E-3 Production of transgenic

rodents rodents III-E-2: Whole plantsIII-E-2: Whole plants

Section III: Exempt Section III: Exempt ExperimentsExperiments

III-F-1 through III-F-6III-F-1 through III-F-6 not in organisms/viruses, PCR, known not in organisms/viruses, PCR, known

exchangers, in/out of same hostexchangers, in/out of same host Appendix C-1 through C-VIAppendix C-1 through C-VI

< 50% viral genome, E.coli, B. subtilis, < 50% viral genome, E.coli, B. subtilis, S.cerevisiae, Purchase transfer of S.cerevisiae, Purchase transfer of transgenic rodents, extrachromosomal transgenic rodents, extrachromosomal elements of gm+ organismselements of gm+ organisms

Appendices to NIH Appendices to NIH GuidelinesGuidelines

Appendix B:Appendix B: Classification of Classification of Etiologic Agents on the Basis of Etiologic Agents on the Basis of HazardHazard

Appendix F: Containment for toxin Appendix F: Containment for toxin experimentsexperiments

Appendix G: Biosafety containment Appendix G: Biosafety containment levels (in vitro experiments)levels (in vitro experiments)

Appendix H: Shipment Appendix H: Shipment

Appendices to NIH Appendices to NIH GuidelinesGuidelines

Appendix K:Appendix K: Large Scale Large Scale containmentcontainment

Appendix M: Human gene transferAppendix M: Human gene transfer Appendix P: Plants (biocontainment Appendix P: Plants (biocontainment

for rDNA plant experiments)for rDNA plant experiments) Appendix Q: Animal Biosafety Appendix Q: Animal Biosafety

containment levelscontainment levels

TuberculosisTuberculosisExposure Exposure ControlControl

Mycobacterium Mycobacterium tuberculosistuberculosis

Ancient Ancient AirborneAirborne

droplet nucleidroplet nuclei ID50 < 10 bacilliID50 < 10 bacilli Generally requires close, Generally requires close,

prolonged contactprolonged contact infectiousness of patient, infectiousness of patient,

#bacilli expelled#bacilli expelled forcefullness of coughforcefullness of cough ventilation, duration of exposureventilation, duration of exposure


2 million deaths/year 2 million deaths/year worldwide (2002)worldwide (2002) 1/3 of world population 1/3 of world population

TB positiveTB positive 1 new TB infection every 1 new TB infection every

secondsecond

Africa/Asia - 100 - Africa/Asia - 100 - 300+/100,000 (2002)300+/100,000 (2002)

USA - 5.2 cases/100,000 USA - 5.2 cases/100,000 (2002)(2002) D.C.- 14.4, HI-11.9, CA-D.C.- 14.4, HI-11.9, CA-

9.0, NY-7.5 (2002)9.0, NY-7.5 (2002)


Rod shaped (0.3-0.6 um wide x Rod shaped (0.3-0.6 um wide x 1-4um long)1-4um long)

Obligate intracellular pathogenObligate intracellular pathogen Slow-growing (18-24 hour Slow-growing (18-24 hour

doubling time)doubling time) 3-12 week incubation3-12 week incubation PPD+ 2-10 weeks after PPD+ 2-10 weeks after

infectioninfection

TB PathogenesisTB Pathogenesis

Site of infection: lung, other Site of infection: lung, other tissues/organstissues/organs

Initial infection: usually Initial infection: usually unnoticed, lesions heal unnoticed, lesions heal without residual changeswithout residual changes

5% with progressive 5% with progressive pulmonary diseasepulmonary disease

95% in latent phase (lifetime 95% in latent phase (lifetime reactivation risk)reactivation risk)

TB PathwayTB Pathway

Phagocytized by macrophagesPhagocytized by macrophages Multiplication with in Multiplication with in

macrophagesmacrophages Spread to lymph nodesSpread to lymph nodes Heart, lung, bloodstreamHeart, lung, bloodstream All organs of body susceptibleAll organs of body susceptible In 5%: TB multiplies in upper In 5%: TB multiplies in upper

lunglung Fuse into multinucleated cells Fuse into multinucleated cells

consumption, wasting, fever, consumption, wasting, fever, coughcough

Risk FactorsRisk Factors

Diabetes, silicosis, abnormal chest X-Diabetes, silicosis, abnormal chest X-rayray

Prolonged corticosteroid therapyProlonged corticosteroid therapy Certain cancers (leukemia, hodgkins)Certain cancers (leukemia, hodgkins) Kidney disease, certain intestinal Kidney disease, certain intestinal

conditionsconditions Low body weightLow body weight HIV, IV drug useHIV, IV drug use Recent TB infection (w/in 2 years)Recent TB infection (w/in 2 years)

TB TreatmentTB Treatment

50% of untreated will die50% of untreated will die Isoniazid, rifampim, ethambutol, Isoniazid, rifampim, ethambutol,

etc.etc. Prolonged treatment (6-9 months)Prolonged treatment (6-9 months)

Directly Observed TherapyDirectly Observed Therapy MDR-TB - high fatality rate (50-MDR-TB - high fatality rate (50-

85%)85%) Longer treatment (18 - 24 Longer treatment (18 - 24

months)months)

Signs and Symptoms of Signs and Symptoms of Active TBActive TB

Early signs - fatigue, weakness, Early signs - fatigue, weakness, fever, chills, night sweats, loss fever, chills, night sweats, loss of appetite, weight lossof appetite, weight loss

Advanced stages - sputum Advanced stages - sputum producing cough, coughing up producing cough, coughing up blood, chest pain, hoarseness blood, chest pain, hoarseness of voiceof voice

Graphic produced by Coastal VideoGraphic produced by Coastal Video

Proposed OSHA TB Proposed OSHA TB StandardStandard

*VACATED 2002**VACATED 2002* Resurgence of TB casesResurgence of TB cases

Annual increase from 1985-1992Annual increase from 1985-1992

Multi-drug resistant TBMulti-drug resistant TB

OSHA General Duty CauseOSHA General Duty Cause

Current OSHA Current OSHA EnforcementEnforcement

CPL 2.106 (2/9/96)CPL 2.106 (2/9/96) 5(a)(1) General Duty Clause of OSH 5(a)(1) General Duty Clause of OSH

Act of 1970Act of 1970 recognized hazardrecognized hazard abatement economically and abatement economically and

technologically feasibletechnologically feasible CoverageCoverage

>> 1 suspect/confirmed TB case w/in 1 suspect/confirmed TB case w/in previous 6 monthsprevious 6 months

Related OSHA LawRelated OSHA Law

Respiratory Protection - Respiratory Protection - 29 CFR 1910.13429 CFR 1910.134 Accident Prevention Signs and Tags Accident Prevention Signs and Tags

- - 29 CFR 1910.145 29 CFR 1910.145

Employee Exposure and Medical Employee Exposure and Medical Records - Records - 29 CFR 1910.1020 29 CFR 1910.1020

Recording and Reporting Recording and Reporting Occupational Injuries and Illness - Occupational Injuries and Illness - 29 29 CFR 1904 CFR 1904

TB Control Measures - TB Control Measures - ClinicalClinical

Identify exposed employees Identify exposed employees TrainingTraining Respiratory protectionRespiratory protection Early identification/isolationEarly identification/isolation Medical Surveillance: TB Medical Surveillance: TB

ScreeningScreening at time of hire (within 2 weeks)at time of hire (within 2 weeks) after occupational exposureafter occupational exposure at least annuallyat least annually

Medical SurveillanceMedical Surveillance Periodic tuberculin skin testingPeriodic tuberculin skin testing History, physical exam, medical managementHistory, physical exam, medical management Provide:Provide:

before initiation of work before initiation of work upon signs/symptomsupon signs/symptoms after exposure incidentafter exposure incident after skin test conversionafter skin test conversion w/in 30 days of termination of workw/in 30 days of termination of work when deemed necessarywhen deemed necessary

TB ScreeningTB Screening

Test for infection: Test for infection: PPD (anergy)PPD (anergy)

Test for active Test for active disease:disease: Sputum cultureSputum culture Chest X-RayChest X-Ray

Respiratory ProtectionRespiratory Protection Targeted for:Targeted for:

entry to TB isolation room (in use)entry to TB isolation room (in use) during procedures on unmasked TB patientduring procedures on unmasked TB patient transport (in vehicle/unmasked patient in transport (in vehicle/unmasked patient in

facility)facility) work on contaminated ventilation systemswork on contaminated ventilation systems area where unmasked TB patient is presentarea where unmasked TB patient is present in residence of TB patientin residence of TB patient

Respiratory ProtectionRespiratory Protection ProgramProgram

TrainingTraining Selection of an air-Selection of an air-

purifying respirator purifying respirator (NIOSH approved)(NIOSH approved)

Fit testingFit testing UseUse Storage/disposalStorage/disposal

Remember: Surgical Remember: Surgical masks are not respiratorsmasks are not respirators

RecordkeepingRecordkeeping

Medical (duration + 30 Medical (duration + 30 years)years)

OSHA illness and injuryOSHA illness and injury Training (3 years)Training (3 years) Engineering control Engineering control

maintenance and maintenance and monitoring (3 years)monitoring (3 years)

TB Exposure Control TB Exposure Control ProceduresProcedures

Ask patient to cover their nose Ask patient to cover their nose and mouthand mouth

Provide surgical mask for Provide surgical mask for patientpatient

Wear a NIOSH certified Wear a NIOSH certified *respirator for close or *respirator for close or prolonged contactprolonged contact

* a 95% filter efficiency * a 95% filter efficiency for particles 1 micron in sizefor particles 1 micron in size

Graphic produced by Coastal VideoGraphic produced by Coastal Video

TB Exposure Control TB Exposure Control ProceduresProcedures

Isolate patient (negative Isolate patient (negative pressure room or pressure room or dedicated/segregated area)dedicated/segregated area)

Notify supervisor or infection Notify supervisor or infection control representativecontrol representative

Refer patient to emergency Refer patient to emergency medical assistance (w/in 5 medical assistance (w/in 5 hours)hours)

Engineering ControlsEngineering Controls

Verify negative pressureVerify negative pressure Room exhaust away from entry doorRoom exhaust away from entry door Ducts w/in building under negative pressureDucts w/in building under negative pressure Exhaust to outside away from intakesExhaust to outside away from intakes HEPA filter if re-circulated or positive ductsHEPA filter if re-circulated or positive ducts HEPA checked periodicallyHEPA checked periodically AHU/system labeled - TB warningAHU/system labeled - TB warning

Signs/LabelsSigns/Labels

Treatment rooms (signal word & Treatment rooms (signal word & necessary precautions)necessary precautions)

Air transport components (fans, Air transport components (fans, ducts, filters)ducts, filters)

OSHA 300 LogOSHA 300 Log

TB infections (+PPD)TB infections (+PPD) +PPD’s after 2 weeks of hire +PPD’s after 2 weeks of hire

must be recorded whether must be recorded whether deemed work related or not!deemed work related or not!

TB diseaseTB disease

OSHA Law, OSHA Law, Standards, and Standards, and

DirectivesDirectivesRelated to BiohazardsRelated to Biohazards

OSHA Act of 1970OSHA Act of 197029 CFR 1904 29 CFR 1904

OSHA 300 Log, Log and Summary of OSHA 300 Log, Log and Summary of Occupational Injuries and Illnesses (as Occupational Injuries and Illnesses (as of 1/1/02 -only 1 column, excludes 1st of 1/1/02 -only 1 column, excludes 1st Aid)Aid) must post annual summary of workplace must post annual summary of workplace

injuries and illnesses for the previous injuries and illnesses for the previous calendar year no later than 2/1 kept to at calendar year no later than 2/1 kept to at least 3/1.least 3/1.

satellite locations includedsatellite locations included records maintained and updated for 5 yearsrecords maintained and updated for 5 years

29 CFR 1903.229 CFR 1903.2OSHA PosterOSHA Poster

each workplace must display an each workplace must display an OSHA Poster alerting employees:OSHA Poster alerting employees: availability of OSHA Act, Regulations availability of OSHA Act, Regulations

and Standardsand Standards posting of noticeposting of notice

poster size (8.5” x 14”)poster size (8.5” x 14”)

29 CFR 1910.103029 CFR 1910.1030Bloodborne Pathogens Bloodborne Pathogens Standard UpdateStandard UpdateOSHA CPL 2.44D, updated OSHA CPL 2.44D, updated

Compliance Assistance DirectiveCompliance Assistance Directive mandatory evaluation of safe sharps mandatory evaluation of safe sharps

devices and work practicesdevices and work practices previous incidents at your workplaceprevious incidents at your workplace after each future sharps incidentafter each future sharps incident document evaluationdocument evaluation continue searching for effective devicecontinue searching for effective device

29 CFR 1910.141 29 CFR 1910.141 SanitationSanitation

Housekeeping, waste/vermin disposal, Housekeeping, waste/vermin disposal, toilet facilities, potable water, toilet facilities, potable water, washing facilitieswashing facilities

Showers, change rooms, Showers, change rooms, eating/drinking locationseating/drinking locations

Sanitary storage (food not stored in Sanitary storage (food not stored in toilets or areas exposed to toxic toilets or areas exposed to toxic materials)materials)

1910.145 Specification 1910.145 Specification forfor

Accident Prevention Accident Prevention Signs/TagsSigns/Tags (e)(4)Biological Hazard Signs(e)(4)Biological Hazard Signs

to signify actual/potential presence of to signify actual/potential presence of biohazardbiohazard

identify equipment, containers, rooms, identify equipment, containers, rooms, materials, experimental animals, …materials, experimental animals, …which contain or are contaminated which contain or are contaminated with, viable hazardous agents.with, viable hazardous agents.

only those infectious agents presenting only those infectious agents presenting a risk or potential risk to the well-being a risk or potential risk to the well-being of manof man

29 CFR 1910.145 29 CFR 1910.145

(f)(2) Biohazard - those infectious (f)(2) Biohazard - those infectious agents presenting a risk of death, agents presenting a risk of death, injury or illness to employees.injury or illness to employees.

Tags - contain signal word/major Tags - contain signal word/major messagemessage signal word readable from 5 feet or signal word readable from 5 feet or

more (warranted by the hazard)more (warranted by the hazard) affixed as close as possible to the affixed as close as possible to the

hazardhazard

29 CFR 1910.14529 CFR 1910.145

Symbol presented:Symbol presented: Biohazard - fluorescent orange or Biohazard - fluorescent orange or

orange-red, or predominantly so, with orange-red, or predominantly so, with lettering or symbols in a contrasting lettering or symbols in a contrasting color.color.

Year Biohazard Symbol created?Year Biohazard Symbol created?

29 CFR 1910.120 29 CFR 1910.120 HAZWOPERHAZWOPER

Hazardous Waste Operations and Hazardous Waste Operations and Emergency ResponseEmergency Response (a)(v)emergency response operations (a)(v)emergency response operations

for release of, or substantial threats of for release of, or substantial threats of releases of, hazardous substances releases of, hazardous substances without regard to the location of the without regard to the location of the hazardhazard

29 CFR 1910.12029 CFR 1910.120

(a)(3) Hazardous substance(a)(3) Hazardous substance (B) any biological agent and other (B) any biological agent and other

disease-causing agent which after disease-causing agent which after release into the environment and upon release into the environment and upon exposure… will or may cause death, exposure… will or may cause death, disease,…disease,…

RequirementsRequirements written program, training, medical written program, training, medical

surveillance, risk assessment, controls, surveillance, risk assessment, controls, monitoring, decontamination, etc...monitoring, decontamination, etc...

29 CFR 1910.132 - 29 CFR 1910.132 - 1910.1391910.139

Personal Protective Personal Protective EquipmentEquipment 1910.132 Personal Protective 1910.132 Personal Protective

EquipmentEquipment 1910.133 Face & Eye Protection1910.133 Face & Eye Protection 1910.134 Respiratory Protection1910.134 Respiratory Protection 1910.138 Hand Protection1910.138 Hand Protection 1910.139 Respiratory Protection 1910.139 Respiratory Protection

(for Mycobacterium tuberculosis - (for Mycobacterium tuberculosis - old 1910.134)old 1910.134)

29 CFR 1910.132 29 CFR 1910.132 Personal Protective Personal Protective

EquipmentEquipment PPE for eyes, face, head, & PPE for eyes, face, head, &

extremitiesextremities Protective clothingProtective clothing Respiratory devicesRespiratory devices Protective shields and barriersProtective shields and barriers ……shall be provided, used, and shall be provided, used, and

maintained in a sanitary mannermaintained in a sanitary manner

29 CFR 1910.13229 CFR 1910.132

Hazard assessmentHazard assessment Selection/fitSelection/fit TrainingTraining

situations required, required PPEsituations required, required PPE donning/adjusting/doffing & limitationsdonning/adjusting/doffing & limitations care, maintenance, service life & care, maintenance, service life &

disposaldisposal demonstration before usedemonstration before use retrain as neededretrain as needed

29 CFR 1910.13429 CFR 1910.134Respiratory ProtectionRespiratory Protection

Engineering controls 1st option Engineering controls 1st option (wear when not feasible)(wear when not feasible)

ProgramProgram written plan, selection, medical written plan, selection, medical

evaluationevaluation fit testing, procedures for proper usefit testing, procedures for proper use cleaning, disinfection, storing, cleaning, disinfection, storing,

inspecting, discardinginspecting, discarding trainingtraining

29 CFR 1910.13429 CFR 1910.134

Medical evaluation (questionnaire/exam)Medical evaluation (questionnaire/exam) written medical determinationwritten medical determination

Program AdministratorProgram Administrator identify, evaluate hazards, select respiratoridentify, evaluate hazards, select respirator program evaluationprogram evaluation

Annual fit-test for tight fitting face piecesAnnual fit-test for tight fitting face pieces Annual training requirement Annual training requirement

(performance)(performance)

29 CFR 1910.138 29 CFR 1910.138 Hand ProtectionHand Protection

Required for listed hazards:Required for listed hazards: skin absorption of harmful substancesskin absorption of harmful substances severe cuts, lacerations, puncturessevere cuts, lacerations, punctures burns (chemical and thermal)burns (chemical and thermal) harmful temperature extremesharmful temperature extremes

29 CFR 1910.13929 CFR 1910.139Respiratory Protection Respiratory Protection

(M.TB)(M.TB) Applies only to respiratory Applies only to respiratory

protection against M. tuberculosis in protection against M. tuberculosis in lieu of 1910.134lieu of 1910.134

NIOSH approved particulate NIOSH approved particulate respirators (N-95 or greater respirators (N-95 or greater efficiency)efficiency)

29 CFR 1910.15129 CFR 1910.151Medical Services and Medical Services and

First AidFirst Aid Ready availability of medical personnel Ready availability of medical personnel

for advice/consultationfor advice/consultation Person trained in first aid (in absence Person trained in first aid (in absence

of infirmary or clinic in near proximity)of infirmary or clinic in near proximity) Suitable facilities for quick drenching Suitable facilities for quick drenching

or flushing of eyes and body in the or flushing of eyes and body in the work area (where eyes/body…may be work area (where eyes/body…may be exposed to injurious corrosive exposed to injurious corrosive materials)materials)

29 CFR 1910.15729 CFR 1910.157Portable Fire Portable Fire ExtinguishersExtinguishers

Placement/use (75 ft.- Class A or D, 50 Placement/use (75 ft.- Class A or D, 50 ft.-Class B, Class C mirrors A or B)ft.-Class B, Class C mirrors A or B)

MaintenanceMaintenance annual verificationannual verification

TrainingTraining initial & annualinitial & annual

ExemptionsExemptions written plan for immediate evacuationwritten plan for immediate evacuation designated personnel designated personnel

29 CFR 1910.38 29 CFR 1910.38 Employee Employee

Emergency/Fire Emergency/Fire Prevention PlansPrevention Plans Written Emergency Action PlanWritten Emergency Action Plan

fire, toxic chemical releases, other fire, toxic chemical releases, other emergenciesemergencies

Alarm SystemAlarm System EvacuationEvacuation

floor plan/map w/ colored evacuation routesfloor plan/map w/ colored evacuation routes safe refuge area delineatedsafe refuge area delineated

Training (to ensure orderly evacuation)Training (to ensure orderly evacuation) before implementation (sufficient # trained)before implementation (sufficient # trained)

29 CFR 1910.1020 29 CFR 1910.1020 Access to Exposure & Access to Exposure &

Medical RecordsMedical Records Access (right to examine and copy)Access (right to examine and copy)

personal/area samples, biological personal/area samples, biological monitoring, MSDS’s, chemical inventoriesmonitoring, MSDS’s, chemical inventories

records from similar employee if no data records from similar employee if no data provided w/in 15 days (reasonable place, provided w/in 15 days (reasonable place,

free)free) PreservationPreservation

medical - duration of work plus 30 yearsmedical - duration of work plus 30 years exposure - 30 yearsexposure - 30 years

29 CFR 1910.1020 29 CFR 1910.1020 Access to Exposure & Access to Exposure &

Medical RecordsMedical Records Information to Employees (@ start of Information to Employees (@ start of

work and annually)work and annually) their right of access their right of access alert of existence, location, availability alert of existence, location, availability

of recordsof records identity of person responsible for identity of person responsible for

maintenance/access of recordsmaintenance/access of records copy of 1910.1020 availablecopy of 1910.1020 available

Other Related OSHA Other Related OSHA StandardsStandards

1910.1047 Ethylene Oxide1910.1047 Ethylene Oxide 1910.1048 Formaldehyde1910.1048 Formaldehyde 1910.1200 “HAZCOMM”1910.1200 “HAZCOMM” 1910.1450 “Lab Standard”1910.1450 “Lab Standard” 1910.95 Occupational Noise 1910.95 Occupational Noise

ExposureExposure 1910.106 Flammable/Combustible 1910.106 Flammable/Combustible

LiquidsLiquids

Guidelines and Guidelines and Regulations Regulations Related to Related to

Medical WasteMedical Waste

Medical WasteMedical Waste

Regulations and GuidelinesRegulations and Guidelines LocalLocal StateState FederalFederal

EPA (RCRA)EPA (RCRA) OSHA, DOTOSHA, DOT CDC, NIHCDC, NIH

1976 RCRA 1976 RCRA

Resource Conservation and Resource Conservation and Recovery ActRecovery Act EPA management of hazardous wastesEPA management of hazardous wastes Environmentally soundEnvironmentally sound Cradle-to-grave responsibilityCradle-to-grave responsibility

OSHA Bloodborne OSHA Bloodborne Pathogens StandardPathogens Standard

(d)(4)(iii)(c) “disposal of all (d)(4)(iii)(c) “disposal of all regulated waste shall be in regulated waste shall be in accordance with applicable accordance with applicable regulations of the United States …”regulations of the United States …”

Contaminated sharpsContaminated sharps Other regulated waste Other regulated waste

NIH rDNA GuidelinesNIH rDNA Guidelines

Appendix G (BL1): “all Appendix G (BL1): “all contaminated liquid or solid wastes contaminated liquid or solid wastes are decontaminated before disposal”are decontaminated before disposal”

CDC/NIH BMBL, 4th CDC/NIH BMBL, 4th EditionEdition

BL1: “All cultures, stocks and other BL1: “All cultures, stocks and other regulated wastes are regulated wastes are decontaminated before disposal by decontaminated before disposal by an approved decontamination an approved decontamination method such as autoclaving.”method such as autoclaving.”

CT DEP (sample state CT DEP (sample state definition)definition)

Sec. 22a-209-15. Biomedical WasteSec. 22a-209-15. Biomedical Waste ““infectious waste”infectious waste”

any discarded cultures/stocks of infectious any discarded cultures/stocks of infectious agents and associated biologicals;agents and associated biologicals;

human body fluids or materials saturated or human body fluids or materials saturated or caked with them;caked with them;

discarded sharps, including syringes discarded sharps, including syringes (whether used or not)(whether used or not)

contaminated carcasses, parts, bedding from contaminated carcasses, parts, bedding from animal experiments with infectious agents;animal experiments with infectious agents;

isolation waste; and spill clean up wasteisolation waste; and spill clean up waste

Medical Waste ProgramMedical Waste Program

Identification of regulated wasteIdentification of regulated waste HandlingHandling

segregation/packaging/storage/segregation/packaging/storage/transporttransport

Treatment/DisposalTreatment/Disposal Monitoring treatment processesMonitoring treatment processes Compliance w/ local & state Compliance w/ local & state

regulationsregulations


Segregation (at point of origin)Segregation (at point of origin) SharpsSharps Other contaminated solidsOther contaminated solids Pathological wastePathological waste LiquidsLiquids Mixed hazardous wasteMixed hazardous waste Pharmaceutical wastePharmaceutical waste


PackagingPackaging Protect personnel handling wasteProtect personnel handling waste Adequate containmentAdequate containment LabelingLabeling


Storage (short term)Storage (short term) restricted accessrestricted access sanitarysanitary labelinglabeling


TransportTransport on-site (leak proof, puncture resistance)on-site (leak proof, puncture resistance) off-site (regulatory compliance)off-site (regulatory compliance)

approved registered companyapproved registered company tracking formstracking forms


Treatment & DisposalTreatment & Disposal Definition?Definition? IncinerationIncineration Steam sterilizationSteam sterilization Chemical Chemical Other (approved by regulatory entity)Other (approved by regulatory entity) Monitoring (biological indicators)Monitoring (biological indicators)


Contingency PlanningContingency Planning equipment failureequipment failure failed treatment runfailed treatment run regulated waste in non-hazardous regulated waste in non-hazardous

streamstream TrainingTraining

all personnel (generators, transporters)all personnel (generators, transporters) updates as requiredupdates as required


State law details requirements for:State law details requirements for: GeneratorsGenerators TransportersTransporters Treatment facilitiesTreatment facilities

validation requirementsvalidation requirements Record keepingRecord keeping

reporting detailsreporting details

Transport and Transport and Transfer ofTransfer ofHazardous Hazardous Biological Biological MaterialsMaterials

Who must attend Who must attend training?training?

Training required by DOT and IATATraining required by DOT and IATA Employees performing any of the Employees performing any of the

following with infectious material:following with infectious material: Packaging and handlingPackaging and handling TransportingTransporting

Those who receive “should” also be trainedThose who receive “should” also be trained

Retraining is mandatory every:Retraining is mandatory every: 2 years under IATA2 years under IATA 3 years under 49 CFR3 years under 49 CFR

Training must include:Training must include:

General awarenessGeneral awareness Function specific:Function specific:

PackagingPackaging Handling/transportHandling/transport Receiving (safety precautions appropriate Receiving (safety precautions appropriate

for the materials being shipped)for the materials being shipped) SafetySafety

IncidentsIncidents Emergency responseEmergency response

General PhilosophyGeneral PhilosophyNine Hazard ClassesNine Hazard Classes

1 - Explosives1 - Explosives 2 - Gases2 - Gases

Liquid NitrogenLiquid Nitrogen

3 - Flammable 3 - Flammable liquidsliquids

alcohol, formaldehydealcohol, formaldehyde

4 - Flammable solids4 - Flammable solids 5 - Oxidizing 5 - Oxidizing

substances and substances and Organic peroxidesOrganic peroxides

6 - Toxic & 6 - Toxic & infectious infectious substancessubstances

Infectious Infectious substancessubstances

7 - Radioactives7 - Radioactives 8 - Corrosives8 - Corrosives 9 - Miscellaneous 9 - Miscellaneous

dangerous goodsdangerous goods Dry IceDry Ice Genetically Genetically

modified organismsmodified organisms

Definition:Definition:Infectious SubstanceInfectious Substance

Infectious Substance:Infectious Substance: are substances which are known or are are substances which are known or are

reasonably expected to contain pathogens.reasonably expected to contain pathogens. Are classified as UN 2814, UN 2900, or UN Are classified as UN 2814, UN 2900, or UN

3373 as appropriate3373 as appropriate Category A Infectious Substance:Category A Infectious Substance:

an infectious substance which if transported in a an infectious substance which if transported in a form that, when exposure to it occurs, is capable of form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or causing permanent disability, life-threatening or fatal disease to humans or animals.fatal disease to humans or animals.

See indicative list of Category A Infectious See indicative list of Category A Infectious SubstancesSubstances

Category A Infectious Category A Infectious SubstancesSubstances

Also includesAlso includes All BL4 or RG4 agentsAll BL4 or RG4 agents All CDC/USDA Select AgentsAll CDC/USDA Select Agents

Notify OEHS before shipping/receiving a Select Notify OEHS before shipping/receiving a Select Agent or immediately upon identificationAgent or immediately upon identification

Cultures or Stocks of human or animal Cultures or Stocks of human or animal pathogenspathogens

Genetically modified microorganisms Genetically modified microorganisms that meet the definition of an infectious that meet the definition of an infectious agentagent

Definition:Definition:Category B Infectious Category B Infectious (Biological) Substance(Biological) Substance

Category B Infectious (Biological) Category B Infectious (Biological) SubstanceSubstance

an infectious substance that is not in a an infectious substance that is not in a form generally capable of causing form generally capable of causing permanent disability of life-threatening permanent disability of life-threatening or fatal disease in otherwise healthy or fatal disease in otherwise healthy humans or animals when exposure to it humans or animals when exposure to it occurs. Category B Infectious occurs. Category B Infectious (Biological) Substances are assigned (Biological) Substances are assigned the identification number UN 3373.the identification number UN 3373.

Definition:Definition:Exempt Human/Animal Exempt Human/Animal

SpecimenSpecimen Exempt Human/Animal SpecimenExempt Human/Animal Specimen

– – human or animal sample (including, but not human or animal sample (including, but not limited to, secreta, excreta, blood and its limited to, secreta, excreta, blood and its components, tissue and tissue fluids, and components, tissue and tissue fluids, and body parts) body parts) being transported for routine being transported for routine testing not related to the diagnosis of an testing not related to the diagnosis of an infectious diseaseinfectious disease, such as for drug/alcohol , such as for drug/alcohol testing, cholesterol testing, blood glucose testing, cholesterol testing, blood glucose level testing, …… for tests for diagnosis of level testing, …… for tests for diagnosis of non-infectious diseases, such as cancer non-infectious diseases, such as cancer biopsies, and biopsies, and for which there is low for which there is low probability the sample is infectious.probability the sample is infectious.

Cargo Aircraft Only Cargo Aircraft Only LabelLabel

All packages exceeding All packages exceeding the quantity limitations the quantity limitations for passenger aircraft, for passenger aircraft, but acceptable on cargo but acceptable on cargo aircraft, must be labeled aircraft, must be labeled with the “Cargo Aircraft with the “Cargo Aircraft Only” label in addition to Only” label in addition to the infectious substance the infectious substance label and, if shipping on label and, if shipping on dry ice, the required dry ice, the required labels for dry icelabels for dry ice

Passenger section Passenger section prohibitionprohibition

Infectious substances, toxins and other Infectious substances, toxins and other dangerous goods are dangerous goods are not allowednot allowed in the in the passenger section of the transport passenger section of the transport vehicle regardless of the mode of vehicle regardless of the mode of transportation. transportation.

Infectious substances Infectious substances must be declaredmust be declared before transport in accordance with before transport in accordance with transportation regulations. transportation regulations. Violators of this policy may incur severe Violators of this policy may incur severe

penalties including fines and imprisonment.penalties including fines and imprisonment.

Passenger section Passenger section prohibitionprohibition

IATAIATA ““Category B Infectious Substances” Category B Infectious Substances”

are not permitted in carry-on or are not permitted in carry-on or checked baggage and must not be checked baggage and must not be carried on a person.”carried on a person.”

““Operators must not load or Operators must not load or transport Category B Infectious transport Category B Infectious Substances unless they are Substances unless they are transported as cargo in accordance transported as cargo in accordance with the Dangerous Goods with the Dangerous Goods Regulations.”Regulations.”

Regulating AuthoritiesRegulating Authorities International Air Transport Association (IATA)International Air Transport Association (IATA)

Dangerous Goods Regulations (DGR)Dangerous Goods Regulations (DGR) Department of Transportation (DOT)Department of Transportation (DOT) Department of Commerce (Export Controls)Department of Commerce (Export Controls) Dept. of Health and Human Services (DHHS)Dept. of Health and Human Services (DHHS)

Centers for Disease Control (CDC) 42 CFR 72Centers for Disease Control (CDC) 42 CFR 72 United States Department of Agriculture (USDA) United States Department of Agriculture (USDA)

Animal Plant Health Inspection Service (APHIS)Animal Plant Health Inspection Service (APHIS) National Institutes of Health (NIH)National Institutes of Health (NIH) Individual Carriers (FedEx, UPS, Postal Service)Individual Carriers (FedEx, UPS, Postal Service)

State and Operator State and Operator VariationsVariations

(Country and Carrier)(Country and Carrier) Country examplesCountry examples

AustraliaAustralia ChinaChina CanadaCanada BahrainBahrain

Require permit to Require permit to bring infectious bring infectious agents in any agents in any quantity therequantity there

Operator examplesOperator examples FEDEXFEDEX

3 copies of shipping 3 copies of shipping declaration formdeclaration form

No BL4 transportNo BL4 transport Typed declaration Typed declaration

UPSUPS No infectious agentsNo infectious agents

British AirwaysBritish Airways Continental AirlinesContinental Airlines

Won’t allow Won’t allow infectious agentsinfectious agents

Infectious Substances - Infectious Substances - Class 6.2Class 6.2

UN 2814UN 2814 Infectious substance affecting human onlyInfectious substance affecting human only Infectious substance affecting humans & Infectious substance affecting humans &

animalsanimals includes prionsincludes prions

UN 2900UN 2900 Infectious substances affecting animals Infectious substances affecting animals

onlyonly UN 3373UN 3373

diagnostic or clinical specimens from diagnostic or clinical specimens from humans or animals known to contain a humans or animals known to contain a pathogen or high probability of harboring pathogen or high probability of harboring a pathogen.a pathogen.

IATA Packaging IATA Packaging Instruction 602Instruction 602

Infectious SubstancesInfectious Substances

Watertight primary receptacleWatertight primary receptacle Absorbent materialAbsorbent material Watertight secondary receptacleWatertight secondary receptacle List of contentsList of contents Outer container with minimum Outer container with minimum

external dimension of four inchesexternal dimension of four inches

Packaging performancePackaging performance

Primary or secondary packaging able Primary or secondary packaging able to withstand, without leaking, a to withstand, without leaking, a pressure differential of not less than pressure differential of not less than 13.8 psi in the range of - 4013.8 psi in the range of - 40ooF to F to 130130ooFF

Capable of passing:Capable of passing: 30 ft drop test30 ft drop test Penetration testPenetration test Vibration standardVibration standard

Infectious substance Infectious substance packagingpackaging

UN 2814, Infectious Substance, Affecting Humans, 25 ml

Infectious substances Infectious substances outer package labelingouter package labeling

Name address and telephone number of Name address and telephone number of shipper and receiver (& responsible shipper and receiver (& responsible person)person)

Infectious substance labelInfectious substance label Orientation arrows on opposite sides of Orientation arrows on opposite sides of

package (for liquids > 50 ml)package (for liquids > 50 ml) UN package certification markUN package certification mark Proper shipping name: UN 2814,Proper shipping name: UN 2814,

Infectious substance, affecting humans, Infectious substance, affecting humans, 50 ml50 ml

Shipping Shipping << 50 ml of an 50 ml of an Infectious Agent on Dry Infectious Agent on Dry

IceIce

Responsible Person:

UN 2814, Infectious substance, affecting humans, 40 ml

5 Kg UN 4G/Class 6.2/CAN/87

UN

Shipping > 50 ml of an Shipping > 50 ml of an Infectious Agent on Dry Infectious Agent on Dry

IceIce

Responsible Person:

UN 2814, Infectious substance, affecting humans, 60 ml

5 Kg UN 4G/Class 6.2/CAN/87

UN

Category B Infectious Category B Infectious SubstanceSubstance

UN 3373UN 3373 Human or animal material being Human or animal material being

transported for diagnostic or investigational transported for diagnostic or investigational purposes (excluding live animals)purposes (excluding live animals)

become UN 2900 or UN 2814 if source has become UN 2900 or UN 2814 if source has or may have serious disease which can be or may have serious disease which can be readily transmitted, and effective treatment readily transmitted, and effective treatment is not readily availableis not readily available based on known medical history, endemic local based on known medical history, endemic local

conditions, symptoms, or professional judgementconditions, symptoms, or professional judgement

IATA Packaging IATA Packaging Instruction 650Instruction 650

Category B Infectious Category B Infectious SubstanceSubstance Is not UN approvedIs not UN approved

Does not bear the UN markDoes not bear the UN mark Triple packaging still requiredTriple packaging still required

must pass series of 4’ drop testsmust pass series of 4’ drop tests primary or secondary container must primary or secondary container must

be capable of withstanding pressure be capable of withstanding pressure of 95kPa for liquid specimens shipped of 95kPa for liquid specimens shipped by airby air

Category B Biological Category B Biological Substance PackagingSubstance Packaging

Culture

Biological Substance, Category B 95 kPa (13.8 psi) rated primary or secondary

container for shipments of liquids by air

Category B Infectious Category B Infectious Substance Substance

outer package labelingouter package labeling Name address and telephone number Name address and telephone number

of shipper and receiverof shipper and receiver Responsible person also neededResponsible person also needed

UN3373 label and words “Biological UN3373 label and words “Biological Substance, Category B” near labelSubstance, Category B” near label

Orientation arrows on opposite sides of Orientation arrows on opposite sides of package (for liquids > 50 ml)package (for liquids > 50 ml)

Dry ice labels if applicableDry ice labels if applicable

Shipping a Category B Shipping a Category B Infectious Substance on Infectious Substance on

Dry IceDry Ice

UN 1845, Dry Ice, 5 Kg

To: Bob Smith

Virus World

111 Viremia Way

Boston, MA 02115

From: Jill Reynolds

Yale University, LEPH

60 College Street

New Haven, CT 06510

Responsible Person: Jill Reynolds (203) 555-1125

Biological Substance, Category B

Shipping an Exempt Shipping an Exempt Human Specimen on Dry Human Specimen on Dry

IceIce

UN 1845, Dry Ice, 5 Kg

To: Bob Smith

Virus World

111 Viremia Way

Boston, MA 02115

From: Jill Reynolds

Yale University, LEPH

60 College Street

New Haven, CT 06510

Exempt Human Specimen

Shipper’s DeclarationShipper’s Declaration

Required when shipping:

Category A infectious substances;

Liquid Nitrogen;

Must be completed and signed the person who packaged the material

Not required for diagnostic or clinical specimens

SHIPPER'S DECLARATION FOR DANGEROUS GOODS

Shipper

This shipment is within thelimitations prescribed for:

(delete non- applicable)

PASSENGER CARGOAND CARGO AIRCRAFTAIRCRAFT ONLY

Airport of Destination:

Airport of Departure

(Provide at least two copies to the airline)

Air Waybill No.

Page 1 Of Pages

Shipper's Reference Number(optional)

WARNING

Federal Express

Failure to comply in all respects with the applicableDangerous Goods Regulations may be in breach of theapplicable law, subject to legal penalties. ThisDeclaration must not, in any circumstances, becompleted and/or signed by a consolidator, aforwarder, or an IATA cargo agent.

Shipment type: (delete non-applicable)

Two completed and signed copies of this Declarationmust be handed to the operator.

ExFed

NON-RADIOACTIVE RADIOACTIVE

TRANSPORT DETAILS

Consignee

Ben FontesOffice of Environmental Health and Safety135 College StreetNew Haven, CT 06510-2411

John DoeSomewhere UniversityAnywhere StreetLos Angeles, CA 90210Responsible Person: John Doe (801) 555 -2211

X BDL Hartford

LAX Los Angeles

1

X

NATURE AND QUANTITY OF DANGEROUS GOODS

Dangerous Goods Identification

Proper Shipping NameClass

Division

UNor

ID No.

Pack-ing

Group

Subsi-diaryRisk

Quantity andtype of packaging

Packing Instr.

Authorization

Additional Handling Information

Emergency Telephone Number

I hereby declare that the contents of this consignment are fully and accurately described above by the proper shipping name, and are classified, packaged, marked and labeled/placarded, and are in all respects in proper condition for transport according to applicable international and national Governmental Regulations.

Name/Title of Signatory

Place and Date

Signature(see warning above)

IF ACCEPTABLE FOR PASSENGER AIRCRAFT, THIS SHIPMENT CONTAINS RADIOACTIVE MATERIAL INTENDED FOR USE IN OR INCIDENT TO RESEARCH MEDICAL DIAGNOSIS OR TREATMENT

Infectious substance,affecting humans(Hepatitis B Virus)

Dry Ice

6.2UN2814 10 ml in 2 sealed

plastic tubes

602

9UN1845

III5 kgAll packed in one fibreboard box

904

CHEMTREC 1-800-424-9300

Benjamin FontesBiosafety Officer

New Haven, CTJune 30, 2000

Benjamin Fontes

Shipping Declaration Shipping Declaration FormsForms

Must maintain copy (paper or Must maintain copy (paper or electronic) of each shipping electronic) of each shipping declaration for 2 years!declaration for 2 years!

Should be kept by Shipper (or Should be kept by Shipper (or representative for group)representative for group)

Suggest keeping for 2-3 years as a Suggest keeping for 2-3 years as a precautionprecaution

PenaltiesPenalties Violation of shipping requirementsViolation of shipping requirements

Individuals - no more than $250,000 or one Individuals - no more than $250,000 or one year in jail, or bothyear in jail, or both

Organizations - no more than $500,000 per Organizations - no more than $500,000 per eventevent

False, fictitious, or fraudulent statement False, fictitious, or fraudulent statement or representation on required formsor representation on required forms Individuals - fine or imprisonment for not Individuals - fine or imprisonment for not

more than five years, or bothmore than five years, or both Organization - unspecified fine Organization - unspecified fine