Regulatory Aspects, Standards,and Guidelines

1
Regulatory Aspects, Standards,and Guidelines

• EMD 545b
• Lecture 4

2
OSHA Law, Standards, and Directives

• Related to Biohazards

3
OSHA Act of 1970

• Section 1, An Act
• To assure safe/healthful working conditions
• Section 2, Congressional Findings/Purpose
• to assure so far as possiblesafe/healthful
  working conditions and to preserve our human
  resources

4
Section 5 DutiesGeneral Duty Clause

• (5)(A)(1)Each Employer shall furnish
• employment
• workplace free from recognized hazards that are
  causing death or serious physical harm
• (5)(A)(2) Each Employer shall comply with OSHA
  Standards

5
General Duty Clause

• Applicability to Biohazards
• recognized hazard exists (substantial probability
  that death or serious harm could occur)
• Risk Group 3/4 Agents
• Some Risk Group 2 Agents
• existing measure of abatement
• economically/technologically feasible (BMBL, etc)
  

6
Section 17 Penalties

• A) willful or repeat violation (5,000 lt x lt
  70,000)
• B) serious violation (up to 7,000 each)
• C) less than serious (up to 7,000 each)
• D) extending beyond period of correction (up to
  7,000 each day)
• Employer pays (who is your employer?)

7
Section 17 Penalties

• E) willful resulting in death (10,000 and 6
  months jail).
• repeat of E) 20,000 and 1 year jail
• knowingly provide false info (10,000 and 6 months
  jail)
• violations of posting requirements (7,000)
• killing an OSHA Inspector - life in prison

8
OSHA BBP Standard 1910.1030

• Applicable to all occupational exposure to blood
  or other potentially infectious materials.
• Bloodborne Pathogens
• Pathogenic microbes present in blood which can
  cause disease in humans (include, but not limited
  to HIV, HBV, and HCV).

9
OPIM

• Other Potentially Infectious Materials
• human body fluids
• amniotic, cerebrospinal, pericardial, peritoneal,
  pleural, semen, synovial, vaginal secretions,
  saliva in dental settings, unknown fluids, any
  body fluid visibly contaminated with blood.
• unfixed human tissues or organs (except skin)
• cell cultures/animal tissues containing BBPs

10
Exposure Control Plan

• Written document, updated and reviewed annually
• Identifies occupationally exposed employees
• Outlines procedures to protect them
• Documents ongoing consideration of new
  engineering controls

11
Exposure Determination

• Evaluate new employees at time or hire
• Evaluate existing employees who change jobs
• List of jobs where all employees have exposure
• List of jobs where some have exposure
• detailed list of tasks that include exposure

12
Exposure Control Plan

• Hepatitis B Vaccine Offer
• free, 3 shot vaccination
• offer w/in 10 days of hire
• signed declination statement
• Training
• at time of hire, before work involving exposure
• retraining each year w/in 365 days

13
Methods of Compliance

• Universal Precautions
• Infection control concept where all human blood
  and certain body fluids are treated as if known
  to be infectious for HIV or HBV.
• Sharps Precautions
• Sharps w/ Engineered Sharps Injury Protections
  (SESIP) non-needle sharp or needle device or
  other sharp with built-in safety feature or
  mechanism that effectively reduces risk of
  exposure.

14
Methods of Compliance

• Sharps precautions, sharps containers
• Good work practices
• Leakproof containers for transport, storage
• Labels, signs
• Decontamination
• Personal Protective Equipment
• free, all sizes, appropriate for task,
  replacement supplies, laundered by employer

15
Records

• Medical (duration of work 30 years)
• post-exposure evaluation and follow-up
• Training (maintained 3 years)
• Sharps Injury Log
• type, brand of sharp
• Dept., work area of incident
• incident description
• SESIP evaluation applicable?

16
Scenario 1

• New employee with occupational exposure to human
  blood and other potentially infectious materials
  has just been hired by your institution.
• Outline OSHA BBP Standard requirements for this
  employee

17
Scenario 1 - New Employee

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

18
Scenario 1- New Employee

• Healthcare professionals written evaluation for
  HBV vaccine
• Offer retraining every 365 days, updates as
  necessary
• Evaluate prior work experience of employee
• Audit procedures, facility, supervision

19
Scenario 2-HIV Experiment

• An existing employee from your bloodborne
  pathogen program submits a request to work with
  HIV in cell culture.
• What is the appropriate Institutional response?

20
Scenario 2-HIV Work

• Document prior work experience
• Demonstrated proficiency with techniques, safety
  practices,equipment and operations
• Adequate trained supervision
• Appropriate facility (lab inspection)
• Medical Surveillance (serum storage,
  post-exposure prophylaxis

21
Scenario 3 - Exposure Response

• An employee at your institution has just
  experienced an exposure to human blood.
• What should happen next?

22
Scenario 3 - Exposure Response

• Treat exposed area immediately-wash/flush
• Promptly seek medical evaluation (1-2 hr)
  confidential and follow-up
• Document the route of exposure and circumstances
• Attempt to ID source individual (HIV/HBV/HCV)

23
Scenario 3 - Exposure Response

• Collect exposed workers blood with consent (test
  baseline, 6, 12 and 36 weeks)
• Hold blood sample for at least 90 days
• HIV HBIG post exposure prophylaxis is available
• Counseling offered
• Worker aware of signs/symptoms of Agents

24
Scenario 3 - Exposure Response

• Healthcare provider must receive
• copy of regulation
• description of job duties
• documentation of exposure routes
• results of source individuals blood tests
• all relevant medical records

25
Scenario 3 - Exposure Response

• Health care professionals written opinion
• to employee w/in 15 days of completion
• employee instructed on conditions that may
  require further evaluation
• All other findings/diagnoses CONFIDENTIAL

26
Biowarfare/Bioterrorism

• Geneva Protocol (1925)
• Biological Weapons Convention (1972)
• Biological Weapons Act (1989)
• Public Law 101-298
• Chemical and Biological Weapons Control and
  Warfare Elimination Act of 1991
• Public Law 102-182

27
Anthrax Letters - Fall 2001

• 5 deaths (FL, NJ, NY, CT)
• 22 total infections
• Mass terror
• White powder fever!
• Unsolved crime

28
Other bioterror events

• Salmonella in salad bars
• Shigella in pastries
• 125-I Saxitoxin in take-out food
• Ricin at IRS building -thwarted before use
• UCONN anthrax
• Texas Tech
• lost Yersinia samples
• Hoaxes

29
Select Biological Agents/Toxins

• Anti-terrorism and Effective Death Penalty Act of
  1996 (Public Law 104-132)
• Additional Requirements for Facilities
  Transferring or Receiving Select Agents
  42 CFR Part 72.6 (Select Agent Rule)
• USA Patriot Act (Public Law 107-56
• Uniting and Strengthening America by Providing
  Appropriate Tools Required to Intercept and
  Obstruct Terrorism Act of 2001
• Possession now addressed

30
DHHS-CDC, USDA-APHIS

• Public Health Security and Bioterrorism
  Preparedness Response Act of 2002
• Public Law 107-188
• 42 CFR Part 73, 9 CFR Part 121, 7 CFR Part 331
• Regulatory language for USA PATRIOT ACT
• Lists of Select Agents

31
Select Agent List DHHS-CDC

• Crimean Congo haemorrhagic fever virus
• Coccidiodiodes posadasii
• Ebola viruses
• Cercopithecine herpesvirus 1
• (Herpes B virus)
• Lassa fever virus
• Marburg virus
• Monkeypox virus
• Rickettsia prowazekii
• Rickettsia rickettsii
• South American haemorrhagic fever viruses
• Junin, Machupo, Sabia, Flexal, Guanarito

32
Select Agent List DHHS-CDC

• Tick-borne encephalitis complex (flavi) viruses
• Central European tick-borne encephalitis
• Far Eastern tick-borne encephalitis
• Russian spring and summer encephalitis
• Kyasanur forest disease
• Omsk hemorrhagic fever
• Variola major virus (Smallpox virus)
• Variola minor virus (Alastrim)
• Yersinia pestis

33
Select Agent List DHHS-CDC

• Abrin
• Conotoxins
• Diacetoxyscirpenol
• Ricin
• Saxitoxin
• Shiga-like ribosome inactivating proteins
• Tetrodotoxin

34
DHHS-CDC USDA Overlap Agents

• Bacillus anthracis
• Brucella abortus, B. melitensis, B. suis
• Burkholderia mallei, B. pseudomallei
• Botulinum neurotoxin producing species of
  Clostridium
• Coccidioides immitis
• Coxiella burnetii
• Eastern equine encephalitis virus
• Hendra virus
• Francisella tularensis
• Nipah virus

35
DHHS-CDC USDA Overlap Agents

• Rift Valley fever virus
• Venezuelen equine encephalitis virus
• Botulinum neurotoxin
• Clostridium perfringens epsilon toxin
• Shigatoxin
• Staphylococcal enterotoxins
• T-2 Toxin

36
Select Agent List USDA

• Akabane virus
• African swine fever virus
• African horse sickness virus
• Avian influenza virus (highly pathogenic)
• Blue tongue virus (Exotic)
• Bovine spongiform encephalopathy agent
• Camel pox virus
• Classical swine fever virus
• Cowdria ruminantium (Heartwater)
• Foot and mouth disease virus
• Goat pox virus

37
Select Agent List USDA

• Lumpy skin disease virus
• Japanese encephalitis virus
• Malignant catarrhal fever virus (exotic)
• Menangle virus
• Mycoplasma capricolum/M.F38/M. mycoides capri
• Mycoplasma mycoides mycoides
• Newcastle disease virus (velogenic)
• Peste Des Petits Ruminants virus
• Rinderpest virus
• Sheep pox virus
• Swine vesicular disease virus
• Vesicular stomatis virus (exotic)

38
Select Agent List APHIS

• Candidatus Liberobacter africanus
• Candidatus Liberobacter asiaticus
• Peronosclerospora philipinensis
• Ralstonia solanacearum race 3, biovar 2
• Schlerophthora rayssiae var zeae
• Synchytrium endobioticum
• Xanthomonas oryzae pv. oryzicola
• Xylella fastidiosa (citrus variegated chlorosis
  strain)

39
USA PATRIOT ACT

• Restricted person (cant possess,
  receive, transport)
• under indictment for a crime punishable by
  imprisonment for a term gt 1 year
• has been convicted of crime punishable by
  imprisonment gt 1 year
• fugitive from justice
• unlawful user of a controlled substance
• illegal alien
• adjudicated as a mental defective
• dishonorable discharge from US Armed Services

40
Restricted Person

• Is an alien who is a national from a country that
  has history of supporting terrorism
• Syria
• Sudan
• Lybia
• Cuba
• Iran
• Iraq
• North Korea

41
Components of Bioterrorism Law

• Registration of individuals (possess, access)
• Registration of agents, location
• Description of storage and security requirements
• Pre-authorization of transfers
• Select Agent Inventory

42
Components of Bioterrorism Law

• Restricted Access
• Facility
• fences, guards, video monitor
• Building
• locked access (key, keycard, guard, video)
• floors (keycard access, alarms, labels)
• Lab
• locked, lockboxes, away from office and traffic
  areas
• Security Training/Manuals/Inspections

43
Components of Bioterrorism Law

• Security Plan
• procedures for reporting loss of keys, password
• reporting suspicious people/packages
• removal of unauthorized personnel
• reporting release, loss, or theft
• Access control
• Emergency response plans
• Inventory tracking quantities of SAs

44
NIH Guidelines for Research Involving rDNA
Molecules (April, 2002)
45
NIH Guidelines - April 2002

• NIH - OBA (Office of Biotechnology Activities)
• Outline scope of regulated rDNA work and required
  containment levels (changes approved by NIH-OBA)
• Applicability
• NIH Sponsored Institutions
• NIH Supported projects (US Abroad)

46
Responsibilities Institution

• Ensure full conformity with Guidelines
• Establish an IBC
• Appoint a BSO (if necessary)
• Ensure adequate expertise for protocol review
  (plant, animal, human gene transfer)
• Training (IBC/BSO/PIs/Lab staff)
• Health Surveillance (BL3/Large scale)

47
Responsibilities - IBC

• 5 members (2 from community)
• Expertise (rDNA, biosafety, containment, legal)
• Annual report to NIH-OBA (roster/CVs)
• Assess
• Containment level, facilities, procedures
• Develop emergency plans, report violations

48
Responsibilities Biosafety Officer

• IBC Member
• Inspections
• Report problems to IBC
• Develop emergency plans
• Advise on lab security

49
Responsibilities Principal Investigator

• Full compliance with Guidelines
• Cant start/modify non-exempt work w/out approval
• Report violations w/in 30 days
• Make initial determination of containment
• Instruct/train lab staff
• Supervise safety performance

50
Section III Experiments covered by the NIH
Guidelines

• Require approval before initiation
• III-A Transfer significant drug-resistant trait
  (IBC/RAC review/NIH Director)
• III-B Cloning toxins (IBC/NIH-OBA)
• III-C Human gene transfer (IBC/IRB/FDA
  NIH-OBA registration)
• III-D Risk group 2-4 restricted, defective
  virus in cell culture, animals, plants, large
  scale

51
Section III Experiments Covered by the
Guidelines

• IBC Notice at time of initiation
• III-E-1 lt 2/3 viral genome
• III-E-3 Production of transgenic rodents
• III-E-2 Whole plants

52
Section III Exempt Experiments

• III-F-1 through III-F-6
• not in organisms/viruses, PCR, known exchangers,
  in/out of same host
• Appendix C-1 through C-VI
• lt 50 viral genome, E.coli, B. subtilis,
  S.cerevisiae, Purchase transfer of transgenic
  rodents, extrachromosomal elements of gm
  organisms

53
Appendices to NIH Guidelines

• Appendix B Classification of Etiologic Agents on
  the Basis of Hazard
• Appendix F Containment for toxin experiments
• Appendix G Biosafety containment levels (in
  vitro experiments)
• Appendix H Shipment

54
Appendices to NIH Guidelines

• Appendix K Large Scale containment
• Appendix M Human gene transfer
• Appendix P Plants (biocontainment for rDNA
  plant experiments)
• Appendix Q Animal Biosafety containment levels

55
TuberculosisExposure Control
56
Mycobacterium tuberculosis

• Ancient
• Airborne
• droplet nuclei
• ID50 lt 10 bacilli
• Generally requires close, prolonged contact
• infectiousness of patient, bacilli expelled
• forcefullness of cough
• ventilation, duration of exposure

57
Mycobacterium tuberculosis

• 2 million deaths/year worldwide (2002)
• 1/3 of world population TB positive
• 1 new TB infection every second
• Africa/Asia - 100 - 300/100,000 (2002)
• USA - 5.2 cases/100,000 (2002)
• D.C.- 14.4, HI-11.9, CA-9.0, NY-7.5 (2002)

58
Mycobacterium tuberculosis

• Rod shaped (0.3-0.6 um wide x 1-4um long)
• Obligate intracellular pathogen
• Slow-growing (18-24 hour doubling time)
• 3-12 week incubation
• PPD 2-10 weeks after infection

59
TB Pathogenesis

• Site of infection lung, other tissues/organs
• Initial infection usually unnoticed, lesions
  heal without residual changes
• 5 with progressive pulmonary disease
• 95 in latent phase (lifetime reactivation risk)

60
TB Pathway

• Phagocytized by macrophages
• Multiplication with in macrophages
• Spread to lymph nodes
• Heart, lung, bloodstream
• All organs of body susceptible
• In 5 TB multiplies in upper lung
• Fuse into multinucleated cells
• consumption, wasting, fever, cough

61
Risk Factors

• Diabetes, silicosis, abnormal chest X-ray
• Prolonged corticosteroid therapy
• Certain cancers (leukemia, hodgkins)
• Kidney disease, certain intestinal conditions
• Low body weight
• HIV, IV drug use
• Recent TB infection (w/in 2 years)

62
TB Treatment

• 50 of untreated will die
• Isoniazid, rifampim, ethambutol, etc.
• Prolonged treatment (6-9 months)
• Directly Observed Therapy
• MDR-TB - high fatality rate (50-85)
• Longer treatment (18 - 24 months)

63
Signs and Symptoms of Active TB

• Early signs - fatigue, weakness, fever, chills,
  night sweats, loss of appetite, weight loss
• Advanced stages - sputum producing cough,
  coughing up blood, chest pain, hoarseness of voice

Graphic produced by Coastal Video
64
Proposed OSHA TB StandardVACATED 2002

• Resurgence of TB cases
• Annual increase from 1985-1992
• Multi-drug resistant TB
• OSHA General Duty Cause

65
Current OSHA Enforcement

• CPL 2.106 (2/9/96)
• 5(a)(1) General Duty Clause of OSH Act of 1970
• recognized hazard
• abatement economically and technologically
  feasible
• Coverage
• gt 1 suspect/confirmed TB case w/in previous 6
  months

66
Related OSHA Law

• Respiratory Protection - 29 CFR 1910.134
• Accident Prevention Signs and Tags - 29 CFR
  1910.145
• Employee Exposure and Medical Records - 29 CFR
  1910.1020
• Recording and Reporting Occupational Injuries and
  Illness - 29 CFR 1904

67
TB Control Measures - Clinical

• Identify exposed employees
• Training
• Respiratory protection
• Early identification/isolation
• Medical Surveillance TB Screening
• at time of hire (within 2 weeks)
• after occupational exposure
• at least annually

68
Medical Surveillance

• Periodic tuberculin skin testing
• History, physical exam, medical management
• Provide
• before initiation of work
• upon signs/symptoms
• after exposure incident
• after skin test conversion
• w/in 30 days of termination of work
• when deemed necessary

69
TB Screening

• Test for infection PPD (anergy)
• Test for active disease
• Sputum culture
• Chest X-Ray

70
Respiratory Protection

• Targeted for
• entry to TB isolation room (in use)
• during procedures on unmasked TB patient
• transport (in vehicle/unmasked patient in
  facility)
• work on contaminated ventilation systems
• area where unmasked TB patient is present
• in residence of TB patient

71
Respiratory Protection

• Program
• Training
• Selection of an air-purifying respirator (NIOSH
  approved)
• Fit testing
• Use
• Storage/disposal
• Remember Surgical masks are not respirators

72
Recordkeeping

• Medical (duration 30 years)
• OSHA illness and injury
• Training (3 years)
• Engineering control maintenance and monitoring (3
  years)

73
TB Exposure Control Procedures

• Ask patient to cover their nose and mouth
• Provide surgical mask for patient
• Wear a NIOSH certified respirator for close or
  prolonged contact
• a 95 filter efficiency
• for particles 1 micron in size

Graphic produced by Coastal Video
74
TB Exposure Control Procedures

• Isolate patient (negative pressure room or
  dedicated/segregated area)
• Notify supervisor or infection control
  representative
• Refer patient to emergency medical assistance
  (w/in 5 hours)

75
Engineering Controls

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

76
Signs/Labels

• Treatment rooms (signal word necessary
  precautions)
• Air transport components (fans, ducts, filters)

77
OSHA 300 Log

• TB infections (PPD)
• PPDs after 2 weeks of hire must be recorded
  whether deemed work related or not!
• TB disease

78
OSHA Law, Standards, and Directives

• Related to Biohazards

79
OSHA Act of 197029 CFR 1904

• OSHA 300 Log, Log and Summary of Occupational
  Injuries and Illnesses (as of 1/1/02 -only 1
  column, excludes 1st Aid)
• must post annual summary of workplace injuries
  and illnesses for the previous calendar year no
  later than 2/1 kept to at least 3/1.
• satellite locations included
• records maintained and updated for 5 years

80
29 CFR 1903.2OSHA Poster

• each workplace must display an OSHA Poster
  alerting employees
• availability of OSHA Act, Regulations and
  Standards
• posting of notice
• poster size (8.5 x 14)

81
29 CFR 1910.1030Bloodborne Pathogens Standard
Update

• OSHA CPL 2.44D, updated Compliance Assistance
  Directive
• mandatory evaluation of safe sharps devices and
  work practices
• previous incidents at your workplace
• after each future sharps incident
• document evaluation
• continue searching for effective device

82
29 CFR 1910.141 Sanitation

• Housekeeping, waste/vermin disposal, toilet
  facilities, potable water, washing facilities
• Showers, change rooms, eating/drinking locations
• Sanitary storage (food not stored in toilets or
  areas exposed to toxic materials)

83
1910.145 Specification forAccident Prevention
Signs/Tags

• (e)(4)Biological Hazard Signs
• to signify actual/potential presence of biohazard
• identify equipment, containers, rooms, materials,
  experimental animals, which contain or are
  contaminated with, viable hazardous agents.
• only those infectious agents presenting a risk or
  potential risk to the well-being of man

84
29 CFR 1910.145

• (f)(2) Biohazard - those infectious agents
  presenting a risk of death, injury or illness to
  employees.
• Tags - contain signal word/major message
• signal word readable from 5 feet or more
  (warranted by the hazard)
• affixed as close as possible to the hazard

85
29 CFR 1910.145

• Symbol presented
• Biohazard - fluorescent orange or orange-red, or
  predominantly so, with lettering or symbols in a
  contrasting color.
• Year Biohazard Symbol created?

86
29 CFR 1910.120 HAZWOPER

• Hazardous Waste Operations and Emergency Response
• (a)(v)emergency response operations for release
  of, or substantial threats of releases of,
  hazardous substances without regard to the
  location of the hazard

87
29 CFR 1910.120

• (a)(3) Hazardous substance
• (B) any biological agent and other
  disease-causing agent which after release into
  the environment and upon exposure will or may
  cause death, disease,
• Requirements
• written program, training, medical surveillance,
  risk assessment, controls, monitoring,
  decontamination, etc...

88
29 CFR 1910.132 - 1910.139Personal Protective
Equipment

• 1910.132 Personal Protective Equipment
• 1910.133 Face Eye Protection
• 1910.134 Respiratory Protection
• 1910.138 Hand Protection
• 1910.139 Respiratory Protection (for
  Mycobacterium tuberculosis - old 1910.134)

89
29 CFR 1910.132 Personal Protective Equipment

• PPE for eyes, face, head, extremities
• Protective clothing
• Respiratory devices
• Protective shields and barriers
• shall be provided, used, and maintained in a
  sanitary manner

90
29 CFR 1910.132

• Hazard assessment
• Selection/fit
• Training
• situations required, required PPE
• donning/adjusting/doffing limitations
• care, maintenance, service life disposal
• demonstration before use
• retrain as needed

91
29 CFR 1910.134Respiratory Protection

• Engineering controls 1st option (wear when not
  feasible)
• Program
• written plan, selection, medical evaluation
• fit testing, procedures for proper use
• cleaning, disinfection, storing, inspecting,
  discarding
• training

92
29 CFR 1910.134

• Medical evaluation (questionnaire/exam)
• written medical determination
• Program Administrator
• identify, evaluate hazards, select respirator
• program evaluation
• Annual fit-test for tight fitting face pieces
• Annual training requirement (performance)

93
29 CFR 1910.138 Hand Protection

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

94
29 CFR 1910.139Respiratory Protection (M.TB)

• Applies only to respiratory protection against M.
  tuberculosis in lieu of 1910.134
• NIOSH approved particulate respirators (N-95 or
  greater efficiency)

95
29 CFR 1910.151Medical Services and First Aid

• Ready availability of medical personnel for
  advice/consultation
• Person trained in first aid (in absence of
  infirmary or clinic in near proximity)
• Suitable facilities for quick drenching or
  flushing of eyes and body in the work area (where
  eyes/bodymay be exposed to injurious corrosive
  materials)

96
29 CFR 1910.157Portable Fire Extinguishers

• Placement/use (75 ft.- Class A or D, 50 ft.-Class
  B, Class C mirrors A or B)
• Maintenance
• annual verification
• Training
• initial annual
• Exemptions
• written plan for immediate evacuation
• designated personnel

97
29 CFR 1910.38 Employee Emergency/Fire Prevention
Plans

• Written Emergency Action Plan
• fire, toxic chemical releases, other emergencies
• Alarm System
• Evacuation
• floor plan/map w/ colored evacuation routes
• safe refuge area delineated
• Training (to ensure orderly evacuation)
• before implementation (sufficient trained)

98
29 CFR 1910.1020 Access to Exposure Medical
Records

• Access (right to examine and copy)
• personal/area samples, biological monitoring,
  MSDSs, chemical inventories
• records from similar employee if no data
• provided w/in 15 days (reasonable place, free)
• Preservation
• medical - duration of work plus 30 years
• exposure - 30 years

99
29 CFR 1910.1020 Access to Exposure Medical
Records

• Information to Employees (_at_ start of work and
  annually)
• their right of access
• alert of existence, location, availability of
  records
• identity of person responsible for
  maintenance/access of records
• copy of 1910.1020 available

100
Other Related OSHA Standards

• 1910.1047 Ethylene Oxide
• 1910.1048 Formaldehyde
• 1910.1200 HAZCOMM
• 1910.1450 Lab Standard
• 1910.95 Occupational Noise Exposure
• 1910.106 Flammable/Combustible Liquids

101
Guidelines and Regulations Related to Medical
Waste
102
Medical Waste

• Regulations and Guidelines
• Local
• State
• Federal
• EPA (RCRA)
• OSHA, DOT
• CDC, NIH

103
1976 RCRA

• Resource Conservation and Recovery Act
• EPA management of hazardous wastes
• Environmentally sound
• Cradle-to-grave responsibility

104
OSHA Bloodborne Pathogens Standard

• (d)(4)(iii)(c) disposal of all regulated waste
  shall be in accordance with applicable
  regulations of the United States
• Contaminated sharps
• Other regulated waste

105
NIH rDNA Guidelines

• Appendix G (BL1) all contaminated liquid or
  solid wastes are decontaminated before disposal

106
CDC/NIH BMBL, 4th Edition

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

107
CT DEP (sample state definition)

• Sec. 22a-209-15. Biomedical Waste
• infectious waste
• any discarded cultures/stocks of infectious
  agents and associated biologicals
• human body fluids or materials saturated or caked
  with them
• discarded sharps, including syringes (whether
  used or not)
• contaminated carcasses, parts, bedding from
  animal experiments with infectious agents
• isolation waste and spill clean up waste

108
Medical Waste Program

• Identification of regulated waste
• Handling
• segregation/packaging/storage/transport
• Treatment/Disposal
• Monitoring treatment processes
• Compliance w/ local state regulations

109
Medical Waste Program

• Segregation (at point of origin)
• Sharps
• Other contaminated solids
• Pathological waste
• Liquids
• Mixed hazardous waste
• Pharmaceutical waste

110
Medical Waste Program

• Packaging
• Protect personnel handling waste
• Adequate containment
• Labeling

111
Medical Waste Program

• Storage (short term)
• restricted access
• sanitary
• labeling

112
Medical Waste Program

• Transport
• on-site (leak proof, puncture resistance)
• off-site (regulatory compliance)
• approved registered company
• tracking forms

113
Medical Waste Program

• Treatment Disposal
• Definition?
• Incineration
• Steam sterilization
• Chemical
• Other (approved by regulatory entity)
• Monitoring (biological indicators)

114
Medical Waste Program

• Contingency Planning
• equipment failure
• failed treatment run
• regulated waste in non-hazardous stream
• Training
• all personnel (generators, transporters)
• updates as required

115
Medical Waste Program

• State law details requirements for
• Generators
• Transporters
• Treatment facilities
• validation requirements
• Record keeping
• reporting details

116
Transport and Transfer ofHazardous Biological
Materials
117
Who must attend training?

• Training required by DOT and IATA
• Employees performing any of the following with
  infectious material
• Packaging and handling
• Transporting
• Those who receive should also be trained
• Retraining is mandatory every
• 2 years under IATA
• 3 years under 49 CFR

118
Training must include

• General awareness
• Function specific
• Packaging
• Handling/transport
• Receiving (safety precautions appropriate for the
  materials being shipped)
• Safety
• Incidents
• Emergency response

119
General PhilosophyNine Hazard Classes

• 1 - Explosives
• 2 - Gases
• Liquid Nitrogen
• 3 - Flammable liquids
• alcohol, formaldehyde
• 4 - Flammable solids
• 5 - Oxidizing substances and Organic peroxides

• 6 - Toxic infectious substances
• Infectious substances
• 7 - Radioactives
• 8 - Corrosives
• 9 - Miscellaneous dangerous goods
• Dry Ice
• Genetically modified organisms

120
DefinitionInfectious Substance

• Infectious Substance
• are substances which are known or are reasonably
  expected to contain pathogens.
• Are classified as UN 2814, UN 2900, or UN 3373 as
  appropriate
• Category A Infectious Substance
• an infectious substance which if transported in a
  form that, when exposure to it occurs, is capable
  of causing permanent disability, life-threatening
  or fatal disease to humans or animals.
• See indicative list of Category A Infectious
  Substances

121
Category A Infectious Substances

• Also includes
• All BL4 or RG4 agents
• All CDC/USDA Select Agents
• Notify OEHS before shipping/receiving a Select
  Agent or immediately upon identification
• Cultures or Stocks of human or animal pathogens
• Genetically modified microorganisms that meet the
  definition of an infectious agent

122
DefinitionCategory B Infectious (Biological)
Substance

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

123
DefinitionExempt Human/Animal Specimen

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

124
Cargo Aircraft Only Label

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

125
Passenger section prohibition

• Infectious substances, toxins and other dangerous
  goods are not allowed in the passenger section of
  the transport vehicle regardless of the mode of
  transportation.
• Infectious substances must be declared before
  transport in accordance with transportation
  regulations.
• Violators of this policy may incur severe
  penalties including fines and imprisonment.

126
Passenger section prohibitionIATA

• Category B Infectious Substances are not
  permitted in carry-on or checked baggage and must
  not be carried on a person.
• Operators must not load or transport Category B
  Infectious Substances unless they are transported
  as cargo in accordance with the Dangerous Goods
  Regulations.

127
Regulating Authorities

• International Air Transport Association (IATA)
• Dangerous Goods Regulations (DGR)
• Department of Transportation (DOT)
• Department of Commerce (Export Controls)
• Dept. of Health and Human Services (DHHS)
• Centers for Disease Control (CDC) 42 CFR 72
• United States Department of Agriculture (USDA)
  Animal Plant Health Inspection Service (APHIS)
• National Institutes of Health (NIH)
• Individual Carriers (FedEx, UPS, Postal Service)

128
State and Operator Variations(Country and
Carrier)

• Country examples
• Australia
• China
• Canada
• Bahrain
• Require permit to bring infectious agents in any
  quantity there

• Operator examples
• FEDEX
• 3 copies of shipping declaration form
• No BL4 transport
• Typed declaration
• UPS
• No infectious agents
• British Airways
• Continental Airlines
• Wont allow infectious agents

129
Infectious Substances - Class 6.2

• UN 2814
• Infectious substance affecting human only
• Infectious substance affecting humans animals
• includes prions
• UN 2900
• Infectious substances affecting animals only
• UN 3373
• diagnostic or clinical specimens from humans or
  animals known to contain a pathogen or high
  probability of harboring a pathogen.

130
IATA Packaging Instruction 602Infectious
Substances

• Watertight primary receptacle
• Absorbent material
• Watertight secondary receptacle
• List of contents
• Outer container with minimum external dimension
  of four inches

131
Packaging performance

• Primary or secondary packaging able to withstand,
  without leaking, a pressure differential of not
  less than 13.8 psi in the range of - 40oF to
  130oF
• Capable of passing
• 30 ft drop test
• Penetration test
• Vibration standard

132
Infectious substance packaging
UN 2814, Infectious Substance, Affecting Humans,
25 ml
133
Infectious substances outer package labeling

• Name address and telephone number of shipper and
  receiver ( responsible person)
• Infectious substance label
• Orientation arrows on opposite sides of package
  (for liquids gt 50 ml)
• UN package certification mark
• Proper shipping name UN 2814,
• Infectious substance, affecting humans, 50 ml

134
Shipping lt 50 ml of an Infectious Agent on Dry Ice
Responsible Person
UN 2814, Infectious substance, affecting humans,
40 ml
UN 4G/Class 6.2/CAN/87
U N
5 Kg
135
Shipping gt 50 ml of an Infectious Agent on Dry Ice
Responsible Person
UN 2814, Infectious substance, affecting humans,
60 ml
UN 4G/Class 6.2/CAN/87
U N
5 Kg
136
Category B Infectious Substance

• UN 3373
• Human or animal material being transported for
  diagnostic or investigational purposes (excluding
  live animals)
• become UN 2900 or UN 2814 if source has or may
  have serious disease which can be readily
  transmitted, and effective treatment is not
  readily available
• based on known medical history, endemic local
  conditions, symptoms, or professional judgement

137
IATA Packaging Instruction 650Category B
Infectious Substance

• Is not UN approved
• Does not bear the UN mark
• Triple packaging still required
• must pass series of 4 drop tests
• primary or secondary container must be capable of
  withstanding pressure of 95kPa for liquid
  specimens shipped by air

138
Category B Biological Substance Packaging
Culture
Biological Substance, Category B
95 kPa (13.8 psi) rated primary or secondary
container for shipments of liquids by air
139
Category B Infectious Substance outer package
labeling

• Name address and telephone number of shipper and
  receiver
• Responsible person also needed
• UN3373 label and words Biological Substance,
  Category B near label
• Orientation arrows on opposite sides of package
  (for liquids gt 50 ml)
• Dry ice labels if applicable

140
Shipping a Category B Infectious Substance on Dry
Ice
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 [phone]
Biological Substance, Category B
UN 1845, Dry Ice, 5 Kg
141
Shipping an Exempt Human Specimen on Dry Ice
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
UN 1845, Dry Ice, 5 Kg
142
Shippers 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

143
Ben Fontes Office of Environmental Health and
Safety 135 College Street New Haven, CT
06510-2411
1
John Doe Somewhere University Anywhere Street Los
Angeles, CA 90210 Responsible Person John Doe
(801) 555 -2211
X
BDL Hartford
X
LAX Los Angeles
144
NATURE AND QUANTITY OF DANGEROUS GOODS
Dangerous Goods Identification
Quantity and type of packaging
Packing Instr.
Authorization
UN or ID No.
Class Division
Pack-ing Group
Subsi-diary Risk
Proper Shipping Name
Infectious substance, affecting humans (Hepatitis
B Virus)
6.2
UN 2814
602
10 ml in 2 sealed plastic tubes
III
Dry Ice
9
UN 1845
5 kg All packed in one fibreboard box
904
Additional Handling Information
CHEMTREC 1-800-424-9300
Emergency Telephone Number
Benjamin Fontes Biosafety Officer
Name/Title of Signatory
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.
New Haven, CT June 30, 2000
Place and Date
Benjamin Fontes
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
145
Shipping Declaration Forms

• Must maintain copy (paper or electronic) of each
  shipping declaration for 2 years!
• Should be kept by Shipper (or representative for
  group)
• Suggest keeping for 2-3 years as a precaution

146
Penalties

• Violation of shipping requirements
• Individuals - no more than 250,000 or one year
  in jail, or both
• Organizations - no more than 500,000 per event
• False, fictitious, or fraudulent statement or
  representation on required forms
• Individuals - fine or imprisonment for not more
  than five years, or both
• Organization - unspecified fine