Transcript Regulatory Aspects, Standards,and Guidelines

Regulatory Aspects,
Standards,and
Guidelines
EMD 545b
Lecture #4
OSHA Law, Standards,
and Directives
Related to Biohazards
OSHA Act of 1970
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Section 1, An Act


To assure safe/healthful working conditions
Section 2, Congressional Findings/Purpose
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…to assure so far as possible…safe/healthful
working conditions and to preserve our human
resources
Section 5 Duties
“General Duty Clause”
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(5)(A)(1)Each Employer shall furnish:
employment
 workplace free from recognized hazards that are
causing death or serious physical harm
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(5)(A)(2) Each Employer shall comply with
OSHA Standards
General Duty Clause
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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
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existing measure of abatement

economically/technologically feasible (BMBL, etc)
Section 17 Penalties
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A) willful or repeat violation (5,000 < x <
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?)
Section 17 Penalties
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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
OSHA BBP Standard 1910.1030
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Applicable to all occupational exposure to blood
or other potentially infectious materials.
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Bloodborne Pathogens:

Pathogenic microbes present in blood which can
cause disease in humans (include, but not limited to
HIV, HBV, and HCV).
“OPIM”
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Other Potentially Infectious Materials

human body fluids
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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 BBP’s
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Exposure Control Plan
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Written document, updated and reviewed
annually
Identifies occupationally exposed employees
Outlines procedures to protect them
Documents ongoing consideration of new
engineering controls
Exposure Determination
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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
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detailed list of tasks that include exposure
Exposure Control Plan
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Hepatitis B Vaccine Offer
free, 3 shot vaccination
 offer w/in 10 days of hire
 signed declination statement
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Training
at time of hire, before work involving exposure
 retraining each year w/in 365 days
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Methods of Compliance
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Universal Precautions
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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
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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.
Methods of Compliance
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Sharps precautions, sharps containers
Good work practices
Leakproof containers for transport, storage
Labels, signs
Decontamination
Personal Protective Equipment
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free, all sizes, appropriate for task, replacement
supplies, laundered by employer
Records
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Medical (duration of work + 30 years)
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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?
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Scenario #1
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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
Scenario #1 - New Employee
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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)
Scenario #1- New Employee
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Healthcare professional’s written evaluation for
HBV vaccine
Offer retraining every 365 days, updates as
necessary
Evaluate prior work experience of employee
Audit procedures, facility, supervision
Scenario #2-HIV Experiment
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An existing employee from your bloodborne
pathogen program submits a request to work
with HIV in cell culture.
What is the appropriate Institutional response?
Scenario #2-HIV Work
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Document prior work experience
Demonstrated proficiency with techniques,
safety practices,equipment and operations
Adequate trained supervision
Appropriate facility (lab inspection)
Medical Surveillance (serum storage, postexposure prophylaxis
Scenario #3 - Exposure Response
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An employee at your institution has just
experienced an exposure to human blood.
What should happen next?
Scenario #3 - Exposure Response
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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)
Scenario #3 - Exposure Response
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Collect exposed worker’s 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
Scenario #3 - Exposure Response
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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
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Scenario #3 - Exposure Response
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Health care professional’s written opinion
to employee w/in 15 days of completion
 employee instructed on conditions that may require
further evaluation
 All other findings/diagnoses CONFIDENTIAL
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Biowarfare/
Bioterrorism
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Geneva Protocol (1925)
Biological Weapons Convention (1972)
Biological Weapons Act (1989)
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Public Law 101-298
Chemical and Biological Weapons Control and
Warfare Elimination Act of 1991
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Public Law 102-182
Anthrax Letters - Fall 2001
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5 deaths (FL, NJ, NY,
CT)
22 total infections
Mass terror
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White powder fever!
Unsolved crime
Other “bioterror” events
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Salmonella in salad bars
Shigella in pastries
125-I Saxitoxin in takeout food
Ricin at IRS building thwarted before use
UCONN anthrax
Texas Tech
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lost Yersinia samples
Hoaxes
Select Biological
Agents/Toxins
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Anti-terrorism and Effective Death Penalty
Act of 1996 (Public Law 104-132)
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Additional Requirements for Facilities
Transferring or Receiving Select Agents
42 CFR Part 72.6 (Select Agent Rule)
USA Patriot Act (Public Law 107-56
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Uniting and Strengthening America by Providing
Appropriate Tools Required to Intercept and
Obstruct Terrorism Act of 2001
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Possession now addressed
DHHS-CDC, USDA-APHIS
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Public Health Security and Bioterrorism
Preparedness Response Act of 2002
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Public Law 107-188
42 CFR Part 73, 9 CFR Part 121, 7 CFR Part
331
Regulatory language for USA PATRIOT
ACT
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Lists of Select Agents
Select Agent List DHHS-CDC
Crimean Congo haemorrhagic fever virus
 Coccidiodiodes posadasii
 Ebola viruses
 Cercopithecine herpesvirus 1
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(Herpes B virus)
Lassa fever virus
 Marburg virus
 Monkeypox virus
 Rickettsia prowazekii
 Rickettsia rickettsii
 South American haemorrhagic fever viruses
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Junin, Machupo, Sabia, Flexal, Guanarito
Select Agent List DHHS-CDC
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Tick-borne encephalitis complex (flavi) viruses
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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
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Select Agent List DHHS-CDC
Abrin
 Conotoxins
 Diacetoxyscirpenol
 Ricin
 Saxitoxin
 Shiga-like ribosome inactivating proteins
 Tetrodotoxin
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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
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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
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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
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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)
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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)
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USA PATRIOT ACT
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Restricted person (can’t possess,
receive, transport)
under indictment for a crime punishable by
imprisonment for a term > 1 year
 has been convicted of crime punishable by
imprisonment > 1 year
 fugitive from justice
 unlawful user of a controlled substance
 illegal alien
 adjudicated as a mental defective
 dishonorable discharge from US Armed Services
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Restricted Person
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Is an alien who is a national from a country
that has history of supporting terrorism:
Syria
 Sudan
 Lybia
 Cuba
 Iran
 Iraq
 North Korea
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Components of Bioterrorism Law
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Registration of individuals (possess, access)
Registration of agents, location
Description of storage and security
requirements
Pre-authorization of transfers
Select Agent Inventory
Components of Bioterrorism Law
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Restricted Access
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Facility
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fences, guards, video monitor
Building
locked access (key, keycard, guard, video)
 floors (keycard access, alarms, labels)
 Lab
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locked, lockboxes, away from office and traffic areas
Security Training/Manuals/Inspections
Components of Bioterrorism Law
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Security Plan
procedures for reporting loss of keys, password
 reporting suspicious people/packages
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removal of unauthorized personnel
reporting release, loss, or theft
 Access control
 Emergency response plans
 Inventory tracking quantities of SA’s
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NIH Guidelines for
Research Involving
rDNA Molecules
(April, 2002)
NIH Guidelines - April 2002
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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)
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Responsibilities: Institution
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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/PI’s/Lab staff)
Health Surveillance (BL3/Large scale)
Responsibilities - IBC
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5 members (2 from community)
Expertise (rDNA, biosafety, containment, legal)
Annual report to NIH-OBA (roster/CV’s)
Assess
Containment level, facilities, procedures
 Develop emergency plans, report violations
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Responsibilities: Biosafety
Officer
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IBC Member
Inspections
Report problems to IBC
Develop emergency plans
Advise on lab security
Responsibilities: Principal
Investigator
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Full compliance with Guidelines
Can’t 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
Section III: Experiments covered
by the NIH Guidelines
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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
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Section III: Experiments
Covered by the Guidelines
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IBC Notice at time of initiation
III-E-1: < 2/3 viral genome
 III-E-3 Production of transgenic rodents
 III-E-2: Whole plants
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Section III: Exempt Experiments
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III-F-1 through III-F-6
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not in organisms/viruses, PCR, known exchangers,
in/out of same host
Appendix C-1 through C-VI
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< 50% viral genome, E.coli, B. subtilis, S.cerevisiae,
Purchase transfer of transgenic rodents,
extrachromosomal elements of gm+ organisms
Appendices to NIH Guidelines
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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
Appendices to NIH Guidelines
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Appendix K: Large Scale containment
Appendix M: Human gene transfer
Appendix P: Plants (biocontainment for rDNA
plant experiments)
Appendix Q: Animal Biosafety containment
levels
Tuberculosis
Exposure Control
Mycobacterium tuberculosis
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Ancient
Airborne
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droplet nuclei
ID50 < 10 bacilli
Generally requires close, prolonged
contact
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infectiousness of patient, #bacilli
expelled
forcefullness of cough
ventilation, duration of exposure
Mycobacterium tuberculosis
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2 million deaths/year worldwide
(2002)
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1/3 of world population TB
positive
1 new TB infection every second
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Africa/Asia - 100 300+/100,000 (2002)
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USA - 5.2 cases/100,000 (2002)
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D.C.- 14.4, HI-11.9, CA-9.0, NY7.5 (2002)
Mycobacterium tuberculosis
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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
TB Pathogenesis
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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)
TB Pathway
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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
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consumption, wasting, fever, cough
Risk Factors
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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)
TB Treatment
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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)
Signs and Symptoms of Active TB
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Early signs - fatigue, weakness, fever,
chills, night sweats, loss of appetite,
weight loss
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Advanced stages - sputum producing
cough, coughing up blood, chest pain,
hoarseness of voice
Graphic produced by Coastal Video
Proposed OSHA TB Standard
*VACATED 2002*
Resurgence of TB cases
Annual increase from 1985-1992
Multi-drug resistant TB
OSHA General Duty Cause
Current OSHA Enforcement
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CPL 2.106 (2/9/96)
5(a)(1) General Duty Clause of OSH Act of
1970
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
recognized hazard
abatement economically and technologically
feasible
Coverage
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> 1 suspect/confirmed TB case w/in previous 6
months
Related OSHA Law
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Respiratory Protection - 29 CFR 1910.134
Accident Prevention Signs and Tags - 29 CFR
1910.145
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Employee Exposure and Medical Records - 29
CFR 1910.1020
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Recording and Reporting Occupational
Injuries and Illness - 29 CFR 1904
TB Control Measures - Clinical
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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
Medical Surveillance
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Periodic tuberculin skin testing
History, physical exam, medical management
Provide:
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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
TB Screening
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Test for infection: PPD
(anergy)
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Test for active disease:
 Sputum culture
 Chest X-Ray
Respiratory Protection
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Targeted for:
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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
Respiratory Protection

Program
 Training
 Selection of an air-purifying
respirator (NIOSH approved)
 Fit testing
 Use
 Storage/disposal
Remember: Surgical masks
are not respirators
Recordkeeping
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Medical (duration + 30 years)
OSHA illness and injury
Training (3 years)
Engineering control
maintenance and monitoring (3
years)
TB Exposure Control Procedures
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Ask patient to cover their nose and
mouth
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Provide surgical mask for patient
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Wear a NIOSH certified *respirator
for close or prolonged contact
Graphic produced by Coastal Video
* a 95% filter efficiency
for particles 1 micron in size
TB Exposure Control Procedures
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Isolate patient (negative pressure
room or dedicated/segregated
area)
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Notify supervisor or infection
control representative
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Refer patient to emergency medical
assistance (w/in 5 hours)
Engineering Controls
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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
Signs/Labels
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Treatment rooms (signal word & necessary
precautions)
Air transport components (fans, ducts, filters)
OSHA 300 Log
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TB infections (+PPD)
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+PPD’s after 2 weeks of hire must be
recorded whether deemed work related or
not!
TB disease
OSHA Law, Standards,
and Directives
Related to Biohazards
OSHA Act of 1970
29 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

29 CFR 1903.2
OSHA 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”)
29 CFR 1910.1030
Bloodborne 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

29 CFR 1910.141 Sanitation

Housekeeping, waste/vermin disposal, toilet
facilities, potable water, washing facilities
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Showers, change rooms, eating/drinking
locations
Sanitary storage (food not stored in toilets or
areas exposed to toxic materials)

1910.145 Specification for
Accident 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

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

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?

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
29 CFR 1910.120

(a)(3) Hazardous substance
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
(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...
29 CFR 1910.132 - 1910.139
Personal Protective Equipment
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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)
29 CFR 1910.132
Personal Protective Equipment
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PPE for eyes, face, head, & extremities
Protective clothing
Respiratory devices
Protective shields and barriers
…shall be provided, used, and maintained in a
sanitary manner
29 CFR 1910.132
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
Hazard assessment
Selection/fit
Training
situations required, required PPE
 donning/adjusting/doffing & limitations
 care, maintenance, service life & disposal
 demonstration before use
 retrain as needed

29 CFR 1910.134
Respiratory 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

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)
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

29 CFR 1910.139
Respiratory 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)
29 CFR 1910.151
Medical 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/body…may be exposed to injurious
corrosive materials)
29 CFR 1910.157
Portable Fire Extinguishers


Placement/use (75 ft.- Class A or D, 50 ft.-Class
B, Class C mirrors A or B)
Maintenance


Training


annual verification
initial & annual
Exemptions
written plan for immediate evacuation
 designated personnel

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)
29 CFR 1910.1020 Access to
Exposure & Medical Records

Access (right to examine and copy)
personal/area samples, biological monitoring,
MSDS’s, 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

29 CFR 1910.1020 Access to
Exposure & Medical Records

Information to Employees (@ 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

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
Guidelines and
Regulations Related to
Medical Waste
Medical Waste

Regulations and Guidelines
Local
 State
 Federal

EPA (RCRA)
 OSHA, DOT
 CDC, NIH

1976 RCRA

Resource Conservation and Recovery Act
EPA management of hazardous wastes
 Environmentally sound
 Cradle-to-grave responsibility

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

NIH rDNA Guidelines

Appendix G (BL1): “all contaminated liquid or
solid wastes are decontaminated before
disposal”
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.”
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

Medical Waste Program


Identification of regulated waste
Handling




segregation/packaging/storage/transport
Treatment/Disposal
Monitoring treatment processes
Compliance w/ local & state regulations
Medical Waste Program

Segregation (at point of origin)
Sharps
 Other contaminated solids
 Pathological waste
 Liquids
 Mixed hazardous waste
 Pharmaceutical waste

Medical Waste Program

Packaging
Protect personnel handling waste
 Adequate containment
 Labeling

Medical Waste Program

Storage (short term)
restricted access
 sanitary
 labeling

Medical Waste Program

Transport
on-site (leak proof, puncture resistance)
 off-site (regulatory compliance)

approved registered company
 tracking forms

Medical Waste Program

Treatment & Disposal
Definition?
 Incineration
 Steam sterilization
 Chemical
 Other (approved by regulatory entity)
 Monitoring (biological indicators)

Medical Waste Program

Contingency Planning
equipment failure
 failed treatment run
 regulated waste in non-hazardous stream


Training
all personnel (generators, transporters)
 updates as required

Medical Waste Program

State law details requirements for:
Generators
 Transporters
 Treatment facilities



validation requirements
Record keeping

reporting details
Transport and Transfer
of
Hazardous Biological
Materials
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

Training must include:


General awareness
Function specific:
Packaging
 Handling/transport
 Receiving (safety precautions appropriate for the
materials being shipped)


Safety
Incidents
 Emergency response

General Philosophy
Nine Hazard Classes
 1 - Explosives
 2 - Gases
 Liquid Nitrogen
 6 - Toxic & infectious
substances
 Infectious substances
 7 - Radioactives
 alcohol, formaldehyde
 8 - Corrosives
 4 - Flammable solids
 9 - Miscellaneous
dangerous goods
 5 - Oxidizing substances
 Dry Ice
and Organic peroxides
 3 - Flammable liquids
 Genetically modified
organisms
Definition:
Infectious 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

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
Definition:
Category 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.
Definition:
Exempt 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.
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
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.
Passenger section prohibition
IATA


“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.”
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)
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




UPS



3 copies of shipping
declaration form
No BL4 transport
Typed declaration
No infectious agents
British Airways
Continental Airlines

Won’t allow infectious
agents
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.
IATA Packaging Instruction 602
Infectious Substances





Watertight primary receptacle
Absorbent material
Watertight secondary receptacle
List of contents
Outer container with minimum external
dimension of four inches
Packaging performance


Primary or secondary packaging able to
withstand, without leaking, a pressure
differential of not less than 13.8 psi in the range
o
o
of - 40 F to 130 F
Capable of passing:
30 ft drop test
 Penetration test
 Vibration standard

Infectious substance packaging
UN 2814, Infectious Substance, Affecting Humans, 25 ml
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 > 50 ml)
UN package certification mark
Proper shipping name: UN 2814,
Infectious substance, affecting humans, 50 ml
Shipping < 50 ml of an Infectious
Agent on Dry Ice
Responsible Person:
UN 2814, Infectious substance,
affecting humans, 40 ml
U
N
UN 4G/Class
6.2/CAN/87
5 Kg
Shipping > 50 ml of an Infectious
Agent on Dry Ice
Responsible Person:
UN 2814, Infectious substance,
affecting humans, 60 ml
U
N
UN 4G/Class
6.2/CAN/87
5 Kg
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
IATA Packaging Instruction 650
Category 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

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
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 > 50 ml)
Dry ice labels if applicable
Shipping a Category B Infectious
Substance on Dry Ice
To: Bob Smith
From: Jill Reynolds
Virus World
Yale University, LEPH
111 Viremia Way
60 College Street
Boston, MA 02115
New Haven, CT 06510
Responsible Person: Jill Reynolds
(203) 555-1125
Biological Substance,
Category B
UN 1845, Dry Ice, 5 Kg
Shipping an Exempt Human
Specimen on Dry Ice
To: Bob Smith
From: Jill Reynolds
Virus World
Yale University, LEPH
111 Viremia Way
60 College Street
Boston, MA 02115
New Haven, CT 06510
Exempt
Human
Specimen
UN 1845, Dry Ice, 5 Kg
Shipper’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
(Provide at least two copies to the airline)
SHIPPER'S DECLARATION FOR DANGEROUS GOODS
Ben Fontes
Office of Environmental Health and Safety
135 College Street
New Haven, CT 06510-2411
Air Waybill No.
1
Page
1
Of
Pages
Shipper's Reference Number
(optional)
Consignee John Doe
Somewhere University
Anywhere Street
Los Angeles, CA 90210
Responsible Person: John Doe (801) 555 -2211
Two completed and signed copies of this Declaration
must be handed to the operator.
TRANSPORT DETAILS
Airport of Departure
This shipment is within the
limitations prescribed for:
X
(delete non- applicable)
PASSENGER
AND CARGO
AIRCRAFT
CARGO
AIRCRAFT
ONLY
Airport of Destination:
BDL Hartford
FedEx
Federal Express
WARNING
Failure to comply in all respects with the applicable
Dangerous Goods Regulations may be in breach of the
applicable law, subject to legal penalties. This
Declaration must not, in any circumstances, be
completed and/or signed by a consolidator, a
forwarder, or an IATA cargo agent.
Shipment type: (delete non-applicable)
LAX Los Angeles
NON-RADIOACTIVE
X
Shipper
RADIOACTIVE
NATURE AND QUANTITY OF DANGEROUS GOODS
Dangerous Goods Identification
UN
or
ID No.
UN
2814
UN
1845
Proper Shipping Name
Infectious substance,
affecting humans
(Hepatitis B Virus)
Dry Ice
Class
Division
Packing
Group
Subsidiary
Risk
Quantity and
type of packaging
6.2
Packing
Instr.
Authorization
602
10 ml in 2 sealed
plastic tubes
9
III
5 kg
All packed in
one fibreboard
box
904
Additional Handling Information
Emergency Telephone Number
CHEMTREC
1-800-424-9300
Name/Title of Signatory Benjamin Fontes
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.
Biosafety Officer
Place and Date
Signature
(see warning above)
New Haven, CT
June 30, 2000
Benjamin Fontes
IF ACCEPTABLE FOR PASSENGER AIRCRAFT, THIS SHIPMENT CONTAINS RADIOACTIVE MATERIAL INTENDED
FOR USE IN OR INCIDENT TO RESEARCH MEDICAL DIAGNOSIS OR TREATMENT
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
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
