Transcript Risk Assessment - University of Texas Health Science

Objectives
Define risk assessment as it relates to
biosafety
 Understand the risk assessment
process and how to implement it
 Discuss risk factors in the risk
assessment process
 Address exam topics 15, 16, 17, 18, 22,
23, 26, & 30.

Risk

Risk implies the probability that harm,
injury, or disease will occur – CDC/NIH
BMBL
Biological Risk Assessment
Risk assessment is a process used to
identify the hazardous characteristics of
a biological agent, the activities that can
expose an individual, the likelihood of
infection, and the consequences of an
infection. – CDC/NIH BMBL 5th ed.
 Subjective process
 The key to biosafety

Risk Assessment Methodologies
CDC/NIH Biosafety in Microbiological and
Biomedical Laboratories, section II
 NIH recombinant DNA guidelines, section
II-A
 WHO Laboratory Safety Manual, Part I 2.
 Sandia National Laboratory Report Biosafety Risk Assessment Methodology
http://www.biosecurity.sandia.gov/BioRAM/
Biosafety%20Risk%20Assessment%20Re
port.pdf

Risk Assessment Goal

Assign appropriate practices and facility
requirements to a protocol
Individual
 Community
 Environment

Primary Considerations

Agent(s)

Procedures

Experience
Risk Groups

Risk Group 1
 No or low individual and community risk
 Unlikely to cause disease in healthy subject

Risk Group 2
 Moderate individual risk, low community risk
 Can cause disease Lab exposures may result in infection, but effective treatment and
preventative measures are likely available and risk of spread of infection is limited
 Usually fecal/oral or inoculation hazard

Risk Group 3
 High individual risk, low community risk
 Usually causes serious disease but does not easily spread. Effective treatment and
preventative measures are likely available.
 Usually airborne hazard

Risk Group 4
 High individual and community risk
 Causes serious disease and can be readily transmitted. Effective treatment and
preventative measures are not usually available
 viral
Risk Group Examples

RG 1 – Bacillus subtilis

RG 2 – Salmonella typhi

RG 3 – Coxiella burnetii

RG 4 – Herpesvirus simiae
Risk Group Resources

ABSA database
 http://www.absa.org/riskgroups/index.html

NIH rDNA guidelines
 http://oba.od.nih.gov/oba/rac/Guidelines/AP
PENDIX_B.htm
WHO
 Others – Canada

 http://www.phac-aspc.gc.ca/lab-bio/res/psds-
ftss/index-eng.php
Risk Group does not
automatically equate to
Biosafety Level
Risk Group Exercise
Adeno-associated virus (AAV)
 Adenovirus
 Escherichia coli K-12
 Escherichia coli O157:H7
 Mycobacterium tuberculosis
 Bacillus anthracis
 Coccidiodes immitis

Other Agent Factors to Consider
Pathogenicity
 Routes of exposure
 Concentration / Infectious dose
 Stability
 Treatment options / vaccine availability

Host Susceptibility
Assume “normal” host
 Age
 Sex
 Vaccination status
 Assess personnel performing work
 Reproductive risks?
 Remember animal and plant pathogens

Procedural Considerations
Location of work
 Scale
 Aersolization potential
 Use of sharps
 Personal protective equipment
 Containment equipment
 Animal or plant models
 Cell cultures
 Genetic manipulation

Recombinant DNA
Genes inserted
 Antimicrobial resistance
 Oncogenes
 Toxins
 Increase of virulence
 Extension of host range
 Stability in environment improvement
 Human gene transfer

Experience
Personnel proficiency
 Previous experience
 Technique
 Training

The Process

Who performs the risk assessment?
 PI or lab director initially

Available tools
 CDC -
http://www.cdc.gov/biosafety/publications/BiologicalRisk
AssessmentWorksheet.pdf
 Sandia http://biosecurity.sandia.gov/BioRAM/Biosafety%20Risk
%20Assessment%20Report.pdf
 IBC forms


Documentation
http://www.lbl.gov/ehs/biosafety/manual/html/3.0.s
html
Biotoxins
Chemicals of biological origin
 LD50
 NIH rDNA guidelines
 Select Agent toxins
 Examples

 Botulism, Cholera, Diptheria
Additional Considerations
Biosecurity
 Field studies
 Shipping
 Effluent / Waste

Risk Assessment Challenge

What facilities and practices would you
require?
Analysis of clinical samples of TB
 Antibiotic susceptibility testing of INDs for TB
 Imaging study of Yellow fever vaccine strain
 Diagnostic studies of CJD
 Vaccine research on HIV

Questions?