INDIAN GCP GUIDELINE. for Regulatory affair 1st sem CRR
PDC on Hazard and Risk Assessment by Maharshi Mehta, ISS, Occucon
1. Hazard and Risk Assessment
PDC on Hazard and Risk Assessment
Occucon 2014, Goa
February 11, 2014
Maharshi Mehta, CSP, CIH
International Safety Systems, Inc.,
Washingtonville New York, USA
www.issehs.com
3. Industrial Hygiene
Hazard Anticipation-Hazards likely to be present?
Hazard Recognition-What are health hazards?
Risk Evaluation-Exposed to health hazard? How much?
Risk Control-How can exposure be reduced?
So that.. Health risk is minimized
And potential for occupational illnesses, material loss are
reduced and the company liability minimized
4. The Need
Prevent occupational illness and injury by
reducing/eliminating health risk
Significant cost savings by reducing/recovering
particulate/vapor emissions
Regulatory requirements
Productivity increase
•In the Europe, 150 million workdays are lost each year due to work
accidents and illnesses and the insurance costs 20 billion Euros
•Annual cost of occupational illnesses and injuries in Latin America is
about $75 billion
5. Exposure Limits
Airborne concentration of a substance
Repeated exposure to the substance below exposure limit
day after day is unlikely to produce adverse health effects
in healthy workers
High Health Hazard Chemicals have low exposure limits.
Examples of exposure limits at Huntsman
– Hydrochloric acid 5 ppm ceiling limit
– Ammonia 25 ppm long term limit for 8 hours exposure
Exposure limits are not
a fine line between safe and
dangerous concentrations
6. Organizations Establishing
Occupational Exposure Limits
(OELs)
American Conference of Governmental Industrial
Hygienists (ACGIH), USA
Local Regulatory Agencies
– Occupational Safety and Health Administration (OSHA), USA
– Health and Safety Executive (HSE), UK
– Technical Rules for Hazardous Substances (TRGS), Germany
GE Established OELs
– More stringent
7. Units of Exposure Limits
Expressed as concentration of the airborne substance in a volume of air
Vapor/gaseous airborne substances:
ppm (parts per million)- the parts of airborne
substance per million parts of air
ppb (parts per billion)- the parts of airborne
substance per billion parts of air
Particulate airborne substances:
mg/m3 -milligrams of airborne
substance per cubic meter of air
μg/m3 -micrograms of airborne
substance per cubic meter of air
Airborne fibers:
Fibers/cc -fibers per cubic
centimeter of air
. 1 mg
Concentration of
airborne substance is 1
mg/m3
8. What are Hazards and Risks
Hazard – Chemical, Physical and or Biological agent that
can cause harm
Risk - The likelihood that the potential for harm will be
caused by hazards
Hazardous substances are present most of the time
Risk is dependant on (a) human exposure to hazards and
(b) degree of exposures
Degree of exposure is dependant on controls provided
and work practices followed
Industrial Hygiene Risk Assessment (IHRA) is process of
determining degree of health RISK based on degree of
HAZARDS and extent of EXPOSURE
9. The Need
Assist in determining:
– the need for exposure controls
– respiratory protection and types of respirators
– if an illness is work related or not
Assist in protecting company in occupational illness
litigations
Targeted medical surveillance
– Medical surveillance focused on potentially exposed
individuals
10. Methodology - Planning
Obtain and review process information, chemical
lists before hand
Obtain and review past mentoring data and
historical assessment
Review floor plan and mark areas CRA to ensure
all areas are covered
Review applicable regulation and standards
Obtain list of chemicals and ingredients
11. Where and When Should Chemical
Risk Assesment be Done
Where:
– Include all operations and activities
– Include all non-routine operations and activities such
as, maintenance
– Include activities with no apparent health risk also
E.g., Warehouse; potential risk from noise and
carbon monoxide (CO) from forklift may be present
When
– Before any new process begins
– When change in process occurs
Required for Employees, Contract Employees, Temporary
Workers
12. Chemical Risk Assessment
Degree of hazards
– Hydrochloric acid and ammonia
Frequency and duration of handling/exposure
– How long tanker unloading is done
The risk of the material becoming airborne
– % of HCl and does it become airborne
Historical air monitoring results (if available)
Existing engineering controls and work practices followed
– How do we collect QC sample
Effectiveness of exposure control is determined or not
Chemical properties: volatility, particle size, dryness
– Fly ash , coal dust
Ingestion
Skin contact
13. Site Visit
Determine frequency/duration of operation/personal
exposures
Determine approximate quantities of materials used
Observe controls - make subjective assessment of
effectiveness
Interview workers and/or supervisors at each stage of
process
Gather data on raw materials, finished products, by-products
Collect relevant MSDSs
Note specific PPE used
Start to complete Risk Ranking
19. Observations and
Recommendations
Very important as observation based degree of risk is
more important than number based risk
Provides bases for ranking used
Obtain and enter as much of the pertinent information as
possible based on observations and interviews
While making recommendations, consider
– “Quick Fix”
– Feasibility
– Cost effectiveness
Mention PPEs used, if any
20. Quantitative Exposure Assessment
Chemical exposure monitoring
– Direct reading instruments
– Detector tubes (Colorimetric tubes)
– Passive monitoring with Diffusion badges/tubes
– Active monitoring with sampling pumps
Noise monitoring
– Area noise monitoring
– Personal noise exposure monitoring (Dosimetry)
Heat stress monitoring
Ionizing radiation monitoring
Vibration monitoring
Bio-aerosol monitoring
22. Active Air Monitoring
Process:
– Air is drawn through a sampling media, kept in the
breathing zone of the person potentially exposed, with a
battery operated sampling pump
– The sampling media is analyzed and weight of
contaminant determined
– The weight is divided by the volume of air drawn
through the media to determine contaminant
concentration
Substance-specific accurate identification of
exposure
Corporate and regulatory requirements
Acceptable in litigation
Determines exposure during actual work. Not an
instantaneous concentration determination as in
direct reading instrument
23. Quality Assurance in Exposure Monitoring
Health of working people depends on exposure monitoring results
Ensure sampling duration is closed to the exposure duration.
– Do not miss beginning and ending of shifts as high exposure
may occur during this time (e.g., cleaning of work area)
– Exposure monitoring may have to begin at 6 am if shift starts at
6 am.
Ensure calibration of sampling device before and after sampling
Ensure sampling device is calibrated annually
Ensure sampling time is exact. Ensure sampling time does not end
with 0 and 5 (e.g., 8:05 am, 8:10 am)
29. Enhanced IH Module
Assessment w/Risk Assessment integrated into IH module
30. Enhanced IH Module (Cont.)
Streamlined Add New Assessment form
Risk Assessment
Details section
31. Enhanced IH Module (Cont.)
Risk Assessment Details Pending for an Existing Assessment Record
Risk Assessment Details Completed
32. Enhanced IH Module (Cont.)
Streamlined Risk Assessment Details Form with Guidance Mouseovers
33. Enhanced IH Module (Cont)
Risk Assessment Workflow Option to Submit to Reviewer
34. Enhanced IH Module (Cont.)
Risk Assessment Review Option – Special Right Required
35. HSE (UK) COSHH Essentials
Control banding tool for small to medium size
enterprises to do risk assessments for chemicals &
mixtures of chemicals
Required information
– Type of task – shoveling, drilling
– Hazard classification (using risk & safety phrases
from MSDS )
– Volatility or dustiness (from guidance material)
– Amount used- kg,mg,litres,milliliters
36. HSE (UK) COSHH Essentials
(cont)
System identifies
– Control band (control approach)
– Produces advice on controlling risk from the
chemical being used in the task
– Provides written guidance & documentation
37. ILO Chemical Control Tool kit
Very similar to COSHH Essentials
Does not apply to process dusts or fumes due to
the fact that these are not classified by the
supplier of individual chemicals
Has general application to many situations in
developing countries but susceptible groups
(child workers & pregnant women) need to be
considered