Environmental and iIH sampling challenges - Washington DC 2016

1. Industrial Hygiene and Environmental Sampling
Challenges Globally
(Limited reference to South Africa, Kenya, Nigeria)
ORCHSE Strategies, LLC Meeting,
Washington DC
November 11, 2016
Maharshi Mehta, CSP, CIH
International Safety Systems, Inc.,
Washingtonville New York, USA
+1 203 685 8808, www.issehs.com
USA (New York, Houston), Mexico, Brazil, India (New Delhi, Baroda,
Bangalore, Hyderabad), China (Shanghai)

2. Agenda
 Sources of presentation
 Industrial Hygiene Sampling Challenges
– Chemical Agents
– Physical Agents
– Biological Agents
 Environmental sampling challenges
 Addressing challenges
 Control banding
 Statistical analysis of data
 Industrial hygiene sampling – future
 Limited Occupational Hygiene framework – South Africa, Nigeria,
Kenya
 Summary
©International Safety Systems, Inc.
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3. Sources
 Industrial hygiene sampling at
100+ workplaces in 25+
countries
 More than 5000 samples
 Audit observations
 Literature search
 Other IH Professionals

4. Industrial Hygiene Sampling and
Ethics
 Life of working people depends on monitoring
results
 Ethics is challenged invariably
 Strict adherence to ethics – quality assurance is
critical
– Reliable, Representative and Reproducible Results
 Human impact of high exposures identified as
low exposures due to wrong methods and vice
versa
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5. Qualitative Exposure Assessment (QLEA),
Quantitative Exposure Assessment (QNEA)
 Essential before sampling begins
– Case studies – Consultant determined number of
samples to be collected
 Cost savings in QNEA
– Without QLEA, 10 times more
 Ingredients and %
– EnSolve 5408 contains?
 Other benefits
©International Safety Systems, Inc.
www.issehs.com

6. Reliable
 Validated method
 Calibration – before after – With rotameter?
 Calibration of calibrator
 Is sampling time exact or ends with 0 and 5 (e.g., 8:05 am, 8:10 am)
 Analytical laboratory
– AIHA accredited – Questionable results
– Countries with no IH accreditation
 Country specific requirements
– Only area sampling
– One hour sampling
©International Safety Systems, Inc.
www.issehs.com

7. Sampling Method -
Pharmaceuticals
 IOM or conventional cassette
 Task based or full shift-interpretation of results
 Limited compounds with validated methods
 Limited compounds with OEL
– Especially intermediates
 LOQ for high potent compounds
 “Our lab does product analysis so they can do
exposure sample analysis also”
©International Safety Systems, Inc.
www.issehs.com

8. Representative
 Sampling duration
– Work started at 6 am, when did sampling start?
– Missed beginning and end of shift?
 Was the work normal? Spill leaks?
– Case study – call operators in canteen, place sampling
pumps and have them deliver at 3 pm
 Is night shift exposure similar to day shift?
©International Safety Systems, Inc.
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9. Reproducible
 Number of samples for each SEG
– Six?
– Three?
– One?
 Statistically significant
 Statistical analysis
– Of the three samples one above OEL and two below
OEL
– All 3 samples >50% of OEL <OEL
 Minimum three samples and stat analysis
©International Safety Systems, Inc.
www.issehs.com

10. Personal exposure: Laboratory Scale
weighing in VBSE
 Sample size: 10
 Range of results: < 0.04 – 0.41 μg/m3
 Sample Duration: 27 - 34 Minutes
 Sample Weight: < 1 gram
 GSD: 2.59
 95th%ile – 1.57 μg/m3
 Lognormal distribution hypothesis is
not rejected
10
©International Safety Systems, Inc.
www.issehs.com

11. Personal exposure: Laboratory
weighing- no exposure controls
 Sample size: 12
 Range of results: 0.078 – 3.84 μg/m3
 Sample Duration: 5 – 15 minutes
 Sample Weight: < 1 gram
 GSD – 4.48
 95th%ile – 4.21 μg/m3
 Lognormal distribution hypothesis is
not rejected
11
©International Safety Systems, Inc.
www.issehs.com

12. Comparison of laboratory scale weighing
results
12
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13. Report
 50 pages? 2 pages?
 Key Report Content
– Activity descriptions
– Results and result interpretation
– Contributory factors
– Recommendations
– Limitations
©International Safety Systems, Inc.
www.issehs.com

14. OEL challenges
 Difficulty in achieving OELs with process controls
– Hexavalent chromium, strontium chromate
– Cadmium
– Potent pharma compounds
 Changing OEL
– Benzene
– Isopropanol
 Uncertainty
– Metal working fluid
©International Safety Systems, Inc.
www.issehs.com

15. Control Bands – Example ( Chemicals by
Inhalation)
 Band 1 – Use good industrial hygiene practice &
general ventilation
 Band 2 – Use local exhaust ventilation
 Band 3 – Enclose the process
 Band 4 – Seek expert help

16. Systems Currently in Place or Under
Development
 HSE (UK) COSHH Essentials
 ILO Chemical Control Tool kit
 Systems currently being developed in:
– Belgium (REGETOX)
– Netherlands (Stoffenmanager)
– Norway (KjemiRisk)
 Occupational Exposure Banding in
Pharmaceutical Industries

17. Reconcile Country Regulations
and Quality Assurance
 Conduct limited monitoring required by a country
regulation
– China Case study
 Conduct comprehensive and robust monitoring using
validated methods that meets QA standards
 Country Certified Professionals
– Malesia case Study
– Kenya
 Have country certified professional do monitoring under
the guidance of CIH
©International Safety Systems, Inc.
www.issehs.com

18. Managing with limited resources
 Qualified service providers
– Corporate qualified
– Discussions with procurement not to go for lowest
bidder
– Periodically monitor “experts”
 Develop in-house IH 101 capabilities
– EHS, maintenance and line managers
 Internal laboratory approval process
– NIOSH PAT and Round Robin Test Participation
©International Safety Systems, Inc.
www.issehs.com

19. Developing In-house Capabilities
 Company specific 3 day onsite
Workshops on Applied Industrial
Hygiene
 BOHS Training Modules
http://ohlearning.com/default.aspx
 Applied IH on Webex
– Nine training programs, 4 hours/day,
4 days
– Interactive, with polling questions
and workshop assignments
– Video of faculties and
instrumentation
– 250 employees covered in nine
training programs, 2 years
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20. South Africa
 Occupational Hygiene Regulations in South Africa
– http://www.saioh.co.za/?page=Legislation
 Regulations for:
– Hazardous Chemicals and biological agents
– Noise
– Asbestos
– Lead
– Indoor air quality (reference ASHRAE standard)
 Refers to NIOSH manual of analytical methods
 Specific and detailed
– Illumination
– Vibration
 Compliance with reference and regulation seem to meet QA
requirements
©International Safety Systems, Inc.
www.issehs.com

21. Kenya
 Directorate of Occupational Health and Safety
Services
http://www.labour.go.ke/2016-04-14-11-48-
28/directorate-of-occupational-safety-and-health-
services-doshs.html
 Occupational Health and Safety Act of 2007-
Similar to UK Factories Act
– Permissible exposure limits are specified
 Hazardous Substances Rules LN 60/2007
 List of approved Air Quality Monitors
©International Safety Systems, Inc.
www.issehs.com

22. Nigeria
 Federal Ministry of Labor and Employment
– Factories Act CAP F1 LFN, 2004
– http://www.labour.gov.ng/index.php?option=com_co
ntent&view=article&id=41&Itemid=157
 Ratified ILO conventions
– C155- Occupational Safety and Health Convention
1981
©International Safety Systems, Inc.
www.issehs.com

23. Summary
 Credibility of exposure monitoring outcome is
questionable globally, more so in emerging economies
 Systematic approach of developing internal exposure
assessment tool and implementing globally is viable
option
 Approaches have been successfully implemented to build
resources, work with qualified service providers, address
country specific sampling requirements and maintain QA
 Statistical analysis of globally available sampling results
would greatly assist in identifying and controlling
potential health risk with minimal resources
©International Safety Systems, Inc.
www.issehs.com