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Control Banding: Getting from Here to There. St. Louis Safety Council – St. Louis October 20, 2010 Thomas Kibby, MD MPH BJC Corporate Health Services. Control Banding - Definitions.

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control banding getting from here to there
Control Banding:Getting from Here to There

St. Louis Safety Council – St. Louis

October 20, 2010

Thomas Kibby, MD MPH

BJC Corporate Health Services

control banding definitions
Control Banding - Definitions
  • A method of linking control methods to the hazard assessment of the materials handled (AIHA)… “an evolving strategy”
  • A process in which a single control technology is applied to one range or band of exposures to a chemical that falls within a given hazard group (NIOSH)

“My company doesn’t have the money to take air samples for all the chemicals used in our plant. Many of these chemicals don’t have permissible exposure limits. How do I know which tasks in my facility may need controls?”

why use control bands
Why Use Control Bands?
  • Not needed if already use an OEL and specific IH monitoring to the control technology.
  • But most of our products do not have the luxury of OEL’s, IH methods and validated control technologies.
  • Control banding gets the IH from here to there



Control Band












  • Most substances can be grouped into health hazard bands, such as four categories of increasing toxicity.
  • Each band can be assigned a target maximum exposure that should not be exceeded.
  • Exposures are primarily a function of quantity, dustiness (or volatility), and the level of control.
  • Most manufacturing facilities use similar unit operations (e.g., bag filling, mixing, material transfer).
  • A combination of unit operation and exposure control can be recommended so that the target maximum exposure is not exceeded.
hazard assessment
Hazard Assessment

Assign to highest Category that pertains:

  • Skin or respiratory irritant
  • Harmful on single exposure
  • Very Toxic on single exposure; Severely irritating & corrosive; or a skin sensitizer
  • Very toxic on single exposure; or a reproductive hazard; carcinogens, asthmagens
exposure assessment
Exposure Assessment

Combined judgment based on

  • Quantity used
  • Tendency to become airborne
match to control strategy
Match to Control Strategy
  • Use good industrial hygiene practice and general ventilation.
  • Use local exhaust ventilation.
  • Enclose the process.
  • Seek expert advice
history of control banding
History of Control Banding
  • 1980’s: Pharmaceutical benchmarking of Tox, IH and Medical (OTR) begins meeting
  • 1988: OTR develops concept of Category Band; all participants develop own CB but not uniform
  • Late 1990’s: UK HSE develops COSHH Essentials
  • 2000’s: UN-WHO and Canada develop own versions
why did pharma start banding
Why Did Pharma Start Banding?
  • Many potent compounds:
    • highly active pharmaceuticals: API
    • chemotherapy, hormones with occ exposures
  • Many unknown compounds:
    • R&D environment
    • isolated process intermediates (IPI)
  • Standard processes:
    • bulk quantities of powders, fine particle size

Generic Control Band Scheme

From NIOSH Safety and Health Topic: Control Banding

coshh enhancements
COSHH Enhancements

UK’s Health and Safety Executive (HSE)

Control of Substances Hazardous to Health (COSHH) regulations

Applies to materials identified as “dangerous for health” as listed by:

Supplier for the material

Regulation: CHIP Approved Supply List

Substances with Workplace Exposure Limits

coshh essentials steps
COSHH Essentials Steps
  • Assess the hazard (toxicity)
  • Assess dispersal potential
    • Dustiness for solids
    • Volatility for liquids
  • Determine amount in use
  • Above will determine process controls
step 1 hazard assessment
Step 1: Hazard Assessment

MSDS Risk phrases: A classification number and a description of the level of the danger is allocated to the chemical according to set rules. This is called a "Risk phrase" or "R-phrase".There are three levels of danger:

  • "harmful"
  • "toxic"
  • "very toxic" - being the most dangerous.
risk phrase examples
Risk Phrase Examples
  • R20 Harmful by inhalation  
  • R20/21 Harmful by inhalation and in contact with skin  
  • R20/21/22 Harmful by inhalation, in contact with skin and if swallowed  
  • R20/22 Harmful by inhalation and if swallowed  
  • R21 Harmful in contact with skin  
  • R21/22 Harmful in contact with skin and if swallowed  
  • R22 Harmful if swallowed  
  • R23 Toxic by inhalation  
  • R23/24 Toxic by inhalation and in contact with skin
  • (61 total health phrases)
hazard groups human health effects
Hazard GroupsHuman Health Effects
  • A Irritant
  • B Harmful on single exposure
  • C Toxic, corrosive, etc; skin sensitizer
  • D Very toxic, toxic to reproduction
  • E No health-based limit: Asthma, cancer, genetic damage
  • S Special conditions







coshh hazard groups airborne concentration range
Dust mg/m3

A 1 - 10

B 0.1 - 1

C 0.01 – 0.1

D <0.01

E seek specialist advice


Vapor ppm

A 50 - 500

B 5 - 50

C 0.5 - 5

D <0.5

E seek specialist advice


COSHH Hazard GroupsAirborne Concentration Range
step 2 exposure potential
Step 2: Exposure Potential
  • Tendency to Go Airborne
    • Solids: dustiness potential
    • Liquids: volatility
  • Scale of Use
    • Volumes handled
dustiness potential



Pellet-like solids PVC pellets, waxes

Crystalline, granular solids soap powder, sugar

Fine, light powders cement, titanium dioxide

Dustiness Potential
scale of use
Small volumes

Medium volumes

Large volumes



tons or cubic meters

Scale of Use
step 3 controls strategies
Step 3: Controls Strategies
  • CS1: general ventilation
  • CS2: engineering control
  • CS3: containment
  • CS4: expert advice
coshh worked example
COSHH Worked Example

TOUGH LACQUER CO manufactures lacquers.They buy liquid Citox from their supplier in drums. They transfer it from the drum in a batch process to a reactor containing resins where it gets mixed to make lacquers. They do this twice a day for a period of 2 hours each batch.

msds for citox
MSDS for Citox
  • Section 9 Chemical & physical properties
    • Physical state: Liquid at normal temperatures 
    • Boiling point: 134°C; Flashpoint: 36°C 
    • Flammability limits: 2.3-6.6%
  • Section 15 Regulatory hazard information
    • R10 (flammable)
    • R21/22 (harmful in contact with skin or if swallowed)
    • R36/37/38 (irritating to eyes, respiratory system of skin)
  • Citox is a liquid and the Tough Lacquer Co now needs to say how volatile this is. Section 9 of the safety data sheet says that citox has a boiling point of 134 ºC This is shown on the screen.If the vapor pressure has been given (it wasn't) this could have been entered instead of the boiling point. If using vapor pressure the Tough Lacquer Co would have needed to check they were entering the right units.
operating conditions
Operating conditions
  • Twice a day, for each batch, the Tough Lacquer Co add 50 - 100 liters of citox to the reactor over a period of 120 minutes. Because they are using liters of the chemical they are using a medium quantity.All this information is now entered on the screen.
summary of coshh advice
Summary of COSHH Advice

COSHH Essentials allocates control approach 'Containment' to transferring Citox, available as PDF files.

COSHH Essentials recommends 7 control guidance sheets,

  • G300 gives general advice
  • 4 for specific transferring tasks, (the Tough Lacquer Co consider G306 is most relevant to them)
  • 2 on skin protection.
is e coshh validated
Is e-COSHH Validated?
  • During drafting, substances with accepted OEL’s and control measures were used as a reference point
  • Field studies have shown good but not perfect controls using materials with established OEL’s.
limit of coshh essentials
Limit of COSHH Essentials
  • Not suitable for gases
  • Does not address by-products or substances generated by the process
  • Does not address safety or environmental risks (e.g. flammability)
  • R-phrases not available outside of EU
  • Still needs “reality check”
ilo chemical control toolkit
ILO Chemical Control Toolkit
  • Developed for
    • Small to Medium Enterprises (SME’s)
    • Developing countries
  • Like COSHH but
    • Uses R-phrase and GHS system on MSDS, so user judgment needed to assign hazard band
    • Somewhat larger margin of safety
the purdue pharma approach
The Purdue Pharma. Approach
  • Occupational Exposure Bands (OEB’s) provide a common language of hazard assessment and exposure control.
  • A band describes a distinct range of OEL’s, grouped so that a single recommendation of exposure control technology can adequately protect employees engaged in a similar task or process
setting an oel
Setting an OEL
  • OEL mg/m3 =
  • NOEL (mg/kg-day) x 50 kg x α
  • 10m3 x β x UF
  • Where:
  • α= bioavailability in test species
  • β= bioavailability in exposed workers
  • 10m3 = assumed 8-hr ventilation rate
  • Uncertainty Factors:
  • 10X Interspecies Variation
  • 10X Sub-Chronic to Chronic
  • 10X LOEL to NOEL
future of control banding
Future of Control Banding
  • Nanotechnology
  • Banding where no PEL
  • Simple yet precise
  • Further assistance to international SME’s
  • Further benchmarking of specific process activities and dust exposures

Elements of a Comprehensive Occupational Health Program

  • Compound hazard rating scheme
  • General and specific guidance in handling
  • Occupational Exposure Limits (OELs)
  • Sensitive IH analytical methods
  • IH exposure assessment
  • Control plan
  • Awareness training
  • Medical surveillance
  • AIHA: Guidance for Conducting Control Banding Analyses
  • COSHH Essentials
  • ILO Chemical Control Toolkit (2006)