Susan Ripple, MS, CIH, Fellow
Global Manager – Industrial Hygiene
The Dow Chemical Company
Midland, MI

 Value of Occupational Exposure Bands (OEB) to supplement other authoritative OELs
 Value of OEBs to the industrial hygiene process
(ERAM)
 OEB Framework
 Exposure Risk Assessment & Management
(ERAM)

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Risk Assessment
(Qualitative or Quantitative)

Risk Management

 “ERAM is a concise framework to help illustrate the core skills of the industrial hygiene profession.
Taken at a high level, ERAM is the anticipation, recognition, evaluation and control of chemical, physical and biological hazards to prevent illness and injury in workers, customers and communities.”
 It is the science of understanding and managing human exposure risks.

 ERAM is the core competency of IH. Owning the science of ERAM both strengthens our CORE and expands our market opportunities.
 ERAM is an important skill set needed for parts of…
▪ Sustainability
▪ Product Stewardship
▪ EHS Management
 When we are viewed as being ERAM experts, these
Allied Professions will put a higher value on our services. This creates greater need for internal and external IH Consultants

IH
Expert
IH Generalist
EHS Generalist
Affiliated Professionals
Level of
ERAM
Expertise

Percent of ERAM needed in job
100%
IH
Expert
IH Generalist
50-100%
5-50%
EHS Generalist
Affiliated Professionals 1-15%

Exposure Management
Exposure risk assessment knowledge gaps
(Controls & Programs)
<2000 OELs
<2% REACH
HAZARD
Assessment
EXPOSURE
Assessment
Chemicals with OELs
Occupational
Exposure
Bands (OEBs)
& Exposure
Limits (OELs)
Occupational
Health Hazard
Criteria & Process
~21,000,000 commercialavailable chemicals; >107,000
REACH
Exposure Risk
Assessment
( modeling, monitoring, analogy)
Courtesy of
Elizabeth Pullen and ERAM
Working Group
IH Expertise
Understanding
Exposure & Controls
“Exposure Gap”



 But…only ~ 500 PELs, ~ 650 RELs, ~
125 WEELs, ~ 650 TLVs
*REACH – Registration, Evaluation, Authorization, and Restriction of Chemicals




*REACH – Registration, Evaluation, Authorization, and Restriction of Chemicals

 Hygienists prefer the more official peerreviewed Traditional OELs ,

14

 Occupational Exposure Banding provides a mechanism for the evaluation of hazard and risk to offset the misconceptions by employers and workers that a substance must be non-toxic if there is not an OEL!
MIHS

 “Hazard banding is simply the first step in the
control banding process”
Susan D. Ripple. The Synergist: October 2009
 “Occupational Exposure Bands” are a more appropriate description of Hazard Grouping or
Hazard Banding
Donna Heidel and Susan Ripple. The Synergist: April 2012
BOHS OEL-Setting Plenary





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Facilitates more rapid evaluation of health risk & provides guidance for many materials without OELs
Highlights areas where data are missing (highlights uncertainties)
Identifies hazards to be evaluated for elimination or substitution
Aligned with GHS for hazard communication
Supports the definition of OEL-ranges for families of materials

1.
2.
3.
4.
5.
6.
Establish minimum viable dataset, including data quality requirements
Establish process and decision logic
Validate data endpoints and band cut points, process, and decision logic
Identify data sources
Develop NIOSH guidance
Educate stakeholders

 Criteria include qualitative, semi-quantitative, and quantitative data for each toxicological endpoint
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Acute toxicity
Skin corrosion/irritation
Serious eye damage/eye irritation
Respiratory and skin sensitization
Germ cell mutagenicity
Carcinogenicity
Specific target organ toxicity, both single and repeated exposure
Reproductive toxicity

 OEB toxicological endpoints are aligned with
GHS classification and labeling system*
 Important goal is to relate potency of each toxicological hazard-banding endpoint to
GHS hazard statements and categories, when possible
 Data quality is also considered

Band
Signal Word
A
Warning
> 1,000 µg/m 3
B
Warning
C (default)
Danger
> 100 and < 1,000 µg/m 3 > 10 and < 100 µg/m 3
D
Danger
> 1 and < 10 µg/m 3
E
Danger
< 1 µg/m 3
OEL Ranges
Examples of Health
Outcomes and
Potency
Considerations
Minor, reversible health effects occurring at high doses. Skin and eye irritation.
Examples of GHS
Hazard Statements and Hazard
Categories
> 1000 ppm
May cause drowsiness or dizziness
> 100 - < 1000 ppm > 10 - < 100 ppm > 1 - < 10 ppm < 1 ppm
Reversible organ toxicity, skin and eye corrosion
(reversible), possible dermal sensitizer at high doses.
Irreversible organ toxicity at high doses, irreversible skin and eye corrosion, dermal sensitizer at moderate doses.
Irreversible organ toxicity at low doses, in vivo genotoxicity, dermal sensitizer at low doses, evidence of mutagenicity, potential developmental and reproductive toxicants.
Human carcinogens at low doses, respiratory sensitization
Harmful if inhaled (4).
Harmful in contact with skin (4).
Toxic if inhaled (3).
Toxic in contact with skin (3). Suspected of causing cancer (2).
May cause damage to organs (2)
Fatal if inhaled (2).
Fatal in contact with skin (1). Causes damage to organs (1).
May cause cancer (by route of exposure) —1A or B. Presumed or known human reproductive toxicant
(1A or 1B). Causes damage to organs through prolonged or repeated exposure (1)
Fatal if inhaled (1).
Fatal in contact with skin (1). May cause cancer (by route of exposure) —1A. May cause allergy or asthma symptoms or breathing difficulties if inhaled (1A resp.).
Known human repro toxicant (1A). Causes damage to organs through prolonged or repeated exposure (1)

MIHS

A B
A B
C
C D
D-E
E
A B C D E
A B C D E
Tier 1a—Qualitative
Use GHS Hazard Phrases to identify chemicals with potential for irreversible health effects at relatively low doses (Band
D-E) or remain at default Band C
Tier 1b—Semi-quantitative
Use GHS Hazard Categories to assign chemicals into Bands D or E or remain at default Band C
Tier 2—Quantitative
Determine point of departure, factoring data availability, hierarchy, and quality to support assigning chemicals into Bands
A, B, or C
Tier 3—Weight of Evidence
Involves integration of all available data and determining the degree of conviction of the outcome.

• Tier 1 a & b: GHS hazard code or statement from SDS or the preferred GHS database (Annex VI, REACH, GESTIS, etc.).
Hazard category will further define Bands D and E
— User: H&S generalist; may overestimate risk
Warning – negative results vs. absence of data
• Tier 2: quantitative data from authoritative sources
— User: skilled industrial hygienist
• Tier 3: toxicological weight of evidence – determine the critical study from which a scientifically sound point of departure (POD) can be determined
— User: toxicologist or experienced industrial hygienist

Chemical for
OEB
Tier 1 a & b
Identify Bands D-E from Default Band C
Authoritative
OEL available?
no
Health statements available?
yes
D or E statement?
yes
Band D-E assigned yes no no
No OEB necessary
Band C default assigned
Band C default assigned
Tier 2 process to determine
Band A or B
Need to define
Band D vs.
E?
yes
Review available
Hazard categories no
Remain at Band
D-E
E Hazard categories
?
no
D Hazard categories
?
yes
Assign Band E yes
Assign Band D

 Using GHS hazard statements or codes (qualitative hazard banding), for most criteria, cannot separate the “D” from the “E” bands
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Acute toxicity H codes: H300, H330, H310
Sensitization H code: H334
Germ cell mutagenicity: H340
Carcinogenicity: H350
Toxic to reproduction: H360f, H360d, or H360fd
STOT(RE): H372
 Using the GHS hazard category and/or a Tier II process will be required to separate D from E

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
1-bromopropane
TIER 1a
 Signal word: danger
 H360FD: May damage fertility or the unborn child (D or E)
▪ OSHA-GHS: Presumed human reproductive toxicant
 H373: May cause damage to organs through prolonged or repeated exposure
(STOT-RE-2)
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H319: Causes serious eye irritation
H335: May cause respiratory irritation
H315: Causes skin irritation
H336: May cause drowsiness or dizziness
TIER 1a outcome: Band D-E
TIER 1b
 Hazard Category Repro 1B
Tier 1b outcome: Band D: (1-10 ppm)
 TLV: 10 ppm

• OEB based on point of departure (POD) at which adverse effects are observed o LD50 (oral and dermal) or LC50 (inhalation) for acute toxicity data; o RD50 (in mice) for sensory irritation; o Irritation threshold (mice, rats or human volunteers) for irritation; o NOAEL, BMDL or LOAEL for target organ systemic toxicity, developmental/reproductive toxicity; and o CSFs, IUR, TD
05
/TC
05
, NSRLs (CalEPA Prop 65) of tumorigenic doses for carcinogenicity (still being investigated)

Tier 1 Process results in Band C
Endpoint PODs from authoritative reviews
Score data quality and relevance
Establish Total
Determinant
Score (TDS)
Can Band A or B be considered?
Does TDS exceed threshold for minimum, quality dataset?
yes
Establish OEB no Data insufficient for OEB, “C” default band
TDS reflects the availability of qualitative info and/or quantitative data for each endpoint under consideration. Endpoint scores include data relevance and quality factors. TDS is the sum of the endpoint scores.

Endpoint
LD50 (Oral)
LD50 (Dermal)
Acute Toxicity
LC50 (Gases)
LC50 (Vapors)
LC50
(Dusts/mists)
Skin Corrosion / Irritation
Serious Eye Damage
Eye Damage / Irritation
Respiratory Sensitization
Skin Sensitization
Germ Cell Mutagenicity
Carcinogenicity
Reproduction
Specific Target Organ (Single
Exposure)
Specific Target Organ (Repeated
Exposure)
A B
Bands
C D E Quality
Data
Relevance
Total Overall

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Finalize criteria for each band, including weight of evidence and dose-response considerations
Develop process, decision logic, and algorithms
Validate process and tools
Develop stakeholder education materials and guidance document
Identify data sources

 NIOSH guidance
 Overall process, including the decision logic
 Tools to facilitate finding and evaluating hazard data and assign chemicals to hazard bands
 Education materials for H&S professionals, managers, and workers

MIHS

Hazard group
A -Skin and eye irritants
B - Harmful on single exposure
C -Severely irritating & corrosive, skin sensitizers
D -Very toxic on single exposure, reproductive hazard
E - Carcinogen, occupational asthma
S: Skin and eye contact
Target airborne concentration range for
Control Banding
>1-10 mg/m ppm vapor
3 dust or >50-500
>01-1 mg/m 3 dust or >5-50 ppm vapor
>0.01-0.1 mg/m 3 dust or >0.5-5 ppm vapor
< 0.01 mg/m 3 dust or < 0 5 ppm vapor
Seek Specialist Advice
Prevention or reduction of skin and/or eye exposure
B - E
39/23/24/25;
R phrases*
36; 38; 36/38; 65;66; All substances that do not have R phrases in groups
20; 20/21; 20/21/22; 20/22; 21; 21/22;
22; 40/20/21/22;33;67
23; 23/24; 23/24/25; 23/25; 24; 24/25;
25; 34; 35; 36/37; 36/37/38; 37; 37/38;
41; 43; 48/20; 48/20/21; 48/20/21/22;
48/20/22; 48/21; 48/21/22; 48/22;
26; 26/27; 26/27/28; 26/28; 27; 27/28;
28; Carc Cat 3 R40; 48/23; 48/23/24;
48/23/24/25; 48/23/25; 48/24;
48/24/25; 48/25; 60; 61; 62; 63;
39/26/27/28
Muta Cat 3 R40; 42; 42/43; 45; 46;
49; 68
21; 24; 27; 34; 35; 36; 38; 41; 43;
48/21; 48/24;
39/24;39/27;40/21;66;plus R -phrase combinations containing these. Sk
GHS Hazard Classification (class/level)
Acute toxicity (lethality), any route, class 5;
Skin irritancy class 2 or 3;
Eye irritancy class 2;
All dusts and vapors not allocated to another band
Acute toxicity (lethality), any route, class 4;
Acute toxicity (systemic), any route, class 2
Acute toxicity (lethality), any route, class 3;
Acute toxicity (systemic), any route, class 1;
Corrosivity, subclass 1A, 1B or 1C; Eye irritancy class 1;
Respiratory system irritancy (GHS criteria to be agreed);
Skin sensitization;
Repeated exposure toxicity, any route, class 2
Acute toxicity (lethality), any route, class 1 or 2;
Carcinogenicity class 2;
Repeated exposure toxicity, any route, class 1;
Reproductive toxicity class 1 or 2
Mutagenicity class 1 or 2; Carcinogenicity class 1;
Respiratory sensitization
Acute toxicity (lethality), dermal only, class 1, 2, 3 or 4;
Acute toxicity (systemic), dermal only, class 1 or 2;
Corrosivity, subclass 1A, 1B or 1C; Skin irritation class 2;
Eye irritation class 1 or 2;
Skin sensitization;
Repeated exposure toxicity, dermal only, class 1 or 2
MIHS

MIHS

 Hazard Bands are screening level hazard groups, often based on limited data.
 One of the critical limitations to the use of
Hazard Banding has been the lack of standardization of hazard phrases in MSDSs and the lack of expertise to translate those phrases into hazard groups by nontoxicologists.
MIHS

 Since Hazard Banding is a preliminary attempt to categorize the relative hazards of the substance to assist OEHS personnel to assign the right controls such as ventilation and PPE, lack of the ability to categorize the hazards can seem insurmountable.
MIHS

 But, where this data exists, it is helpful to compare the relative hazard risk to other more well characterized substances.
 Another concern is when a substance is a solid particle or aerosol, the same dilemma exists as often exists for setting an OEL since there is rarely sufficient inhalation toxicology data for these substances.
MIHS

Most Extensive Data Requirements
( human epidemiology studies)
> quality
> certainty
Moderate Data
Requirements
(human data & insight )
> quality
> certainty
Traditional OELs
• Regulatory, Authoritative
• Health-based
(TLVs, MAKs, WEELs, PELs, MACs,
RELs)
Working Provisional OELs
(internal company, trade association, vendor limits)
Hierarchy of OELs
As more toxicological and epidemiological data becomes available, we move up the hierarchy of OELs.
multiple animal studies
Prescriptive Process Based OELs
(REACH DNELs/DMELs)
Hazard Banding Strategies = Occupational Exposure Bands (OEBs)
• Biosafety Levels (1,2,3,4)
Least Data
Requirements
• Pharmaceutical Banding
• WEEL-Banding Matrix
( in vitro , SAR ( in silico ) & few EPA SNUR New Chemical Exposure Limits Potential animal studies)
Health Hazard
(NCEL)

Hierarchy of
OELs / Banding
Strategies
Traditional OEL
Working OEL
DNEL / DMEL
(Prescriptive)
Hazard Banding
Hierarchy of
Exposure
Controls
Elimination of
Hazards
Engineering
Controls
Administrative
Controls
PPE
Hierarchy of
Exposure
Assessment
Validated Monitoring
Monitoring
Modeling
Qualitative

Susan Ripple, MS, CIH
Manager
Industrial Hygiene Expertise Center
The Dow Chemical Co.
Midland, MI sdripple@dow.com
MIHS